Maintenance Pemetrexed (Alimta) vs. Placebo

[CaroleHammett]

I missed the following ASCO clinical trial abstract at the time it was posted on ASCO website in late May/early June, but basically it's good news re Alimta/pemetrexed for all NSCLC patients EXCEPT squamous cell carcinoma, in which latter case there is apparently no benefit at all.

Dr. West also discusses this study at http://www.cancergrace.org (See http://cancergrace.org/lung/2008/06/06/ ... -followup/)

Given that I have squamous cell carcinoma, am on maintenance pemetrexed, and have experienced signifcant side effects, I have contacted my oncologist re possibility of halting treatment (particularly if CT scan shows no improvement or worse). This decision would be based on my eternal balancing of time-buying vs. quality of life.

Carole

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http://www.asco.org/ASCO/Abstracts+%26+ ... ctID=31696

Abstracts > 2008 ASCO Annual Meeting

Maintenance pemetrexed plus best supportive care (BSC) versus placebo plus BSC: A phase III study.

Sub-category: Metastatic Lung Cancer

Category: Lung Cancer--Metastatic Lung Cancer

Abstract No: 8011

Citation: J Clin Oncol 26: 2008 (May 20 suppl; abstr 8011)

Author(s): T. E. Ciuleanu, T. Brodowicz, C. P. Belani, J. Kim, M. Krzakowski, E. Laack, Y. Wu, P. Peterson, S. Adachi, C. C. Zielinski

Abstract: Background: This multicenter phase III trial compared the efficacy and safety of pemetrexed (Pem) versus placebo (Plac) in pts with stage IIIB/IV NSCLC who had not progressed on four cycles of platinum-based induction chemotherapy. Per protocol, final analyses were completed for all outcomes except overall survival (OS). Sub-group analyses were based on results from prior studies. Methods: In this double-blind trial, pts were randomized (2:1 ratio; balanced for stage, ECOG PS, sex, response to induction therapy, non-platinum component of induction therapy, and brain metastases) to receive Pem (500 mg/m2, day 1) plus BSC or Plac plus BSC in 21-day cycles until disease progression. All pts received vitamin B12, folic acid and dexamethasone. The primary analysis of progression-free survival (PFS) was based on an unadjusted Cox HR (target n=660; alpha=0.05; power=85% to show HR<1.00 assuming 462 events and HR=0.75). Results: A total of 663 pts were enrolled (Pem=441; Plac=222). Pt characteristics were well balanced between arms: median age=61 years; 27% female; 39% PS 0, 60% PS 1; 19% Stage IIIB; 23% East Asian; 50% adenocarcinoma, 27% squamous cell, 3% large cell, and 20% other/indeterminate histology; 49% induction CR/PR; and 8% with brain metastases. Pem had better efficacy with respect to PFS (4.3 vs 2.6 mos

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) and tumor response (p <0.001), especially in non-squamous pts. With 55% censoring (all pts), preliminary OS was 13.0 mos with Pem and 10.2 mos with Plac (HR 0.798, 95% CI 0.63-1.01, p = 0.060). There were no significant toxicity differences between arms except for grade 3-4 anemia (Pem 4.5%, Plac 1.4%) and total SAEs due to drug (Pem 4.3%, Plac 0%). Conclusions: Post-induction maintenance therapy with Pem is well tolerated and offers superior PFS compared with Plac in pts with advanced NSCLC. This trial confirms that Pem has greater efficacy in patients with non-squamous histology.

Median PFS (mos) HR

p-value Objective Tumor Response

(CR+PR+SD) p-value

Pem Placebo Pem Placebo

All patients 4.3 2.6 0.502 <0.00001 51.7 33.3 <0.001

Non-squamous (n=482) 4.5 2.6 0.444 <0.00001 57.7 32.7 <0.001

Adenocarcinoma (n=329) 4.7 2.6 0.452 <0.00001 61.0 33.0 <0.001

Large Cell (n=20) 3.5 2.1 0.400 0.109 45.5 33.3 0.670

Other (n=133) 4.2 2.8 0.433 0.0002 51.1 31.7 0.041

Squamous (n=181) 2.8 2.6 0.692 0.039 34.8 34.8 1.000

...

© 2005-2008 American Society of Clinical Oncology (ASCO). All rights reserved worldwide.

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