Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer

Lung Cancer

Volumn 77, Issue 2, 2012, Pages 346-352

  Ahn, Myung Ju ^a   Yang, James Chih Hsin ^b   Liang, Jun ^c   Kang, Jin Hyoung ^d   Xiu, Qingyu ^e   Chen, Yuh Min ^f   Blair, Julie Michelle ^g   Peng, Guangbin ^h   Linn, Carlos ^h   Orlando, Mauro ^h  

^a Sungkyunkwan University School of Medicine   (South Korea)

^b NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^c QINGDAO UNIVERSITY MEDICAL COLLEGE   (China)

^d The Catholic University of Korea   (South Korea)

^e SECOND MILITARY MEDICAL UNIVERSITY   (China)

^f NATIONAL YANG MING UNIVERSITY   (Taiwan)

^g ELI LILLY AUSTRALIA PTY LTD   (Australia)

^h ELI LILLY AND COMPANY   (United States)

Author keywords

Gefitinib; Maintenance therapy; Never smoker; Non small cell lung cancer; Pemetrexed; Unknown EGFR mutation status

Indexed keywords

CISPLATIN; CYANOCOBALAMIN; DEXAMETHASONE; EPIDERMAL GROWTH FACTOR RECEPTOR; FOLIC ACID; GEFITINIB; PEMETREXED;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASIAN; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CHEMOTHERAPY INDUCED EMESIS; CHINA; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; GENE EXPRESSION; GENE MUTATION; GRANULOCYTOPENIA; HAZARD RATIO; HISTOPATHOLOGY; HUMAN; HYPOKALEMIA; HYPONATREMIA; KOREA; LUNG ADENOCARCINOMA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUDDEN DEATH; TAIWAN; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASIAN CONTINENTAL ANCESTRY GROUP; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; FEMALE; GLUTAMATES; GUANINE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; QUINAZOLINES; TREATMENT OUTCOME;

EID: 84863783193     PISSN: 01695002     EISSN: 18728332     Source Type: Journal    
DOI: 10.1016/j.lungcan.2012.03.011     Document Type: Article

References (18)

1. Ferlay J., Shin H.-R., Bray F., Forman D., Mathers C., Parkin D.P. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010, 127:2893-2917.
2. Scagliotti G.V., Parikh P., von Pawel J., Biesma B., Vansteenkiste J., Manegold C., et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008, 26:3543-3551.
3. Socinski M.A., Stinchcombe T.E. Duration of first-line chemotherapy is advanced non-small-cell lung cancer: less is more in the era of effective subsequent therapies. J Clin Oncol 2007, 25:5155-5157.
4. Ciuleanu T., Brodowicz T., Zielinski C., Kim J.H., Krzakowski M., Laack E., et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small cell lung cancer: a randomised, double-blind, phase 3 study. Lancet 2009, 374:1432-1440.
5. Fidias P.M., Dakhil S.R., Lyss A.P., Loesch D.M., Waterhouse D.M., Bromund J.L., et al. Phase III study of immediate compared with delayed docetaxel after front-line therapy with gemcitabine plus carboplatin in advanced non-small cell lung cancer. J Clin Oncol 2009, 27:591-598.
6. Yang C.-H., Shih J.-Y., Chen K.-C., Yu C.-J., Yang T.-Y., Lin C.-P., et al. Survival outcome and predictors of gefitinib antitumor activity in East Asian chemonaive patients with advanced nonsmall cell lung cancer. Cancer 2006, 107:1873-1882.
7. Kimura H., Kasahara K., Shibata K., Sone T., Yoshimoto A., Kita T., et al. EGFR mutation of tumor and serum in gefitinib-treated patients with chemotherapy-naive non-small cell lung cancer. J Thorac Oncol 2006, 1:260-267.
8. Niho S., Kubota K., Goto K., Yoh K., Ohmatsu H., Kakinuma R., et al. First-line single agent treatment with gefitinib in patients with advanced non-small cell lung cancer: a phase II study. J Clin Oncol 2006, 24:64-69.
9. Mok T.S., Wu Y.-L., Thongprasert S., Yang C.-H., Chu D.-T., Saijo N., et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. New Engl J Med 2009, 361:947-957.
10. Yang C.-H., Fukuoka M., Mok T.S., Wu Y.-L., Thongprasert S., Saijo N., et al. Final overall survival (OS) results from a phase III, randomised, open-label, first-line study of gefitinib (G) v carboplatin-paclitaxel (C/P) in clinically selected patients with advanced non-small cell lung cancer (NSCLC) in Asia (IPASS). Ann Oncol 2010, 21(Suppl. 8):viii1-viii2. (abstract).
11. Takeda K., Hida T., Sato T., Ando M., Seto T., Satouchi M., et al. Randomized phase III trial of platinum-doublet chemotherapy followed by gefitinib compared with continued platinum-doublet chemotherapy in Japanese patients with advanced non-small-cell lung cancer: results of a west Japan thoracic oncology group trial (WJTOG0203). J Clin Oncol 2010, 28:753-760.
12. Simon R., Wittes R.E., Ellenberg S.S. Randomized phase II clinical trials. Cancer Treat Rep 1985, 69:1375-1381.
13. Kaplan E.L., Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958, 53:457-481.
14. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000, 92:205-216.
15. Cappuzzo F., Ciuleanu T., Stelmakh L., Cicenas S., Szczésna A., Juhász E., et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 2010, 11:521-529.
16. Yang C.-H., Simms L., Park K., Lee J.S., Scagliotti G., Orlando M. Efficacy and safety of cisplatin/pemetrexed versus cisplatin/gemcitabine as first-line treatment in East Asian patients with advanced non-small cell lung cancer: results of an exploratory subgroup analysis of a phase III trial. J Thorac Oncol 2010, 5:688-695.
17. Rosell R., Moran T., Queralt C., Porta R., Cardenal F., Camps C., et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009, 361:958-967.
18. Paz-Ares L.G., De Marinis F., Dediu M., Thomas M., Pujol J.L., Bidoli P., et al. PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC). J Clin Oncol 2011, 29:18s. (CRA7510).