Cited by 196Colorectal Cancer Treatments and StudiesColorectal Cancer Surgical TreatmentsIntraperitoneal and Appendiceal Malignancies

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Pooled Safety and Efficacy Analysis Examining the Effect of Performance Status on Outcomes in Nine First-Line Treatment Trials Using Individual Data From Patients With Metastatic Colorectal Cancer

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Sargent, Daniel J., Köhne, Claus Henning, Sanoff, Hanna Kelly, Bot, Brian M., Seymour, Matthew T., de Gramont, Aimery, Porschen, Ranier, Saltz, Leonard B., Rougier, Philippe, Tournigand, Christopher, Douillard, Jean-Yves, Stephens, Richard J., Grothey, Axel, Goldberg, Richard M.·2009·Journal of Clinical Oncology

DOI 10.1200/jco.2008.20.2879PMC PMC2669760

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Abstract

Purpose: Performance status (PS) is a prognostic factor in patients with metastatic colorectal cancer. Clinical trials typically enroll less than 10% of patients with a PS of 2 (PS2); thus, the benefit of systemic chemotherapy in PS2 patients is uncertain. Patients and Methods: Individual data from 6,286 patients (509 PS2 patients) from nine clinical trials were used to compare treatment efficacy by PS. Progression-free survival (PFS), grade ≥ 3 adverse events, 60-day all-cause mortality, overall survival (OS), and response rate (RR) were explored in the full set of nine trials and in the five trials comparing first-line monotherapy with combination therapy. Results: Compared with patients with PS of 0 or 1, PS2 patients had significantly higher rates of grade ≥ 3 nausea (8.5% v 16.4%, respectively; P < .0001) and vomiting (7.6% v 11.9%, respectively; P = .006) and 60-day all-cause mortality (2.8% v 12.0%, respectively; P < .0001). PS2 was prognostic for PFS (hazard ratio [HR] = 1.52; P < .0001; median PFS, 7.6 months for PS 0 or 1 v 4.9 months for PS2), OS (HR = 2.18; P < .0001; median OS, 17.3 months for PS 0 or 1 v 8.5 months for PS2), and RR (odds ratio = 0.61; P < .0001; 43.8% for PS 0 or 1 v 32.0% for PS2). The relative benefit and toxicity of experimental versus control treatment and monotherapy versus combination therapy were not different in PS 0 or 1 patients versus PS2 patients. Conclusion: In clinical trials, PS2 patients derive similar benefit from superior treatment as patients with PS of 0 to 1 but with an increased risk of toxicities and 12% 60-day mortality. Although current treatment provides benefit, new approaches are required to approach 1-year median survival for PS2 patients.

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Authors: Sargent, D. J., Köhne, C. H., Sanoff, H. K., Bot, B. M., Seymour, M. T., de Gramont, A., Porschen, R., Saltz, L. B., Rougier, P., Tournigand, C., Douillard, J.-Y., Stephens, R. J., Grothey, A., & Goldberg, R. M.
Affiliations: University of North Carolina at Chapel Hill (US)
From the Mayo Clinic, Rochester, MN; University of North Carolina, Chapel Hill, NC; Memorial Sloan-Kettering Cancer Center, New York, NY; Klinikum Oldenburg, Oldenburg; Klinikum Bremen, Bremen, Germany; Cancer Research Center UK Clinical Centre, Leeds; Medical Research Council, London, United Kingdom; Hopital Saint Antoine, Paris; Hopital Ambroise Pare, Boulogne; and Center R. Gauducheau, St Herblain, France.
ORCID: Sargent, Daniel J.
Sanoff, Hanna Kelly
Bot, Brian M.
Saltz, Leonard B.
Douillard, Jean-Yves
Stephens, Richard J.
Goldberg, Richard M.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2009-04-20
Volume: 27
Issue: 12
Pages: 1948-1955
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2008.20.2879
PMC: PMC2669760
OpenAlex: W2101472517
Cited by: 196
References: 32
Citations by year: 2026: 6 · 2025: 9 · 2024: 7 · 2023: 14 · 2022: 20 · 2021: 15 · 2020: 10 · 2019: 9 · 2018: 12 · 2017: 6 · 2016: 8 · 2015: 8 · 2014: 13 · 2013: 16 · 2012: 9
FWCI: 6.99
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: Amgen
Bristol-Myers Squibb
Pfizer
Sanofi
American Society of Clinical Oncology
Celgene
Taiho Pharmaceutical
Genentech
National Cancer Institute ((CA-25224, U10CA025224)
Topics: Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
Health Sciences › Medicine › Surgery › Intraperitoneal and Appendiceal Malignancies
Keywords: metastatic colorectal cancer, performance status, first-line chemotherapy, prognostic factors, progression-free survival, overall survival, treatment toxicity, nausea and vomiting, all-cause mortality, combination chemotherapy, individual patient data
MeSH terms: Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Male, Middle Aged, Prognosis, Retrospective Studies, Colorectal Neoplasms, Survival Rate, Treatment Outcome, Clinical Trials, Phase III as Topic, Young Adult

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Pooled Safety and Efficacy Analysis Examining the Effect of Performance Status on Outcomes in Nine First-Line Treatment Trials Using Individual Data From Patients With Metastatic Colorectal Cancer

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