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A. Niimi



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    P1.03 - Chemotherapy/Targeted Therapy (ID 689)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Chemotherapy/Targeted Therapy
    • Presentations: 1
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      P1.03-027 - Randomized Phase 2 Study Comparing CBDCA+PTX+BEV and CDDP+PEM+BEV in Treatment-Naïve Advanced Non-Sq NSCLC (CLEAR Study) (ID 8490)

      09:30 - 09:30  |  Author(s): A. Niimi

      • Abstract

      Background:
      The study objective was to compare efficacy and safety of CBDCA+PTX+BEV and CDDP+PEM+BEV in non-squamous (non-Sq) NSCLC patients.

      Method:
      Treatment-naïve patients aged 20-74 with advanced or recurrent EGFR/ALK-negative non-Sq NSCLC were randomly assigned at 1:2 ratio to either treatment A (4 cycles of CBDCA [AUC 6] + PTX [200mg/m[2]] + BEV [15mg/kg] q3wk, and maintenance therapy with BEV q3wk until progression) or treatment B (4 cycles of CDDP [75mg/m[2]] + PEM [500mg/m[2]] + BEV q3wk, and maintenance therapy with PEM + BEV until progression). The primary endpoint was PFS by central review. The secondary endpoints included OS and safety profile. Target enrollment number was 210.

      Result:
      A total of 55 sites across Japan enrolled 199 patients: 67/132 (A/B). The median age was 67/66 years, 70%/74% were male, 54%/52% were PS 0, 75%/73% were stage IV and 93%/98% had adenocarcinomas. As of April 14, 2017, patients had completed a median of 7/8 treatment cycles, while 94%/80% had discontinued treatment. The most common ≥G3 adverse events were neutropenia (75%/24%), and hyponatraemia (6%/10%). The most common BEV-related adverse events (≥G1) were hypertension (44%/58%), proteinuria (52%/43%) and epistaxis (26%/14%). Dose reduction was necessary due to an adverse event in 31%/22% patients. Treatment-related death (pulmonary infection) was reported in 1 patient receiving treatment B.

      Conclusion:
      CBDCA+PTX+BEV and CDDP+PEM+BEV had different safety profiles. Efficacy results including the primary endpoints will be presented in 2018.