Radiation therapy with and without extrafascial hysterectomy for bulky stage IB cervical carcinoma: a randomized trial of the Gynecologic Oncology Group☆
| Autor: | Frederick B. Stehman, Alexander F. Burnett, Donald G. Gallup, Brian N. Bundy, Wesley C. Fowler, Takashi Okagaki, Henry M. Keys, Marvin Rotman |
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| Rok vydání: | 2003 |
| Předmět: |
Adult
medicine.medical_specialty medicine.medical_treatment Urology Uterine Cervical Neoplasms Gynecologic oncology Hysterectomy Lower risk Disease-Free Survival medicine Humans Cumulative incidence Prospective Studies Aged Neoplasm Staging Performance status business.industry Obstetrics and Gynecology Middle Aged Combined Modality Therapy Surgery Radiation therapy Regimen Oncology Epidermoid carcinoma Regression Analysis Female business |
| Zdroj: | Gynecologic Oncology. 89:343-353 |
| ISSN: | 0090-8258 |
| DOI: | 10.1016/s0090-8258(03)00173-2 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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