EFFICACY OF CISPLATIN-BASED CHEMOTHERAPY AS FIRST-LINE TREATMENT IN ASIAN PATIENTS WITH METASTATIC UROTHELIAL CARCINOMA RESULTS OF AN EXPLORATORY SUBGROUP ANALYSIS OF A POOL ANALYSIS OF PHASE II/III TRIALS

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Abstract

Background

Patients with metastatic urothelial cancer (UC) treated with cisplatin-based chemotherapy have heterogeneous clinical outcomes. Pre-treatment prognostic variables have previously been defined (Bajorin, JCO, 1999) but have not been extensively validated or expanded upon. Here we conducted an exploratory subgroup analysis of the Asian patients in this pool analysis of the phase II/III trials of cisplatin-based chemotherapy as first-line treatment of metastatic UC.

Methods

Six hundred patients with metastatic UC, including 81 Asian patients (14%), were enrolled in the phase II and III first-line trials with cisplatin-based chemotherapy from Nov 1997 to Oct 2011 were evaluated (cisplatin + gemcitabine ± paclitaxel or ± antiangiogenic agent = 345; MVAC = 176; cisplatin + 5FU ± paclitaxel = 79). Parameters were subjected to multivariable regression analysis to determine which patient characteristics had independent prognostic significance for survival.

Results

Compared with the entire patient population, Asian patients had more female gender (25 versus 19%, P = 0.04), upper urinary tract primary site (41 versus 19%, P = 0.03), bone metastasis (35 versus 19%, P = 0.03) and abnormal baseline serum creatinine level (39 versus 26%, P = 0.046). The response rate of Asian patients was higher than that of the non-Asian patients (64 versus 46%, P < 0.05) Median progression-free survival was 8.0 (95% CI, 7.1–8.9) and 8.0 (7.5–8.5) months in Asian and the entire patients (log-rank P = 0.517), respectively. Median overall survival was 15.5 (11.8–19.1) and 13.3 months (12.0–14.5) in Asian and the entire patients (log-rank P = 0.122), respectively; 459 have died. In multivariable analysis, ethnicity (Asian versus non-Asian) was not significantly associated with survival (P > 0.05).

Conclusions

Asian patients with metastatic UC have more presumed adverse prognostic factors (upper urinary tract primary site, bone metastasis, and renal dysfunction). The treatment outcome of Asian patients is the same as that of non-Asian patients.

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