Randomized multicenter phase II study of gemcitabine versus docetaxel as first-line therapy with second-line crossover in advanced-stage non-small-cell lung cancer

Clinical Lung Cancer

Volumn 7, Issue 3, 2005, Pages 208-214

  Manegold, Christian ^a   Pilz, Lothar Richard ^b   Koschel, Gabriele ^c   Schott von Römer, Katrin ^d   Mezger, Jörg ^e   Hruska, Dagmar ^f   Dornof, Wolfgang ^g   Gosse, Helga ^h   Gatzemeier, Ulrich ⁱ  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^c Asklepios Klinik Harburg   (Germany)

^d UNIVERSITY OF HEIDELBERG   (Germany)

^e St Vincentius Hospital   (Germany)

^f Schillerhöhe Specialist Hospital   (Germany)

^g Borromäerinnen Hospital   (Germany)

^h Klinikum St Georg   (Germany)

ⁱ KRANKENHAUS GROSSHANSDORF   (Germany)

Author keywords

Feasibility study; Quality of life; Single agent chemotherapy

Indexed keywords

DEXAMETHASONE; DOCETAXEL; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REGIMEN; DRUG EFFICACY; FEMALE; GRANULOCYTOPENIA; HUMAN; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; PHASE 2 CLINICAL TRIAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RANK SUM TEST; SURVIVAL TIME; VOMITING;

EID: 33244468533     PISSN: 15257304     EISSN: None     Source Type: Journal    
DOI: 10.3816/CLC.2005.n.038     Document Type: Article

References (52)

1. ESMO minimum clinical recommendations for diagnosis, treatment and follow-up of non-small-cell lung cancer (NSCLC). Ann Oncol 2001; 12:1049-1050.
2. Pfister DG, Johnson DH, Azzoli CG, et al. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 2004; 22:330-353.
3. Govindan R. Management of patients with non-small cell lung cancer and poor performmce status. Curr Treat Options Oncol 2003; 4:55-59.
4. Gridelli C, Ardizzoni A, Le Chevalier T, et al. Treatment of advanced non-small-cell lung cancer patients with ECOG performance status 2: results of an European Experts Panel. Ann Oncol 2004; 15:419-426.
5. Anderson H, Hopwood P, Stephens RJ, et al. Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer-a randomized trial with quality of life as the primary outcome. Br J Cancer 2000; 83:447-453.
6. Roszkowski K, Pluzanska A, Krzakowski M, et al. A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC). Lung Cancer 2000; 27:145-157.
7. Manegold C, Bergman B, Chemaissani A, et al. Single-agent gemcitabine versus cisplatin-etoposide: early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer. Ann Oncol 1997; 8:525-529.
8. Crino L, Mosconi AM, Scagliotti G, et al. Gemcitabine as second-line treatment for advanced non-small-cell lung cancer: A phase II trial. J Clin Oncol 1999; 17:2081-2085.
9. Manegold C, Drings P. Second-line-chemotherapie mit docetaxel (Taxotere) beim nicht-kleinzelligen bronchialkarzinom (NSCLC). Onkologie 2000; 11:1098-1106.
10. Manegold C, Zatloukal P, Krejcy K, et al. Gemcitabine in non-small cell lung cancer (NSCLC). Invest New Drugs 2000; 18:29-42.
11. Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized study of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000; 18:2095-2103.
12. Manegold C. Gemcitabine (Gemzar) in non-small cell lung cancer. Expert Rev Anticancer Ther 2004; 4:345-360.
13. Fayers P, Bottomley A, on behalf of the EORTC Quality of Life Group and of the Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. Eur J Cancer 2002; 38(suppl):S125-S133.
14. Bergman B, Aaronson NK, Ahmedzai S, et al. 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 1994; 30A:635-642.
15. World Health Organisation. WHO handbook for reporting results of cancer treatment, No. 48. Geneva: WHO Offset Publication, 1979.
16. German Phase I, II, and III Study Group of the Association for Medical Oncology of the German Cancer Society. Phase I and Phase II Study Groups. Onkologie 1998; 21 (suppl 3):1-61.
17. Manegold C. Chemotherapy for advanced non-small cell lung cancer. Semin Oncol 2001; 28(suppl 7):1-6.
18. Le Chevalier T, Brisgand D, Douillard J, et al. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced NSCLC: Results of an European multicenter trial including 612 patients. J Clin Oncol 1994; 12:360-367.
19. Gatzemeier U, von Pawel J, Gottfried M, et al. Phase III comparative study of high dose cisplatin versus a combination of paclitaxel and cisplatin in patients with advanced NSCLC. J Clin Oncol 2000; 18:3390-3399.
20. Georgoulias V, Ardavanis A, Agelidou A, et al. Docetaxel versus docetaxel plus cisplatin as front-line treatment of patients with advanced non-small-cell lung cancer: a randomized, multicenter phase III trial. J Clin Oncol 2004; 22:2602-2609.
21. Sederholm C. Gemcitabine versus gemcitabine/carboplatin in advanced NSCLC: Preliminary findings in a phase III trial of a Swedish lung cancer study group. Semin Oncol 2002; 29(suppl 9): 50-54.
22. Depierre A, Chastang C, Quoix E, et al. Vinorelbine versus vinorelbine plus cisplatin in advanced NSCLC: a randomized trial. Ann Oncol 1994; 5:37-42.
23. Manegold C, Bergman B, Chemaissani A, et al. Single-agent gemcicabine versus cisplatin-etoposide: early results of a randomized phase II study in locally advanced or metastatic NSCLC. Ann Oncol 1997; 8:525-529.
24. Perng RP, Chen YM, Ming-Liu J, et al. Gemcitabine versus the combination of cisplatin and etoposide in patients with inoperable NSCLC in a phase II randomized study. J Clin Oncol 1997; 15:2097-2102.
25. Vansteenkiste JF, Vandebroek JE, Nackaerts KL, et al. Clinical benefit response in advanced NSCLC: A multicentre prospective randomized phase III study of single agent gemcitabine versus cisplatin-vindesine. Ann Oncol 2001; 12:1221-1230.
26. Negoro S, Masuda N, Takada Y, et al. Randomized phase III trial of irinotecan combined with cisplatin for advanced NSCLC. Br J Cancer 2003; 88:335-341.
27. Wozniak AJ, Crowley JJ, Balcerzak SP et al. Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced NSCLC: a Southwest Oncology Group study. J Clin Oncol 1998; 16:2459-2465.
28. Sandler A, Nemunaitis J, Denham C et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic NSCLC. J Clin Oncol 2000; 18:122-130.
29. The Elderly Lung Cancer Vinorelbine Italian Study Group. Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 1999; 91:66-72.
30. Manegold C. Treatment of elderly patients with non-small-cell lung cancer. Oncology (Huntingt) 2001; 15(suppl 6):46-51.
31. Gridelli C, Perrone F, Gallo C, et al. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst 2003; 95:362-372.
32. Ferrigno D, Buccheri G; Cuneo Lung Cancer Study Group. Front-line weekly chemotherapy with gemcitabine for unfit patients with non-small cell lung cancer (NSCLC). Lung Cancer 2004; 45:373-380.
33. Neubauer MA, Reynolds CH, Joppert MG, et al. Results of a phase II trial of gemcitabine in patients with non-small-cell lung cancer and a performance status of 2. Clin Lung Cancer 2005; 6:245-249.
34. Lück HJ, Donnè S, Glaubitz M, et al. Phase I study of weekly docetaxel (Taxotere®) in heavily pretreated breast cancer patients. Eur J Cancer 1997; 33(suppl 8):S158 (Abstract #703).
35. Burris H. Weekly schedules of docetaxel. Semin Oncol 1998; 25(suppl 13):21-23
36. Hainsworth JD, Burris HA III, Erland JB, et al. Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer. J Clin Oncol 1998; 16:2164-2168.
37. Löffler TM. Is there a place for "dose-dense" weekly schedules of the taxoids? Semin Oncol 1998; 25(suppl 12):32-34.
38. Gumerlock PH, Pryde BJ, Kimura T, et al. Enhanced cytotoxicity of docetaxel OSI-774 combination in non-small cell lung carcinoma (NSCLC) Proc Am Soc Clin Oncol 2003; 22:662 (Abstract #2661).
39. Davies AM, Lara PN, Lau DH, et al. Intermittent erlotinib in combination with docetaxel (DOC): phase I schedules designed to achieve pharmacodynamic separation. J Clin Oncol 2005; 23(16 suppl):630s (Abstract #7038).
40. Le Chevalier T, Brisgand D, Douillard JY, et al. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced nonsmall-cell lung cancer: results of a European multicenter trial including 612 patients. J Clin Oncol 1994; 12:360-367.
41. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002; 346:92-98.
42. Hoang T, Xu R, Schiller JH, et al. Clinical model to predict survival in chemonaive patients with advanced non-small-cell lung cancer treated with third-generation chemotherapy regimens based on eastern cooperative oncology group data. J Clin Oncol 2005; 23:175-183.
43. Perng RP, Chen YM, Ming-Liu J, et al. 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 1997; 15:2097-2102.
44. Vansteenkiste JF, Vandebroek JE, Nackaerts KL, et al. Clinical-benefit response in advanced non-small-cell lung cancer: A multicenter prospective randomised phase III study of single agent gemcitabine versus cisplatin-vindesine. Ann Oncol 2001; 12:1221-1230.
45. Ardizzoni A, Acquati M, Fagnani D, et al. Second line therapy with weekly low-dose docetaxel for pretreated non-small-cell lung carcinoma patients: a multicenter Italian phase II study. Lung 2004; 182:1-8.
46. Esteban E, Gonzalez de Sande L, Fernandez Y, et al. Prospective randomised phase II study of docetaxel versus paclitaxel administered weekly in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. Ann Oncol 2003; 14:1640-1647.
47. Rossi D, Graziano E Ugolini M, et al. Weekly docetaxel as second-line therapy in non-small cell lung cancer: a phase II study. Tumori 2004; 90:50-53.
48. Fossella FV, DeVore R, Kerr RN, et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 2000; 18:2354-2362.
49. Groen H, Schramel FM, Van der Hoeven JJM, et al. Docetaxel and carboplatin once every 3 weeks versus weekly docetaxel in advanced non-small cell lung cancer (NSCLC). An interim analysis of a multicenter phase III trial. Proc Am Soc Clin Oncol 2003; 22:623 (Abstract #2505).
50. Lilenbaum R, Rubin M, Samuel J, et al. A phase II randomized trial of docetaxel weekly or every 3 weeks in elderly and/or poor performance status (PS) patients (pts) with advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 2004; 23:627 (Abstract #7057).
51. Monnier A, Zatloukal P, Siffnerova H, et al. Docetaxel (D) versus vinorelbine-cisplatin (VC) as front-line treatment for patients with advanced non-small cell lung cancer (NSCLC) and with a normal level of serum al-acid glycoprotein (AAG): additional data on quality of life (QoL): preliminary results. Proc Am Soc Clin Oncol 2003; 22:666 (Abstract #2680).
52. Schott K, Manegold C, Pilz LR, et al. Final results from a randomised phase II study with single-agent gemcitabine (G) and docetaxel (D) given sequentially every 3 weeks in advanced NSCLC. Ann Oncol 2002; 13(suppl 5):145 (Abstract #529P).