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

Autor: Marc De Man, Pascal Pierre, Erik Vanderstraeten, Ghislain Houbiers, Lionel D'Hondt, Jacques Van Der Auwera, Hassan Rezaei Kalantari, Amélie Deleporte, Ahmad Awada, Lieveke Ameye, Alain Hendlisz, Thierry Delaunoit, Stéphanie Laurent, Francesco Sclafani, Bjorn Ghillemijn, Marylene Clausse, Marianne Paesmans, Angelique Covas, Marc Van den Eynde, Frédéric Forget, Philippe Vergauwe, Stéphane Holbrechts
Přispěvatelé: UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (MGD) Service d'oncologie médicale, UCL - (SLuc) Service d'oncologie médicale, UCL - (SLuc) Centre du cancer, Medical Oncology
Rok vydání: 2021
Předmět:
Male
0301 basic medicine
Cancer Research
MONOTHERAPY
MULTICENTER
cisplatin
Gastroesophageal Junction Adenocarcinoma
THERAPY
Gastroenterology
DOUBLE-BLIND
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
Granulocyte Colony-Stimulating Factor
Clinical endpoint
docetaxel
Medicine
hematological growth factors
Fatigue
RC254-282
Original Research
Aged
80 and over
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Middle Aged
CANCER
Progression-Free Survival
Anorexia
Oncology
Docetaxel
030220 oncology & carcinogenesis
Toxicity
fortnightly
Vomiting
Female
Esophagogastric Junction
Fluorouracil
medicine.symptom
Life Sciences & Biomedicine
medicine.drug
Adult
Diarrhea
medicine.medical_specialty
Neutropenia
MODIFIED DOCETAXEL
Adenocarcinoma
Drug Administration Schedule
gastroesophageal cancer
03 medical and health sciences
Stomach Neoplasms
Internal medicine
Humans
Radiology
Nuclear Medicine and imaging
5-FU
Aged
Febrile Neutropenia
Cisplatin
Science & Technology
business.industry
gastric cancer
NIVOLUMAB
Clinical Cancer Research
weekly
medicine.disease
FLUOROURACIL
5‐FU
030104 developmental biology
PLUS CHEMOTHERAPY
business
Febrile neutropenia
Zdroj: Cancer medicine, Vol. 10, no. 13, p. 4366-4374 (2021)
Cancer Medicine, Vol 10, Iss 13, Pp 4366-4374 (2021)
Cancer Medicine
ISSN: 2045-7634
DOI: 10.1002/cam4.3976
Popis: 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/m2, 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/m2, 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.
The DoGE multicenter study randomised prospectively patients with chemonaïve gastric cancer between fractionated weekly and fortnightly DCF regimens. Both 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.
Databáze: OpenAIRE
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