Completion axillary lymph node dissection for the identification of pN2–3 status as an indication for adjuvant CDK4/6 inhibitor treatment: a post-hoc analysis of the randomised, phase 3 SENOMAC trial
In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can rev...
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| Published in | The lancet oncology Vol. 25; no. 9; pp. 1222 - 1230 |
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| Main Authors | , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Elsevier Ltd
01.09.2024
Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1470-2045 1474-5488 1474-5488 |
| DOI | 10.1016/S1470-2045(24)00350-4 |
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| Abstract | In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2–3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial.
In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1–T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1–2, histological grade 1–2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing.
Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52–71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6–59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ2 test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery.
As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose.
Swedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association. |
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| AbstractList | In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2-3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial.BACKGROUNDIn luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2-3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial.In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1-T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1-2, histological grade 1-2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing.METHODSIn the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1-T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1-2, histological grade 1-2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing.Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52-71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6-59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ2 test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery.FINDINGSBetween Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52-71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6-59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ2 test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery.As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose.INTERPRETATIONAs a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose.Swedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association.FUNDINGSwedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association. In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2-3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial. In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1-T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1-2, histological grade 1-2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing. Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52-71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6-59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery. As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose. Swedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association. In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2–3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial. In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1–T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1–2, histological grade 1–2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing. Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52–71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6–59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ2 test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery. As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose. Swedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association. Background: In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2–3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial. Methods: In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1–T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1–2, histological grade 1–2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing. Findings: Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52–71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6–59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ2 test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery. Interpretation: As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose. Funding: Swedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association. Background: In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2–3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial. Methods: In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1–T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1–2, histological grade 1–2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing. Findings: Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52–71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6–59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ2 test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery. Interpretation: As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose. Funding: Swedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association. Summary Background In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2–3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial. Methods In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1–T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1–2, histological grade 1–2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing. Findings Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52–71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6–59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ2 test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery. Interpretation As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose. Funding Swedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association. SummaryBackgroundIn luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2–3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial. MethodsIn the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1–T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1–2, histological grade 1–2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing. FindingsBetween Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52–71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6–59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ 2 test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery. InterpretationAs a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose. FundingSwedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association. Background In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2-3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial. Methods In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1-T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post- hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2negative, T1-2, histological grade 1-2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing. Findings Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52-71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45.2 months (IQR 25.6-59.8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (chi(2) test p<0.0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery. Interpretation As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose. Background: In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2-3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial. Methods: In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1-T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post- hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2negative, T1-2, histological grade 1-2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing. Findings: Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52-71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45.2 months (IQR 25.6-59.8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (chi(2) test p<0.0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery. Interpretation: As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose. |
| Author | Alkner, Sara Kontos, Michalis Filtenborg Tvedskov, Tove Gentilini, Oreste Davide de Boniface, Jana Bergkvist, Leif Kühn, Thorsten Christiansen, Peer Olofsson Bagge, Roger Rydén, Lisa Lundstedt, Dan Offersen, Birgitte Vrou Szulkin, Robert Frisell, Jan Reimer, Toralf Sund, Malin Andersson, Yvette Appelgren, Matilda |
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| CitedBy_id | crossref_primary_10_1016_j_breast_2025_104453 crossref_primary_10_1016_j_lanepe_2024_101083 crossref_primary_10_3390_cancers16173072 crossref_primary_10_1056_NEJMoa2412063 crossref_primary_10_1055_a_2509_5739 crossref_primary_10_1055_a_2519_2132 crossref_primary_10_3389_or_2024_1495133 crossref_primary_10_1016_S1470_2045_24_00385_1 crossref_primary_10_1055_a_2409_6735 |
| Cites_doi | 10.1200/JCO.22.01565 10.1016/S1470-2045(14)70460-7 10.1200/JCO.20.02514 10.1002/bjs.9401 10.1136/bmj.317.7168.1309 10.1136/bmj.310.6977.452 10.1001/jama.2017.11470 10.1200/JCO.22.00173 10.1200/JCO.21.02742 10.1002/cncr.35136 10.1056/NEJMoa2305488 10.1016/S1470-2045(23)00165-1 10.1245/s10434-022-11866-w 10.1016/j.annonc.2021.09.015 10.1056/NEJM198806303182605 10.1038/s41416-024-02580-3 10.1186/s12885-017-3361-y 10.2522/ptj.20100087 10.1016/S1470-2045(22)00694-5 10.1016/j.breast.2022.02.013 10.1001/jama.2011.90 10.1016/j.ejso.2016.12.011 10.1056/NEJMoa2313487 10.1200/JCO.23.01994 |
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| CorporateAuthor | SENOMAC Trialists’ Group Bröstcancerkirurgi LUCC: Lunds universitets cancercentrum Kirurgi, Lund Övriga starka forskningsmiljöer Bröstcancerbehandling Section V Institutionen för kliniska vetenskaper, Lund Lunds universitet Profile areas and other strong research environments Lund University Sektion V Breast Cancer Surgery Breast cancer treatment Department of Clinical Sciences, Lund Section I Other Strong Research Environments Faculty of Medicine Surgery (Lund) Sektion I Medicinska fakulteten LUCC: Lund University Cancer Centre Profilområden och andra starka forskningsmiljöer The Liquid Biopsy och Tumörprogression i Bröstcancer The Liquid Biopsy and Tumor Progression in Breast Cancer |
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| References | Cook, Sackett (bib17) 1995; 310 Johnston, Harbeck, Hegg (bib20) 2020; 38 Meirson, Goldstein, Gyawali, Tannock (bib22) 2023; 24 Sackey, Magnuson, Sandelin (bib26) 2014; 101 Rastogi, O’Shaughnessy, Martin (bib7) 2024; 42 Williams, Ruth, Shaikh (bib11) 2024; 130 Giuliano, Ballman, McCall (bib2) 2017; 318 Sávolt, Péley, Polgár (bib3) 2017; 43 Gaillard, Piketty, Feron (bib21) 2024; 130 Giuliano, Hunt, Ballman (bib25) 2011; 305 Harbeck, Rastogi, Martin (bib9) 2021; 32 Tinterri, Gentile, Gatzemeier (bib4) 2022; 29 Donker, van Tienhoven, Straver (bib5) 2014; 15 Laupacis, Sackett, Roberts (bib18) 1988; 318 de Boniface, Filtenborg Tvedskov, Rydén (bib12) 2024; 390 Devoogdt, Van Kampen, Geraerts, Coremans, Christiaens (bib16) 2011; 91 Mittendorf, King, Tolaney (bib10) 2022; 40 Johnston, Toi, O’Shaughnessy (bib6) 2023; 24 Bartels, Donker, Poncet (bib1) 2023; 41 Altman (bib19) 1998; 317 bib24 Royce, Osgood, Mulkey (bib23) 2022; 40 de Boniface, Frisell, Andersson (bib14) 2017; 17 Devoogdt, Van Kampen, Geraerts, Coremans, Christiaens (bib15) 2011; 91 Slamon, Lipatov, Nowecki (bib8) 2024; 390 Appelgren, Sackey, Wengström (bib13) 2022; 63 Donker (10.1016/S1470-2045(24)00350-4_bib5) 2014; 15 Sávolt (10.1016/S1470-2045(24)00350-4_bib3) 2017; 43 de Boniface (10.1016/S1470-2045(24)00350-4_bib12) 2024; 390 Harbeck (10.1016/S1470-2045(24)00350-4_bib9) 2021; 32 Cook (10.1016/S1470-2045(24)00350-4_bib17) 1995; 310 Royce (10.1016/S1470-2045(24)00350-4_bib23) 2022; 40 Johnston (10.1016/S1470-2045(24)00350-4_bib6) 2023; 24 Giuliano (10.1016/S1470-2045(24)00350-4_bib2) 2017; 318 Devoogdt (10.1016/S1470-2045(24)00350-4_bib16) 2011; 91 Mittendorf (10.1016/S1470-2045(24)00350-4_bib10) 2022; 40 Giuliano (10.1016/S1470-2045(24)00350-4_bib25) 2011; 305 Bartels (10.1016/S1470-2045(24)00350-4_bib1) 2023; 41 Laupacis (10.1016/S1470-2045(24)00350-4_bib18) 1988; 318 Appelgren (10.1016/S1470-2045(24)00350-4_bib13) 2022; 63 Rastogi (10.1016/S1470-2045(24)00350-4_bib7) 2024; 42 Slamon (10.1016/S1470-2045(24)00350-4_bib8) 2024; 390 Altman (10.1016/S1470-2045(24)00350-4_bib19) 1998; 317 Sackey (10.1016/S1470-2045(24)00350-4_bib26) 2014; 101 Devoogdt (10.1016/S1470-2045(24)00350-4_bib15) 2011; 91 de Boniface (10.1016/S1470-2045(24)00350-4_bib14) 2017; 17 Tinterri (10.1016/S1470-2045(24)00350-4_bib4) 2022; 29 Meirson (10.1016/S1470-2045(24)00350-4_bib22) 2023; 24 Gaillard (10.1016/S1470-2045(24)00350-4_bib21) 2024; 130 Williams (10.1016/S1470-2045(24)00350-4_bib11) 2024; 130 Johnston (10.1016/S1470-2045(24)00350-4_bib20) 2020; 38 40405964 - Gland Surg. 2025 Apr 30;14(4):781-784. doi: 10.21037/gs-2025-34. 40405951 - Gland Surg. 2025 Apr 30;14(4):776-780. doi: 10.21037/gs-2025-38. 40771385 - Gland Surg. 2025 Jul 31;14(7):1183-1186. doi: 10.21037/gs-2025-178. |
| References_xml | – volume: 38 start-page: 3987 year: 2020 end-page: 3998 ident: bib20 article-title: Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE) publication-title: J Clin Oncol – ident: bib24 article-title: Verzenios (abemaciclib). Amsterdam: 2022 – volume: 130 start-page: 1052 year: 2024 end-page: 1060 ident: bib11 article-title: Should patients with hormone receptor-positive, HER2-negative breast cancer and one or two positive sentinel nodes undergo axillary dissection to determine candidacy for adjuvant abemaciclib? publication-title: Cancer – volume: 130 start-page: 1141 year: 2024 end-page: 1148 ident: bib21 article-title: Rethinking surgical revisions: impact of the MonarchE trial on axillary dissection in hormone-positive HER2-negative early breast cancer patients potentially eligible for abemaciclib publication-title: Br J Cancer – volume: 24 start-page: 77 year: 2023 end-page: 90 ident: bib6 article-title: Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial publication-title: Lancet Oncol – volume: 29 start-page: 5732 year: 2022 end-page: 5744 ident: bib4 article-title: Preservation of axillary lymph nodes compared with complete dissection in T1-2 breast cancer patients presenting one or two metastatic sentinel lymph nodes: the SINODAR-ONE multicenter randomized clinical trial publication-title: Ann Surg Oncol – volume: 41 start-page: 2159 year: 2023 end-page: 2165 ident: bib1 article-title: Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial publication-title: J Clin Oncol – volume: 91 start-page: 944 year: 2011 end-page: 957 ident: bib15 article-title: Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity publication-title: Phys Ther – volume: 318 start-page: 1728 year: 1988 end-page: 1733 ident: bib18 article-title: An assessment of clinically useful measures of the consequences of treatment publication-title: N Engl J Med – volume: 32 start-page: 1571 year: 2021 end-page: 1581 ident: bib9 article-title: Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study publication-title: Ann Oncol – volume: 390 start-page: 1080 year: 2024 end-page: 1091 ident: bib8 article-title: Ribociclib plus endocrine therapy in early breast cancer publication-title: N Engl J Med – volume: 101 start-page: 390 year: 2014 end-page: 397 ident: bib26 article-title: Arm lymphoedema after axillary surgery in women with invasive breast cancer publication-title: Br J Surg – volume: 42 start-page: 987 year: 2024 end-page: 993 ident: bib7 article-title: Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, High-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes publication-title: J Clin Oncol – volume: 305 start-page: 569 year: 2011 end-page: 575 ident: bib25 article-title: Axillary dissection publication-title: JAMA – volume: 40 start-page: 3361 year: 2022 end-page: 3364 ident: bib10 article-title: Impact of RxPONDER and monarchE on the surgical management of the axilla in patients with breast cancer publication-title: J Clin Oncol – volume: 17 start-page: 379 year: 2017 ident: bib14 article-title: Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial publication-title: BMC Cancer – volume: 40 start-page: 1155 year: 2022 end-page: 1162 ident: bib23 article-title: FDA approval summary: abemaciclib with endocrine therapy for high-risk early breast cancer publication-title: J Clin Oncol – volume: 318 start-page: 918 year: 2017 end-page: 926 ident: bib2 article-title: Effect of axillary dissection publication-title: JAMA – volume: 310 start-page: 452 year: 1995 end-page: 454 ident: bib17 article-title: The number needed to treat: a clinically useful measure of treatment effect publication-title: BMJ – volume: 91 start-page: 944 year: 2011 end-page: 957 ident: bib16 article-title: Lymphoedema functioning, disability and health questionnaire (Lymph-ICF): reliability and validity publication-title: Phys Ther – volume: 317 start-page: 1309 year: 1998 end-page: 1312 ident: bib19 article-title: Confidence intervals for the number needed to treat publication-title: BMJ – volume: 15 start-page: 1303 year: 2014 end-page: 1310 ident: bib5 article-title: Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial publication-title: Lancet Oncol – volume: 390 start-page: 1163 year: 2024 end-page: 1175 ident: bib12 article-title: Omitting axillary dissection in breast cancer with sentinel-node metastases publication-title: N Engl J Med – volume: 43 start-page: 672 year: 2017 end-page: 679 ident: bib3 article-title: Eight-year follow up result of the OTOASOR trial: the optimal treatment of the axilla - surgery or radiotherapy after positive sentinel lymph node biopsy in early-stage breast cancer: a randomized, single centre, phase III, non-inferiority trial publication-title: Eur J Surg Oncol – volume: 63 start-page: 16 year: 2022 end-page: 23 ident: bib13 article-title: Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial publication-title: Breast – volume: 24 start-page: 589 year: 2023 end-page: 593 ident: bib22 article-title: Review of the monarchE trial suggests no evidence to support use of adjuvant abemaciclib in women with breast cancer publication-title: Lancet Oncol – volume: 41 start-page: 2159 year: 2023 ident: 10.1016/S1470-2045(24)00350-4_bib1 article-title: Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial publication-title: J Clin Oncol doi: 10.1200/JCO.22.01565 – volume: 15 start-page: 1303 year: 2014 ident: 10.1016/S1470-2045(24)00350-4_bib5 article-title: Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial publication-title: Lancet Oncol doi: 10.1016/S1470-2045(14)70460-7 – volume: 38 start-page: 3987 year: 2020 ident: 10.1016/S1470-2045(24)00350-4_bib20 article-title: Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE) publication-title: J Clin Oncol doi: 10.1200/JCO.20.02514 – volume: 101 start-page: 390 year: 2014 ident: 10.1016/S1470-2045(24)00350-4_bib26 article-title: Arm lymphoedema after axillary surgery in women with invasive breast cancer publication-title: Br J Surg doi: 10.1002/bjs.9401 – volume: 317 start-page: 1309 year: 1998 ident: 10.1016/S1470-2045(24)00350-4_bib19 article-title: Confidence intervals for the number needed to treat publication-title: BMJ doi: 10.1136/bmj.317.7168.1309 – volume: 310 start-page: 452 year: 1995 ident: 10.1016/S1470-2045(24)00350-4_bib17 article-title: The number needed to treat: a clinically useful measure of treatment effect publication-title: BMJ doi: 10.1136/bmj.310.6977.452 – volume: 318 start-page: 918 year: 2017 ident: 10.1016/S1470-2045(24)00350-4_bib2 article-title: Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) randomized clinical trial publication-title: JAMA doi: 10.1001/jama.2017.11470 – volume: 40 start-page: 3361 year: 2022 ident: 10.1016/S1470-2045(24)00350-4_bib10 article-title: Impact of RxPONDER and monarchE on the surgical management of the axilla in patients with breast cancer publication-title: J Clin Oncol doi: 10.1200/JCO.22.00173 – volume: 40 start-page: 1155 year: 2022 ident: 10.1016/S1470-2045(24)00350-4_bib23 article-title: FDA approval summary: abemaciclib with endocrine therapy for high-risk early breast cancer publication-title: J Clin Oncol doi: 10.1200/JCO.21.02742 – volume: 130 start-page: 1052 year: 2024 ident: 10.1016/S1470-2045(24)00350-4_bib11 article-title: Should patients with hormone receptor-positive, HER2-negative breast cancer and one or two positive sentinel nodes undergo axillary dissection to determine candidacy for adjuvant abemaciclib? publication-title: Cancer doi: 10.1002/cncr.35136 – volume: 390 start-page: 1080 year: 2024 ident: 10.1016/S1470-2045(24)00350-4_bib8 article-title: Ribociclib plus endocrine therapy in early breast cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa2305488 – volume: 24 start-page: 589 year: 2023 ident: 10.1016/S1470-2045(24)00350-4_bib22 article-title: Review of the monarchE trial suggests no evidence to support use of adjuvant abemaciclib in women with breast cancer publication-title: Lancet Oncol doi: 10.1016/S1470-2045(23)00165-1 – volume: 29 start-page: 5732 year: 2022 ident: 10.1016/S1470-2045(24)00350-4_bib4 article-title: Preservation of axillary lymph nodes compared with complete dissection in T1-2 breast cancer patients presenting one or two metastatic sentinel lymph nodes: the SINODAR-ONE multicenter randomized clinical trial publication-title: Ann Surg Oncol doi: 10.1245/s10434-022-11866-w – volume: 32 start-page: 1571 year: 2021 ident: 10.1016/S1470-2045(24)00350-4_bib9 article-title: Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study publication-title: Ann Oncol doi: 10.1016/j.annonc.2021.09.015 – volume: 318 start-page: 1728 year: 1988 ident: 10.1016/S1470-2045(24)00350-4_bib18 article-title: An assessment of clinically useful measures of the consequences of treatment publication-title: N Engl J Med doi: 10.1056/NEJM198806303182605 – volume: 130 start-page: 1141 year: 2024 ident: 10.1016/S1470-2045(24)00350-4_bib21 article-title: Rethinking surgical revisions: impact of the MonarchE trial on axillary dissection in hormone-positive HER2-negative early breast cancer patients potentially eligible for abemaciclib publication-title: Br J Cancer doi: 10.1038/s41416-024-02580-3 – volume: 17 start-page: 379 year: 2017 ident: 10.1016/S1470-2045(24)00350-4_bib14 article-title: Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial publication-title: BMC Cancer doi: 10.1186/s12885-017-3361-y – volume: 91 start-page: 944 year: 2011 ident: 10.1016/S1470-2045(24)00350-4_bib16 article-title: Lymphoedema functioning, disability and health questionnaire (Lymph-ICF): reliability and validity publication-title: Phys Ther doi: 10.2522/ptj.20100087 – volume: 24 start-page: 77 year: 2023 ident: 10.1016/S1470-2045(24)00350-4_bib6 article-title: Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial publication-title: Lancet Oncol doi: 10.1016/S1470-2045(22)00694-5 – volume: 91 start-page: 944 year: 2011 ident: 10.1016/S1470-2045(24)00350-4_bib15 article-title: Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity publication-title: Phys Ther doi: 10.2522/ptj.20100087 – volume: 63 start-page: 16 year: 2022 ident: 10.1016/S1470-2045(24)00350-4_bib13 article-title: Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial publication-title: Breast doi: 10.1016/j.breast.2022.02.013 – volume: 305 start-page: 569 year: 2011 ident: 10.1016/S1470-2045(24)00350-4_bib25 article-title: Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial publication-title: JAMA doi: 10.1001/jama.2011.90 – volume: 43 start-page: 672 year: 2017 ident: 10.1016/S1470-2045(24)00350-4_bib3 article-title: Eight-year follow up result of the OTOASOR trial: the optimal treatment of the axilla - surgery or radiotherapy after positive sentinel lymph node biopsy in early-stage breast cancer: a randomized, single centre, phase III, non-inferiority trial publication-title: Eur J Surg Oncol doi: 10.1016/j.ejso.2016.12.011 – volume: 390 start-page: 1163 year: 2024 ident: 10.1016/S1470-2045(24)00350-4_bib12 article-title: Omitting axillary dissection in breast cancer with sentinel-node metastases publication-title: N Engl J Med doi: 10.1056/NEJMoa2313487 – volume: 42 start-page: 987 year: 2024 ident: 10.1016/S1470-2045(24)00350-4_bib7 publication-title: J Clin Oncol doi: 10.1200/JCO.23.01994 – reference: 40405951 - Gland Surg. 2025 Apr 30;14(4):776-780. doi: 10.21037/gs-2025-38. – reference: 40405964 - Gland Surg. 2025 Apr 30;14(4):781-784. doi: 10.21037/gs-2025-34. – reference: 40771385 - Gland Surg. 2025 Jul 31;14(7):1183-1186. doi: 10.21037/gs-2025-178. |
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| Snippet | In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2 tumours, and... SummaryBackgroundIn luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade... In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2 tumours, and... Summary Background In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade... Background: In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2... Background: In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2... Background In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2... |
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| SubjectTerms | Adult Aged Aminopyridines - therapeutic use Axilla Benzimidazoles Biopsy Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - pathology Breast Neoplasms - surgery Cancer and Oncology Cancer och onkologi Chemotherapy, Adjuvant Clinical Medicine Clinical outcomes Cyclin-dependent kinase 4 Cyclin-Dependent Kinase 4 - antagonists & inhibitors Cyclin-Dependent Kinase 6 - antagonists & inhibitors Disease-Free Survival Dissection ErbB-2 protein Estrogens Female Hematology, Oncology, and Palliative Medicine Humans Invasiveness Klinisk medicin Lymph Node Excision Lymph nodes Lymphatic Metastasis Lymphatic system Lymphedema Medical and Health Sciences Medicin och hälsovetenskap Metastases Metastasis Middle Aged Morbidity Neoplasm Staging Patients Protein Kinase Inhibitors - therapeutic use Quality of life Questionnaires Radiation therapy Surgery Survival |
| Title | Completion axillary lymph node dissection for the identification of pN2–3 status as an indication for adjuvant CDK4/6 inhibitor treatment: a post-hoc analysis of the randomised, phase 3 SENOMAC trial |
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