Treatment of (“bulky”) stage IB cervical cancer with or without neoadjuvant vincristine and cisplatin prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy: A phase III tr

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• 作者：Gary L. Eddy ; Brian N. Bundy ; William T. Creasman ; Nick M. Spirtos ; Robert S. Mannel ; Edward Hannigan ; Dennis O’ ; Connor
• 关键词：Suboptimal stage IB cervical cancer ; Vincristine/cisplatin ; Survival ; GOG 141
• 刊名：Gynecologic Oncology
• 出版年：2007
• 出版时间：August 2007
• 年：2007
• 卷：106
• 期：2
• 页码：362-369
• 全文大小：272 K

文摘

A randomized phase III trial was conducted to determine if neoadjuvant chemotherapy (NACT) prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy (RHPPL) could improve progression-free survival (PFS) and overall survival (OS), as well as operability, with acceptable levels of toxicity. Adjuvant radiation therapy was prescribed for specific surgical/pathological risk factors for both regimens.

Methods

Eligible patients were required to have bulky FIGO Stage IB cervical cancer, tumor diameter ≥ 4 cm, adequate bone marrow, renal and hepatic function, and performance status ≤ 2. Prospective random allocation was to either NACT (vincristine-cisplatin chemotherapy every 10 days for 3 cycles) before exploratory laparotomy and planned RHPPL (NACT + RHPPL), or RHPPL only.

Results

The study was closed prematurely, because of slow accrual, after 291 patients were enrolled, three were ineligible; thus 288 were eligible and randomly allocated to RHPPL (N = 143) or NACT + RHPPL (N = 145). There were no notable differences between regimens with regard to patient age, race, performance status, or tumor size. The median follow-up time is 62 months among living patients. The NACT + RHPPL group had very similar recurrence rates (relative risk: 0.998) and death rates (relative risk: 1.008) when compared to the RHPPL group. There were 79 % that had surgery in the RHPPL group compared to 78 % in the NACT RHPPL group. There were 52 % who received post op RT in the RHPPL group compared to 45 % in the NACT + RHPPL group (not statistically significant).

Conclusion

There is no evidence from this trial that NACT offered any additional objective benefit to patients undergoing RHPPL for suboptimal Stage IB cervical cancer.