Phase II study of sunitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer

Radj Gervais, John D. Hainsworth, Normand Blais, Benjamin Besse, Janessa Laskin, John T. Hamm, Allan Lipton, Kathy S. Albain, Gregory A. Masters, Ronald B. Natale, Paulina Selaru, Sindy T. Kim, Richard C. Chao, Ray D. Page

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Abstract

This open-label, phase II study evaluated the antitumor activity and safety of sunitinib monotherapy as maintenance treatment following first-line chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Following treatment with standard doublet chemotherapy (paclitaxel and carboplatin), patients received oral sunitinib (starting dose 50. mg/day) in 6-week cycles (Schedule 4/2: 4 weeks on treatment, 2 weeks off treatment) until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint was probability of survival at 1 year ≥55%. Of 84 patients who received first-line chemotherapy, 66 (79%) received sunitinib maintenance therapy (median sunitinib cycles started: 2 [range 1-20]). Probability of survival at 1 year was 40.5% (95% confidence interval [CI]: 29.8, 51.0). Median overall survival was 10.4 months (95% CI: 8.0, 12.2). The objective response rate was 27.4% (95% CI: 18.2, 38.2). The most frequently reported all-causality adverse events of any grade during sunitinib maintenance therapy were fatigue/asthenia (55%), diarrhea (36%), and nausea (32%). These data suggest that maintenance therapy may have value in NSCLC, although the primary endpoint of the study was not met.

Original languageEnglish (US)
Pages (from-to)474-480
Number of pages7
JournalLung Cancer
Volume74
Issue number3
DOIs
StatePublished - Dec 1 2011

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Non-Small Cell Lung Carcinoma
Confidence Intervals
Drug Therapy
Therapeutics
Survival
Asthenia
Carboplatin
Paclitaxel
sunitinib
Causality
Nausea
Fatigue
Disease Progression
Diarrhea
Appointments and Schedules
Safety

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Gervais, R., Hainsworth, J. D., Blais, N., Besse, B., Laskin, J., Hamm, J. T., ... Page, R. D. (2011). Phase II study of sunitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer. Lung Cancer, 74(3), 474-480. https://doi.org/10.1016/j.lungcan.2011.05.004
Gervais, Radj ; Hainsworth, John D. ; Blais, Normand ; Besse, Benjamin ; Laskin, Janessa ; Hamm, John T. ; Lipton, Allan ; Albain, Kathy S. ; Masters, Gregory A. ; Natale, Ronald B. ; Selaru, Paulina ; Kim, Sindy T. ; Chao, Richard C. ; Page, Ray D. / Phase II study of sunitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer. In: Lung Cancer. 2011 ; Vol. 74, No. 3. pp. 474-480.
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Gervais, R, Hainsworth, JD, Blais, N, Besse, B, Laskin, J, Hamm, JT, Lipton, A, Albain, KS, Masters, GA, Natale, RB, Selaru, P, Kim, ST, Chao, RC & Page, RD 2011, 'Phase II study of sunitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer', Lung Cancer, vol. 74, no. 3, pp. 474-480. https://doi.org/10.1016/j.lungcan.2011.05.004

Phase II study of sunitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer. / Gervais, Radj; Hainsworth, John D.; Blais, Normand; Besse, Benjamin; Laskin, Janessa; Hamm, John T.; Lipton, Allan; Albain, Kathy S.; Masters, Gregory A.; Natale, Ronald B.; Selaru, Paulina; Kim, Sindy T.; Chao, Richard C.; Page, Ray D.

In: Lung Cancer, Vol. 74, No. 3, 01.12.2011, p. 474-480.

Research output: Contribution to journalArticle

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T1 - Phase II study of sunitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer

AU - Gervais, Radj

AU - Hainsworth, John D.

AU - Blais, Normand

AU - Besse, Benjamin

AU - Laskin, Janessa

AU - Hamm, John T.

AU - Lipton, Allan

AU - Albain, Kathy S.

AU - Masters, Gregory A.

AU - Natale, Ronald B.

AU - Selaru, Paulina

AU - Kim, Sindy T.

AU - Chao, Richard C.

AU - Page, Ray D.

PY - 2011/12/1

Y1 - 2011/12/1

N2 - This open-label, phase II study evaluated the antitumor activity and safety of sunitinib monotherapy as maintenance treatment following first-line chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Following treatment with standard doublet chemotherapy (paclitaxel and carboplatin), patients received oral sunitinib (starting dose 50. mg/day) in 6-week cycles (Schedule 4/2: 4 weeks on treatment, 2 weeks off treatment) until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint was probability of survival at 1 year ≥55%. Of 84 patients who received first-line chemotherapy, 66 (79%) received sunitinib maintenance therapy (median sunitinib cycles started: 2 [range 1-20]). Probability of survival at 1 year was 40.5% (95% confidence interval [CI]: 29.8, 51.0). Median overall survival was 10.4 months (95% CI: 8.0, 12.2). The objective response rate was 27.4% (95% CI: 18.2, 38.2). The most frequently reported all-causality adverse events of any grade during sunitinib maintenance therapy were fatigue/asthenia (55%), diarrhea (36%), and nausea (32%). These data suggest that maintenance therapy may have value in NSCLC, although the primary endpoint of the study was not met.

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