Randomized Phase II Study of Dacomitinib (PF-00299804), an Irreversible Pan–Human Epidermal Growth Factor Receptor Inhibitor, Versus Erlotinib in Patients With Advanced Non–Small-Cell Lung Cancer
-
- Suresh S. Ramalingam
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Fiona Blackhall
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Maciej Krzakowski
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Carlos H. Barrios
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Keunchil Park
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Isabel Bover
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Dae Seog Heo
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Rafael Rosell
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Denis C. Talbot
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Richard Frank
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Stephen P. Letrent
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Ana Ruiz-Garcia
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Ian Taylor
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Jane Q. Liang
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Alicyn K. Campbell
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Joseph O'Connell
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
-
- Michael Boyer
- Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; Fiona Blackhall, Christie National Health Service Foundation Trust, Manchester, United Kingdom; Denis C. Talbot, Oxford Oncology Centre, Oxford, United Kingdom; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Poland; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Keunchil Park, Sungkyunkwan University School of Medicine; Dae Seog Heo, Seoul National University Hospital, Seoul,...
Description
<jats:sec><jats:title>Purpose</jats:title><jats:p> This randomized, open-label trial compared dacomitinib (PF-00299804), an irreversible inhibitor of human epidermal growth factor receptors (EGFR)/HER1, HER2, and HER4, with erlotinib, a reversible EGFR inhibitor, in patients with advanced non–small-cell lung cancer (NSCLC). </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Patients with NSCLC, Eastern Cooperative Oncology Group performance status 0 to 2, no prior HER-directed therapy, and one/two prior chemotherapy regimens received dacomitinib 45 mg or erlotinib 150 mg once daily. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> One hundred eighty-eight patients were randomly assigned. Treatment arms were balanced for most clinical and molecular characteristics. Median progression-free survival (PFS; primary end point) was 2.86 months for patients treated with dacomitinib and 1.91 months for patients treated with erlotinib (hazard ratio [HR] = 0.66; 95% CI, 0.47 to 0.91; two-sided P = .012); in patients with KRAS wild-type tumors, median PFS was 3.71 months for patients treated with dacomitinib and 1.91 months for patients treated with erlotinib (HR = 0.55; 95% CI, 0.35 to 0.85; two-sided P = .006); and in patients with KRAS wild-type/EGFR wild-type tumors, median PFS was 2.21 months for patients treated with dacomitinib and 1.84 months for patients treated with erlotinib (HR = 0.61; 95% CI, 0.37 to 0.99; two-sided P = .043). Median overall survival was 9.53 months for patients treated with dacomitinib and 7.44 months for patients treated with erlotinib (HR = 0.80; 95% CI, 0.56 to 1.13; two-sided P = .205). Adverse event-related discontinuations were uncommon in both arms. Common treatment-related adverse events were dermatologic and gastrointestinal, predominantly grade 1 to 2, and more frequent with dacomitinib. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Dacomitinib demonstrated significantly improved PFS versus erlotinib, with acceptable toxicity. PFS benefit was observed in most clinical and molecular subsets, notably KRAS wild-type/EGFR any status, KRAS wild-type/EGFR wild-type, and EGFR mutants. </jats:p></jats:sec>
Journal
-
- Journal of Clinical Oncology
-
Journal of Clinical Oncology 30 (27), 3337-3344, 2012-09-20
American Society of Clinical Oncology (ASCO)
- Tweet
Details 詳細情報について
-
- CRID
- 1361418520727138048
-
- ISSN
- 15277755
- 0732183X
-
- Data Source
-
- Crossref