1267P - Quality-of-life (QoL), tolerability, and supportive care results: Necitumumab Phase 3 SQUIRE study

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Supportive Care
Non-Small-Cell Lung Cancer, Metastatic
Presenter Martin Reck
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors M. Reck1, M.A. Socinski2, A. Luft3, A. Szczesna4, M. Dediu5, R. Ramlau6, G. Losonczy7, O. Molinier8, C. Schumann9, J. Brown10, V. Soldatenkova11, N. Chouaki12, N. Thatcher13
  • 1Thoracic Oncology, Krankenhaus Grosshansdorf, 22927 - Grosshansdorf/DE
  • 2Upmc Cancer Pavilion, University of Pittsburgh, Pittsburgh/US
  • 3Thoracic Surgery, St. Petersburg Regional Clinic and Hospital, St. Petersburg/RU
  • 4Lung Diseases, Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock/PL
  • 5Medical Oncology, Institute of Oncology Bucharest, Fundeni Clinical HospitalAlexandru Treistoreanu, RO-022328 - Bucharest/RO
  • 6Lung Diseases Center, Poznan University of Medical Sciences, PL-60-569 - Poznan/PL
  • 7Department Of Pulmonology, Semmelweis University, Budapest/HU
  • 8Oncology, Le Mans Regional Hospital, Le Mans/FR
  • 9Department Of Internal Medicine Ii, Pnemology, University Hospital Ulm, Pneumology, Ulm/DE
  • 10Gporwe-oncology (uk), Eli Lilly and Company, Hampshire/GB
  • 11European Statistics Oncology, Lilly Deutschland GmbH, Bad Homburg/DE
  • 12Medical Oncology, Eli Lilly and Company, Neuilly-sur-Seine/FR
  • 13Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB

Abstract

Aim

Characterize QoL, tolerability, and supportive care of patients (pts) receiving necitumumab (N) + gemcitabine-cisplatin (GC) in the SQUIRE study.

Methods

Pts with ECOG performance status (PS) 0-2, stage IV squamous NSCLC were randomized 1:1 to GC (G = 1250 mg/m2 IV days 1, 8; C = 75 mg/m2 IV day 1) + N (800 mg absolute dose IV), or GC alone (every 21 days up to 6 cycles). Pts treated with GC + N with no disease progression (PD) continued on N monotherapy until PD. Pt reported symptoms were measured by the Lung Cancer Symptom Scale (LCSS) prior to the start of each cycle (1-6) and every 6 weeks thereafter until PD. Physician reported PS was measured before every cycle. Tolerability was measured by number of cycles received, treatment discontinuation for adverse events (AEs), rates of serious AEs (SAEs), % of pts receiving N monotherapy post-induction. AEs (Safety Common Terminology Criteria [v3.0]) and supportive care data were collected while pts were on study.

Results

1093 pts were randomized (545 GC + N Arm, 548 GC Arm); 7 pts in each arm were not treated. 88.3% (GC + N) and 88.0% (GC) pts had a baseline and ≥ 1 post-baseline LCSS assessment. 95% CIs for the hazard ratios (HRs) for time to deterioration (TTD) of all 12 variables contained 1. The HR for TTD of PS by ≥1 point (cycles 1-6) was 0.861 (95% CI: 0.692-1.071). GC + N pts received a median of 6 cycles (interquartile [IQ] range 3-6) of GC, and a median of 6 cycles (IQ range 3-10) of N. GC pts received a median of 5 cycles (IQ range 3-6). Treatment discontinuation rates due to AEs were 13.6% (GC + N) and 14.6% (GC). SAEs were 47.8% (GC + N) and 37.5% (GC). The most common grade ≥3 AE was neutropenia, 24.3% (GC + N) and 27.5% (GC). 51% of GC + N pts continued on N monotherapy (median: 4 additional cycles). Select supportive care for treated patients is summarized in Table below.

GC + N (538 pts) (%) GC (541 pts) (%)
Concomitant medications 100 100
Transfusions 21.9 20.5
Hospitalizations 41.1 34.0
Colony stimulating factors 13.4 16.8
Erythropoietin 0.2 1.5

Conclusions

Long-term use of N was well tolerated. There were no major differences in AE rates, no detrimental effect overall of adding N to GC in terms of patients' QoL (symptoms and PS). Supportive care and associated resource use were modest.

Disclosure

M. Reck: Member of Advisory Board: Hoffmann-La Roche, Lilly, AstraZeneca, BMS, Novartis, Pfizer, Boehringer – Ingelheim Honoraria for lectures: Hoffmann-La Roche, Lilly, AstraZeneca, BMS, Novartis, Pfizer, Boehringer-Ingelheim; M. Dediu: Consultant and Advisory Role (C) - Eli Lilly, Amgen, Boehringer-Ingleheim, Novartis. Speaker fee - TEVA, Boehringer-Ingelheim, MSD, GlaxoSmithkline, Amgen, Astra-Zeneca, Roche, Janssen, Eli Lilly, Pfizer; O. Molinier: Dr Olivier MOLINIER declares -consultant and advisory role for Eli Lilly and Roche -Speaker for Boehringer-Ingleheim; C. Schumann: Consultant and Advisory Role: -Eli Lilly, Pfizer, Roche, Boehringer-Ingelheim Speaker fee: -Eli Lilly, Novartis, Pfizer, Roche, Astra-Zeneca, Amgen, Boehringer-Ingelheim; J. Brown: I am an employee of Eli Lilly and Company and hold stock options and equity with Eli Lilly and Company; V. Soldatenkova: Employment: Lilly Deutschland GmbH, stock ownership. N. Chouaki: Employee of Eli Lilly and Company, I have stock ownership; N. Thatcher: Honoraria for advisory boards and speaker bureaus Eli Lilly and other companies. All other authors have declared no conflicts of interest.