Abstract
3619 Background: Delivering l-OHP over 2 days together with 5FU may enhance the synergism and reduce neurotoxicity. In this study we assessed activity, toxicity and both the activity of daily living (ADL) and instrumental activity of daily living (IADL) of a bi-fractionated l-OHP plus 5FU/LV regimen as first line chemotherapy for elderly pts with metastatic CRC. Methods: Eligibility criteria included no previous chemotherapy for advanced disease, age >= 70 yrs, ECOG PS <= 2. Schedule was: l-OHP 45 mg/m2 + bolus 5FU 400 mg/m2 + 24-h infusional 5FU 600 mg/m2 + LV 200 mg/m2, days 1 and 2, every 2 weeks. Responses (WHO criteria) and ADL/IADL were assessed every 6 cycles. A two-staged Simon accrual design was adopted for this phase II study, with response rate as main endpoint (p1 45%; p0 30%). Results: From Aug ‘01 to Jul ‘04, 78 pts entered the study: M/F 54/24, median age was 75 years (r. 70–85), PS 0/1/2 in 31/38/9, liver/lung/peritoneum metastases in 58%/31%/11% of pts. A total of 651 courses were administered, with a median of 8 cycles per pt (r. 1–19). The mean weekly DI of l-OHP was 34 mg/m2 (76% of the planned). Response (77 pts evaluable) was as follow: CR in 7 (9.0%) and PR in 32 (41.5%) pts, for an overall RR of 50.5%; SD and PD both in 19 (24.7%) pts. Median duration of response was 9.0 mo. Second-line chemotherapy was delivered to 47% of pts. With a median f-u of 12.5 mo, according K-M method, median TTP and OS was 8.1 (r. 0.3–21.9) and 20.1 (r. 0.8–29.5) mo, respectively. NCI-CTC grade 3/4 toxicities were: neutropenia in 32% of pts (febrile in 2 pts), diarrhea 10%, mucositis 4%, fatigue 4%. G2 and G3 sensory neuropathy occurred in 17% and 6% of pts, respectively. Median ADL/IADL scores at T0, T6 and T12 were 6/4, 6/4, and 6/5, respectively, without significant differences. Conclusions: l-OHP and 5FU/LV was highly active and did not interfere with ADL/IADL of elderly pts with advanced CRC. The bi-fractionated delivering of l-OHP demonstrated to reduce neurotoxicity. No significant financial relationships to disclose.
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