1275P - Updated safety and quality of life (QOL) results of paramount study: maintenance pemetrexed (PEM) plus best supportive care (BSC) vs placebo (PBO) p...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Supportive Care
Non-Small-Cell Lung Cancer, Metastatic
Presenter Carla Visseren-Grul
Authors C.M. Visseren-Grul1, L. Paz-Ares2, M. Dediu3, M. Thomas4, P. Bidoli5, J. Corral6, N. Chouaki7, A. Zimmermann8, J. Pujol9, C. Gridelli10
  • 1Medical, Eli Lilly, RA Houten/NL
  • 2Hospital Universitario Virgen del Rocío, Seville/ES
  • 3Medical Oncology, Institute of Oncology Bucharest, Fundeni Clinical HospitalAlexandru Treistoreanu, RO-022328 - Bucharest/RO
  • 4Department Of Thoracic Oncology, University of Heidelberg, Thoraxklinik Heidelberg/DE
  • 5Azienda Ospedaliera S. GerardoU.O. Oncologia Medica, IT-20052 - Monza/IT
  • 6Medical Oncology, Instituto de Biomedicina de Sevilla, Seville/ES
  • 7Medical Department, Eli Lilly, Paris/FR
  • 8Oncology, Eli Lilly and Company, Indianapolis/US
  • 9Montpellier Academic Hospital, Hospital Arnaud De Villeneuve, Montpellier, 34295 - Montpellier/FR
  • 10Medical Oncology, UO Oncologia Medica"S.G. Moscati Hospital", IT-83100 - Avellino/IT

Abstract

Objectives

The PARAMOUNT trial showed that continuation maintenance therapy with pem after induction therapy with pem plus CP significantly reduced the risk of disease progression (HR = 0.62) and death (HR = 0.78) in patients (pts) with advanced NS-NSCLC. The purpose of this abstract is to present the updated safety and patients' QoL results from the continuation maintenance treatment of the PARAMOUNT trial.

Methods

In this phase III, randomized, double-blind, PBO-controlled study, 939 pts were treated with pem (500 mg/m2) plus CP (75 mg/m2) on day 1 of four 21-day cycles. Patients (n = 539) who had not progressed and had an Eastern Cooperative Oncology Group performance status (PS) of 0/1, were randomized (2:1; stratified for PS, induction response, and disease stage) to maintenance pem (500 mg/m2, day 1) plus BSC (n = 359) or PBO plus BSC (n = 180) until disease progression. All pts received vitamin B12, folic acid, and dexamethasone. All randomized pts were qualified for the maintenance phase safety analyses, which included summaries of the incidence of adverse events by maximum Common Terminology Criteria Adverse Events, version 3, grade. All enrolled patients that had provided baseline and at least 1 subsequent measurement for EuroQol 5-dimensional (EQ-5D) scale were included in the analysis of patient-reported outcomes.

Results

Safety and the QoL analyses in the continuation maintenance therapy will be presented.

Conclusions

The long-term and low-grade toxicities of continuation maintenance therapy with pem will be discussed.

Disclosure

C.M. Visseren-Grul: Employed by and own stock in Eli Lilly and Company.

L. Paz-Ares: I have advisory board relationship and honararia to disclose with Eli Lilly and Company, Bayer, Roche, Pfizer. I.

M. Dediu: Advisory Board - Eli Lilly and Company.

M. Thomas: Advisory Board - Eli Lilly and Company Corporate Sponsored Trial - Eli Lilly and Company.

N. Chouaki: Employed by and own stock in Eli Lilly and Company.

A. Zimmermann: Employed by and own stock in Eli Lilly and Company.

J. Pujol: Advisory Board - Eli Lilly and Company.

C. Gridelli: Advisory Board, corporate-sponsored research, and honoraria/speaker bureau with Eli Lilly and Company.

All other authors have declared no conflicts of interest.