Department of Medical Oncology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands.
Melanoma Institute Australia, The University of Sydney, 40 Rocklands Rd, Wollstonecraft NSW 2065, Australia; Royal North Shore and Mater Hospitals, 25 Rocklands Rd, North Sydney NSW 2060, Australia.
Eur J Cancer. 2021 May;148:51-57. doi: 10.1016/j.ejca.2021.02.012. Epub 2021 Mar 15.
Patients with synchronous clinical stage III melanoma can present with primary melanoma lesions, locally recurrent melanoma or in-transit metastases. Neoadjuvant ipilimumab plus nivolumab induces high pathologic response rates and an impressive relapse-free survival in patients with nodal macroscopic stage III melanoma. Whether primary site melanoma and in-transit metastases respond similarly to lymph node metastases with neoadjuvant immunotherapy is largely unknown. Such data would clarify whether surgical excision of these melanoma lesions should be performed before neoadjuvant therapy or whether it could be deferred and performed in conjunction with lymphadenectomy following neoadjuvant immunotherapy.
Patients with synchronous clinical stage III melanoma were identified from the OpACIN, OpACIN-neo and PRADO neoadjuvant trials, where all patients were treated with ipilimumab plus nivolumab. An additional case treated outside those clinical trials was included.
Seven patients were identified; six patients had a concordant response in primary site melanoma lesions or in-transit metastasis and the lymph node metastases. One patient had concordant progression in both the primary and nodal tumour lesions and developed stage IV disease during neoadjuvant treatment, and thus, no resection was performed.
Pathologic response following neoadjuvant ipilimumab plus nivolumab in primary site melanoma lesions or in-transit metastasis is concordant with a response in the lymph node metastases, indicating that there may be no need to perform upfront surgery to these melanoma lesions prior to neoadjuvant treatment.
同步临床 III 期黑色素瘤患者可表现为原发性黑色素瘤病变、局部复发性黑色素瘤或转移灶。新辅助伊匹单抗联合nivolumab 可诱导淋巴结转移性 III 期黑色素瘤患者获得高病理缓解率和显著的无复发生存率。新辅助免疫治疗是否能使原发性黑色素瘤和转移灶与淋巴结转移灶同样发生应答,在很大程度上尚不清楚。这些数据将阐明这些黑色素瘤病变是否应在新辅助治疗前进行手术切除,或者是否可以推迟并在新辅助免疫治疗后与淋巴结清扫术同时进行。
从 OpACIN、OpACIN-neo 和 PRADO 新辅助试验中确定了同步临床 III 期黑色素瘤患者,所有患者均接受伊匹单抗联合 nivolumab 治疗。还纳入了一例在这些临床试验之外接受治疗的病例。
共确定了 7 例患者;6 例患者在原发性黑色素瘤病变或转移灶和淋巴结转移灶中均有一致的缓解。1 例患者在原发性和淋巴结肿瘤病变中均有一致的进展,并在新辅助治疗期间发展为 IV 期疾病,因此未进行手术切除。
新辅助伊匹单抗联合 nivolumab 治疗后,原发性黑色素瘤病变或转移灶的病理缓解与淋巴结转移灶的缓解一致,表明在新辅助治疗前可能无需对这些黑色素瘤病变进行术前手术。