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Y. Ohashi



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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-011 - Observational study of treatment of epidermal growth factor receptor activating mutation positive (EGFRm+) advanced or recurrent non-small-cell lung cancer (NSCLC), after radiological progression to the first-line therapy with EGFR tyrosine kinase inhibitors (EGFR-TKI). (ID 1077)

      09:30 - 09:30  |  Author(s): Y. Ohashi

      • Abstract

      Background
      Although NSCLC with activating EGFR mutation is generally sensitive to EGFR-TKI, such as gefitinib or erlotinib, it eventually gets acquired resistance. However, the clinical course after radiological (RECIST-based) “progressive disease (PD) judgment" is highly variable. Some patients are reported to do well with continuation of TKI beyond PD, with or without local therapy. But, prior reports are only on small-numbered and selected cases. The objective of this study is to investigate the clinical course and the actual pattern of care after radiological "progressive disease" to the first-line therapy with EGFR-TKI in such cases.

      Methods
      Thirty-four institutions in Japan participate in the survey of the patterns of care and outcomes of the patients with EGFRm+ advanced or recurrent NSCLC, who received first-line gefitinib or erlotinib during the period from 2009 to 2011. The primary endpoint is the time from RECIST-based radiological PD to clinical PD in patients who were continuously received EGFR-TKI beyond “RECIST PD”. Clinical PD was defined as one or more of the following events: 1) symptomatic progression, 2) worsening of performance status due to progression, 3) threat to major vital organ(s), 4) multi-organ unequivocal progression. Durations of TKI administration and reasons of discontinuation (RECEIST PD vs. clinical PD vs. toxicity), concomitant administration of chemotherapy and/or local therapy with TKI, occurrence of “flare” phenomenon after TKI stoppage, and overall survival were also recorded.

      Results
      At the time of the abstract submission, 24 institutions reported the number of patients. There were 1,177 patients (395 in 2009, 397 in 2010 and 385 in 2011) with EGFRm+ advanced or recurrent NSCLC. Among them, 602 (51.1%) received first-line EGFR-TKI. The median number of EGFRm+ patients per institution was 32 (range: 9 to 151). The rates of those who received first-line TKI varied substantially among institutions, ranging from 30% to 88%, and tended to increase over time (41.0% in 2009, 56.9% in 2010 and 55.6% in 2011). In 2009, there were no institutions which administered TKI to every EGFRm+ patient, whereas there were 1 and 3 such institutions in 2010 and 2011, respectively.

      Conclusion
      In this large observational study, we will collect data on approximately 1,600 patients with EGFRm+ NSCLC, some 800 of them received first-line EGFR-TKI. Since the median progression-free survival of those patients with TKI has generally been reported to be 1 year or less, we will be able to see the pattern of care and outcome after PD in the majority of the cases. Clinical significance of continuation of EGFR-TKI “beyond PD” in the real world will be clarified. This research was conducted by Comprehensive Support Project for Oncology Research (CSPOR) of Public Health Research Foundation. The research fund was provided to CSPOR with support from an Investigator Sponsored Study Programme of AstraZeneca. Trial registry with UMIN#000010538.

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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): Y. Ohashi

      • 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.