Randomized phase III trial of 2nd line gemcitabine and paclitaxel chemotherapy in patients with advanced bladder cancer: Short-term versus prolonged treatment [German Association of Urological Oncology (AUO) trial AB 20/99]

Annals of Oncology

Volumn 22, Issue 2, 2011, Pages 288-294

  Albers, P ^a   Park, S I ^b   Niegisch, G ^a   Fechner, G ^b   Steiner, U ^c   Lehmann, J ^d   Heimbach, D ^e   Heidenreich, A ^f   Fimmers, R ^b   Siener, R ^b  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b UNIVERSITY OF BONN   (Germany)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d Homburg University   (Germany)

^e St Vincenz Hospital   (Germany)

^f UNIVERSITY HOSPITAL RWTH AACHEN   (Germany)

Author keywords

Bladder cancer; Chemotherapy; Clinical trial; Phase III; Second line; Transitional cell carcinoma

Indexed keywords

CISPLATIN; CLEMASTINE; DEXAMETHASONE; GEMCITABINE; PACLITAXEL;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; BLADDER CANCER; BLOOD TOXICITY; CANCER LOCALIZATION; CANCER RECURRENCE; COMPARATIVE STUDY; DISEASE COURSE; DOSAGE SCHEDULE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; GERMANY; HUMAN; LONG TERM CARE; LUNG FIBROSIS; MAJOR CLINICAL STUDY; METASTASIS; NEUTROPENIA; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SEPTICEMIA; SHORT COURSE THERAPY; TREATMENT DURATION; TREATMENT RESPONSE;

EID: 79251542085     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdq398     Document Type: Article

References (25)

1. Vaidya A, Soloway MS, Hawke C et al. De novo muscle invasive bladder cancer: is there a change in trend? J Urol 2001; 165(1): 47-50.
2. Lehmann J, Franzaring L, Thüroff J et al. Complete long-term survival data from a trial of adjuvant chemotherapy vs control after radical cystectomy for locally advanced bladder cancer. BJU Int 2006; 97(1): 42-47.
3. von der Maase H, Sengelov L, Roberts JT et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol 2005; 2(21): 4602-4608.
4. nd line therapy after a platinum-containing regimen in advanced transitional cell carcinoma of the urothelium (TCCU). J Clin Oncol 2009; 27(27): 4454-4461.
5. Roth BJ, Dreicer R, Einhorn LH et al. Significant activity of paclitaxel in advanced transitional-cell carcinoma of the urothelium: a phase II trial of the Eastern Cooperative Oncology Group. J Clin Oncol 1994; 12(11): 2264-2270.
6. Vaugh DJ, Broome CM, Hussain M. Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer. J Clin Oncol 2000; 20(4): 937-940.
7. Sternberg CN, Calabro F, Pizzocaro G et al. Chemotherapy with an every-2-week regimen of gemcitabine and paclitaxel in patients with transitional cell carcinoma who have received prior cisplatin-based therapy. Cancer 2001; 92(12): 2993-2998.
8. Meluch AA, Greco FA, Burris HA et al. Paclitaxel and gemcitabine chemotherapy for advanced transitional-cell carcinoma of the urothelial tract: a phase II trial of the Minnie Pearl Cancer Research Network. J Clin Oncol 2001; 19(12): 3018-3024.
9. Parameswaran R, Fisch MJ, Rafat HA et al. Hoosier Oncology Group phase II study of weekly paclitaxel and gemcitabine in advanced transitional cell (TCC) carcinoma of the bladder. J Clin Oncol 2001; 19 (Suppl) (Abstr 798).
10. Marini L, Sternberg CN, Sella A et al. A new regimen of gemcitabine and paclitaxel in previously treated patients with advanced transitional cell carcinoma. Proc Am Soc Clin Oncol 1999; 18: 346a (1335).
11. Albers P, Perabo F, Lindner H et al. Simultaneous and sequential combination schedules of gemcitabine and paclitaxel in human bladder cancer cell lines. Proc Am Soc Clin Oncol 2000 (Abstr 1389).
12. Fechner G, Siener R, Reimann M et al. Randomised phase II trial of gemcitabine and paclitaxel second-line chemotherapy in patients with transitional cell carcinoma (AUO Trial AB 20/99). Int J Clin Pract 2006; 60(1): 27-31.
13. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92(3): 205-216.
14. Eisenhauer E, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: revised RECIST guideline. Eur J Cancer 2009; 45(2): 228-247.
15. Dupont WD, Plummer WD Jr. Power and sample size calculation. A review and computer program. Control Clin Trials 1990; 11(2): 116-128.
16. Guardino AE, Srinivas S. Gemcitabine and paclitaxel as second line chemotherapy for advanced urothelial malignancies. Proc Am Soc Clin Oncol 2002; 21: (Abstr 2413).
17. Li J, Juliar B, Yiannoutsos C et al. Weekly paclitaxel and gemcitabine in advanced transitional-cell carcinoma of the urothelium: a phase II Hoosier Oncology Group study. J Clin Oncol 2006; 23(6): 1185-1191.
18. Matsumoto K, Irie A, Satoh T et al. Gemcitabine and paclitaxel chemotherapy as a second-line treatment for advanced or metastatic urothelial carcinoma. Int J Urol 2007; 14: 1000-1004.
19. Kanai K, Kikuchi E, Ohigashi T et al. Gemcitabine and paclitaxel chemotherapy for advanced urothelial carcinoma in patients who have received prior cisplatin-based chemotherapy. Int J Clin Oncol 2008; 13(6): 510-514.
20. Suyama T, Ueda T, Fukasawa S et al. Combination of gemcitabine and paclitaxel as second-line chemotherapy for advanced urothelial carcinoma. Jpn J Clin Oncol 2009; 39(4): 244-250.
21. Calabro S, Lorusso V, Rosati G et al. Gemcitabine and paclitaxel every 2 weeks in patients with previously untreated urothelial carcinoma. Cancer 2009; 115(12): 2652-2659.
22. Kaufmann DS, Carducci MA, Kuzel TM et al. A multi-institutional phase II trial of gemcitabine plus paclitaxel in patients with locally advanced or metastatic urothelial cancer. Urol Oncol 2004; 22(5): 393-397.
23. Culine S, Theodore C, De Santis M et al. A phase II study of vinflunine in bladder cancer patients progressing after first-line platinum-containing regimen. Br J Cancer 2006; 94(10): 1395-1401.
24. Kouno T, Ando M, Yonemori K et al. Weekly paclitaxel and carboplatin against advanced transitional cell cancer after failure of a platinum-based regimen. Eur Urol 2007; 52(4): 1115-1122.
25. Sweeney CJ, Roth BJ, Kabbinavar FF et al. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol 2006; 24(21): 3451-3457.