Author of

• 10743

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  P1.10 - Poster Session 1 - Chemotherapy (ID 204)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10759

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    P1.10-016 - TULUNG registry: Analysis of data from PS 0-1 patients with advanced/metastatic non-squamous NSCLC (adenocarcinoma, large cell carcinoma) treated in second line with pemetrexed (ID 962)

    09:30 - 09:30  |  Author(s): K. Kosatova
    • Abstract

    Background
    The TULUNG registry is an independent national non-interventional clinical registry, focused on collection and analysis of epidemiologic and clinical data of non-small cell lung cancer (NSCLC) patients who have been treated with pemetrexed (Alimta®), erlotinib (Tarceva®), gefitinib (Iressa®) and/or bevacizumab (Avastin®) in 10 centers of complex thoracic oncology care in the Czech Republic. The report is based on data analysis of 476 advanced/metastatic non-squamous (adenocarcinoma or large cell carcinoma) NSCLC patients, who had good performance status (PS 0-1), were treated with pemetrexed in the second line of treatment, and whose data were recorded in TULUNG registry as of March 18, 2013.

    Methods
    There were analyzed baseline demographic data, information about treatment aministered and efficacy and safety clinical outcomes of pemetrexed second line treatment in this selected registry patient population, using descriptive statistics.

    Results
    In analyzed group of 476 patients slightly prevailed men (56.9%) over women, median age at start of pemetrexed treatment was 62 years (range 27-81 let). Majority of patiens were current smokers and ex-smokers (41.0% and 32.8% resp.). 95% of tumours had adenocarcinoma histology. Vast majority of analyzed patiens (87.4%) had metastatic disease at start of second line pemetrexed treatment, the rest had stage IIIb. 83.8% of patiens had ECOG PS 1 at start of second line pemetrexed treatment and 87.4% of patiens received pemetrexed in monotherapy. At the moment of analysis, pemetrexed treatment was already terminated in 408 patients out of 476 patients (the most frequent reasons for discontinuation of treatment were disease progression in 56.9% and planned completion of treatment in 28.2%), treatment was at moment of analysis ongoing in 68 patients. Median duration of treatment with pemetrexed was 12.3 weeks (corresponds with 4 cycles). When focusing on the subset of patients with finished pemetrexed treatment, the disease control rate (i.e. CR+PR+SD) was reported in 59.6% of patients, while progressive disease (PD) was reported in 33.3%. For 7,1% of patiens there were missing data on treatment response. Median overall survival was 11.3 months (95% CI 9.6 – 13.0) and median progression-free survival was 3.3 months (95% CI 2.7 – 3.8). 1-year survival rate from start of pemetrexed treatment was 47,5%. Adverse events were reported to registry for 21.8% of pemetrexed treated patiens from analysed population. The most frequent (>5% patients) reported adverse events were neutropenia (9.7%), anemia (6.5%), leukocytopenia (6.1%), and fatigue (6.1%).

    Conclusion
    Reported efficacy and safety outcomes from registry are more favourable than results of published controlled randomized registrational trial. It probably reflects the different methodology of data collection and more prudent approach to patient selection for pemetrexed second line treatment in real clinical practice in the Czech Republic in participating centers. Based on registry data, pemetrexed treatment was in suitable patiens with good PS very well tolerated (78.2% of patiens without reported adverse events in registry) and allowed for reaching disease control in almost 60% of treated patiens, with median OS approaching one year from starting second line therapy.

• 12648

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  P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

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

  • 12657

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    P3.11-009 - Tulung registry: data analysis of patients with non-squamous NSCLC (adenocarcinoma, large cell carcinoma) and PS 0-1 treated with erlotinib in second line setting (ID 971)

    09:30 - 09:30  |  Author(s): K. Kosatova
    • Abstract

    Background
    We conducted a systematic review of data from patients reported in the TULUNG registry (data cut-off 18-Mar-13). The TULUNG registry prospectively collects data from all NSCLC patients treated by erlotinib in the Czech Republic.

    Methods
    Our analysis was performed on a subgroup of patients with non-squamous NSCLC (adenocarcinoma or large-cell carcinoma) with good performance status (PS 0-1), treated with erloninib in a second-line setting.

    Results
    521 of 2365 patients reported in the the TULUNG registry met the above-mentioned criteria. Of 521 patients analyzed, 51,2% were female; the median age at erlotinib treatment initiation was 64 years (range 29-88). The majority of patients were smokers and ex-smokers (34.4% and 34.0% respectively) and 93.1% of tumours were adenocarcinomas by histology. 86.1% patients were at the metastatic stage at the initiation of second-line erlotinib treatment, 12.8% of patients were in stage IIIb and only 1.1% of patients in stage IIIa. The majority of patients (87.7%) was in PS 1 at the initiation of second-line erlotinib treatment. From 521 of all analyzed patients, erlotinib therapy was terminated in 410 (78.7%) patients at data cut-off (the most frequent reasons for termination were disease progression, in 74.6% and death in 11.5% of patients) and treatment was ongoing in 111 (21.3%) patients. In 410 of patients with terminated treatment, the median duration of treatment was 3.0 months (95% CI 0.7 – 16.9), ORR assessment showed CR in 0.7%, PR in 8.3% and SD in 54.6% of patients. Median progression free survival was 4.0 months (95% CI 3.5 – 4.5), median overall survival 11.8 months (95% CI 9.6 – 14.0). 1-year survival from erlotinib treatment initiation was 49.4%. Adverse events were reported in 42.8% of patients, the most frequently reported adverse events (in >5% of patients) were skin toxicity (35.3%) and diarrhea (13.6%). Grade ≥3 adverse events were reported in 10.5% of patients, G≥3 skin toxicity 7.5% and G≥3 diarrhea in 1.3% of patients.

    Conclusion
    Erlotinib therapy of advanced metastatic adenocarcinoma or large cell carcinoma in a second-line setting was very well tolerated in eligible patients with PS 0-1; only 3.4% of patients had to discontinue erlotinib therapy due to adverse effects. In patients with completed erlotinib therapy 63.6% disease control rate was reached with a median survival of approximately 1 year from initiation of second-line erlotinib therapy.