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: Author Summary: 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.