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

Sun, Chao; Liu, Yunpeng; Zhang, Peng; Xu, Wenrong; Xu, Yinghui; Lin, Xingyu; Ma, Xiaobo; Guo, Ye; Qiu, Shi; Shao, Guoguang; Yang, Zhiyong; Ma, Kewei

doi:10.1007/s00432-021-03896-w

Cited by 17 publications

(28 citation statements)

References 32 publications

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“…In this study, the MPR rate was 62.5%, which demonstrates the ideal effect of neoadjuvant sintilimab plus chemotherapy. This MPR rate is consistent with that reported by Sun et al (62.5%) and is higher than that reported by Zhang et al (43.3%) ( 14 , 15 ). The PCR rates reported by Sun et al and Zhang et al reached 31% and 20%, respectively, whereas none of the patients in our study reached PCR ( 14 , 15 ).…”

Section: Discussionsupporting

confidence: 93%

“…This MPR rate is consistent with that reported by Sun et al (62.5%) and is higher than that reported by Zhang et al (43.3%) ( 14 , 15 ). The PCR rates reported by Sun et al and Zhang et al reached 31% and 20%, respectively, whereas none of the patients in our study reached PCR ( 14 , 15 ). This inconsistency can be explained by the different chemotherapy regimens and cycles.…”

Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 91%

“…This inconsistency can be explained by the different chemotherapy regimens and cycles. In our study, the proportion of patients who received one, two, and three cycles of treatment before surgery was 12.5%, 75%, and 12.5%, respectively, compared with 0%, 35%, and 65% in Sun et al and 2%, 72%, and 20% in Zhang et al (14,15). In addition, 6% of the patients in Zhang et al received four cycles of treatment (14).…”

Section: Discussionmentioning

confidence: 48%

“…Sintilimab, as a PD-1 inhibitor from China, is reportedly tolerable for patients and has achieved a 40.5% major pathological response (MPR) rate in neoadjuvant therapy for stage IA–IIIB NSCLC ( 13 ). Recently, two phase 2 trials reported its safety and feasibility when combined with chemotherapy for resectable stage IIIA/IIIB NSCLC ( 14 , 15 ). However, the number of cases enrolled in these two studies was small and more cases are essential to better identify the efficiency of sintilimab combined with on stage III NSCLC.…”

Section: Introductionmentioning

confidence: 99%

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Short-term outcomes of neoadjuvant sintilimab with chemotherapy in stage III non-small cell lung cancer: a case series

Fan¹,

Wang²,

Zhao³

et al. 2022

Transl Cancer Res TCR

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Background: Neoadjuvant chemoimmunotherapy seems to be a promising treatment option for stage III non-small cell lung cancer (NSCLC). Sintilimab, as a programmed death receptor-1 inhibitor, has exhibited a fine performance in treating NSCLC. However, the efficiency of sintilimab combined with chemotherapy for stage IIIA/IIIB NSCLC remains inconclusive. The purpose of this study was to share our experience on sintilimab in neoadjuvant chemoimmunotherapy for stage III NSCLC.Methods: This study retrospectively reviewed patients who received surgical resection following 1-3 cycles of neoadjuvant sintilimab (200 mg) with chemotherapy for stage III NSCLC between June 2020 and March 2022 in our center. Patients characteristics, surgical factors, surgery-related complications 30 days postoperatively, and treatment-related adverse events (TRAEs) before surgery were recorded through reviewing medical record data and telephone follow-up.Results: A total of eight patients were enrolled, including six cases of squamous cell carcinoma and two cases of adenocarcinoma. All of the patients received 1-3 cycles of neoadjuvant therapy. There were no treatment-related surgical delays. All patients underwent lobectomy, among which two underwent sleeve lobectomy and one received bronchoplasty. Five patients underwent open thoracotomy. Fibrosis of the primary tumor and lymph nodes was observed in all the cases. There were no surgery-related complications > grade 2 at 30 days postoperatively. According to the radiographic findings, one patient had stable disease and all of the others achieved a partial response. The median of maximum standardized uptake value change from baseline was a 52.75% reduction (range, 37.2-68.8%). Five patients achieved a major pathological response. R0 resection was achieved in all eight cases. One grade 4 event was observed. Neutropenia was the most common TRAE > grade 2 (3/8). There were no cases of treatment discontinuation or dose reduction due to TRAEs. Conclusions:The current study found that neoadjuvant sintilimab plus chemotherapy bring a high rate of major pathological response and acceptable TRAEs. Even though it increased the difficulties of surgery, there is still no evidence suggesting that it will brings additional surgical death. We believe that neoadjuvant sintilimab plus chemotherapy might be feasible for stage III NSCLC.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 48%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Short-term outcomes of neoadjuvant sintilimab with chemotherapy in stage III non-small cell lung cancer: a case series

Fan¹,

Wang²,

Zhao³

et al. 2022

Transl Cancer Res TCR

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Neoadjuvant Chemoimmunotherapy for NSCLC

Sorin,

Prosty,

Ghaleb

et al. 2024

JAMA Oncol

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ImportanceTo date, no meta-analyses have comprehensively assessed the association of neoadjuvant chemoimmunotherapy with clinical outcomes in non–small cell lung cancer (NSCLC) in randomized and nonrandomized settings. In addition, there exists controversy concerning the efficacy of neoadjuvant chemoimmunotherapy for patients with NSCLC with programmed cell death 1 ligand 1 (PD-L1) levels less than 1%.ObjectiveTo compare neoadjuvant chemoimmunotherapy with chemotherapy by adverse events and surgical, pathological, and efficacy outcomes using recently published randomized clinical trials and nonrandomized trials.Data SourcesMEDLINE and Embase were systematically searched from January 1, 2013, to October 25, 2023, for all clinical trials of neoadjuvant chemoimmunotherapy and chemotherapy that included at least 10 patients.Study SelectionObservational studies and trials reporting the use of neoadjuvant radiotherapy, including chemoradiotherapy, molecular targeted therapy, or immunotherapy monotherapy, were excluded.Main Outcomes and MeasuresSurgical, pathological, and efficacy end points and adverse events were pooled using a random-effects meta-analysis.ResultsAmong 43 eligible trials comprising 5431 patients (4020 males [74.0%]; median age range, 55-70 years), there were 8 randomized clinical trials with 3387 patients. For randomized clinical trials, pooled overall survival (hazard ratio, 0.65; 95% CI, 0.54-0.79; I2 = 0%), event-free survival (hazard ratio, 0.59; 95% CI, 0.52-0.67; I2 = 14.9%), major pathological response (risk ratio, 3.42; 95% CI, 2.83-4.15; I2 = 31.2%), and complete pathological response (risk ratio, 5.52; 95% CI, 4.25-7.15; I2 = 27.4%) favored neoadjuvant chemoimmunotherapy over neoadjuvant chemotherapy. For patients with baseline tumor PD-L1 levels less than 1%, there was a significant benefit in event-free survival for neoadjuvant chemoimmunotherapy compared with chemotherapy (hazard ratio, 0.74; 95% CI, 0.62-0.89; I2 = 0%).Conclusion and RelevanceThis study found that neoadjuvant chemoimmunotherapy was superior to neoadjuvant chemotherapy across surgical, pathological, and efficacy outcomes. These findings suggest that patients with resectable NSCLC with tumor PD-L1 levels less than 1% may have an event-free survival benefit with neoadjuvant chemoimmunotherapy.

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Delayed bronchopleural fistula as a complication of sleeve lobectomy in a patient after induction immuno-chemotherapy

Yao,

Wang,

Yang

et al. 2023

Asian Journal of Surgery

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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

Cited by 17 publications

References 32 publications

Short-term outcomes of neoadjuvant sintilimab with chemotherapy in stage III non-small cell lung cancer: a case series

Short-term outcomes of neoadjuvant sintilimab with chemotherapy in stage III non-small cell lung cancer: a case series

Neoadjuvant Chemoimmunotherapy for NSCLC

Delayed bronchopleural fistula as a complication of sleeve lobectomy in a patient after induction immuno-chemotherapy

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