Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2012
A multiple-center phase II study of weekly docetaxel and oxaliplatin as first-line treatment in patients with advanced gastric cancer.
Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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1 citing paper in PubMed, 4 citations in OpenAlex.
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9 authors at 5 institutions in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundDocetaxel and oxaliplatin are active agents for advanced gastric cancer (GC). The combination of these two drugs in a triweekly schedule is an active and attractive regimen for gastric cancer but with significant hematological toxicities. A multicenter phase II study was designed to establish an active regimen with good tolerability by using a weekly docetaxel-oxaliplatin (DO) combination in GC patients.
methodsEligible patients had histologically confirmed stage IV gastric cancer without previous palliative chemotherapy; age ≥18 years; Eastern Cooperative Oncology Group (ECOG) performance status ≤2; at least one measurable lesion; and adequate hematological, renal, and liver functions. All patients received premedications with dexamethasone and 5-HT3 antagonist before the chemotherapy. Docetaxel (Taxotere®; Sanofi-Aventis) 30 mg/m(2) followed by oxaliplatin (Eloxatin®; Sanofi-Aventis) 65 mg/m(2) were administered on days 1 and 8 of each 21-day cycle. Treatment continued until disease progression, intolerable toxicity, or consent withdrawal. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0. Tumor responses were evaluated every 2 cycles by the Response Evaluation Criteria in Solid Tumors Guidelines.
resultsFrom May 2007 to December 2008, a total of 47 patients were enrolled. There were 8 females and 39 males with a median age of 57 years (range 26-76). Forty-three patients were evaluable for response. Two patients obtained a complete response (4.7%) and 12 patients had a partial response (27.9%), with an overall response rate of 32.6% (95% confidence interval [CI] 19.1-48.5); 20 patients experienced stable disease (46.5%), and the disease progressed in 9 patients (20.9%). Median time to disease progression was 4.2 months and median overall survival was 8.3 months. All 47 patients were assessable for toxicity. Major grade 3/4 hematological toxicities were anemia (5 patients, 10.6%), neutropenia (2 patients, 4.3%), and leukopenia (1 patient, 2.1%). The most common grade 3/4 non-hematological toxicities were fatigue (3 patients, 6.4%) and aspartate aminotransferase (AST) elevation in 3 patients (6.4%).
conclusionsThe combination of weekly DO demonstrated a well-tolerated profile with moderate activity in the treatment of advanced gastric cancer. Further studies of the combination together with a fluoropyrimidine are warranted.
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