Results of a randomized, phase III trial of nab-paclitaxel (nab-P) and carboplatin (C) compared with cremophor-based paclitaxel (P) and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC)

SUMMARY: In this randomized phase III trial, the efficacy of nab-paclitaxel (ABRAXANE®) and carboplatin was compared with paclitaxel and carboplatin in advanced NSCLC of all histologic types. Patients enrolled were chemonaïve, with stage IIIb and stage IV non small cell lung cancer. Five hundred and twenty one (521) received ABRAXANE® without any premedications at 100 mg/m2 on days 1, 8 and 15 along with carboplatin given on day 1 at an AUC of 6. The control group of 525 patients received standard Paclitaxel 200mg/m2 and carboplatin at an AUC of 6 on day 1. The primary end point was overall response rate. The ABRAXANE® group had a response rate of 33% compared to 25% for the standard paclitaxel group. When broken down by histology, the response rates in those with squamous cell carcinoma was 41% in the ABRAXANE® group versus 24% in the standard paclitaxel arm and the non squamous subtypes had a response rate of 26% versus 25% in the ABRAXANE® and paclitaxel group respectively. It is hypothesized that the superior response rates in squamous cell histology may be due to the overexpression by this sub type of an albumin receptor called Caveolin–1. ABRAXANE® which is an albumin bound paclitaxel utilizes the albumin receptor Caveolin-1 (CAV1) pathway and thereby may achieve a higher intratumoral drug concentration. J Clin Oncol 28:18s, 2010 (suppl; abstr LBA7511)