Journal
JOURNAL OF THORACIC ONCOLOGY
Volume 3, Issue 5, Pages 516-520Publisher
ELSEVIER SCIENCE INC
DOI: 10.1097/JTO.0b013e31816de276
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Funding
- NCI NIH HHS [U10 CA037404, U10 CA035103, U10 CA060276, N01 CA035119, CA-35090, CA-25224, N01 CA015083, CA-63849, CA-35267, CA-15083, CA-60276, U10 CA035267, CA-35113, U10 CA035431, CA-35269, U10 CA035090, U10 CA037417, N01 CA035431, U10 CA035269, CA-37404, U10 CA063848, U10 CA035195, CA-35103, U10 CA035113, P30 CA015083, CA-52654, CA-63848, U10 CA063849, U10 CA035119, CA-37417, U10 CA052654, U10 CA025224, CA-35195] Funding Source: Medline
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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(2) on days 1, 4, and 8; paclitaxel 175 mg/m(2) 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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