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

  • 11702

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    P2.10-010 - Full oral vinorelbine (NVBO) on D1 and D8 with carboplatin (CBDCA) as first line treatment in advanced non-small lung cancer (NSCLC) patients: results of a prospective study in nonrandomized and unselected population of 396 patient (ID 911)

    09:30 - 09:30  |  Author(s): O. Venclicek
    • Abstract

    Background
    Lung cancer is the leading cause of cancer mortality in the Czech Republic. Approximately 80%are NSCLC and 65% of patients have advanced disease at the time of diagnosis. Most patients who receive first-line chemotherapy experience disease progression within 3 to 6 months of initiating therapy and the median survival time observed is 8 to 10 months. In this situation, there is a need to find effective therapeutic regimen with an administration as simple as possible and the most favorable toxicity profile. The purpose of this study was to evaluate the activity and feasibility of CBDCA together with full oral vinorelbin (NVBO).

    Methods
    Patients with advanced NSCLC received NVBO 80 mg/m² on D1 and D8 with CBDCA AUC5 on D1 every three weeks. In stage III, chemotherapy was followed by external radiotherapy. The outcomes include following: response, median overall survival (mOS) and median progression free survival (mPFS). Response was assessed by imaging techniques after 4-6 weeks of treatment and was confirmed one month later by chest X-ray and/or CT scanning. The difference in response relative to baseline characteristics was determined using Pearson Chi-square test. Differences in OS and PFS relative to baseline characteristics were evaluated for significance using Log-rank test.

    Results
    396 patients were treated: 311 men (78,5) and 50 women (21,5%), median age 65 years. ECOG performance status at inclusion was PS 0 in 51 (12,9% patients, PS 1 in 287 (72,7%) and PS 2 in 57 (14,4%) patients. Most patients had stage IIIB 116 (29,3%) and stage IV NSCLC 257 (64,9), only 32 (5,84%) were stage IIIA . Adenocarcinoma was confirmed in 90 patients (22,7%), squamous-cell carcinoma in 238 (60,1%), large-cell carcinoma 11 and other in 57 (17,2%). Complete response was confirmed in 2 (0,5%) patient, partial response in 136 (34,3%), stable disease in 104 (26,3%), 154 (38,9%) patients progressed. The regimen was well tolerated. Median cycles was 4, the dosage of NVBO was without changes in 268 (67,7%) patients, the dosage of NVBO was reduced in 28 (7,1%) and escalated in 77 (19,48%). In 23 (5,8%)of patients was the dosage of NVBO reduced after escalation. Major toxicities (Grade 3-4) were neutropenia in 29%, leucopenia in 20,8%, anemia in 3,3% and thrombocytopenia in 1,8% patients. Febrile neutropenia was observed in 6,1% patients. Gastrointestinal toxicity grade 3-4 was observed in 4,6% patients. The mPFS was 7,4 moths and mOS was 9,92 months by median follow-up 8,5 months. The differences between groups of pts according to PS (0+1 vs. 2) were statistically significant (p < 0,001) better for patiens with PS 0+1. The differences between groups of pts according histology were not statistically significant (p=0,3975).

    Conclusion
    In this group of 396 unselected patients with advanced NSCLC was the treatment with full NVBO and-CBDCA in first line more convenient and well tolerated with evidence of high antitumour activity. This combination was active in all groups patients according histology (mOS was 9,92 and mPFS was 7,4 months). Statistically significant better were the results in patients with PS 0+1.