Comparison of Treatment Tolerance and Outcomes in Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy in a Prospective Randomized Trial or With Standard Treatment

Purpose: To compare the treatment and outcomes of cervical cancer patients treated with concurrent chemoradiotherapy (CT-RT) in a multi-institutional trial or as standard care. Patients and Methods: We reviewed the records of 302 patients treated with CT-RT for locoregionally confined, intact cervical cancer between 1990 and 2005. Of the 302 patients, 76 were treated using cisplatin and 5-fluorouracil (C/F) on Radiation Therapy Oncology Group protocol 90-01 (CT-RT_90-01); 226 underwent CT-RT as standard care with either C/F [CT-RT_SC(C/F); n = 115] or weekly cisplatin [CT-RT_SC(WC); n = 111). Results: The CT-RT_90-01 patients more often had tumors ≥6 cm and were less often diabetic than were the CT-RT_SC patients. The CT-RT_SC(WC) patients were more likely than the CT-RT_SC(C/F) patients to be ≥60 years old or to have Stage III-IV disease. During treatment, CT-RT_SC(C/F) patients experienced more Grade 2-3 neutropenia and were, therefore, less likely to receive 200 mg/m² cisplatin than were either CT-RT_SC(WC) or CT-RT_90-01 patients (52% vs. 77% vs. 85%, respectively; p <0.001). At 5 years, the disease-specific survival rates were greater for patients treated with C/F [CT-RT_SC(C/F), 75%; CT-RT_90-01, 79%] than for those treated with CT-RT_SC(WC) (58%; p = 0.02). On multivariate analysis, C/F chemotherapy, cisplatin dose ≥200 mg/m², Stage I-II disease, and negative pelvic lymph nodes were independent predictors of improved disease-specific survival. Conclusions: Even within a large comprehensive cancer center, the high rates of chemotherapy completion achieved on a multi-institutional trial can be difficult to reproduce in standard practice. Although C/F toxicity was greater in the standard care patients, their outcomes were similar to those of patients treated with C/F on Radiation Therapy Oncology Group protocol 90-01.