Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study

Huang, Jing; Xu, Jianming; Chen, Yun; Zhuang, W.; Zhang, Yiping; Chen, Zhendong; Chen, Jia; Zhang, Helong; Niu, Zuoxing; Fan, Qingxia; Lin, Lizhu; Gu, Kai; Liu, Ying; Ba, Yi; Miao, Zhanhui; Jiang, Xiaodong; Zeng, Ming; Chen, Jianhua; Fu, Zhichao; Gan, Lu; Wang, Jun; Zhan, Xi; Liu, Tianshu; Li, Zhiping; Shen, Lin; Shu, Yongqian; Zhang, Tao; Yang, Qing; Zou, Jianjun; Luo, Suxia; Peng, Feng; Wu, Gang; Xu, Nong; Zhao, Lin; Ma, Ding; Qin, Shukui; Ren, Wei; Li, Enxiao; Lu, Hongda; Pan, Yueyin; Xiong, Jianping; Yuan, Ying; Bai, Yuxian; Chen, Lei; Hu, Yi; Zhang, Li; Gao, Yong

doi:10.1016/s1470-2045(20)30110-8

Cited by 446 publications

(611 citation statements)

References 22 publications

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“…Unsimilar to the trend of pyrexia risk, the majority of febrile neutropenia incidents were of grades 3-5 (7, 11, 13, 15, 16, 18, 19, 23-25, 28-31, 33, 35). Compared to chemotherapy, the risk of febrile neutropenia for all-grade fever was significantly lower in the PD-1/PD-L1 inhibitor group (OR = 0.02, 95% CI: 0.01, 0.05; Figure 5B) (7,11,18,19,23,24,28,30,31,33). A similar trend could also be found for grades 3-5 (OR = 0.02, 95% CI: 0.01, 0.05; Figure 6B) (7,11,18,19,23,24,28,30,31,33).…”

Section: Discussionsupporting

confidence: 61%

“…Compared to chemotherapy, the risk of febrile neutropenia for all-grade fever was significantly lower in the PD-1/PD-L1 inhibitor group (OR = 0.02, 95% CI: 0.01, 0.05; Figure 5B) (7,11,18,19,23,24,28,30,31,33). A similar trend could also be found for grades 3-5 (OR = 0.02, 95% CI: 0.01, 0.05; Figure 6B) (7,11,18,19,23,24,28,30,31,33). On the other hand, statistically significant differences were found in other groups (Figures 5A,C, 6A,C) (13,15,16,25,29,35).…”

Section: Discussionmentioning

confidence: 98%

“…Sixteen clinical trials reported data of febrile neutropenia and were included in the final comprehensive meta-analysis (7, 11, 13, 15, 16, 18, 19, 23-25, 28-31, 33, 35). The data were divided into three groups according to the treatment regimen: group A (PD-1/PD-L1 inhibitor + chemotherapy vs. chemotherapy) (13,15,16,25), group B (PD-1/PD-L1 inhibitor vs. chemotherapy) (7,11,18,19,23,24,28,30,31,33), and group C (PD-1/PD-L1 inhibitor + CTLA-4 vs. CTLA-4) (29,35). Then, the risk of febrile neutropenia for all grades and grades 3-5 was checked.…”

Section: The Risk Of Febrile Neutropeniamentioning

confidence: 99%

“…No heterogeneity was found. The corresponding plots are provided in Supplementary Figures 5B, 6B (7,11,18,19,23,24,28,30,31,33).…”

Section: The Risk Of Febrile Neutropeniamentioning

confidence: 99%

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Systematic Assessment of Risk of Fever in Solid Tumor Patients Treated With PD-1/PD-L1 Inhibitors: A Systematic Review and Meta-Analysis

Wang

et al. 2020

Front. Oncol.

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Purpose: Drug-induced fever is frequently reported in cancer patients treated with anti-programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1), and stoppage of the offending agent is the management of choice. However, given the complex management of cancer patients, this needs to be carefully studied. Therefore, we conducted a meta-analysis to estimate the risk of fever associated with anti-PD-1/PD-L1 in cancer patients. Methods: From May 2010 to 2020, an electronic search was conducted through PubMed for relevant studies. All clinical trials reporting fever in cancer patients treated with PD-1/PD-L1 inhibitors were included, while other designs were excluded. A manual search was also conducted to search for relevant articles. Outcomes included the risk of pyrexia and febrile neutropenia in the overall population and based on the grade of fever (all grades vs. grades 3-5). The Newcastle-Ottawa Scale was used to assess the quality of included studies. Results: Thirty-one articles, involving 27 clinical trials and 15,867 participants, were included. The increased risk of pyrexia for all grades is only found when PD-1/PD-L1 plus cytotoxic T lymphocyte-associated protein 4 (CTLA-4) was compared to CTLA-4 [odds ratio (OR) = 2.48, 95% CI: 1.17, 5.23]. The risk of febrile neutropenia for all-grade fever was significantly lower in the PD-1/PD-L1 group compared to that of chemotherapy alone (OR = 0.02, 95% CI: 0.01, 0.05). A similar trend in the risk of febrile neutropenia was also found for grades 3-5 (OR = 0.02, 95% CI: 0.01, 0.05). Conclusion: The increased risk of pyrexia for all grades could only be found when PD-1/PD-L1 plus CTLA-4 was compared with CTLA-4. Meanwhile, compared to chemotherapy, PD-1/PD-L1 inhibitors reduced the risk of febrile neutropenia.

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Section: Discussionsupporting

confidence: 61%

Section: Discussionmentioning

confidence: 98%

Section: The Risk Of Febrile Neutropeniamentioning

confidence: 99%

“…No heterogeneity was found. The corresponding plots are provided in Supplementary Figures 5B, 6B (7,11,18,19,23,24,28,30,31,33).…”

Section: The Risk Of Febrile Neutropeniamentioning

confidence: 99%

See 2 more Smart Citations

Systematic Assessment of Risk of Fever in Solid Tumor Patients Treated With PD-1/PD-L1 Inhibitors: A Systematic Review and Meta-Analysis

Wang

et al. 2020

Front. Oncol.

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“…Up-regulation of the expression of CD94/NK group 2 member A (NKG2A) by these immune cells suggested a functional exhaustion of cytotoxic lymphocytes in the development of COVID-19 ( Zheng et al 2020 ). These features can result in high mortality and more severity of the disease ( Chan et al 2020 ; Huang et al 2020 ; Qin et al 2020 ).…”

Section: Druggable Targets In Covid-19-host Signaling Pathwaysmentioning

confidence: 99%

Repurposing anticancer drugs for the management of COVID-19

Bairi

Trapani

Petrillo

et al. 2020

European Journal of Cancer

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Since its outbreak in the last December, coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has rapidly spread worldwide at a pandemic proportion, thus regarded as a global public health emergency. The existing therapeutic options for COVID-19 beyond the intensive supportive care are limited, with an undefined or modest efficacy reported so far. Drug repurposing represents an enthusiastic mechanism to use approved drugs outside the scope of their original indication and accelerate the discovery of new therapeutic options. With the emergence of COVID-19, drug repurposing has been largely applied for early clinical testing. In this Review , we discuss some repurposed anticancer drugs for the treatment of COVID-19 and under investigation in clinical trials or proposed for the clinical testing. .

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Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Luo

Bai

et al. 2021

JAMA

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IMPORTANCE Standard first-line therapy for advanced or metastatic esophageal carcinoma is chemotherapy, but the prognosis remains poor. Camrelizumab (an anti-programmed death receptor 1 [PD-1] antibody) showed antitumor activity in previously treated advanced or metastatic esophageal squamous cell carcinoma.OBJECTIVE To evaluate the efficacy and adverse events of camrelizumab plus chemotherapy vs placebo plus chemotherapy as a first-line treatment in advanced or metastatic esophageal squamous cell carcinoma. DESIGN, SETTING, AND PARTICIPANTSThis randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (ESCORT-1st study) enrolled patients from 60 hospitals in China between December 3, 2018, and May 12, 2020 (final follow-up, October 30, 2020. A total of 751 patients were screened and 596 eligible patients with untreated advanced or metastatic esophageal squamous cell carcinoma were randomized.INTERVENTIONS Patients were randomized 1:1 to receive either camrelizumab 200 mg (n = 298) or placebo (n = 298), combined with up to 6 cycles of paclitaxel (175 mg/m 2 ) and cisplatin (75 mg/m 2 ). All treatments were given intravenously every 3 weeks. MAIN OUTCOMES AND MEASURESCoprimary end points were overall survival (significance threshold, 1-sided P < .02) and progression-free survival (significance threshold, 1-sided P < .005). RESULTSOf the 596 patients randomized (median age, 62 years [interquartile range, 56-67 years]; 523 men [87.8%]), 1 patient in the placebo-chemotherapy group did not receive planned treatment. A total of 490 patients (82.2%) had discontinued the study treatment. The median follow-up was 10.8 months. The overall survival for the camrelizumabchemotherapy group was a median of 15.3 months (95% CI, 12.8-17.3; 135 deaths) vs a median of 12.0 months (95% CI, 11.0-13.3; 174 deaths) for the placebo-chemotherapy group (hazard ratio [HR] for death, 0.70 [95% CI, 0.56-0.88]; 1-sided P = .001). Progression-free survival for camrelizumab plus chemotherapy was a median of 6.9 months (95% CI, 5.8-7.4; 199 progression or deaths) vs 5.6 months (95% CI, 5.5-5.7; 229 progression or deaths) for the placebo-chemotherapy group (HR for progression or death, 0.56 [95% CI, 0.46-0.68]; 1-sided P < .001). Treatment-related adverse events of grade 3 or higher occurred in 189 patients (63.4%) in the camrelizumab-chemotherapy group and 201 (67.7%) in the placebo-chemotherapy group, including treatment-related deaths among 9 patients (3.0%) and 11 patients (3.7%), respectively.CONCLUSIONS AND RELEVANCE Among patients with advanced or metastatic esophageal squamous cell carcinoma, the addition of camrelizumab to chemotherapy, compared with placebo and chemotherapy, significantly improved overall survival and progression-free survival.

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Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study

Cited by 446 publications

References 22 publications

Systematic Assessment of Risk of Fever in Solid Tumor Patients Treated With PD-1/PD-L1 Inhibitors: A Systematic Review and Meta-Analysis

Systematic Assessment of Risk of Fever in Solid Tumor Patients Treated With PD-1/PD-L1 Inhibitors: A Systematic Review and Meta-Analysis

Repurposing anticancer drugs for the management of COVID-19

Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma

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