Sunitinib Plus Erlotinib Versus Placebo Plus Erlotinib in Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer: A Phase III Trial
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- Giorgio V. Scagliotti
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Maciej Krzakowski
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Aleksandra Szczesna
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Janos Strausz
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Anatoly Makhson
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Martin Reck
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Rafal F. Wierzbicki
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Istvan Albert
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Michael Thomas
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Jose Elias Abrao Miziara
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Zsolt S. Papai
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Nina Karaseva
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Sumitra Thongprasert
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Elsa Dalmau Portulas
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Joachim von Pawel
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Ke Zhang
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Paulina Selaru
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Lesley Tye
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Richard C. Chao
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
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- Ramaswamy Govindan
- Giorgio V. Scagliotti, University of Turin, Orbassano (Turin), Italy; Maciej Krzakowski, Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw; Aleksandra Szczesna, Regional Lung Diseases Hospital, Otwock, Poland; Janos Strausz, Koranyi National Institute for Pulmonology, Budapest; Istvan Albert, Matrai Gyogyintezet, Matrahaza; Zsolt S. Papai, Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, Hungary; Anatoly Makhson, Moscow City Clinical Hospital of Oncology #62, Moscow; Nina Karaseva, City...
Abstract
<jats:sec><jats:title>Purpose</jats:title><jats:p> Sunitinib plus erlotinib may enhance antitumor activity compared with either agent alone in non–small-cell lung cancer (NSCLC), based on the importance of the signaling pathways involved in tumor growth, angiogenesis, and metastasis. This phase III trial investigated overall survival (OS) for sunitinib plus erlotinib versus placebo plus erlotinib in patients with refractory NSCLC. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Patients previously treated with one to two chemotherapy regimens (including one platinum-based regimen) for recurrent NSCLC, and for whom erlotinib was indicated, were randomly assigned (1:1) to sunitinib 37.5 mg/d plus erlotinib 150 mg/d or to placebo plus erlotinib 150 mg/d, stratified by prior bevacizumab use, smoking history, and epidermal growth factor receptor expression. The primary end point was OS. Key secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In all, 960 patients were randomly assigned, and baseline characteristics were balanced. Median OS was 9.0 months for sunitinib plus erlotinib versus 8.5 months for erlotinib alone (hazard ratio [HR], 0.922; 95% CI, 0.797 to 1.067; one-sided stratified log-rank P = .1388). Median PFS was 3.6 months versus 2.0 months (HR, 0.807; 95% CI, 0.695 to 0.937; one-sided stratified log-rank P = .0023), and ORR was 10.6% versus 6.9% (two-sided stratified log-rank P = .0471), respectively. Treatment-related toxicities of grade 3 or higher, including rash/dermatitis, diarrhea, and asthenia/fatigue were more frequent in the sunitinib plus erlotinib arm. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> In patients with refractory NSCLC, sunitinib plus erlotinib did not improve OS compared with erlotinib alone, but the combination was associated with a statistically significantly longer PFS and greater ORR. The incidence of grade 3 or higher toxicities was greater with combination therapy. </jats:p></jats:sec>
Journal
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 30 (17), 2070-2078, 2012-06-10
American Society of Clinical Oncology (ASCO)
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Details 詳細情報について
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- CRID
- 1362544420083094656
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- ISSN
- 15277755
- 0732183X
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- Data Source
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- Crossref