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主题演讲:对膀胱癌新辅助(先发制人)化疗试验的批判性评估:联合模式治疗未来研究的经验教训

Keynote address: a critical assessment of trials of neoadjuvant (preemptive) chemotherapy for bladder cancer: lesson for future studies of combined modality treatment.

作者信息

Raghavan D

机构信息

Urological Cancer Research Unit, Royal Prince Alfred Hospital, Sydney, NSW, Australia.

出版信息

Int J Radiat Oncol Biol Phys. 1991 Feb;20(2):233-7. doi: 10.1016/0360-3016(91)90096-m.

DOI:10.1016/0360-3016(91)90096-m
PMID:1991684
Abstract

The 5-year survival of patients with invasive, clinically non-metastatic bladder cancer (Stages T2-4N2Mo) is less than 50%, whether treated by radical radiotherapy, radical cystectomy, or combinations of the two modalities. Cytotoxic regimens, incorporating single agents or combination protocols, produce objective response rates of 10-30 and 10-70%, respectively. Hence, it has been postulated that the use of cytotoxics before or with radiotherapy or surgery ("neoadjuvant", "preemptive", or "concurrent" chemotherapy) could improve the cure rate of invasive bladder cancer. Initial Phase I-II clinical trials have shown such approaches to be feasible, with mild to moderate toxicity. To date, few randomized trials that compare conventional treatment with these new approaches have been initiated or completed, with the majority of eligible patients being treated in increasingly complex Phase II studies. Accordingly, progress has been retarded, and after a decade of investigation, the true role of preemptive or concurrent chemotherapy for invasive bladder cancer is not known. Patients should be entered into well designed, randomized clinical trials in which new approaches to treatment are compared to standard therapy.

摘要

浸润性、临床无转移的膀胱癌患者(T2 - 4N0M0期),无论接受根治性放疗、根治性膀胱切除术还是两种方式联合治疗,其5年生存率均低于50%。采用单药或联合方案的细胞毒性治疗方案,客观缓解率分别为10% - 30%和10% - 70%。因此,有人推测在放疗或手术前或同时使用细胞毒性药物(“新辅助”、“先发制人”或“同步”化疗)可能会提高浸润性膀胱癌的治愈率。最初的I - II期临床试验表明这些方法是可行的,毒性为轻至中度。迄今为止,很少有比较传统治疗与这些新方法的随机试验启动或完成,大多数符合条件的患者在日益复杂的II期研究中接受治疗。因此,进展受阻,经过十年的研究,先发制人或同步化疗对浸润性膀胱癌的真正作用仍不清楚。患者应参加精心设计的随机临床试验,将新的治疗方法与标准疗法进行比较。

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