Researchers sought to establish a more complete understanding of a biweekly dose-dense regimen of docetaxel and 5-fluorouracil as first-line treatment for patients with advanced gastric cancer and the effect is has on matters such as efficacy, safety, and quality of life.
The study included 39 patients with a median age of 55 (range 28-80). The primary endpoint of the study was response rate, and secondary endpoints included progression-free survival, overall survival, quality of life, and toxicity.
Patients were given docetaxel 60 mg/m2 and 5-fluorouracil 400 mg/m2 bolus followed by 2,400 mg/m2 46-hour infusion every 2 weeks. All patients adopted prophylactic use of G-CSF. Researchers found that the response rate in patients was 51.3% and median overall survival and progression-free survival were 14.0 and 6.7 months, respectively.
Adverse events were reported at all grade levels, the most common being anemia (87.2%), fatigue (74.4%), neutropenia (66.7%), nail change (48.7%), and liver dysfunction (38.5%). Grade 3/4 toxicities were noted as anemia (28.2%), liver dysfunction (7.7%), and fatigue (7.7%). The researchers also conducted an analysis focused on quality of life and noted improvements in seven scales and drops in 3 scales.
The researchers concluded that a biweekly dose-dense regiment of docetaxel and 5-fluorouracil as first-line treatment for patients with advanced gastric cancer has promising indications as a tolerable and safe treatment option that improves response rates for patients.
This study evaluated the efficacy, safety and impact on quality of life (QoL) of a dose-dense biweekly regimen of docetaxel and 5-fluorouracil in first-line treatment of advanced gastric cancer (AGC). This novel regimen is a promising option for AGC, showing high RR, improvement on QoL and acceptable toxicity.