Abstract
3577 Background: Sequential combinations of FU and IRI or OXA are currently used as 1st and 2nd line therapy for advanced CRC. Multiple trials are also investigating the concomitant use of the three drugs up-front. Progressing pts with an acceptable PS often continue to require treatment. GEM has shown clinical activity in adenocarcinomas of multiple sites and has a favorable toxicity profile. Methods: Since September 2000, 41 pts with progressive advanced CRC (males/females: 27/14; median age 66; ECOG PS 0/1/2: 10/25/6) previously treated with FU, IRI and OXA were accrued in a phase II study of GEM (1000 mg/m2 weekly x 7, then weekly x 3 q 4 weeks) with abrogation of progression as the main end-point. 22 pts had been treated with a triple combination including FU, IRI and OXA as 1st line therapy receiving GEM as 2nd line treatment, while for 19 pts GEM was given as salvage treatment after a median of 2 previous CT lines (range 2–4). Results: Overall, 71 cycles (1 cycle=8 weeks) were delivered (92.6% of the planned weekly administrations). The median number of cycles administered to each patient was 2 (range 1–4) and the median number of weeks of CT was 7 (range 6–22). Only 29/425 (6.8%) weeks of GEM were delayed while 39/425 (9.2%) were delivered at a reduced dose. Toxicity was mild with only 1 and 7 of the pts experiencing grade IV (neutropenia) and grade III (1 vomiting, 1 asthenia, 3 thrombocytopenia and 1 neutropenia) events, respectively. Flu-like syndrome was observed in 16 pts, of which only 3 complained of grade II. 3 pts are still completing the first cycle. Response was analysed on all the other pts according to the intention-to-treat principle (n=38) and 1 PR, 2 MR, 17 SD and 18 PD were observed. Overall, disease control was obtained in 20 of 37 cases, equally distributed in the two subgroups (54.5% in the cohort receiving GEM as 2nd line treatment and 50.0% in the group receiving GEM as salvage therapy; p=0.78, chi-square test). Conclusions: These data suggest that GEM is well tolerated and may abrogate disease-progression in approximately half of the pts refractory to FU, IRI and OXA. A larger confirmatory trial is planned. No significant financial relationships to disclose.
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