1. Chemoradiotherapy with concurrent gemcitabine and cisplatin with or without sequential chemotherapy with gemcitabine/cisplatin vs chemoradiotherapy with concurrent 5-fluorouracil in patients with locally advanced pancreatic cancer – a multi-centre randomised phase II study
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Stefan Boeck, H D Boettcher, S. Ostermaier, S Miethe, Axel Hinke, R Wilkowski, Rainer Fietkau, Volker Heinemann, Rolf Sauer, Michael Flentje, T Scholten, H. G. Rau, Christiane J. Bruns, and Herbst M
- Subjects
Oncology ,Cancer Research ,medicine.medical_specialty ,medicine.drug_class ,medicine.medical_treatment ,pancreatic cancer ,cisplatin ,Phases of clinical research ,Antimetabolite ,chemoradiotherapy ,Internal medicine ,Pancreatic cancer ,Clinical Studies ,medicine ,Cisplatin ,Chemotherapy ,business.industry ,gemcitabine ,medicine.disease ,Gemcitabine ,Surgery ,Fluorouracil ,business ,Chemoradiotherapy ,medicine.drug - Abstract
Background: No standard treatment for locally advanced pancreatic cancer (LAPC) is defined. Patients and methods Within a multi-centre, randomised phase II trial, 95 patients with LAPC were assigned to three different chemoradiotherapy (CRT) regimens: patients received conventionally fractionated radiotherapy of 50 Gy and were randomised to concurrent 5-fluorouracil (350 mg m−2 per day on each day of radiotherapy, RT-5-FU arm), concurrent gemcitabine (300 mg m−2), and cisplatin (30 mg m−2) on days 1, 8, 22, and 29 (RT-GC arm), or the same concurrent treatment followed by sequential full-dose gemcitabine (1000 mg m−2) and cisplatin (50 mg m−2) every 2 weeks (RT-GC+GC arm). Primary end point was the overall survival (OS) rate after 9 months. Results: The 9-month OS rate was 58% in the RT-5-FU arm, 52% in the RT-GC arm, and 45% in the RT-GC+GC arm. Corresponding median survival times were 9.6, 9.3, and 7.3 months (P=0.61) respectively. The intent-to-treat response rate was 19, 22, and 13% respectively. Median progression-free survival was estimated with 4.0, 5.6, and 6.0 months (P=0.21). Grade 3/4 haematological toxicities were more frequent in the two GC-containing arms, no grade 3/4 febrile neutropaenia was observed. Conclusion: None of the three CRT regimens tested met the investigators' definition for efficacy; the median OS was similar to those previously reported with gemcitabine alone in LAPC.
- Published
- 2009
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