Gemcitabine plus nab-paclitaxel followed by maintenance treatment with gemcitabine alone as first-line treatment for older adults with locally advanced or metastatic pancreatic cancer

Abstract

The aim of this study was to evaluate the efficacy and safety of the combination Gemcitabine (Gem) plus nab-Paclitaxel (NabP) (Gem/NabP), followed by maintenance Gem in older adults with locally advanced or metastatic pancreatic cancer (PC). Materials and methods: In this prospective observational study, the induction chemotherapy consisted of NabP 125 mg/m 2 followed by Gem 1000 mg/m 2 on days 1, 8, and 15 of a 4-week cycle. After a maximum of 3 cycles, patients without evidence of progressive disease (PD) were administered Gem 1000 mg/m2 weekly for 3 of 4 weeks as maintenance therapy until documentation of PD or unacceptable toxicity. The primary endpoint was six-month disease-control rate (DCR). Results: Overall, 36 patients N70 years with metastatic or locally advanced PC were enrolled at participating Institutions. After completion of Gem/NabP, 18 (50%) patients achieved partial response, 13 (36%) had stable disease, and 5 (14%) had PD. Thirty-one patients (86%) received Gem monotherapy as maintenance treatment for a median of 3 cycles (range, 2-9 cycles). Six-month DCR was 61% (95% CI, 45-77), median PFS was 6.4 months (95% CI, 5.4-8.3), and median OS was 13.4 months (95% CI, 11.1-16.7). During Gem/NabP regimen, the most common grade 3 toxicity included neutropenia (22%), anemia (19%) and thrombocytopenia (8%). Grade 3 neuropathy was not observed. During Gem maintenance therapy, grade 3 hematological toxicity was described in 6 patients (19%). Conclusion: Gem/NabP followed by maintenance Gem appears to be safe and effective for older patients with locally advanced or metastatic PC.

Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study

“…From May 2015 to June 2019, a total of 317 patients with mPC were recruited across 20 Austrian sites and assigned to first-line treatment with nab-paclitaxel/ gemcitabine. Eighteen patients were excluded owing to no metastasis (12), prior chemotherapy in the metastatic setting (4) or no therapy (2). Hence, 299 patients were eligible for analysis, thus forming the ITT population.…”

“…A number of studies examined nab-paclitaxel/ gemcitabine efficacy for elderly patients with mPC, either using the MPACT schedule [9e14] or dose-modified regimens [15e17]. However, except for a few prospective trials [12,17,18], most available data originate from retrospective analyses in diverse, small cohorts of patients with PC [9e11, 13,15,19]. None of them reported prospective, non-interventional evidence with first-line nabpaclitaxel/gemcitabine from a comparably large cohort of elderly patients with mPC.…”

FOLFIRINOX De-Escalation in Advanced Pancreatic Cancer: A Multicenter Real-Life Study

“…To date, this strategy has been underevaluated in aPC but is used in other cancers such as colon [10], lung [11], and head and neck cancers [12], making it possible to maintain antitumoral pressure while reducing toxicities [9]. A few studies have addressed the maintenance in aPC: Reni et al [13] sought to show the benefit of maintenance with sunitinib after chemotherapy, whereas Petrioli et al [14] demonstrated that maintenance with gemcitabine after doublet chemotherapy with gemcitabine and nab‐paclitaxel was feasible in older patients.…”

Advanced Pancreatic Ductal Adenocarcinoma: Moving Forward

“…Gemcitabine maintenance after GA was studied for elderly patients in a prospective observational study [41]. A total of 36 patients >70 years with metastatic or locally advanced PDAC initially received GA for a maximum of three cycles (three months).…”