Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer
| Autor: | Seiichi Takagi, Norisuke Nakayama, Satoru Iwasa, Tetsuya Hamaguchi, Yasuhiro Shimada, Yushi Nagai, Akihito Tsuji, Takako E. Nakajima, Ken Kato, Junichi Matsubara, Yasuhide Yamada, Kazuma Kobayashi, Akira Yoshioka |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Paclitaxel medicine.medical_treatment Leucovorin Phases of clinical research Disease-Free Survival First line therapy Bolus (medicine) Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols Humans Medicine Neoplasm Metastasis Aged Neoplasm Staging Chemotherapy business.industry Weekly paclitaxel General Medicine Middle Aged Advanced gastric cancer digestive system diseases Clinical trial Fluorouracil Female business medicine.drug |
| Zdroj: | Oncology. 81:291-297 |
| ISSN: | 1423-0232 0030-2414 |
| DOI: | 10.1159/000334462 |
| Popis: | Objective: We evaluated the efficacy and safety of bolus 5-fluorouracil (5-FU) and leucovorin combined with weekly paclitaxel (FLTAX) in advanced gastric cancer (GC) patients. Methods: Patients with untreated stage IV GC received paclitaxel 80 mg/m2 as a 1-hour infusion, followed by 5-FU 600 mg/m2 as a bolus infusion and L-leucovorin 250 mg/m2 as a 2-hour infusion on days 1, 8 and 15. Treatment cycles were repeated every 28 days. The primary endpoint was response rate. Results: Thirty-five patients were enrolled. The median age was 62 years (range 34–75). Twenty-one patients (60%) had diffuse-type cancer and 11 had peritoneal metastasis. The confirmed response rate was 43% (95% CI 26–61) with 15 partial responses. Stable disease was observed in 16 (46%) patients. Median progression-free survival and overall survival were 6.8 months (95% CI 5.8–7.4) and 16.2 months (95% CI 10.0–22.8), respectively. Grade 3–4 adverse events were: neutropenia (54%), febrile neutropenia (3%), diarrhea (6%) and sensory neuropathy (11%). Conclusion: FLTAX showed a desirable safety profile, and the efficacy against advanced GC was encouraging. FLTAX may be a good option for GC patients with deteriorated general condition, and a randomized clinical trial in such patients is currently underway. |
| Databáze: | OpenAIRE |
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