1698 - Multicenter retrospective study of gemcitabine plus nab-paclitaxel for elderly patients with advanced pancreatic cancer

Background

Although gemcitabine plus nab–paclitaxel (GnP) is a standard treatment for advanced pancreatic cancer as the result of phase III trial ((MPACT), its therapeutic benefit for elderly patients is unclear. This study aimed to assess the effectiveness and safety of GnP for these patients.

Methods

We retrospectively enrolled patients aged > =75 years in whom GnP was initiated as first–line treatment for advanced pancreatic cancer between December 2014 and December 2016. Overall survival and progression–free survival according to disease status were calculated using Kaplan–Meier method. Objective response was estimated according to RECISTv1.1. Adverse events were evaluated according to based on the Common Terminology Criteria of Adverse Events version4.0. The incidence of adverse events and early discontinuation (i.e., treatment discontinuation due to adverse events within 2 months from initiation) was compared via Fishers’ exact test for univariate analysis and via logistic regression model with step wise method for multivariate analysis.

Results

The cohort comprised 116 selected patients with a median age of 77 years (range: 75–84 years). Within a median follow-up of 13 months, the median overall survival and progression-free survival of locally advanced cancer patients were 21.8 and 12.1 months, respectively. In patients with metastasis, these were 13.3 and 5.9 months. The response rate was 31% and the disease control rate was 81%. Within the first 2 months of treatment, grade 4 hematological and grade 3–4 non-hematological toxicities were observed in 10 and 23 patients, respectively. Early treatment discontinuation of GnP occurred in 12 patients, and the associated risk factors were age > =80 years [odds ratio (OR), 9.43; 95% confidence interval (CI), 2.25–39.60] and serum albumin <35 g/L (OR, 5.12; 95% CI, 1.11–23.61).

Conclusions

GnP in selected patients aged > =75 years showed acceptable toxicities and comparable effectiveness to that in the previous studies of the non-elderly population, but patients aged > =80 years and with serum albumin <35 d/L should be carefully assessed for treatment eligibility.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Satoshi Kobayashi.

Funding

Has not received any funding.

Disclosure

M. Ozaka: Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Pfizer; Honoraria (self): Novartis Pharma; Honoraria (self): Bayer Yakuhin; Honoraria (self): Yakult Honsha; Honoraria (self): Eisai; Honoraria (self): EA Pharma. S. Kobayashi: Honoraria (self), Research grant / Funding (institution): Taiho pharmaceutical; Honoraria (self): Boston Scientific; Honoraria (self), Speaker Bureau / Expert testimony: Kyowa Hakko Kirin; Honoraria (self), Research grant / Funding (institution): Daiichi Sankyo; Honoraria (self), Speaker Bureau / Expert testimony: Bayer Yakuhin; Honoraria (self): Teijin Pharma; Honoraria (self), Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Dainippon Sumitomo Pharma; Research grant / Funding (institution): Chugai Pharma; Research grant / Funding (institution): Yakult Honsha; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Takara Bio; Research grant / Funding (institution): Merck Serono; Research grant / Funding (institution): Ono Pharmaceutical; Research grant / Funding (institution): MSD Oncology; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Beigene; Research grant / Funding (institution): Takeda. M. Ikeda: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bayer Yakuhin; Honoraria (self), Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eisai; Honoraria (self), Research grant / Funding (institution): Taiho Pharmaceutical; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Honoraria (self), Research grant / Funding (institution): Yakult; Honoraria (self): Otsuka Pharmaceutical; Honoraria (self): Nobel Pharma; Honoraria (self), Advisory / Consultancy: Daiichi-Sankyo; Honoraria (self): Sumitomo Dainippon Pharma; Honoraria (self): Teijin Pharma; Honoraria (self): EA Pharma; Honoraria (self): Kaken Pharmaceutical; Advisory / Consultancy: Shire; Advisory / Consultancy: MSD; Advisory / Consultancy, Research grant / Funding (institution): ASLAN Pharmaceutical; Advisory / Consultancy, Research grant / Funding (institution): Chugai Pharmaceutical; Research grant / Funding (institution): Kyowa Hakko Kirin; Research grant / Funding (institution): Ono Pharmaceutical; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Baxalta Japan Limited; Research grant / Funding (institution): Merck Serono; Research grant / Funding (institution): Nano Carrier; Research grant / Funding (institution): Takara-Bio. M. Ueno: Honoraria (self), Research grant / Funding (institution): Yakult Honsha; Honoraria (self), Research grant / Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): ASLAN; Research grant / Funding (institution): Ono pharmaceutical; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): MSD; Research grant / Funding (institution): Merck Serono; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Beigene; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Eisai; Honoraria (self): Novel pharma; Honoraria (self): Novartis; Honoraria (self): Teijin Pharma; Research grant / Funding (institution): Takara Bio.