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Clinical Trial
. 2011 Jun;6(6):1121-7.
doi: 10.1097/JTO.0b013e31821529a9.

Preoperative taxane-based chemotherapy and celecoxib for carcinoma of the esophagus and gastroesophageal junction: results of a phase 2 trial

Nasser K Altorki  1 , Paul Christos, Jeff L Port, Paul C Lee, Farooq Mirza, Cathy Spinelli, Roger Keresztes, Debra Beneck, Subroto Paul, Brendon M Stiles, Yuwei Zhang, David S Schrump
Affiliations
Clinical Trial

Preoperative taxane-based chemotherapy and celecoxib for carcinoma of the esophagus and gastroesophageal junction: results of a phase 2 trial

Nasser K Altorki et al. J Thorac Oncol. 2011 Jun.

Abstract

Purpose: The primary objective of this study was to determine the rate of pathological response after preoperative celecoxib and concurrent taxane-based chemotherapy in patients with cancer of the esophagus and gastroesophageal junction.

Methods: Thirty-nine patients were enrolled in this single-arm, phase II clinical trial. Patients were administered daily celecoxib in combination with two to three cycles of carboplatin and paclitaxel with preoperative intent. Levels of cyclooxygenase (COX)-2 expression in resected tumors were analyzed by immunohistochemistry and correlated with clinical outcome measures. Postoperatively, patients were administered daily celecoxib for 1 year or until documented tumor recurrence.

Results: All patients received two to three cycles of chemotherapy plus celecoxib 800 mg/d. Toxicities were as expected. A major clinical response (complete response + partial response) was noted in 22 patients (56%); six patients (15%) had a complete clinical response. Thirty-seven patients underwent esophagectomy. Five patients had a major pathological response (12.8%). Four-year overall and disease-free survivals were 40.9% and 30.3%, respectively. Patients with tumors expressing COX-2 demonstrated a higher likelihood of a major clinical response response (62% versus 50%) and an improved overall survival, compared with patients with COX-2-negative tumors.

Conclusions: Preoperative celecoxib with concurrent chemotherapy demonstrated sufficient effect on pathologic response to warrant further study. Patients with tumors expressing COX-2 demonstrated trends toward improved response to preoperative therapy and improved overall survival compared with nonexpressors.

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Figures

FIGURE 1.
FIGURE 1.
Overall survival (OS) for the entire cohort. N = 39 patients, 25 deaths. Median OS time 31.1 months (95% confidence interval [CI] = 18.5–59.4). Four-year OS = 40.9% (95% CI = 25.5–55.7%).
FIGURE 2.
FIGURE 2.
Disease-free survival (DFS) for the entire cohort. N = 39 patients, 28 recurrences or deaths. Median DFS = 24.0 months (95% confidence interval [CI] = 13.0–37.7 months). Four-year DFS = 30.3% (95% CI = 16.7–45.0%).
FIGURE 3.
FIGURE 3.
Overall survival (OS) comparison between expressors and nonexpressors of cyclooxygenase (COX)-2. No expression: N = 14 patients, 11 deaths. Median OS time = 26.2 months (95% confidence interval [CI] = 12.1–43.7). Four-year OS = 21.4% (95% CI = 5.2–44.8%). Expression: N = 21 patients, 12 deaths. Median OS time = 38.1 months (95% CI = 17.0, not estimated). Four-year OS = 47.6% (95% CI = 25.7–66.7%).
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References

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