Premium
Intra‐arterial versus intravenous chemoradiation for advanced head and neck cancer: Results of a randomized phase 3 trial
Author(s) -
Rasch Coen R. N.,
Hauptmann Michael,
Schornagel Jan,
Wijers Oda,
Buter Jan,
Gregor Theo,
Wiggenraad Ruud,
de Boer Jan Paul,
Ackerstaff Annemiek H.,
Kroger Robert,
Hoebers Frank J. P.,
Balm Alfons J. M.
Publication year - 2010
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.24916
Subject(s) - medicine , head and neck cancer , regimen , cisplatin , chemoradiotherapy , surgery , cancer , radiation therapy , chemotherapy , phases of clinical research , randomization , randomized controlled trial , urology
BACKGROUND: Chemoradiation is the preferred treatment for advanced stage IV head and neck cancer. Higher doses of chemotherapy yielded promising results in vitro and vivo, confirmed by intra‐arterial (IA) cisplatin‐based chemoradiation in phase 2 studies. METHODS: Two hundred and thirty‐nine patients with (functionally) unresectable head and neck cancer were included, from 2000 to 2004, in a multicenter, randomized phase 3 trial, comparing IA and intravenous chemoradiation. Intravenous chemoradiation comprised 3×100 mg/m 2 cisplatin infusion on Days 1, 22, 43 combined with 70 Gy in 35 daily fractions. The IA chemoradiation treatment arm comprised 4x150 mg/m 2 cisplatin administered in the tumor‐feeding artery on Days 1, 8, 15, 22, immediately followed by systemic rescue with sodium thiosulfate with the same radiotherapeutic regimen. RESULTS: Two patients were excluded from analysis because of nontreatment‐related death immediately after randomization (n = 1) and esophageal carcinoma (n = 1). The median follow‐up was 33 months 1‐104 months. Ninety percent of the patients required tube feeding during treatment. Renal toxicity >grade 2 was 9% in the intravenous compared with 1% in the IA treatment arm ( P ≤ .0001). There was no difference in locoregional control, disease‐free survival (DFS) or overall survival (OS), between the treatment arms. At 3 years, local control, locoregional control, DFS, and OS was .76, .63, .44, .51 in the IA versus .70, .65, .47, .47 in the intravenous treatment arm, respectively. CONCLUSIONS: Cisplatin‐based IA chemoradiation was not superior to intravenous chemoradiation for advanced stage IV head and neck cancer regarding locoregional control and survival. Cancer 2010. © 2010 American Cancer Society.