Administration of chemoimmunotherapy using concurrent chemotherapy and an anti-GD2 monoclonal antibody (mAb), dinutuximab (DIN), demonstrated efficacy for the treatment of relapsed and refractory neuroblastoma. Chemoimmunotherapy, using a humanized anti-GD2 mAb, demonstrated a signal of activity in a phase 2 study for the treatment of patients with newly diagnosed high-risk neuroblastoma (HRNBL). In this single-institution retrospective study, patients with HRNBL received an Induction chemotherapy regimen plus DIN in all Induction cycles. Toxicity and response data were abstracted from the electronic medical record. Toxicities were graded by CTCAE v.5.0. The end of Induction (EOI) objective response rate was determined using the Revised International Neuroblastoma Response Criteria. Twenty-seven patients with HRNBL (23 newly diagnosed, 16 females, median age 3.9 years) started Induction chemoimmunotherapy from 27 January 2017 to 28 December 2022. All patients received DIN with all cycles of Induction therapy, and all but one patient completed Induction therapy. The most common non-hematologic grade ≥ 3 toxicities included fever (44%), hypoxemia (20%), and hypoalbuminemia (11%). End of Induction responses included eighteen with a complete response (CR), seven with a partial response (PR), one with progressive disease (PD), and zero with a minor response or stable disease. Twenty-six of twenty-seven patients (96%) completed all Induction cycles and were evaluable for a response. The EOI response of PR or better in the evaluable cohort was 96%. Dinutuximab was well tolerated with all Induction cycles, demonstrated an encouraging EOI response rate, and should be evaluated in a randomized study.
采用化疗联合抗GD2单克隆抗体(mAb)迪努妥昔单抗(DIN)的同步放化疗方案,在治疗复发难治性神经母细胞瘤中显示出疗效。一项针对新诊断高危神经母细胞瘤(HRNBL)患者的II期研究表明,使用人源化抗GD2单克隆抗体的化疗免疫治疗方案显示出活性信号。本项单中心回顾性研究中,HRNBL患者在所有诱导化疗周期中均接受诱导化疗方案联合DIN治疗。毒性和反应数据从电子病历中提取,毒性分级采用CTCAE v.5.0标准。诱导治疗结束(EOI)的客观缓解率依据修订版国际神经母细胞瘤反应标准进行评估。2017年1月27日至2022年12月28日期间,27例HRNBL患者(23例为新诊断,16例女性,中位年龄3.9岁)开始接受诱导化疗免疫治疗。所有患者在每个诱导治疗周期均接受DIN治疗,除1例患者外均完成诱导治疗。最常见的≥3级非血液学毒性包括发热(44%)、低氧血症(20%)和低白蛋白血症(11%)。诱导治疗结束时的反应包括:18例完全缓解(CR),7例部分缓解(PR),1例疾病进展(PD),无轻微缓解或疾病稳定病例。27例患者中26例(96%)完成所有诱导周期并可评估反应。在可评估队列中,EOI达到PR或更好的缓解率为96%。迪努妥昔单抗在所有诱导周期中耐受性良好,显示出令人鼓舞的EOI缓解率,值得通过随机研究进一步评估。