For patients with advanced, nonsquamous, non-small cell lung cancer who receive Alimta® (pemetrexed) as part of their initial treatment, continued (maintenance) treatment with Alimta can improve outcomes. The results of this Phase III clinical trial were presented at the 2011 annual meeting of the American Society of Clinical Oncology.
Lung cancer remains the leading cause of cancer death in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers.
Treatment of advanced NSCLC often involves chemotherapy. Currently available combination chemotherapy regimens can improve the duration of survival as well as quality of life, but researchers continue to search for ways to improve outcomes for patients with this disease.
Maintenance therapy refers to treatment that is given after initial treatment but before cancer progression. Alimta was the first drug to be approved as maintenance therapy for advanced NSCLC.
To assess whether Alimta maintenance therapy benefits patients who also receive Alimta as part of their initial treatment (an approach sometimes referred to as “continuation maintenance”), researchers conducted a Phase III clinical trial known as PARAMOUNT. The study enrolled 939 patients with advanced, nonsquamous, non-small cell lung cancer.
All patients received initial treatment with Alimta and cisplatin. The 539 patients whose cancer did not progress on this treatment were then assigned to receive either maintenance Alimta plus best supportive care (care to manage symptoms) or best supportive care alone.
- Maintenance therapy with Alimta delayed cancer progression. Survival without cancer progression was 4.1 months among patients who received Alimta maintenance and 2.8 months among patients who did not receive Alimta maintenance.
- The disease-control rate (the rate of tumor shrinkage or stabilization) was 71.8% among patients who received Alimta maintenance and 59.6% among patients who did not receive Alimta maintenance.
These results suggest that Alimta maintenance therapy can benefit NSCLC patients who received Alimta as part of their initial treatment. This approach may not be for everyone, however. In a prepared statement, the lead author of the study noted “Some may have significant toxicity during induction treatment, and it may be worth having a treatment break. On the other hand, a patient who is having a good response in the absence of significant toxicity may be a good candidate for maintenance therapy. A lot of factors go into the treatment decision, and each patient should be informed.”
Reference: Paz-Ares LG, De Marinis F, Dediu M et al. PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC).