Concurrent Chemotherapy and Pelvic Radiation Therapy Compared With Pelvic Radiation Therapy Alone as Adjuvant Therapy After Radical Surgery in High-Risk Early-Stage Cancer of the Cervix

PURPOSE: To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma. PATIENTS AND METHODS: Patients with clinical stage IA 2 , IB, and IIA carcinoma of the cervix, initia...

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Published in	Journal of clinical oncology Vol. 18; no. 8; pp. 1606 - 1613
Main Authors	Peters, William A., Liu, P.Y., Barrett, Rolland J., Stock, Richard J., Monk, Bradley J., Berek, Jonathan S., Souhami, Luis, Grigsby, Perry, Gordon, William, Alberts, David S.
Format	Journal Article
Language	English
Published	Baltimore, MD American Society of Clinical Oncology 01.04.2000 Lippincott Williams & Wilkins
Subjects	Adult Aged Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Cisplatin - administration & dosage Combined Modality Therapy Disease Progression Female Female genital diseases Fluorouracil - administration & dosage Gynecology. Andrology. Obstetrics Humans Hysterectomy Lymph Node Excision Medical sciences Middle Aged Pelvis - radiation effects Radiotherapy Dosage Radiotherapy, Adjuvant Survival Rate Tumors Uterine Cervical Neoplasms - mortality Uterine Cervical Neoplasms - radiotherapy Uterine Cervical Neoplasms - surgery Uterine Cervical Neoplasms - therapy Antineoplastic agent Human Postoperative Treatment efficiency Early stage Uterine cervix Hysterectomy Malignant tumor Radiotherapy Cisplatin Female genital diseases Lymphadenectomy Chemotherapy Surgery Female Uterine cervix diseases Comparative study Platinum II Complexes
Online Access	Get full text
ISSN	0732-183X 1527-7755
DOI	10.1200/JCO.2000.18.8.1606

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Abstract	PURPOSE: To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma. PATIENTS AND METHODS: Patients with clinical stage IA 2 , IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m 2 and a 96-hour infusion of fluorouracil 1,000 mg/m 2 /d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT. RESULTS: Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P = .003) and 1.96 (P = .007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group. CONCLUSION: The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix.
AbstractList	To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma.PURPOSETo determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma.Patients with clinical stage IA(2), IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m(2) and a 96-hour infusion of fluorouracil 1,000 mg/m(2)/d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT.PATIENTS AND METHODSPatients with clinical stage IA(2), IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m(2) and a 96-hour infusion of fluorouracil 1,000 mg/m(2)/d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT.Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P =.003) and 1.96 (P =. 007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group.RESULTSBetween 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P =.003) and 1.96 (P =. 007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group.The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix.CONCLUSIONThe addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix. To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma. Patients with clinical stage IA(2), IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m(2) and a 96-hour infusion of fluorouracil 1,000 mg/m(2)/d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT. Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P =.003) and 1.96 (P =. 007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group. The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix. PURPOSE: To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma. PATIENTS AND METHODS: Patients with clinical stage IA 2 , IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m 2 and a 96-hour infusion of fluorouracil 1,000 mg/m 2 /d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT. RESULTS: Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P = .003) and 1.96 (P = .007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group. CONCLUSION: The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix.
Author	William Gordon Jr Jonathan S. Berek William A. Peters III Richard J. Stock David S. Alberts Luis Souhami P.Y. Liu Perry Grigsby Rolland J. Barrett II Bradley J. Monk
Author_xml	– sequence: 1 givenname: William A. surname: Peters fullname: Peters, William A. organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ – sequence: 2 givenname: P.Y. surname: Liu fullname: Liu, P.Y. organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ – sequence: 3 givenname: Rolland J. surname: Barrett fullname: Barrett, Rolland J. organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ – sequence: 4 givenname: Richard J. surname: Stock fullname: Stock, Richard J. organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ – sequence: 5 givenname: Bradley J. surname: Monk fullname: Monk, Bradley J. organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ – sequence: 6 givenname: Jonathan S. surname: Berek fullname: Berek, Jonathan S. organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ – sequence: 7 givenname: Luis surname: Souhami fullname: Souhami, Luis organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ – sequence: 8 givenname: Perry surname: Grigsby fullname: Grigsby, Perry organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ – sequence: 9 givenname: William surname: Gordon fullname: Gordon, William organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ – sequence: 10 givenname: David S. surname: Alberts fullname: Alberts, David S. organization: From the Puget Sound Oncology Consortium; and Southwest Oncology Group Statistical CenterSeattle, WA; Bowman Gray School of Medicine, Winston-Salem, NC; Walter Reed Army Medical Center, Washington, DC; University of California at Irvine, Irvine; University of California at Los Angeles, Los Angeles, CA; McGill University, Montreal, Quebec, Canada; Mallinckrodt Institute of Radiology, St Louis, MO; Clear Lake Regional Medical Center, Webster, TX; University of Arizona Cancer Center, Tucson, AZ
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Snippet	PURPOSE: To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage,... To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk...
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SubjectTerms	Adult Aged Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Cisplatin - administration & dosage Combined Modality Therapy Disease Progression Female Female genital diseases Fluorouracil - administration & dosage Gynecology. Andrology. Obstetrics Humans Hysterectomy Lymph Node Excision Medical sciences Middle Aged Pelvis - radiation effects Radiotherapy Dosage Radiotherapy, Adjuvant Survival Rate Tumors Uterine Cervical Neoplasms - mortality Uterine Cervical Neoplasms - radiotherapy Uterine Cervical Neoplasms - surgery Uterine Cervical Neoplasms - therapy
Title	Concurrent Chemotherapy and Pelvic Radiation Therapy Compared With Pelvic Radiation Therapy Alone as Adjuvant Therapy After Radical Surgery in High-Risk Early-Stage Cancer of the Cervix
URI	http://jco.ascopubs.org/content/18/8/1606.abstract https://www.ncbi.nlm.nih.gov/pubmed/10764420 https://www.proquest.com/docview/71046527
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