Perioperative safety and feasibility outcomes of stage IIIA-N2 non-small cell lung cancer following neoadjuvant immunotherapy or neoadjuvant chemotherapy: a retrospective study

Abstract

Background: We sought to determine the perioperative safety and feasibility outcomes of stage IIIA (N2) non-small cell lung cancer (NSCLC) following neoadjuvant immunotherapy or neoadjuvant chemotherapy. Methods:The clinical details of patients who attended the Affiliated Hospital of Qingdao University between January 2019 and December 2020 were retrospectively evaluated. Eligible patients had pathologically proven stage IIIA (N2) NSCLC and were randomly prescribed neoadjuvant therapy. Those in the neoadjuvant immunotherapy group received two cycles of nivolumab (3 mg/kg) and those in the control group received neoadjuvant chemotherapy (1,000 mg/m 2 gemcitabine and 80 mg/m 2 cisplatin). All patients were scheduled to undergo surgery. The primary endpoint was the risk of major complications within 30 days of surgery and the secondary endpoints were interval to surgery and 30-day mortality.Results: A total of 107 eligible patients were evaluated of whom 25 were allocated to the neoadjuvant immunotherapy group and 82 to the neoadjuvant chemotherapy group. The median interval to surgery was similar in the two groups at 29.2 days [95% confidence interval (CI), 27.1 to 31.4 days] in the immunotherapy group and 28.7 days (95% CI, 27.6 to 29.8 days) in the chemotherapy group (P=0.656). While treatmentrelated adverse events were reported in most patients, all 25 patients completed two cycles of neoadjuvant immunotherapy and 80 of 82 patients completed two cycles of neoadjuvant chemotherapy, although one patient in the latter group died within 30 days of surgery. There was no statistically significant difference between the groups in the probability of grade 3 or higher postoperative complications within 30 days after surgery (P=0.757).Conclusions: Most patients achieved the primary and secondary endpoints of the study. However, the major pathological response (MPR) showed statistically significant differences between the neoadjuvant immunotherapy and neoadjuvant chemotherapy groups.

Neoadjuvant Nivolumab and Chemotherapy in Patients with Locally Advanced Non-Small Cell Lung Cancer: A Retrospective Study

“…25 In addition, immune-related AEs were well monitored and managed, which is consistent with the findings on immunotherapy in a series of studies. 18,19,26 Subgroup analysis demonstrated that patients with negative PD-L1 expression did not have worse radiological or pathological responses and survival benefit. In another words, patients benefited from neoadjuvant chemoimmunotherapy regardless of PD-L1 expression, which was consistent with the findings of several studies.…”

“…A meta-analysis showed that neoadjuvant chemotherapy had a significant survival benefit for patients with NSCLC, with a 5-year OS benefit increased by 5%. 6 Huang et al reported a better pathological response in neoadjuvant immunotherapy compared with neoadjuvant chemotherapy in stage III (N2) NSCLC, 18 with a MPR of 12.8% and a pCR of 2.6% in the neoadjuvant chemotherapy group. In terms of neoadjuvant chemoradiotherapy, a retrospective multi-institutional Phase II study compared the pathological responses of neoadjuvant chemotherapy or chemoradiotherapy in stage III (N2) NSCLC, 28 which reported a MPR of 54.5% in the tumor and 80% downstaging in the neoadjuvant chemoradiotherapy group, and 9.5% and 33.3% in the neoadjuvant chemotherapy group, respectively.…”

“…Recently, several retrospective studies reported that induction ICI-chemotherapy may be a valid treatment in patients with resectable or locally advanced NSCLC. [17][18][19] Our study was aimed to retrospectively evaluate the feasibility, safety, and survival outcomes of neoadjuvant nivolumab in combination with standard chemotherapy for patients with locally advanced (stage IIIA-IIIB) NSCLC patients in the real-world setting.…”

Meta-Analysis of Neoadjuvant Immunotherapy for Patients with Resectable Non-Small Cell Lung Cancer

“…A total of 4143 references were identified through the electronic search; 2914 potentially relevant articles remained for screening after the removal of duplicated studies. After applying the selection criteria, 33 studies remained for full assessment, and 18 publications from 16 studies were selected for quantitative analysis [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. Two publications reported on the same trials with a focus on different clinical outcomes [6,7,12,13].…”

“…Pathological response outcomes were reported as 'major pathological response' (MPR) when less than 10% of the viable tumor was identified in the primary lesion, and 'complete pathological response' (pCR) when no viable tumor was identified. However, some studies specifically reported pCR when both the primary lesion as well as the sampled lymph nodes were free from any viable tumor [5][6][7]9,10,[12][13][14]17,19,22], whereas others did not specify if nodal assessments were performed for pathological responses [8,11,15,16,18,20,21]. In addition, two studies defined MPR and pCR as being mutually exclusive, whereby patients who achieved a complete pathological response were not included within the group defined as a major pathological response [9,21].…”