Abstract
e15577 Background: GemOx (G 1000 mg/m2 over 100 mins on d1 and Oxaliplatin (Ox) 100 mg/m2 on d2 q2 wks) achieved a RR of 26.8%, improved PFS but failed to demonstrate a benefit in OS vs G in PBC. This regimen has regained attention after recent pooled- and meta-analysis suggesting a survival benefit of G-platinum doublets over G. However, GemOx is associated with inconvenience to pts, early cumulative dose to develop neuropathy and thrombocytopenia. In addition, prolonged infusion of G showed no benefit over 30 mins in ECOG 6201study. Pharmacokinetic profile of both drugs did not show statistically significant differences regardless the order of administration. We modified GemOx as S-GemOx (G 1000 mg/m2 over 30 mins and Ox 85–100 mg/m2over 2 hrs on d1 q2 wks) given on same day to create a more convenient and equally effective regimen for these pts. Methods: A retrospective study was conducted to evaluate PBC pts who received S-GemOx from Sep 06 to Dec 08. Adverse events were graded according to NCI-CTC v3.0. Response was assessed with RECIST by a CT scan q 8 wks. Results: 34 pts (median age 60y, M/F: 17/17) who received S-GemOx were evaluated: PC (26), BC (7) and ampullary ca (1). 7 pts received S-GemOx plus a biological agent (3 bevacizumab, 3 cetuximab and 1 panitumumab). Median duration of therapy was 12 wks (r: 2–56). Median cumulative dose of Ox was 510mg/m2(r: 85–2380). 27 pts were evaluated for efficacy after initial staging: 1 (3.7%) CR, 4 (14.8%) PR, 18 (66.7%) SD and 4 (14.8%) PD. ORR (CR+PR) and ODC (CR+PR+SD) were 18.5% and 85.2% respectively. Median EFS, PFS and OS were 12, 16.7 and 37.6 wks respectively. 13 (38%) pts required Ox dose reduction due to toxicities (cytopenia, HSR, elevated LFTs and diarrhea). G3/4 hematological toxicities include anemia (8%), neutropenia (11%), thrombocytopenia (5%), N/V (3%), diarrhea (3%), HSR (14%) and neuropathy (3%). No deaths occurred due to therapy. 1 pt received a total of 1,025 mg/m2 of Ox on OPTIMOX approach. 9 pts discontinued therapy due to PD and 19 due to toxicities. Currently 4 pts are still receiving therapy. Conclusions: S-GemOx regimen provides convenient schedule, appears to be less toxic (G3/4 neuropathy: 3% vs 19.1%; thrombocytopenia 5% vs 14 %) and has comparable efficacy vs GemOx. Prospective studies of S-GemOx in a large pt population are warranted. [Table: see text]
Published Version
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