Dana-Farber Cancer Institute, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts.
Statistics and Data Center, Children's Oncology Group, Monrovia, California.
Cancer. 2019 Oct 15;125(20):3649-3656. doi: 10.1002/cncr.32363. Epub 2019 Jul 29.
There are several studies describing the correlation between unsatisfactory tumor marker decline and a poor prognosis for adult patients treated for germ cell tumors. In pediatric patients, the data are limited. Therefore, this study retrospectively analyzed data from Children's Oncology Group (COG) protocol AGCT0132 to determine whether a relationship exists between α-fetoprotein (AFP) decline and outcome.
One hundred thirty-one patients with germ cell tumors who were enrolled in COG protocol AGCT0132 were eligible for this analysis of AFP decline. The serum AFP half-life was calculated from levels collected postoperatively as a baseline and after the start of chemotherapy. AFP decline was defined as automatically satisfactory (AFP normalized within the first 2 AFP measures after the start of chemotherapy), calculated satisfactory (AFP half-life ≤7 days after the start of chemotherapy), and unsatisfactory.
The 3-year cumulative incidence of relapse was 11% (95% confidence interval [CI], 6.0%-18%) for patients with a satisfactory decline and 38% (95% CI, 13%-64%) for patients with an unsatisfactory decline (P = .006). In stratified analyses, this effect was limited to patients who were 11 years of age or older and had standard risk 2 (SR2) disease (P = .004 and P = .007, respectively). Three-year overall survival (OS) for patients with a satisfactory decline versus an unsatisfactory decline was not statistically significant.
This study is the first to show an association between AFP decline and the cumulative incidence of relapse in pediatric patients treated for germ cell tumors. Recognition of patients at high risk for relapse may allow for early intensification of therapy, which could affect future clinical trial design.
有几项研究描述了未达到满意的肿瘤标志物下降与成年生殖细胞瘤患者预后不良之间的相关性。在儿科患者中,相关数据有限。因此,本研究回顾性分析了儿童肿瘤学组(COG)协议 AGCT0132 的数据,以确定甲胎蛋白(AFP)下降与结局之间是否存在关系。
符合 COG 协议 AGCT0132 纳入标准的 131 例生殖细胞瘤患者有资格进行 AFP 下降分析。血清 AFP 半衰期是从术后基线和化疗开始后采集的水平计算得出的。AFP 下降定义为自动满意(化疗开始后 AFP 在最初 2 次 AFP 测量中正常化)、计算满意(AFP 半衰期≤化疗开始后 7 天)和不满意。
满意下降患者的 3 年累积复发率为 11%(95%置信区间[CI],6.0%-18%),不满意下降患者的 3 年累积复发率为 38%(95% CI,13%-64%)(P=0.006)。分层分析显示,这种影响仅限于 11 岁及以上且具有标准风险 2(SR2)疾病的患者(分别为 P=0.004 和 P=0.007)。满意下降患者与不满意下降患者的 3 年总生存率(OS)无统计学意义。
本研究首次显示 AFP 下降与接受生殖细胞瘤治疗的儿科患者累积复发率之间存在关联。对高复发风险患者的识别可能允许早期强化治疗,这可能影响未来临床试验的设计。