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Pelvic radiation with concurrent chemotherapy versus pelvic and para-aortic radiation for high-risk cervical cancer: an update of RTOG 90–01

2002; Elsevier BV; Volume: 54; Issue: 2 Linguagem: Inglês

10.1016/s0360-3016(02)03056-0

1879-355X

Patricia J. Eifel, Kathryn Winter, Michael B. Morris, Charles Levenback, Perry W. Grigsby, Randy E. Stevens, Marvin Rotman, David M. Gershenson, David G. Mutch,

Multiple and Secondary Primary Cancers

Purpose/Objective: To report mature results of a randomized trial that compared extended field radiotherapy (EFRT) with chemoradiation (CT-RT) in women with loco-regionally advanced carcinomas of the uterine cervix. Materials/Methods: Between 1990 and 1997, 403 women were randomized to receive either EFRT (45 Gy to the pelvis and paraaortic nodes followed by low dose-rate intracavitary radiation (ICRT)) or CT-RT (45 Gy pelvic RT and ICRT with 3 cycles of concomitant 5-FU and cisplatin). Patients with cervical cancer were eligible if they had stages IIB–IVA, stages IB2–IIA with tumor diameter ≥ 5 cm, or positive pelvic lymph nodes. Paraaortic lymph nodes (PAN) were evaluated with either lymphangiogram or lymphadenectomy. To achieve balance between the treatment arms, patients were stratified by stage (IB–IIB and III-IVA) and by method of lymph node evaluation. Overall, 96 patients (25%) had positive pelvic lymph nodes and 118 (30%) had stages III-IVA disease. For patients with stages IB–IIA the median tumor diameter was 6 cm. Median follow-up of surviving patients was 5.8 years. Results: Of 403 patients randomized, 195 and 194 could be evaluated in the EFRT and CT-RT arms, respectively. Overall 5-yr survival rates for patients treated with EFRT and CT-RT were 52% and 72%, respectively (p < 0.0001). Disease-free survival rates were 43% and 67%, respectively (p < 0.0001) and pelvic recurrence rates were 34% and 18%, respectively (p < 0.0001). The rates of PAN recurrence were not significantly different for patients treated with EFRT and CT-RT (4% and 7%, respectively; p = 0.15). However, other distant metastases were significantly more frequent for patients treated with EFRT (31% vs. 18%, p = 0.001). Although the study was not powered to detect a treatment difference within the stratified subgroups, of the 272 patients with stages IB–IIA those treated with CT-RT had a significantly better OS than those treated with EFRT (78% vs. 55%, p < 0.0001); of the 117 patients with stages III-IVA, there was a trend toward better OS for those treated with CT-RT (59% vs. 47%, p = 0.066). The 5-yr rates of late grade 3 or higher treatment-related toxicity were comparable for patients treated with EFRT and CT-RT (12% and 14%, respectively; p = 0.65). Conclusions: Mature analysis confirms that the addition of 5-FU and cisplatin to radiation therapy significantly improved the survival rate of women with locally advanced cervical cancer, decreasing both local and distant recurrences without significantly increasing the rate of late treatment-related side effects.