Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2): A randomised, double-blind trial

Yi Long Wu, Jin Soo Lee, Sumitra Thongprasert, Chong Jen Yu, Li Zhang, Guia Ladrera, Vichien Srimuninnimit, Virote Sriuranpong, Jennifer Sandoval-Tan, Yunzhong Zhu, Meilin Liao, Caicun Zhou, Hongming Pan, Victor Lee, Yuh Min Chen, Yan Sun, Benjamin Margono, Fatima Fuerte, Gee Chen Chang, Kasan SeetalaromJie Wang, Ashley Cheng, Elisna Syahruddin, Xiaoping Qian, James Ho, Johan Kurnianda, Hsingjin Eugene Liu, Kate Jin, Matt Truman, Ilze Bara, Tony Mok

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Abstract

Background: The results of FASTACT, a randomised, placebo-controlled, phase 2 study, showed that intercalated chemotherapy and erlotinib significantly prolonged progression-free survival (PFS) in patients with advanced non-small-cell lung cancer. We undertook FASTACT-2, a phase 3 study in a similar patient population. Methods: In this phase 3 trial, patients with untreated stage IIIB/IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm (stratified by disease stage, tumour histology, smoking status, and chemotherapy regimen) to receive six cycles of gemcitabine (1250 mg/m2 on days 1 and 8, intravenously) plus platinum (carboplatin 5 × area under the curve or cisplatin 75 mg/m2 on day 1, intravenously) with intercalated erlotinib (150 mg/day on days 15-28, orally; chemotherapy plus erlotinib) or placebo orally (chemotherapy plus placebo) every 4 weeks. With the exception of an independent group responsible for monitoring data and safety monitoring board, everyone outside the interactive internet response system company was masked to treatment allocation. Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death, and all patients in the placebo group were offered second-line erlotinib at the time of progression. The primary endpoint was PFS in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00883779. Findings: From April 29, 2009, to Sept 9, 2010, 451 patients were randomly assigned to chemotherapy plus erlotinib (n=226) or chemotherapy plus placebo (n=225). PFS was significantly prolonged with chemotherapy plus erlotinib versus chemotherapy plus placebo (median PFS 7·6 months [95% CI 7·2-8·3], vs 6·0 months [5·6-7·1], hazard ratio [HR] 0·57 [0·47-0·69]; p

Original languageEnglish
Pages (from-to)777-786
Number of pages10
JournalThe Lancet Oncology
Volume14
Issue number8
DOIs
Publication statusPublished - Jul 2013

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Combination Drug Therapy
Non-Small Cell Lung Carcinoma
Placebos
Drug Therapy
Disease-Free Survival
gemcitabine
Internet
Clinical Trials Data Monitoring Committees
Erlotinib Hydrochloride
Carboplatin
Platinum
Cisplatin
Population
Area Under Curve
Histology
Smoking
Neoplasms

ASJC Scopus subject areas

  • Oncology

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Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2) : A randomised, double-blind trial. / Wu, Yi Long; Lee, Jin Soo; Thongprasert, Sumitra; Yu, Chong Jen; Zhang, Li; Ladrera, Guia; Srimuninnimit, Vichien; Sriuranpong, Virote; Sandoval-Tan, Jennifer; Zhu, Yunzhong; Liao, Meilin; Zhou, Caicun; Pan, Hongming; Lee, Victor; Chen, Yuh Min; Sun, Yan; Margono, Benjamin; Fuerte, Fatima; Chang, Gee Chen; Seetalarom, Kasan; Wang, Jie; Cheng, Ashley; Syahruddin, Elisna; Qian, Xiaoping; Ho, James; Kurnianda, Johan; Liu, Hsingjin Eugene; Jin, Kate; Truman, Matt; Bara, Ilze; Mok, Tony.

In: The Lancet Oncology, Vol. 14, No. 8, 07.2013, p. 777-786.

Research output: Contribution to journalArticle

Wu, YL, Lee, JS, Thongprasert, S, Yu, CJ, Zhang, L, Ladrera, G, Srimuninnimit, V, Sriuranpong, V, Sandoval-Tan, J, Zhu, Y, Liao, M, Zhou, C, Pan, H, Lee, V, Chen, YM, Sun, Y, Margono, B, Fuerte, F, Chang, GC, Seetalarom, K, Wang, J, Cheng, A, Syahruddin, E, Qian, X, Ho, J, Kurnianda, J, Liu, HE, Jin, K, Truman, M, Bara, I & Mok, T 2013, 'Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2): A randomised, double-blind trial', The Lancet Oncology, vol. 14, no. 8, pp. 777-786. https://doi.org/10.1016/S1470-2045(13)70254-7
Wu, Yi Long ; Lee, Jin Soo ; Thongprasert, Sumitra ; Yu, Chong Jen ; Zhang, Li ; Ladrera, Guia ; Srimuninnimit, Vichien ; Sriuranpong, Virote ; Sandoval-Tan, Jennifer ; Zhu, Yunzhong ; Liao, Meilin ; Zhou, Caicun ; Pan, Hongming ; Lee, Victor ; Chen, Yuh Min ; Sun, Yan ; Margono, Benjamin ; Fuerte, Fatima ; Chang, Gee Chen ; Seetalarom, Kasan ; Wang, Jie ; Cheng, Ashley ; Syahruddin, Elisna ; Qian, Xiaoping ; Ho, James ; Kurnianda, Johan ; Liu, Hsingjin Eugene ; Jin, Kate ; Truman, Matt ; Bara, Ilze ; Mok, Tony. / Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2) : A randomised, double-blind trial. In: The Lancet Oncology. 2013 ; Vol. 14, No. 8. pp. 777-786.
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T1 - Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2)

T2 - A randomised, double-blind trial

AU - Wu, Yi Long

AU - Lee, Jin Soo

AU - Thongprasert, Sumitra

AU - Yu, Chong Jen

AU - Zhang, Li

AU - Ladrera, Guia

AU - Srimuninnimit, Vichien

AU - Sriuranpong, Virote

AU - Sandoval-Tan, Jennifer

AU - Zhu, Yunzhong

AU - Liao, Meilin

AU - Zhou, Caicun

AU - Pan, Hongming

AU - Lee, Victor

AU - Chen, Yuh Min

AU - Sun, Yan

AU - Margono, Benjamin

AU - Fuerte, Fatima

AU - Chang, Gee Chen

AU - Seetalarom, Kasan

AU - Wang, Jie

AU - Cheng, Ashley

AU - Syahruddin, Elisna

AU - Qian, Xiaoping

AU - Ho, James

AU - Kurnianda, Johan

AU - Liu, Hsingjin Eugene

AU - Jin, Kate

AU - Truman, Matt

AU - Bara, Ilze

AU - Mok, Tony

PY - 2013/7

Y1 - 2013/7

N2 - Background: The results of FASTACT, a randomised, placebo-controlled, phase 2 study, showed that intercalated chemotherapy and erlotinib significantly prolonged progression-free survival (PFS) in patients with advanced non-small-cell lung cancer. We undertook FASTACT-2, a phase 3 study in a similar patient population. Methods: In this phase 3 trial, patients with untreated stage IIIB/IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm (stratified by disease stage, tumour histology, smoking status, and chemotherapy regimen) to receive six cycles of gemcitabine (1250 mg/m2 on days 1 and 8, intravenously) plus platinum (carboplatin 5 × area under the curve or cisplatin 75 mg/m2 on day 1, intravenously) with intercalated erlotinib (150 mg/day on days 15-28, orally; chemotherapy plus erlotinib) or placebo orally (chemotherapy plus placebo) every 4 weeks. With the exception of an independent group responsible for monitoring data and safety monitoring board, everyone outside the interactive internet response system company was masked to treatment allocation. Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death, and all patients in the placebo group were offered second-line erlotinib at the time of progression. The primary endpoint was PFS in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00883779. Findings: From April 29, 2009, to Sept 9, 2010, 451 patients were randomly assigned to chemotherapy plus erlotinib (n=226) or chemotherapy plus placebo (n=225). PFS was significantly prolonged with chemotherapy plus erlotinib versus chemotherapy plus placebo (median PFS 7·6 months [95% CI 7·2-8·3], vs 6·0 months [5·6-7·1], hazard ratio [HR] 0·57 [0·47-0·69]; p

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