ESTRO 2024 - Abstract Book

S2274

Clinical - Upper GI

ESTRO 2024

Keywords: Pancreas, SBRT, elderly

2954

Proffered Paper

A phase II study of neoadjuvant FOLFIRINOX and chemoradiation in locally advanced pancreatic cancer

Gabriele D'Ercole 1 , Michele Fiore 1,2 , Gian Marco Petrianni 2 , Pasquale Trecca 2 , Martina Benincasa 1 , Barnaba Floreno 2 , Edy Ippolito 1,2 , Damiano Caputo 3,4 , Giuseppe Tonini 5,6 , Roberto Coppola 3,4 , Sara Ramella 1,2 1 Università Campus Bio-Medico di Roma, Research Unit of Radiation Oncology, Roma, Italy. 2 Fondazione Policlinico Universitario Campus Bio-Medico, Operative Research Unit of Radiation Oncology, Roma, Italy. 3 Università Campus Bio-Medico di Roma, Research Unit of General Surgery, Roma, Italy. 4 Fondazione Policlinico Universitario Campus Bio-Medico, Operative Research Unit of General Surgery, Roma, Italy. 5 Università Campus Bio-Medico di Roma, Research Unit of Medical Oncology, Roma, Italy. 6 Fondazione Policlinico Universitario Campus Bio-Medico, Operative Research Unit of Medical Oncology, Roma, Italy

Purpose/Objective:

To evaluate the margin-negative (R0) resection rate in borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma (PDAC) after induction FOLFIRINOX followed by chemoradiation (CRT).

Material/Methods:

In this single-arm, phase 2 clinical trial, patients with locally advanced PDAC underwent CT scan, 18FDG PET-CT scan and a staging laparoscopy to detect occult metastasis before the treatment. Patients received four cycles of FOLFIRINOX scheme. Those without disease progression, as detected by restaging exams, proceeded to long-course CRT with concurrent gemcitabine (600 mg/m² weekly). Four weeks after the completion of CRT, CT scan and PET-CT scan were performed. Surgery was considered for patients with technically resectable tumors. The primary objective was R0 resection rate with an alternate hypothesis of 55%. Secondary objectives included progression-free survival (PFS), overall survival (OS), local progression-free survival (LPFS), metastases free-survival (MFS), and safety. Adverse events were recorded using the NCICTC scale. The trial is registered under NCT05399394.

Results:

We evaluated 65 patients, of whom 3 are in the early stage of the systemic staging. Twenty-two patients (34.9%) were excluded due to evidence of metastatic disease, leaving a total of 40 enrolled patients. Among them, 17 patients (48.6%) had locally advanced unresectable tumors, while 18 patients (51.4%) had borderline resectable disease. Four patients (10%) experienced disease progression after induction chemotherapy. Surgical exploration was performed in 19 patients, all of them underwent radical resection. R0 resection was achieved in all 19 of the 35 eligible patients (54.3%) (Figure 1) The median follow-up was 15.6 months (range, 8.5 to 72.9). Median OS and