FOLFIRINOX for advanced pancreatic adenocarcinoma in Brazil: a single-institution experience

ABSTRACT

Objective: Data is lacking about FOLFIRINOX use for advanced pancreatic ductal adenocarcinoma in emerging countries. The objective of this study was to report outcomes of efficacy and safety in the setting of a South American institution.

Methods: Patients treated with FOLFIRINOX for metastatic or locally advanced pancreatic cancer at Instituto do Câncer do Estado de São Paulo (Brazil), between November 2012 and January 2016 were retrospectively reviewed. Baseline characteristics, safety, response and overall survival were analyzed.

Results: Sixty-one patients were enrolled (metastatic disease: 31). Median age was 61 years (range 37-74), and 88.5% had ECOG 0 or 1; 90.2% had T3 or T4 tumors and 36.1% had node-positive disease. FOLFIRINOX was given as the first-line treatment in 88.5% of patients, and was discontinued due to disease progression (55.7%), limiting toxicity (31.1%) or maximum benefit (13.1%). Median number of cycles was 10 (range 1-32). Dose reductions occurred in 81.9%. Grade 3 or 4 toxicity were found in 60.6% and were mainly hematological (36%), neuropathy (19.6%), fatigue (8.2%) and diarrhea (14.7%). Two patients had febrile neutropenia. Hospitalization during treatment occurred in 31.1% of cases, with three potential treatment-related deaths. Median overall survival was 16.26 in the full cohort; 13.6 in patients with metastatic disease, and 18.7 months in locally advanced disease. The response rate was 39.3% (32.2% in metastatic disease and 43.3% in locally advanced disease).

Conclusion: Despite the high prevalence of grade 3 or 4 toxicities, FOLFIRINOX showed efficacy for the treatment of patients with advanced pancreatic adenocarcinoma, and is an excellent treatment option in emerging countries.

RESUMO

Objetivo: São escassos os dados sobre uso de FOLFIRINOX para adenocarcinoma de pâncreas avançado em países emergentes. O objetivo desse estudo foi reportar os desfechos de eficácia e segurança do uso de FOLFIRINOX para adenocarcinoma de pâncreas avançado em uma instituição terciária Sul-Americana.

Métodos: Pacientes tratados com FOLFIRINOX para adenocarcinoma de pâncreas avançado ou metastático no Instituto do Câncer do Estado de São Paulo (Brasil), entre Novembro de 2012 e Janeiro de 2016, foram retros-pectivamente analisados. As características dos pacientes, dados de segurança, resposta e sobrevida global foram analisadas.

Resultados: Sessenta e um pacientes foram avaliados (31 com doença metastática). Idade mediana foi de 61 anos (amplitude: 37 a 74 anos) e 88,5% eram ECOG 0 ou 1; 90,2% tinham tumores T3 ou T4, sendo 36,1% doença linfonodo--positiva. FOLFIRINOX foi administrado como primeira linha de tratamento em 88,5% dos pacientes avaliados e interrompido por progressão de doença (55,7%), toxicidade limitante (31,1%), ou benefício máximo (13,1%). O número mediano de ciclos foi 10 (amplitude: 1-32). Reduções de dose ocorreram em 81,9% dos pacientes. Toxicidades grau 3 ou 4 foram encontradas em 60,6% dos pacientes, sendo principalmente toxicidade hematológica (36%), neuropatia (19,6%), fadiga (8,2%), e diarreia (14,7%). Dois pacientes tiveram neutropenia febril. Hospitalização durante o tratamento ocorreu em 31,1% dos casos, tendo ocorrido 3 mortes potencialmente relacionadas ao tratamento. A sobrevida mediana foi de 16,26 meses na coorte completa, tendo sido de 13,6 meses nos pacientes com doença metastática e 18,7 meses na doença localmente avançada. A taxa de resposta foi de 39,3% (32,2% na doença metastática e 43,3% na doença localmente avançada).

Conclusão: Apesar da alta prevalência de toxicidades grau 3 ou 4, FOLFIRINOX mostrou eficácia no tratamento de pacientes com adenocarcinoma de pâncreas avançado, sendo opção de tratamento em países emergentes.

Keywords:

Pancreatic neoplasms/drug therapy - FOLFIRINOX - Cohort studies - Brazil

Descritores:

Neoplasias pancreáticas/tratamento farmacológico - FOLFIRINOX - Estudos de coortes - Brasil

Publikationsverlauf

Eingereicht: 20. Februar 2018

Angenommen: 21. März 2018

Artikel online veröffentlicht:
25. Februar 2025

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