Price Timothy, Depauw Laura, Cehic Gabrielle, Wachter Eric, Sebben Ruben, Reid Jessica, Neuhaus Susan, Alawawdeh Anas, Kirkwood Ian D, Solanki Rahul, McGregor Mark, Leopardi Lisa, Rodrigues Dominic, Maddern Guy
The Queen Elizabeth Hospital, Woodville, SA, Australia.
University of Adelaide, Adelaide, SA, Australia.
Br J Cancer. 2025 Jun;132(10):888-896. doi: 10.1038/s41416-025-02976-9. Epub 2025 Mar 26.
Metastatic neuroendocrine neoplasms (mNEN) require new treatment options. Intralesional (IL) PV-10 is an autolytic chemotherapy that may elicit an adaptive immune response.
This phase 1 study evaluated IL PV-10 administered percutaneously to hepatic lesions in patients with progressive mNEN. IL PV-10 was injected in a single lesion per treatment cycle. A treatment cycle could be repeated after ≥ 6 weeks if multiple targetable lesions were present. The primary endpoint was safety.
Twelve patients were enrolled with a median age of 66 years (range 47-79). All patients had progressive disease at enrolment and received prior somatostatin analogues; 10 patients had peptide receptor radionuclide therapy (PRRT) treatment. One lesion was injected per cycle for all 12 patients. Reported grade 3 side effects were photosensitivity (1 patient), face oedema (1 patient), elevated transaminases (1 patient), hypertension (2 patients). Response rate was 42% of injected lesions with patient-level disease control of 84%, PFS 9.4 months and median OS 24.0 months.
IL PV-10 elicited no safety concerns. Encouraging evidence of local and systemic disease control was seen in a heavily pre-treated, progressing mNEN population.
NCT02693067.
转移性神经内分泌肿瘤（mNEN）需要新的治疗选择。病灶内（IL）注射PV-10是一种自溶化疗方法，可能引发适应性免疫反应。
本1期研究评估了经皮向进展期mNEN患者的肝脏病灶注射IL PV-10的情况。每个治疗周期在单个病灶内注射IL PV-10。如果存在多个可靶向病灶，≥6周后可重复一个治疗周期。主要终点是安全性。
入组12例患者，中位年龄66岁（范围47 - 79岁）。所有患者入组时均为疾病进展状态，且之前接受过生长抑素类似物治疗；10例患者接受过肽受体放射性核素治疗（PRRT）。12例患者均每个周期在一个病灶内注射。报告的3级副作用有光敏反应（1例患者）、面部水肿（1例患者）、转氨酶升高（1例患者）、高血压（2例患者）。注射病灶的缓解率为42%，患者水平的疾病控制率为84%，无进展生存期为9.4个月，中位总生存期为24.0个月。
IL PV-10未引起安全性问题。在经过大量前期治疗、疾病进展的mNEN人群中，观察到了局部和全身疾病控制的鼓舞人心的证据。
NCT02693067。
