Department of Medicine, Royal Marsden Hospital, Sutton, Surrey, SM2 5PT, UK.
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 135-710, Korea.
Br J Cancer. 2018 Jul;119(1):19-26. doi: 10.1038/s41416-018-0103-0. Epub 2018 May 29.
Post-hoc analyses of AFP response and progression and their relationship with objective measures of response and survival were performed in patients from REACH.
Serum AFP was measured at baseline and every 3 cycles (2 weeks/cycle). Associations between AFP and radiographic progression and efficacy end points were analysed.
Median percent AFP increase from baseline was smaller in the ramucirumab than in the placebo arm throughout treatment. Time to AFP progression (HR 0.621; P < 0.0001) and to radiographic progression (HR 0.613; P < 0.0001) favoured ramucirumab. Association between AFP and radiographic progression was shown at 6 (OR 6.44, 95% CI 4.03, 10.29; P < 0.0001) and 12 weeks (OR 2.28, 95% CI 1.47, 3.53; P = 0.0002). AFP response was higher with ramucirumab compared with placebo (P < 0.0001). More patients in the ramucirumab arm experienced tumour shrinkage and AFP response compared with placebo. Survival was longer in patients with AFP response (13.6 months) than in patients without (6.2 months), irrespective of treatment (HR 0.457, P < 0.0001).
Treatment with ramucirumab prolonged time to AFP progression, slowed AFP increase and was more likely to induce AFP response. Similar benefits in radiographic progression and response correlated with AFP changes.
对 REACH 研究中的患者进行了 AFP 反应和进展的事后分析及其与客观反应和生存终点的关系。
在基线和每 3 个周期（每 2 周 1 个周期）测量血清 AFP。分析 AFP 与影像学进展和疗效终点之间的关系。
在整个治疗过程中，与安慰剂组相比，ramucirumab 组的 AFP 从基线的百分比增加中位数较小。AFP 进展时间（HR 0.621；P < 0.0001）和影像学进展时间（HR 0.613；P < 0.0001）均有利于 ramucirumab。在 6 周（OR 6.44，95%CI 4.03，10.29；P < 0.0001）和 12 周（OR 2.28，95%CI 1.47，3.53；P = 0.0002）时，AFP 与影像学进展之间存在相关性。与安慰剂相比，ramucirumab 组的 AFP 反应更高（P < 0.0001）。与安慰剂相比，ramucirumab 组有更多的患者发生肿瘤缩小和 AFP 反应。无论治疗如何，AFP 有反应的患者（13.6 个月）的生存时间均长于无反应的患者（6.2 个月）（HR 0.457，P < 0.0001）。
ramucirumab 治疗可延长 AFP 进展时间，减缓 AFP 增加，更有可能诱导 AFP 反应。影像学进展和反应的类似获益与 AFP 变化相关。
