Mohanty Nayan Kumar, Nayak Rajiba L, Vasudeva Pawan, Arora Rajender P
Department of Urology, V.M. Medical College and Safdarjang Hospital, New Delhi, India.
Urol Oncol. 2008 Nov-Dec;26(6):616-9. doi: 10.1016/j.urolonc.2007.10.016. Epub 2008 Feb 4.
The incidence of bladder malignancy is increasing worldwide and the projected rise is 28% by 2010 for both sexes (according to the WHO). Though intravesical adjuvant therapy with bacillus Calmette-Guérin (BCG) is superior to any other immunotherapeutic/chemotherapeutic agent in reducing tumor recurrences and disease progression, its real efficacy remains controversial as one-third of the patients will soon develop BCG failure. Hence, there is a need for an alternative intravesical agent for treatment of BCG failure. Our aim is to study the efficacy, tolerability, and safety of intravesical gemcitabine in managing BCG refractory superficial bladder malignancy.
Thirty-five BCG failure patients, 26 males and 9 females between 20 and 72 years of age were instilled 2000 mg of gemcitabine in 50 ml of normal saline intravesically 2 weeks post-tumor resection, for 6 consecutive weeks. Mean follow-up for 18 months with cystoscopy was done.
Twenty-one patients (60%) showed no recurrences, 11 patients (31.4%) had superficial recurrences, while 3 patients (8.75%) progressed to muscle invasiveness. Average time to first recurrence was 12 months and to disease progression was 16 months. Adverse event was low and mild. Therapy was well tolerated.
Gemcitabine fulfills all requirements as an alternative agent in treating BCG failure patients with low adverse events, well tolerated, and highly effective in reducing tumor recurrences.
全球范围内膀胱恶性肿瘤的发病率正在上升，据世界卫生组织预计，到2010年男女发病率将上升28%。尽管卡介苗（BCG）膀胱内辅助治疗在降低肿瘤复发和疾病进展方面优于任何其他免疫治疗/化学治疗药物，但其实际疗效仍存在争议，因为三分之一的患者很快就会出现卡介苗治疗失败。因此，需要一种替代的膀胱内用药来治疗卡介苗治疗失败的情况。我们的目的是研究膀胱内使用吉西他滨治疗卡介苗难治性浅表膀胱恶性肿瘤的疗效、耐受性和安全性。
35例卡介苗治疗失败的患者，年龄在20至72岁之间，其中男性26例，女性9例，在肿瘤切除术后2周，膀胱内灌注2000毫克吉西他滨溶于50毫升生理盐水中，连续6周。平均随访18个月并进行膀胱镜检查。
21例患者（60%）未复发，11例患者（31.4%）有浅表复发，而3例患者（8.75%）进展为肌层浸润性病变。首次复发的平均时间为12个月，疾病进展的平均时间为16个月。不良事件发生率低且症状轻微。治疗耐受性良好。
吉西他滨满足作为替代药物治疗卡介苗治疗失败患者的所有要求，不良事件少，耐受性好，在减少肿瘤复发方面高效。
