A pilot study of neoadjuvant FOLFIRINOX followed by chemoradiation for gastric and gastroesophageal cancer: Preliminary results.

Abstract

4057 Background: We performed a single-arm pilot study of total neoadjuvant approach including FOLFIRINOX and chemoradiation (CRT) with concurrent carboplatin/taxol (C/T) followed by surgery in patients with locally advanced gastric or gastroesophageal junction (GEJ) cancer. Methods: Patients were enrolled on a NCI sponsored, prospective, single arm study (NCT03279237). Key eligibility criteria included: histologically confirmed T3/4 or lymph node (LN) positive gastric or GEJ cancer, ECOG PS ≤1, age 18+, life expectancy > 3 months. Exclusion criteria included: visceral metastases, prior chemotherapy or RT, or prior targeted therapy. Extensive LN disease beyond the surgical field (supraclavicular or para-aortic) was permitted if deemed feasible to be encompassed within a RT field. Laparoscopy was not required. Pts were treated with neoadjuvant FOLFIRINOX x 8, restaging, CRT (45 Gy for gastric, 50.4 Gy for GEJ) with concurrent C/T, restaging, followed by surgical resection. Dose reductions were at discretion of the treating physician. The primary objective was to determine the rate of completion of FOLFIRINOX x 8 followed by CRT delivered in the preoperative setting. Secondary endpoints included: 1) acute toxicity and 2) pathologic complete response (pCR). Results: From Oct 2017 to June 2018, 25 pts were enrolled. Median age was 60 (range:30-76), 17 pts were male (68%). All pts started FOLFIRINOX; 23 (92%) pts completed all 8 planned cycles. Two pts did not complete the planned 8 cycles due to metastatic progression. Rates of grade 3+ overall, gastrointestinal, and hematologic toxicities were 28%, 12%, and 28% respectively. Of the entire cohort, 23 (92%) pts started chemoRT and 22 (88%) pts completed chemoRT (1 pt died during CRT due to pulseless electrical activity arrest). All 22 pts (88%) who completed CRT went for surgical exploration, of whom 2 pts were found with intraoperative metastases. Therefore, 20 (80%) pts underwent surgical resection. At time of abstract, 1 pt’s pathology is in process; 7 pts had a pCR (37% in resected cohort, 28% in ITT cohort), all with R0 resection. Conclusions: Total neoadjuvant FOLFIRINOX followed by CRT is feasible with acceptable rates of treatment completion and grade 3+ toxicity. In our small series, the rate of pCR is promising and a follow-up study is currently planned. Clinical trial information: NCT03279237.