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Title:

Neoadjuvant continuous infusion of weekly 5-fluorouracil and escalating doses of oxaliplatin plus concurrent radiation in locally advanced oesophageal squamous cell carcinoma: results of a phase I/II trial.

Document type:
Journal Article; Article
Author(s):
Lorenzen, S; Brucher, B; Zimmermann, F; Geinitz, H; Riera, J; Schuster, T; Roethling, N; Höfler, H; Ott, K; Peschel, C; Siewert, JR; Molls, M; Lordick, F
Abstract:
Oxaliplatin and 5-fluorouracil have a significant activity in locally advanced oesophageal squamous cell cancer (OSCC). However, their optimal dosage and efficacy when combined with concurrent radiotherapy as neoadjuvant treatment are unknown. This non-randomised, phase I/II study aimed to define the maximum tolerated dose (MTD) and assessed the histopathological tumour response rate to neoadjuvant oxaliplatin in weekly escalating doses (40, 45, 50 mg m(-2)) and continuous infusional 5-fluorouracil (CI-5FU; 225 mg m(-2)) plus concurrent radiotherapy. Patients had resectable OSCC. Resection was scheduled for 4-6 weeks after chemoradiotherapy. During phase I (dose escalation; n=19), weekly oxaliplatin 45 mg m(-2) plus CI-5FU 225 mg m(-2) was established as the MTD and was the recommended dosage for phase II. Oesophageal mucositis was the dose-limiting toxicity at higher doses. During phase II, histopathological responses (<10% residual tumour cells within the specimen) were observed in 10 of 16 patients (63%; 95% confidence interval: 39-82%). Overall, 16 of the 25 patients (64%) who underwent resection had a histopathological response; tumour-free resection (R0) was achieved in 80%. Neoadjuvant weekly oxaliplatin 45 mg m(-2) plus CI-5FU 225 mg m(-2) with concurrent radiotherapy provides promising histological response rates and R0 resection rates in locally advanced OSCC.
Journal title abbreviation:
Br J Cancer
Year:
2008
Journal volume:
99
Journal issue:
7
Pages contribution:
1020-6
Language:
eng
Fulltext / DOI:
doi:10.1038/sj.bjc.6604659
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/18797462
Print-ISSN:
0007-0920
TUM Institution:
III. Medizinische Klinik und Poliklinik (Hämatologie / Onkologie); Institut für Allgemeine Pathologie und Pathologische Anatomie; Institut für Medizinische Statistik und Epidemiologie; Klinik und Poliklinik für RadioOnkologie und Strahlentherapie
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