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K. Kishi



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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.10-022 - Prospective observational cohort study of second-line chemotherapy administration after first-line platinum-based chemotherapy for patients with advanced NSCLC in Japan (SAPPHIRE study) (ID 1438)

      09:30 - 09:30  |  Author(s): K. Kishi

      • Abstract

      Background
      In advanced non- small cell lung cancer (NSCLC), second-line chemotherapy (second-CT) after the progression of the first-line platinum-based chemotherapy (first-CT) is the standard of care. More recently, maintenance therapy after the first-CT has been reported to be beneficial. However, its impact on overall survival appears to be marginal or negligible, when most patients could receive timely active second-CT after progression. The purposes of this study are to investigate the proportion of those who actually received the second-CT, and to elucidate factors associated with its administration in advanced NSCLC patients.

      Methods
      From April 2010 to September 2011, patients with advanced NSCLC who received platinum-based first-CT at 30 institutions in Japan were enrolled in this prospective observational study. Baseline characteristics, regimens and responses to the first-CT, presence or absense of the second-CT administration, and if not administered, its reasons were recorded. This is an interim report describing patients with at least 6 months of follow up. This study was supported by the Public Health Research Center Foundation CSPOR and registered at UMIN#000006393.

      Results
      A total of 865 eligible patients with advanced NSCLC provided patient characteristics and details of the first-CT. Median age was 65 (range: 24-86), proportion of patients with adenocarcinoma/squamous/NOS/others were 70/20/8/2%, and with EGFR mutant/wild/unknown were 10/60/30%. Platinum compound used in the first-CT were: cisplatin in 38.3% of the cases, carboplatin in 57.9%, and nedaplatin in 2.8%. Of the patients with non-squamous histology, 24% received bevacizumab. At the time of cut off, 797 patients were assessable for response of the first-CT. Among them, 225 patients had either disease progression or inadequate data (NE) to the first-CT and 572 patients were evaluated CR/PR/SD; 194 (22%) received maintenance therapy, including bevacizumab. Of the 572 patients, 51 have no disease progression after the first-CT, and data are not yet available in another 13. Therefore, 508 patients were further analyzed for the administaration of the second-CT. Among those, 132 patients (26%) failed to receive the second-CT. The reasons for not receiving were as follows: declined PS, 79 (60%); patient refusal, 28 (21%); death of any cause, 6 (5%); loss of follow-up and others, 19 (14%). Explorative analysis of association between characterisics and administration of the second-CT revealed age (<65 vs ≥65, odds ratio [OR], 0.59; 95% CI, 0.39-0.90, p=0.01), PS (0 vs 1-4, OR 0.33, 95% CI 0.22-0.53, p<0.0001), and smoking status (never vs ever, OR 0.47, 95% CI 0.26-0.85, p=0.01) as possible factors.

      Conclusion
      Preliminary results of this large observational study in Japan suggested that around one-fourth of the patients missed an opportunity to receive appropriate the second-CT. Further investigation is needed to clarify optimal management of the patients after the first-CT, particularly on how to identify the patients that would be less likely to receive the second-CT after disease progression and thus would be more likely to receive benefit from maintenance therapy strategy.

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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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      P3.10-021 - Phase II Multicenter Trial of Erlotinib for Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Mutations (ID 1417)

      09:30 - 09:30  |  Author(s): K. Kishi

      • Abstract

      Background
      Erlotinib is effective for non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations and also recommended in NCCN guidelines. However, there has been a few study done on second-line therapy in NSCLC with EGFR mutations in Japan. The aim of this phase II study was to evaluate the efficacy and safety of erlotinib therapy as second-line treatment in EGFR-mutated NSCLC who was previously treated with platinum doublet.

      Methods
      NSCLC patients with EGFR mutations (exon19 or 21) who were treated with platinum doublet previously as first-line therapy were treated with daily erlotinib (150mg/ day). The primary endpoint in this phase II study was response rate (RR), and the secondary endpoints were progression-free survival time (PFS), overall survival time (OS), and safety.

      Results
      From August 2009 to February 2012, 31 NSCLC patients were eligible in this phase II study. The patient’s demographics were a median age of 65 years (range 50-75 years), 21 men and 10 women, 30 adenocarcinomas and 1 other type of cancer, 9 never-smokers and 22 former smokers, PS (ECOG) were 0 in 15, 1 in 14, 2 in 2 patients, exon19 mutation in 15 and exon21 mutation in 16, respectively. Total RR of erlotinib treatment was 61.3%. The disease control rate was 93.5%. Median PFS was 308 days and OS was not reached. Toxicities such as acne, rush and diarrhea were less than Grade 2. Treatment-related death caused by pneumonitis in one patient.

      Conclusion
      Erlotinib therapy as second-line treatment in EGFR-mutated NSCLC patients who were treated with platinum doublet previously was effective with an acceptable toxicity profile.