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Radiation Therapy With or Without Extrafascial Hysterectomy for Bulky Stage IB Cervical Carcinoma
Abstract & Commentary
Synopsis: Following radiation therapy, adjuvant extrafascial hysterectomy decreased the risk of relapse for patients with "bulky" stage IB cervical cancer without improving survival.
Source: Keys HM, et al. Gynecol Oncol. 2003;89: 343-353.
Keys and colleagues have reported a study of the Gynecologic Oncology Group in which the principal objective was to evaluate, in a randomized trial, the role of adjuvant hysterectomy after standardized radiation in improving progression-free survival and survival for patients with "bulky" stage IB cervical cancer. 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). 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 was no statistical difference in outcomes between regimens except for the adjusted comparison of progression-free survival, although all indicated a lower risk in the adjuvant hysterectomy regimen. Keys et al concluded that, 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 benefited from extrafascial hysterectomy.
Comment by David M. Gershenson, MD
Adjuvant hysterectomy after preoperative irradiation rather than irradiation alone in patients with bulky stage IB cervical cancer was first highlighted in a series of reports from M.D. Anderson Cancer Center in the 1960s and 1970s. The rationale of this strategy was based on the premise that tumor hypoxia within a large cervical tumor would be better treated with surgical resection than brachytherapy following external therapy. Of course, the principal objectives of such an approach were to reduce the incidence or local pelvic relapse and to thereby improve overall survival. Following these reports, this treatment approach became widely used throughout the United States without any definitive evidence to support its use. Although the approach was essentially abandoned at M.D. Anderson Cancer Center by the early 1980s, its popularity continued to increase. Amazingly, this GOG trial was conducted between 1984 and 1991, but it was only reported in June 2003. Although Keys et al provide a very positive spin to their conclusions, this study should really signal the death knell for adjuvant extrafascial hysterectomy, except in very specific clinical scenarios. There was only a modest improvement in pelvic control, only a trend toward improvement in progression-free survival, and no improvement in overall survival. Potential indications for adjuvant extrafascial hysterectomy would include patients who have poor anatomy for brachytherapy, those with poor tumor response to irradiation, those with large uterine leiomyomata, and patients in whom there is confusion regarding the primary site of cancer (cervix vs endometrium). The accompanying editorial authored by a well-respected radiation oncologist, Dr. Anthony H. Russell, is very thoughtful and puts this article in the proper perspective.1
1. Russell A. Gynecol Oncol. 2003;89:341-342.