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

Giandomenico Roviello, Roberto Petrioli, Valerio Nardone, Pietro Rosellini, Andrea Giovanni Multari, Raffaele Conca, Michele Aieta

Research output: Contribution to journalArticle

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 languageEnglish
Pages (from-to)e10745
JournalMedicine
Volume97
Issue number20
DOIs
Publication statusPublished - May 2018

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oxaliplatin
docetaxel
Esophagogastric Junction
Fluorouracil
Stomach
Neoplasms
Confidence Intervals
Therapeutics
Neutropenia
Disease-Free Survival
Safety
Survival
Trastuzumab

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

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title = "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",
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.",
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",
author = "Giandomenico Roviello and Roberto Petrioli and Valerio Nardone and Pietro Rosellini and Multari, {Andrea Giovanni} and Raffaele Conca and Michele Aieta",
year = "2018",
month = "5",
doi = "10.1097/MD.0000000000010745",
language = "English",
volume = "97",
pages = "e10745",
journal = "Medicine; analytical reviews of general medicine, neurology, psychiatry, dermatology, and pediatries",
issn = "0025-7974",
publisher = "Lippincott Williams and Wilkins",
number = "20",

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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 -