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T. Kato



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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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      P2.10-051 - The final analysis of prospective, feasibility study of S-1 and carboplatin combination chemotherapy for the patients with interstitial pneumonia (IP) and advanced non small cell lung cancer (NSCLC). (ID 3451)

      09:30 - 09:30  |  Author(s): T. Kato

      • Abstract

      Background
      IP is commonly concomitant disorder with lung cancer. Because IP sometimes deteriorates and results unfavorable clinical course, patients with IP are excluded from most cancer clinical trials. S-1 is a novel active oral fluoropyrimidine anticancer agent consisting of tegafur, gimeracil and oteracil potassium. Although most anti-cancer agent has pulmonary toxicity, post marketing surveillance reported S-1 has lower pulmonary toxicity incidence. We have conducted feasibility study of S-1 and carboplatin combination for patients with advanced or ineligible for other treatment modality of NSCLC patients.

      Methods
      Patients with confirmed NSCLC, clinical and radiological diagnosed interstitial pneumonia, aged 80 years old or younger, performance status 0-2 and chemo-naive patients were eligible for the study. Carboplatin (AUC 5) was administered on day 1 and S-1 (80mg/m[2]/day) on day 1 to 14 for four to six cycles. Study objectives are safety estimation especially pulmonary adverse events, and efficacy evaluation as tumor response and survival. Pulmonary adverse events were evaluated by CTCAE ver.4.0 and acute exacerbation criteria.

      Results
      From March 2009 to December 2011, 21 patients were enrolled. Male/female: 19/2, age: 67(55 to 77), adeno/squamous/adenosquamous: 10/10/1, stage IIB/IIIA/IIIB/IV/rec.: 1/2/10/4/4, PaO2 at rest: 70.6(51.4 to 96.7) mmHg, %VC: 91.0 (69.0 to 119.0), %DLco; 63.4(48.1 to 90.4). Treatment delivery cycles 1/2/3/4/5/6: 3/3/2/10/2/1. PR/SD/PD/NE: 7/7/4/3 (RR 33%, DCR 67%), the median progression free survival was 4.0 months and the median overall survival was 10.4 months. During the treatment, two patient experienced moderate level of acute deterioration of IP, one patient experienced infectious pneumonia, all these patients recovered from the event. Acute exacerbation rate were estimated as 9.5% with 22.1% of upper limit of 95% C.I. There was no treatment related death. After first line treatment, four patients experienced acute exacerbation of IP, two during second line treatment, one during immune therapy, and another during no treatment period. From begging of first line chemotherapy, 6 out of 21 patients (29%) experienced some forms of acute exacerbation of IP during any treatment or observational periods. Besides pulmonary toxicity, the profile of hematological and non hematological toxicities was similar to past studies.

      Conclusion
      First and largest prospective trial for the patients with IP and NSCLC was completed. The study revealed S-1 and carboplatin combination was feasible and active even in patients with IP and NSCLC who are usually excluded from clinical trials. Acute exacerbation of IP was observed during not only fist line treatment but also latter line or observational period.