Author of

• 11692

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

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11714

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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. Goto
    • 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.