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

Abstract

BackgroundThis 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)MethodsPatients with histologically confirmed SCCE were treated with paclitaxel 80 mg/m2 intravenously on days 1 and 8 plus capecitabine 900 mg/m2 orally twice a day on days 1-14. Treatment cycles were repeated every 3 weeks until disease progression or unacceptable toxicity.ResultsBetween 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%).ConclusionsWeekly 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.

Nanoparticle albumin-bound paclitaxel combined with cisplatin as the first-line treatment for metastatic esophageal squamous cell carcinoma

“…The most common toxicity related to DDP was nausea/vomiting, as expected. Hematological toxicity, especially myelosuppression, was slighter compared with previous studies on taxane-based regimens in esophageal cancer 5,26. Only four patients experienced grade 3 adverse events.…”

“…Thus, it is important to find effective regimens for metastatic ESCC. It is reported that taxane-based regimens have demonstrated high clinical activities and survival advantages in metastatic ESCC,26–31 and it was hypothesized that replacing PTX with solvent-free Nab-PTX might provide even better clinical benefits to patients with metastatic ESCC. Therefore, in this study, a novel formulation of Nab-PTX was explored for combination with DDP as a first-line regimen for patients with metastatic ESCC.…”

Phase II Study of S-1 plus Cisplatin as First-Line Therapy in Patients with Metastatic Esophageal Carcinoma

“…In a phase II study, combined weekly paclitaxel and capecitabine proved to be a highly active regimen with a PFS of 5.23 months and an OS of 14.3 months. However, the cohort size was small with only 12 patients in the first-line setting [29]. Although direct comparisons are difficult across several trials due to different clinicopathologic patient characteristics, our study shows comparable efficacy and outcomes, especially the competitive median OS of 1 year, which has rarely been exceeded for metastatic ESCC despite the improvements in chemotherapy regimens and supportive care.…”

A Phase II Study of Temozolomide in Patients with Advanced Aerodigestive Tract and Colorectal Cancers and Methylation of theO6-Methylguanine-DNA Methyltransferase Promoter

“…38-40) or second-line paclitaxel and capecitabine (45%; ref. 41). As such, the role of temozolomide monotherapy for CRC and esophageal cancer seems limited.…”