RECIST 1.1 for Response Evaluation Apply Not Only to Chemotherapy-Treated Patients But Also to Targeted Cancer Agents: A Pooled Database Analysis.

Autor:	Litière S; 1 European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium., Isaac G; 1 European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium., De Vries EGE; 2 University Groningen, Groningen, the Netherlands., Bogaerts J; 1 European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium., Chen A; 3 National Cancer Institute, Bethesda, MD., Dancey J; 4 Queen's University, Kingston, Ontario, Canada., Ford R; 5 Clinical Trials Imaging Consulting, Belle Mead, NJ., Gwyther S; 6 East Surrey Hospital, Redhill, United Kingdom., Hoekstra O; 7 Vrije Universiteit Medical Center, Amsterdam, the Netherlands., Huang E; 3 National Cancer Institute, Bethesda, MD., Lin N; 8 Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA., Liu Y; 1 European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium., Mandrekar S; 9 Mayo Clinic, Rochester, MN., Schwartz LH; 10 Columbia University Medical Center and New York Presbyterian Hospital, New York, NY., Shankar L; 3 National Cancer Institute, Bethesda, MD., Therasse P; 11 Institut de Recherche International Servier, Paris, France., Seymour L; 4 Queen's University, Kingston, Ontario, Canada.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2019 May 01; Vol. 37 (13), pp. 1102-1110. Date of Electronic Publication: 2019 Mar 12.
DOI:	10.1200/JCO.18.01100
Abstrakt:	Purpose: The mode of action of targeted cancer agents (TCAs) differs from classic chemotherapy, which leads to concerns about the role of RECIST in evaluating tumor response in trials with TCAs. We investigated the performance of RECIST using a pooled database from 50 clinical trials with at least one TCA. Methods: We examined the impact of the number of target lesions (TLs) on within-patient variability of tumor response. The prognostic effect of TL response (at 12 weeks or on study on the basis of a maximum five TLs) on survival was studied through landmark and time-dependent Cox models adjusted for baseline tumor load, occurrence of new lesions, or unequivocal progression of nontarget disease. Results: Data were obtained from 23,259 patients with cancer (36% lung, 28% colorectal, 11% breast, and 25% other); 15,620 received TCAs, predominantly transduction or angiogenesis inhibitors, as a single agent (37%), combined with other TCAs (7%), or as chemotherapy (56%); 28% received chemotherapy only; and 5% received best supportive care or placebo. A total of 17,222 patients contributed to the analyses. Within-patient variability decreased with increasing number of TLs, similarly for TCAs (with/without chemotherapy) and chemotherapy only. Mixed responses occurred proportionally in all treatment classes. Landmark analyses showed an ordinal relationship between percentage change from baseline to 12 weeks and overall survival, and demonstrated a clear distinction between tumor shrinkage and progressive disease according to RECIST. Time-dependent analysis showed no marked improvement in the ability to predict survival on the basis of TL tumor growth compared with nontarget progression or new lesion occurrence, regardless of treatment. Similar results were seen for major tumor types and different classes of TCAs. Conclusion: This work reinforces that RECIST version 1.1 perform well for response assessment of TCAs.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu