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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- Daniel J. Sargent
- 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.
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- Claus Henning Köhne
- 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.
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- Hanna Kelly Sanoff
- 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.
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- Brian M. Bot
- 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.
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- Matthew T. Seymour
- 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.
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- Aimery de Gramont
- 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.
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- Ranier Porschen
- 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.
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- Leonard B. Saltz
- 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.
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- Philippe Rougier
- 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.
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- Christopher Tournigand
- 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.
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- Jean-Yves Douillard
- 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.
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- Richard J. Stephens
- 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.
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- Axel Grothey
- 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.
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- Richard M. Goldberg
- 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.
説明
<jats:sec><jats:title>Purpose</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> 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. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 27 (12), 1948-1955, 2009-04-20
American Society of Clinical Oncology (ASCO)