Abstract
Objective. To evaluate efficacy and safety of FOLFIRINOX regimen as induction therapy in borderline resectable and unresectable pancreatic cancer. Materials and methods. A prospective study included patients with borderline resectable and unresectable pancreatic cancer without distant metastases. Patients received up to 6 courses of induction chemotherapy with FOLFIRINOX regimen (oxaliplatin 85 mg/m2 i. v., irinotecan 180 mg/m2 i. v., calcium folinate 400 mg/m2 i. v., 5‑fluorouracil 400 mg/m2 i. v. bolus and 2 400 mg/m2 i. v. 46‑hours infusion) repeated every 14 days. Patients underwent surgery when radiologic signs of resectability were achieved. Maintenance chemotherapy was prescribed to the patients in cases of unresectability preservation. The primary endpoint was 1‑year progression-free survival. Results of the study. The study included 32 patients. The median follow-up was 7.0 months. The one-year progression-free survival was 55.3%. The one-year overall survival of patients in this study was 83.2%. Eight patients (25%) underwent surgery after induction therapy, and in 7 of them it was possible to perform R0 resection. The main manifestations of 3–4 grade toxicity were neutropenia (46.9%), diarrhea (12.5%), and elevation of hepatic transaminases (12.5%). Conclusions. The FOLFIRINOX regimen showed high potential as induction chemotherapy in pancreatic cancer. The use of this regimen is possible only in patients with good performance status due to its high toxicity.
Highlights
Maintenance chemotherapy was prescribed to the patients in cases of unresectability preservation
Petrelli F., Coinu A., Borgonovo K., Cabiddu M., Ghilardi M., Lonati V. et al FOLFIRINOX-based neoadjuvant therapy in borderline resectable or unresectable pancreatic cancer: a meta-analytical review of published studies
Summary
Первичной конечной точкой выбрана выживаемость без прогрессирования. Исследование пред‐ полагало оценку частоты объективных эффектов, ча‐ стоты резекций поджелудочной железы, общей выжи‐ ваемости, а также безопасности химиотерапии. Описательная статистика номинальных и поряд‐ ковых переменных предусматривала расчет доли и представлена в виде n (%). Описательная стати‐ стика количественных переменных включала расчет медианы, а также минимального и максимального значений переменной. Использование такого спосо‐ ба представления результатов продиктовано неболь‐ шим числом пациентов в группе и ненормальным характером распределения при анализе количествен‐ ных переменных. Статистический анализ полученных результатов выполнен с использованием программ Microsoft Excel 2007 и IBM SPSS Statistics v. Статистический анализ полученных результатов выполнен с использованием программ Microsoft Excel 2007 и IBM SPSS Statistics v. 17.0
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