Kunikowska Jolanta, Pawlak Dariusz, Bąk Marianna I, Kos-Kudła Beata, Mikołajczak Renata, Królicki Leszek
Nuclear Medicine Department, Medical University of Warsaw, ul. Banacha 1 a, 02-097, Warsaw, Poland.
Radioisotope Centre POLATOM, National Centre for Nuclear Research, ul. Andrzeja Sołtana 7, 05-400, Otwock-Świerk, Poland.
Ann Nucl Med. 2017 Jun;31(5):347-356. doi: 10.1007/s12149-017-1163-6. Epub 2017 Mar 18.
The peptide receptor radionuclide therapy (PRRT) with Y and Lu is a form of molecular targeted therapy for inoperable or disseminated neuroendocrine tumors (NET).
The aim of the study was to evaluate clinical results and long-term side effects of tandem Y /Lu-DOTATATE therapy in patients with NET. Additionally, we evaluated clinical results with reference to the primary site.
59 patients with disseminated NET were included in the study prospectively. 3-5 cycles of combined 1:1 Y/Lu-DOTATATE (total injected activity 11.1-16.65 GBq) with mixed amino acids for kidney protection were performed.
During a median follow-up of 75.8 months, the PFS was 32.2 months, and the OS was 82 months; 25 patients died. Depending on primary tumor's site, the PFS and the OS for pancreatic NET vs. small bowel, NET vs. large bowel, NET were 30.4 vs. 29.5 vs. 40.3 and 78.9 vs. 58.1 vs. 82.5, respectively. The observed 5-year overall survival was 63%, and a 2-year risk of progression was 39.4%. The following imaging response was observed: CR in 2%, PR in 22%, SD in 65%, and PD in 6% patients. The disease control rate was 89%. The objective response rate was 24%. The PRRT was well tolerated by all patients. One patient (2%) revealed MDS, and one patient (2%) grade 3 nephrotoxicity. No other grade 3 and 4 hematological or renal toxicity was observed.
These results indicated the tandem Y/Lu-DOTATATE therapy for patients with disseminated/inoperable NET as highly effective and safe, considering long-term side effects. In the majority of patients, clinical improvement was observed.
钇和镥的肽受体放射性核素治疗（PRRT）是一种针对无法手术切除或已扩散的神经内分泌肿瘤（NET）的分子靶向治疗形式。
本研究的目的是评估串联钇/镥-奥曲肽治疗NET患者的临床结果和长期副作用。此外，我们参照原发部位评估了临床结果。
前瞻性纳入59例已扩散的NET患者。进行3 - 5个周期的1:1钇/镥-奥曲肽联合治疗（总注射活度11.1 - 16.65GBq），并使用混合氨基酸保护肾脏。
在中位随访75.8个月期间，无进展生存期（PFS）为32.2个月，总生存期（OS）为82个月；25例患者死亡。根据原发肿瘤部位，胰腺NET与小肠NET、大肠NET的PFS分别为30.4个月、29.5个月、40.3个月，OS分别为78.9个月、58.1个月、82.5个月。观察到的5年总生存率为63%，2年疾病进展风险为39.4%。观察到的影像反应如下：2%的患者为完全缓解（CR），22%为部分缓解（PR），65%为疾病稳定（SD），6%为疾病进展（PD）。疾病控制率为89%。客观缓解率为24%。所有患者对PRRT耐受性良好。1例患者（2%）出现骨髓增生异常综合征（MDS），1例患者（2%）出现3级肾毒性。未观察到其他3级和4级血液学或肾脏毒性。
考虑到长期副作用，这些结果表明串联钇/镥-奥曲肽治疗已扩散/无法手术切除的NET患者是高效且安全的。在大多数患者中观察到了临床改善。
