M.D. Anderson Cancer Center Orlando, 1400 S. Orange Avenue, Orlando, FL 32806, USA.
Gynecol Oncol. 2011 Dec;123(3):479-85. doi: 10.1016/j.ygyno.2011.08.018. Epub 2011 Oct 5.
The safety and efficacy of gemcitabine plus carboplatin (GC) or paclitaxel plus carboplatin (TC) induction regimens with or without paclitaxel consolidation therapy were assessed in ovarian cancer (OC).
Patients with stage IC-IV OC were randomized to either GC (gemcitabine 1,000 mg/m(2), days 1 and 8, plus carboplatin area under the curve [AUC] 5, day 1) or TC (paclitaxel 175 mg/m(2) plus carboplatin AUC 6, day 1) every 21 days for up to six cycles. Patients with complete response (CR) were allowed optional consolidation with paclitaxel 135 mg/m(2) every 28 days for ≤ 12 months. Patients without CR received single-agent crossover therapy at induction doses/schedules until CR, disease progression (PD), or unacceptable toxicity. PD or death in 636 patients was required to compare induction arms with 80% statistical power for progression-free survival (PFS), the primary endpoint.
Randomized induction therapy was received by 820 of 919 patients enrolled; 352 patients with CR received paclitaxel consolidation whereas 155 patients without CR received single-agent crossover therapy. PFS was similar for GC and TC (median, 20.0 and 22.2 months, respectively; P=.199). Despite high censoring rates (>52%), overall survival was longer for TC (median, 57.3 versus 43.8 months for GC; P=.013). Controlling for patient characteristics including performance status, residual tumor size, and tumor stage, there was no statistical difference in a multivariate analysis (HR=1.22; 95% CI=0.99-1.52; P=.067).
GC does not improve PFS over TC as first-line induction chemotherapy in OC. Although favoring TC, overall survival analyses were limited by the study design and high censoring rates.
评估吉西他滨联合卡铂（GC）或紫杉醇联合卡铂（TC）诱导方案联合或不联合紫杉醇巩固治疗在卵巢癌（OC）中的安全性和疗效。
将 IC-IV 期 OC 患者随机分为 GC（吉西他滨 1000mg/m2，第 1 和 8 天，加卡铂 AUC5，第 1 天）或 TC（紫杉醇 175mg/m2 加卡铂 AUC6，第 1 天），每 21 天为一个周期，最多进行六个周期。完全缓解（CR）的患者可选择接受每 28 天 135mg/m2 的紫杉醇巩固治疗，最长 12 个月。CR 患者接受诱导剂量/方案的单药交叉治疗，直至 CR、疾病进展（PD）或不可接受的毒性。需要 636 例患者的 PD 或死亡来比较诱导臂的无进展生存期（PFS），这是主要终点，具有 80%的统计效力。
820 例入组患者接受了随机诱导治疗；352 例 CR 患者接受了紫杉醇巩固治疗，而 155 例无 CR 的患者接受了单药交叉治疗。GC 和 TC 的 PFS 相似（中位数分别为 20.0 和 22.2 个月，P=.199）。尽管存在高删失率（>52%），TC 的总生存期更长（中位数分别为 57.3 和 43.8 个月，GC；P=.013）。在控制包括体能状态、残留肿瘤大小和肿瘤分期在内的患者特征后，多变量分析无统计学差异（HR=1.22；95%CI=0.99-1.52；P=.067）。
GC 作为 OC 的一线诱导化疗，其无进展生存期并不优于 TC。尽管 TC 有优势，但由于研究设计和高删失率的限制，总生存分析受到限制。
