Open AccessFortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study
Author(s) -
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
Publication year - 2021
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.3976
Subject(s) - medicine , neutropenia , gastroenterology , docetaxel , clinical endpoint , febrile neutropenia , phases of clinical research , surgery , toxicity , chemotherapy , randomized controlled trial
Background While docetaxel/cisplatin/5‐fluorouracil (DCF) outperforms CF in first‐line gastric adenocarcinoma, toxicity remains an issue. Methods This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m 2 , 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 2 , 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). Results 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. Conclusions 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.