免疫治療在轉移性尿路上皮癌的治療效果及預後因子之評估-台北榮總經驗
戴盟哲1、魏子鈞1,2、鍾孝仁1,2、張延驊1,2、黃志賢1,2
台北榮民總醫院 泌尿部1；國立陽明大學醫學院 泌尿學科 書田泌尿科學研究中心2
The response of immunotherapy in patients with metastatic urothelial carcinoma and predictive factors evaluations – a single institute experience
Meng-Che Tai1, Tzu-Chun Wei1,2, Xiao-Jen Zhong1,2, Yen-Hwa Chang1,2,
William J.S. Huang1,2
Department of Urology, Taipei Veterans General Hospital, Taiwan1
Department of Urology, School of Medicine and Shu-Tien Urological Institute, National Yang-Ming University, Taipei, Taiwan2
Purpose:
For patients with advanced or metastatic urothelial carcinoma in bladder or upper urinary tract, cisplatin-based chemotherapy regimen is the first-line systemic therapy. However, for those refractory to chemotherapy by the phase 3 KEYNOTE-045 study and those not eligible for chemotherapy as first-line by the phase 2 KEYNOTE-052 and IMVigor 210 study and, immunotherapy may be the alternative choice. Thus, we aimed to evaluate the treatment response of immunotherapy and predictive factors in a single institude.
Materials and Methods:
From January 2017 to July 2018, total 18 patients with metastatic urothelial carcinoma were treated with immunotherapy at Taipei Veterans General Hospital. The patient was divided to two groups according to the treatment response. Demographic data (gender, age, BMI, ECOG, hemoglobin, AST, ALT, ALKP, eGFR), clinical stage, and other predictive factors were compared with Mann-Whitney U test and Fisher’s exact tests. The progression-free survival was analyzed with Kaplan-Meier curves. Risk group by Bellmunt et al was also adapted.
Results:
Of total 18 patients included, 13 patients received immunotherapy with Pembrolizumab alone and 5 with Pembrolizumab plus chemotherapy(Gemcitabine plus Cisplatin or Carboplatin). The mean age was 71.7±8.5 years old and the male gender accounted for 50 %. Fourteen (77.7%) patients received immunotherapy as first-line treatment. The objective response rate (ORR) was 44% (Group I) and 10 patients (56%) had tumor progression (Group II), with no stable disease. There were no differences in demographic data, clinical stage and predictive factors except lung involvement (P=0.036) between two groups. The median progression-free survival of group without lung metastasis versus group with lung metastasis were 12.0 (95% CI, 7.4 to 16.6) versus 4.2 months (95% CI, 2.4 to 6.0; P=0.024). The progression-free survival according to risk group by Bellmunt showed 10.1 versus 6.6 months in group 0+1 and group 2+3, but without statistical significance.
Conclusion:
In our retrospective analysis, there were no differences between responders and non-responders in age, stage, liver metastases or other laboratory factors. Only the progression free survival showed significant difference by the presence of lung metastasis.