Neoadjuvant epirubicyn, oxaliplatin, capecitabine and radiation therapy (NEOX-RT) followed by surgery for locally advanced gastric cancer (LAGC): A phase II multicentric study.
2019; Lippincott Williams & Wilkins; Volume: 37; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2019.37.15_suppl.4066
ISSN1527-7755
AutoresAntonino De Paoli, Federico Navarria, Elena Torrisi, Jerry Polesel, Eleonora Fort, Luisa Foltran, Elisa Palazzari, R. Innocente, Renato Cannizzaro, Vincenzo Canzonieri, D.M. Tonin, Paolo Ubiali, Sara Lonardi, Francesca Bergamo, Sara Galuppo, C. Bellucco, Stefano Merigliano, Salvatore Pucciarelli, Giulio Bertola, Angela Buonadonna,
Tópico(s)Cholangiocarcinoma and Gallbladder Cancer Studies
Resumo4066 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 2 nd 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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