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Docetaxel-oxaliplatin-capecitabine/5-fluorouracil (DOX/F) followed by docetaxel versus oxaliplatin-capecitabine/5-fluorouracil (CAPOX/FOLFOX) in HER2-negative advanced gastric cancers.
Ramaswamy, Anant; Bhargava, Prabhat; Dubashi, Biswajit; Gupta, Anuj; Kapoor, Akhil; Srinivas, Sujay; Shetty, Omshree; Jadhav, Poonam; Desai, Veena; Noronha, Vanita; Joshi, Amit; Menon, Nandini; Patil, Vijay M; Mishra, Bal Krishna; Sansar, Bipinesh; Singh, Arpita; Patel, Swapnil; Singh, Satyendra Narayan; Dhal, Ipsita; Vinayak, Kunal Ranjan; Pal, Vikash; Mandavkar, Sarika; Kannan, Sadhana; Chaugule, Deepali; Patil, Rajshree; Parulekar, Manali; Nashikkar, Chaitali; Ankathi, Suman Kumar; Kaushal, Rajiv Kumar; Shah, Aekta; Ganesan, Prasanth; Kayal, Smita; Ananthakrishnan, Ramesh; Syed, Noorzia; Samaddar, Debdeep; Kapu, Venkatesh; Shah, Anokhi; Kaaviya, D; Suganiya, R; Srinivasan, Nirmala Devi; Prabhash, Kumar; Ostwal, Vikas.
Afiliación
  • 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.
JNCI Cancer Spectr ; 8(4)2024 Jul 01.
Article en En | MEDLINE | ID: mdl-39067037
ABSTRACT

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).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Gástricas / Adenocarcinoma / Protocolos de Quimioterapia Combinada Antineoplásica / Leucovorina / Receptor ErbB-2 / Unión Esofagogástrica / Capecitabina / Fluorouracilo / Docetaxel / Oxaliplatino Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JNCI Cancer Spectr Año: 2024 Tipo del documento: Article País de afiliación: India Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Gástricas / Adenocarcinoma / Protocolos de Quimioterapia Combinada Antineoplásica / Leucovorina / Receptor ErbB-2 / Unión Esofagogástrica / Capecitabina / Fluorouracilo / Docetaxel / Oxaliplatino Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JNCI Cancer Spectr Año: 2024 Tipo del documento: Article País de afiliación: India Pais de publicación: Reino Unido