Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer

Mark A. Socinski, Silvia Novello, Julie R. Brahmer, Rafael Rosell, Jose M. Sanchez, Chandra Belani, Ramaswamy Govindan, James N. Atkins, Heidi H. Gillenwater, Cinta Pallares, Lesley Tye, Paulina Selaru, Richard C. Chao, Giorgio V. Scagliotti

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Abstract

Purpose: Aberrant vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) signaling have been shown to play a role in non-small-cell lung cancer (NSCLC) pathogenesis and are associated with decreased survival. We evaluated the clinical activity and tolerability of sunitinib malate (SU11248), an oral, multitargeted tyrosine kinase inhibitor that blocks the activity of receptors for VEGF and PDGF, as well as related tyrosine kinases in patients with previously treated, advanced NSCLC. Patients and Methods: Patients with stage IIIB or IV NSCLC for whom platinum-based chemotherapy had failed received 50 mg/d of sunitinib for 4 weeks followed by 2 weeks of no treatment in 6-week treatment cycles. The primary end point was objective response rate (ORR); secondary end points included progression-free survival, overall survival, and safety. Results: Of the 63 patients treated with sunitinib, seven patients had confirmed partial responses, yielding an ORR of 11.1% (95% CI, 4.6% to 21.6%). An additional 18 patients (28.6%) experienced stable disease of at least 8 weeks in duration. Median progression-free survival was 12.0 weeks (95% CI, 10.0 to 16.1 weeks), and median overall survival was 23.4 weeks (95% CI, 17.0 to 28.3 weeks). Therapy was generally well tolerated. Conclusion: Sunitinib has promising single-agent activity in patients with recurrent NSCLC, with an ORR similar to that of currently approved agents and an acceptable safety profile. Further evaluation in combination with other targeted agents and chemotherapy in patients with NSCLC is warranted.

Original languageEnglish (US)
Pages (from-to)650-656
Number of pages7
JournalJournal of Clinical Oncology
Volume26
Issue number4
DOIs
StatePublished - Feb 1 2008

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Non-Small Cell Lung Carcinoma
Platelet-Derived Growth Factor
Protein-Tyrosine Kinases
Disease-Free Survival
Survival
Safety
Drug Therapy
Vascular Endothelial Growth Factor Receptor
sunitinib
Platinum
Vascular Endothelial Growth Factor A
Therapeutics

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Socinski, M. A., Novello, S., Brahmer, J. R., Rosell, R., Sanchez, J. M., Belani, C., ... Scagliotti, G. V. (2008). Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. Journal of Clinical Oncology, 26(4), 650-656. https://doi.org/10.1200/JCO.2007.13.9303
Socinski, Mark A. ; Novello, Silvia ; Brahmer, Julie R. ; Rosell, Rafael ; Sanchez, Jose M. ; Belani, Chandra ; Govindan, Ramaswamy ; Atkins, James N. ; Gillenwater, Heidi H. ; Pallares, Cinta ; Tye, Lesley ; Selaru, Paulina ; Chao, Richard C. ; Scagliotti, Giorgio V. / Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. In: Journal of Clinical Oncology. 2008 ; Vol. 26, No. 4. pp. 650-656.
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abstract = "Purpose: Aberrant vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) signaling have been shown to play a role in non-small-cell lung cancer (NSCLC) pathogenesis and are associated with decreased survival. We evaluated the clinical activity and tolerability of sunitinib malate (SU11248), an oral, multitargeted tyrosine kinase inhibitor that blocks the activity of receptors for VEGF and PDGF, as well as related tyrosine kinases in patients with previously treated, advanced NSCLC. Patients and Methods: Patients with stage IIIB or IV NSCLC for whom platinum-based chemotherapy had failed received 50 mg/d of sunitinib for 4 weeks followed by 2 weeks of no treatment in 6-week treatment cycles. The primary end point was objective response rate (ORR); secondary end points included progression-free survival, overall survival, and safety. Results: Of the 63 patients treated with sunitinib, seven patients had confirmed partial responses, yielding an ORR of 11.1{\%} (95{\%} CI, 4.6{\%} to 21.6{\%}). An additional 18 patients (28.6{\%}) experienced stable disease of at least 8 weeks in duration. Median progression-free survival was 12.0 weeks (95{\%} CI, 10.0 to 16.1 weeks), and median overall survival was 23.4 weeks (95{\%} CI, 17.0 to 28.3 weeks). Therapy was generally well tolerated. Conclusion: Sunitinib has promising single-agent activity in patients with recurrent NSCLC, with an ORR similar to that of currently approved agents and an acceptable safety profile. Further evaluation in combination with other targeted agents and chemotherapy in patients with NSCLC is warranted.",
author = "Socinski, {Mark A.} and Silvia Novello and Brahmer, {Julie R.} and Rafael Rosell and Sanchez, {Jose M.} and Chandra Belani and Ramaswamy Govindan and Atkins, {James N.} and Gillenwater, {Heidi H.} and Cinta Pallares and Lesley Tye and Paulina Selaru and Chao, {Richard C.} and Scagliotti, {Giorgio V.}",
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Socinski, MA, Novello, S, Brahmer, JR, Rosell, R, Sanchez, JM, Belani, C, Govindan, R, Atkins, JN, Gillenwater, HH, Pallares, C, Tye, L, Selaru, P, Chao, RC & Scagliotti, GV 2008, 'Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer', Journal of Clinical Oncology, vol. 26, no. 4, pp. 650-656. https://doi.org/10.1200/JCO.2007.13.9303

Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. / Socinski, Mark A.; Novello, Silvia; Brahmer, Julie R.; Rosell, Rafael; Sanchez, Jose M.; Belani, Chandra; Govindan, Ramaswamy; Atkins, James N.; Gillenwater, Heidi H.; Pallares, Cinta; Tye, Lesley; Selaru, Paulina; Chao, Richard C.; Scagliotti, Giorgio V.

In: Journal of Clinical Oncology, Vol. 26, No. 4, 01.02.2008, p. 650-656.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer

AU - Socinski, Mark A.

AU - Novello, Silvia

AU - Brahmer, Julie R.

AU - Rosell, Rafael

AU - Sanchez, Jose M.

AU - Belani, Chandra

AU - Govindan, Ramaswamy

AU - Atkins, James N.

AU - Gillenwater, Heidi H.

AU - Pallares, Cinta

AU - Tye, Lesley

AU - Selaru, Paulina

AU - Chao, Richard C.

AU - Scagliotti, Giorgio V.

PY - 2008/2/1

Y1 - 2008/2/1

N2 - Purpose: Aberrant vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) signaling have been shown to play a role in non-small-cell lung cancer (NSCLC) pathogenesis and are associated with decreased survival. We evaluated the clinical activity and tolerability of sunitinib malate (SU11248), an oral, multitargeted tyrosine kinase inhibitor that blocks the activity of receptors for VEGF and PDGF, as well as related tyrosine kinases in patients with previously treated, advanced NSCLC. Patients and Methods: Patients with stage IIIB or IV NSCLC for whom platinum-based chemotherapy had failed received 50 mg/d of sunitinib for 4 weeks followed by 2 weeks of no treatment in 6-week treatment cycles. The primary end point was objective response rate (ORR); secondary end points included progression-free survival, overall survival, and safety. Results: Of the 63 patients treated with sunitinib, seven patients had confirmed partial responses, yielding an ORR of 11.1% (95% CI, 4.6% to 21.6%). An additional 18 patients (28.6%) experienced stable disease of at least 8 weeks in duration. Median progression-free survival was 12.0 weeks (95% CI, 10.0 to 16.1 weeks), and median overall survival was 23.4 weeks (95% CI, 17.0 to 28.3 weeks). Therapy was generally well tolerated. Conclusion: Sunitinib has promising single-agent activity in patients with recurrent NSCLC, with an ORR similar to that of currently approved agents and an acceptable safety profile. Further evaluation in combination with other targeted agents and chemotherapy in patients with NSCLC is warranted.

AB - Purpose: Aberrant vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) signaling have been shown to play a role in non-small-cell lung cancer (NSCLC) pathogenesis and are associated with decreased survival. We evaluated the clinical activity and tolerability of sunitinib malate (SU11248), an oral, multitargeted tyrosine kinase inhibitor that blocks the activity of receptors for VEGF and PDGF, as well as related tyrosine kinases in patients with previously treated, advanced NSCLC. Patients and Methods: Patients with stage IIIB or IV NSCLC for whom platinum-based chemotherapy had failed received 50 mg/d of sunitinib for 4 weeks followed by 2 weeks of no treatment in 6-week treatment cycles. The primary end point was objective response rate (ORR); secondary end points included progression-free survival, overall survival, and safety. Results: Of the 63 patients treated with sunitinib, seven patients had confirmed partial responses, yielding an ORR of 11.1% (95% CI, 4.6% to 21.6%). An additional 18 patients (28.6%) experienced stable disease of at least 8 weeks in duration. Median progression-free survival was 12.0 weeks (95% CI, 10.0 to 16.1 weeks), and median overall survival was 23.4 weeks (95% CI, 17.0 to 28.3 weeks). Therapy was generally well tolerated. Conclusion: Sunitinib has promising single-agent activity in patients with recurrent NSCLC, with an ORR similar to that of currently approved agents and an acceptable safety profile. Further evaluation in combination with other targeted agents and chemotherapy in patients with NSCLC is warranted.

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JO - Journal of Clinical Oncology

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SN - 0732-183X

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