Evaluation of safety and efficacy of salvage therapy with sunitinib, docetaxel (Tyxane) and cisplatinum followed by maintenance vinorelbine for unresectable/metastatic nonsmall cell lung cancer

Stage 1 of a simon 2 stage clinical trial

Chen Jei Tai, Cheng Jeng Tai, Chien Kai Wang, Ching Tzao, Yung Chang Lien, Chih Cheng Hsieh, Cheng I. Hsieh, Hong Cheng Wu, Chih Hsiung Wu, Chun Chao Chang, Ray Jade Chen, Hung Yi Chiou

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Abstract

Current chemotherapeutic regimens for nonsmall cell lung cancer (NSCLC) have reached a plateau over the last few years. Targeted therapy makes use of tyrosine kinase inhibitors (TKIs) to suppress a number of signaling pathways including epidermal growth factor receptor and vascular endothelial growth factor which are active in NSCLC biology. In this study, we used sunitinib, a multi-target receptor TKI, combined with chemotherapy for unresectable/metastatic NSCLC. This open label Simon's 2 stage clinical trial enrolled a total of 6 NSCLC patients who received docetaxel (40 mg) and cisplatin (50 mg) on day 1 of each cycle (14 day interval between cycles) and sunitinib (25mg qd for 10 days between cycles) for a total of 12 cycles (24 weeks), after which patients received maintenance therapy with vinorelbine (30mg TIW) until disease progression. The sample size was based on a Simon's Optimal Two-Stage Designs for Phase II clinical trials. The expected response rate was set as 35% for P0 and as 60% for P1. The study was designed for a minimum of 6 patients for first stage and 15 patients until second stage with a significance level alpha = 0.10 and power = 70%. Diagnosis of a poor response in the second of 6 patients in Stage I or seventh of the 15 patients in Stage II would lead to early termination of the trial. The overall response rate was 66.7%. Four patients had an overall survival >60 months. The time to PFS ranged from 3 to 42 months. The combination therapy was well-tolerated. Sunitinib combined with chemotherapy shows promise and warrants further investigation.

Original languageEnglish
Article numbere2303
JournalMedicine (United States)
Volume94
Issue number52
DOIs
Publication statusPublished - 2015
Externally publishedYes

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docetaxel
Salvage Therapy
Non-Small Cell Lung Carcinoma
Maintenance
Clinical Trials
Safety
Drug Therapy
Phase II Clinical Trials
Receptor Protein-Tyrosine Kinases
sunitinib
vinorelbine
Epidermal Growth Factor Receptor
Sample Size
Protein-Tyrosine Kinases
Vascular Endothelial Growth Factor A
Cisplatin
Disease Progression
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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title = "Evaluation of safety and efficacy of salvage therapy with sunitinib, docetaxel (Tyxane) and cisplatinum followed by maintenance vinorelbine for unresectable/metastatic nonsmall cell lung cancer: Stage 1 of a simon 2 stage clinical trial",
abstract = "Current chemotherapeutic regimens for nonsmall cell lung cancer (NSCLC) have reached a plateau over the last few years. Targeted therapy makes use of tyrosine kinase inhibitors (TKIs) to suppress a number of signaling pathways including epidermal growth factor receptor and vascular endothelial growth factor which are active in NSCLC biology. In this study, we used sunitinib, a multi-target receptor TKI, combined with chemotherapy for unresectable/metastatic NSCLC. This open label Simon's 2 stage clinical trial enrolled a total of 6 NSCLC patients who received docetaxel (40 mg) and cisplatin (50 mg) on day 1 of each cycle (14 day interval between cycles) and sunitinib (25mg qd for 10 days between cycles) for a total of 12 cycles (24 weeks), after which patients received maintenance therapy with vinorelbine (30mg TIW) until disease progression. The sample size was based on a Simon's Optimal Two-Stage Designs for Phase II clinical trials. The expected response rate was set as 35{\%} for P0 and as 60{\%} for P1. The study was designed for a minimum of 6 patients for first stage and 15 patients until second stage with a significance level alpha = 0.10 and power = 70{\%}. Diagnosis of a poor response in the second of 6 patients in Stage I or seventh of the 15 patients in Stage II would lead to early termination of the trial. The overall response rate was 66.7{\%}. Four patients had an overall survival >60 months. The time to PFS ranged from 3 to 42 months. The combination therapy was well-tolerated. Sunitinib combined with chemotherapy shows promise and warrants further investigation.",
author = "Tai, {Chen Jei} and Tai, {Cheng Jeng} and Wang, {Chien Kai} and Ching Tzao and Lien, {Yung Chang} and Hsieh, {Chih Cheng} and Hsieh, {Cheng I.} and Wu, {Hong Cheng} and Wu, {Chih Hsiung} and Chang, {Chun Chao} and Chen, {Ray Jade} and Chiou, {Hung Yi}",
year = "2015",
doi = "10.1097/MD.0000000000002303",
language = "English",
volume = "94",
journal = "Medicine; analytical reviews of general medicine, neurology, psychiatry, dermatology, and pediatries",
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T1 - Evaluation of safety and efficacy of salvage therapy with sunitinib, docetaxel (Tyxane) and cisplatinum followed by maintenance vinorelbine for unresectable/metastatic nonsmall cell lung cancer

T2 - Stage 1 of a simon 2 stage clinical trial

AU - Tai, Chen Jei

AU - Tai, Cheng Jeng

AU - Wang, Chien Kai

AU - Tzao, Ching

AU - Lien, Yung Chang

AU - Hsieh, Chih Cheng

AU - Hsieh, Cheng I.

AU - Wu, Hong Cheng

AU - Wu, Chih Hsiung

AU - Chang, Chun Chao

AU - Chen, Ray Jade

AU - Chiou, Hung Yi

PY - 2015

Y1 - 2015

N2 - Current chemotherapeutic regimens for nonsmall cell lung cancer (NSCLC) have reached a plateau over the last few years. Targeted therapy makes use of tyrosine kinase inhibitors (TKIs) to suppress a number of signaling pathways including epidermal growth factor receptor and vascular endothelial growth factor which are active in NSCLC biology. In this study, we used sunitinib, a multi-target receptor TKI, combined with chemotherapy for unresectable/metastatic NSCLC. This open label Simon's 2 stage clinical trial enrolled a total of 6 NSCLC patients who received docetaxel (40 mg) and cisplatin (50 mg) on day 1 of each cycle (14 day interval between cycles) and sunitinib (25mg qd for 10 days between cycles) for a total of 12 cycles (24 weeks), after which patients received maintenance therapy with vinorelbine (30mg TIW) until disease progression. The sample size was based on a Simon's Optimal Two-Stage Designs for Phase II clinical trials. The expected response rate was set as 35% for P0 and as 60% for P1. The study was designed for a minimum of 6 patients for first stage and 15 patients until second stage with a significance level alpha = 0.10 and power = 70%. Diagnosis of a poor response in the second of 6 patients in Stage I or seventh of the 15 patients in Stage II would lead to early termination of the trial. The overall response rate was 66.7%. Four patients had an overall survival >60 months. The time to PFS ranged from 3 to 42 months. The combination therapy was well-tolerated. Sunitinib combined with chemotherapy shows promise and warrants further investigation.

AB - Current chemotherapeutic regimens for nonsmall cell lung cancer (NSCLC) have reached a plateau over the last few years. Targeted therapy makes use of tyrosine kinase inhibitors (TKIs) to suppress a number of signaling pathways including epidermal growth factor receptor and vascular endothelial growth factor which are active in NSCLC biology. In this study, we used sunitinib, a multi-target receptor TKI, combined with chemotherapy for unresectable/metastatic NSCLC. This open label Simon's 2 stage clinical trial enrolled a total of 6 NSCLC patients who received docetaxel (40 mg) and cisplatin (50 mg) on day 1 of each cycle (14 day interval between cycles) and sunitinib (25mg qd for 10 days between cycles) for a total of 12 cycles (24 weeks), after which patients received maintenance therapy with vinorelbine (30mg TIW) until disease progression. The sample size was based on a Simon's Optimal Two-Stage Designs for Phase II clinical trials. The expected response rate was set as 35% for P0 and as 60% for P1. The study was designed for a minimum of 6 patients for first stage and 15 patients until second stage with a significance level alpha = 0.10 and power = 70%. Diagnosis of a poor response in the second of 6 patients in Stage I or seventh of the 15 patients in Stage II would lead to early termination of the trial. The overall response rate was 66.7%. Four patients had an overall survival >60 months. The time to PFS ranged from 3 to 42 months. The combination therapy was well-tolerated. Sunitinib combined with chemotherapy shows promise and warrants further investigation.

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