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P. Zhang



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    P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P2.01-063 - Dynamic Change of Fatigue for East-Asian Patients in the JMEN Trial (ID 843)

      09:30 - 09:30  |  Author(s): P. Zhang

      • Abstract

      Background:
      In the JMEN trial (Ciuleanu et al., Lancet 374:1432-1440, 2009), patients with advanced non-squamous non-small cell lung cancer (NSCLC) derived a benefit from pemetrexed maintenance therapy after platinum-based initial therapy by extending survival, delaying disease progression, and maintaining overall quality of life (QoL). However, fatigue was the most common physician-reported toxic effect in the pemetrexed treated group. We conducted a post-hoc analysis to investigate the dynamic change of fatigue in overall population and East-Asian (EA) patients treated on the JMEN trial.

      Methods:
      This analysis was performed in the overall safety population (N=656) and the EA subgroup safety population (N=152) mainly from China, Taiwan, and Korea including squamous and non-squamous NSCLC patients. The Common Terminology Criteria for Adverse Events (version 3.0) was used for summary of the AE incidence rates by cycle and AE severity reported by investigator. The Lung Cancer Symptom Scale (LCSS) was used to evaluate patients’ QoL. Worsening of fatigue was defined as an increase of 15 mm or more from baseline on a 100 mm scale in LCSS reported by the patients. The percentage of patients with worsening fatigue was also summarized by cycle. The time to worsening of fatigue symptom was analyzed using Kaplan-Meier method and Cox proportional model.

      Results:
      In the EA population drug-related fatigue (grade 1-4) occurred more frequently in pemetrexed arm compared with placebo arm (30.4% vs 16.0%, p=0.075). The grade 3/4 drug-related fatigue was rare in both arms (1 event reported in each arm). For both overall and EA populations, the fatigue incidence by cycle during the maintenance treatment with pemetrexed did not increase during subsequent cycles (Figure 1A, B). The percentage of patients who experienced worsening of fatigue based on the patients-reported LCSS scores was also comparable between the two arms in the overall and EA populations (Figure 1C, D). EA Patients in the pemetrexed arm experienced a numerically longer median time to worsening of fatigue compared to EA patients in the placebo arm, although the difference is not statistically significant (5.95 months vs. 3.91 months, HR= 0.84, 95% confidence interval [CI]: 0.51-1.37, p= 0.471). Figure 1



      Conclusion:
      These analyses suggest that despite a higher incidence of grade 1/2 drug-related fatigue compared with placebo, pemetrexed maintenance treatment for EA patients with advanced NSCLC will not impair patient-reported QoL.

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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
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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): P. Zhang

      • 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.