%0 Journal Article
%T Docetaxel-oxaliplatin-capecitabine/5-fluorouracil (DOX/F) followed by docetaxel versus oxaliplatin-capecitabine/5-fluorouracil (CAPOX/FOLFOX) in HER2-negative advanced gastric cancers.
%A Ramaswamy A
%A Bhargava P
%A Dubashi B
%A Gupta A
%A Kapoor A
%A Srinivas S
%A Shetty O
%A Jadhav P
%A Desai V
%A Noronha V
%A Joshi A
%A Menon N
%A Patil VM
%A Mishra BK
%A Sansar B
%A Singh A
%A Patel S
%A Singh SN
%A Dhal I
%A Vinayak KR
%A Pal V
%A Mandavkar S
%A Kannan S
%A Chaugule D
%A Patil R
%A Parulekar M
%A Nashikkar C
%A Ankathi SK
%A Kaushal RK
%A Shah A
%A Ganesan P
%A Kayal S
%A Ananthakrishnan R
%A Syed N
%A Samaddar D
%A Kapu V
%A Shah A
%A Kaaviya D
%A Suganiya R
%A Srinivasan ND
%A Prabhash K
%A Ostwal V
%J JNCI Cancer Spectr
%V 8
%N 4
%D 2024 Jul 1
%M 39067037
暂无%R 10.1093/jncics/pkae054
%X <B>BACKGROUND: </B>We evaluated whether the addition of docetaxel (D) to a combination comprising 5-fluorouracil/leucovorin (5-FU/LV) or capecitabine (C) plus oxaliplatin (O) (DOF/DOX) improved overall survival (OS) compared with 6 months of 5-fluorouracil (5-FU) or capecitabine in combination with oxaliplatin (FOLFOX/CAPOX) alone in advanced HER2-negative gastroesophageal junction and gastric adenocarcinomas (G/GEJ).<BR><B>METHODS: </B>This study was an investigator-initiated, open-label, multi-institutional, randomized phase III trial in adult patients with HER2-negative advanced G/GEJs. The primary endpoint of the study was a comparison of median OS by Kaplan-Meier method. Next-generation sequencing was performed on tissue.<BR><B>RESULTS: </B>Of the 324 patients randomly assigned between July 2020 and November 2022, 305 patients were evaluable for analysis (FOLFOX/CAPOX: 156; DOF/DOX: 149). With a median follow-up time of 19.2 months (95% Confidence Interval [CI] = 16.5 months to 21.9 months) for the entire cohort, the median OS was 10.1 months (95% CI = 9.2 to 10.9) for FOLFOX/CAPOX and 8.9 months (95% CI = 7.3 to 10.5) for DOF/DOX, and this difference was not statistically significant (P = .70). An increased proportion of grade 3 or grade 4 neutropenia (21% vs 3%; P < .001) and grade 2/3 neuropathy (17% vs 7%; P = .005) was seen in patients receiving DOF/DOX. Genomic profiling revealed a low incidence of microsatellite instability (1%) and a high incidence of BRCA1 (8.4%) and BRCA2 (7.5%) somatic alterations.<BR><B>CONCLUSIONS: </B>FOLFOX or CAPOX chemotherapy for 6 months remains one of the standards of care in advanced HER2-negative gastroesophageal junction and gastric adenocarcinomas, with no additional survival benefit seen with the addition of docetaxel. Genomic profiling of patients revealed a higher than previously known incidence of somatic BRCA alterations, which requires further evaluation.CTRI (Clinical Trial Registry of India: CTRI/2020/03/023944).