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題 名 | A Randomized Trial Comparing Intravesical Instillations of Mitoxantrone and Doxorubicin in Patients with Superficial Bladder Cancer=隨機研究Mitoxantrone及Doxorubicin治療表淺性膀胱癌 |
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作 者 | 黃仁聖; 陳文祥; 林承家; 廖宗琦; 王正旭; 藍以政; 賴建宏; 劉仁沛; | 書刊名 | 長庚醫學 |
卷 期 | 26:2 2003.02[民92.02] |
頁 次 | 頁91-97 |
分類號 | 415.837 |
關鍵詞 | 膀胱癌; 膀胱化療灌注; Bladder cancer; Intravesical chemotherapy; Mitoxantrone; Doxorubicin; |
語 文 | 英文(English) |
中文摘要 | 背景:這是個隨機研究比較Mitoxantrone及Doxorubicin兩種藥物在膀胱灌注的效果及副作用。 方法:63位表淺性膀胱癌病患手術後,隨機分配接受Mitoxantrone 14mg或Doxorubicin 30mg作膀胱灌注。大多數的病人均為老年人(平均年齡71歲)。我們用Fisher’s exact test比較兩種藥物的效果及副作用,用long-rank test比較二者發生復發的時間,並用Kaplan-Meir的圖形表示。 結果:追蹤期的中位數為36個月,其中33位接受Mitoxantrone,其復發率為27.3%(95% C.I.: 17.5-36.8%),無疾病復發存活期的中位數為22個月,其他30位接受Doxorubicin,其復發率為30% (95% C.I.:19.8-38.8%),無疾病復發存活期的中位數為20個月。雖然Mitoxantrone之復發率較低(p=0.784)及發生復發時間較長(p=0.580),但二者之差別並沒有達到統計意義;而分化度為Grade III或多發性原發位腫瘤較容易復發。膀胱灌注的副作用包括血尿、頻尿、解尿疼痛及泌尿道感染,其中Mitoxantrone副作用的發生率為21.2%,而Doxorubicin則為20%,但二者之差別也無統計意義(p>0.99)。 結論:膀胱化療灌注的確可降低復發率,而Mitoxantrone及Mitoxantrone二者在治療效果及副作用都差不多。對於肺結核好發區或不適合BCG膀胱灌注的病人,這二項藥物可考慮選擇。 |
英文摘要 | Background: This randomized trial was conducted to compare the efficacy and side effects of intravesical mitoxantrone instillation with those of doxorubicin in superficial bladder cancer following transurethral resection. Methods: Sixty-three patients were randomized into motoxantrone and doxorubicin groups. Most of the patients enrolled were elderly people (mean age, 71 years). The instilled doses of doxorubicin and mitoxantrone were 30 and 14mg, respectively. Disease recurrence and side effects wee compared using Fisher’s exact test. The interval to recurrence was shown by Kaplan-Meier survivorship curves, and the log-rank test was used to compare the time to recurrence. Results: The median follow-up period was 36 months. Thirty-three patients received mitoxantrone, whereas 30 patients used doxorubicin. The recurrence rate in the doxorubicin group was 30% (95% CI: 19.8%-38.8%), WHILE IT WAS 27.3% (95% CI: 17.5%-36.8%) in the mitoxantrone group. The median recurrence free survival in the mitoxantrone group and in the doxorubicin group was 22 and 20 months, respectively (p=0.580). Higher recurrence rates were found for Grade III and multiple primary tumors. There was no significant difference in response rates (p=0.784). The incidence of side effects was 20% in the doxorubicin group and 21.2% in the mitoxantrone group. However, the difference was not significant (p>0.99). Conclusions: The results revealed that the efficacy and side effects of mitoxantronewere similar to those of doxorubicin. Especially for patients with pulmonary tuberculosis or aged patients with primary bladder tumors, mitoxantrone and doxorubicin may be the tolerable and effective intravesical agents. |
本系統中英文摘要資訊取自各篇刊載內容。