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Original Article
Volume 340:1137-1143 April 15, 1999 Number 15
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Pelvic Radiation with Concurrent Chemotherapy Compared with Pelvic and Para-Aortic Radiation for High-Risk Cervical Cancer
Mitchell Morris, M.D., Patricia J. Eifel, M.D., Jiandong Lu, Ph.D., Perry W. Grigsby, M.D., Charles Levenback, M.D., Randy E. Stevens, M.D., Marvin Rotman, M.D., David M. Gershenson, M.D., and David G. Mutch, M.D.

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ABSTRACT

Background and Methods We compared the effect of radiotherapy to a pelvic and para-aortic field with that of pelvic radiation and concurrent chemotherapy with fluorouracil and cisplatin in women with advanced cervical cancer. Between 1990 and 1997, 403 women with advanced cervical cancer confined to the pelvis (stages IIB through IVA or stage IB or IIA with a tumor diameter of at least 5 cm or involvement of pelvic lymph nodes) were randomly assigned to receive either 45 Gy of radiation to the pelvis and para-aortic lymph nodes or 45 Gy of radiation to the pelvis alone plus two cycles of fluorouracil and cisplatin (days 1 through 5 and days 22 through 26 of radiation). Patients were then to receive one or two applications of low-dose-rate intracavitary radiation, with a third cycle of chemotherapy planned for the second intracavitary procedure in the combined-therapy group.

Results Of the 403 eligible patients, 193 in each group could be evaluated. The median duration of follow-up was 43 months. Estimated cumulative rates of survival at five years were 73 percent among patients treated with radiotherapy and chemotherapy and 58 percent among patients treated with radiotherapy alone (P=0.004). Cumulative rates of disease-free survival at five years were 67 percent among patients in the combined-therapy group and 40 percent among patients in the radiotherapy group (P<0.001). The rates of both distant metastases (P<0.001) and locoregional recurrences (P<0.001) were significantly higher among patients treated with radiotherapy alone. The seriousness of side effects was similar in the two groups, with a higher rate of reversible hematologic effects in the combined-therapy group.

Conclusions The addition of chemotherapy with fluorouracil and cisplatin to treatment with external-beam and intracavitary radiation significantly improved survival among women with locally advanced cervical cancer.


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From the Departments of Gynecologic Oncology (M.M., C.L., D.M.G.) and Radiation Oncology (P.J.E.), University of Texas M.D. Anderson Cancer Center, Houston; the Statistical Unit, Radiation Therapy Oncology Group, Philadelphia (J.L.); the Mallinckrodt Institute of Radiology (P.W.G.) and the Division of Gynecologic Oncology (D.G.M.), Washington University School of Medicine, St. Louis; the Department of Radiation Oncology, New York University, New York (R.E.S.); and the Department of Radiation Oncology, State University of New York Health Science Center, Brooklyn (M.R.).

Address reprint requests to Dr. Morris at the Department of Gynecologic Oncology, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd., Box 34, Houston, TX 77030, or at morris{at}mdanderson.org.

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Related Letters:

Treatment of High-Risk Cervical Cancer
Pearcey R. G., Mohamed I. G., Hanson J., Piver M. S., Morris M., Eifel P. J., Rose P. G., Bundy B. N.
Extract | Full Text  
N Engl J Med 1999; 341:695-697, Aug 26, 1999. Correspondence

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