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. 2018 Oct 15;24(20):4960-4967.
doi: 10.1158/1078-0432.CCR-17-2386. Epub 2018 Apr 23.

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

Richard W Joseph #  1 , Jeroen Elassaiss-Schaap #  2 , Richard Kefford  3   4 , Wen-Jen Hwu  5 , Jedd D Wolchok  6 , Anthony M Joshua  7   8 , Antoni Ribas  9 , F Stephen Hodi  10 , Omid Hamid  11 , Caroline Robert  12 , Adil Daud  13 , Roxana Dronca  14 , Peter Hersey  15 , Jeffrey S Weber  16 , Amita Patnaik  17 , Dinesh P de Alwis  18 , Andrea Perrone  18 , Jin Zhang  19 , S Peter Kang  18 , Scot Ebbinghaus  18 , Keaven M Anderson  19 , Tara C Gangadhar  20
Affiliations

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

Richard W Joseph et al. Clin Cancer Res. .

Erratum in

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.

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Figures

Figure 1.
Figure 1.. Relationship between baseline tumor size and survival.
(A) Kaplan-Meier estimate of OS. (B) Baseline tumor size as a continuous effect on OS. CI, confidence interval; HR, hazard ratio; OS, overall survival.
Figure 1.
Figure 1.. Relationship between baseline tumor size and survival.
(A) Kaplan-Meier estimate of OS. (B) Baseline tumor size as a continuous effect on OS. CI, confidence interval; HR, hazard ratio; OS, overall survival.
See this image and copyright information in PMC

Comment in

References

    1. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649–55. - PubMed
    1. Balch CM, Buzaid AC, Soong S-J, Atkins MB, Cascinelli N, Coit DG, et al. Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol 2001;19:3635–48. - PubMed
    1. Agarwala SS, Keilholz U, Gilles E, Bedikian AY, Wu J, Kay R, et al. LDH correlation with survival in advanced melanoma from two large, randomised trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer 2009;45:1807–14. - PubMed
    1. Bedikian AY, Johnson MM, Warneke CL, Papadopoulos NE, Kim K, Hwu WJ, et al. Prognostic factors that determine the long-term survival of patients with unresectable metastatic melanoma. Cancer Invest 2008;26:624–33. - PubMed
    1. Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 2013;369:134–44. - PMC - PubMed

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