Author of

• 14451

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  P2.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 213)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Treatment of Locoregional Disease – NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 14482

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    P2.03-031 - Subgroup Analysis of East Asian Patients in the Phase III PROCLAIM Trial (ID 1293)

    09:30 - 09:30  |  Author(s): T. Puri
    • Abstract

    Background:
    PROCLAIM is a phase III trial comparing overall survival (OS) in patients with stage III, unresectable, nonsquamous non-small cell lung cancer (NSCLC) receiving pemetrexed (Pem) plus cisplatin (Cis) and concurrent thoracic radiation therapy (TRT) for 3 cycles followed by 4 cycles of Pem consolidation (Pem+Cis arm) versus etoposide (Etop) plus Cis and concurrent TRT for 2 cycles followed by up to 2 cycles of consolidation with a platinum-based doublet of choice (Etop+Cis arm). Overall efficacy and safety results for the intent-to-treat (ITT) population (N=598) will be presented in a separate disclosure. Efficacy and safety results from an East Asia (EA) subgroup analysis are presented here.
    
    Methods:
    A subgroup analysis was performed using the EA randomized population (N=97), which consisted of all patients who were randomized to the study from China (n=61), Taiwan (n=25), and The Republic of Korea (n=11). OS and progression-free survival (PFS) were evaluated by the Kaplan-Meier method and hazard ratios (HRs) were calculated using a Cox regression model. The log-rank test was used to compare treatment arms. Objective response rates (ORRs) were compared using an unadjusted, normal distribution approximation for the difference in rates. ClinicalTrials.gov number NCT00686959.
    
    Results:
    Baseline characteristics were balanced between treatment arms for EA patients. In the 97 randomized EA patients (n=44 in the Pem+Cis arm; n=53 in the Etop+Cis arm), median PFS was 10.0 months for the Pem+Cis arm and 7.6 months for the Etop+Cis arm (HR: 0.97, 95% confidence interval [CI]: 0.61–1.54, p=0.890). The censoring rate was high for OS (Pem+Cis arm: 43.2%; Etop+Cis arm: 52.8%), and there was no significant difference in OS between the Pem+Cis arm and the Etop+Cis arm (HR: 1.23, 95% CI: 0.70–2.14, p=0.469). The interaction test for region and treatment effect for OS was not significant (p=0.374). The ORRs were 47.7% (95% CI: 32.46–63.31) in the Pem+Cis arm and 34.0% (95% CI: 21.52–48.27) in the Etop+Cis arm. In the 90 treated EA patients (n=44 in the Pem+Cis arm; n=46 in the Etop+Cis arm), the overall incidence of drug-related grade 3/4 treatment-emergent adverse events (TEAEs) was significantly lower in the Pem+Cis arm versus the Etop+Cis arm (61.4% vs. 91.3%; p=0.001). All drug-related grade 3/4 TEAEs occurring in ≥5% of patients had a numerically lower incidence in the Pem+Cis arm than in the Etop+Cis arm except lymphopenia (17 [38.6%] vs. 17 [37.0%]).
    
    Conclusion:
    For EA patients with nonsquamous NSCLC, Pem+Cis did not improve OS, but did have a good safety profile and numerically improved PFS and ORR compared to Etop+Cis.