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: 2
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11715

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    P2.10-023 - Feasibility study of pemetrexed (PEM) plus bevacizumab (BV) as the first-line treatment for elderly advanced or recurrent non-squamous (non-Sq) non-small cell lung cancer (NSCLC): TORG1015. (ID 1487)

    09:30 - 09:30  |  Author(s): T. Ogura
    • Abstract

    Background
    The addition of BV to cytotoxic agent(s) prolonged survival for non-Sq NSCLC patients (pts). However, there is no definitive evidence for the cytotoxic agent(s) plus BV is superior to the cytotoxic agent(s) alone for elderly non-Sq NSCLC. We conducted the feasibility study of PEM plus BV as the first-line treatment for elderly advanced or recurrent non-Sq NSCLC.

    Methods
    Major eligibility and exclusion criteria were followings; chemotherapy-naïve; unfit for bolus combination chemotherapy; stage III/IV or relapsed non-Sq NSCLC; age≥70; PS 0-1; no evidence of brain metastasis; no history of hemoptysis and irradiation for thorax. PEM (500mg/m[2]) and BV (15mg/kg) were administrated intravenously on day 1 every 3 weeks. The primary endpoint was toxicity and the secondary endpoints were objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and the percentage of pts who completed more than 3 cycles.

    Results
    From November 2010 to April 2012, total 12 pts were enrolled. Patients characteristics were following; Male/Female=6/6; Median age (range) 78 (72-81); Histology was all adenocarcinoma; Activating EGFR mutation No/Yes/unknown=9/2/1; Stage IIIB/IV/Recurrence=2/8/2; ECOG PS 0/1=6/6; Smoking History Yes/No=6/6. Severe toxicities (Grade 3≥) were leukopenia (25%), neutropenia (25%), anemia (8%), thrombocytopenia (8%), febrile neutropenia (8%), anorexia (8%), hypertension (8%), fatigue (8%), nausea (8%), and perforation (colon) (8%). No dose-limiting toxicity and treatment-related death was occurred. Three patients achieved PR and the ORR was 25%. The median PFS and OS were 5.6 months (mo) (95% C.I. 1.1-7.9 mo) and 10.3 mo (95% C.I. 6.9-15.6 mo) in 11 evaluated pts, respectively. The 1-year survival rate was 49% (95% C.I. 12-79%). Seven of 12 pts (58%) received more than 3 cycles.

    Conclusion
    PEM plus BV as first-line treatment for elderly non-Sq NSCLC was well tolerable and promising.

  • 11743

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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. Ogura
    • 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.