1252P - NSCLC patients with brain metastases treated with platinum-based doublets as first-line therapy: analyses from the European FRAME observational study

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Denis Moro-Sibilot
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors D. Moro-Sibilot1, E.F. Smit2, J. De Castro Carpeno3, K. Lesniewski-Kmak4, J.G. Aerts5, R. Villatoro6, K. Kraaij7, K. Nacerddine8, Y. Dyachkova9, K. Smith10, A. Girvan10, C.M. Visseren-Grul11, P.A. Schnabel12
  • 1Pneumologie, CHU grenoble, 38 - grenoble/FR
  • 2Dept. Of Pulmonary Diseases, Vrije University Medical Centre (VUMC), NL-1081 HV - Amsterdam/NL
  • 3Unidad De Oncología Traslacional, Hospital Universitario La Paz, Madrid/ES
  • 4Onkologii, Medical University of Gda´nsk, Gdynia/PL
  • 5Pulmonary Diseases, Amphia Hospital/Erasmus MC, 4818CK - Breda/NL
  • 6Unidad Oncologia Médica, Hospital Costa del Sol, Marbella/ES
  • 7Oncology, Eli Lilly and Company, Houten/NL
  • 8Oncology, Eli Lilly and Company, Neuilly-sur-Seine/FR
  • 9Statistics, Eli Lilly GmbH, Vienna/AT
  • 10Oncology, Eli Lilly and Company, Indianapolis/US
  • 11Medical Oncology, Eli Lilly and Company, Houten/NL
  • 12Institute Of Pathology, University of Heidelberg, Heidelberg/DE

Abstract

Aim

Patients (pts) with brain metastases (mets) are often excluded from clinical trials and limited data exists. FRAME (2009-2012) was a prospective, non-interventional observational study of pts with advanced NSCLC receiving platinum (plt)-doublet chemotherapy as first-line treatment (FLT) across Europe. Thus, in FRAME unique real-life data could be collected on baseline characteristics, FLT and survival for NSCLC pts with brain mets.

Methods

FLT decisions were at the discretion of the physicians under routine clinical practice. The primary objective of overall survival (OS) from FRAME was previously reported. Here, we describe baseline characteristics and survival for pts with brain mets at FLT initiation. Survival was estimated using Kaplan-Meier methods and unadjusted estimates are presented.

Results

In FRAME overall, 1564 pts received plt in combination with: pemetrexed (pem; n = 569), gemcitabine (gem; n = 360), taxanes (tax; n = 295), vinorelbine (vin; n = 300), or other (n = 40); 263 (17%) of these pts had brain mets at FLT initiation. Pts with brain mets had a median age of 58 years [range: 33-84] (overall 64 years [range: 33-87], n = 1564), 64% were male (overall 72%), 84% had non-squamous histology (overall 72%), 21% had an ECOG performance status (PS) 2-3 (overall 17%), 58% received cisplatin as FLT plt backbone (overall 55%) and 34% received prior radiotherapy to the brain (overall 6%). Several baseline characteristics for pts with brain mets numerically varied among cohorts (Table 1, “other” cohort [n = 5] is not shown). For the overall study, median OS was 10.3 months (95% CI: 9.5-11.2). For pts with brain mets, median OS was 7.2 months (95% CI: 6.1-8.2); OS estimates for cohorts are shown in Table 1.

Pts with brain mets

FLT
Baseline characteristics Pem n = 117 Gem n = 49 Tax n = 54 Vin n = 38
≥70 yrs, % 12 25 20 21
ECOG PS 2-3, % 18 14 30 21
Never smoker, % 14 6 6 5
Non-squamous, % 97 69 70 82
Median OS, mos. (95% CI) 9.3 (6.2-11.9) 5.6 (4.1-8.4) 6.6 (3.7-7.8) 6.7 (5.2-9.3)

Conclusions

Real-world data from the European FRAME study provide relevant information on NSCLC pts with brain mets, and may have implications on FLT management decisions for these pts.

Disclosure

D. Moro-Sibilot: Consulting fees from Eli Lilly and Company, Roche, Astra Zeneca, Boehringer Ingelheim France, Amgen; J. De Castro Carpeño: Advisory board for Eli Lilly and Company, Roche and Pfizer; speakers bureau for Roche; K. Lesniewski-Kmak: Invited speaker for Eli Lilly and Company, Roche, Astra Zeneca, GSK, Amgen; J.G. Aerts: Research grant from and consultant for Eli Lilly and Company; advisory board for Eli Lilly and Company, Genentech, BMS; R. Villatoro: Speaker fee from Jansen, Pfizer; K. Kraaij: Employee and stockholder of Eli Lilly and Company; K. Nacerddine: Employee and stockholder of Eli Lilly and Company; Y. Dyachkova: Employee of Eli Lilly and Company; K. Smith: Employee and stockholder of Eli Lilly and Company; A. Girvan: Employee and stockholder of Eli Lilly and Company; C.M. Visseren-Grul: Employee and stockholder of Eli Lilly and Company; P.A. Schnabel: Research funding from Eli Lilly and Company. Speakers bureau for AstraZeneca, InterMune, Eli Lilly and Company, Novartis, Pfizer and Roche. Advisory board for Eli Lilly and Company, AstraZeneca, Novartis and Roche. All other authors have declared no conflicts of interest.