Kosmidis P A, Bacoyiannis C, Fountzilas G, Aravantinos G, Tsavaris N, Milathianakis C, Skarlos D
Metaxa Cancer Hospital, Piraeus, Greece.
Ann Oncol. 1997 Apr;8(4):373-8. doi: 10.1023/a:1008287814252.
To evaluate the efficacy and toxicity of the FAP combination chemotherapy as first-line treatment in advanced urothelial cancer.
Thirty-four patients with histologically confirmed advanced urothelial cancer, with measurable disease and without previous chemotherapy entered the study; all 34 are evaluable. The 28 males and 6 females had a median age of 65 (19-75) and a median ECOG performance status of 1 (0-2). Twenty-eight patients had bladder cancer, four had renal pelvic cancer and two ureteral cancer. Thirty patients had transitional cell carcinoma and four mixed, mostly of grade 3. Sites of disease included lymph nodes (18), bladder (9), liver (9), pelvic mass (9), lung (7), etc. The treatment plan was as follows: 5-fluorouracil 500 mg/m2 continuous infusion D1-D5 and D22-D26; interferon-alpha-2b 5 million i.u./m2 D1-D5 followed by 3x/week and then D22-D26; cisplatin 25 mg/m2 D1, D8, D15, D22. Cycles were repeated every 36 days.
The median number of cycles administered was 3 (1-6). The relative dose intensities for 5-fluorouracil, interferon and cisplatin were 76%, 71% and 75%, respectively. Twenty-two of 34 patients (65%, 95% confidence interval [95% CI], 46% to 80%) had objective responses, including six complete clinical responses (CR) (18%, 95% CI, 7% to 35%) and 16 partial responses (PR) (47%, 95% CI, 30% to 65%). Three patients had stable disease and seven progressed. Two patients discontinued treatment after the first cycle because of toxicity. The median survival is 15.30 months (1.40-37.60), the median time to progression 11.60 months (4.13-37.60), and the median survival of complete responders 20.75+ months (8+ to 38+). The only significant hematologic toxicity was the grade 3-4 neutropenia in 44%. Non-hematologic toxic effects were unremarkable.
The FAP combination as first-line chemotherapy is highly active in the treatment of advanced urothelial cancer, and has limited toxicity. Further phase III studies are in progress to compare FAP and M-VAC.
评估FAP联合化疗作为晚期尿路上皮癌一线治疗的疗效和毒性。
34例经组织学确诊为晚期尿路上皮癌、具有可测量病灶且未接受过化疗的患者进入本研究；全部34例均可评估。28例男性和6例女性，中位年龄65岁（19 - 75岁），中位东部肿瘤协作组（ECOG）体能状态为1（0 - 2）。28例患者患有膀胱癌，4例患有肾盂癌，2例患有输尿管癌。30例为移行细胞癌，4例为混合型，大多为3级。疾病部位包括淋巴结（18例）、膀胱（9例）、肝脏（9例）、盆腔肿块（9例）、肺（7例）等。治疗方案如下：5 - 氟尿嘧啶500 mg/m²持续输注，第1 - 5天和第22 - 26天；干扰素α - 2b 500万国际单位/m²，第1 - 5天，之后每周3次，然后在第22 - 26天使用；顺铂25 mg/m²，第1、8、15、22天。每36天重复一个周期。
中位给药周期数为3（1 - 6）。5 - 氟尿嘧啶、干扰素和顺铂的相对剂量强度分别为76%、71%和75%。34例患者中有22例（65%，95%置信区间[95% CI]，46%至80%）有客观反应，包括6例完全临床缓解（CR）（18%，95% CI，7%至35%）和16例部分缓解（PR）（47%，95% CI，30%至65%）。3例患者疾病稳定，7例进展。2例患者在第一个周期后因毒性而停止治疗。中位生存期为15.30个月（1.40 - 37.60），中位疾病进展时间为11.60个月（4.13 - 37.60），完全缓解者的中位生存期为20.75 +个月（8 +至38 +）。唯一显著的血液学毒性是44%的患者出现3 - 4级中性粒细胞减少。非血液学毒性不明显。
FAP联合化疗作为一线化疗在晚期尿路上皮癌治疗中具有高活性且毒性有限。正在进行进一步的III期研究以比较FAP和M - VAC。
