Efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy for resectable non-small cell lung cancer_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

YANG Dongbao ¹ , ZHONG Kaize ² , MA Hongmei ² , ZHANG Shifa ² , LIU Hongfeng ² , CHEN Liji ¹ , ZHANG Jishen ¹ ,  CAI Haibo ²

1. Jining Medical University, Jining, 272000, Shandong, P. R. China;
2. Department of Thoracic Surgery, The First People's Hospital of Jining, Jining, 272000, Shandong, P. R. China;

Corresponding?author：

CAI Haibo, Email: 13518670801@163.com

Keywords：

Non-small cell lung cancer; neoadjuvant therapy; immunotherapy; chemotherapy; pathological reaction; surgery

DOI：

10.7507/1007-4848.202406013

Video：

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Objective To explore the efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in patients with locally advanced resectable non-small cell lung cancer (NSCLC). Methods The clinical data of patients with stage ⅡA-ⅢB NSCLC who underwent surgical treatment after receiving neoadjuvant immunotherapy combined with chemotherapy or chemotherapy alone at the First People’s Hospital of Jining between April 2021 and January 2024 were retrospectively analyzed. According to the preoperative neoadjuvant regimens, the patients were divided into a combined group and a chemotherapy group, and the clinical data of the two groups were compared. Results A total of 66 patients were included, including 61 males and 5 females. There were 53 patients in the combined group with a mean age of (63.40±6.80) years, and 13 patients in the chemotherapy group with a mean age of (58.62±8.30) years. There was a statistical difference in age between the two groups (P＜0.001), while no statistical difference was observed in other baseline data (P>0.05). The major pathological response rates in the combined group and the chemotherapy group were 54.7% and 23.1%, respectively (P=0.041), and the pathological complete response rates were 39.6% and 0.0%, respectively (P=0.006). The operative time in the combined group was shorter (P=0.039). There were no statistical differences between the two groups in intraoperative blood loss, duration of postoperative tube carrying, incidence of postoperative complications, overall survival, or event-free survival (P>0.05). Conclusion Surgical treatment following neoadjuvant immunotherapy combined with chemotherapy is safe and feasible, and its long-term efficacy requires further follow-up for confirmation.

Citation： YANG Dongbao, ZHONG Kaize, MA Hongmei, ZHANG Shifa, LIU Hongfeng, CHEN Liji, ZHANG Jishen, CAI Haibo. Efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy for resectable non-small cell lung cancer. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2026, 33(6): 920-926. doi: 10.7507/1007-4848.202406013 Copy

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3.	NSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data. Lancet, 2014, 383(9928): 1561-1571.
4.	Pless M, Stupp R, Ris HB, et al. Induction chemoradiation in stage ⅢA/N2 non-small-cell lung cancer: a phase 3 randomised trial. Lancet, 2015, 386(9998): 1049-1056.
5.	Forde PM, Spicer J, Lu S, et al. Neoadjuvant nivolumab plus chemotherapy in resectable lung cancer. N Engl J Med, 2022, 386(21): 1973-1985.
6.	Wakelee H, Liberman M, Kato T, et al. Perioperative pembrolizumab for early-stage non-small-cell lung cancer. N Engl J Med, 2023, 389(6): 491-503.
7.	Heymach JV, Harpole D, Mitsudomi T, et al. Perioperative durvalumab for resectable non-small-cell lung cancer. N Engl J Med, 2023, 389(18): 1672-1684.
8.	Cascone T, Awad MM, Spicer JD, et al. LBA1 CheckMate 77T: phase Ⅲ study comparing neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) vs neoadjuvant placebo plus chemo followed by surgery and adjuvant NIVO or placebo for previously untreated, resectable stage Ⅱ–Ⅲb NSCLC. Ann Oncol, 2023, 34(suppl_2): S1295.
9.	Lu S, Zhang W, Wu L, et al. Perioperative toripalimab plus chemotherapy for patients with resectable non-small cell lung cancer: the neotorch randomized clinical trial. JAMA, 2024, 331(3): 201-211.
10.	Yue D, Wang W, Liu H, et al. LBA58 pathological response to neoadjuvant tislelizumab (TIS) plus platinum-doublet (PtDb) chemotherapy (CT) in resectable stage Ⅱ-ⅢA NSCLC patients (pts) in the phase Ⅲ (Ph3) RATIONALE-315 trial. Ann Oncol, 2023, 34: S1299.
11.	O'Brien M, Paz-Ares L, Marreaud S, et al. Pembrolizumab versus placebo as adjuvant therapy for completely resected stage ⅠB-ⅢA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial. Lancet Oncol, 2022, 23(10): 1274-1286.
12.	Felip E, Altorki N, Zhou C, et al. Overall survival with adjuvant atezolizumab after chemotherapy in resected stage Ⅱ-ⅢA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase Ⅲ trial. Ann Oncol, 2023, 34(10): 907-919.
13.	Blank CU, Rozeman EA, Fanchi LF, et al. Neoadjuvant versus adjuvant ipilimumab plus nivolumab in macroscopic stage Ⅲ melanoma. Nat Med, 2018, 24(11): 1655-1661.
14.	Lee JM, Tsuboi M, Brunelli A. Surgical perspective on neoadjuvant immunotherapy in non-small cell lung cancer. Ann Thorac Surg, 2022, 114(4): 1505-1515.
15.	Patel SP, Othus M, Chen Y, et al. Neoadjuvant-adjuvant or adjuvant-only pembrolizumab in advanced melanoma. N Engl J Med, 2023, 388(9): 813-823.
16.	Lee JM, Kim AW, Marjanski T, et al. Important surgical and clinical end points in neoadjuvant immunotherapy trials in resectable NSCLC. JTO Clin Res Rep, 2021, 2(10): 100221.
17.	Lei J, Zhao J, Gong L, et al. Neoadjuvant camrelizumab plus platinum-based chemotherapy vs chemotherapy alone for Chinese patients with resectable stage ⅢA or ⅢB (T3N2) non-small cell lung cancer: the TD-FOREKNOW randomized clinical trial. JAMA Oncol, 2023, 9(10): 1348-1355.
18.	Sun C, Liu Y, Zhang P, et al. Interim analysis of the efficiency and safety of neoadjuvant PD-1 inhibitor (sintilimab) combined with chemotherapy (nab-paclitaxel and carboplatin) in potentially resectable stage ⅢA/ⅢB non-small cell lung cancer: a single-arm, phase 2 trial. J Cancer Res Clin Oncol, 2023, 149(2): 819-831.
19.	Spicer J, Forde PM, Provencio M, et al. Clinical outcomes with neoadjuvant nivolumab (N) + chemotherapy (C) vs C by definitive surgery in patients (pts) with resectable NSCLC: 3-y results from the phase 3 CheckMate 816 trial. J Clin Oncol, 2023, 41(suppl_16): 8521-8521.
20.	Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage Ⅲ non-small-cell lung cancer. N Engl J Med, 2017, 377(20): 1919-1929.
21.	Solomon B, Ahn JS, Dziadziuszko R, et al. LBA2 ALINA: efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ non-small cell lung cancer (NSCLC). Ann Oncol, 2023, 34(suppl_2): S1254-S1335.
22.	Tsuboi M, Herbst RS, John T, et al. Overall survival with osimertinib in resected EGFR-mutated NSCLC. N Engl J Med, 2023, 389(2): 137-147.
23.	Jardim DL, Goodman A, de Melo Gagliato D, et al. The challenges of tumor mutational burden as an immunotherapy biomarker. Cancer Cell, 2021, 39(2): 154-173.
24.	Ricciuti B, Wang X, Alessi JV, et al. Association of high tumor mutation burden in non-small cell lung cancers with increased immune infiltration and improved clinical outcomes of PD-L1 blockade across PD-L1 expression levels. JAMA Oncol, 2022, 8(8): 1160-1168.
25.	Rizvi NA, Hellmann MD, Snyder A, et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science, 2015, 348(6230): 124-128.
26.	Castellanos E, Snider J, Ali SM, et al. Tumor mutational burden (TMB) and PD-L1 expression as predictors of response to immunotherapy (IO) in NSCLC. J Clin Oncol, 2019, 37(suppl_15): 2630.
27.	Felip E, Srivastava M, Reck M, et al. MA11.08 IMpower010: exploratory analysis of tumour mutational burden and disease-free survival with adjuvant atezolizumab in NSCLC . J Thorac Oncol, 2023, 18(suppl_11): S139.

1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2024, 74(3): 229-263.
2. Goldstraw P, Chansky K, Crowley J, et al. The IASLC lung cancer staging project: proposals for revision of the TNM stage groupings in the forthcoming (eighth) edition of the TNM classification for lung cancer. J Thorac Oncol, 2016, 11(1): 39-51.
3. NSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data. Lancet, 2014, 383(9928): 1561-1571.
4. Pless M, Stupp R, Ris HB, et al. Induction chemoradiation in stage ⅢA/N2 non-small-cell lung cancer: a phase 3 randomised trial. Lancet, 2015, 386(9998): 1049-1056.
5. Forde PM, Spicer J, Lu S, et al. Neoadjuvant nivolumab plus chemotherapy in resectable lung cancer. N Engl J Med, 2022, 386(21): 1973-1985.
6. Wakelee H, Liberman M, Kato T, et al. Perioperative pembrolizumab for early-stage non-small-cell lung cancer. N Engl J Med, 2023, 389(6): 491-503.
7. Heymach JV, Harpole D, Mitsudomi T, et al. Perioperative durvalumab for resectable non-small-cell lung cancer. N Engl J Med, 2023, 389(18): 1672-1684.
8. Cascone T, Awad MM, Spicer JD, et al. LBA1 CheckMate 77T: phase Ⅲ study comparing neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) vs neoadjuvant placebo plus chemo followed by surgery and adjuvant NIVO or placebo for previously untreated, resectable stage Ⅱ–Ⅲb NSCLC. Ann Oncol, 2023, 34(suppl_2): S1295.
9. Lu S, Zhang W, Wu L, et al. Perioperative toripalimab plus chemotherapy for patients with resectable non-small cell lung cancer: the neotorch randomized clinical trial. JAMA, 2024, 331(3): 201-211.
10. Yue D, Wang W, Liu H, et al. LBA58 pathological response to neoadjuvant tislelizumab (TIS) plus platinum-doublet (PtDb) chemotherapy (CT) in resectable stage Ⅱ-ⅢA NSCLC patients (pts) in the phase Ⅲ (Ph3) RATIONALE-315 trial. Ann Oncol, 2023, 34: S1299.
11. O'Brien M, Paz-Ares L, Marreaud S, et al. Pembrolizumab versus placebo as adjuvant therapy for completely resected stage ⅠB-ⅢA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial. Lancet Oncol, 2022, 23(10): 1274-1286.
12. Felip E, Altorki N, Zhou C, et al. Overall survival with adjuvant atezolizumab after chemotherapy in resected stage Ⅱ-ⅢA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase Ⅲ trial. Ann Oncol, 2023, 34(10): 907-919.
13. Blank CU, Rozeman EA, Fanchi LF, et al. Neoadjuvant versus adjuvant ipilimumab plus nivolumab in macroscopic stage Ⅲ melanoma. Nat Med, 2018, 24(11): 1655-1661.
14. Lee JM, Tsuboi M, Brunelli A. Surgical perspective on neoadjuvant immunotherapy in non-small cell lung cancer. Ann Thorac Surg, 2022, 114(4): 1505-1515.
15. Patel SP, Othus M, Chen Y, et al. Neoadjuvant-adjuvant or adjuvant-only pembrolizumab in advanced melanoma. N Engl J Med, 2023, 388(9): 813-823.
16. Lee JM, Kim AW, Marjanski T, et al. Important surgical and clinical end points in neoadjuvant immunotherapy trials in resectable NSCLC. JTO Clin Res Rep, 2021, 2(10): 100221.
17. Lei J, Zhao J, Gong L, et al. Neoadjuvant camrelizumab plus platinum-based chemotherapy vs chemotherapy alone for Chinese patients with resectable stage ⅢA or ⅢB (T3N2) non-small cell lung cancer: the TD-FOREKNOW randomized clinical trial. JAMA Oncol, 2023, 9(10): 1348-1355.
18. Sun C, Liu Y, Zhang P, et al. Interim analysis of the efficiency and safety of neoadjuvant PD-1 inhibitor (sintilimab) combined with chemotherapy (nab-paclitaxel and carboplatin) in potentially resectable stage ⅢA/ⅢB non-small cell lung cancer: a single-arm, phase 2 trial. J Cancer Res Clin Oncol, 2023, 149(2): 819-831.
19. Spicer J, Forde PM, Provencio M, et al. Clinical outcomes with neoadjuvant nivolumab (N) + chemotherapy (C) vs C by definitive surgery in patients (pts) with resectable NSCLC: 3-y results from the phase 3 CheckMate 816 trial. J Clin Oncol, 2023, 41(suppl_16): 8521-8521.
20. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage Ⅲ non-small-cell lung cancer. N Engl J Med, 2017, 377(20): 1919-1929.
21. Solomon B, Ahn JS, Dziadziuszko R, et al. LBA2 ALINA: efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ non-small cell lung cancer (NSCLC). Ann Oncol, 2023, 34(suppl_2): S1254-S1335.
22. Tsuboi M, Herbst RS, John T, et al. Overall survival with osimertinib in resected EGFR-mutated NSCLC. N Engl J Med, 2023, 389(2): 137-147.
23. Jardim DL, Goodman A, de Melo Gagliato D, et al. The challenges of tumor mutational burden as an immunotherapy biomarker. Cancer Cell, 2021, 39(2): 154-173.
24. Ricciuti B, Wang X, Alessi JV, et al. Association of high tumor mutation burden in non-small cell lung cancers with increased immune infiltration and improved clinical outcomes of PD-L1 blockade across PD-L1 expression levels. JAMA Oncol, 2022, 8(8): 1160-1168.
25. Rizvi NA, Hellmann MD, Snyder A, et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science, 2015, 348(6230): 124-128.
26. Castellanos E, Snider J, Ali SM, et al. Tumor mutational burden (TMB) and PD-L1 expression as predictors of response to immunotherapy (IO) in NSCLC. J Clin Oncol, 2019, 37(suppl_15): 2630.
27. Felip E, Srivastava M, Reck M, et al. MA11.08 IMpower010: exploratory analysis of tumour mutational burden and disease-free survival with adjuvant atezolizumab in NSCLC . J Thorac Oncol, 2023, 18(suppl_11): S139.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy for resectable non-small cell lung cancer

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