Efficacy and Safety of FOLFIRI for Previously Treated Advanced Pancreatic Cancer

The treatment of 5-fluorouracil (5-FU) with levofolinate and irinotecan (FOLFIRI) was found to be well-tolerated and effective as a second-line treatment for patients with gemcitabine-refractory advanced pancreatic cancer (APC), according to presentation at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

Currently, FOLFIRI has been established in the National Comprehensive Cancer Network guidelines as a preferred regimen for patients with APC who had received prior treatment with gemcitabine, yet the survival benefit or safety in clinical practice has remained unclear.

For this reason, researchers retrospectively analyzed data from patients at the Shizuoka Cancer Center between the period of May 2014 and March 2020. The researchers examined consecutive patients with APC who received FOLFIRI as a second- or later-line treatment following treatment with gemcitabine.

In the analysis of 102 patients, characteristics included a median age of 67 years with a range between 39 and 78 years; 55 male patients and 47 female patients; Eastern Cooperative Oncology Group performance status of 0/1/2, 21/72/9; the number of metastatic sites among patients being 0/1/2/3/4, 7/48/35/8/4; unresectable tumors among patients were 84 and recurrent tumors were 18; and User Datagram Protocol Glucuronosyltransferase Family 1 Member A1 status was wild/*6 or*28 heterozygous/homo or double-heterozygous/unknown, 40/40/5/17.

The researchers observed that the median treatment cycle was 5 within a range of 1 to 55. The median treatment cycle for the second line was 7 within a range of 1 to 55, for the third line it was 4 within a range of 1 to 14, for the fourth line it was 3.5 within a range of 1 to 10. Additionally, the initial dose for each cytotoxic agent was bolus 5-FU injected/omitted 72/30; continuous 5-FU 2400/2000/1200 mg/m2, 88/13/1; irinotecan 180/150/120/less than or equal to 100 mg/m2, 27/59/13/3.

The researchers found that the overall response rate (ORR) was 5.9% and disease control rate (DCR) was 52.9%. For each treatment line, the ORR and DCR was as follows: second line was 9.3 and 64.1%, third line was 0 and 68.8%, and fourth line was 0 and 50.0%.

The researchers also noted the median follow up was 6.5 months, with the median overall survival (OS) at 6.6 months and progression free survival (PFS) at 3.1 months. Based on the treatment line, the median OS and PFS were as follows: second line was 8.1 months and 3.6 months; third line was 5.1 months and 2.1 months, and fourth line was 6.6 months and 2.0 months.

In 70.8% of patients, adverse events (AEs) were observed, with grade 3 or higher AEs occurring in 27.2% patients. AEs included neutropenia in 25.2% (26) of patients, febrile neutropenia in 3.9% (4) of patients, nausea in 3.9% (4) patients, decreased appetite in 2.9% (3) patients. The researchers observed no treatment-related deaths among the patients.

REFERENCE

Shirasu H, Kawakami T, Hamauchi S, et al. Efficacy and safety of 5-fluorouracil (5-FU) / levofolinate / irinotecan (FOLFIRI) for previously treated advanced pancreatic cancer (APC). Paper presented at: 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium; January 15-17, 2021; virtual. https://meetinglibrary.asco.org/record/194474/abstract. Accessed January 26, 2021.