Neoadjuvant epirubicyn, oxaliplatin, capecitabine and radiation therapy (NEOX-RT) followed by surgery for locally advanced gastric cancer (LAGC): A phase II multicentric study.

Authors

null

Antonino De Paoli

Radiation Oncology Dept - IRCCS CRO Aviano-National Cancer Institute, Aviano, Italy

Antonino De Paoli , Federico Navarria , Elena Torrisi , Jerry Polesel , Eleonora Fort , Luisa Foltran , Elisa Palazzari , Roberto Innocente , Renato Cannizzaro , Vincenzo Canzonieri , Dino Tonin , Paolo Ubiali , Sara Lonardi , Francesca Bergamo , Sara Galuppo , Claudio Bellucco , Stefano Merigliano , Salvatore Pucciarelli , Giulio Bertola , Angela Buonadonna

Organizations

Radiation Oncology Dept - IRCCS CRO Aviano-National Cancer Institute, Aviano, Italy, Medical Oncology Dept. RCCS CRO Aviano-National Cancer Institute, Aviano, Italy, Cancer Epidemiology Dept-IRCCS CRO Aviano-National Cancer Institute, Aviano, Italy, Clinical Trial Office - IRCCS CRO Aviano-National Cancer Institute, Aviano, Italy, Gastroenterology Dept-IRCCS CRO Aviano-National Cancer Institute, Aviano, Italy, Pathology Dept - IRCCS CRO Aviano-National Cancer Institute, Aviano, Italy, Department of Surgery - General Hospital Pordenone, Pordenone, Italy, Department of Clinical and Experimental Oncology, Medical Oncology 1 Unit, Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy, Radiation Oncology Dept - IOV - IRCCS Padova, Padova, Italy, Surgical Oncology Dept - IRCCS CRO Aviano-National Cancer Institute, Aviano, Italy, Department of Oncological and Surgical Sciences, Surgical Clinic III, University of Padova, Padova, Italy, Department of Oncological and Surgical Sciences, Surgical Clinic I, University of Padova, Padova, Italy

Research Funding

Other

Background: This study evaluates the feasibility, safety and efficacy of a trimodality treatment, with surgery postponed after neoadjuvant chemotherapy (CT) and chemoradiotherapy (CRT), in LAGC. Methods: Patients (pts) with cT3-4 and/or N+ LAGC were eligible. Staging included endoscopic ultrasound, PET-CT and laparoscopy. Three cycles of EOX (Epirubicyn 50mg/m2,q21 days, Oxaliplatin 130mg/m2,q21 days, and Capecitabine 625mg/m2 bid, by continuous oral administration (c.a.), followed by IMRT with 45Gy/25 frs, concurrent Capecitabine 625mg/m2 bid c.a. and weekly Oxaliplatin 30mg/m2 for 5 wks, was planned. Early PET-CT was performed after the 2nd EOX cycle to assess response or disease progression. Restaging was repeated after CT and CRT. Surgery was planned 4-6 wks after CRT, 22 wks from the start of NEOX-RT. Pathologic complete response (pCR) was the primary endpoint. Results: From November 2008 to March 2016, 51 pts (5 G-E Junction, 17 Cardia, 15 Corpus, 14 Antrum) entered the study. The NEOX-RT program was completed in 46 pts (90%) who proceeded to surgery and are assessable. Grade 3-4 toxicity (NCI-CTC criteria v.3) occurred in 13/51 pts (25%) during EOX, including 1 toxic death, and 9.5% CT cycles required dose modification, resulting in a CT compliance of 90%. No pts had progression during CT. Persistent G2-G3 toxicity occurred in 32/46 pts (69%) during CRT. However, 41/46 pts (89%) received the planned 45Gy with Capecitabine at dose ≥75% and 4-5 cycles of weekly Oxaliplatin in 52% pts. Curative resection (R0) rate was 89%; 4 pts (8.7%) had peritoneal carcinomatosis at surgery done after a median of 23 wks. pCR was reported in 9/46 pts (19.6%). Major postop complications occurred in 5 pts (11%). At median f-up of 62 mos (23-109), 5-yr OS and DFS in all and pCR pts were 58%, 100% and 51%, 75%, respectively. Conclusions: This trimodality program was feasible and safe. Most pts completed the planned treatment. The pCR rate of 19.6% was remarkable and met the hypothesis of pCR = 20%. A high R0 rate was also reported and delayed surgery didn’t increase complications. The notable survival rates are available to be compared with ongoing phase III trials. Clinical trial information: 2008-002715-40.

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Abstract Details

Meeting

2019 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

2008-002715-40

Citation

J Clin Oncol 37, 2019 (suppl; abstr 4066)

DOI

10.1200/JCO.2019.37.15_suppl.4066

Abstract #

4066

Poster Bd #

171

Abstract Disclosures