Phase II randomized trial of erlotinib or vinorelbine in chemonaive, advanced, non-small cell lung cancer patients aged 70 years or older

Yuh Min Chen, Chun Ming Tsai, Wen Chien Fan, Jen Fu Shih, Shih Hao Liu, Chieh Hung Wu, Teh Ying Chou, Yu Chin Lee, Reury Perng Perng, Jacqueline Whang-Peng

    Research output: Contribution to journalArticle

    52 Citations (Scopus)

    Abstract

    Introduction: The primary objective of this study was to compare the response rates of elderly, chemonaive patients with advanced non-small cell lung cancer (NSCLC) treated with daily oral erlotinib versus oral vinorelbine. Methods: Chemonaive Taiwanese patients aged 70 years or older who had advanced NSCLC were randomized to receive either oral erlotinib 150 mg (E) daily or oral vinorelbine 60 mg/m 2 (V) on days 1 and 8 every 3 weeks. Results: From February 2007 to July 2008, 116 patients were enrolled and 113 were included in the intent-to-treat population: 57 patients in the E group and 56 patients in the V group. Objective response rates were 22.8% (13 of 57) in E and 8.9% (5 of 56) in V (p = 0.0388). Median progression-free survival (PFS) was 4.57 months in E and 2.53 months in V (p = 0.0287), with an 80.6% increase in median PFS for E compared with V. Median survival time was 11.67 months in E and 9.3 months in V (p = 0.6975). Toxicities were generally mild in both groups. Median PFS was longest for epidermal growth factor receptor gene (EGFR)-mutated patients in the E group, followed by EGFR-mutated patients in V, EGFR wild type in E, and EGFR wild type in V (p = 0.0034). Overall survival was longer for EGFR-mutated patients than for EGFR wild-type patients (p < 0.0001). Conclusions: Erlotinib is highly effective compared with oral vinorelbine in elderly, chemonaive, Taiwanese patients with NSCLC. EGFR-mutated patients had better survival than those with EGFR wild-type disease, regardless of the treatment received.

    Original languageEnglish
    Pages (from-to)412-418
    Number of pages7
    JournalJournal of Thoracic Oncology
    Volume7
    Issue number2
    DOIs
    Publication statusPublished - Feb 2012

    Fingerprint

    erbB-1 Genes
    Non-Small Cell Lung Carcinoma
    Disease-Free Survival
    Survival
    vinorelbine
    Erlotinib Hydrochloride

    Keywords

    • Chemotherapy
    • Epidermal growth factor receptor
    • Nonsmall-cell lung cancer
    • Targeted therapy
    • Tyrosine-kinase inhibitor

    ASJC Scopus subject areas

    • Oncology
    • Pulmonary and Respiratory Medicine

    Cite this

    Phase II randomized trial of erlotinib or vinorelbine in chemonaive, advanced, non-small cell lung cancer patients aged 70 years or older. / Chen, Yuh Min; Tsai, Chun Ming; Fan, Wen Chien; Shih, Jen Fu; Liu, Shih Hao; Wu, Chieh Hung; Chou, Teh Ying; Lee, Yu Chin ; Perng, Reury Perng; Whang-Peng, Jacqueline.

    In: Journal of Thoracic Oncology, Vol. 7, No. 2, 02.2012, p. 412-418.

    Research output: Contribution to journalArticle

    Chen, Yuh Min ; Tsai, Chun Ming ; Fan, Wen Chien ; Shih, Jen Fu ; Liu, Shih Hao ; Wu, Chieh Hung ; Chou, Teh Ying ; Lee, Yu Chin ; Perng, Reury Perng ; Whang-Peng, Jacqueline. / Phase II randomized trial of erlotinib or vinorelbine in chemonaive, advanced, non-small cell lung cancer patients aged 70 years or older. In: Journal of Thoracic Oncology. 2012 ; Vol. 7, No. 2. pp. 412-418.
    @article{00e020834ccb4698a5b46d44d02aa406,
    title = "Phase II randomized trial of erlotinib or vinorelbine in chemonaive, advanced, non-small cell lung cancer patients aged 70 years or older",
    abstract = "Introduction: The primary objective of this study was to compare the response rates of elderly, chemonaive patients with advanced non-small cell lung cancer (NSCLC) treated with daily oral erlotinib versus oral vinorelbine. Methods: Chemonaive Taiwanese patients aged 70 years or older who had advanced NSCLC were randomized to receive either oral erlotinib 150 mg (E) daily or oral vinorelbine 60 mg/m 2 (V) on days 1 and 8 every 3 weeks. Results: From February 2007 to July 2008, 116 patients were enrolled and 113 were included in the intent-to-treat population: 57 patients in the E group and 56 patients in the V group. Objective response rates were 22.8{\%} (13 of 57) in E and 8.9{\%} (5 of 56) in V (p = 0.0388). Median progression-free survival (PFS) was 4.57 months in E and 2.53 months in V (p = 0.0287), with an 80.6{\%} increase in median PFS for E compared with V. Median survival time was 11.67 months in E and 9.3 months in V (p = 0.6975). Toxicities were generally mild in both groups. Median PFS was longest for epidermal growth factor receptor gene (EGFR)-mutated patients in the E group, followed by EGFR-mutated patients in V, EGFR wild type in E, and EGFR wild type in V (p = 0.0034). Overall survival was longer for EGFR-mutated patients than for EGFR wild-type patients (p < 0.0001). Conclusions: Erlotinib is highly effective compared with oral vinorelbine in elderly, chemonaive, Taiwanese patients with NSCLC. EGFR-mutated patients had better survival than those with EGFR wild-type disease, regardless of the treatment received.",
    keywords = "Chemotherapy, Epidermal growth factor receptor, Nonsmall-cell lung cancer, Targeted therapy, Tyrosine-kinase inhibitor",
    author = "Chen, {Yuh Min} and Tsai, {Chun Ming} and Fan, {Wen Chien} and Shih, {Jen Fu} and Liu, {Shih Hao} and Wu, {Chieh Hung} and Chou, {Teh Ying} and Lee, {Yu Chin} and Perng, {Reury Perng} and Jacqueline Whang-Peng",
    year = "2012",
    month = "2",
    doi = "10.1097/JTO.0b013e31823a39e8",
    language = "English",
    volume = "7",
    pages = "412--418",
    journal = "Journal of Thoracic Oncology",
    issn = "1556-0864",
    publisher = "International Association for the Study of Lung Cancer",
    number = "2",

    }

    TY - JOUR

    T1 - Phase II randomized trial of erlotinib or vinorelbine in chemonaive, advanced, non-small cell lung cancer patients aged 70 years or older

    AU - Chen, Yuh Min

    AU - Tsai, Chun Ming

    AU - Fan, Wen Chien

    AU - Shih, Jen Fu

    AU - Liu, Shih Hao

    AU - Wu, Chieh Hung

    AU - Chou, Teh Ying

    AU - Lee, Yu Chin

    AU - Perng, Reury Perng

    AU - Whang-Peng, Jacqueline

    PY - 2012/2

    Y1 - 2012/2

    N2 - Introduction: The primary objective of this study was to compare the response rates of elderly, chemonaive patients with advanced non-small cell lung cancer (NSCLC) treated with daily oral erlotinib versus oral vinorelbine. Methods: Chemonaive Taiwanese patients aged 70 years or older who had advanced NSCLC were randomized to receive either oral erlotinib 150 mg (E) daily or oral vinorelbine 60 mg/m 2 (V) on days 1 and 8 every 3 weeks. Results: From February 2007 to July 2008, 116 patients were enrolled and 113 were included in the intent-to-treat population: 57 patients in the E group and 56 patients in the V group. Objective response rates were 22.8% (13 of 57) in E and 8.9% (5 of 56) in V (p = 0.0388). Median progression-free survival (PFS) was 4.57 months in E and 2.53 months in V (p = 0.0287), with an 80.6% increase in median PFS for E compared with V. Median survival time was 11.67 months in E and 9.3 months in V (p = 0.6975). Toxicities were generally mild in both groups. Median PFS was longest for epidermal growth factor receptor gene (EGFR)-mutated patients in the E group, followed by EGFR-mutated patients in V, EGFR wild type in E, and EGFR wild type in V (p = 0.0034). Overall survival was longer for EGFR-mutated patients than for EGFR wild-type patients (p < 0.0001). Conclusions: Erlotinib is highly effective compared with oral vinorelbine in elderly, chemonaive, Taiwanese patients with NSCLC. EGFR-mutated patients had better survival than those with EGFR wild-type disease, regardless of the treatment received.

    AB - Introduction: The primary objective of this study was to compare the response rates of elderly, chemonaive patients with advanced non-small cell lung cancer (NSCLC) treated with daily oral erlotinib versus oral vinorelbine. Methods: Chemonaive Taiwanese patients aged 70 years or older who had advanced NSCLC were randomized to receive either oral erlotinib 150 mg (E) daily or oral vinorelbine 60 mg/m 2 (V) on days 1 and 8 every 3 weeks. Results: From February 2007 to July 2008, 116 patients were enrolled and 113 were included in the intent-to-treat population: 57 patients in the E group and 56 patients in the V group. Objective response rates were 22.8% (13 of 57) in E and 8.9% (5 of 56) in V (p = 0.0388). Median progression-free survival (PFS) was 4.57 months in E and 2.53 months in V (p = 0.0287), with an 80.6% increase in median PFS for E compared with V. Median survival time was 11.67 months in E and 9.3 months in V (p = 0.6975). Toxicities were generally mild in both groups. Median PFS was longest for epidermal growth factor receptor gene (EGFR)-mutated patients in the E group, followed by EGFR-mutated patients in V, EGFR wild type in E, and EGFR wild type in V (p = 0.0034). Overall survival was longer for EGFR-mutated patients than for EGFR wild-type patients (p < 0.0001). Conclusions: Erlotinib is highly effective compared with oral vinorelbine in elderly, chemonaive, Taiwanese patients with NSCLC. EGFR-mutated patients had better survival than those with EGFR wild-type disease, regardless of the treatment received.

    KW - Chemotherapy

    KW - Epidermal growth factor receptor

    KW - Nonsmall-cell lung cancer

    KW - Targeted therapy

    KW - Tyrosine-kinase inhibitor

    UR - http://www.scopus.com/inward/record.url?scp=84858339030&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=84858339030&partnerID=8YFLogxK

    U2 - 10.1097/JTO.0b013e31823a39e8

    DO - 10.1097/JTO.0b013e31823a39e8

    M3 - Article

    C2 - 22157367

    AN - SCOPUS:84858339030

    VL - 7

    SP - 412

    EP - 418

    JO - Journal of Thoracic Oncology

    JF - Journal of Thoracic Oncology

    SN - 1556-0864

    IS - 2

    ER -