Abstract 5744
Background
G/GEA is relatively chemosensitive, but triplet chemotherapy (CT) regimens with docetaxel have the most efficacy with overall response rate (ORR) 37-58%, median progression free survival (MPFS) 5.2-9.7 mo, median overall survival 9.2-18.8 mo. Irinotecan is active drug for the 1st line CT of G/GEA patients (pts). FOLFIRINOX regimen have shown promising activity in other GI cancers (pancreatic, colorectal). The aim of our study was to evaluate efficacy and tolerability of mFOLFIRINOX in G/GEA.
Methods
G/GEA patients (pts) received 9 cycles of irinotecan 180mg/m2+oxaliplatin 85mg/m2+leucovorin 200mg/m2+5-fluorouracil 250mg/m2 bolus followed by 2200mg/m2x48h (mFOLFIRINOX) on d1 every 2 weeks without subsequent maintenance therapy. Primary G-CSF prophylaxis was not provided.
Results
108 CT-naïve pts with G/GEA were included from Jan 2012 to Oct 2015 (48 female, 60 male). ECOG 0/1/2/3/4 were 41/51/7/1% pts. ORR was 52,8%, SD–39,8%, PD–5,6%. MPFS and MOS were 7,83 mo and 16,8 mo, respectively. The main toxicities Grade(gr) ≥3 in pts included neutropenia–47,2%, febrile neutropenia–5,6%, diarrhea–5,6%; we noted else thrombocytopenia gr 1-2 - 29,6%, asthenia gr 1-3 - 87%, hepatotoxicity - 25%/gr 3–0,9%, neurotoxicity–15,7%/gr–1,9%. 31(28,7%) pts received G-CSF on 8,5% cycles. There were no deaths and treatment discontinuation due to toxicity. After the complete regression of distant metastases 11 pts were operated (D2 gastrectomy). For these pts MPFS was18,47 mo, MOS–29,33 mo.
Conclusions
mFOLFIRINOX showed remarkable ORR, PFS and OS in patients with advanced gastroesophageal or gastric adenocarcinoma in the fist-line setting. This regimen may be one more reasonable therapeutic option for these pts. We recommend mFOLFIRINOX for Phase III clinical trial compared with FLOT regimen.
Clinical trial identification
Legal entity responsible for the study
Besova N.
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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