Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma.

BACKGROUND: Bulky stage IB cervical cancers have a poorer prognosis than smaller stage I cervical cancers. For the Gynecologic Oncology Group, we conducted a trial to determine whether weekly infusions of cisplatin during radiotherapy improve progression-free and overall survival among patients with bulky stage IB cervical cancer. METHODS: Women with bulky stage IB cervical cancers (tumor, > or =4 cm in diameter) were randomly assigned to receive radiotherapy alone or in combination with cisplatin (40 mg per square meter of body-surface area once a week for up to six doses; maximal weekly dose, 70 mg), followed in all patients by adjuvant hysterectomy. Women with evidence of lymphadenopathy on computed tomographic scanning or lymphangiography were ineligible unless histologic analysis showed that there was no lymph-node involvement. The cumulative dose of external pelvic and intracavitary radiation was 75 Gy to point A (cervical parametrium) and 55 Gy to point B (pelvic wall). Cisplatin was given during external radiotherapy, and adjuvant hysterectomy was performed three to six weeks later. RESULTS: The relative risks of progression of disease and death among the 183 women assigned to receive radiotherapy and chemotherapy with cisplatin, as compared with the 186 women assigned to receive radiotherapy alone, were 0.51 (95 percent confidence interval, 0.34 to 0.75) and 0.54 (95 percent confidence interval, 0.34 to 0.86), respectively. The rates of both progression-free survival (P<0.001) and overall survival (P=0.008) were significantly higher in the combined-therapy group at four years. In the combined-therapy group there were higher frequencies of transient grade 3 (moderate) and grade 4 (severe) adverse hematologic effects (21 percent, vs. 2 percent in the radiotherapy group) and adverse gastrointestinal effects (14 percent vs. 5 percent). CONCLUSIONS: Adding weekly infusions of cisplatin to pelvic radiotherapy followed by hysterectomy significantly reduced the risk of disease recurrence and death in women with bulky stage IB cervical cancers.

Stage IB or IIA-B carcinoma of the intact uterine cervix greater than or equal to 6 cm in diameter: is adjuvant extrafascial hysterectomy beneficial?

This is an analysis of 150 patients with Stage IB or IIA-B carcinoma of the intact uterine cervix greater than or equal to 6 cm in diameter treated with irradiation alone (75 patients) or irradiation followed by surgery (75 patients) at the University of Florida between October 1964 and June 1983. Minimum follow-up in this series was 5 years. There was no significant difference in the distribution of prognostic factors between the two treatment groups. The 5-year local control rate was 74% with irradiation alone and 76% with irradiation and surgery. The 5-year survival rates for irradiation alone versus irradiation plus surgery were as follows: cause specific, 62% and 55%, and absolute, 54% and 52%. The proportion of patients who developed treatment complications necessitating hospitalization or a second operation was 4/75 (5%) after irradiation alone and 12/75 (16%) after irradiation and surgery. The authors conclude that the routine use of adjuvant extrafascial hysterectomy is not warranted in this patient population.

Clinical stage I and II endometrial carcinoma treated with surgery and/or radiation therapy: analysis of prognostic and treatment-related factors.

This is an analysis of 266 patients with clinical stage I and II endometrial carcinoma treated with curative intent at the University of Florida between October 1964 and December 1980. There was a minimum 5-year follow-up. Thirty-nine patients who died of intercurrent disease less than 5 years from treatment were excluded from analysis of pelvic disease control and determinate disease-free survival. All patients were included in the analysis of complications. Pelvic disease control and determinate disease-free survival rates at 5 years were 91 and 88%, respectively, for stage I and 84 and 68% for stage II. There was no apparent difference in the rates of local control and survival or in the incidence of complications when comparing preoperative with postoperative radiation therapy. Tumor grade, stage, depth of myometrial invasion, and history of exogenous estrogen use or abnormal estrogen balance were of prognostic significance. Data on pelvic disease control, survival, and treatment complications are outlined, and management guidelines are discussed.