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Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab.

Joseph, Richard W; Elassaiss-Schaap, Jeroen; Kefford, Richard; Hwu, Wen-Jen; Wolchok, Jedd D; Joshua, Anthony M; Ribas, Antoni; Hodi, F Stephen; Hamid, Omid; Robert, Caroline; Daud, Adil; Dronca, Roxana; Hersey, Peter; Weber, Jeffrey S; Patnaik, Amita; de Alwis, Dinesh P; Perrone, Andrea; Zhang, Jin; Kang, S Peter; Ebbinghaus, Scot; Anderson, Keaven M; Gangadhar, Tara C.
Clin Cancer Res; 24(20): 4960-4967, 2018 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-29685882

PURPOSE:

The purpose of this study was to assess the association of baseline tumor size (BTS) with other baseline clinical factors and outcomes in pembrolizumab-treated patients with advanced melanoma in KEYNOTE-001 (NCT01295827).

EXPERIMENTAL DESIGN:

BTS was quantified by adding the sum of the longest dimensions of all measurable baseline target lesions. BTS as a dichotomous and continuous variable was evaluated with other baseline factors using logistic regression for objective response rate (ORR) and Cox regression for overall survival (OS). Nominal P values with no multiplicity adjustment describe the strength of observed associations.

RESULTS:

Per central review by RECIST v1.1, 583 of 655 patients had baseline measurable disease and were included in this post hoc analysis. Median BTS was 10.2 cm (range, 1-89.5). Larger median BTS was associated with Eastern Cooperative Oncology Group performance status 1, elevated lactate dehydrogenase (LDH), stage M1c disease, and liver metastases (with or without any other sites; all P ≤ 0.001). In univariate analyses, BTS below the median was associated with higher ORR (44% vs. 23%; P < 0.001) and improved OS (HR, 0.38; P < 0.001). In multivariate analyses, BTS below the median remained an independent prognostic marker of OS (P < 0.001) but not ORR. In 459 patients with available tumor programmed death ligand 1 (PD-L1) expression, BTS below the median and PD-L1-positive tumors were independently associated with higher ORR and longer OS.

CONCLUSIONS:

BTS is associated with many other baseline clinical factors but is also independently prognostic of survival in pembrolizumab-treated patients with advanced melanoma. Clin Cancer Res; 24(20); 4960-7. ©2018 AACR See related commentary by Warner and Postow, p. 4915.
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