Journal
GYNECOLOGIC ONCOLOGY
Volume 89, Issue 3, Pages 343-353Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/S0090-8258(03)00173-2
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Funding
- NCI NIH HHS [CA 23501, CA 37569, CA 23073, CA 40296, CA 13630, CA 21946, CA 21720, CA 23765, CA 34477, CA 27469, CA 12485, CA 37517, CA 12484, CA 12477, CA 37234, CA 28160, CA 13633, CA 15975, CA 16386, CA 19502] Funding Source: Medline
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Objective. To evaluate, in a randomized clinical trial, the role of adjuvant hysterectomy after standardized radiation in improving progression-free survival and survival for patients with bulky stage IB cervical cancer. Methods. A total of 256 eligible patients with exophytic or barrel shaped tumors measuring greater than or equal to 4 cut were randomized to either external and intracavitary irradiation (RT, N = 124) or attenuated irradiation followed by extrafascial hysterectomy (RT + HYST, N = 132). Twenty-five percent of patients had tumors with a maximum diameter of :7 cm. Results. Tumor size was the most pronounced prognostic factor followed by performance status 2 and age at diagnosis. Hysterectomy did not increase the frequency of reported grade 3 and 4 adverse effects (both groups, 10%). The majority of these adverse effects were from the gastrointestinal or genitourinary tracts exclusively. There was a lower cumulative incidence of local relapse in the RT + HYST group (at 5 years, 27% vs. 14%). There were no statistical differences in outcomes between regimens except for the adjusted comparison of progression-free survival, although all indicated a lower risk in the adjuvant hysterectomy regimen (unadjusted relative risk [URR] of progression, 0.77, P = 0.07; URR of death, P = 0.26, both one tail). Conclusion. Overall, there was no clinically important benefit with the use of extrafascial hysterectomy. However, there is good evidence to suggest that patients with 4-, 5-, and 6-cm tumors may have benefitted from extrafascial hysterectomy (URR of progression; 0.58; URR of death, 0.60). (C) 2003 Elsevier Science (USA). All rights reserved.
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