To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Pemetrexed Maintenance Therapy Extends Survival in Some Patients With Non-Small-Cell Lung Cancer: Presented at ASCO URL: http://www.pslgroup.com/dg/222A8A.htm Doctor's Guide June 1, 2008
By Cameron Johnston CHICAGO -- June 1, 2008 -- Lung-cancer patients who receive pemetrexed as maintenance therapy following platinum-based treatment might double their progression-free survival (PFS) compared with patients who do not receive any maintenance therapy, according to trial results presented here at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting. In this multicentre study, patients with advanced non-small-cell lung cancer (NSCLC) who were treated with pemetrexed (500 mg/m2) had a mean PFS of 4.3 months compared with patients who did not receive additional therapy (2.6 months). Overall, 663 patients were randomised in a 2 to 1 ratio to receive either pemetrexed (n = 441) or placebo (n = 222) in 21-day cycles until disease progression. Patients were started on the pemetrexed therapy within 3 to 6 weeks of completing at least 4 courses of induction platinum-based therapy. This finding represents the first time that maintenance therapy has been offered to patients with advanced NSCLC, according to lead author Tudor E. Ciuleanu, MD, PhD, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania, speaking here at a press conference on May 31. Typically, when a patient has had one form of chemotherapy, additional treatments will be withheld until there has been disease progression. The aim of this study was to determine whether disease progression could be delayed by offering the patient additional therapy once either cisplatin or carboplatin treatment had been completed. All subjects also received vitamin B12, folic acid, and dexamethasone. Histologically, patients in this study had a variety of cancer subtypes, including nonsquamous, large-cell, squamous, and adenocarcinomatous. Study subjects were matched for demographic characteristics. The mean age was 61 years; approximately 25% of subjects were female; and 60% were performance status 1. The majority of subjects were tumour stage 4, while 19% had stage 3b tumours. Half of the patients exhibited either partial or complete response with the induction course of platinum therapy alone, but 8% had already developed brain metastases before the maintenance phase of the study began. The primary analysis of PFS was based on an unadjusted Cox hazard ratio. PFS results were similar and statistically significant depending on whether the patient had adenocarcinoma or nonsquamous-cell carcinoma. No difference was seen, however, among patients with squamous-cell carcinoma or large-cell disease. There also was no difference in overall survival between patients who received pemetrexed (surviving an average of 13 months) and those who received placebo (surviving an average of 10.2 months) (P = .06). In general, adverse events were few, although numerically there were more seen among patients who received the study drug (4.3% vs 0%). Grade 3 anaemia was seen in 4.5% of patients who received pemetrexed and in 1.4% of those who received placebo. Dr. Ciuleanu cautioned that these results are still preliminary and that subjects need to be followed for a longer time period before definite conclusions on treatment efficacy can be reached. Pemetrexed is already available in many countries for the treatment of NSCLC, but this study was designed to test its utility in prolonging PFS after the patients had already been treated with a platinum-based regimen. "We recommend giving pemetrexed after a patient completes initial induction therapy, but before cancer progression occurs," Dr. Ciuleanu concluded. "This approach affords the greatest chance of killing stray cancer cells before they have a chance to contribute to further tumour growth." Funding for this study was provided by Eli Lilly and Company. [Presentation title: Maintenance Pemetrexed Plus Best Supportive Care (BSC) Versus Placebo Plus BSC: A Phase III Study. Abstract 8011] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.