BA06-30894 - Trial

Fragestellung

Verbessert eine präoperative CMV-Chemotherapie das Behandlungsergebnis radikal operierter oder bestrahlter muskelinvasiver Blasenkarzinome?

Purpose international multicenter randomized trial neoadjuvant cisplatin, methotrexate, and vinblastine (CMV) chemotherapy muscle-invasive urothelial cancer of the bladder cystectomy and/or radiotherapy 976 patients 1989 and 1995 median follow-up 8.0 years. randomized phase III trial no neoadjuvant chemotherapy or three cycles of CMV. significant 5% 16% reduction in the risk of death (hazard ratio, 0.84; 95% CI, 0.72 to 0.99; P .037 10-year survival 30% to 36% after CMV. We conclude that CMV chemotherapy improves outcome as first-line adjunctive treatment for invasive bladder cancer. Two large randomized trials (by the Medical Research Council/European Organisation for Research and Treatment of Cancer and Southwest Oncology Group) have confirmed a statistically significant and clinically relevant survival benefit, and neoadjuvant chemotherapy followed by definitive local therapy should be viewed as state of the art, as compared with cystectomy or radiotherapy alone, for deeply invasive bladder cancer. J Clin Oncol 29:2171-2177. © 2011 by American Society of Clinical Oncology

Antwort

Eine präoperative CMV-Chemotherapie erhöht die 10a-Überlebensrate radikal operierter oder bestrahlter muskelinvasiver Blasenkarzinome signifikant!

Ergebnisse

-	ohne präoperative Chemotherapie	mit präoperativer Chemotherapie	Bemerkungen
10-OS	30%	36%
	33	25	58

Studie

Multizentrische, internationale, randomisierte Phase - III - Studie. .

Patienten

976 Ppatienten
Blasenkarzinom
Urothelkarzinom
muskelinvasiv
1989 - 1995
medianer Follow-up 8a
.

Tumor

muskelinvasives Blasenkarzinom. T2, T3, T4a No Mo

T1	T2	T3a	T3b	T4a
1	297	25	22	1

Chemotherapie

Fluorouracil 500 mg / qm an Tag 1 - 5 und Tag 16 - 20.

Mitomycin C 12 mg /qm an Tag 1. Neoadjuvante Platin-Chemotherapie erlaubt.

Radiotherapie

Bestrahlung der gesamten Blase oder modifiziertes Zielvolumen.

Dosis	Fraktionen	Patienten
55 Gy	20	142
64 Gy	32	217

Ergebnis	mit Chemotherapie	ohne Chemotherapie	p
2a-LDFS	67%	54%
5a-OS	48%	35%	0,16
NW Grad 3,4 während der Therapie	36%	27,5%	0,07
NW Grad 3,4 im Follow-up	8,3%	15,7%	0,07

Quellen

1.) Griffiths G, et al. für die International Collaboration of Trialists on behalf of the Medical Research Council Advanced Bladder Cancer Working Party:
International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial.
J Clin Oncol 29(2011):2171–2177

Impressum Zuletzt geändert am 10.09.2019 23:47