Author of

• 11794

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  P2.12 - Poster Session 2 - NSCLC Early Stage (ID 205)

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

  • 11803

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    P2.12-009 - Adjuvant chemotherapy with oral vinorelbine used in doublet with carboplatin in non-small cell lung cancer after radical resection - tolerability and short term survival. (ID 1244)

    09:30 - 09:30  |  Author(s): J. Roubec
    • Abstract

    Background
    Adjuvant cisplatinum-based chemotherapy is recommended for routine use in patients with stages IIA, IIB, and IIIA of non small-cell lung cancer (NSCLC) after radical resection. Results in stage IB were not conclusive. Vinorelbine is a preferable drug in this indication and a randomized study proved the comparable effectiveness and tolerability of vinorelbine given both orally or intravenously (i.v.) in advanced NSCLC, meanwhile oral vinorelbine gives better comfort to patients. Only few studies evaluated the position of vinorelbine in doublet with carboplatin (CBDCA) none of them used oral vinorelbine in this doublet as adjuvant chemotherapy (ACT).

    Methods
    This prospective multicentre study evaluates the feasibility, toxicity and short time survival of ACT based on CBDCA (AUC 5) with oral vinorelbine after radical resection. Vinorelbine was applied orally 80 mg/m[2] D1 and D8 after the first cycle of 60mg/m[2]. ACT (4 cycles of 21 day regimen) was applied to patients with stage IB, II, and IIIA of NSCLC (6[th] TNM revision) in 16 centres. Therapy was applied from the 1[st] of April 2009 to the 28[th] of February 2010. Median of follow-up period was 31 months Histology of tumor, type of surgery, grading, visceral pleura and angio-invasion were evaluated as potencial predictors of survival.

    Results
    ACT was applied to 104 eligible patients (72 men, 32 women, median of age 64 years). Out of them 41 were smokers, 57 ex-smokers and 5 non smokers. Surgically determined stages were IB in 32 pts, II in 36 pts and IIIA in 36 pts. Altogether 399.5 cycles (mean no 3.82) were administered, 86,5 % of patients finished four cycles of planned ACT. The reasons for 14 (13.5%) patients ending ACT prematurely were hematological toxicity in 8 pts, non-hematological toxicity in 3 pts, other reasons in 3 pts . Relative dose intensity (RDI) was 80.8% for vinorelbine and 95.4% for CBDCA. The most frequent WHO grade 3/4 of toxicity were neutropenia in 10.6%, leucopenia in 5.6%, anemia in 1.3%, thrombocytopenia in 1.3%, alopecia in 3.3%, nausea in 4.8%, neurotoxicity, nephrotoxicity, diarrhoea and mucositis in 0.3%. During the median of follow-up period, 45 (43.2%) pts died and 38 (36.5%) out of them died on lung cancer. Median DFS was 29.1 months, 2-year survival was 70.6%, 2.5-year survival was 63.9%. Predictors of significantly better DFS and 2.5 year survival were stage IB (p = 0.0045) and lobectomy (p = 0.0465). Trend of better DFS and 2.5 year survival was observed in cases without angioinvasion and pleural invasion.

    Conclusion
    Applied ACT had excellent tolerability, high RDI was achieved and preliminary parameters of survival are acceptable. Study is ongoing and long term survival results will be evaluated in the future. This study was supported by Grant NT- 13569 and NS-9959-3 of the Czech Ministry of Health