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N. Cherny



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    MS 27 - Advocacy in Practice (ID 45)

    • Event: WCLC 2015
    • Type: Mini Symposium
    • Track: Advocacy
    • Presentations: 1
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      MS27.02 - Incorporating Quality of Life & Palliative Care Measures in Clinical Trial Designs (ID 1969)

      14:15 - 15:45  |  Author(s): N. Cherny

      • Abstract
      • Presentation
      • Slides

      Abstract:
      Evidence for clinical benefit from new treatment approaches is derived from phase III randomised clinical trials, which generate ostensibly unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. The potential benefits of a new treatment can be summarised as either living longer and/or living better, evaluated in clinical studies through the treatment effect on overall survival (OS) and/or quality of life (QoL), and their surrogates. In studies of interventions with curative intent in which mature survival data is not yet available disease-free survival (DFS), recurrence-free survival (RFS), event-free survival (EFS), distant disease free survival (DDFS), and time to recurrence (TTR), are used as surrogate measures. The validity of this approach, though not uncontroversial is well supported by data. In studies evaluating therapies in non-curative settings, progression-free survival (PFS), and time to progression (TTP) provide information about biological activity and may indicate benefit for some patients however they are not reliable surrogates for improved survival or QoL. Indeed in studies in which PFS benefit is observed, but because of subsequent treatments or crossover OS is not improved, QoL data is critical to evaluate the real meaning of the PFS. When QoL has been evaluated and there is either improvement or delayed deterioration this augments the significance of the PFS finding. Where is measured and PFS does not demonstrate improvement in QoL, this diminishes from the meaning of the PFS finding. QoL measurement has been widely adapted in the recent generation of lung cancer research and it has made a major contribution in verifying and amplifying the major clinical benefit conferred by Gefitinib, Afatanib and Crizotinib all of which were evaluated in PFS studies with crossover allowed. QoL has also been a critical primary outcome in an important study that demonstrated the QoL can be improved by initiating early palliative care for patients with metastatic lung cancer. 1. Fukuoka M, Wu Y-L, Thongprasert S et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non–small-cell lung cancer in Asia (IPASS). Journal of Clinical Oncology 2011; 29: 2866-2874. 2. Mok TS, Wu Y-L, Thongprasert S et al. Gefitinib or carboplatin–paclitaxel in pulmonary adenocarcinoma. New Engl J Med 2009; 361: 947-957. 3. Sequist LV, Yang JC-H, Yamamoto N et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. Journal of Clinical Oncology 2013; 31: 3327-3334. 4. Yang JC-H, Hirsh V, Schuler M et al. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. Journal of Clinical Oncology 2013; 31: 3342-3350. 5. Shaw AT, Kim D-W, Nakagawa K et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. New Engl J Med 2013; 368: 2385-2394. 6. Solomon BJ, Mok T, Kim DW et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. The New England journal of medicine 2014; 371: 2167-2177. 7. Temel JS, Greer JA, Muzikansky A et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 2010; 363: 733-742.

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