台灣局部晚期或轉移性尿路上皮癌患者之成纖維細胞生長因子受體變異表現及臨床治療結果分析

李建儀¹、馮盈勳²、陳忠信³、陳彥廷⁴、黃志賢⁵

¹臺中榮民總醫院 外科部 泌尿科  ²奇美醫院 內科部 血液腫瘤科

³臺大醫院 泌尿部  ⁴楊森藥廠 醫藥學術部門

⁵臺北榮民總醫院 泌尿部

Treatment Outcome and FGFR alteration rate in unresectable locally advanced or metastatic urothelial cancer in Taiwan

Jian-Ri Li¹, Yin-Hsun Feng ², Chung-Hsin Chen³, Yen-Ting Chen⁴, William J. Huang⁵

¹Division of Urology, Department of Surgery, Taichung Veterans General Hospital, Taichung, Taiwan

²Division of Hematology, Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan

³Department of Urology, National Taiwan University Hospital, Taipei, Taiwan

⁴Medical Affairs, Janssen, Taipei, Taiwan

⁵Department of Urology, Taipei Veterans General Hospital, School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan

Purpose:

We evaluate fibroblast growth factor receptor (FGFR) alteration rate (mutation and gene fusion) and programmed death-ligand 1 (PD-L1) expression pattern in unresectable locally advanced or metastatic UC patients in Taiwan. Furthermore, we investigate the overall treatment pattern and clinical outcome (objective response rate, overall survival, progression-free survival) for unresectable locally advanced or metastatic UC patients under standard of cares (SOCs).

Materials and methods:

This was a retrospective, multi-center, non-interventional study. Patients must be diagnosed as metastatic or unresectable urothelial carcinoma (expired patients with available medical records and had experienced at least one course of systemic treatment). Eligible patients must have available archival tumor tissue sample which was collected between 2015-2019 for further FGFR aberration and PD-L1 expression analysis. The FGFR alteration was determined by QIAGEN therascreen FGFR RGQ RT-PCR kit. The PD-L1 expression level was evaluated by immunohistochemistry using DAKO 22C3.

Results:

Of the 196 patients enrolled in the study, more than half (109 [55.6%]) of patients had renal disease, and greater than one-third of patients’ cancers were Stage III (70 [35.7%]) or Stage IV (69 [35.2%]). FGFR alteration was observed in 13 (6.6%) of the 196 patients with locally advanced or metastatic UC enrolled in the study.

In terms of treatment pattern and clinical outcome, firstly, among the 196 patients who received any systemic 1L treatment, an ORR of 12.2% (95% CI, 8.01-17.67) was observed. And among the 54 patients who received any systemic 2L treatment, an ORR of 9.3% (95% CI, 3.08-20.30) was observed. Secondly, among the 181 patients who received any 1L treatment, median PFS was 3.58 m (95% CI, 2.92-4.60). And for the 48 patients who received any 2L treatment, median PFS was 2.30 m (95% CI, 1.45-3.32). Lastly, median OS was 7.39 m (95% CI, 5.95-8.34) among the 195 of 196 patients with events. Among the 172 patients who received chemotherapy, median OS was 7.23 m (95% CI, 5.95-8.34). Among the 13 patients who received immunotherapy, median OS was 9.46 m (95% CI, 1.64-13.63).

Conclusion:

Based on current study, there are still high unmet medical needs for metastatic UC patients in Taiwan, while the clinical outcomes are generally unfavorable under current SOCs. Furthermore, the FGFR alteration rate was observed in around 6.6%.