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中華民國泌尿科醫學會雜誌

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篇名 Phase II Clinical Trial of Monthly Triptorelin Injection for Prostate Cancer
卷期 8:1
並列篇名 每月注射Triptorelin治療前列腺癌—第二相臨床試驗
作者 蒲永孝陳淳賴明坤吳桂麗周怡君謝德生蔡崇璋
頁次 7-13
關鍵字 前列腺癌荷爾蒙治療前列腺特異抗原促性腺激素prostate neoplasmshormone therapyprostate specific antigengonadotropin-releasing hormoneTSCI
出刊日期 199703

中文摘要

本研究是一個第二相臨床試驗,收納了10名前列腺癌病人並給予每個月3.75毫克triptorelin之肌肉注射,觀察其抑制腫瘤進行之效果及副作用。在給予第一劑triptorelin之前,每位病人先接受一至三週之抗男性荷爾蒙治療,以壓制可能發生之初期症狀惡化現象。結果有一名病人在研究期間死於癌瘤之擴散,表示治療失敗。另外9名病人在觀察期間(6至10個月)都存活良好。根據修改過的美東癌症合作組織腫瘤反應標準及前列腺特異抗原標準(其中2名為全緩解,3名為部份緩解)。除了一名治療失敗之病人以外,其餘9人之前列腺特異抗原都有8週以上50%以上的降低,其範圍由90%至100%。這9名病人之卡諾夫斯基活動指數(Karnofsky performance status) 都獲得改善或穩定。7名病人完成了治療前後各種性荷爾蒙值之測定,其中5人之黃體素及睪丸酮在2至3個月之治療後,呈現大幅壓抑之效果,而另外2人沒有明顯的降低,雖然如此,這2人的前列腺特異抗原仍有90%及100%之降低。在10病人中僅有2人之骨骼轉移病灶在同位素骨骼攝影中呈現減少或消失。經過6個月之治療後,所有存活之9名病人都呈現性無能之狀態。有一人抱怨有臉部潮紅,手腳浮腫,夜盜汗及頭暈,而被視為典型的不良反應,總結來說,每月注射triptorelin可以有效地抑制前列腺癌細胞之擴散且副作用極輕微。

英文摘要

Ten patients with prostate adenocarcinoma entered into the phase II clinical trial and treated with monthly intramuscular 3.75 mg triptorelin injection to assess its efficacy in suppressing tunmor progression and side effects. All patients were given one to three weeks of antiandrogen to inhibit the possible flare-up by the initiation of triptorelin. In results, one patient died of disseminated prostate cancer in the study period, indicating treatment failure. The other 9 patients alive after 6 to 10 months of treatment were considered as being responders by the modified Eastern Cooperative Oncology Group Tumor Response Criteria and prostate specific antigen (PSA) criteria. Of the 6 patients with measurable lesions, 5 had objective response (2 CR and 3 PR). All but the case of failure had more than 50% PSA reduction (range:90% to 100%) for 8 weeks or more. All the 9 responding patients had improvement or stabilization of the Karnofsky performance status. Of the 7 patients with complete hormonal profile checked, 5 showed significant suppression of luteinizing hormone (LH) and testosterone after 2 to 3 months of treatment. The other 2 showed no evident suppression of testosterone or LH levels, although their PSA’s declined for 90% and 100%, respectively. Only two patients had evident improvement in bone scanning as shown by the resolution of previous metastatic hot spots. All the 9 responding patients turned sexually impotent after 6 months of triptorelin treatment. One complained of hot flush, hand and foot swelling, night sweating and dizziness, which were considered as typical side effects of triptorelin as well as other forms of gonadotropin releasing hormone agonists. In conclusion, monthly triptorelin treatment is effective in suppressing prostate cancer progression and causes negligible side effects in most patients with prostate adenocarcinoma.

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