Annals of Oncology Advance Access originally published online on July 28, 2007
Annals of Oncology 2007 18(10):1673-1679; doi:10.1093/annonc/mdm269
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© 2007 European Society for Medical Oncology
gastrointestinal tumors |
Split-dose docetaxel, cisplatin and leucovorin/fluorouracil as first-line therapy in advanced gastric cancer and adenocarcinoma of the gastroesophageal junction: results of a phase II trial
1 Technical University Munich, 3rd Department of Internal Medicine (Hematology/Medical Oncology), Munich
2 Clinic Harlaching, 4th Medical Department
3 Elisabeth-Hospital Straubing, Internal Medicine
4 LMU Munich, Klinikum GroBhadern, Dept. of Hematology-Oncology, Munich
5 Technical University of Munich, Institute for Medical Statistics and Epidemiology, Munich
6 Sanofi-Aventis GmbH
7 Klinikum rechts der Isar, Munich Center for Clinical Studies
8 Technical University Munich, III. Department of Medicine, Munich, Germany
* Correspondence to: Florian Lordick, M.D., Ph.D, Technical University of Munich - 3rd Department of Internal Medicine (Hematology/Medical Oncology), Ismaninger Strasse 22, Klinikum rechts der Isar, Muenchen 81675, Germany. Tel: +49 4140 6321; Fax: +49 4140 6322; E-mail: f.lordick{at}lrz.tum.de
Background: Phase II and III trials of docetaxel, cisplatin and fluorouracil (DCF) have shown superior efficacy versus cisplatin and fluorouracil alone but high rates of hematologic toxicity in advanced gastric cancer. To reduce toxicity while maintaining the efficacy of DCF, we investigated split doses of docetaxel (T), cisplatin (P), leucovorin (L) and fluorouracil (F).
Patients and methods: Chemotherapy-naive patients with advanced gastric-/esophageal adenocarcinomas received T 50 mg/m2 and P 50 mg/m2 on days 1, 15 and 29 and L 500 mg/m2 plus F 2000 mg/m2 weekly, every 8 weeks. Because significant dose reductions to <80% became necessary in 80% of patients, the regimen was amended after the first 15 patients to T 40 mg/m2, P 40 mg/m2, L 200 mg/m2 and F 2000 mg/m2. The primary endpoint was response rate.
Results: Sixty patients were enrolled: 24 had locally advanced (LA) tumors and 36 had metastatic disease. Grade 3/4 toxicities included neutropenia (22%), febrile neutropenia (5%), diarrhea (20%) and lethargy (18%). The overall response rate was 47%. Twenty-three LA patients underwent secondary surgical resection (96%); complete resection was achieved in 87%. Overall, median time to progression and overall survival were 9.4 and 17.9 months, respectively (8.1 and 15.1 months, respectively, for patients with metastatic disease).
Conclusion: T-PLF regimen is highly active and has a favorable toxicity profile.
Key words: cisplatin, gastric cancer, leucovorin/fluorouracil, split-dose docetaxel
Received for publication March 4, 2007. Revision received April 28, 2007. Accepted for publication April 30, 2007.
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