Radiation therapy with and without extrafascial hysterectomy for bulky stage IB cervical carcinoma: A randomized trial of the Gynecologic Oncology Group

Henry M. Keys, Brian N. Bundy, Frederick B. Stehman, Takashi Okagaki, Donald G. Gallup, Alexander F. Burnett, Marvin Z. Rotman, Wesley C. Fowler

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193 Scopus citations


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 ≥4 cm 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).

Original languageEnglish (US)
Pages (from-to)343-353
Number of pages11
JournalGynecologic Oncology
Issue number3
StatePublished - Jun 1 2003


ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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