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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; Biostatistician, Sadhana Kannan; Chaugule, Deepali; [...]

Docetaxel-oxaliplatin-capecitabine/5 fluorouracil (DOC/F) followed by docetaxel versus Oxaliplatin-Capecitabine/5 fluorouracil (CAPOX/mFOLFOX-7) in HER2 negative advanced gastric cancers

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  • Media type: E-Article
  • Title: Docetaxel-oxaliplatin-capecitabine/5 fluorouracil (DOC/F) followed by docetaxel versus Oxaliplatin-Capecitabine/5 fluorouracil (CAPOX/mFOLFOX-7) in HER2 negative advanced gastric cancers
  • Contributor: 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; Biostatistician, Sadhana Kannan; Chaugule, Deepali; [...]
  • Published: Oxford University Press (OUP), 2024
  • Published in: JNCI Cancer Spectrum (2024)
  • Language: English
  • DOI: 10.1093/jncics/pkae054
  • ISSN: 2515-5091
  • Origination:
  • Footnote:
  • Description: Abstract PURPOSE We evaluated 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 to six months of FOLFOX/CAPOX alone in advanced HER2-negative gastro-esophageal junction and gastric adenocarcinomas (GEJ/GC). PATIENTS AND METHODS This study was an investigator-initiated, open-label, multi-institutional, randomized phase III trial in adult patients with HER2-negative advanced GEJ/GCs. The primary end point 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 randomized 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% CI: 16.5–21.9) for the entire cohort, the median OS was 10.1 months (95%: 9.2-10.9) for FOLFOX/CAPOX and 8.9 months (95% CI: 7.3-10.5) for DOF/DOX and this difference was not statistically significant [p = .70]. An increased proportion of grade 3/4 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 high incidence of BRCA1 (7.5%) and BRCA2 (8.4%) somatic alterations. CONCLUSION FOLFOX or CAPOX chemotherapy for six months remains one of the standards of care in advanced HER2-negative gastro-esophageal 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.
  • Access State: Open Access