Two studies presented at the 2012 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois shed new light on the best way to treat non-small cell lung cancer (NSCLC)—one indicating that chemotherapy may be superior to targeted therapy as second-line treatment for wild-type EGFR NSCLC and the other showing that maintenance with Alimta® (pemetrexed) improved overall survival in patients with advanced nonsquamous NSCLC.
Lung cancer remains the leading cause of cancer death in the United States. NSCLC accounts for approximately 85% of all lung cancers. 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—including treatment with targeted therapies and/or maintenance therapy (treatment that is given after initial treatment but before cancer progression).
The TAILOR Trial
The TAILOR trail was a phase III study designed to compare Tarceva (erlotinib) with docetaxel in the second-line treatment of NSCLC patients with wild-type EGFR. The epidermal growth factor receptor (EGFR) pathway is involved in cell growth and replication. Targeted agents like Tarceva work to block this pathway and stall cancer growth. Wild-type EGFR NSCLC refers to cancer where no mutation of the EGFR gene has been detected.
The study included 222 patients with confirmed wild-type EGFR who were randomly assigned to receive either docetaxel or Tarceva as second-line treatment. All patients had received previous platinum-based chemotherapy, but previous chemotherapy with taxanes and other anti-EGFR agents was excluded. The primary endpoint of the study is overall survival—but survival data is not yet mature. However, preliminary results indicate that docetaxel is superior to Tarceva in prolonging progression-free survival (PFS). At the six-month analysis, 28.9% of patients in the docetaxel group were free from disease progression, compared with 16.9% in the Tarceva group. Furthermore, the rate of disease control was double in the docetaxel group.
The researchers concluded that docetaxel significantly improved PFS, response rates and the rates of disease control—suggesting that Tarceva is not effective in the treatment of wild-type EGFR NSCLC.
The PARAMOUNT Trial
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The PARAMOUNT Trial was a double-blind, placebo-controlled, phase III study designed to evaluate maintenance therapy with Alimta. In this study, 939 patients received induction therapy and 539 patients who did not experience disease progression were then randomized 2:1 to receive Alimta plus best supportive care or placebo plus best supportive care.
After 12 months of follow-up, the overall survival was 58% in the Alimta group compared to 45% in the placebo group. After 24 months, overall survival rates were 32% and 21%, respectively. Median overall survival from the time of induction therapy was 16.9 months in the Alimta group, compared to 14 months in the placebo group—which reflected a 22% increase in survival among patients who received maintenance therapy with Alimta.
The researchers concluded that continuous maintenance therapy with Alimta prolonged overall survival compared with placebo in patients with advanced nonsquamous NSCLC who first received induction therapy with four cycles of Alimta/cisplatin. These new data confirm what preliminary data indicated—maintenance therapy with Alimta produces a persistent benefit. They suggest that continuous treatment with Alimta benefits patients over induction therapy alone—which could change the treatment paradigm for advanced nonsquamous NSCLC.
 Garassino MC, Martelli O, Bettini A, et al. TAILOR: A phase III trial comparing erlotinib with docetaxel as the second-line treatment of NSCLC patients with wild-type (wt) EGFR. Presented at the 2012 annual meeting of the American Society of Clinical Oncology, June 1-5, 2012, Chicago, IL. Abstract LBA7501.
 Paz-Ares L, De Marinis F, Dediu M, et al. PARAMOUNT: Final overall survival (OS) results of the phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo (plb) plus BSC immediately following induction treatment with pem plus cisplatin (cis) for advanced nonsquamous (NS) non-small cell lung cancer (NSCLC). Presented at the 2012 annual meeting of the American Society of Clinical Oncology, June 1-5, 2012, Chicago, IL. Abstract LBA7507.
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