Abstract
Purpose
We aimed to evaluate the safety, tolerability, and efficacy of combination preoperative chemoradiotherapy as first-line treatment in patients with advanced esophageal cancer.
Methods
We performed a phase I dose-escalation trial of docetaxel at 25–40 mg/m2 in four planned dose levels in 3–6 patient cohorts on days 1, 15, 29, and 43 administered in combination with cisplatin (70 mg/m2 on days 1 and 29) and 5-fluorouracil (70 mg/m2/day on days 1–4 and 29–32) and concurrent radiation therapy (40 Gy). The tumors were resected during weeks 10–13.
Results
This study included 7 patients with esophageal cancer. The dose-limiting toxicity was observed at a biweekly docetaxel dose of 30 mg/m2 when patients developed grade 3 febrile neutropenia, grade 4 thrombocytopenia, and grade 4 pain/esophagus, resulting in a maximum tolerated dose of 25 mg/m2. Grade 3/4 hematological toxicity was observed in 71% of the patients and grade 3/4 non-hematological toxicity in 57%. The overall tumor response rate was 86% (complete, 57% and partial, 29%). All patients underwent surgery, and there were no deaths as a result of postoperative complications.
Conclusions
This preoperative chemoradiotherapy regimen using triplets is feasible but results in moderate toxicity. It is noteworthy that this regimen was associated with a high rate of pathological complete remission.
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Emi, M., Hihara, J., Hamai, Y. et al. Neoadjuvant chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil for esophageal cancer. Cancer Chemother Pharmacol 69, 1499–1505 (2012). https://doi.org/10.1007/s00280-012-1853-7
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DOI: https://doi.org/10.1007/s00280-012-1853-7