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


ABSTRACT: 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.

SUBMITTER: Joseph RW 

PROVIDER: S-EPMC6916264 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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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 RW   Elassaiss-Schaap Jeroen J   Kefford Richard R   Hwu Wen-Jen WJ   Wolchok Jedd D JD   Joshua Anthony M AM   Ribas Antoni A   Hodi F Stephen FS   Hamid Omid O   Robert Caroline C   Daud Adil A   Dronca Roxana R   Hersey Peter P   Weber Jeffrey S JS   Patnaik Amita A   de Alwis Dinesh P DP   Perrone Andrea A   Zhang Jin J   Kang S Peter SP   Ebbinghaus Scot S   Anderson Keaven M KM   Gangadhar Tara C TC  

Clinical cancer research : an official journal of the American Association for Cancer Research 20180423 20


<b>Purpose:</b> 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).<b>Experimental Design:</b> 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 re  ...[more]

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