Dataset Information

[Progress in Neoadjuvant Immunotherapies for Resectable Non-small Cell Lung Cancer].

ABSTRACT: Resectable non-small cell lung cancer (NSCLC) is currently considered as a potentially curable disease. Surgery is still the main treatment mode for resectable NSCLC, but quite a few patients will have local recurrence and distant metastasis after surgery. Therefore, preoperative and postoperative adjuvant therapy may be necessary in order to improve the long term outcome. Immunocheckpoint inhibitor has been demonstrated clinically to be effective andapproved as first- or second-line treatment agent in metastatic NSCLC or partially locally advanced NSCLC. The remarkable efficacy of immunotherapy for advanced lung cancer has attracted more and more attention from the researchers to the role of immunotherapy as neoadjuvent therapy in resectable non-small cell lung cancer. This article systematically reviewed the clinical trials of neoadjuvant immunotherapy for resectable NSCLC before surgery.

SUBMITTER: Wang S

PROVIDER: S-EPMC7260379 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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[Progress in Neoadjuvant Immunotherapies for Resectable Non-small Cell Lung Cancer].

Wang Shuaibo S Mao Yousheng Y

Zhongguo fei ai za zhi = Chinese journal of lung cancer 20200414 5

Resectable non-small cell lung cancer (NSCLC) is currently considered as a potentially curable disease. Surgery is still the main treatment mode for resectable NSCLC, but quite a few patients will have local recurrence and distant metastasis after surgery. Therefore, preoperative and postoperative adjuvant therapy may be necessary in order to improve the long term outcome. Immunocheckpoint inhibitor has been demonstrated clinically to be effective andapproved as first- or second-line treatment a ...[more]

PMID: 32283581

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Project description:We conducted the first trial of neoadjuvant PD-1 blockade in resectable non-small cell lung cancer (NSCLC), finding nivolumab monotherapy to be safe and feasible with an encouraging rate of pathologic response. Building on these results, and promising data for nivolumab plus ipilimumab (anti-CTLA-4) in advanced NSCLC, we expanded our study to include an arm investigating neoadjuvant nivolumab plus ipilimumab. Patients with resectable stage IB (≥4 cm)-IIIA (American Joint Committee on Cancer Tumor Node Metastases seventh edition), histologically confirmed, treatment-naïve NSCLC received nivolumab 3 mg/kg intravenously plus ipilimumab 1 mg/kg intravenously 6 weeks prior to planned resection. Nivolumab 3 mg/kg was given again approximately 4 and 2 weeks preoperatively. Primary endpoints were safety and feasibility with a planned enrollment of 15 patients. Pathologic response was a key secondary endpoint. While the treatment regimen was feasible per protocol, due to toxicity, the study arm was terminated early by investigator consensus after 9 of 15 patients were enrolled. All patients received every scheduled dose of therapy and were fit for planned surgery; however, 6 of 9 (67%) experienced treatment-related adverse events (TRAEs) and 3 (33%) experienced grade ≥3 TRAEs. Three of 9 patients (33%) had biopsy-confirmed tumor progression precluding definitive surgery. Of the 6 patients who underwent resection, 3 are alive and disease-free, 2 experienced recurrence and are actively receiving systemic treatment, and one died postoperatively due to acute respiratory distress syndrome. Two patients who underwent resection had tumor pathologic complete responses (pCRs) and continue to remain disease-free over 24 months since surgery. Pathologic response correlated with pre-treatment tumor PD-L1 expression, but not tumor mutation burden. Tumor KRAS/STK11 co-mutations were identified in 5 of 9 patients (59%), of whom two with disease progression precluding surgery had tumor KRAS/STK11/KEAP1 co-mutations. Though treatment was feasible, due to toxicity the study arm was terminated early by investigator consensus. In light of this, and while the long-term disease-free status of patients who achieved pCR is encouraging, further investigation of neoadjuvant nivolumab plus ipilimumab in patients with resectable NSCLC requires the identification of predictive biomarkers that enrich for response.

Dataset Information

[Progress in Neoadjuvant Immunotherapies for Resectable Non-small Cell Lung Cancer].

Publications

[Progress in Neoadjuvant Immunotherapies for Resectable Non-small Cell Lung Cancer].

Similar Datasets

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