Cabozantinib in patients with platinum-refractory metastatic urothelial carcinoma: an open-label, single-centre, phase 2 trial
Cabozantinib is a multikinase inhibitor of MET, VEGFR, AXL, and RET, which also has an effect on the tumour immune microenvironment by decreasing regulatory T cells and myeloid-derived suppressor cells. In this study, we examined the activity of cabozantinib in patients with metastatic platinum-refr...
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Published in | The lancet oncology Vol. 21; no. 8; pp. 1099 - 1109 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
Elsevier Ltd
01.08.2020
Elsevier Limited |
Subjects | |
Online Access | Get full text |
ISSN | 1470-2045 1474-5488 1474-5488 |
DOI | 10.1016/S1470-2045(20)30202-3 |
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Abstract | Cabozantinib is a multikinase inhibitor of MET, VEGFR, AXL, and RET, which also has an effect on the tumour immune microenvironment by decreasing regulatory T cells and myeloid-derived suppressor cells. In this study, we examined the activity of cabozantinib in patients with metastatic platinum-refractory urothelial carcinoma.
This study was an open-label, single-arm, three-cohort phase 2 trial done at the National Cancer Institute (Bethesda, MD, USA). Eligible patients were 18 years or older, had histologically confirmed urothelial carcinoma or rare genitourinary tract histologies, Karnofsky performance scale index of 60% or higher, and documented disease progression after at least one previous line of platinum-based chemotherapy (platinum-refractory). Cohort one included patients with metastatic urothelial carcinoma with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Two additional cohorts that enrolled in parallel (patients with bone-only urothelial carcinoma metastases and patients with rare histologies of the genitourinary tract) were exploratory. Patients received cabozantinib 60 mg orally once daily in 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed objective response rate by RECIST in cohort one. Response was assessed in all patients who met the eligibility criteria and who received at least 8 weeks of therapy. All patients who received at least one dose of cabozantinib were included in the safety analysis. This completed study is registered with ClinicalTrials.gov, NCT01688999.
Between Sept 28, 2012, and Oct, 20, 2015, 68 patients were enrolled on the study (49 in cohort one, six in cohort two, and 13 in cohort three). All patients received at least one dose of cabozantinib. The median follow-up was 61·2 months (IQR 53·8–70·0) for the 57 patients evaluable for response. In the 42 evaluable patients in cohort one, there was one complete response and seven partial responses (objective response rate 19%, 95% CI 9–34). The most common grade 3–4 adverse events were fatigue (six [9%] patients), hypertension (five [7%]), proteinuria (four [6%]), and hypophosphataemia (four [6%]). There were no treatment-related deaths.
Cabozantinib has single-agent clinical activity in patients with heavily pretreated, platinum-refractory metastatic urothelial carcinoma with measurable disease and bone metastases and is generally well tolerated. Cabozantinib has innate and adaptive immunomodulatory properties providing a rationale for combining cabozantinib with immunotherapeutic strategies.
National Cancer Institute Intramural Program and the Cancer Therapy Evaluation Program. |
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AbstractList | SummaryBackgroundCabozantinib is a multikinase inhibitor of MET, VEGFR, AXL, and RET, which also has an effect on the tumour immune microenvironment by decreasing regulatory T cells and myeloid-derived suppressor cells. In this study, we examined the activity of cabozantinib in patients with metastatic platinum-refractory urothelial carcinoma. MethodsThis study was an open-label, single-arm, three-cohort phase 2 trial done at the National Cancer Institute (Bethesda, MD, USA). Eligible patients were 18 years or older, had histologically confirmed urothelial carcinoma or rare genitourinary tract histologies, Karnofsky performance scale index of 60% or higher, and documented disease progression after at least one previous line of platinum-based chemotherapy (platinum-refractory). Cohort one included patients with metastatic urothelial carcinoma with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Two additional cohorts that enrolled in parallel (patients with bone-only urothelial carcinoma metastases and patients with rare histologies of the genitourinary tract) were exploratory. Patients received cabozantinib 60 mg orally once daily in 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed objective response rate by RECIST in cohort one. Response was assessed in all patients who met the eligibility criteria and who received at least 8 weeks of therapy. All patients who received at least one dose of cabozantinib were included in the safety analysis. This completed study is registered with ClinicalTrials.gov, NCT01688999. FindingsBetween Sept 28, 2012, and Oct, 20, 2015, 68 patients were enrolled on the study (49 in cohort one, six in cohort two, and 13 in cohort three). All patients received at least one dose of cabozantinib. The median follow-up was 61·2 months (IQR 53·8–70·0) for the 57 patients evaluable for response. In the 42 evaluable patients in cohort one, there was one complete response and seven partial responses (objective response rate 19%, 95% CI 9–34). The most common grade 3–4 adverse events were fatigue (six [9%] patients), hypertension (five [7%]), proteinuria (four [6%]), and hypophosphataemia (four [6%]). There were no treatment-related deaths. InterpretationCabozantinib has single-agent clinical activity in patients with heavily pretreated, platinum-refractory metastatic urothelial carcinoma with measurable disease and bone metastases and is generally well tolerated. Cabozantinib has innate and adaptive immunomodulatory properties providing a rationale for combining cabozantinib with immunotherapeutic strategies. FundingNational Cancer Institute Intramural Program and the Cancer Therapy Evaluation Program. Summary Background Cabozantinib is a multikinase inhibitor of MET, VEGFR, AXL, and RET, which also has an effect on the tumour immune microenvironment by decreasing regulatory T cells and myeloid-derived suppressor cells. In this study, we examined the activity of cabozantinib in patients with metastatic platinum-refractory urothelial carcinoma. Methods This study was an open-label, single-arm, three-cohort phase 2 trial done at the National Cancer Institute (Bethesda, MD, USA). Eligible patients were 18 years or older, had histologically confirmed urothelial carcinoma or rare genitourinary tract histologies, Karnofsky performance scale index of 60% or higher, and documented disease progression after at least one previous line of platinum-based chemotherapy (platinum-refractory). Cohort one included patients with metastatic urothelial carcinoma with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Two additional cohorts that enrolled in parallel (patients with bone-only urothelial carcinoma metastases and patients with rare histologies of the genitourinary tract) were exploratory. Patients received cabozantinib 60 mg orally once daily in 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed objective response rate by RECIST in cohort one. Response was assessed in all patients who met the eligibility criteria and who received at least 8 weeks of therapy. All patients who received at least one dose of cabozantinib were included in the safety analysis. This completed study is registered with ClinicalTrials.gov, NCT01688999. Findings Between Sept 28, 2012, and Oct, 20, 2015, 68 patients were enrolled on the study (49 in cohort one, six in cohort two, and 13 in cohort three). All patients received at least one dose of cabozantinib. The median follow-up was 61·2 months (IQR 53·8–70·0) for the 57 patients evaluable for response. In the 42 evaluable patients in cohort one, there was one complete response and seven partial responses (objective response rate 19%, 95% CI 9–34). The most common grade 3–4 adverse events were fatigue (six [9%] patients), hypertension (five [7%]), proteinuria (four [6%]), and hypophosphataemia (four [6%]). There were no treatment-related deaths. Interpretation Cabozantinib has single-agent clinical activity in patients with heavily pretreated, platinum-refractory metastatic urothelial carcinoma with measurable disease and bone metastases and is generally well tolerated. Cabozantinib has innate and adaptive immunomodulatory properties providing a rationale for combining cabozantinib with immunotherapeutic strategies. Funding National Cancer Institute Intramural Program and the Cancer Therapy Evaluation Program. Cabozantinib is a multikinase inhibitor of MET, VEGFR, AXL, and RET, which also has an effect on the tumour immune microenvironment by decreasing regulatory T cells and myeloid-derived suppressor cells. In this study, we examined the activity of cabozantinib in patients with metastatic platinum-refractory urothelial carcinoma. This study was an open-label, single-arm, three-cohort phase 2 trial done at the National Cancer Institute (Bethesda, MD, USA). Eligible patients were 18 years or older, had histologically confirmed urothelial carcinoma or rare genitourinary tract histologies, Karnofsky performance scale index of 60% or higher, and documented disease progression after at least one previous line of platinum-based chemotherapy (platinum-refractory). Cohort one included patients with metastatic urothelial carcinoma with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Two additional cohorts that enrolled in parallel (patients with bone-only urothelial carcinoma metastases and patients with rare histologies of the genitourinary tract) were exploratory. Patients received cabozantinib 60 mg orally once daily in 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed objective response rate by RECIST in cohort one. Response was assessed in all patients who met the eligibility criteria and who received at least 8 weeks of therapy. All patients who received at least one dose of cabozantinib were included in the safety analysis. This completed study is registered with ClinicalTrials.gov, NCT01688999. Between Sept 28, 2012, and Oct, 20, 2015, 68 patients were enrolled on the study (49 in cohort one, six in cohort two, and 13 in cohort three). All patients received at least one dose of cabozantinib. The median follow-up was 61·2 months (IQR 53·8-70·0) for the 57 patients evaluable for response. In the 42 evaluable patients in cohort one, there was one complete response and seven partial responses (objective response rate 19%, 95% CI 9-34). The most common grade 3-4 adverse events were fatigue (six [9%] patients), hypertension (five [7%]), proteinuria (four [6%]), and hypophosphataemia (four [6%]). There were no treatment-related deaths. Cabozantinib has single-agent clinical activity in patients with heavily pretreated, platinum-refractory metastatic urothelial carcinoma with measurable disease and bone metastases and is generally well tolerated. Cabozantinib has innate and adaptive immunomodulatory properties providing a rationale for combining cabozantinib with immunotherapeutic strategies. National Cancer Institute Intramural Program and the Cancer Therapy Evaluation Program. Cabozantinib is a multikinase inhibitor of MET, VEGFR, AXL, and RET, which also has an effect on the tumour immune microenvironment by decreasing regulatory T cells and myeloid-derived suppressor cells. In this study, we examined the activity of cabozantinib in patients with metastatic platinum-refractory urothelial carcinoma.BACKGROUNDCabozantinib is a multikinase inhibitor of MET, VEGFR, AXL, and RET, which also has an effect on the tumour immune microenvironment by decreasing regulatory T cells and myeloid-derived suppressor cells. In this study, we examined the activity of cabozantinib in patients with metastatic platinum-refractory urothelial carcinoma.This study was an open-label, single-arm, three-cohort phase 2 trial done at the National Cancer Institute (Bethesda, MD, USA). Eligible patients were 18 years or older, had histologically confirmed urothelial carcinoma or rare genitourinary tract histologies, Karnofsky performance scale index of 60% or higher, and documented disease progression after at least one previous line of platinum-based chemotherapy (platinum-refractory). Cohort one included patients with metastatic urothelial carcinoma with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Two additional cohorts that enrolled in parallel (patients with bone-only urothelial carcinoma metastases and patients with rare histologies of the genitourinary tract) were exploratory. Patients received cabozantinib 60 mg orally once daily in 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed objective response rate by RECIST in cohort one. Response was assessed in all patients who met the eligibility criteria and who received at least 8 weeks of therapy. All patients who received at least one dose of cabozantinib were included in the safety analysis. This completed study is registered with ClinicalTrials.gov, NCT01688999.METHODSThis study was an open-label, single-arm, three-cohort phase 2 trial done at the National Cancer Institute (Bethesda, MD, USA). Eligible patients were 18 years or older, had histologically confirmed urothelial carcinoma or rare genitourinary tract histologies, Karnofsky performance scale index of 60% or higher, and documented disease progression after at least one previous line of platinum-based chemotherapy (platinum-refractory). Cohort one included patients with metastatic urothelial carcinoma with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Two additional cohorts that enrolled in parallel (patients with bone-only urothelial carcinoma metastases and patients with rare histologies of the genitourinary tract) were exploratory. Patients received cabozantinib 60 mg orally once daily in 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed objective response rate by RECIST in cohort one. Response was assessed in all patients who met the eligibility criteria and who received at least 8 weeks of therapy. All patients who received at least one dose of cabozantinib were included in the safety analysis. This completed study is registered with ClinicalTrials.gov, NCT01688999.Between Sept 28, 2012, and Oct, 20, 2015, 68 patients were enrolled on the study (49 in cohort one, six in cohort two, and 13 in cohort three). All patients received at least one dose of cabozantinib. The median follow-up was 61·2 months (IQR 53·8-70·0) for the 57 patients evaluable for response. In the 42 evaluable patients in cohort one, there was one complete response and seven partial responses (objective response rate 19%, 95% CI 9-34). The most common grade 3-4 adverse events were fatigue (six [9%] patients), hypertension (five [7%]), proteinuria (four [6%]), and hypophosphataemia (four [6%]). There were no treatment-related deaths.FINDINGSBetween Sept 28, 2012, and Oct, 20, 2015, 68 patients were enrolled on the study (49 in cohort one, six in cohort two, and 13 in cohort three). All patients received at least one dose of cabozantinib. The median follow-up was 61·2 months (IQR 53·8-70·0) for the 57 patients evaluable for response. In the 42 evaluable patients in cohort one, there was one complete response and seven partial responses (objective response rate 19%, 95% CI 9-34). The most common grade 3-4 adverse events were fatigue (six [9%] patients), hypertension (five [7%]), proteinuria (four [6%]), and hypophosphataemia (four [6%]). There were no treatment-related deaths.Cabozantinib has single-agent clinical activity in patients with heavily pretreated, platinum-refractory metastatic urothelial carcinoma with measurable disease and bone metastases and is generally well tolerated. Cabozantinib has innate and adaptive immunomodulatory properties providing a rationale for combining cabozantinib with immunotherapeutic strategies.INTERPRETATIONCabozantinib has single-agent clinical activity in patients with heavily pretreated, platinum-refractory metastatic urothelial carcinoma with measurable disease and bone metastases and is generally well tolerated. Cabozantinib has innate and adaptive immunomodulatory properties providing a rationale for combining cabozantinib with immunotherapeutic strategies.National Cancer Institute Intramural Program and the Cancer Therapy Evaluation Program.FUNDINGNational Cancer Institute Intramural Program and the Cancer Therapy Evaluation Program. |
Author | Dahut, William L Cao, Liang Lindenberg, Liza Lin, Jeffrey Figg, William D Nadal, Rosa Cordes, Lisa M Dawson, Nancy A Gulley, James L Apolo, Andrea B Raffeld, Mark Sissung, Tristan M Alarcon, Sylvia V Lee, Min-Jung Davarpanah, Nicole N Merino, Maria J Ning, Yangmin M Costello, Rene Lee, Sunmin Lee, Molly M Tomita, Yusuke Yuno, Akira Wright, John J Parnes, Howard L Agarwal, Piyush K Steinberg, Seth M Roy, Arpita Folio, Les R Allette, Kimaada Bottaro, Donald P De Silva, Dinuka Trepel, Jane B |
Author_xml | – sequence: 1 givenname: Andrea B surname: Apolo fullname: Apolo, Andrea B email: andrea.apolo@nih.gov organization: Genitourinary Malignancies Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 2 givenname: Rosa surname: Nadal fullname: Nadal, Rosa organization: Genitourinary Malignancies Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 3 givenname: Yusuke surname: Tomita fullname: Tomita, Yusuke organization: Developmental Therapeutics Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 4 givenname: Nicole N surname: Davarpanah fullname: Davarpanah, Nicole N organization: Genitourinary Malignancies Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 5 givenname: Lisa M surname: Cordes fullname: Cordes, Lisa M organization: Genitourinary Malignancies Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 6 givenname: Seth M surname: Steinberg fullname: Steinberg, Seth M organization: Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA – sequence: 7 givenname: Liang surname: Cao fullname: Cao, Liang organization: Genetics Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 8 givenname: Howard L surname: Parnes fullname: Parnes, Howard L organization: Genitourinary Malignancies Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 9 givenname: Rene surname: Costello fullname: Costello, Rene organization: Genitourinary Malignancies Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 10 givenname: Maria J surname: Merino fullname: Merino, Maria J organization: Laboratory of Pathology, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 11 givenname: Les R surname: Folio fullname: Folio, Les R organization: Radiology and Imaging Sciences, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 12 givenname: Liza surname: Lindenberg fullname: Lindenberg, Liza organization: Molecular Imaging Program, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 13 givenname: Mark surname: Raffeld fullname: Raffeld, Mark organization: Laboratory of Pathology, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 14 givenname: Jeffrey surname: Lin fullname: Lin, Jeffrey organization: Genitourinary Malignancies Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 15 givenname: Min-Jung surname: Lee fullname: Lee, Min-Jung organization: Developmental Therapeutics Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 16 givenname: Sunmin surname: Lee fullname: Lee, Sunmin organization: Developmental Therapeutics Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 17 givenname: Sylvia V surname: Alarcon fullname: Alarcon, Sylvia V organization: Developmental Therapeutics Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 18 givenname: Akira surname: Yuno fullname: Yuno, Akira organization: Developmental Therapeutics Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 19 givenname: Nancy A surname: Dawson fullname: Dawson, Nancy A organization: Lombardi Comprehensive Cancer Center, Medstar Georgetown University Hospital, Washington DC, USA – sequence: 20 givenname: Kimaada surname: Allette fullname: Allette, Kimaada organization: Genitourinary Malignancies Branch, Center for Cancer Research, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 21 givenname: Arpita surname: Roy fullname: Roy, Arpita organization: Urologic Oncology Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 22 givenname: Dinuka surname: De Silva fullname: De Silva, Dinuka organization: Urologic Oncology Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 23 givenname: Molly M surname: Lee fullname: Lee, Molly M organization: Urologic Oncology Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 24 givenname: Tristan M surname: Sissung fullname: Sissung, Tristan M organization: Genitourinary Malignancies Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 25 givenname: William D surname: Figg fullname: Figg, William D organization: Genitourinary Malignancies Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 26 givenname: Piyush K surname: Agarwal fullname: Agarwal, Piyush K organization: Urologic Oncology Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 27 givenname: John J surname: Wright fullname: Wright, John J organization: Genitourinary Malignancies Branch, Center for Cancer Research, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 28 givenname: Yangmin M surname: Ning fullname: Ning, Yangmin M organization: Genitourinary Malignancies Branch, Center for Cancer Research, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 29 givenname: James L surname: Gulley fullname: Gulley, James L organization: Developmental Therapeutics Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 30 givenname: William L surname: Dahut fullname: Dahut, William L organization: Developmental Therapeutics Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 31 givenname: Donald P surname: Bottaro fullname: Bottaro, Donald P organization: Urologic Oncology Branch, Magnuson Clinical Center, Bethesda, MD, USA – sequence: 32 givenname: Jane B surname: Trepel fullname: Trepel, Jane B organization: Developmental Therapeutics Branch, Magnuson Clinical Center, Bethesda, MD, USA |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32645282$$D View this record in MEDLINE/PubMed |
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SubjectTerms | Adult Aged Anilides - therapeutic use Antineoplastic Agents - therapeutic use Axl protein Bladder cancer Cancer therapies Carcinoma, Transitional Cell - drug therapy Chemotherapy Creatinine Drug dosages Drug Resistance, Neoplasm - drug effects FDA approval Female Genitourinary tract Hematology, Oncology, and Palliative Medicine Humans Hypophosphatemia Immune checkpoint inhibitors Immunomodulation Immunomodulators Immunoregulation Immunotherapy Inhibitor drugs Kinases Lymphocytes T Male Metastases Metastasis Middle Aged Patients Phosphatase Platinum Platinum Compounds - therapeutic use Protein Kinase Inhibitors - therapeutic use Proteinuria Pyridines - therapeutic use Radiation therapy Solid tumors Suppressor cells Targeted cancer therapy Thyroid cancer Toxicity Tumors Urologic Neoplasms - drug therapy Urothelial carcinoma Vascular endothelial growth factor receptors |
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