Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: A Southwest Oncology Group (SWOG) trialT

Stephen K. Williamson, Sheryl A. McCoy, David R. Gandara, Shaker R. Dakhil, Kathleen J. Yost, Jorge C. Paradelo, James N. Atkins, Charles Blanke, James L. Abbruzzese

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

OBJECTIVES: Metastatic esophageal carcinoma is an incurable disease with median survival duration of 6 to 8 months. Based on preclinical data suggesting a dose-dependent synergy between gemcitabine and irinotecan we have conducted a phase II trial in patients with advanced or metastatic esophageal carcinoma. METHODS: Patient eligibility included a diagnosis of squamous cell or adenocarcinoma of the esophagus/gastroesophageal (GE) junction, metastatic or recurrent disease, no CNS metastasis, no prior chemotherapy, prior adjuvant/neoadjuvant chemotherapy was allowed, no prior gemcitabine or irinotecan, performance status of 0 to 2 and adequate organ function. Patients received gemcitabine 1000 mg/m and irinotecan 100 mg/m given day 1 and day 8, every 3 weeks. The primary end point was the 6-month survival rate. The secondary end point was to assess qualitative and quantitative toxicities. RESULTS: Fifty-seven eligible patients were accrued. There were 4 treatment-related deaths. The primary grade 3 to 4 toxic events were diarrhea, dehydration, neutropenia, thrombocytopenia, anemia, and anorexia; and 4 episodes of grade 3 to 5 febrile neutropenia, 1 fatal. The study was designed to detect a difference between the null hypothesis of 30% 6-month survival and the alternative hypothesis of 50% 6-month survival. The Kaplan-Meier estimate of 6-month survival is 56% (95% CI: 43-69%), with a median of 6.3 months. The median time to progression was 3.7 months. The 6-month progression-free survival estimate is 25% (95% CI: 13-36%). CONCLUSIONS: The length of survival suggests that this combination has benefit similar to platinum containing regimens, however, the toxicity is substantial and is unlikely to prove superior to platinum containing regimens.

Original languageEnglish (US)
Pages (from-to)116-122
Number of pages7
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume29
Issue number2
DOIs
StatePublished - Apr 2006

Fingerprint

irinotecan
gemcitabine
Esophageal Neoplasms
Survival
Platinum
Carcinoma
Esophagogastric Junction
Febrile Neutropenia
Poisons
Central Nervous System Diseases
Kaplan-Meier Estimate
Anorexia
Adjuvant Chemotherapy
Neutropenia
Dehydration
Thrombocytopenia
Disease-Free Survival
Anemia
Diarrhea
Survival Rate

Keywords

  • Esophageal carcinoma
  • Gemcitabine
  • Irinotecan
  • Phase 2

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer : A Southwest Oncology Group (SWOG) trialT. / Williamson, Stephen K.; McCoy, Sheryl A.; Gandara, David R.; Dakhil, Shaker R.; Yost, Kathleen J.; Paradelo, Jorge C.; Atkins, James N.; Blanke, Charles; Abbruzzese, James L.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 29, No. 2, 04.2006, p. 116-122.

Research output: Contribution to journalArticle

Williamson, Stephen K. ; McCoy, Sheryl A. ; Gandara, David R. ; Dakhil, Shaker R. ; Yost, Kathleen J. ; Paradelo, Jorge C. ; Atkins, James N. ; Blanke, Charles ; Abbruzzese, James L. / Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer : A Southwest Oncology Group (SWOG) trialT. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2006 ; Vol. 29, No. 2. pp. 116-122.
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T1 - Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer

T2 - A Southwest Oncology Group (SWOG) trialT

AU - Williamson, Stephen K.

AU - McCoy, Sheryl A.

AU - Gandara, David R.

AU - Dakhil, Shaker R.

AU - Yost, Kathleen J.

AU - Paradelo, Jorge C.

AU - Atkins, James N.

AU - Blanke, Charles

AU - Abbruzzese, James L.

PY - 2006/4

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N2 - OBJECTIVES: Metastatic esophageal carcinoma is an incurable disease with median survival duration of 6 to 8 months. Based on preclinical data suggesting a dose-dependent synergy between gemcitabine and irinotecan we have conducted a phase II trial in patients with advanced or metastatic esophageal carcinoma. METHODS: Patient eligibility included a diagnosis of squamous cell or adenocarcinoma of the esophagus/gastroesophageal (GE) junction, metastatic or recurrent disease, no CNS metastasis, no prior chemotherapy, prior adjuvant/neoadjuvant chemotherapy was allowed, no prior gemcitabine or irinotecan, performance status of 0 to 2 and adequate organ function. Patients received gemcitabine 1000 mg/m and irinotecan 100 mg/m given day 1 and day 8, every 3 weeks. The primary end point was the 6-month survival rate. The secondary end point was to assess qualitative and quantitative toxicities. RESULTS: Fifty-seven eligible patients were accrued. There were 4 treatment-related deaths. The primary grade 3 to 4 toxic events were diarrhea, dehydration, neutropenia, thrombocytopenia, anemia, and anorexia; and 4 episodes of grade 3 to 5 febrile neutropenia, 1 fatal. The study was designed to detect a difference between the null hypothesis of 30% 6-month survival and the alternative hypothesis of 50% 6-month survival. The Kaplan-Meier estimate of 6-month survival is 56% (95% CI: 43-69%), with a median of 6.3 months. The median time to progression was 3.7 months. The 6-month progression-free survival estimate is 25% (95% CI: 13-36%). CONCLUSIONS: The length of survival suggests that this combination has benefit similar to platinum containing regimens, however, the toxicity is substantial and is unlikely to prove superior to platinum containing regimens.

AB - OBJECTIVES: Metastatic esophageal carcinoma is an incurable disease with median survival duration of 6 to 8 months. Based on preclinical data suggesting a dose-dependent synergy between gemcitabine and irinotecan we have conducted a phase II trial in patients with advanced or metastatic esophageal carcinoma. METHODS: Patient eligibility included a diagnosis of squamous cell or adenocarcinoma of the esophagus/gastroesophageal (GE) junction, metastatic or recurrent disease, no CNS metastasis, no prior chemotherapy, prior adjuvant/neoadjuvant chemotherapy was allowed, no prior gemcitabine or irinotecan, performance status of 0 to 2 and adequate organ function. Patients received gemcitabine 1000 mg/m and irinotecan 100 mg/m given day 1 and day 8, every 3 weeks. The primary end point was the 6-month survival rate. The secondary end point was to assess qualitative and quantitative toxicities. RESULTS: Fifty-seven eligible patients were accrued. There were 4 treatment-related deaths. The primary grade 3 to 4 toxic events were diarrhea, dehydration, neutropenia, thrombocytopenia, anemia, and anorexia; and 4 episodes of grade 3 to 5 febrile neutropenia, 1 fatal. The study was designed to detect a difference between the null hypothesis of 30% 6-month survival and the alternative hypothesis of 50% 6-month survival. The Kaplan-Meier estimate of 6-month survival is 56% (95% CI: 43-69%), with a median of 6.3 months. The median time to progression was 3.7 months. The 6-month progression-free survival estimate is 25% (95% CI: 13-36%). CONCLUSIONS: The length of survival suggests that this combination has benefit similar to platinum containing regimens, however, the toxicity is substantial and is unlikely to prove superior to platinum containing regimens.

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KW - Gemcitabine

KW - Irinotecan

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