Randomized phase III trial of three versus six cycles of adjuvant carboplatin and paclitaxel in early stage epithelial ovarian carcinoma: A Gynecologic Oncology Group study
Randomized phase III trial of three versus six cycles of adjuvant carboplatin and paclitaxel in early stage epithelial ovarian carcinoma: A Gynecologic Oncology Group study
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DOI：
10.1016/j.ygyno.2006.06.013
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发表时间：
2006-09-01
影响因子：
4.7
通讯作者：
Spirtos, Nick M.
中科院分区：
文献类型：
--
作者：
Bell, Jeffrey;Brady, Mark F.;Spirtos, Nick M.
Objective.与3个周期相比，确定6个周期的辅助卡铂（C）和紫杉醇（P）是否显著降低了手术分期为IA 3级、113 3级、透明细胞、IC和完全切除的11期上皮性卵巢癌（EOC）患者的复发率;并比较毒性。术后，随机分为3个或6个周期的化疗，包括P（175 mg/m2，3小时）和C（7.5 AUC，30分钟），每21天一次。复发是指任何新肿瘤的临床或放射学证据。在457例患者中，427例（93%）在组织学和医学上合格。虽然需要彻底的手术分期，但在29%的其他符合条件的患者中，手术分期不完整或记录不充分。中位年龄为55.5岁; 69%的患者患有I期疾病。最后一次联系时存活的344名妇女的中位随访时间为6.8年。在3个周期和6个周期治疗方案中，分别有4/211（2%）和24/212（11%）例患者发生了3级或4级神经毒性（p < 0.01）; 6个周期还导致了明显更严重的贫血和粒细胞减少症。6个周期的复发率降低了24%（风险比[HR]：0.761; 95%置信区间[Cl]：0.51-1.13，p=0.18），5年内估计的复发概率为20.1%（6个周期）vs 25.4%（3个周期）。这些方案的总体死亡率相似（FIR：1.02; 95%CI：0.662-1.57）。结论。与3个周期相比，6个周期的C和P治疗对高危早期EOC的复发率无显著影响，但与更多的毒性相关。(c)2006年爱思唯尔公司All rights reserved.
Objective. Compared to 3 cycles, to determine if 6 cycles of adjuvant carboplatin (C) and paclitaxel (P) significantly lower the rate of recurrence in surgically staged patients with stage IA grade 3, 113 grade 3, clear cell, IC, and completely resected stage 11 epithelial ovarian cancer (EOC); and to compare toxicities.Methods. Postoperatively, randomization was to either 3 or 6 cycles of chemotherapy consisting of P (175 mg/m(2) over 3 h) and C (7.5 AUC over 30 min) every 21 days. Recurrence was any clinical or radiological evidence of new tumor.Results. Of 457 patients, 427 (93%) were histologically and medically eligible. While thorough surgical staging was required, it was incomplete or inadequately documented in 29% of otherwise eligible patients. Median age was 55.5 years; 69% of patients had stage I disease. Median follow-up is 6.8 years for 344 women alive at last contact. Grade 3 or 4 neurotoxicity occurred in 4/211 (2%) and 24/212 (11%) treated patients on the 3- and 6-cycle regimens, respectively (p < 0.01); 6 cycles also caused significantly more severe anemia and granulocytopenia. The recurrence rate for 6 cycles was 24% lower (hazard ratio [HR]: 0.761; 95% confidence interval [Cl]: 0.51-1.13, p=0.18), and the estimated probability of recurrence within 5 years was 20.1% (6 cycles) versus 25.4% (3 cycles). The overall death rate was similar for these regimens (FIR: 1.02; 95% Cl: 0.662-1.57).Conclusions. Compared to 3 cycles, 6 cycles of C and P do not significantly alter the recurrence rate in high risk early stage EOC but are associated with more toxicity. (c) 2006 Elsevier Inc. All rights reserved.