103PD - Subgroup analysis of elderly patients in SQUIRE: A randomized, multicenter, open-label, phase III study of necitumumab (N) plus gemcitabine-cisplati...

Date 16 April 2015
Event ELCC 2015
Session Medical and radiation oncology
Topics Anti-Cancer Agents & Biologic Therapy
Geriatric Oncology
Non-Small-Cell Lung Cancer, Metastatic
Presenter Nicholas Thatcher
Citation Annals of Oncology (2015) 26 (suppl_1): 29-44. 10.1093/annonc/mdv050
Authors N. Thatcher1, T. Ciuleanu2, R. Ramlau3, C. Schumann4, L. Paz-Ares5, H. Depenbrock6, S. Nanda7, N. Chouaki8, M. Socinski9
  • 1Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/UK
  • 2Radiochemotherapy Department, Ion Chiricuta Oncology Institute-IOCN, 400015 - Cluj Napoca/RO
  • 3Medical Oncology, Poznan University of Medical Sciences, Poznan/PL
  • 4Department Of Internal Medicine Ii, University Hospital of Ulm and Clinic for Pneumology, Kempten/DE
  • 5Department Of Medical Oncology, Instituto de Biomedicina de Sevilla-IBIS (Hospital Virgen del Rocío, Universidad de Sevilla & CSIC), Sevilla/ES
  • 6Medical Oncology, Lilly Deutschland GmbH, 61352 - Bad Homburg/DE
  • 7Oncology, Eli Lilly and Company, Bridgewater/US
  • 8Oncology, Eli Lilly and Company, Paris/FR
  • 9Hematology/oncology, University of Pittsburgh, Pittsburgh/US

Abstract

Aim/Background

SQUIRE demonstrated that the addition of N to GC improved survival in patients with stage IV sq-NSCLC. Here we present overall survival (OS), progression-free survival (PFS), and safety data from this study for the elderly.

Methods

Pts were randomized 1:1 to N (800 mg iv, days 1 and 8) plus GC (G = 1250 mg/m2 iv, days 1 and 8; C = 75 mg/m2 iv, day 1) (N + GC arm), or GC alone (GC arm) every 21 days for up to 6 cycles. N + GC pts with no progression continued on N alone until progressive disease or intolerable toxicity. The primary endpoint (OS) and key secondary endpoints (PFS and safety) were previously reported. Here we report results from subgroup analyses for pts <70, ≥70, and ≥75 yrs.

Results

Subgroups (<70: n = 888, 81%, ≥70: n = 205, 19%) had similar baseline characteristics except for ECOG PS and sex (<70, PS 0/1/2: 33%/60%/7%, M/F: 82%/18%; ≥70, PS 0/1/2: 27%/58%/15%, M/F: 88%/12%). Median ages were 60 yrs (<70) and 73 yrs (≥70). Exposure to N and GC was slightly lower in the population ≥70 yrs. OS HRs (N + GC vs. GC) were 0.81 (95% CI: 0.70-0.94, p = 0.006) for <70 yrs and 1.03 (95% CI: 0.75-1.42, p = 0.858) for ≥70 yrs. PFS HRs (N + GC vs. GC) were 0.82 (95% CI: 0.70-0.95, p = 0.007) for <70 yrs and 1.07 (95% CI: 0.77-1.49, p = 0.686) for ≥70 yrs. Additionally, in the subgroup ≥75 yrs (n = 44, 4.0%), the OS HR (N + GC vs. GC) was 0.98 (95% CI: 0.48-2.00, p = 0.964), and the PFS HR (N + GC vs. GC) was 0.83 (95% CI: 0.41-1.69, p = 0.615). Select treatment-emergent adverse events (TEAEs) are shown in the Table.

<70 yrs <70 yrs ≥70 yrs ≥70 yrs
N + GC GC N + GC GC
Event Gr ≥ 3 (%) Gr ≥ 3 (%) Gr ≥ 3 (%) Gr ≥ 3 (%)
Neutropenia 24.8 26.8 19.8 27.8
Hypomagnesemia 9.5 1.1 8.5 1.0
Rash 7.6 0.5 4.7 0.0
Arterial thromboembolic events 3.5 1.6 5.7 4.1
Venous thromboembolic events 4.9 2.5 5.7 3.1

Conclusions

Substantial variation was seen in age subgroups for OS and PFS outcomes; however, age groups were well balanced in baseline characteristics. There was no evidence for an increased safety risk due to N for the elderly.

Clinical Trial detail NCT00981058

Disclosure

N. Thatcher: Lilly speaker and advisory board fees.

T.-E. Ciuleanu: Lilly advisory board.

R. Ramlau: I have honoraria to disclose: Eli Lilly, Boehringer Ingelheim, Roche. I have a consulting and advisory role to disclose: Eli Lilly, Boehringer Ingelheim, Roche. I have a speakers bureau to disclose: Eli Lilly, Boehringer Ingelheim.

C. Schumann: I received fee from Eli Lilly for speaking.

L. Paz-Ares: Dr. Paz-Ares reports personal fees from Lilly.

H. Depenbrock, S. Nanda and N. Chouaki: Employee of Eli Lilly and Company.

All other authors have declared no conflicts of interest.