Randomized phase II trial of either fluorouracil, parenteral hydroxyurea, interferon-α-2a, and filgrastim or doxorubicin/docetaxel in patients with advanced gastric cancer with quality-of-life assessment: Eastern Cooperative Oncology Group study E6296

Scott Wadler, Carlos Brain, Paul Catalano, Avi Israel Einzig, David Cella, Al B. Benson

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

PURPOSE: The Eastern Cooperative Oncology Group conducted a randomized phase II trial to determine the objective response rates, toxicities, and overall survival and to assess effects on quality of life for two combination regimens in patients with advanced gastric cancer. PATIENTS AND METHODS: All patients had biopsy-proven, untreated metastatic gastric cancer with measurable disease. The FHIG arm employed infusional fluorouracil (F), 2.6 g/m2, given intravenously over 24 hours once per week for 6 weeks; infusional hydroxyurea (H), 4.3 g/m2, given intravenously over 24 hours once per week for 6 weeks; and interferon-α-2a (I), 9 MU given subcutaneously three times per week, once per week for 6 weeks. The AD arm employed doxorubicin (A), 50 mg/m2, and docetaxel (D), 75 mg/m2, both given intravenously every 21 days. Quality of life was measured by the FACT-Fatigue scale and a novel questionnaire assessing interferon-mediated fatigue. RESULTS: Twenty-nine patients were enrolled; 23 were eligible and evaluable. Twelve were enrolled on FHIG and 11 on AD. The major grade ≥ 3 toxicities were neuromotor (46%) in patients receiving FHIG and granulocytopenia (91%) in those receiving AD. There were two fatalities in the AD arm. There was one partial responder on FHIG (8.3%) and none on AD. The median survival was 6.6 months for FHIG and 10.1 months for AD. Quality-of-life analysis did not show substantial cumulative fatigue in patients treated with FHIG. CONCLUSIONS: Neither regimen demonstrated enough activity to serve as a platform for the development of further clinical regimens against gastric carcinoma. A subset of patients receiving interferon was able to tolerate therapy without deterioration in quality of life.

Original languageEnglish (US)
Pages (from-to)282-286
Number of pages5
JournalCancer Journal
Volume8
Issue number3
DOIs
StatePublished - Jun 1 2002

Fingerprint

docetaxel
Hydroxyurea
Fluorouracil
Doxorubicin
Interferons
Stomach Neoplasms
Quality of Life
Fatigue
Agranulocytosis
Survival
Filgrastim
Stomach
Carcinoma
Biopsy

Keywords

  • Docetaxel
  • Fatigue
  • Gastric cancer
  • Hydroxyurea
  • Interferon
  • Quality of life
  • Stomach cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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title = "Randomized phase II trial of either fluorouracil, parenteral hydroxyurea, interferon-α-2a, and filgrastim or doxorubicin/docetaxel in patients with advanced gastric cancer with quality-of-life assessment: Eastern Cooperative Oncology Group study E6296",
abstract = "PURPOSE: The Eastern Cooperative Oncology Group conducted a randomized phase II trial to determine the objective response rates, toxicities, and overall survival and to assess effects on quality of life for two combination regimens in patients with advanced gastric cancer. PATIENTS AND METHODS: All patients had biopsy-proven, untreated metastatic gastric cancer with measurable disease. The FHIG arm employed infusional fluorouracil (F), 2.6 g/m2, given intravenously over 24 hours once per week for 6 weeks; infusional hydroxyurea (H), 4.3 g/m2, given intravenously over 24 hours once per week for 6 weeks; and interferon-α-2a (I), 9 MU given subcutaneously three times per week, once per week for 6 weeks. The AD arm employed doxorubicin (A), 50 mg/m2, and docetaxel (D), 75 mg/m2, both given intravenously every 21 days. Quality of life was measured by the FACT-Fatigue scale and a novel questionnaire assessing interferon-mediated fatigue. RESULTS: Twenty-nine patients were enrolled; 23 were eligible and evaluable. Twelve were enrolled on FHIG and 11 on AD. The major grade ≥ 3 toxicities were neuromotor (46{\%}) in patients receiving FHIG and granulocytopenia (91{\%}) in those receiving AD. There were two fatalities in the AD arm. There was one partial responder on FHIG (8.3{\%}) and none on AD. The median survival was 6.6 months for FHIG and 10.1 months for AD. Quality-of-life analysis did not show substantial cumulative fatigue in patients treated with FHIG. CONCLUSIONS: Neither regimen demonstrated enough activity to serve as a platform for the development of further clinical regimens against gastric carcinoma. A subset of patients receiving interferon was able to tolerate therapy without deterioration in quality of life.",
keywords = "Docetaxel, Fatigue, Gastric cancer, Hydroxyurea, Interferon, Quality of life, Stomach cancer",
author = "Scott Wadler and Carlos Brain and Paul Catalano and Einzig, {Avi Israel} and David Cella and Benson, {Al B.}",
year = "2002",
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T1 - Randomized phase II trial of either fluorouracil, parenteral hydroxyurea, interferon-α-2a, and filgrastim or doxorubicin/docetaxel in patients with advanced gastric cancer with quality-of-life assessment

T2 - Eastern Cooperative Oncology Group study E6296

AU - Wadler, Scott

AU - Brain, Carlos

AU - Catalano, Paul

AU - Einzig, Avi Israel

AU - Cella, David

AU - Benson, Al B.

PY - 2002/6/1

Y1 - 2002/6/1

N2 - PURPOSE: The Eastern Cooperative Oncology Group conducted a randomized phase II trial to determine the objective response rates, toxicities, and overall survival and to assess effects on quality of life for two combination regimens in patients with advanced gastric cancer. PATIENTS AND METHODS: All patients had biopsy-proven, untreated metastatic gastric cancer with measurable disease. The FHIG arm employed infusional fluorouracil (F), 2.6 g/m2, given intravenously over 24 hours once per week for 6 weeks; infusional hydroxyurea (H), 4.3 g/m2, given intravenously over 24 hours once per week for 6 weeks; and interferon-α-2a (I), 9 MU given subcutaneously three times per week, once per week for 6 weeks. The AD arm employed doxorubicin (A), 50 mg/m2, and docetaxel (D), 75 mg/m2, both given intravenously every 21 days. Quality of life was measured by the FACT-Fatigue scale and a novel questionnaire assessing interferon-mediated fatigue. RESULTS: Twenty-nine patients were enrolled; 23 were eligible and evaluable. Twelve were enrolled on FHIG and 11 on AD. The major grade ≥ 3 toxicities were neuromotor (46%) in patients receiving FHIG and granulocytopenia (91%) in those receiving AD. There were two fatalities in the AD arm. There was one partial responder on FHIG (8.3%) and none on AD. The median survival was 6.6 months for FHIG and 10.1 months for AD. Quality-of-life analysis did not show substantial cumulative fatigue in patients treated with FHIG. CONCLUSIONS: Neither regimen demonstrated enough activity to serve as a platform for the development of further clinical regimens against gastric carcinoma. A subset of patients receiving interferon was able to tolerate therapy without deterioration in quality of life.

AB - PURPOSE: The Eastern Cooperative Oncology Group conducted a randomized phase II trial to determine the objective response rates, toxicities, and overall survival and to assess effects on quality of life for two combination regimens in patients with advanced gastric cancer. PATIENTS AND METHODS: All patients had biopsy-proven, untreated metastatic gastric cancer with measurable disease. The FHIG arm employed infusional fluorouracil (F), 2.6 g/m2, given intravenously over 24 hours once per week for 6 weeks; infusional hydroxyurea (H), 4.3 g/m2, given intravenously over 24 hours once per week for 6 weeks; and interferon-α-2a (I), 9 MU given subcutaneously three times per week, once per week for 6 weeks. The AD arm employed doxorubicin (A), 50 mg/m2, and docetaxel (D), 75 mg/m2, both given intravenously every 21 days. Quality of life was measured by the FACT-Fatigue scale and a novel questionnaire assessing interferon-mediated fatigue. RESULTS: Twenty-nine patients were enrolled; 23 were eligible and evaluable. Twelve were enrolled on FHIG and 11 on AD. The major grade ≥ 3 toxicities were neuromotor (46%) in patients receiving FHIG and granulocytopenia (91%) in those receiving AD. There were two fatalities in the AD arm. There was one partial responder on FHIG (8.3%) and none on AD. The median survival was 6.6 months for FHIG and 10.1 months for AD. Quality-of-life analysis did not show substantial cumulative fatigue in patients treated with FHIG. CONCLUSIONS: Neither regimen demonstrated enough activity to serve as a platform for the development of further clinical regimens against gastric carcinoma. A subset of patients receiving interferon was able to tolerate therapy without deterioration in quality of life.

KW - Docetaxel

KW - Fatigue

KW - Gastric cancer

KW - Hydroxyurea

KW - Interferon

KW - Quality of life

KW - Stomach cancer

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