Oxaliplatin, 5FU and nab-paclitaxel as neoadjuvant regimen in patients with resectable oesogastric adenocarcinoma: A GERCOR phase 2 study (FOXAGAST).

Authors

null

Sarah Sophie Watson

Institut Mutualiste Montsouris, Paris, France

Sarah Sophie Watson , Christelle De La Fouchardiere , Stefano Chong Hun Kim , Romain Cohen , Jean-Baptiste Bachet , Christophe Tournigand , Jean-Marc Ferraz , Marine Lefevre , Delphine Colin , Magali Svrcek , Aurelia Meurisse , Christophe Louvet

Organizations

Institut Mutualiste Montsouris, Paris, France, Centre Léon-Bérard, Lyon, France, Centre Hospitalier-Universitaire de Besançon, Besançon, France, Saint-Antoine Hospital, Paris, France, Hospital Pitié-Salpêtrière, Paris, FR, Hôpital Mondor, AP-HP, Créteil, France, AP-HP, hôpital Saint-Antoine, Paris, FR, CHU Besancon, Besancon, France

Research Funding

Other Foundation

Background: Peri-operative chemotherapy is the standard of care in Resectable OesoGastric Adenocarcinoma (ROGA), with several validated regimens such as Cisplatin-5FU, FOLFOX, ECF/X, or FLOT. Nanoparticle-bound (Nab) paclitaxel is active in OGA. Tumor regression grade (TRG) is an objective parameter for assessing efficacy of neoadjuvant chemotherapy (NACT). The study objective was to evaluate TRG with Nab-paclitaxel combined with FOLFOX in ROGA patients (pts). Methods: HER2-negative ROGA pts over 18 yrs received Nab-paclitaxel (150mg/m2) and FOLFOX (oxaliplatin 85 mg/m2; 5FU 2400mg/m2 over 48h, and leucovorin 400mg/m2) on D1 q2w for 6 cycles in preoperative setting. 6 postoperative cycles were kept at investigator’s discretion. Primary endpoint was pathological complete response rate (TRG1) after NACT. According to Fleming design 49 pts had to be included to test H0 (10% TRG1) and H1 (25% TRG1) with unilateral α of 5% and ß of 10%. To reject H0, TRG1 had to be achieved in at least 8 pts. Results: 49 pts (36 male, median age 63.7 yrs, 53% N+) were included between 6/2015 and 3/2017. Median number of NACT cycles was 6 (range 3-6). Median dose-intensity was 96% (38-103), 97% (47-103) and 99% (50-112) for Nab-paclitaxel, oxaliplatin, and 5FU, respectively. Surgery could not be performed in 5 (10.2%) pts due to tumor progression or poor performance status. Tumor resection was R0 for 42/44 (95.5%) pts. Centrally blinded review classified tumors as TRG1 to TRG5 for 8 (16.3%), 11 (22.5%), 4 (8.2%), 18 (36.7%) and 3 (6.1%) pts, respectively. With a median follow-up of 14.2 m, 12 m-PFS was 88.4 % (95% CI: 74.2-95.0). Grade 3 or worse toxicities in NACT phase were non febrile neutropenia in 10 pts (20.4%), nausea in 4 (8.2%), diarrhea in 4 (8.2%) and neuropathy in 3 (6.1%). 14/44 (31.8%) pts experienced per or post-operative complications, including fistulas (5 pts), ischemic complications (4), infections (3), and anesthesia-related complications (2). 3/44 (6.8%) pts died from surgical complications. Conclusions: This regimen shows promising activity in ROGA with a high rate of TRG1/TRG2 responses. Toxicity is manageable but a high rate of surgical complications was observed. Clinical trial information: NCT02486601

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT02486601

Citation

J Clin Oncol 36, 2018 (suppl; abstr 4035)

DOI

10.1200/JCO.2018.36.15_suppl.4035

Abstract #

4035

Poster Bd #

224

Abstract Disclosures