First-line gemcitabine with cisplatin or epirubicin in advanced non-small-cell lung cancer: A phase III trial

British Journal of Cancer

Volumn 89, Issue 7, 2003, Pages 1192-1199

  Wachters, F M ^a   Van Putten, J W J ^a   Kramer, H ^a   Erjavec, Z ^b   Eppinga, P ^c   Strijbos, J H ^c   De Leede, G P J ^d   Boezen, H M ^e   De Vries, E G E ^a   Groen, H J M ^a  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^b Delfzicht Ziekenhuis   (Netherlands)

^c NIJ SMELLINGHE HOSPITAL   (Netherlands)

^d Bethesda Hospital   (Netherlands)

^e UNIVERSITY OF GRONINGEN   (Netherlands)

Author keywords

Chemotherapy; Epirubicin; Gemcitabine; Non small cell lung cancer cisplatin; Phase III trial

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CISPLATIN; CREATININE; DEXAMETHASONE; DOCETAXEL; EPIRUBICIN; GEMCITABINE; GRANULOCYTE COLONY STIMULATING FACTOR; ONDANSETRON; PACLITAXEL;

ADULT; ADVANCED CANCER; AGED; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTICLE; BLEEDING; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CARDIOMYOPATHY; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE COURSE; DISEASE SEVERITY; DOSE TIME EFFECT RELATION; DYSPHAGIA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GRANULOCYTOPENIA; HEART FAILURE; HUMAN; INFECTION; LEUKOPENIA; LIVER TOXICITY; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; NAUSEA; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SKIN MANIFESTATION; STATISTICAL SIGNIFICANCE; SURVIVAL; TASK PERFORMANCE; THROMBOCYTOPENIA; VOMITING;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, LARGE CELL; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; CISPLATIN; DEOXYCYTIDINE; EPIRUBICIN; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PROGNOSIS; QUALITY OF LIFE; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 0242361194     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bjc.6601283     Document Type: Article

References (38)

1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, De Haes JC (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85: 365 - 376
2. American Society of Clinical Oncology (1997) Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer. Adopted on May 16, 1997 by the American Society of Clinical Oncology. J Clin Oncol 15: 2996 - 3018
3. Anderson H, Lund B, Bach F, Thatcher N, Walling J, Hansen HH (1994) Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 12: 1821 - 1826
4. Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M (1994) The EORTC QLQ-LC13: a modular supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of life. Eur J Cancer 30 A: 635 - 642
5. Bunn Jr PA, Kelly K (1998) New chemotherapeutic agents prolong survival and improve quality of life in non-small cell lung cancer: a review of the literature and future directions. Clin Cancer Res 4: 1087 - 1100
6. Cardenal F, Lopez-Cabrerizo MP, Anton A, Alberola V, Massuti B, Carrato A, Barneto I, Lomas M, Garcia M, Lianes P, Montalar J, Vadell C, Gonzalez-Larriba JL, Nguyen B, Artal A, Rosell R (1999) Randomized phase III study of gemcitabine - cisplatin versus etoposide - cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 17: 12 - 18
7. Cockcroft DW, Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16: 31 - 41
8. Comella P, Frasci G, De Cataldis G, Panza N, Cioffi R, Curcio C, Belli M, Bianco A, Ianniello G, Maiorino L, Della VM, Perchard J, Comella G (1996) Cisplatin/carboplatin+etoposide+vinorelbine in advanced non-small-cell lung cancer: a multicentre randomised trial. Gruppo Oncologico Campano. Br J Cancer 74: 1805 - 1811
9. Comella P, Frasci G, Panza N, Manzione L, De Cataldis G, Cioffi R, Maiorino L, Micillo E, Lorusso V, Di Rienzo G, Filippelli G, Lamberti A, Natale M, Bilancia D, Nicolella G, Di Nota A, Comella G (2000) Randomized trial comparing cisplatin, gemcitabine, and vinorelbine with either cisplatin and gemcitabine or cisplatin and vinorelbine in advanced non-small-cell lung cancer: interim analysis of a phase III trial of the Southern Italy Cooperative Oncology Group. J Clin Oncol 18: 1451 - 1457
10. Crino L, Scagliotti GV, Ricci S, De Marinis F, Rinaldi M, Gridelli C, Ceribelli A, Bianco R, Marangolo M, Di Costanzo F, Sassi M, Barni S, Ravaioli A, Adamo V, Portalone L, Cruciani G, Masotti A, Ferrara G, Gozzelino F, Tonato M (1999) Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer: a randomized phase III study of the Italian Lung Cancer Project. J Clin Oncol 17: 3522 - 3530
11. Cullen MH, Billingham LJ, Woodroffe CM, Chetiyawardana AD, Gower NH, Joshi R, Ferry DR, Rudd RM, Spiro SG, Cook JE, Trask C, Bessell E, Connolly CK, Tobias J, Souhami RL (1999) Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life. J Clin Oncol 17: 3188 - 3194
12. Feld R, Wierzbicki R, Walde PL, Shepherd FA, Evans WK, Gupta S, Shannon P, Lassus M (1992) Phase I-II study of high-dose epirubicin in advanced non-small-cell lung cancer. J Clin Oncol 10: 297 - 303
13. Frasci G (2002) Chemotherapy of lung cancer in the elderly. Crit Rev Oncol Hematol 41: 349 - 361
14. Fry WA, Phillips JL, Menck HR (1999) Ten-year survey of lung cancer treatment and survival in hospitals in the United States: a national cancer data base report. Cancer 86: 1867 - 1876
15. Gatzemeier U, Heckmayr M, Hossfeld DK, Kaukel E, Koschel G, Neuhauss R (1991) A randomized trial with mitomycin C/ifosfamide versus mitomycin C/vindesine versus cisplatin/etoposide in advanced non-small-cell lung cancer. Am J Clin Oncol 14: 405 - 411
16. Gatzemeier U, Shepherd FA, Le Chevalier T, Weynants P, Cottier B, Groen HJM, Rosso R, Mattson K, Cortes-Funes H, Tonato M, Burkes RL, Gottfried M, Voi M (1996) Activity of gemcitabine in patients with non-small-cell lung cancer: a multicentre, extended phase II study. Eur J Cancer 32A: 243 - 248
17. Georgoulias V, Papadakis E, Alexopoulos A, Tsiafaki X, Rapti A, Veslemes M, Palamidas P, Vlachonikolis I (2001) Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomised multicentre trial. Lancet 357: 1478 - 1484
18. Gridelli C, Perrone F, Palmeri S, D'Aprile M, Cognetti F, Rossi A, Gebbia V, Pepe R, Veltri E, Airoma G, Russo A, Incoronato P, Scinto AF, Palazzolo G, Natali M, Leonardi V, Gallo C, De Placido S, Bianco AR (1996) Mitomycin C plus vindesine plus etoposide (MEV) versus mitomycin C plus vindesine plus cisplatin (MVP) in stage IV non-small-cell lung cancer: a phase III multicentre randomised trial. The 'Gruppo Oncologico Centro-Sud-Isole' (G.O.C.S.I.). Ann Oncol 7: 821 - 826
19. Halme M, Jekunen A, Tamminen K, Mattson K (1997) Phase II study of weekly gemcitabine in advanced non-small cell lung cancer. Respir Med 91: 423 - 426
20. Huisman C, Smit EF, Giaccone G, Postmus PE (2000) Second-line chemotherapy in relapsing or refractory non-small-cell lung cancer: a review. J Clin Oncol 18: 3722 - 3730
21. Kosmidis P, Mylonakis N, Nicolaides C, Kalophonos C, Samantas E, Boukovinas J, Fountzilas G, Skarlos D, Economopoulos T, Tsavdaridis D, Papakostas P, Bacoyiannis C, Dimopoulos M (2002) Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol 20: 3578 - 3585
22. Le Chevalier T, Brisgand D, Soria JC, Douillard JY, Pujol JL, Ruffle P, Aberola V, Cigolari S (2001) Long term analysis of survival in the European randomized trial comparing vinorelbine/cisplatin to vindesine/cisplatin and vinorelbine alone in advanced non-small cell lung cancer. Oncologist 6(suppl 1): 8 - 11
23. Non-small Cell Lung Cancer Collaborative Group (1995) Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. BMJ 311: 899 - 909
24. Perng RP, Chen YM, Ming-Liu J, Tsai CM, Lin WC, Yang KY, Whang-Peng J (1997) Gemcitabine versus the combination of cisplatin and etoposide in patients with inoperable non-small-cell lung cancer in a phase II randomized study. J Clin Oncol 15: 2097 - 2102
25. Rosell R, Gatzemeier U, Betticher DC, Keppler U, Macha HN, Pirker R, Berthet P, Breau JL, Lianes P, Nicholson M, Ardizzoni A, Chemaissani A, Bogaerts J, Gallant G (2002) Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial. Ann Oncol 13: 1539 - 1549
26. Sandler AB, Nemunaitis J, Denham C, Von Pawel J, Cormier Y, Gatzemeier U, Mattson K, Manegold C, Palmer MC, Gregor A, Nguyen B, Niyikiza C, Einhorn LH (2000) Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 18: 122 - 130
27. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH (2002) Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346: 92 - 98
28. Sculier JP, Lafitte JJ, Lecomte J, Berghmans T, Thiriaux J, Florin MC, Efremidis A, Alexopoulos CG, Recloux P, Ninane V, Mommen P, Paesmans M, Klastersky J (2002) A three-arm phase III randomised trial comparing combinations of platinum derivatives, ifosfamide and/or gemcitabine in stage IV non-small-cell lung cancer. Ann Oncol 13: 874 - 882
29. Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J (2000) Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18: 2095 - 2103
30. Smit EF, Berendsen HH, Piers DA, Smeets J, Riva A, Postmus PE (1992) A phase II study of high dose epirubicin in unresectable non small cell lung cancer. Br J Cancer 65: 405 - 408
31. Sweeney CJ, Zhu J, Sandler AB, Schiller J, Belani CP, Langer C, Krook J, Harrington D, Johnson DH (2001) Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group Study E1594: a phase II trial in patients with metastatic non-small-cell lung carcinoma. Cancer 92: 2639 - 2647
32. Takada M, Negoro S, Kudo S, Furuse K, Nishikawa H, Takada Y, Kamei T, Niitani H, Fukuoka M (1998) Activity of gemcitabine in non-small-cell lung cancer: results of the Japan gemcitabine group (A) phase II study. Cancer Chemother Pharmacol 41: 217 - 222
33. Ten Bokkel Huinink WW, Bergman B, Chemaissani A, Dornoff W, Drings P, Kellokumpu-Lehtinen PL, Liippo K, Mattson K, Von Pawel J, Ricci S, Sederholm C, Stahel RA, Wagenius G, Walree NV, Manegold C (1999) Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer. Lung Cancer 26: 85 - 94
34. Van Putten JWG, Eppinga P, Erjavec Z, De Leede GPJ, Nabers J, Smeets JB, Th SD, Groen HJM (2000) Activity of high-dose epirubicin combined with gemcitabine in advanced non-small-cell lung cancer: a multicenter phase I and II study. Br J Cancer 82: 806 - 811
35. Wils J, Utama I, Sala L, Smeets J, Riva A (1990) Phase II study of high-dose epirubicin in non-small cell lung cancer. Eur J Cancer 26: 1140 - 1141
36. World Health Organisation (1979) WHO Handbook for reporting results of cancer treatment. Geneva, Switzerland
37. Yokoyama A, Nakai Y, Yoneda S, Kurita Y, Niitani H (1997) Activity of gemcitabine in the treatment of patients with non-small-cell lung cancer: a multicenter phase II study. Anticancer Drugs 8: 574 - 581
38. Zatloukal P, Kanitz E, Magyar P, Jassem J, Krzakowski M, Pawlicki M, Petruzelka L, Chovan L, Pesek M, Janko C, Krejcy K (1998) Gemcitabine in locally advanced and metastatic non-small cell lung cancer: the Central European phase II study. Lung Cancer 22; 243 - 250