Bladder Cancer Center at the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Harvard Medical School, 450 Brookline Avenue, 1230 DANA, Boston, MA 02215, USA.
Br J Cancer. 2013 Nov 12;109(10):2548-53. doi: 10.1038/bjc.2013.617. Epub 2013 Oct 15.
A phase III trial demonstrated an overall survival advantage with the addition of vinflunine to best supportive care (BSC) in platinum-refractory advanced urothelial cancer. We subsequently examined the impact of an additional 2 years of survival follow-up and evaluated the influence of first-line platinum therapy on survival.
The 357 eligible patients from the phase III study were categorised into two cohorts depending on prior cisplatin treatment: cisplatin or non-cisplatin. Survival was calculated using the Kaplan-Meier method.
The majority had received prior cisplatin (70.3%). Survival was higher in the cisplatin group (HR: 0.76; CI 95% 0.58-0.99; P=0.04) irrespective of treatment arm. Multivariate analysis including known prognostic factors (liver involvement, haemoglobin, performance status) and prior platinum administration did not show an independent effect of cisplatin. Vinflunine reduced the risk of death by 24% in the cisplatin-group (HR: 0.76; CI 95% 0.58-0.99; P=0.04) and by 35% in non-cisplatin patients (HR: 0.65; CI 95% 0.41-1.04; P=0.07).
Differences in prognostic factors between patients who can receive prior cisplatin and those who cannot may explain the survival differences in patients who undergo second line therapy. Prior cisplatin administration did not diminish the subsequent benefit of vinflunine over BSC.
一项 III 期临床试验表明,在铂类难治性晚期尿路上皮癌中,长春氟宁联合最佳支持治疗(BSC)可显著提高总生存期。随后,我们进一步考察了额外 2 年生存随访的影响,并评估了一线铂类治疗对生存的影响。
来自 III 期研究的 357 例合格患者根据先前顺铂治疗情况分为两个队列:顺铂组或非顺铂组。采用 Kaplan-Meier 法计算生存。
大多数患者曾接受过顺铂治疗(70.3%)。顺铂组的生存时间较高(HR:0.76;95%CI:0.58-0.99;P=0.04),与治疗组无关。多变量分析包括已知的预后因素(肝转移、血红蛋白、体能状态)和既往铂类治疗并未显示顺铂的独立作用。在顺铂组中,长春氟宁可降低 24%的死亡风险(HR:0.76;95%CI:0.58-0.99;P=0.04),在非顺铂组中降低 35%(HR:0.65;95%CI:0.41-1.04;P=0.07)。
能接受顺铂治疗的患者和不能接受顺铂治疗的患者之间的预后因素差异可能解释了二线治疗患者生存差异的原因。既往顺铂治疗并未降低长春氟宁相对于 BSC 的后续获益。