Epirubicin in rectal cancer.

J Moreno Nogueira, E Murillo, A Duque, J Jimeno, L Iglesias, F Romero, M Codes, X Bona
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Abstract

Taking into account previous results with epirubicin in colorectal cancer, in January, 1985, an oriented Phase II trial was started in patients with measurable rectal cancer, previously untreated with chemotherapy. Ten patients were treated with 80 mg/m2 every 3 weeks, and another 10 patients with 100 mg/m2 every 3 weeks. One patient from the 80 mg/m2 group and 3 from the 100 mg/m2 group reached partial remission for 4, 9+, 15 and 72+ weeks. Median survival for all patients was 16 months. Hematological toxicity was not a limiting factor. Anemia was significantly more frequent in the higher dose group; clinical cardiotoxicity was not observed. The incidences of nausea/vomiting and mucositis were low. Considering the low toxicity and the responses observed, additional studies seem to be indicated with an increase in the epirubicin dose.

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表柔比星在直肠癌中的作用。
考虑到表柔比星治疗结直肠癌的既往结果,1985年1月,一项定向II期试验在未接受化疗的可测量的直肠癌患者中开始。10例患者每3周给药80 mg/m2, 10例患者每3周给药100 mg/m2。80 mg/m2组的1例患者和100 mg/m2组的3例患者在4周、9周、15周和72周以上达到部分缓解。所有患者的中位生存期为16个月。血液毒性不是限制因素。高剂量组贫血发生率明显增高;未观察到临床心脏毒性。恶心/呕吐和黏膜炎的发生率较低。考虑到低毒性和观察到的反应,进一步的研究似乎表明增加表阿霉素的剂量。
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