納武單抗或納武單抗加伊匹單抗治療非小細胞肺癌的外科預後

Surgical Outcomes Following Nivolumab or Nivolumab Plus Ipilimumab In Non-Small Cell Lung Cancer

(Nat Rev Cancer;IF:60.716)

• Sepesi B, Zhou N, William Jr. WN, Lin H, Leung CH, Weissferdt A, MitchellKG, Pataer A, Walsh GL, Rice DC, Roth JA, Mehran RJ, Hofstetter WL, Antonoff. MB, Rajaram R,Negrao MV, Tsao AS, Gibbons DL, Lee JJ, Heymach JV, Vaporciyan AA, Swisher SG, CasconeT, Surgical Outcomes Following Nivolumab or Nivolumab Plus Ipilimumab In Non-Small Cell
• LungCancer, The Journal of Thoracic and Cardiovascular Surgery (2022), doi: https://doi.org/10.1016/j.jtcvs.2022.01.019

BACKGROUND 背景

Surgical outcomes in non-small cell lung cancer following neoadjuvant immune checkpoint inhibitors (ICIs) continue to be debated. We assessed perioperative outcomes of NEOSTAR trial patients after immunotherapy.

新輔助免疫檢查點抑制劑(ICIs)治療非小細胞肺癌的手術結果仍存在争議。我們評估了免疫治療後NEOSTAR試驗患者的圍手術期結果。

METHODS 方法

Forty-four patients with stage I-IIIA NSCLC (AJCC 7 th ) were randomized to nivolumab (N, 3 mg/kg IV, days 1, 15, 29; n=23) or nivolumab plus ipilimumab (NI, 1 mg/kg IV, day 1; n=21). Curative-intent operations were planned between 3-6 weeks after the last dose of neoadjuvant N. Patients who completed resection upfront or following chemotherapy from the same time period were used as comparison.

44例I-IIIA期NSCLC (AJCC第7版)患者随機接受納武單抗 (N, 3 mg/kg IV，第1、15、29天;n=23)或納武單抗+伊匹單抗(NI, 1 mg/kg IV，第1天;n = 21)。計劃在最後一次新輔助治療後3-6周内進行根治性手術。将同一時期化療前完成切除或化療後完成切除的患者作為對比。

RESULTS 結果

In the N-arm, 21 (91%) were resected on-trial, one underwent surgery off-trial, and one was not resected (toxicity-related). In the NI-arm, 16 (76%) resections were on-trial, one off trial, and four not resected (none toxicity-related). Median time to operation was 31 days, and consisted of 2 (5%) pneumonectomies, 33 (89%) lobectomies, and 1 (3%) each of segmentectomy and wedge resection. Approach was 27 (73%) thoracotomy, 7 (19%) thoracoscopy, and 3 (8%) robotic-assisted. Conversion occurred in 17% (n=2/12) of minimally-invasive cases. All 37 achieved R0 resections. Pulmonary, cardiac, enteric, neurologic, and wound complications occurred in 9 (24%), 4 (11%), 2 (5%), 1 (3%), and 1 (3%) patient, respectively. The 30- and 90-day mortality rate was 0 and 2.7% (n=1), respectively. Postoperative complications rates were comparable to lung resection upfront or following chemotherapy.

在N組中，21例(91%)在試驗中切除，1例在試驗外進行手術，1例未切除(毒性相關)。在NI組中，16例(76%)切除是在試驗中進行的，1例非試驗，4例未切除(無毒性相關)。中位手術時間為31天，包括2例(5%)全肺切除術，33例(89%)肺葉切除術，以及分别1例(3%)肺段切除和楔形切除。入路為27例(73%)開胸，7例(19%)胸腔鏡，3例(8%)機器人輔助。17% (n=2/12)的微創病例發生中轉。所有37例均實作R0切除。肺部、心髒、腸道、神經系統和傷口并發症分别為9例(24%)、4例(11%)、2例(5%)、1例(3%)和1例(3%)。30和90天的死亡率分别為0和2.7% (n=1)。術後并發症發生率與化療前或化療後肺切除術相當。

CONCLUSIONS 結論

Operating following neoadjuvant N or NI is safe and effective and yields perioperative outcomes similar to those achieved after chemotherapy or upfront resection.

在新輔助N或NI術後進行手術是安全有效的，其圍手術期效果與化療或前切除術後相似。