The Neo-PLANET phase II trial of neoadjuvant camrelizumab plus concurrent chemoradiotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction

Tang, Zhaoqing; Wang, Yan; Liú, Dan; Wang, Xuefei; Xu, Chen; Yu, Yiyi; Cui, Yuehong; Tang, Cheng; Li, Qian; Sun, Jing; Zhang, Qian; Ji, Yuan; Ma, Guansheng; Li, Haojie; Shen, Zhenbin; Shen, Kuntang; Zheng, Rongrong; Hou, Zhiguo; Liu, Tianshu; Wang, Jiping; Sun, Yihong

doi:10.1038/s41467-022-34403-5

Cited by 55 publications

(41 citation statements)

References 48 publications

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“…However, PERFECT trail suggested that the combining nCRT with immunotherapy didn't show satisfactory database in patients with EAC (30). In addition, many trails also evaluated the clinical result of neoadjuvant immunotherapy in locally advanced EC patients, and the security of treatment was also analyzed (12,(35)(36)(37)(38)(39)(40). The MPR and pCR for ESCC patients, received surgery, were 52.9%-72.0% and 30.2%-50.0% respectively.…”

Section: Discussionmentioning

confidence: 99%

“…Recent Neo-PLANET trail suggested that neoadjuvant camrelizumab plus nCRT exhibited pCR rate was 33.3% and MPR rate was 44.4% in patients with locally advanced EAC patients, with an acceptable safety profile. Although didn’t reach final survival outcome, Two-year progression free survival (PFS) and over survival (OS) rates were 66.9% and 76.1%, respectively ( 13 ). However, PERFECT trail suggested that the combining nCRT with immunotherapy didn’t show satisfactory database in patients with EAC ( 30 ).…”

Section: Discussionmentioning

confidence: 99%

“…Immune checkpoint inhibitors (ICIs) combined with chemotherapy, as first line, obviously improved survival data of patients with advanced/metastatic esophageal cancer (7)(8)(9)(10)(11). The efficacy of neoadjuvant ICIs combined with nCT has been previously reported in esophageal cancer (12,13). Recent metaanalyses have demonstrated the neoadjuvant ICIs combined with nCT or nCRT had promising clinical result and acceptable safety outcomes for patients with locally advanced EC (14-17).…”

Section: Introductionmentioning

confidence: 88%

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Comparison of neoadjuvant immunotherapy versus routine neoadjuvant therapy for patients with locally advanced esophageal cancer: A systematic review and meta-analysis

et al. 2023

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BackgroundThe neoadjuvant use of immune checkpoint inhibitor combined with chemotherapy (nICT) or chemoradiotherapy (nICRT) in locally advanced esophageal cancer (EC) is currently an area of active ongoing research. Therefore, we carried out a comprehensive meta-analysis to compare the efficacy and safety of the new strategy with routine neoadjuvant strategy, which included neoadjuvant chemotherapy (nCT) and neoadjuvant chemoradiotherapy (nCRT).Patients and methodsMEDLINE (via PubMed), Embase (via OVID), ISI Web of Science database and Cochrane Library were included. And, all of them were searched for eligible studies between January, 2000 and February, 2023. The pathological complete response (pCR) and major pathological response (MPR) were primary outcome of our study. The second outcome of interest was R0 resection rate. Odds ratio (OR) and associated 95% CI were used as the effect indicators comparing the safety and efficiency of the neoadjuvant immunotherapy with the routine neoadjuvant therapy. Fixed-effect model (Inverse Variance) or random-effect model (Mantel-Haenszel method) was performed depending on the statistically heterogeneity.ResultsThere were eight trials with 652 patients were included in our meta-analysis. The estimated pCR rate was higher in the neoadjuvant immunotherapy group (OR =1.86; 95% CI, 1.25–2.75; I2 = 32.8%, P=0.166). The different results were found in the esophageal squamous cell carcinoma (ESCC) and esophageal adenocarcinoma (EAC) subgroups, the estimated OR was 2.35 (95%CI, 1.00–2.72; I2 = 30.9%, P=0.215) in the EAC subgroup, and 2.35 (95% CI, 1.20–4.54; I2 = 45.3%, P=0.161) in the ESCC subgroup, respectively. The neoadjuvant immunotherapy also showed the advantage in the MPR rates (OR =2.66; 95% CI, 1.69–4.19; I2 = 24.3%, P=0.252). There was no obvious difference between the neoadjuvant immunotherapy and routine neoadjuvant therapy with respect to surgical resection rate, R0 resection rate, surgical delay rate; while more treatment-related adverse events were observed for the neoadjuvant immunotherapy for pneumonitis/pneumonia (OR=3.46, 95% CI, 1.31–9.16; I2 = 67.3%, P=0.005) and thyroid dysfunction (OR=4.69, 95% CI, 1.53–14.36; I2 = 56.5%, P=0.032).ConclusionThe pooled correlations indicated that the neoadjuvant immunotherapy (both nICT and nICRT) could significantly increase the rates of pCR and MPR, compared with routine neoadjuvant therapy (both nCT and nCRT) in the treatment of locally advanced EC. The neoadjuvant immunotherapy and routine neoadjuvant therapy were with acceptable toxicity. However, randomized studies with larger groups of patients need to performed to confirm these results.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42020155802.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 88%

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Comparison of neoadjuvant immunotherapy versus routine neoadjuvant therapy for patients with locally advanced esophageal cancer: A systematic review and meta-analysis

et al. 2023

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“…Accumulating evidence has shown that neoadjuvant therapy can effectively improve the clinical outcomes of EGC patients such as large clinical trials CheckMate 577 [12], PRODIGY [13], and CROSS [14]. Combined neoadjuvant immunotherapy and chemoradiotherapy have also demonstrated favorable efficacy and safety [15]. However, whether neoadjuvant therapy affects the number of dissected LNs remains unclear.…”

Section: Introductionmentioning

confidence: 99%

Impacts of neoadjuvant therapy on the number of dissected lymph nodes in esophagogastric junction cancer patients

Wang

et al. 2023

BMC Gastroenterol

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Background Neoadjuvant therapy favors the prognosis of various cancers, including esophagogastric junction cancer (EGC). However, the impacts of neoadjuvant therapy on the number of dissected lymph nodes (LNs) have not yet been evaluated in EGC. Methods We selected EGC patients from the Surveillance, Epidemiology, and End Results (SEER) database (2006–2017). The optimal number of resected LNs was determined using X-tile software. Overall survival (OS) curves were plotted with the Kaplan–Meier method. Prognostic factors were evaluated using univariate and multivariate COX regression analyses. Results Neoadjuvant radiotherapy significantly decreased the mean number of LN examination compared to the mean number of patients without neoadjuvant therapy (12.2 vs. 17.5, P = 0.003). The mean LN number of patients with neoadjuvant chemoradiotherapy was 16.3, which was also statistically lower than 17.5 (P = 0.001). In contrast, neoadjuvant chemotherapy caused a significant increase in the number of dissected LNs (21.0, P < 0.001). For patients with neoadjuvant chemotherapy, the optimal cutoff value was 19. Patients with > 19 LNs had a better prognosis than those with 1–19 LNs (P < 0.05). For patients with neoadjuvant chemoradiotherapy, the optimal cutoff value was 9. Patients with > 9 LNs had a better prognosis than those with 1–9 LNs (P < 0.05). Conclusions Neoadjuvant radiotherapy and chemoradiotherapy decreased the number of dissected LNs, while neoadjuvant chemotherapy increased it in EGC patients. Hence, at least 10 LNs should be dissected for neoadjuvant chemoradiotherapy and 20 for neoadjuvant chemotherapy, which could be applied in clinical practice.

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“…Although there is no indication for camrelizumab in GC, camrelizumab in combination with chemotherapy in first-line therapy of GC followed by camrelizumab plus apatinib maintenance therapy achieved favorable results in phase II study ( 7 ). There has also been recent clinical study ( 8 ) of neoadjuvant camrelizumab plus concurrent chemoradiotherapy exhibits promising pathological response in patients with locally advanced gastric adenocarcinoma, with an acceptable safety profile.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of camrelizumab plus chemotherapy versus chemotherapy alone in patients with untreated, HER2-negative, unresectable locally advanced, or metastatic gastric cancer or gastroesophageal junction cancer: a retrospective comparative cohort study

Xiang

Gong

Sun

et al. 2022

J Gastrointest Oncol

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Background: Nivolumab combined with chemotherapy has been shown to improve prognosis in patients with untreated, human epidermal growth factor receptor 2 (HER2)-negative advanced gastric cancer (GC) and programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥5. However, the available firstline treatment options for advanced GC are limited. Analysis of efficacy and safety of other programmed cell death protein 1 (PD-1) antibodies combined with chemotherapy may provide alternative treatment options.Methods: This retrospective study included patients with untreated, HER2-negative, unresectable locally advanced, or metastatic GC or gastroesophageal junction (GEJ) cancer who received either camrelizumab combined with oxaliplatin plus S-1 (SOX)/capecitabine plus oxaliplatin (CapeOX) or SOX/CapOX alone between November 2020 and April 2022. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety were evaluated.Results: This study included 49 patients in camrelizumab plus chemotherapy group and 54 in chemotherapy group. The baseline clinical characteristics beyond Epstein-Barr virus (EBV) status and PD-L1 CPS had no difference between combination group and chemotherapy group. ORR and DCR were significantly higher in combination therapy group than in chemotherapy group (59.18% vs. 38.89%, P=0.048; 83.67% vs. 62.96%, P=0.018). The median PFS in combination group was significantly longer than chemotherapy group [10.03 vs. 6.24 months, hazard ratio (HR) 0.603, 95% confidence interval (CI): 0.368-0.989, P=0.045]. The OS was not mature at the time of the OS analysis, with 40% patients died. Subgroup analyses showed that PFS was longer in patients with PD-L1 CPS ≥1 compared with CPS <1 and in patients with a neutrophil-lymphocyte ratio (NLR) <2.38 compared with ≥2.38. The most common grade 3-4 treatment-related adverse events (TRAEs) were granulocytopenia (57% in combination group vs. 54% in chemotherapy group), anemia (39% vs. 33%, respectively), and thrombocytopenia (39% vs. 33%, respectively). The proportion of reactive cutaneous capillary endothelial proliferation (RCCEP, 73% vs. 0%) was higher in combination group relative to chemotherapy group; all were grades 1-2.

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The Neo-PLANET phase II trial of neoadjuvant camrelizumab plus concurrent chemoradiotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction

Cited by 55 publications

References 48 publications

Comparison of neoadjuvant immunotherapy versus routine neoadjuvant therapy for patients with locally advanced esophageal cancer: A systematic review and meta-analysis

Comparison of neoadjuvant immunotherapy versus routine neoadjuvant therapy for patients with locally advanced esophageal cancer: A systematic review and meta-analysis

Impacts of neoadjuvant therapy on the number of dissected lymph nodes in esophagogastric junction cancer patients

Efficacy and safety of camrelizumab plus chemotherapy versus chemotherapy alone in patients with untreated, HER2-negative, unresectable locally advanced, or metastatic gastric cancer or gastroesophageal junction cancer: a retrospective comparative cohort study

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