Abstract
The aim of this study is to report first preliminary results of patients enrolled in a phase II study that will investigate the activity and safety of docetaxel, oxaliplatin, and 5-fluorouracil (DOF) in combination with trastuzumab in human epidermal receptor-2 (HER-2) positive patients with advanced gastric or gastroesophageal junction (GEJ) cancer.Treatment consisted of docetaxel 70 mg/m combined with oxaliplatin 130 mg/m on day 1, and continuous infusion 5-fluorouracil mg/m days 1-5 plus trastuzumab at the standard dose on day 1, every 3 weeks for a maximum of 8 cycles.Fifteen patients were enrolled. The overall response rate was 60%. The median progression-free survival was 9.2 months (95% confidence interval [CI], 4.4-10.1 months) and the median overall survival was 19.4 months (95% CI, 8.9-21.1 months). Grade 3 neutropenia was observed in 3 patients (20%).The DOF plus trastuzumab seems active in HER-2 positive advanced gastric or GEJ cancer, final results of the phase II study are awaited.
| Original language | English |
|---|---|
| Pages (from-to) | e10745 |
| Journal | Medicine |
| Volume | 97 |
| Issue number | 20 |
| DOIs | |
| Publication status | Published - May 2018 |
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Keywords
- Adenocarcinoma/drug therapy
- Administration, Intravenous
- Adult
- Antineoplastic Agents/administration & dosage
- Antineoplastic Combined Chemotherapy Protocols
- Disease-Free Survival
- Docetaxel
- Esophagogastric Junction/pathology
- Female
- Fluorouracil/administration & dosage
- Humans
- Kaplan-Meier Estimate
- Male
- Neoplasm Staging
- Organoplatinum Compounds/administration & dosage
- Oxaliplatin
- Receptor, ErbB-2/antagonists & inhibitors
- Stomach/pathology
- Stomach Neoplasms/drug therapy
- Taxoids/administration & dosage
- Trastuzumab/administration & dosage
Cite this
Docetaxel, oxaliplatin, 5FU, and trastuzumab as first-line therapy in patients with human epidermal receptor 2-positive advanced gastric or gastroesophageal junction cancer : Preliminary results of a phase II study. / Roviello, Giandomenico; Petrioli, Roberto; Nardone, Valerio; Rosellini, Pietro; Multari, Andrea Giovanni; Conca, Raffaele; Aieta, Michele.
In: Medicine, Vol. 97, No. 20, 05.2018, p. e10745.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Docetaxel, oxaliplatin, 5FU, and trastuzumab as first-line therapy in patients with human epidermal receptor 2-positive advanced gastric or gastroesophageal junction cancer
T2 - Preliminary results of a phase II study
AU - Roviello, Giandomenico
AU - Petrioli, Roberto
AU - Nardone, Valerio
AU - Rosellini, Pietro
AU - Multari, Andrea Giovanni
AU - Conca, Raffaele
AU - Aieta, Michele
PY - 2018/5
Y1 - 2018/5
N2 - The aim of this study is to report first preliminary results of patients enrolled in a phase II study that will investigate the activity and safety of docetaxel, oxaliplatin, and 5-fluorouracil (DOF) in combination with trastuzumab in human epidermal receptor-2 (HER-2) positive patients with advanced gastric or gastroesophageal junction (GEJ) cancer.Treatment consisted of docetaxel 70 mg/m combined with oxaliplatin 130 mg/m on day 1, and continuous infusion 5-fluorouracil mg/m days 1-5 plus trastuzumab at the standard dose on day 1, every 3 weeks for a maximum of 8 cycles.Fifteen patients were enrolled. The overall response rate was 60%. The median progression-free survival was 9.2 months (95% confidence interval [CI], 4.4-10.1 months) and the median overall survival was 19.4 months (95% CI, 8.9-21.1 months). Grade 3 neutropenia was observed in 3 patients (20%).The DOF plus trastuzumab seems active in HER-2 positive advanced gastric or GEJ cancer, final results of the phase II study are awaited.
AB - The aim of this study is to report first preliminary results of patients enrolled in a phase II study that will investigate the activity and safety of docetaxel, oxaliplatin, and 5-fluorouracil (DOF) in combination with trastuzumab in human epidermal receptor-2 (HER-2) positive patients with advanced gastric or gastroesophageal junction (GEJ) cancer.Treatment consisted of docetaxel 70 mg/m combined with oxaliplatin 130 mg/m on day 1, and continuous infusion 5-fluorouracil mg/m days 1-5 plus trastuzumab at the standard dose on day 1, every 3 weeks for a maximum of 8 cycles.Fifteen patients were enrolled. The overall response rate was 60%. The median progression-free survival was 9.2 months (95% confidence interval [CI], 4.4-10.1 months) and the median overall survival was 19.4 months (95% CI, 8.9-21.1 months). Grade 3 neutropenia was observed in 3 patients (20%).The DOF plus trastuzumab seems active in HER-2 positive advanced gastric or GEJ cancer, final results of the phase II study are awaited.
KW - Adenocarcinoma/drug therapy
KW - Administration, Intravenous
KW - Adult
KW - Antineoplastic Agents/administration & dosage
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Disease-Free Survival
KW - Docetaxel
KW - Esophagogastric Junction/pathology
KW - Female
KW - Fluorouracil/administration & dosage
KW - Humans
KW - Kaplan-Meier Estimate
KW - Male
KW - Neoplasm Staging
KW - Organoplatinum Compounds/administration & dosage
KW - Oxaliplatin
KW - Receptor, ErbB-2/antagonists & inhibitors
KW - Stomach/pathology
KW - Stomach Neoplasms/drug therapy
KW - Taxoids/administration & dosage
KW - Trastuzumab/administration & dosage
U2 - 10.1097/MD.0000000000010745
DO - 10.1097/MD.0000000000010745
M3 - Article
C2 - 29768350
VL - 97
SP - e10745
JO - Medicine; analytical reviews of general medicine, neurology, psychiatry, dermatology, and pediatries
JF - Medicine; analytical reviews of general medicine, neurology, psychiatry, dermatology, and pediatries
SN - 0025-7974
IS - 20
ER -