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Randomized Controlled Trial
. 2008 Jan 1;70(1):118-25.
doi: 10.1016/j.ijrobp.2007.05.028. Epub 2007 Sep 14.

Comparison of treatment tolerance and outcomes in patients with cervical cancer treated with concurrent chemoradiotherapy in a prospective randomized trial or with standard treatment

Mylin A Torres  1 , Anuja Jhingran, Howard D Thames Jr, Charles F Levenback, Diane C Bodurka, Lois M Ramondetta, Patricia J Eifel
Affiliations
Randomized Controlled Trial

Comparison of treatment tolerance and outcomes in patients with cervical cancer treated with concurrent chemoradiotherapy in a prospective randomized trial or with standard treatment

Mylin A Torres et al. Int J Radiat Oncol Biol Phys. .

Abstract

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 >or=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 >or=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/m(2) 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 >or=200 mg/m(2), 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.

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