216PD - nab-Paclitaxel + carboplatin (nab-P/C) in advanced non-small cell lung cancer (NSCLC): outcomes in elderly patients (pts) with squamous (SCC) histo...

Date 14 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Predictive models for chemo- and radiotherapy
Topics Anticancer agents
Geriatric Oncology
Non-Small Cell Lung Cancer
Therapy
Biological Therapy
Presenter Cesare Gridelli
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors C. Gridelli1, A. Ko2, M. O'Brien3, T.J. Ong4, M.A. Socinski5, P.E. Postmus6
  • 1Medical Oncology, Azienda Ospedaliera S. Giuseppe Moscati, 83100 - Avellino/IT
  • 2Biostats, Celgene Corporation, Summit/US
  • 3Onocology, Royal Marsden Hospital, London/GB
  • 4Medical Affairs, Celgene Corporation, Summit/US
  • 5Hematology/oncology, University of Pittsburgh, Pittsburgh/US
  • 6Oncology, Clatterbridge Cancer Center,, Liverpool/GB

Abstract

Background

In a phase III trial, nab-P/C demonstrated clinical efficacy in pts with advanced NSCLC (Socinski et al. J Clin Oncol. 2012; 30: 2055–2062). This post hoc analysis specifically examined clinical outcomes of pts with SCC from this phase III trial stratified by age, including pts ≥70 years.

Methods

Pts with histologically or cytologically confirmed stage IIIB/IV NSCLC and no prior chemotherapy for metastatic disease received either nab-P 100 mg/m2 on days 1, 8, and 15 or paclitaxel (P) 200 mg/m2 on day 1 in combination with carboplatin (C) AUC 6 on day 1 every 21 days (randomized 1:1). Treatment continued until disease progression. Overall response rate (ORR; primary endpoint) and progression-free survival (PFS) were assessed by blinded, centralized review. P values for ORR were based on a χ2 test, and those for overall survival (OS) were based on a stratified log-rank test (by geographic region: North America/Australia, Eastern Europe, or Asia/Pacific).

Results

A total of 450 of 1052 pts had SCC. Most pts with SCC were male (90%), white (89%), and had an ECOG PS of 1 (79%); 65 pts with SCC were ≥70 years of age. In this patient cohort, the ORR was significantly higher for nab-P/C vs P/C (46% vs 20%; P = 0.029) and median OS was nearly doubled (16.9 vs 8.6 months; P = 0.018). PFS did not significantly differ between treatments in these pts. Similar findings were observed for pts with SCC in other age groups (Table). In the overall treated population, nab-P demonstrated higher dose intensity vs P in pts with SCC and in elderly pts. 216PDT1

 Outcome by age group
 ≥70 years≥65 years≥60 years
 nab-P/C (n = 35)P/C (n = 30)nab-P/C (n = 67)P/C (n = 70)nab-P/C (n = 106)P/C (n = 110)
ORR, %462046264525
Ratio of ORR (P value) 2.286 (0.029) 1.799 (0.012) 1.845 (0.001)
Median OS, months16.98.613.99.411.89.5
Hazard ratio (P value) 0.50 (0.018) 0.62 (0.019) 0.70 (0.027)

Conclusions

Treatment with nab-P/C vs P/C resulted in significant improvements in ORR and OS in pts ≥70 years of age with SCC. This analysis is limited by the small number of pts and thus should be interpreted with caution. However, the results build upon prior analyses supporting the efficacy of nab-P as the taxane of choice for these 2 discrete pt subgroups, the elderly and those with SCC.

Clinical trial identification

NCT00540514

Legal entity responsible for the study

Celgene Corporation

Funding

Celgene

Disclosure

C. Gridelli: Honoraria as advisory board member for Celgene. A. Ko, T.J. Ong: Employee and Stock ownership: Celgene. M. O'Brien: Advisory work for Celgene, GSK, BMS, Pierre Fabre, Medimmune, MSD Pfizer, Daiichi. M.A. Socinski: Honoraria and speakers bureau: Celgene. P.E. Postmus: Ad board member of Celgene, Boehringer Ingelheim, Halozyme, Teva, Clovis Oncology, Eli Lilly.