A non-intensive gemcitabine-cisplatin regimen in pancreatic cancer significantly improves quality of life and pharmacoeconomics with high response rates

Abstract

8155 AIM: This Prospective Phase II study was undertaken to determine whether a dose-modified gemcitabine-cisplatin regimen improved QOL, reduced toxicity, increased compliance and improved delivered dose-intensity, with lowered costs, while preserving response rates. METHODS: 34 Chemotherapy naive patients with inoperable, locally advanced or metastatic pancreatic cancer were enrolled. Quality of life, clinical benefit response, albumin and CA19.9 were assessed cyclically: Patients received gemcitabine 1000mg/m2 day 1 and 8 and Cisplatin 60mg/m2 day 1 only (Q=21 days), all on an out-patient basis, with an intended minimum of 6 cycles. Objective response and toxicity were evaluated with WHO & CTC criteria. RESULTS: A total of 28 patients (19 male 9 female) are assessable currently. 89% (25 patients) had no increase in their analgesia. 77% (21 patients) had at least a 10% increase in dry weight or stabilization. Of the 13 patients with low serum albumin, 8 patients (29% of the total) had an increase or stabilization. This improvement in quality of life was mirrored in the tumor markers and objective disease response.12 patients (43%) had a decrease in their CA19.9 of >50%, and 9 patients had a partial or complete response with a further12 patients having stable disease. Critically, we were able to downstage 3/28 patients to successful pancreatectomies. This regimen caused little clinical toxicity ( 3 patients grade 3 nausea/lethargy). There was mild hematological toxicity with mainly anemia (26 patients (93%) grade 1+2, 2 patients (7%) grade 3+4) and neutropenia (13 patients (46%) grade 1+2, 5 patient (17%) grade 3+4). This regime produced cost savings of up to 1/3 when compared to other standard published regimens of either gemcitabine alone (+/− cisplatin), and more convenient with significantly fewer visits to hospital. CONCLUSION: By adding cisplatin to gemcitabine, at a reduced dose and frequency, we have been able to significantly improve patients quality of life, maintain responses and save on health costs. Currently the projected median survival for patients in this cohort is greater than 11 months. No significant financial relationships to disclose.