Abstract
We previously studied a dose-dense TCF (TCF-dd) regimen demonstrating its feasibility and an activity comparable to epirubicin-based chemotherapy and TCF q3w in terms of overall survival and time to progression (TTP). We report here the final results of a phase II study of chemotherapy with a modified TCF-dd regimen in locally advanced or metastatic gastric cancer (MGC). Patients with histologically confirmed measurable MGC, not previously treated for advanced disease, received docetaxel 70mg/m(2) day 1, cisplatin 60mg/m(2) day 1, l-folinic acid 100mg/m(2) days 1 and 2, followed by 5-fluorouracil (5-FU) 400mg/m(2) bolus days 1 and 2, and then 600mg/m(2) as a 22-h continuous infusion days 1 and 2, every 14days, plus pegfilgrastim 6mg on day 3. Patients aged ≥65years received the same schedule with a dose reduction of 30%. Study duration: December 2007-November 2010. Forty-six consecutive patients were enrolled (78% male, 22% female; median age, 66 years, range, 38-76 years; ECOG PS: 0, 48%, 1, 46%). Primary endpoint was overall response rate (ORR). A median of four cycles (range, one to six) was administered. Forty-three patients were evaluated for response (93.5%) and all for toxicity: 3 complete response (CR), 25 partial response (PR), 10 stable disease (SD), and 5 progressive disease (PD) were observed, for an ORR by intention to treat (ITT) of 61% (95% CI 47-75). Median overall survival (OS) was 17.63months (95% CI, 13.67-20.67); median progression-free survival was 8.9months (95% CI, 6.5-13.4). Twenty-one patients (46.0%) were treated at full doses without any delay, thus respecting the dose-dense criterion. Most frequent grade 3-4 toxicities were neutropenia (20%), leukopenia (4%), thrombocytopenia (2%), anemia (2%), febrile neutropenia (6%), asthenia (22%), diarrhea (4%), nausea/vomiting (11%), and hypokalemia (6%). Overall, TCF-dd was shown to be safe. The TCF-dd regimen in locally advanced or MGC is confirmed to be feasible and very active and needs to be further tested in randomized studies.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
