A Randomized Phase II Study of Carboplatin With Weekly or Every‐3‐Week Nanoparticle Albumin‐Bound Paclitaxel (Abraxane) in Patients With Extensive‐Stage Small Cell Lung Cancer. (23rd January 2015)

• Record Type: Journal Article
• Authors: Grilley‐Olson, Juneko E.; Keedy, Vicki L.; Sandler, Alan; Moore, Dominic T.; Socinski, Mark A.; Stinchcombe, Thomas E.
• Is Part Of: Oncologist. Volume 20:Number 2(2015)
• Page Start: 105
• Page End: 106
• Publication Date: 2015-01-23
• Subjects: Oncology -- Periodicals; Tumors -- Periodicals; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Oncology; Tumors; Neoplasms; Electronic journals; Periodicals; Periodicals; 616.994
• DOI: 10.1634/theoncologist.2014-0327
• Languages: English
• ISSNs: 1083-7159

Abstract

Abstract : Background: Platinum plus etoposide is the standard therapy for extensive‐stage small cell lung cancer (ES‐SCLC) and is associated with significant myelosuppression. We hypothesized that the combination of carboplatin and nanoparticle albumin‐bound paclitaxel (nab‐paclitaxel) would be better tolerated. We investigated carboplatin with nab‐paclitaxel on every‐3‐week and weekly schedules. Methods: This noncomparative randomized phase II trial used a two‐stage design. The primary objective was objective response rate, and secondary objectives were progression‐free survival, overall survival, and toxicity. Patients with ES‐SCLC and an Eastern Cooperative Oncology Group performance status ≤2 and no prior chemotherapy were randomized in a 1:1 ratio to arm A (carboplatin area under the curve [AUC] of 6 on day 1 and nab‐paclitaxel of 300 mg/m 2 on day 1 every 3 weeks) or arm B (carboplatin AUC of 6 on day 1 and nab‐paclitaxel 100 mg/m 2 on days 1, 8, and 15 every 21 days). Response was assessed after every two cycles. Results: Patients required frequent dose reductions, treatment delays, and omission of the weekly therapy. The trial was closed because of slow accrual. Conclusion: Carboplatin and nab‐paclitaxel demonstrated activity in ES‐SCLC but required frequent dose adjustments. Abstract : 摘要 背景 . 铂类联合依托泊苷是广泛期小细胞肺癌（ES‐SCLC）的标准治疗，该方案常导致明显的骨髓抑制。我们推测卡铂联合纳米颗粒白蛋白结合型紫杉醇（nab‐paclitaxel，白蛋白结合型紫杉醇）的耐受性更好。在此基础上开展了本次研究，以观察卡铂联合白蛋白结合型紫杉醇每周 1 次或每 3 周 1 次方案的治疗结果。 方法 . 本项非比较性随机 II 期临床试验采取 2 阶段设计。主要目标为客观缓解率，次要目标为无进展生存期、总生存期以及毒性反应。患者入组标准为确诊 ES‐SCLC，东部肿瘤协作组（ECOG）体能状态评分≤ 2，既往未接受过化疗。这些患者按 1:1 比例随机分配至 A 组[卡铂曲线下面积（AUC）为 6，第 1 天；白蛋白结合型紫杉醇 300 mg/m 2 ，第 1 天，每 3 周 1 次]或 B 组（卡铂 AUC 为 6，第 1 天；白蛋白结合型紫杉醇 100 mg/m 2 ，第 1、8 和 15 天，每 21 天 1 次）。每 2 周期评估 1 次缓解情况。 结果 . 患者需要频繁减量、延迟治疗，每周 1 次组常需要中断治疗。该项临床试验因入组缓慢而关闭。 结论 . 卡铂联合白蛋白结合型紫杉醇方案在 ES‐SCLC 患者中显示出活性，但需要频繁的剂量调整。 The Oncologist 2015;20:105–106