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S. Yamamoto



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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-015 - Phase II study of pemetrexed plus intermittent erlotinib combination therapy for pretreated advanced non-squamous non-small cell lung cancer with documentation of epidermal growth factor receptor mutation status (ID 959)

      09:30 - 09:30  |  Author(s): S. Yamamoto

      • Abstract

      Background
      Erlotinib and pemetrexed are recommended for the second-line treatment of non-small cell lung cancer (NSCLC). With the recommended doses determined by our previous phase I study [BMC Cancer 2012;12(1):296], we conducted a phase II study to evaluate the efficacy and safety of combination of the two agents in patients with pretreated non-squamous NSCLC.Erlotinib and pemetrexed are recommended for the second-line treatment of non-small cell lung cancer (NSCLC). With the recommended doses determined by our previous phase I study [BMC Cancer 2012;12(1):296], we conducted a phase II study to evaluate the efficacy and safety of combination of the two agents in patients with pretreated non-squamous NSCLC.

      Methods
      Patients with stage III/IV or post-surgically recurrent non-squamous NSCLC whose disease had progressed after first-line chemotherapy were enrolled. Patients received 500 mg/m[2] of intravenous pemetrexed every 21 days and 150 mg of oral erlotinib on days 2–16 until disease progression or unacceptable toxicity. The primary objective was the response rate (RR). The secondary objectives were the disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.

      Results
      A total of 27 patients, 16 males and 11 females, with the median age of 70 (range, 48–80) were enrolled. They included 21 stage IV diseases and 22 adenocarcinomas. The Epidermal growth factor receptor (EGFR) gene mutations were examined in all patients and only one patient was positive. The median number of treatment courses was 3 (range, 1 to over 19). The RR and DCR were 11.1% and 63.0%. The median PFS and OS were 2.8 months (95% confidence interval (CI); 1.9 to 7.5) and 15.8 months (95% CI; 9.3 to not available), respectively. As for safety, dermal, hepatic, gastrointestinal and hematological disorders were the frequently observed adverse events. Grade 3/4 toxicities observed in more than 15% patients were neutropenia (n = 10), anemia (n = 6), febrile neutropenia (n = 6), ande anorexia (n = 5). One patient experienced grade 3 drug-induced interstitial lung disease.

      Conclusion
      We could not demonstrate the add-on effect of intermittent erlotinib on pemetrexed in the second-line treatment of non-squamous NSCLC without EGFR mutations.

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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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      P3.10-019 - 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): S. Yamamoto

      • 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.