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

• 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
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2000.18.8.1606

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.