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Deleporte, Amélie; Van den Eynde, Marc; Forget, Frédéric; Holbrechts, Stéphane; Delaunoit, Thierry; Houbiers, Ghislain; Kalantari, Hassan R.; Laurent, Stéphanie; Vanderstraeten, Erik; De Man, Marc; Vergauwe, Philippe; Clausse, Marylene; Van Der Auwera, Jacques; D’Hondt, Lionel; Pierre, Pascal; Ghillemijn, Bjorn; Covas, Angelique; Paesmans, Marianne; Ameye, Lieveke; Awada, Ahmad; Sclafani, Francesco; Hendlisz, Alain

Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study

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  • Media type: E-Article
  • Title: Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study
  • Contributor: Deleporte, Amélie; Van den Eynde, Marc; Forget, Frédéric; Holbrechts, Stéphane; Delaunoit, Thierry; Houbiers, Ghislain; Kalantari, Hassan R.; Laurent, Stéphanie; Vanderstraeten, Erik; De Man, Marc; Vergauwe, Philippe; Clausse, Marylene; Van Der Auwera, Jacques; D’Hondt, Lionel; Pierre, Pascal; Ghillemijn, Bjorn; Covas, Angelique; Paesmans, Marianne; Ameye, Lieveke; Awada, Ahmad; Sclafani, Francesco; Hendlisz, Alain
  • imprint: Wiley, 2021
  • Published in: Cancer Medicine
  • Language: English
  • DOI: 10.1002/cam4.3976
  • ISSN: 2045-7634
  • Keywords: Cancer Research ; Radiology, Nuclear Medicine and imaging ; Oncology
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>While docetaxel/cisplatin/5‐fluorouracil (DCF) outperforms CF in first‐line gastric adenocarcinoma, toxicity remains an issue.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m<jats:sup>2</jats:sup>, C 35 mg/m², F 1800 mg/m² over 24 h, on days 1 and 8 every 3 weeks, arm (1) or fortnightly DCF (D 50 mg/m<jats:sup>2</jats:sup>, C 50 mg/m², F 2000 mg/m² over 48 h every 2 weeks, arm (2). Prophylactic granulocyte colony‐stimulating factor (G‐CSF) was not allowed. The primary endpoint was the rate of febrile neutropenia within the first six treatment weeks (early FN).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 106 eligible patients were recruited. The early and overall FN rates were 9.5% and 17% in arm 1, respectively, and 5.9% and 8% in arm 2, respectively. Grade ≥3 toxicities occurred in 81% of patients in arm 1 and 90% of patients in arm 2, the most common being neutropenia (33% vs. 61%), fatigue (27% vs. 25%), vomiting (21% vs. 12%), anorexia (19% vs. 18%), and diarrhea (17% vs. 10%). Median progression‐free survival and overall survival were 5.1 (95% CI, 3.2–6.5) and 8.2 months (95% CI, 6.0–14.5), respectively, in arm 1 and 5.2 (95% CI, 3.0–6.9) and 11.9 months (95% CI, 7.4–15.9), respectively, in arm 2.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Fractionated weekly and fortnightly DCF regimens are associated with a low risk of early FN, and a better hematological toxicity profile as compared to historical DCF without compromising efficacy. Both regimens offer greater convenience removing the need for systematic use of prophylactic G‐CSF.</jats:p></jats:sec>
  • Access State: Open Access