Parmar M K B, Ledermann J A, Colombo N, du Bois A, Delaloye J-F, Kristensen G B, Wheeler S, Swart A M, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Tropé C
Lancet. 2003 Jun 21;361(9375):2099-106. doi: 10.1016/s0140-6736(03)13718-x.
Despite improvements in the treatment of ovarian cancer, most patients develop recurrent disease within 3 years of diagnosis. There is no agreed second-line treatment at relapse. We assessed paclitaxel plus platinum chemotherapy as such treatment.
In parallel international, multicentre, randomised trials, between January, 1996, and March, 2002, 802 patients with platinum-sensitive ovarian cancer relapsing after 6 months of being treatment-free were enrolled from 119 hospitals in five countries. Patients were randomly assigned paclitaxel plus platinum chemotherapy or conventional platinum-based chemotherapy. Analysis was by intention to treat, except for toxic effects.
With a median follow-up of 42 months, 530 patients have died. Survival curves showed a difference in favour of paclitaxel plus platinum (hazard ratio 0.82 [95% CI 0.69-0.97], p=0.02), corresponding to an absolute difference in 2-year survival of 7% between the paclitaxel and conventional treatment groups (57 vs 50% [95% CI for difference 1-12]), and median survival of 5 months (29 vs 24 months [1-11). 717 patients developed progressive disease or died. The progression-free survival curves show a difference in favour of paclitaxel plus platinum (hazard ratio 0.76 [0.66-0.89], p=0.0004), corresponding to an absolute difference in 1-year progression-free survival of 10% (50 vs 40% [4-15]) and in median progression-free survival of 3 months (13 vs 10 months [1-5]).
Paclitaxel plus platinum chemotherapy seems to improve survival and progression-free survival among patients with relapsed platinum-sensitive ovarian cancer compared with conventional platinum-based chemotherapy.
尽管卵巢癌的治疗有所改善，但大多数患者在确诊后3年内会出现复发疾病。复发时尚无公认的二线治疗方案。我们评估了紫杉醇联合铂类化疗作为此类治疗方案的效果。
在1996年1月至2002年3月期间，通过平行的国际多中心随机试验，从五个国家的119家医院招募了802例铂敏感型卵巢癌患者，这些患者在停止治疗6个月后复发。患者被随机分配接受紫杉醇联合铂类化疗或传统铂类化疗。除毒性作用外，分析采用意向性治疗。
中位随访42个月，530例患者死亡。生存曲线显示紫杉醇联合铂类化疗更具优势（风险比0.82 [95%置信区间0.69 - 0.97]，p = 0.02），这相当于紫杉醇组和传统治疗组的2年生存率绝对差异为7%（57%对50% [差异的95%置信区间1% - 12%]），中位生存期差异为5个月（29个月对24个月 [1 - 11个月]）。717例患者出现疾病进展或死亡。无进展生存曲线显示紫杉醇联合铂类化疗更具优势（风险比0.76 [0.66 - 0.89]，p = 0.0004），这相当于1年无进展生存率的绝对差异为10%（50%对40% [4% - 15%]），中位无进展生存期差异为3个月（13个月对10个月 [1 - 5个月]）。
与传统铂类化疗相比，紫杉醇联合铂类化疗似乎能改善复发铂敏感型卵巢癌患者的生存率和无进展生存率。
