Interim safety results from the phase 2 ABOUND.PS2 study evaluating nab-paclitaxel (nab-P) + carboplatin (C) followed by nab-P monotherapy in patients (pts) with NSCLC and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2

Background

Pts with poor PS can benefit from combination chemotherapy; however, they may be at greater risk for toxicity vs pts with good PS. Here, we report interim safety results in pts with advanced NSCLC and an ECOG PS 2 treated with nab-P/C followed by nab-P monotherapy.

Methods

Pts with stage IIIB/IV NSCLC, no prior anti-cancer therapy for metastatic disease, and an ECOG PS 2 received nab-P 100 mg/m² d 1 and 8 + C area under the curve 5 d 1 (21-d cycles) for 4 cycles. Starting at cycle 5, pts without progression could continue nab-P 100 mg/m² monotherapy d 1 and 8 (21-d cycles) until progression/unacceptable toxicity. The primary endpoint is percentage of pts discontinuing treatment during the first 4 cycles due to treatment-emergent adverse events (TEAEs).

Results

As of April 4, 2016, 31 pts were treated. Median age was 71 y, 61% were male, 61% had nonsquamous NSCLC, and 39% had squamous NSCLC. Overall, 14/31 pts remained on therapy at the time of this analysis; 13 pts discontinued in the first 4 cycles and 4 pts from cycle 5 onwards (5 due to AEs, 5 due to progression, 4 due to pt decision, 2 due to symptomatic deterioration, and 1 due to other reasons). In all treated pts, the median percentage of per-protocol dose of nab-P was 85%. Dose adjustments included at least 1 nab-P dose not administered, dose delay, or dose reduction (13, 12, and 7 pts, respectively). Overall, the median dose intensity for nab-P was 56.58 mg/m²/week (expected, 66.7 mg/m²/week). Serious TEAEs occurred in 48% of pts; the incidence of each individual serious TEAE reported was 

Conclusions

Pts with PS 2 are at risk for greater toxicity with combination therapy, but these interim results indicate that a tailored nab-P/C regimen is feasible with a manageable safety profile, and may be an appropriate treatment option regardless of histology. NCT02289456

Clinical trial identification

NCT02289456

Legal entity responsible for the study

N/A

Funding

Celgene Corporation

Disclosure

A. Gajra: Consultant to Celgene Corporation. K.I. Amiri, T.J. Ong, A. Sanford: Employee of Celgene and owns stock. N. Abdel Karim: Advisory for Pfizer, Prometheus, Novartis and Bayer. E. Santos: Member of the following Speakers' Bureaus: Celgene, Pfizer, Amgen, Genetech, Lily, BI, Millenium. M. Socinski: Honorarium and member of Celgene's Speakers Bureau. D.R. Spigel: Consultant, member of speakers' bureau, received research funding and travel expenses from Celgene. R.C. Lilenbaum: Consulting or Advisory Role: Genentech/Roche, Boehringer Ingelheim, Celgene Travel, Accommodations, Expenses: Roche. All other authors have declared no conflicts of interest.