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Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer

BACKGROUND: Neoadjuvant chemotherapy improves survival of locally advanced gastric cancer patients. However, benefit is limited and the best regimen remains controversial. OBJECTIVES: Our primary objective of this prospective, multicenter phase 2 study was to evaluate the pathological complete respo...

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Detalles Bibliográficos
Autores principales: Chang, Alex Yuang-Chi, Foo, Kian Fong, Koo, Wen-Hsin, Ong, Simon, So, Jimmy, Tan, Daniel, Lim, Khong Hee
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5013330/
https://www.ncbi.nlm.nih.gov/pubmed/27648294
http://dx.doi.org/10.1136/bmjgast-2016-000095
Descripción
Sumario:BACKGROUND: Neoadjuvant chemotherapy improves survival of locally advanced gastric cancer patients. However, benefit is limited and the best regimen remains controversial. OBJECTIVES: Our primary objective of this prospective, multicenter phase 2 study was to evaluate the pathological complete response rate (PCR) with 2 cycles of docetaxel and capecitabine. METHODS: To be eligible, patients had to have histologically documented gastric cancer, a ECOG performance status 0 or 1, T(3or4) N(any) M(0) staging after oesophagogastroduodenoscopy (OGD), endoscopic ultrasound (EUS), CT scan of thorax and abdomen, and negative laparoscopic examination and peritoneal washing. Eligible patients received two cycles of intravenous docetaxel 60 mg/m(2) on day 1 and oral capecitabine 900 mg/m(2) two times per day from day 1 to day 14 every 3 weeks. We evaluated the response by CT scan and EUS. The patients underwent curative resection with D2 lymphadenectomy subsequently. RESULTS: 18 patients were enrolled in the study: 66% were male and the median age was 60 years. 17 patients had T3 disease at diagnosis. There was no pCR noted. 4 patients had a partial response of 22% (95% CI: 7–42%), 8 patients had stable disease and 3 patients had disease progression. The median survival was 17.1 months with 3 long-term survivors after at least 3 years of follow-up. The treatment was well tolerated with neutropenia being the most common toxicity. We observed 22% grade III and 33% grade IV neutropenia, but no neutropenic fever or death was observed from chemotherapy. CONCLUSION: Neo-adjuvant chemotherapy with docetaxel and capecitabine has limited activity against GC. More effective treatment regimens are needed urgently. TRIAL REGISTRATION NUMBER: NCT00414271.