Bortezomib, paclitaxel, and carboplatin as a first-line regimen for patients with metastatic esophageal, gastric, and gastroesophageal cancer: Phase II results from the north central cancer treatment group (N044B)

Aminah Jatoi, Shaker R. Dakhil, Nathan R. Foster, Cynthia Ma, Kendrith M. Rowland, Dennis F. Moore, Anthony J. Jaslowski, Sachdev P. Thomas, Mark D. Hauge, Patrick J. Flynn, Philip J. Stella, Steven Robert Alberts

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Abstract

PURPOSE: This study was undertaken to explore the response rate of a first-line, three-drug regimen that consisted of bortezomib, paclitaxel, and carboplatin in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia. PATIENTS AND METHODS: Patients with the above diagnosis and acceptable organ function were treated intravenously on a 21-day cycle with the following: bortezomib 1.2 mg/m on days 1, 4, and 8; paclitaxel 175 mg/m on day 2; and carboplatin with an area under the curve of 6 on day 2. Patients received indefinite treatment unless they manifested tumor progression or severe adverse events. All were monitored for tumor response as well as other clinical outcomes. RESULTS: The cohort included 35 eligible patients with a median age of 59 years (range, 36-78) and an Eastern Cooperative Oncology Group performance score of 0, 1, and 2 in 60%, 34%, and 6% of patients, respectively. Although this regimen was well tolerated, the tumor response rate was lower than that anticipated at 23% (95% confidence interval: 10%, 40%), thereby prompting premature study closure. There were no complete responses. The median survival for the cohort was 8.9 months (95% confidence interval: 5.9, 12.8). CONCLUSION: As prescribed in this trial and for this indication, this regimen does not merit further testing.

Original languageEnglish (US)
Pages (from-to)516-520
Number of pages5
JournalJournal of Thoracic Oncology
Volume3
Issue number5
DOIs
StatePublished - May 2008

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Carboplatin
Paclitaxel
Stomach Neoplasms
Neoplasms
Confidence Intervals
Therapeutics
Esophagogastric Junction
Cardia
Area Under Curve
Stomach
Bortezomib
Survival
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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Bortezomib, paclitaxel, and carboplatin as a first-line regimen for patients with metastatic esophageal, gastric, and gastroesophageal cancer : Phase II results from the north central cancer treatment group (N044B). / Jatoi, Aminah; Dakhil, Shaker R.; Foster, Nathan R.; Ma, Cynthia; Rowland, Kendrith M.; Moore, Dennis F.; Jaslowski, Anthony J.; Thomas, Sachdev P.; Hauge, Mark D.; Flynn, Patrick J.; Stella, Philip J.; Alberts, Steven Robert.

In: Journal of Thoracic Oncology, Vol. 3, No. 5, 05.2008, p. 516-520.

Research output: Contribution to journalArticle

Jatoi, Aminah ; Dakhil, Shaker R. ; Foster, Nathan R. ; Ma, Cynthia ; Rowland, Kendrith M. ; Moore, Dennis F. ; Jaslowski, Anthony J. ; Thomas, Sachdev P. ; Hauge, Mark D. ; Flynn, Patrick J. ; Stella, Philip J. ; Alberts, Steven Robert. / Bortezomib, paclitaxel, and carboplatin as a first-line regimen for patients with metastatic esophageal, gastric, and gastroesophageal cancer : Phase II results from the north central cancer treatment group (N044B). In: Journal of Thoracic Oncology. 2008 ; Vol. 3, No. 5. pp. 516-520.
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abstract = "PURPOSE: This study was undertaken to explore the response rate of a first-line, three-drug regimen that consisted of bortezomib, paclitaxel, and carboplatin in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia. PATIENTS AND METHODS: Patients with the above diagnosis and acceptable organ function were treated intravenously on a 21-day cycle with the following: bortezomib 1.2 mg/m on days 1, 4, and 8; paclitaxel 175 mg/m on day 2; and carboplatin with an area under the curve of 6 on day 2. Patients received indefinite treatment unless they manifested tumor progression or severe adverse events. All were monitored for tumor response as well as other clinical outcomes. RESULTS: The cohort included 35 eligible patients with a median age of 59 years (range, 36-78) and an Eastern Cooperative Oncology Group performance score of 0, 1, and 2 in 60{\%}, 34{\%}, and 6{\%} of patients, respectively. Although this regimen was well tolerated, the tumor response rate was lower than that anticipated at 23{\%} (95{\%} confidence interval: 10{\%}, 40{\%}), thereby prompting premature study closure. There were no complete responses. The median survival for the cohort was 8.9 months (95{\%} confidence interval: 5.9, 12.8). CONCLUSION: As prescribed in this trial and for this indication, this regimen does not merit further testing.",
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T1 - Bortezomib, paclitaxel, and carboplatin as a first-line regimen for patients with metastatic esophageal, gastric, and gastroesophageal cancer

T2 - Phase II results from the north central cancer treatment group (N044B)

AU - Jatoi, Aminah

AU - Dakhil, Shaker R.

AU - Foster, Nathan R.

AU - Ma, Cynthia

AU - Rowland, Kendrith M.

AU - Moore, Dennis F.

AU - Jaslowski, Anthony J.

AU - Thomas, Sachdev P.

AU - Hauge, Mark D.

AU - Flynn, Patrick J.

AU - Stella, Philip J.

AU - Alberts, Steven Robert

PY - 2008/5

Y1 - 2008/5

N2 - PURPOSE: This study was undertaken to explore the response rate of a first-line, three-drug regimen that consisted of bortezomib, paclitaxel, and carboplatin in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia. PATIENTS AND METHODS: Patients with the above diagnosis and acceptable organ function were treated intravenously on a 21-day cycle with the following: bortezomib 1.2 mg/m on days 1, 4, and 8; paclitaxel 175 mg/m on day 2; and carboplatin with an area under the curve of 6 on day 2. Patients received indefinite treatment unless they manifested tumor progression or severe adverse events. All were monitored for tumor response as well as other clinical outcomes. RESULTS: The cohort included 35 eligible patients with a median age of 59 years (range, 36-78) and an Eastern Cooperative Oncology Group performance score of 0, 1, and 2 in 60%, 34%, and 6% of patients, respectively. Although this regimen was well tolerated, the tumor response rate was lower than that anticipated at 23% (95% confidence interval: 10%, 40%), thereby prompting premature study closure. There were no complete responses. The median survival for the cohort was 8.9 months (95% confidence interval: 5.9, 12.8). CONCLUSION: As prescribed in this trial and for this indication, this regimen does not merit further testing.

AB - PURPOSE: This study was undertaken to explore the response rate of a first-line, three-drug regimen that consisted of bortezomib, paclitaxel, and carboplatin in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia. PATIENTS AND METHODS: Patients with the above diagnosis and acceptable organ function were treated intravenously on a 21-day cycle with the following: bortezomib 1.2 mg/m on days 1, 4, and 8; paclitaxel 175 mg/m on day 2; and carboplatin with an area under the curve of 6 on day 2. Patients received indefinite treatment unless they manifested tumor progression or severe adverse events. All were monitored for tumor response as well as other clinical outcomes. RESULTS: The cohort included 35 eligible patients with a median age of 59 years (range, 36-78) and an Eastern Cooperative Oncology Group performance score of 0, 1, and 2 in 60%, 34%, and 6% of patients, respectively. Although this regimen was well tolerated, the tumor response rate was lower than that anticipated at 23% (95% confidence interval: 10%, 40%), thereby prompting premature study closure. There were no complete responses. The median survival for the cohort was 8.9 months (95% confidence interval: 5.9, 12.8). CONCLUSION: As prescribed in this trial and for this indication, this regimen does not merit further testing.

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