Docetaxel-oxaliplatin-capecitabine/5-fluorouracil (DOX/F) followed by docetaxel versus oxaliplatin-capecitabine/5-fluorouracil (CAPOX/FOLFOX) in HER2-negative advanced gastric cancers.

Autor:	Ramaswamy A; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Bhargava P; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Dubashi B; Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India., Gupta A; Department of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India., Kapoor A; Department of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India., Srinivas S; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Shetty O; Department of Molecular Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Jadhav P; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Desai V; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Noronha V; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Joshi A; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Menon N; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Patil VM; Consultant Medical Oncologist, P.D. Hinduja Hospital & Medical Research Centre, Mumbai, India., Mishra BK; Department of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India., Sansar B; Department of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India., Singh A; Department of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India., Patel S; Department of Surgical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India., Singh SN; Department of Radiology, Homi Bhabha Cancer Hospital, Varanasi, India., Dhal I; Department of Pathology, Homi Bhabha Cancer Hospital, Varanasi, India., Vinayak KR; Department of Palliative Medicine, Homi Bhabha Cancer Hospital, Varanasi, India., Pal V; Department of Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi, India., Mandavkar S; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Kannan S; Department of Statistics, Advanced Centre for Treatment, Research and Education in Cancer, Homi Bhabha National Institute (HBNI), Mumbai, India., Chaugule D; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Patil R; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Parulekar M; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Nashikkar C; Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Ankathi SK; Department of Radiodiagnosis, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Kaushal RK; Department of Pathology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Shah A; Department of Pathology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Ganesan P; Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India., Kayal S; Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India., Ananthakrishnan R; Department of Radiodiagnosis, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India., Syed N; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Samaddar D; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Kapu V; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Shah A; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Kaaviya D; Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India., Suganiya R; Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India., Srinivasan ND; Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India., Prabhash K; Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India., Ostwal V; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.
Jazyk:	angličtina
Zdroj:	JNCI cancer spectrum [JNCI Cancer Spectr] 2024 Jul 01; Vol. 8 (4).
DOI:	10.1093/jncics/pkae054
Abstrakt:	Background: 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). Methods: 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. Results: 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. Conclusion: 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). (© The Author(s) 2024. Published by Oxford University Press.)
Databáze:	MEDLINE
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