Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: A Gynecologic Oncology Group study
Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: A Gynecologic Oncology Group study
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DOI：
10.1200/jco.2003.02.153
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发表时间：
2003-09-01
影响因子：
45.3
通讯作者：
Baergen, R
中科院分区：
文献类型：
--
作者：
Ozols, RF;Bundy, BN;Baergen, R
(P)在bar（u）下bar（r）下bar（p）下bar（o）下bar（s）下bar（e）下bar：在随机试验中，顺铂和紫杉醇联合治疗晚期上皮性卵巢癌上级顺铂和环磷酰胺。尽管在非随机试验中，卡铂和紫杉醇是一种毒性较小且活性较高的联合方案，但其在小体积、切除的III期疾病患者中的疗效仍存在担忧。因此，我们在该人群中进行了顺铂和紫杉醇与卡铂和紫杉醇的非劣效性试验。(P)（a）在酒吧（t）在酒吧（i）在酒吧（e）在酒吧（n）在酒吧（t）在酒吧（a）在酒吧（n）在酒吧（d）在酒吧（M）在酒吧（e）在酒吧（t）在酒吧（h）在酒吧（o）在酒吧（d）在酒吧（s）在酒吧（i）在酒吧（e）在酒吧（n）在酒吧（d）在酒吧（m）在酒吧（e）在酒吧（t）在酒吧（h）在酒吧（o）在酒吧（d）在酒吧（s）在酒吧晚期卵巢癌患者术后无大于1.0 cm的残留肿块，随机接受顺铂75 mg/m2 + 24- 1小时输注紫杉醇135 mg/m2（组I），或3小时静脉注射卡铂+紫杉醇175 mg/m2（组II）曲线下面积7.5。(R)在bar（e）下在bar（s）下在bar（u）下在bar（l）下在bar（t）下在bar（s）下在bar（t）下：792名符合条件的患者入组本研究。两个治疗组的预后因素相似。胃肠道、肾脏和代谢毒性以及4级白细胞减少症在I组中显著更常见。II组中2级或2级以上血小板减少症更常见。两种方案的神经毒性相似。I组的中位无进展生存期和总生存期分别为19.4和48.7个月，而II组分别为20.7和57.4个月。卡铂加紫杉醇组进展的相对风险（RR）为0.88（95%置信区间[CI]，0.75 - 1.03），死亡的RR为0.84（95% CI，0.70 - 1.02）。(C)在bar（o）下在bar（n）下在bar（c）下在bar（l）下在bar（u）下在bar（s）下在bar（i）下在bar（o）下在bar（n）下在bar：在晚期卵巢癌患者中，与顺铂加紫杉醇相比，卡铂加紫杉醇的化疗方案毒性较小，更容易给药，且不劣于顺铂加紫杉醇。(C)2003年，美国临床肿瘤学会。
(P) under bar(u) under bar(r) under bar(p) under bar(o) under bar(s) under bar(e) under bar: In randomized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer. Although in nonrandomized trials, carboplatin and paclitaxel was a less toxic and highly active combination regimen, there remained concern regarding its efficacy in patients with small-volume, resected, stage III disease. Thus, we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population.(P) under bar(a) under bar(t) under bar(i) under bar(e) under bar(n) under bar(t) under bar(s) under bar (a) under bar(n) under bar(d) under bar (M) under bar(e) under bar(t) under bar(h) under bar(o) under bar(d) under bar(s) under bar: Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to receive cisplatin 75 mg/m(2) plus a 24-hour infusion of paclitaxel 135 mg/m(2) (arm I), or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m(2) over 3 hours (arm II).(R) under bar(e) under bar(s) under bar(u) under bar(l) under bar(t) under bar(s) under bar: Seven hundred ninety-two eligible patients were enrolled onto the study. Prognostic factors were similar in the two treatment groups. Gastrointestinal, renal, and metabolic toxicity, as well as grade 4 leukopenia, were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II. Neurologic toxicity was similar in both regimens. Median progression-free survival and overall survival were 19.4 and 48.7 months, respectively, for arm I compared with 20.7 and 57.4 months, respectively, for arm II. The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR of death was 0.84 (95% CI, 0.70 to 1.02).(C) under bar(o) under bar(n) under bar(c) under bar(l) under bar(u) under bar(s) under bar(i) under bar(o) under bar(n) under bar: In patients with advanced ovarian cancer, a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity, is easier to administer, and is not inferior, when compared with cisplatin plus paclitaxel. (C) 2003 by American Society of Clinical Oncology.