Author of

• 12592

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

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12611

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    P3.10-019 - Oral S-1 and carboplatin followed by maintenance S-1 for chemo-naive patients with advanced squamous cell lung cancer (OSAKA-LCSG 1102) (ID 1384)

    09:30 - 09:30  |  Author(s): O. Morimura
    • Abstract

    Background
    The subset analysis of LETS study suggested that S-1 plus carboplatin was more beneficial than paclitaxel plus carboplatin in overall survival (OS) in squamous cell lung cancer. We previously showed the validity of tailored dose S-1 adjusted by BSA and Ccr. No maintenance study focusing on squamous cell lung cancer has been reported yet. Here, we conducted a phase II study to evaluate the efficacy and safety of tailored dose S-1 plus carboplatin followed by S-1 maintenance in chemonaïve patients with advanced and recurrent squamous cell lung cancer.

    Methods
    Patients receive carboplatin (AUC = 5, day1) plus S-1 (tailored dose b.i.d., days 1-14) every 21 days. Non-progressive patients after 4 cycles of induction continued to receive S-1 until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) with a threshold value of 15%. The secondary endpoints were progression-free survival (PFS) and OS from enrollment, PFS in maintenance phase, and safety.

    Results
    Between April 2011 and October 2012, 35 patients were enrolled. Thirty-three patients excluding 2 patients with protocol violations were analyzed. The median age was 72 years (range, 44-82), The ORR was 30.3% (95% CI: 15.6-48.7%) that met the primary endpoint. Disease control rate was 75.8%, and 10 patients (30.3%) received maintenance therapy. The median PFS was 3.7 months. The median OS and maintenance PFS are under follow-up. 10 patients received maintenance S-1 (median: 3 cycles, range: 1-9 cycles); median PFS from the beginning of induction treatment was 5.6 months. Grade 3/4 toxicities with the frequency more than 5% included 4 neutropenia (12.1%), 7 thrombocytopenia (21.2%), 2 anemia (6.1%), 4 appetite loss (12.1%), 2 nausea (6.1%) and 2 fatigue (6.1%). All of them were controllable and febrile neutropenia was not experienced.

    Conclusion
    This is the first trial of S-1 plus carboplatin followed by maintenance S-1 for chemo-naïve advanced and recurrent squamous cell lung cancer. This treatment strategy was effective and feasible.