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C. Jianhua



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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-013 - Open-label, randomized multicentre, phase II trial of Oral vinorelbine (NVBo) or intravenous vinorelbine (NVBiv) with cisplatin (CDDP) in patients (pts) with advanced Non Small Cell Lung Cancer (NSCLC): A Chinese experience (CA225 study) (ID 1188)

      09:30 - 09:30  |  Author(s): C. Jianhua

      • Abstract

      Background
      Aim of the study: to evaluate efficacy (CR, PR) of the two formulations with CDDP in advanced NSCLC. Secondary objectives were progression-free survival (PFS), overall survival (OS) and safety.

      Methods
      NVBo, 60 mg/m² (Arm A) and NVBiv, 25 mg/m² (Arm B) were delivered on D1, D8, repeated every 3 weeks. Doses were increased at cycle 2 (NVBo 80 mg/m[2], NVBiv 30 mg/m[2]) according to hematological tolerance. CDDP doses were 80 mg/m[2] D1 every 3 weeks in both arms. Pts received a maximum of 4 cycles in absence of progression.

      Results
      Between 1/2008 and 6/2009, 132 pts were randomized at 6 investigational centres (cut-off date for final analysis: August, 31[st] 2012 - Arm A 67 pts, Arm B 65 pts). One patient in Arm A was not treated. Among the 131 pts analyzed by an independent panel review, PR was 25.8% (95% CI [15.8-38.0]) in Arm A and 23.1% (95% CI [13.5-35.2]) in Arm B, and disease control (PR+SD) 72.7% (95% CI [60.4-83.0]) in Arm A and 72.3% (95% CI [59.8-82.8]) in Arm B. PFS (months) was 6.2 [3.8-7.7] for Arm A and 6.2 [4.9-7.8] for Arm B. One Year Survival was 59% and 61.6 in Arm A and Arm B, respectively, Two Years Survival: 39% Arm A, 38.7% Arm B, and 30 months Survival 29.2% Arm A, 26.9% Arm B. Median dose intensity (DI): NVBo 44.7 mg/m²/week, NVBiv 15.6 mg/m²/week. Relative dose intensity (RDI): NVBo 89.3%, NVBiv 81.5%. The CDDP median DI was 24.6 mg/m[2]/week in Arm A and 24.5 mg/m[2]/week in Arm B, with a RDI of 92.1% and 91.6% respectively. Grade 3/4 neutropenia: 29 pts and 43 cycles Arm A, 56 pts and 106 cycles Arm B. Febrile neutropenia : 4 (6.1%) pts Arm A, 6 (9.2%) pts Arm B. Grade 3 anaemia : 6 (9.1%) pts and 10 cycles Arm A, 13 pts (20%) and 18 cycles Arm B, with grade 4 anaemia in 3 (4.6%) pts and 5 cycles only in arm B. The most frequent non hematological disorders were nausea (8 pts Grade 3 - 12.1% Arm A; 6 pts Grade 3 - 9.2% Arm B) and vomiting (10 pts Grade 3 - 15.2%, 1 pt Grade 4 - 1.5% Arm A; 9 pts Grade 3 - 13.8%, 1 pt Grade 4 - 1.5% Arm B). Diarrhea was reported in 15 (22.7%) and 9 (13.8%) pts in Arm A and Arm B, respectively.

      Conclusion
      Both arms testing NVBo and NVBiv with CDDP reported similar efficacy results in term of Response Rate, PFS and OS, coupled with an optimal safety profile. NVBo is a step forward in the treatment of NSCLC since it optimises treatment convenience thanks to its oral formulation while maintaining a high level of efficacy.