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With an estimated 2% five year survival rate, pancreatic cancer has a high mortality rate and is the fourth leading cause of cancer-related death. Most patients present at diagnosis with advanced disease due to lack of symptoms specific to pancreatic cancer.1 According to the National Comprehensive Cancer Network guidelines, gemcitabine has been considered the standard first line therapy for patients with metastatic and unresectable pancreatic cancer.2 A study published in 1997 by Burris et al. demonstrated that gemcitabine improved disease related symptoms and prolonged survival versus 5-fluorouracil.3 Recently, FOLFIRINOX regimen was shown to be superior in overall survival to gemcitabine alone in metastatic pancreatic patients with good performance status and under the age of 76.4 Previous studies have shown that nab-paclitaxel demonstrated antitumor activity as a single agent. It has also displayed synergistic activity in combination with gemcitabine in murine models by increased intratumoral concentration of gemcitabine. A phase I/II trial has been completed in patients that were untreated for metastatic pancreatic adenocarcinoma to find the maximum tolerated dose of the two medications. A phase III trial was necessary to question if nab-paclitaxel plus gemcitabine would have any additional benefit compared to gemcitabine alone.

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Von Hoff et al. has recently provided results for a phase III, randomized, multi-center, international, open-label study to compare if there is additional benefit in terms of overall survival of gemcitabine plus nab-paclitaxel versus gemcitabine alone.5 Eligibility criteria included having a definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas measurable according to the Response Evaluation Criteria in Solid Tumors, treatment naïve in metastatic setting, initial diagnosis in metastatic setting within 6 weeks of randomization, and a Karnofsky performance-status score of 70 or greater. Patients participating in this study were randomized to receive either nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks or gemcitabine 1000 mg/m2 weekly for 7 of 8 weeks (cycle 1) and then on days 1, 8, and 15 every 4 weeks monotherapy. The study’s primary endpoint was overall survival, while the secondary endpoints were progression-free survival and overall response rate.

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A total of 861 patients received treatment in this trial with 431 patients given the combination of nab-paclitaxel plus gemcitabine and 430 patients given gemcitabine monotherapy. Patients were not allowed to have any previous chemotherapy or radiotherapy for metastatic disease. Baseline characteristics between the two groups were similar, with a median age of patients in combination arm being 62 years old with a range of 27 to 86 years of age. Overall survival for the combination and gemcitabine groups were 8.5 and 6.7 months, respectively. The overall survival hazard ratio was 0.72 indicating there is statistically significant survival benefit in the combination group. Objective response rates differed significantly between the combination and monotherapy arm with statistically significant advantage for the combination group, 99% vs 31%. The study reports high dose intensity and adherence for both arms ...

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