Adjuvant chemotherapy with cisplatin and gemcitabine versus chemotherapy at relapse in patients with muscle-invasive bladder cancer submitted to radical cystectomy: An italian, multicenter, randomized phase iii trial

Annals of Oncology

Volumn 23, Issue 3, 2012, Pages 695-700

  Cognetti, F ^a   Ruggeri, E M ^b   Felici, A ^a   Gallucci, M ^a   Muto, G ^c   Pollera, C F ^b   Massidda, B ^d   Rubagotti, A ^e   Giannarelli, D ^a   Boccardo, F ^e  

^a REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^b BELCOLLE HOSPITAL   (Italy)

^c MOLINETTE HOSPITAL   (Italy)

^d UNIVERSITY OF CAGLIARI   (Italy)

^e UNIVERSITY OF GENOA   (Italy)

Author keywords

Adjuvant chemotherapy; Bladder cancer; Phase III trial

Indexed keywords

CISPLATIN; GEMCITABINE;

ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; BLADDER CARCINOMA; CANCER ADJUVANT THERAPY; CANCER MORTALITY; CANCER STAGING; CONTROLLED STUDY; CREATININE CLEARANCE; CYSTECTOMY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; FOLLOW UP; HUMAN; HYPERCREATINEMIA; HYPERTRANSAMINASEMIA; INFECTION; ITALY; LEUKOPENIA; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE INVASIVE BLADDER CANCER; NAUSEA AND VOMITING; NEUTROPENIA; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; TRANSITIONAL CELL CARCINOMA;

EID: 84857509409     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdr354     Document Type: Article

References (29)

1. Ferlay J, Autier P, Boniol M et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007; 18(3): 581-592.
2. Stein JP, Grossfeld GD, Freeman JA et al. Orthotopic lower urinary tract reconstruction in women using the Kock ileal neobladder: updated experience in 34 patients. J Urol 1997; 158: 400-405.
3. Elmajian DA, Stein JP, Esrig D et al. The Kock ileal neobladder: updated experience in 295 male patients. J Urol 1996; 156: 920-925.
4. Stein JP, Lieskovsky G, Cote R et al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1054 patients. J Clin Oncol 2001; 19: 666-675.
5. Madersbacher S, Hochreiter W, Burkhard F et al. Radical cystectomy for bladder cancer today-a homogeneous series without neoadjuvant chemotherapy. J Clin Oncol 2003; 21: 690-696.
6. Vale C for the Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: a systematic review and meta-analysis. Lancet 2003; 361: 1927-1934.
7. Winquist E, Kirchner TS, Segal R et al. Neoadjuvant chemotherapy for transitional cell carcinoma of the bladder: a systematic review and meta-analysis. J Urol 2004; 171: 561-569.
8. Skinner DG, Daniels JR, Russell CA et al. The role of adjuvant chemotherapy following cystectomy for invasive bladder cancer: a prospective comparative trial. J Urol 1991; 145: 459-467.
9. Stockle M, Meyenburg W, Wellek S et al. Advanced bladder cancer (stages pT3b, pT4a, pN1 and pN2): improved survival after radical cystectomy and 3 adjuvant cycles of chemotherapy. Results of a controlled prospective study. J Urol 1992; 148: 302-307.
10. Studer UE, Bacchi M, Biedermann C et al. Adjuvant cisplatin chemotherapy following cystectomy for bladder cancer: a prospective randomized trial. J Urol 1994; 152: 81-84.
11. Freiha F, Reese J, Torti FM. A randomised trial of radical cystectomy versus radical cystectomy plus cisplatin, vinblastine and methotrexate chemotherapy for muscle invasive bladder cancer. J Urol 1996; 155: 495-500.
12. Bono AV, Benvenuti C, Reali L et al. Adjuvant chemotherapy in advanced bladder cancer. Prog Clin Biol Res 1989; 303: 533-540.
13. Otto T, Borgermann C, Krege S et al. Adjuvant chemotherapy in locally advanced bladder cancer (pT3/pN1-2, M0): a phase III study. Eur Urol 2001; 39 (Suppl 5): 147. (Abstr).
14. Paz-Ares L, Solsona E, Esteban E et al. Randomized phase III trial comparing adjuvant paclitaxel/gemcitabine/cisplatin (PGC) to observation in patients with resected invasive bladder cancer: results of the SOGUG (Spanish Oncology Genito-Urinary Group) 99/01 study. J Clin Oncol 2010; 28 (Suppl): 7s. (Abstr LBA4518).
15. Sylvester R, Sternberg C. The role of adjuvant combination chemotherapy after cystectomy in locally advanced bladder cancer: what we do not know and why. Ann Oncol 2000; 11: 851-856.
16. Boccardo F, Palmeri L. Adjuvant chemotherapy of bladder cancer. Ann Oncol 2006; 17(suppl 5): 129-132.
17. Adjuvant Bladder Cancer (ABC) Meta-analysis Collaboration. Adjuvant chemotherapy in invasive bladder cancer: a systematic review and meta-analysis of individual patient data. Eur Urol 2005; 48: 189-201.
18. Ruggeri EM, Giannarelli D, Bria E et al. Adjuvant chemotherapy in muscleinvasive bladder carcinoma: a pooled analysis from phase III studies. Cancer 2006; 106: 783-788.
19. National Cancer Institute. Levels of Evidence for Adult Cancer Treatment Studies, Health Professional Version 2003; http://www.cancer.gov (8 August 2011, date last accessed).
20. Piedbois P. Meta-analyses based on abstracted data: a step in the right direction, but only a first step. J Clin Oncol 2004; 9: 3839-3841.
21. Von der Maase H, Hansen SW, Roberts JT et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18(17): 3068-3077.
22. Abrat RP, Bezwoda WR, Goedhals L, Hacking DJ. Weekly gemcitabine with monthly cisplatin: effective chemotherapy for advanced non-small-cell lung cancer. J Clin Oncol 1997; 15(2): 744-749.
23. Crinò L, Scagliotti G, Marangolo M et al. Cisplatin-gemcitabine combination in advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 1997; 15(1): 297-303.
24. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981; 47: 207-214.
25. 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; 23(21): 4602-4608.
26. Saxman SB, Propert KS, Einhorn LH et al. Long-term follow-up of a phase III intergroup study of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study. J Clin Oncol 1997; 15(7): 2564-2569.
27. Sternberg CN, Yagoda A, Scher HI et al. Methotrexate, vinblastine, doxorubicin, and cisplatin for advanced transitional cell carcinoma of the urothelium: efficacy and patterns of response and relapse. Cancer 1989; 64: 2448-2458.
28. Bria E, Ruggeri EM, Pollera CF et al. Adjuvant chemotherapy for bladder cancer: the chance for meta-analyses comparison. Eur Urol 2007; 51(2): 576-577.
29. Bellmunt J, Paz-Ares L, Cuello M et al. Gene expression of ERCC1 as a novel prognostic marker in advanced bladder cancer patients receiving cisplatin-based chemotherapy. Ann Oncol 2007; 18(3): 522-528.