Lorusso V, Pollera C F, Antimi M, Luporini G, Gridelli C, Frassineti G L, Oliva C, Pacini M, De Lena M
Medical Oncology Division, Oncology Hospital, Bari, Italy.
Eur J Cancer. 1998 Jul;34(8):1208-12. doi: 10.1016/s0959-8049(98)00030-6.
The aim of this study was to evaluate the efficacy and safety of gemcitabine, a pyrimidine antimetabolite, in the treatment of advanced transitional cell carcinoma of the urinary tract. 35 patients with unresectable or metastatic transitional cell carcinoma of the urinary tract previously treated with a platinum-based regimen were studied. Gemcitabine was administered at a dosage of 1200 mg/m2 as a 30-min intravenous infusion on days 1, 8 and 15, repeated every 28 days. 31 patients were evaluable for efficacy. 4 patients achieved a complete response (12.9%), 3 a partial response (9.6%) and 13 (42%) were stable for at least 4 weeks (overall response 22.5%; 95% confidence interval 8-37%). The median response duration was 11.8 months (range 3.6-17.7 + months) and median survival for all patients entered was 5 months (range 2-21 + months). 2 patients with complete response are still alive with no evidence of disease after 14 and 21 months. Gemcitabine also provided subjective symptomatic relief from pain, cystitis, dysuria, haematuria and peripheral oedema. Patients experienced little WHO grade 3-4 toxicity, with anaemia in 8 patients (23%), thrombocytopenia in 5 (14.2%), leucopenia in 4 (11.4%) and neutropenia in 7 (20%). WHO grade 3-4 hepatic toxicity occurred in 4 patients (11.4%) and transient elevations of transaminase was noted in 3 (8.6%). No patient had WHO grade 3-4 elevation of serum creatinine level. There was no WHO grade 4 symptomatic toxicity and no alopecia was noted. Transient influenza symptoms with gemcitabine occurred in 18 patients (51.4%) with 13 patients (37.1%) experiencing fever (2.9% WHO grade 3). In conclusion, gemcitabine is an new active agent for the treatment of transitional cell carcinoma of the urinary bladder with a mild toxicity profile; it warrants further investigation in combination with cisplatin in chemotherapy naive patients.
本研究旨在评估嘧啶抗代谢物吉西他滨治疗晚期泌尿道移行细胞癌的疗效和安全性。研究对象为35例先前接受过铂类方案治疗的无法切除或转移性泌尿道移行细胞癌患者。吉西他滨以1200mg/m²的剂量在第1、8和15天进行30分钟静脉输注，每28天重复一次。31例患者可进行疗效评估。4例患者达到完全缓解（12.9%），3例部分缓解（9.6%），13例（42%）病情稳定至少4周（总缓解率22.5%；95%置信区间8 - 37%）。中位缓解持续时间为11.8个月（范围3.6 - 17.7 +个月），所有入组患者的中位生存期为5个月（范围2 - 21 +个月）。2例完全缓解患者在14个月和21个月后仍存活，无疾病证据。吉西他滨还能主观缓解疼痛、膀胱炎、排尿困难、血尿和外周水肿等症状。患者很少出现世界卫生组织3 - 4级毒性反应，8例患者（23%）出现贫血，5例（14.2%）出现血小板减少，4例（11.4%）出现白细胞减少，7例（20%）出现中性粒细胞减少。4例患者（11.4%）出现世界卫生组织3 - 4级肝毒性，3例（8.6%）出现转氨酶短暂升高。无患者出现世界卫生组织3 - 4级血清肌酐水平升高。无世界卫生组织4级症状性毒性反应，未观察到脱发。18例患者（51.4%）出现与吉西他滨相关的短暂流感症状，13例患者（37.1%）出现发热（2.9%为世界卫生组织3级）。总之，吉西他滨是治疗膀胱移行细胞癌的一种新的活性药物，毒性较轻；值得在未接受过化疗的患者中与顺铂联合进行进一步研究。
