Alimta is not Useful in Small Cell Lung Cancer – pro

Alimta and cisplatin are FDA approved for second line therapy of non-small cell(NSC) lung cancer. It is an effective regimen in first line as well. Carboplatin can be substituted for cisplatin.

The National Comprehensive Cancer Network (NCCN), an alliance of nineteen of the world’s leading cancer centers, recently added pemetrexed (Alimta®, Eli Lilly and Company) as an option for second-line therapy for NSC lung cancer. The panel indicated that it has been shown to be equivalent to docetaxel (Taxotere®, Sanofi-Aventis) in efficacy but with less toxicity.  The U.S. Food and Drug Administration granted accelerated approval for Alimta for the treatment of locally advanced or metastatic non-small cell lung cancer in previously treated patients in 2004. It is FDA approved for mesothelioma in combination with cisplatin.

However, this is small cell lung cancer. Just presented in ASCO 2008 was a study that indicates that Alimta is not useful for small cell histology.  This trial was designed to directly compare the regimen of carboplatin/alimta to carboplatin/etoposide, which is a standard regimen for this setting. It was designed to enroll 1820 patients  and look for a significant improvement in survival. The study had enrolled 733 patients when the “Data Safety Monitoring Board”, which reviews results during the conduct of a trial to ensure that one arm isn’t doing so remarkably well or poorly that it would be unethical to continue to randomize patients, found that the carbo/alimta arm was doing so poorly that it was not possible that it would ever emerge as superior. It was closed, and Dr. Socinski presented the results.

Standard treatment for patients with extensive SCLC include VePesid® (etoposide) plus Platinol, VePesid plus Paraplatin or Camptosar® (irinotecan) plus Platinol. However, due to poor long-term outcomes in this disease with current therapies different chemotherapy combinations continue to be evaluated. Alimta is a folate acid antagonist approved by the FDA for treatment of non-small cell lung cancer (NSCLC).

Researchers from several medical institutions in the United States recently conducted a clinical trial to evaluate the addition of Alimta to Platinol or Paraplatin for the treatment of 78 patients with extensive-stage SCLC. Patients were randomly allocated to receive Alimta with either Plainol or Paraplatin. The results were similar in both arms. Alimta must be considered experimental for small cell lung cancer.

Socinski M, Weissman C, Hart L, et al. Randomized Phase II Trial of Pemetrexed Combined With Either Cisplatin or Carboplatin in Untreated Extensive-Stage Small Cell Lung Cancer. Journal of Clinical Oncology . 2006;24:4840-4847.

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