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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
Open accessAbstract
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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“Patients with PS 2 make up fewer than half of patients enrolled onto clinical trials.84”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [84]
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Metadata
- 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
- Venue
- Journal of Clinical Oncology
- Published
- 2009-04-20
- Volume
- 27
- Issue
- 12
- Pages
- 1948-1955
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- 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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