Polverari Giulia, Ceci Francesco, Passera Roberto, Crane Jacquelyn, Du Lin, Li Gang, Fanti Stefano, Bernthal Nicholas, Eilber Fritz C, Allen-Auerbach Martin, Czernin Johannes, Calais Jeremie, Federman Noah
Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California Los Angeles, 200 Medical Plaza, Suite B114-61, Los Angeles, CA, 90095, USA.
Nuclear Medicine, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.
EJNMMI Res. 2020 Oct 15;10(1):122. doi: 10.1186/s13550-020-00715-0.
This is a prospective, single-center trial in pediatric patients with sarcoma aiming to evaluate [F]FDG PET/CT as a tool for early response assessment to neoadjuvant chemotherapy (neo-CTX).
Bone or soft tissue sarcoma patients with (1) baseline [F]FDG PET/CT within 4 weeks prior to the start of neo-CTX (PET1), (2) early interim [F]FDG PET/CT (6 weeks after the start of neo-CTX (PET2), (3) evaluation of neo-CTX response by histology or MRI, and (4) definitive therapy after neo-CTX (surgery or radiation) were included. Semiquantitative PET parameters (SUVmax, SUVmean, SUVpeak, MTV and TLG) and their changes from PET1 to PET2 (ΔPET) were obtained. The primary endpoint was to evaluate the predictive value of PET1, PET2 and ΔPET parameters for overall survival (OS) and time to progression (TTP). The secondary outcome was to evaluate if [F]FDG PET/CT can predict the response to neo-CTX assessed by histopathology or MRI. Primary and secondary outcomes were also evaluated in a subpopulation of patients with bone involvement only.
Thirty-four consecutive patients were enrolled (10 females; 24 males; median age 15.1 years). 17/34 patients (50%) had osteosarcoma, 13/34 (38%) Ewing's sarcoma, 2/34 (6%) synovial sarcoma and 2/34 (6%) embryonal liver sarcoma. Median follow-up was 39 months (range 16-84). Eight of 34 patients (24%) died, 9/34 (27%) were alive with disease, and 17/34 (50%) had no evidence of residual/recurrent disease. Fifteen of 34 (44%) and 19/34 (56%) were responders and non-responders, respectively. PET2-parameters were associated with longer TTP (p < 0.02). ΔMTV was associated with tissue response to neo-CTX (p = 0.047). None of the PET1, PET2 or ΔPET parameters were associated with OS.
[F]FDG PET/CT performed 6 weeks after the start of neo-CTX can serve as an early interim biomarker for TTP and pathologic response but not for OS in pediatric patients with sarcoma.
这是一项针对肉瘤患儿的前瞻性单中心试验，旨在评估[F]FDG PET/CT作为新辅助化疗（neo-CTX）早期反应评估工具的价值。
纳入符合以下条件的骨肉瘤或软组织肉瘤患者：（1）在neo-CTX开始前4周内进行基线[F]FDG PET/CT（PET1）；（2）新辅助化疗开始6周后进行早期中期[F]FDG PET/CT（PET2）；（3）通过组织学或MRI评估新辅助化疗反应；（4）新辅助化疗后进行确定性治疗（手术或放疗）。获取半定量PET参数（SUVmax、SUVmean、SUVpeak、MTV和TLG）及其从PET1到PET2的变化（ΔPET）。主要终点是评估PET1、PET2和ΔPET参数对总生存期（OS）和疾病进展时间（TTP）的预测价值。次要结局是评估[F]FDG PET/CT是否能预测组织病理学或MRI评估的新辅助化疗反应。还在仅累及骨骼的患者亚组中评估了主要和次要结局。
连续纳入34例患者（10例女性；24例男性；中位年龄15.1岁）。34例患者中17例（50%）为骨肉瘤，13例（38%）为尤因肉瘤，2例（6%）为滑膜肉瘤，2例（6%）为胚胎性肝肉瘤。中位随访时间为39个月（范围16 - 84个月）。34例患者中有8例（24%）死亡，9例（27%）带瘤生存，17例（50%）无残留/复发疾病证据。34例患者中15例（44%）为反应者，19例（56%）为无反应者。PET2参数与更长的TTP相关（p < 0.02）。ΔMTV与新辅助化疗的组织反应相关（p = 0.047）。PET1、PET2或ΔPET参数均与OS无关。
新辅助化疗开始6周后进行的[F]FDG PET/CT可作为肉瘤患儿TTP和病理反应的早期中期生物标志物，但不能作为OS的生物标志物。
