Phase II trial of gemcitabine and docetaxel in patients with completely resected stage IIA-IIIA non-small-cell lung cancer

Cancer Chemotherapy and Pharmacology

Volumn 60, Issue 4, 2007, Pages 495-501

  Kawamura, Masafumi ^a   Eguchi, Keisuke ^a   Izumi, Yotaro ^a   Yamato, Yasushi ^b   Koike, Teruaki ^b   Sakaguchi, Hirozo ^c   Hada, Enjo ^c   Kobayashi, Koichi ^a  

^a KEIO UNIVERSITY HOSPITAL   (Japan)

^b NIIGATA CANCER CENTER HOSPITAL   (Japan)

^c MITSUI MEMORIAL HOSPITAL   (Japan)

Author keywords

Adjuvant chemotherapy; Docetaxel; Gemcitabin; Non platinum doublet; Non small cell lung cancer; Surgery

Indexed keywords

CORTICOSTEROID; DOCETAXEL; GEMCITABINE;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; DISEASE COURSE; DRUG EFFICACY; DYSPNEA; FEMALE; FEVER; HEALTH STATUS; HISTOPATHOLOGY; HUMAN; INTERSTITIAL LUNG DISEASE; LUNG NON SMALL CELL CANCER; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; STATISTICAL SIGNIFICANCE; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CHEMOTHERAPY, ADJUVANT; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEUTROPENIA; SURVIVAL RATE; TAXOIDS;

EID: 34447505005     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-006-0391-6     Document Type: Article

References (25)

1. Mountain CF (1997) Revisions in the international system for staging lung cancer. Chest 111:1710-1717
2. Non-small Cell Lung Cancer Collaborative Group. Chemotherapy in non-small cell lung cancer; a meta analysis using updated data on individual patients from 52 randomized clinical trials. BMJ 311:899-909, 1995
3. The International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med 350:351-360, 2004
4. Winton TL, Livingston R, Jhonson D, Rigas J, Johnston M, Butts C, Cormier Y, Goss G, Inculet R, Vallieres E, Fry W, Bethune D, Ayoub J, Ding K, Seymour L, Graham B, Tsao MS, Gandara D, Kesler K, Demmy T, Shepherd F (2005) Vinorelbine plus cisplatin versus observation in resected non-small-cell lung cancer. N Engl J Med 352:2589-2597
5. Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clarv C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riqqi M, Hurteloup P (2006) ANITA: adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer [Adjuvant Navelbine International Trialist Association (ANITA)]: a randomised controlled trial. Lancet Oncol 7:719-27
6. Chevalier TL, Brisgand D, Douillard JY, Pujor JL, Alberola V, Monnier A, Riviere A, Lianes P, Chomy P, Cigolari S, Gottfried M, Ruffie P, Panizo A, Gaspard MH, Ravaioli A, Besenval M, Bessonval M, Besson F, Martinez A, Berthaud P, Tursz T (1994) Randomized study of vinorelbine and cisplatin versus vindesine and cisplatine versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients. J Clin Oncol 12:360-67
7. Kubota K, Watanabe K, Kunitoh H, Noda K, Ichinose Y, Katakami N, Sugiura T, Kawahara M, Yokoyama M, Yokota S, Yoneda S, Matsui K, Kudo S, Shibuya M, Isobe T, Segawa Y, Nishiwaki Y, Ohashi Y, Niitani H (2004) Phase III randomized trial of docetaxel plus cisplatin versus vindesine plus cisplatin in patients with stage IV non-small-cell lung cancer: The Japanese Taxotere Lung Cancer Study Group. J Clin Oncol 22:254-61
8. Rudd RM, Gower NH, Spiro SG, Eisen TG, Harper PG, Littler JAH, Hatton M, Johnson PWM, Martin WMC, Rankin EM, James LE, Gregory WM, Qian W, Lee SM (2005) Gemcitabine plus carboplatin versus mitomycin, ifosfamide, and cisplatin in patients with stage IIIB or IV non-small-cell lung cancer: a phase III randomized study of the London Lung Cancer Group. J Clin Oncol 23:142-53
9. Bonomi P, Kim KM, Fairclough D, Cella D, Kugler J, Rowinsky E, Jiroutek M, Johnson D (2000) Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: results of an Eastern Cooperative Oncology Group trial. J Clin Oncol 18:623-31
10. Pujol JL, Breton JL, Gervais R, Rebattu P, Depierre A, Morère JF, Milleron B, Debieuvre D, Castéra D, Souquet PJ, Moro-Sibilot D, Lemarié E, Kessler R, Janicot H, Braun D, Spaeth D, Quantin X, Clary C (2005) Gemcitabine-docetaxel versus cisplatin-vinorelbine in advanced or metastatic non-small-cell lung cancer: a phase III study addressing the case for cisplatin. Ann Oncol 16:602-606
11. Georgoulias V, Alexandros A, Xanthi T, Athina A, Penelope M, Ourania A, Panagiotis Z, Michael T, Kostas S, Nikolaos S, Aris P, Anna C, Stylianos K, Charalambos K, Nikolaos A, George S, Dora C (2005) Vinorelbine plus cisplatin versus docetaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol 23:2937-2945
12. Chevalier TL (2003) Results of the randomized international adjuvant lung cancer trial (IALT): cisplatin-based chemotherapy (CT) vs no CT in 1867 patients (pts) with resected non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol (abstr 6)
13. Georgoulias V, Papadakis E, Alexopoulos A, Tsiafaki X, Rapti A, Veslemes M, Palamidas P, Vlachonikolis D (2002) Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomized multicentre trial. Lancet 357:1478-1484
14. Matsui K, Hirashima T, Nitta T, Kobayashi M, Ogata T, Furukawa M, Kudoh S, Yoshimura N, Mukohara T, Yamauchi S, Shiraishi S, Kamoi H, Negoro S, Takeda K, Nakagawa K, Takada M, Yana T, Fukuoka M (2005) A phase I/II study comparing regimen schedules of gemcitabine and docetaxel in Japanese patients with stage IIIB/IV non-small-cell lung cancer. Jpn J Clin Oncol 35:181-187
15. Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR (2004) American Society of Clinical Oncology. American society of clinical oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 22:330-53
16. Popa IE, Stewart K, Smith F, Rizvi NA (2002) A phase II trial of gemcitabine and docetaxel in patients with chemotherapy-naive, advanced nonsmall cell lung cancer. Cancer 95:1714-1719
17. Neubauer MA, Garfield DH, Kuerfler PR, Raju RN, Lindquist DL, Soo EW, Khan M, Boehm KA, Asmar L (2005) Members of the US Oncology Study Group: results of a phase II multicenter trial of weekly docetaxel and gemcitabine as first-line therapy for patients with advanced non-small cell lung cancer. Lung Cancer 47:121-127
18. Castro JD, Lorenzo A, Morales S, Belón J, Dorta J, Lizón J, Madroñal C, Gallurt PM, Casado E, Feliu J, González M (2005) Oncopaz Cooperative Group. Phase II study of a fixed dose-rate infusion of gemcitabine associated with docetaxel in advanced non-small-cell lung carcinoma. Cancer Chemother Pharmacol 55:197-202
19. Yasuda H, Yamaya M, Nakayama K, Sasaki T, Ebihara S, Kanda A, Asada M, Inoue D, Suzuki T, Okazaki T, Takahashi H, Yoshida M, Kaneta T, Ishizawa K, Yamanda S, Tomita N, Yamasaki M, Kikuchi A, Kubo H, Sasaki H (2006) Randomized phase II trial comparing nitroglycerin plus vinorelbine and cisplatin with vinorelbine and cisplatin alone in previously untreated stage IIIB/IV non-small-cell lung cancer. J Clin Oncol 24:688-694
20. Kelly K, Crowley J, Bunn PA, Present CA, Grevstad PK, Mainpour CM, Ramsey SD, Wozniak AJ, Weiss GR, Moore DF, Israel VK, Livingston RB, Gandara DR (2001) Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group Trial. J Clin Oncol 19:3210-3218
21. Takeda K, Negora S, Tamura T, Nishiwaki Y, Kudoh S, Fukuda N, Saijo N (2004) Docetaxel versus docetaxel plus gemcitabine for second-line treatment of non-small cell lung cancer: results of a JCOG randomized trial. Proc Am Soc Clin Oncol (abstr 7034)
22. Kouroussis C, Mavroudis D, Kakolyris S, Voloudaki A, Kalbakis K, Souglakos J, Agelaki S, Malas K, Bozionelou V, Georgoulias V (2004) High incidence of pulmonary toxicity of weekly docetaxel and gemcitabine in patients with non-small cell lung cancer: results of a dose-finding study. Lung Cancer 44:363-368
23. Nelson R, Tarassoff P (1995) Dyspnea with gemcitabine is commonly seen. Eur J Cancer 31S:197-198
24. Pavlakis N, Bell DR, Millward MJ, Levi JA (1997) Fatal pulmonary toxicity resulting from treatment with gemicitabine. Cancer 80:286-291
25. Read WL, Mortimer JE, Picue J (2002) Severe interstitial pneumonitis associated with docetaxel administration. Cancer 94:847-853