METHODS: In XELAVIRI, mCRC patients were treated with either fluoropyrimidine/bevacizumab followed by additional irinotecan at first progression (sequential treatment arm; Arm A) or upfront combination of fluoropyrimidine/bevacizumab/irinotecan (intensive treatment arm; Arm B). In the present post hoc analysis, survival was evaluated with respect to the assorted mGPS categories 0, 1 or 2. Interaction between mGPS and gender was analyzed.
RESULTS: Out of 421 mCRC patients treated in XELAVIRI, 362 [119 women (32.9%) and 243 men (67.1%)] were assessable. For the entire study population a significant association between mGPS and overall survival (OS) was observed [mGPS = 0: median 28.9 months, 95% confidence interval (CI) 25.9-33.6 months; mGPS = 1: median 21.4 months, 95% CI 17.6-26.1 months; mGPS = 2: median 16.8 months, 95% CI 14.3-21.2 months; P < 0.00001]. Similar results were found when comparing progression-free survival between groups. The effect of mGPS on survival did not depend on the applied treatment regimen (P = 0.21). In female patients, a trend towards longer OS was observed in Arm A versus Arm B, with this effect being clearly more pronounced in the mGPS cohort 0 (41.6 versus 25.5 months; P = 0.056). By contrast, median OS was longer in male patients with an mGPS of 1-2 treated in Arm B versus Arm A (20.8 versus 17.4 months; P = 0.022).
CONCLUSIONS: We demonstrate the role of mGPS as an independent predictor of OS regardless of the treatment regimen in mCRC patients receiving first-line treatment. mGPS may help identify gender-specific subgroups that benefit more or less from upfront intensive therapy.
方法:在XELAVIRI中,mCRC患者接受氟嘧啶/贝伐单抗治疗,随后在首次进展时(序贯治疗组;A组)或接受氟嘧啶/贝伐单抗/伊立替康的前期组合治疗(强化治疗组;B组).在目前的事后分析中,根据mGPS分类0,1或2对生存率进行评估.分析了mGPS与性别之间的相互作用。
结果:在接受XELAVIRI治疗的421例mCRC患者中,362[119名女性(32.9%)和243名男性(67.1%)]可评估。对于整个研究人群,观察到mGPS与总生存期(OS)之间存在显着关联[mGPS=0:中位数28.9个月,95%置信区间(CI)25.9-33.6个月;mGPS=1:中位数21.4个月,95%CI17.6-26.1个月;mGPS=2:中位数16.8个月,95%CI14.3-21.2个月;P<0.00001]。当比较组间无进展生存期时发现类似的结果。mGPS对生存的影响不依赖于所应用的治疗方案(P=0.21)。在女性患者中,在A臂与B臂中观察到OS更长的趋势,这种影响在mGPS队列0中明显更明显(41.6对25.5个月;P=0.056)。相比之下,与A组相比,B组治疗的mGPS为1-2的男性患者的中位OS更长(20.8个月对17.4个月;P=0.022).
结论:我们证明了在接受一线治疗的mCRC患者中,无论治疗方案如何,mGPS作为OS的独立预测因子的作用。mGPS可能有助于识别或多或少受益于前期强化治疗的性别特异性亚组。