Nab-Paclitaxel in combination withGemcitabine has significantly improved outcomes in advanced pancreatic cancer. However, the published regimen of day1,8 and15 every28 days cycle is associated with significant toxicities and is not deliverable in a timely fashion in many patients. The objective of this study was to evaluate the activity, deliverability, and toxicity associated with the modified regimen of Nab-Paclitaxel andGemcitabine.
Nab-Paclitaxel and Gemcitabine regimen was adapted and implemented at
the Irish national pancreatic surgery centre.This constitutes a retrospective study.Patients had locally advanced or metastatic Pancreatic cancer, no prior chemotherapy for Pancreatic cancer and Performance Status1-2. Treatment regimen was Nab-Paclitaxel 125mg/m2 and Gemcitabine1000mgs/m2 on days1 and8 of each21day cycle.
Treatment was continued until disease progression or unacceptable toxicity.
Between January2013 and December2015, 64patients were treated with the regimen.The median number of cycles was 6. A total of360 cycles was administered. 62 patients (97%) underwent response evaluation. No patient (0%) achieved CR. 12patients (19%) had a PR and 28 patients (46%) achieved SD. The median PFS was 6.0months and the median OS was 8.5 months.The 6-monthPFS was 41%, while the 6- monthsOS was 64%. Survival was better in patients with performance status 0-1 vs 2, locally advanced disease vs metastatic, lung only metastases, patients with only one site of metastases and those with CA 19.9 less than 2 times upper limit of normal.Treatment protocol was generally tolerated well.Grade3 or higher side effects were observed in 27.5% of cycles. There were no treatment related deaths. Treatment protocol was delivered on time in87% of cycles without any delay. Dose reductions occurred in11% of cycles. Treatment was discontinued in6% of patients.
The 21day regimen of days1 and8 Nab-Paclitaxel and Gemcitabine demonstrated comparable efficacy to the 28 day 1,8,15 regimen and was associated with an improved toxicity profile and deliverability. It represents an active alternate treatment schedule for patients with advanced pancreatic cancer.
Clinical trial identification
Legal entity responsible for the study
Mohammed Abdel Osman (1st. Author)
All authors have declared no conflicts of interest.