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Precision Medicine and Imaging

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

Richard W. Joseph, Jeroen Elassaiss-Schaap, Richard Kefford, Wen-Jen Hwu, Jedd D. Wolchok, Anthony M. Joshua, Antoni Ribas, F. Stephen Hodi, Omid Hamid, Caroline Robert, Adil Daud, Roxana Dronca, Peter Hersey, Jeffrey S. Weber, Amita Patnaik, Dinesh P. de Alwis, Andrea Perrone, Jin Zhang, S. Peter Kang, Scot Ebbinghaus, Keaven M. Anderson and Tara C. Gangadhar
Richard W. Joseph
1Department of Medical Oncology, Mayo Clinic, Jacksonville, Florida.
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  • For correspondence: joseph.richard@mayo.edu
Jeroen Elassaiss-Schaap
2PD-value, Pharmacometrics, Utrecht, the Netherlands.
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Richard Kefford
3Department of Clinical Medicine, Macquarie University, Sydney, Australia.
4Department of Clinical Medicine, Crown Princess Mary Cancer Centre, Westmead Hospital and Melanoma Institute Australia, Sydney, Australia.
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Wen-Jen Hwu
5Department of Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Jedd D. Wolchok
6Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
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Anthony M. Joshua
7Department of Medical Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
8Department of Medical Oncology, Kinghorn Cancer Centre, Sydney, Australia.
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Antoni Ribas
9Department of Medicine, University of California, Los Angeles, Los Angeles, California.
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F. Stephen Hodi
10Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
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Omid Hamid
11Department of Hematology/Oncology, The Angeles Clinic and Research Institute, Los Angeles, California.
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Caroline Robert
12Gustave Roussy and Paris-Sud University, Service de Dermatologie, Villejuif, France.
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Adil Daud
13Department of Hematology/Oncology, University of California, San Francisco, San Francisco, California.
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Roxana Dronca
14Department of Medical Oncology, Mayo Clinic, Rochester, Minnesota.
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Peter Hersey
15Department of Medical Oncology, University of Sydney, Sydney, Australia.
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Jeffrey S. Weber
16Department of Medicine, Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, New York.
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Amita Patnaik
17Department of Clinical Research, South Texas Accelerated Research Therapeutics, San Antonio, Texas.
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Dinesh P. de Alwis
18Department of Oncology Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey.
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Andrea Perrone
18Department of Oncology Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey.
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Jin Zhang
19Department of Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, New Jersey.
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S. Peter Kang
18Department of Oncology Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey.
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Scot Ebbinghaus
18Department of Oncology Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey.
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Keaven M. Anderson
19Department of Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, New Jersey.
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Tara C. Gangadhar
20Department of Medicine, Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania.
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DOI: 10.1158/1078-0432.CCR-17-2386 Published October 2018
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This article has a correction. Please see:

  • Correction: Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab - December 3, 2018

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

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Prior Presentation (full or in part):

  • 50th Annual Meeting of the American Society of Clinical Oncology, May 30–June 3, 2014.

  • Eleventh International Congress of the Society for Melanoma Research, November 13–17, 2014.

  • Received August 15, 2017.
  • Revision received December 11, 2017.
  • Accepted April 17, 2018.
  • Published first April 23, 2018.
  • Corrected online October 16, 2018.
  • ©2018 American Association for Cancer Research.
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Clinical Cancer Research: 24 (20)
October 2018
Volume 24, Issue 20
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Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab
Richard W. Joseph, Jeroen Elassaiss-Schaap, Richard Kefford, Wen-Jen Hwu, Jedd D. Wolchok, Anthony M. Joshua, Antoni Ribas, F. Stephen Hodi, Omid Hamid, Caroline Robert, Adil Daud, Roxana Dronca, Peter Hersey, Jeffrey S. Weber, Amita Patnaik, Dinesh P. de Alwis, Andrea Perrone, Jin Zhang, S. Peter Kang, Scot Ebbinghaus, Keaven M. Anderson and Tara C. Gangadhar
Clin Cancer Res October 15 2018 (24) (20) 4960-4967; DOI: 10.1158/1078-0432.CCR-17-2386

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Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab
Richard W. Joseph, Jeroen Elassaiss-Schaap, Richard Kefford, Wen-Jen Hwu, Jedd D. Wolchok, Anthony M. Joshua, Antoni Ribas, F. Stephen Hodi, Omid Hamid, Caroline Robert, Adil Daud, Roxana Dronca, Peter Hersey, Jeffrey S. Weber, Amita Patnaik, Dinesh P. de Alwis, Andrea Perrone, Jin Zhang, S. Peter Kang, Scot Ebbinghaus, Keaven M. Anderson and Tara C. Gangadhar
Clin Cancer Res October 15 2018 (24) (20) 4960-4967; DOI: 10.1158/1078-0432.CCR-17-2386
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