Department of Surgery, Division of Breast & Melanoma Surgical Oncology, Mayo Clinic, Rochester, MN, USA.
Mayo Clinic Cancer Center, Mayo Clinic, Rochester, MN, USA.
Ann Surg Oncol. 2022 Feb;29(2):780-786. doi: 10.1245/s10434-021-11112-9. Epub 2021 Nov 25.
The effect of neoadjuvant systemic therapies (NST) on technical aspects of operation for resectable stage III melanoma is unknown. Prospective capture of the estimated and actual degree of difficulty of therapeutic lymphadenectomy at presentation and after NST may inform the relative merits of NST versus surgery followed by adjuvant therapy.
We designed surgeon survey tools to capture key impressions at baseline prior to NST and postoperatively. We conducted a sub-study within a multi-institutional clinical trial for high-risk operable stage III melanoma (NeoACTIVATE, NCT03554083) which enrolls clinically node-positive patients to 12 weeks of combinatorial NST determined by BRAF status. Survey data were analyzed.
Surveys were completed for 24 of 25 patients (96%). Affected nodal basins were cervical (3, 13%) axillary (9, 38%), inguinal ± pelvic (14, 58%); 2 (8%) involved ≥ 2 basins. Baseline estimates included largest affected node size (median/range 4/1.4-11 cm), number of involved nodes (median/range 3/1-10) and tumor fixation (present in 12, 50%). At operation, actual degree of difficulty increased from the baseline estimate in 4 (17%) and decreased in 6 (25%). Surgery was less difficult, average, or more difficult versus usual operation in 4, 9, and 11 cases (17%, 38%, 46%), respectively.
Although many operations were judged to be more difficult than the usual therapeutic lymphadenectomy, operation following NST was more often perceived as easier than more difficult versus baseline impression. Engaging surgical oncologists to perform similar structured assessments across clinical trials will permit cross-study analysis of the effect of NSTs on the technical conduct of lymphadenectomy.
新辅助全身治疗(NST)对可切除 III 期黑色素瘤手术技术方面的影响尚不清楚。前瞻性地捕获治疗性淋巴结清扫术在 NST 前和 NST 后的预估和实际难度程度,可能有助于了解 NST 与手术加辅助治疗的相对优势。
我们设计了外科医生的调查工具,以在 NST 前和手术后获取关键的初步印象。我们在一项多机构临床试验(NeoACTIVATE,NCT03554083)中进行了一项子研究,该研究招募了临床淋巴结阳性的 III 期高危可切除黑色素瘤患者,接受 12 周的组合 NST,由 BRAF 状态决定。对调查数据进行了分析。
对 25 名患者中的 24 名(96%)完成了调查。受影响的淋巴结区域包括颈部(3 例,13%)、腋窝(9 例,38%)、腹股沟±骨盆(14 例,58%);2 例(8%)涉及≥2 个区域。基线估计包括最大受累淋巴结大小(中位数/范围 4/1.4-11cm)、受累淋巴结数量(中位数/范围 3/1-10)和肿瘤固定(12 例,50%)。在手术中,4 例(17%)的实际难度较基线估计增加,6 例(25%)的实际难度较基线估计减少。4 例(17%)、9 例(38%)和 11 例(46%)的手术难度较常规手术分别认为是较不困难、困难程度相当或更困难。
尽管许多手术被认为比常规的治疗性淋巴结清扫术更困难,但 NST 后的手术往往被认为比基线印象更容易。让外科肿瘤医生在临床试验中进行类似的结构化评估,将允许对 NST 对淋巴结清扫术技术实施的影响进行跨研究分析。