Mitomycin C with continuous fluorouracil or with cisplatin in combination with radiotherapy for locally advanced anal cancer (European Organisation for Research and Treatment of Cancer phase II study 22011-40014).

Details

Serval ID
serval:BIB_D6ABD88E9451
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Mitomycin C with continuous fluorouracil or with cisplatin in combination with radiotherapy for locally advanced anal cancer (European Organisation for Research and Treatment of Cancer phase II study 22011-40014).
Journal
European Journal of Cancer
Author(s)
Matzinger O., Roelofsen F., Mineur L., Koswig S., Van Der Steen-Banasik E.M., Van Houtte P., Haustermans K., Radosevic-Jelic L., Mueller R.P., Maingon P., Collette L., Bosset J.F.
ISSN
1879-0852[electronic]
Publication state
Published
Issued date
2009
Volume
45
Number
16
Pages
2782-2791
Language
english
Abstract
PURPOSE: To assess the feasibility and activity of radio-chemotherapy with mitomycin C (MMC) and cisplatin (CDDP) in locally advanced squamous cell anal carcinoma with reference to radiotherapy (RT) combined with MMC and fluorouracil (5-FU). PATIENTS AND METHODS: Patients with measurable disease >4 cmN0 or N+ received RT (36Gy+2 week gap+23.4Gy) with either MMC/CDDP or MMC/5-FU (MMC 10mg/m(2) d1 of each sequence; 5-FU 200mg/m(2)/day c.i.v. daily; CDDP 25mg/m(2) weekly). Forty patients/arm were needed to exclude a RECIST objective response rate (ORR), 8 weeks after treatment, of <75% (Fleming 1, alpha=10%, beta=10%). RESULTS: The ORR was 79.5% (31/39) (lower bound confidence interval [CI]: 68.8%) with MMC/5-FU versus 91.9% (34/ 37) (lower bound CI: 82.8%) with MMC/CDDP. In the MMC/5-FU group, two patients (5.1%) discontinued treatment due to toxicity versus 11 (29.7%) in the MMC/CDDP group. Nine grade 3 haematological events occurred with MMC/CDDP versus none with 5-FU/MMC. The rate of other toxicities did not differ. There was no toxic death. Thirty-one patients in the MMC/5-FU arm (79.5%) and 18 in the MMC/CDDP arm (48.6%) were fully compliant with the protocol treatment (p=0.005). CONCLUSIONS: Radio-chemotherapy with MMC/CDDP seems promising as only MMC/CDDP demonstrated enough activity (RECIST ORR >75%) to be tested further in phase III trials; MMC/5-FU did not. MMC/CDDP also had an overall acceptable toxicity profile.
Keywords
Anal cancer, Radiotherapy, Radio-chemotherapy, Randomised trial, Mitomycin C, Cisplatin, Gastrointestinal Cooperative Groups, Continuous-Infusion, Randomized-Trial, Carcinoma, Therapy, Chemoradiation, 5-Fluorouracil
Pubmed
Web of science
Create date
15/12/2009 16:27
Last modification date
20/08/2019 15:56
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