Abstract
4237 Background: The weekly PLF regimen with routine filgrastim support showed high activity in elderly patients with AGC (Graziano et al, BJC, 2003). We investigated safety and efficacy of a similar weekly oxaliplatin-based regimen without filgrastim support. Methods: Chemotherapy-naive pts with AGC aged 70 or older were considered eligible for study entry. Inclusion criteria consisted of: ECOG performance status I or II, normal renal, liver, bone marrow functions and measurable disease. Frail elderly pts were excluded after baseline geriatric assessment. Pts received weekly oxaliplatin 40 mg/m2, fluorouracil 500 mg/m2 and folinic acid 250 mg/m2 (OXALF). All drugs were given intavenously on a day-1 schedule. After 8 weekly cycles, pts with complete response (CR), partial response (PR) and stable disease (SD) received six more weekly administrations. Results: 231 cycles were administered to 17 evaluable pts; median age was 75 years (70–81), M/F sex ratio was 12/5. 11 pts had two or more metastatic sites. According to intent-to-treat the overall response rate was 47% (CI: 27%–54%), with 2 CR, 6 PR, 7 SD and 2 progressions. In the whole group, time to disease progression and median survival were 5.9 months and 7.5 months respectively. Due to grade II toxicities, chemotherapy was delayed one or two weeks in 5 pts. No grade III-IV toxicities including peripheral neuropathy were reported in these patients and no toxic deaths occurred. Grade II nausea and fatigue resulted the commonest non-hematologic toxicity (respectively, 29% and 23.5% of pts). Other grade II non-hematologic toxicities were: diarrhea (11.7%), mucositis (5.8%) and transaminases increase (5.8%). No episodes of grade II neurological and hematologic toxicity were reported. Conclusions: Weekly OXALF chemotherapy showed palliative activity with favorable response rates and toxicity profile in elderly pts with AGC. More mature data will be presented during the meeting. No significant financial relationships to disclose.
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