Cancer immunotherapy in second-line treatment of non-small cell lung cancer – is there a need to change the approach to the assessment of clinical benefits?
Journal Title: JOURNAL OF HEALTH POLICY & OUTCOMES RESEARCH - Year 2017, Vol 2, Issue 2
Abstract
Background: The mechanism of action distinctive for immunotherapy leads to the specific pattern of tumour response, different form the one observed with cytotoxic therapy. To enable a complete assessment of immunotherapeutic agents modified criteria for the evaluation of antitumour responses were developed, mainly on the basis of the ipilimumab trials in melanoma. Methods: We conducted a review of RCTs that assessed PD-1/PD-L1 checkpoint inhibitors in previously treated patients with NSCLC, to describe the overall survival results in comparison to the progression-free survival outcomes, as assessed with conventional RECIST and/or with modified criteria of tumour response. Results: Five RCTs were eligible. The studies were heterogeneous with respect to population characteristics and other methodological features. All of the trials showed significant OS improvement in the immunotherapy arms, with the results in the histology and PD-L1-expression subgroups consistent with ITT analyses. The OS gain was not accompanied with the evidence of PFS prolongation. The use of the modified criteria resulted in prolonged median PFS estimates in the immunotherapy-treated patients. Conclusion: Our results in second-line NSCLC population are in line with the previous findings, that the conventional RECIST criteria do not fully capture the benefit of the immunotherapy. In the routine practice the premature diagnosis of a progressive disease may result in treatment withdrawal in patients that might benefit from the continuation of the immunotherapy. Further research and the agreement on the relevant modified criteria are needed for the use in the future immunotherapy clinical trials and to inform real-world clinical decisions.
Authors and Affiliations
Anna Panasiuk, Rafał Wójcik, Małgorzata Budasz-Świderska, Marcin Kaczor
Keywords
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- EP ID EP326205
- DOI 10.7365/JHPOR.2017.2.9
- Views 86
- Downloads 0
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