Phase II trial of 5-fluorouracil and low-dose cisplatin in patients with squamous cell carcinoma of the esophagus |
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Authors: | Hiroyuki Sekiguchi Seiji Akiyama Michitaka Fujiwara Hajime Nakamura Ken Kondo Yasushi Kasai Katsuki Ito Junichi Sakamoto Hiroshi Takagi |
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Institution: | (1) Department of Surgery II, Nagoya University School of Medicine, 65 Tsuruma-cho, Showa-ku, 466 Nagoya, Aichi, Japan;(2) Department of Surgery, Aichi Prefectural Hospital, 18 Kakemachi, Kuriyado, 444 Okazaki, Japan |
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Abstract: | A phase II study was conducted to determine the clinical efficacy and toxicity of 5-fluorouracil (5-FU) and low-dose cisplatin
(CDDP) in patients with squamous cell carcinoma of the esophagus. Chemotherapy consisted of 5-FU at a dose of 330 mg/m2 per day, given as a 24-h infusion on days 1–7, and CDDP at a dose of 6 mg/m2 per day, given as a 2-h infusion on days 1–5. Either two or four cycles of chemotherapy were administered to 20 patients
with stage III advanced esophageal carcinoma. All 20 patients were then assessed for response and toxicity. An objective response
was demonstrated by 11 of the 20 patients, with one complete response (CR) and ten partial responses (PR), bringing the response
rate to 55%, with a 95% confidence interval of 27% to 83%. Surgical resection of the tumor was performed in all 20 patients.
One patient was found to have a grade 3 histological CR. The median survival of all the patients was 20.5 months, with a range
of 4.5 to 48.0 months. Neutropenia and thrombocytopenia developed in five (25%) and two (10%) patients, respectively, and
the nonhematologic toxicities were insignificant. The findings of this phase II study indicate that preoperative treatment
using 5-FU and low-dose CDDP chemotherapy for patients with advanced esophageal carcinoma appears to achieve a high response
rate after shortterm administration without affecting the quality of sophisticated lymph node dissection. |
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Keywords: | esophageal carcinoma preoperative chemotherapy biochemical modulation |
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