Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naive non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002)

被引：425

作者：

Inoue, A. ^{[1
]}

Kobayashi, K. ^{[2
]}

Maemondo, M. ^{[3
]}

Sugawara, S. ^{[4
]}

Oizumi, S. ^{[5
]}

Isobe, H. ^{[6
]}

Gemma, A. ^{[7
]}

Harada, M. ^{[8
]}

Yoshizawa, H. ^{[9
]}

Kinoshita, I. ^{[10
]}

Fujita, Y. ^{[11
]}

Okinaga, S. ^{[12
]}

Hirano, H. ^{[13
]}

Yoshimori, K. ^{[14
]}

Harada, T. ^{[15
]}

Saijo, Y. ^{[16
]}

Hagiwara, K. ^{[17
]}

Morita, S. ^{[18
]}

Nukiwa, T.

机构：

[1] Tohoku Univ Hosp, Dept Resp Med, Aoba Ku, Sendai, Miyagi 9808574, Japan

[2] Saitama Med Univ, Int Med Ctr, Dept Resp Med, Saitama, Japan

[3] Miyagi Canc Ctr, Dept Resp Med, Sendai, Miyagi, Japan

[4] Sendai Kousei Hosp, Dept Pulm Med, Sendai, Miyagi, Japan

[5] Hokkaido Univ, Sch Med, Dept Med 1, Sapporo, Hokkaido 060, Japan

[6] KKR Sapporo Med Ctr, Dept Med Oncol, Sapporo, Hokkaido, Japan

[7] Nipppon Med Sch, Div Pulm Med Infect Dis & Oncol, Dept Internal Med, Tokyo, Japan

[8] Natl Hosp Org, Dept Resp Med, Hokkaido Canc Ctr, Sapporo, Hokkaido, Japan

[9] Niigata Univ, Med & Dent Hosp, Biosci Med Res Ctr, Niigata, Japan

[10] Hokkaido Univ, Grad Sch Med, Dept Med Oncol, Sapporo, Hokkaido, Japan

[11] Natl Hosp Org, Asahikawa Med Ctr, Dept Resp Med, Asahikawa, Hokkaido, Japan

[12] Kesennuma City Hosp, Dept Resp Med, Kesennuma City, Miyagi, Japan

[13] Iwate Cent Prefectural Hosp, Dept Resp Med, Morioka, Iwate, Japan

[14] AntiTB Assoc, Fukujuji Hosp, Div Pulm Med, Tokyo, Japan

[15] Hokkaido Social Insurance Hosp, Ctr Resp Dis, Sapporo, Hokkaido, Japan

[16] Hirosaki Univ, Grad Sch Med, Dept Med Oncol, Hirosaki, Aomori, Japan

[17] Saitama Med Univ, Dept Resp Med, Saitama, Japan

[18] Yokohama City Univ, Med Ctr, Dept Biostat & Epidemiol, Yokohama, Kanagawa 232, Japan

来源：

ANNALS OF ONCOLOGY | 2013年 / 24卷 / 01期

关键词：

EGFR mutation; gefitinib; individualized treatment; lung cancer; GROWTH-FACTOR-RECEPTOR; ACID PCR CLAMP; CHEMOTHERAPY; THERAPY;

D O I：

10.1093/annonc/mds214

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

NEJ002 study, comparing gefitinib with carboplatin (CBDCA) and paclitaxel (PTX; Taxol) as the first-line treatment for advanced non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation, previously reported superiority of gefitinib over CBDCA/PTX on progression-free survival (PFS). Subsequent analysis was carried out mainly regarding overall survival (OS). For all 228 patients in NEJ002, survival data were updated in December, 2010. Detailed information regarding subsequent chemotherapy after the protocol treatment was also assessed retrospectively and the impact of some key drugs on OS was evaluated. The median survival time (MST) was 27.7 months for the gefitinib group, and was 26.6 months for the CBDCA/PTX group (HR, 0.887; P = 0.483). The OS of patients who received platinum throughout their treatment (n = 186) was not statistically different from that of patients who never received platinum (n = 40). The MST of patients treated with gefitinib, platinum, and pemetrexed (PEM) or docetaxel (DOC, Taxotere; n = 76) was around 3 years. No significant difference in OS was observed between gefitinib and CBDCA/PTX in the NEJ002 study, probably due to a high crossover use of gefitinib in the CBDCA/PTX group. Considering the many benefits and the risk of missing an opportunity to use the most effective agent for EGFR-mutated NSCLC, the first-line gefitinib is strongly recommended.

引用

页码：54 / 59

页数：6

共 18 条

[1] A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations [J].

Asahina, H. ;

Yamazaki, K. ;

Kinoshita, I. ;

Sukoh, N. ;

Harada, M. ;

Yokouchi, H. ;

Ishida, T. ;

Ogura, S. ;

Kojima, T. ;

Okamoto, Y. ;

Fujita, Y. ;

Dosaka-Akita, H. ;

Isobe, H. ;

Nishimura, M. .

BRITISH JOURNAL OF CANCER, 2006, 95 (08) :998-1004

[2] American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer [J].

Azzoli, Christopher G. ;

Baker, Sherman, Jr. ;

Temin, Sarah ;

Pao, William ;

Aliff, Timothy ;

Brahmer, Julie ;

Johnson, David H. ;

Laskin, Janessa L. ;

Masters, Gregory ;

Milton, Daniel ;

Nordquist, Luke ;

Pfister, David G. ;

Piantadosi, Steven ;

Schiller, Joan H. ;

Smith, Reily ;

Smith, Thomas J. ;

Strawn, John R. ;

Trent, David ;

Giaccone, Giuseppe .

JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (36) :6251-6266

[3] Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy [J].

Hanna, N ;

Shepherd, FA ;

Fossella, FV ;

Pereira, JR ;

De Marinis, F ;

von Pawel, J ;

Gatzemeier, U ;

Tsao, TCY ;

Pless, M ;

Muller, T ;

Lim, HL ;

Desch, C ;

Szondy, K ;

Gervais, R ;

Shaharyar ;

Manegold, C ;

Paul, S ;

Paoletti, P ;

Einhorn, L ;

Bunn, PA .

JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (09) :1589-1597

[4] Prospective phase II study of gefitinib for chemotherapy-naive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations [J].

Inoue, Akira ;

Suzuki, Takuji ;

Fukuhara, Tatsuro ;

Maemondo, Makoto ;

Kimura, Yuichiro ;

Morikawa, Naoto ;

Watanabe, Hiroshi ;

Saijo, Yasuo ;

Nukiwa, Toshihiro .

JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (21) :3340-3346

[5] Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib [J].

Lynch, TJ ;

Bell, DW ;

Sordella, R ;

Gurubhagavatula, S ;

Okimoto, RA ;

Brannigan, BW ;

Harris, PL ;

Haserlat, SM ;

Supko, JG ;

Haluska, FG ;

Louis, DN ;

Christiani, DC ;

Settleman, J ;

Haber, DA .

NEW ENGLAND JOURNAL OF MEDICINE, 2004, 350 (21) :2129-2139

[6] Gefitinib or Chemotherapy for Non-Small-Cell Lung Cancer with Mutated EGFR. [J].

Maemondo, Makoto ;

Inoue, Akira ;

Kobayashi, Kunihiko ;

Sugawara, Shunichi ;

Oizumi, Satoshi ;

Isobe, Hiroshi ;

Gemma, Akihiko ;

Harada, Masao ;

Yoshizawa, Hirohisa ;

Kinoshita, Ichiro ;

Fujita, Yuka ;

Okinaga, Shoji ;

Hirano, Haruto ;

Yoshimori, Kozo ;

Harada, Toshiyuki ;

Ogura, Takashi ;

Ando, Masahiro ;

Miyazawa, Hitoshi ;

Tanaka, Tomoaki ;

Saijo, Yasuo ;

Hagiwara, Koichi ;

Morita, Satoshi ;

Nukiwa, Toshihiro .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (25) :2380-2388

[7] Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial [J].

Mitsudomi, Tetsuya ;

Morita, Satoshi ;

Yatabe, Yasushi ;

Negoro, Shunichi ;

Okamoto, Isamu ;

Tsurutani, Junji ;

Seto, Takashi ;

Satouchi, Miyako ;

Tada, Hirohito ;

Hirashima, Tomonori ;

Asami, Kazuhiro ;

Katakami, Nobuyuki ;

Takada, Minoru ;

Yoshioka, Hiroshige ;

Shibata, Kazuhiko ;

Kudoh, Shinzoh ;

Shimizu, Eiji ;

Saito, Hiroshi ;

Toyooka, Shinichi ;

Nakagawa, Kazuhiko ;

Fukuoka, Masahiro .

LANCET ONCOLOGY, 2010, 11 (02) :121-128

[8] Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma. [J].

Mok, Tony S. ;

Wu, Yi-Long ;

Thongprasert, Sumitra ;

Yang, Chih-Hsin ;

Chu, Da-Tong ;

Saijo, Nagahiro ;

Sunpaweravong, Patrapim ;

Han, Baohui ;

Margono, Benjamin ;

Ichinose, Yukito ;

Nishiwaki, Yutaka ;

Ohe, Yuichiro ;

Yang, Jin-Ji ;

Chewaskulyong, Busyamas ;

Jiang, Haiyi ;

Duffield, Emma L. ;

Watkins, Claire L. ;

Armour, Alison A. ;

Fukuoka, Masahiro .

NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (10) :947-957

[9] Combined Survival Analysis of Prospective Clinical Trials of Gefitinib for Non-Small Cell Lung Cancer with EGFR Mutations [J].

Morita, Satoshi ;

Okamoto, Isamu ;

Kobayashi, Kunihiko ;

Yamazaki, Koichi ;

Asahina, Hajime ;

Inoue, Akira ;

Hagiwara, Koichi ;

Sunaga, Noriaki ;

Yanagitani, Noriko ;

Hida, Toyoaki ;

Yoshida, Kimihide ;

Hirashima, Tomonori ;

Yasumoto, Kosei ;

Sugio, Kenji ;

Mitsudomi, Tetsuya ;

Fukuoka, Masahiro ;

Nukiwa, Toshihiro .

CLINICAL CANCER RESEARCH, 2009, 15 (13) :4493-4498

[10] Genetic heterogeneity of the epidermal growth factor receptor in non-small cell lung cancer cell lines revealed by a rapid and sensitive detection system, the peptide nucleic acid-locked nucleic acid PCR clamp [J].

Nagai, Y ;

Miyazawa, H ;

Huqun ;

Tanaka, T ;

Udagawa, K ;

Kato, M ;

Fukuyama, S ;

Yokote, A ;

Kobayashi, K ;

Kanazawa, N ;

Hagiwara, K .

CANCER RESEARCH, 2005, 65 (16) :7276-7282

← 1 2 →