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Тoxicity and tolerability of the mFOLFIRINOX regimen in young elderly and older elderly patients with pancreatic carcinoma (PC)
Background
Currently, the median age of PC patients is about 70 years. By 2030 nearly 70% of PC are expected to be diagnosed in the elderly. These patients are poorly represented in large clinical trials. Hence, there are limited data about the tolerability and efficacy of mFOLFIRINOX regimen in elderly patients. Methods We retrospectively analyzed the data of patients with PC 60 years and older who were treated with mFOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, leucovorin 400 mg/m2, 5FU 2400 mg/m2 for 46h) regimen in our center. Results Between 2010 and 2021 104 patients were included in the analysis. 92 patients were young elderly (60-74 years) and 12 were older elderly (75-90 years). The median age was 68 (range, 60 - 78). mFOLFIRINOX was administered postoperatively, as part of induction therapy in borderline/locally advanced or as palliative chemotherapy in 1, 42 and 61 patients, respectively. All patients had ECOG PS 0-2. Most common all grade and grade 3/4 toxicity were neutropenia (69,2% and 42,3%), febrile neutropenia (5,8%), thrombocytopenia (21,2% and 0,96%), anemia (17,3%), diarrhea (41,3% and 8,7%), nausea/vomiting (58,7% and 3,8%), asthenia (50,9% and 3,8%), neurotoxicity (20,1% and 0,96%). Dose reduction was performed in 45 patients (43.2%), 7 (6.7%) permanently discontinued treatment due to toxicity. The median number of cycles administered was 6 (range, 1 - 17). Primary and secondary G-CSF prophylaxis was used in 23% and 28.8% of patients, respectively. No treatment-related deaths were observed. Of the 104 patients, 12 were older elderly. The median age was 76 years (range 75-78). Dose reduction was required more often than the young elderly (58.3% vs 41,3%), but no patient stopped treatment due to toxicity. Most common all grade and grade 3/4 toxicity in older elderly group were neutropenia (16,7% and 50%), thrombocytopenia 1/2 grade (25%), diarrhea (58,3% and 25%), asthenia (66,7% and 0%). Tolerability didn’t differ between ECOG status. mFOLFIRINOX regimen is tolerable and demonstrates manageable toxicity in selected elderly patients with pancreatic carcinoma.
Trial design
This is a retrospective analysis of older patients with pancreatic adenocarcinoma treated with the mFOLFIRINOX regimen. Ages Eligible for Study: 60 Years and older Sexes Eligible for Study: All Criteria Inclusion Criteria: Histologically-confirmed pancreatic adenocarcinoma No prior chemotherapy for pancreatic cancer. ECOG performance status ≤3 Exclusion Criteria: Prior chemotherapy or any other investigational agents for the treatment of pancreatic cancer Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosures
All authors have declared no conflicts of interest.
