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Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study
- Source :
- Annals of oncology
- Publication Year :
- 2015
- Publisher :
- Elsevier BV, 2015.
-
Abstract
- Background Docetaxel/cisplatin/infusional 5-fluorouracil (5-FU; DCF) is a standard chemotherapy regimen for patients with advanced gastric cancer (GC). This phase II study evaluated docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX) in patients with advanced GC. Patients and methods Patients with metastatic or locally recurrent gastric adenocarcinoma (including carcinoma of the gastro-oesophageal junction) were randomly assigned (1 : 1 : 1) to TE, TEF, or TEX. Each regimen was tested at two doses before full evaluation at optimized dose levels. The primary end point was progression-free survival (PFS). Overall survival (OS), tumour response, and safety were also assessed. A therapeutic index (median PFS relative to the incidence of febrile neutropenia) was calculated for each regimen and compared with DCF (historical data). Results Overall, 248 patients were randomly assigned to receive optimized dose treatment. Median PFS was longer with TEF (7.66 [95% confidence interval (CI): 6.97–9.40] months) versus TE (4.50 [3.68–5.32] months) and TEX (5.55 [4.30–6.37] months). Median OS was 14.59 (95% CI: 11.70–21.78) months for TEF versus 8.97 (7.79–10.87) months for TE and 11.30 (8.08–14.03) months for TEX. The rate of tumour response (complete or partial) was 46.6% (95% CI 35.9–57.5) for TEF versus 23.1% (14.3–34.0) for TE and 25.6% (16.6–36.4) for TEX. The frequency and type of adverse events (AEs) were similar across the three arms. Common grade 3/4 AEs were fatigue (21%), sensory neuropathy (14%), and diarrhoea (13%). Febrile neutropenia was reported in 2% (TEF), 14% (TE), and 9% (TEX) of patients. The therapeutic index was improved with TEF versus TEX, TE, or DCF. Conclusion These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC. ClinicalTrials.gov Identifier Trial registration number: NCT00382720.
- Subjects :
- Male
Oncology
Organoplatinum Compounds
EPIRUBICIN
Phases of clinical research
Docetaxel
Deoxycytidine
Gastroenterology
Antineoplastic Combined Chemotherapy Protocols
Prospective Studies
combined
MITOMYCIN
Hematology
CHEMOTHERAPY
Middle Aged
Chemotherapy regimen
Oxaliplatin
Treatment Outcome
GASTROESOPHAGEAL JUNCTION
TRIAL
Female
Taxoids
Fluorouracil
medicine.drug
medicine.medical_specialty
DOXORUBICIN
platinum compounds
Antineoplastic Agents
Adenocarcinoma
Disease-Free Survival
Drug Administration Schedule
Capecitabine
CISPLATIN
Stomach Neoplasms
Internal medicine
medicine
Humans
Progression-free survival
COMBINATION
business.industry
medicine.disease
Regimen
Human medicine
1ST-LINE THERAPY
Neoplasm Recurrence, Local
business
Febrile neutropenia
Subjects
Details
- ISSN :
- 09237534
- Volume :
- 26
- Database :
- OpenAIRE
- Journal :
- Annals of Oncology
- Accession number :
- edsair.doi.dedup.....5d6211c5fc3776bd48f1257e959e66d2