Cancer Res Treat.  2015 Jul;47(3):424-435. 10.4143/crt.2013.266.

Pemetrexed Continuation Maintenance in Patients with Nonsquamous Non-small Cell Lung Cancer: Review of Two East Asian Trials in Reference to PARAMOUNT

Affiliations
  • 1National Taiwan University Hospital, Taipei, Taiwan.
  • 2Samsung Medical Center, Seoul, Korea.
  • 3Kinki University Faculty of Medicine, Osaka, Japan.
  • 4National Cancer Center Hospital, Tokyo, Japan.
  • 5Eli Lilly Australia, West Ryde, Australia.
  • 6Eli Lilly Japan, Kobe, Japan.
  • 7Eli Lilly and Company, Taiwan/Hong Kong/Macao, China.
  • 8Eli Lilly Interamerica, Buenos Aires, Argentina. mauro@lilly.com

Abstract

PURPOSE
A recent phase III study (PARAMOUNT) demonstrated that pemetrexed continuation maintenance therapy is a new treatment paradigm for advanced nonsquamous non-small cell lung cancer (NSCLC). The majority of patients enrolled in PARAMOUNT were Caucasian (94%). We reviewed efficacy and safety data from two clinical trials, which enrolled East Asian (EA) patients, to supplement data from PARAMOUNT on pemetrexed continuation maintenance therapy in patients with nonsquamous NSCLC.
MATERIALS AND METHODS
Study S110 was a phase II, multicenter, randomized, controlled, open-label trial in never-smoker, chemonaive, EA patients (n=31) with locally advanced or metastatic nonsquamous NSCLC (n=27). Study JMII was a multicenter, open-label, single-arm, post-marketing, clinical trial in Japanese patients (n=109) with advanced nonsquamous NSCLC. PARAMOUNT was a multicenter, randomized, double-blind, placebo-controlled trial in patients with advanced nonsquamous NSCLC.
RESULTS
In EA patients with nonsquamous NSCLC, the median progression-free survival (PFS) for pemetrexed continuation maintenance therapy was 4.04 months (95% confidence interval [CI], 3.22 to 5.29 months) in study S110 and 3.9 months (95% CI, 3.2 to 5.2 months) in study JMII. The median PFS for pemetrexed continuation maintenance therapy in PARAMOUNT was 4.1 months (95% CI, 3.2 to 4.6 months). Pemetrexed continuation maintenance therapy in EA patients in studies S110 and JMII did not lead to any unexpected safety events, and was consistent with PARAMOUNT's safety profile.
CONCLUSION
The efficacy and safety data in the EA trials were similar to those in PARAMOUNT despite differences in patient populations and study designs. These data represent consistent evidence for pemetrexed continuation maintenance therapy in EA patients with advanced nonsquamous NSCLC.

Keyword

Pemetrexed; Maintenance chemotherapy; Nonsquamous non-small cell lung carcinoma; Far East
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