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K. Taipale



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    MO24 - NSCLC - Chemotherapy III (ID 110)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO24.08 - Survival outcomes among NSCLC patients in Europe receiving platinum-based therapies as first-line treatment: results from the FRAME observational study (ID 1944)

      11:10 - 11:15  |  Author(s): K. Taipale

      • Abstract
      • Presentation
      • Slides

      Background
      FRAME was a European non-interventional prospective observational study of patients with advanced or metastatic non-small cell lung cancer (NSCLC) initiating platinum-based therapies as first-line treatment (FLT).

      Methods
      Patients were enrolled between April 2009 and February 2011. Consenting adult NSCLC (Stage III/IV) patients initiating FLT with a platinum-based doublet chemotherapy, with or without an additional targeted agent, were eligible for the study. The choice of FLT was left to physician discretion, as per routine clinical practice. The primary objective of FRAME was to evaluate overall survival (OS) among different platinum-based treatment cohorts in patients with and without additional targeted therapy. Secondary objectives included the evaluation of OS in patients with different histological subtypes of NSCLC. Survival outcomes were assessed using Kaplan-Meier analysis, and unadjusted estimates are presented.

      Results
      A total of 1564 eligible patients from 11 EU countries were observed. Patient cohorts were: pemetrexed + platinum, gemcitabine + platinum, vinorelbine + platinum, taxanes + platinum and other therapy + platinum. Table 1 shows a subset of baseline patient characteristics, which varied across several parameters in the treatment cohorts, including age, performance status (PS), stage and histology. The median OS across the 4 main treatment cohorts was 10.3 months (95% CI: 9.5-11.2). A subset of overall survival estimates in the different treatment cohorts is shown in Table 1.

      Table 1. Select baseline patient characteristics and overall survival
      Baseline Patient Characteristics Overall Survival Estimates (unadjusted)
      Treatment Cohort[a] Age ≥70 Years (%) ECOG PS of 2/3 (%) Stage IV (%) Non-squamous Histology (%) All patients Median OS in Months (95% CI) Non-squamous Median OS in Months (95% CI) Non-squamous Cisplatin[b] Median OS in Months (95% CI)
      Pemetrexed + Platinum[b ](n=569) 23 18 86 97 10.7 (9.4-12.3) [n=569] 10.6 (9.4-12.0) [n=553] 11.6 (9.9-13.8) [n=374]
      Gemcitabine + Platinum[b] (n=360) 35 11 74 56 10.0 (8.4-11.8) [n=360] 8.4 (7.0-10.6) [n=201] 8.4 (6.7-10.8) [n=107]
      Taxanes + Platinum[b ](n=295) 36 23 75 64 9.1 (8.0-11.3) [n=295] 8.1 (7.4-10.1) [n=189] 9.6 (7.1-14.1) [n=44]
      Vinorelbine + Platinum[b] (n=300) 28 15 67 53 10.7 (8.9-12.8) [n=300] 10.1 (8.0-13.1) [n=160] 9.9 (7.2-13.4) [n=91]
      [a]A fifth cohort, the ‘other’ + platinum cohort contained a small number of subjects (n=40) and it was not included in the analyses presented here [b]Cisplatin is the platinum agent in the EMA approved prescription drug label

      Conclusion
      This observational study of first-line treatment for advanced NSCLC provides data describing patients and their survival outcomes in a real-world European practice setting between 2009 and 2012.

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-002 - Resource utilization of NSCLC patients receiving platinum-based therapies across Europe; results from the FRAME observational study (ID 183)

      09:30 - 09:30  |  Author(s): K. Taipale

      • Abstract

      Background
      FRAME was a non-interventional, prospective observational study of advanced or metastatic non-small cell lung cancer (NSCLC) patients initiating first-line treatment (FLT) with platinum-based therapies in a routine practice setting across 11 European countries.

      Methods
      Patient enrollment occurred between April 2009 and February 2011. Consenting adults with Stage IIIB or IV NSCLC receiving platinum-based doublet chemotherapy with or without an additional targeted agent as FLT were eligible for this study. Patients were under routine treatment for NSCLC by their doctors and treatment choice and resource use were at the discretion of the treating physician. Secondary objectives of the study included determining resource use during FLT. Hospitalizations, outpatient visits, concomitant therapy use, transfusions and the use of colony stimulating factors (CSFs) are reported here. Cohorts were not adjusted for multivariate parameters prohibiting statistical comparisons.

      Results
      Evaluable patients (n=1564) were categorized into 4 main cohorts based on their FLTs: pemetrexed + platinum (n=569), gemcitabine + platinum (n=360), taxanes + platinum (n=295) or vinorelbine + platinum (n=300). Forty of the evaluable patients received other platinum-doublet treatments and were excluded from the analyses presented here.Across the four main cohorts, 55% of patients were hospitalized.A majority (61%) of hospitalizations were preplanned (71% in the pemetrexed cohort, 45% in the gemcitabine cohort, 67% in the taxanes cohort and 53% in the vinorelbine cohort). Among the unplanned hospitalizations, 54% were related to an adverse event (54% in the pemetrexed cohort, 54% in the gemcitabine cohort, 55% in the taxanes cohort, and 55% in the vinorelbine cohort). The mean (95%-confidence interval) duration of hospitalizations was 13 days (11.6 to 14.6) for pemetrexed (median=9 days), 11 days (9.4 to 12.8) for gemcitabine (median=7 days),17 days (14.0 to 19.7) for taxanes (median=12 days), and 13 days (11.3 to 15.0) for vinorelbine (median=9 days). Nearly half of patients (47%) were seen in an outpatient setting with most outpatient visits (82%)planned for scheduled treatments. Nineteen percent of patients received ≥1 transfusion (16% in the pemetrexed cohort, 24% in the gemcitabine cohort, 15% in the taxanes cohort and 24% in the vinorelbine cohort). Nearly all (94%) of these patients received packed red blood cells. Nineteen percent of patients received ≥1 colony stimulating factor (CSF), which included G-CSF (69%), or erythropoietin (39%). During therapy, 82% of patients used antiemetics and antinauseants, 58% used steroids, 40% used analgesics, and 24% used antibiotics. Twenty-eight percent of patients received radiation during FLT and most often radiation was delivered concurrently with chemotherapy (66% overall, 66% in the pemetrexed cohort, 54% in the gemcitabine cohort, 68% in the taxanes cohort, and 73% in the vinorelbine cohort).

      Conclusion
      The FRAME study provides unique, real-life data reflecting prospectively collected information on resource use not accessible in a clinical trial setting. This study revealed several important findings regarding real-world resource use during NSCLC therapy including data on hospitalizations, outpatient visits, transfusions, concomitant treatments, and radiation.