Abstract
15059 Background: 5FU in combination with P can be considered a standard treatment for MGC. Ir and T are active agents with not complete cross-resistance with P and 5FU. The combination of Ir or T with P and 5FU is feasible but with substantial toxicities. A different way to include Ir and T in the first-line treatment of MGC is to use them sequentially to a P and 5FU containing regimen. Methods: we conducted a phase II study of first-line sequential chemotherapy in MGC pts with measurable disease (RECIST criteria). Treatment consisted of: 3 cycles of PFL (biweekly P 50 mg/sqm d1, LV 200 mg/sqm d1 and 5FU 3200 mg/sqm 48-h c.i. starting on d1) followed by 3 cycles of IrFL (biweekly Ir 180 mg/sqm d1 and 5FU/LV) followed by 3 cycles of TFL (biweekly T 50 mg/sqm d1 and 5FU/LV). Evaluation of disease was performed every 3 cycles. Results: 46 pts have been enrolled. Pts characteristics are: median age = 60 years (37–75), M/F = 36/10, sites of disease (single/multiple) 9/37, ECOG PS 0/1 = 27/19. Treatment was well tolerated. Grade 3–4 non-haematological toxicities were: diarrhea in 2,5% pts with PFL; diarrhea and asthenia in 2,5% and stomatitis in 5% pts with IrFL; stomatitis in 5,7% pts with TFL. Grade 3/4 neutropenia was observed in 14% pts with PFL, 15% with IrFL and 22,9% pts with TFL. Nor febrile neutropenia neither toxic deaths have occurred. Two pts had not evaluable disease and 6 are still receiving treatment. We observed 1 CR and 8 PR with PFL (RR 24%) among the 38 evaluable pts. IrFL improved responses in 10 pts while 4 pts progressed and TFL further improved responses in 6 pts while 5 pts progressed. Response rate at the end of the planned 9 cycles was 40% (4 CR, 11 PR; 95% CI 25–58%). At a median follow-up of 15.5 mos median TTP is 6.8 mos and median OS is 13.5 mos. Conclusions: this sequential treatment is feasible with a very favourable safety profile and produces encouraging results in terms of activity and efficacy in a population of unselected MGC patients. Final data will be presented at the meeting. Partially supported by A.R.C.O. Foundation. No significant financial relationships to disclose.
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.
