Phase II study of weekly paclitaxel and capecitabine in patients with metastatic or recurrent esophageal squamous cell carcinoma

Tak Yun, Ji-Youn Han, Jin Soo Lee, Hyun Lee Choi, Hyae Young Kim, Byung-Ho Nam, Heung Tae Kim, Tak Yun, Ji-Youn Han, Jin Soo Lee, Hyun Lee Choi, Hyae Young Kim, Byung-Ho Nam, Heung Tae Kim

Abstract

Background: This phase II study assessed the response rate and toxicity profile of weekly paclitaxel and capecitabine in patients with metastatic or recurrent squamous cell carcinoma of the esophagus (SCCE) METHODS: Patients with histologically confirmed SCCE were treated with paclitaxel 80 mg/m(2) intravenously on days 1 and 8 plus capecitabine 900 mg/m(2) orally twice a day on days 1-14. Treatment cycles were repeated every 3 weeks until disease progression or unacceptable toxicity.

Results: Between 2006 and 2009, 32 patients were enrolled. Twelve patients were chemotherapy-naïve. Twenty patients had received prior chemotherapy including platinum-based regimens. Patients received a median of 5 cycles of treatment (range, 1-12). The response rate was 75% (95%CI; 50.5~99.5%) in the first-line and 45% (95%CI; 26.9~73.1%) in the second-line. With a median follow-up of 20.7 months, median progression-free survival was 5.2 months (95% CI, 4.0 to 6.4) for all patients and median overall survival (OS) was 11.7 months (95% CI, 5.5 to 18.0) for all patients. The median OS was 14.3 months (95% CI, 10.6 to 18.0) for patients receiving therapy as 1st line and 8.4 months (95% CI, 6.6 to 10.1) for those receiving as 2nd-line therapy. Grade 3/4 neutropenia was observed in 53.3% of the patients, which was the most common cause of dose reduction. G3 non-hematologic toxicity included stomatitis (9.4%), asthenia (6.3%), and hand-foot skin reaction (3.1%).

Conclusions: Weekly paclitaxel and capecitabine is a highly active and well-tolerated regimen in patients with metastatic or recurrent SCCE in the first-line as well as second-line setting.

Trial registration: ClinicalTrials.gov NCT00453323.

Figures

Figure 1
Figure 1
Kaplan-Meier curve of progression free survival for patients treated as 1st line and 2nd line therapy.
Figure 2
Figure 2
Kaplan-Meier curve of overall survival for patients treated as 1st line and 2nd line therapy.

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