Abstract:
Response determined by 18[F]-fluoro-2-deoxy-D-glucose (18F-FDG) positron emission tomography (PET)-CT after induction therapy can predict progression-free survival (PFS) in follicular lymphoma (FL). However, little prospective research has examined the significance of PET after second-line therapy. We conducted a prospective multicenter phase II trial (W-JHS NHL01) of bendamustine plus rituximab (BR) without rituximab maintenance for FL in first relapse. This study aimed to evaluate the usefulness of end-of-treatment (EOT)-PET for predicting PFS in FL patients in first relapse. EOT-PET examinations were performed between 6 and 8 weeks from the start of the last BR cycle. The primary endpoint was 1-year PFS. Key secondary endpoints were overall response rate (ORR), complete response rate (CRR), and 1-year overall survival (OS). Seventy-five patients were enrolled, and 8 were excluded from analysis. ORR was 86.6% and CRR was 59.7%. One-year PFS was 88.9% (95% confidence interval [CI] 80.7-94.3%) and 1-year OS in 75 patients was 97.3% (95% CI 89.6-99.3%). One-year PFS was significantly inferior in EOT-PET-positive patients (n = 9) compared with PET-negative patients (n = 58) (77.8% vs. 93.1%; p = 0.02). We confirmed that EOT-PET after second-line BR therapy could predict early progression in FL patients in first relapse.
摘要:
诱导治疗后18[F]-氟-2-脱氧-D-葡萄糖(18F-FDG)正电子发射断层扫描(PET)-CT确定的反应可以预测滤泡性淋巴瘤(FL)的无进展生存期(PFS)。然而,很少有前瞻性研究探讨二线治疗后PET的意义.我们进行了一项前瞻性多中心II期试验(W-JHSNHL01),在首次复发时苯达莫司汀联合利妥昔单抗(BR)治疗FL。这项研究旨在评估治疗结束(EOT)-PET对预测首次复发的FL患者PFS的有用性。EOT-PET检查从最后一个BR周期开始的6到8周之间进行。主要终点为1年PFS。关键次要终点是总有效率(ORR),完全反应率(CRR),和1年总生存期(OS)。纳入了75名患者,8例排除在分析之外.ORR为86.6%,CRR为59.7%。75例患者的1年PFS为88.9%(95%置信区间[CI]80.7-94.3%),1年OS为97.3%(95%CI89.6-99.3%)。EOT-PET阳性患者(n=9)的一年PFS明显低于PET阴性患者(n=58)(77.8%vs.93.1%;p=0.02)。我们证实,二线BR治疗后的EOT-PET可以预测首次复发的FL患者的早期进展。