Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial

Zhu, Yujia; Wen, Jing; Li, Qiaoqiao; Chen, Baoqing; Zhao, Lei; Liu, Shiliang; Yang, Yingjie; Wang, Sifen; Lv, Yingxin; Li, Jibin; Zhang, Li; Hu, Yonghong; Liu, Mengzhong; Xi, Mian

doi:10.1016/s1470-2045(23)00060-8

Cited by 43 publications

(18 citation statements)

References 28 publications

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“…To some extent, this suggests that patients receiving ICIs treatment do not experience a pronounced decline in lymphocyte counts during treatment, implying a protective effect of ICIs on lymphocytes. This could be another manifestation of the synergy between radiotherapy and ICIs treatment, which aligns with the ndings of Zhu et al [19] . Therefore, we believe that in the early stages of immunotherapy, lymphocyte counts may temporarily decrease, but if this decline continues over time, it should be a cause for signi cant concern.…”

Section: Discussionsupporting

confidence: 90%

“…bene ts observed in patients with high PD-L1 expression. The relatively higher PFS rates observed in the studies mentioned compared to the current study could potentially be attributed to the inclusion of stage IV patients in the present study [19][20][21] .…”

Section: Discussioncontrasting

confidence: 54%

“…Notably, our cohort included 4 cases of esophageal stula, with an incidence rate of 5.1%. Similarly, Ma et al [35] reported an incidence rate of 3.3% for esophageal stula, Zhu et al [19] observed a 14% incidence rate for grade 2 or 3 esophageal stula (6/42), and Zhang et al [20] reported a 10.5% incidence rate (2/19). ESCC patients who previously underwent radical radiotherapy and combined chemotherapy had esophageal stula incidence rates ranging from 5.6% to 33% [36,37] .…”

Section: Discussionmentioning

confidence: 91%

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First-Line Immunotherapy Combined with Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: A Real World Study

Zhao,

Weng,

Yang

et al. 2024

Preprint

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Backgroud: This study aimed to assess the effectiveness, safety, and recurrence patterns of first-line immunotherapy combined with chemoradiotherapy in esophageal squamous cell carcinoma (ESCC) patients. Methods:A retrospective analysis of 79 eligible ESCC patients was conducted. Primary outcomes included overall survival (OS) and progression-free survival (PFS), with secondary outcomes being objective response rate (ORR), disease control rate (DOR), treatment-related adverse events (trAEs), and treatment failure patterns. Results: The median follow-up was 29.4 months, with median OS unreached and median PFS of 14.6 months (95% CI: 10.7-18.5). ORR was 82.3%, and DOR was 96.2%. Factors affecting OS were clinical stage, immunotherapy cycles, immunotherapy and chemoradiotherapy sequence, radiation coverage, mid-treatment lymphocyte count, and short-term efficacy (HR=2.254, 0.374, 2.653, 2.957, 2.309, 2.789; P=0.030, 0.019, 0.009, 0.004, 0.001, 0.014). Factors impacting PFS were clinical stage, immunotherapy and chemoradiotherapy, and post-treatment lymphocyte count (HR=2.135, 2.048, 1.911; P=0.007, 0.010, 0.001). Among the cohort, 46.8% experienced treatment failure, with 33 receiving second-line treatment, resulting in a median OS of 14.17 months (95% CI: 7.303-21.037) and 1- and 2-year OS rates of 56.7% and 24.3%. Notably, 36.7% experienced grade ≥2 trAEs, bone marrow suppression most commonly happened, and 5.1% developed esophageal fistulas. Conclusion: Immunotherapy combined with chemoradiotherapy demonstrates strong anti-tumor activity and tolerability in ESCC patients, The radiation for all leisions, sequential immunotherapy combined with chemoradiotherapy, and higher levels of lymph node cell counts are associated with a better prognosis. Large-scale randomized controlled trials are needed for further validation.

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Section: Discussionsupporting

confidence: 90%

Section: Discussioncontrasting

confidence: 54%

Section: Discussionmentioning

confidence: 91%

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First-Line Immunotherapy Combined with Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: A Real World Study

Zhao,

Weng,

Yang

et al. 2024

Preprint

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“…Previous studies have reported encouraging pathologic complete response rates following neoadjuvant chemoradiotherapy combined with ICIs, with rates of 25% for adenocarcinoma and 55.6% for squamous cell carcinoma ( 16 , 17 ). In studies where patients received CCRT combined with ICIs, complete response rates varied, ranging from 10% at a radiation dose of 40 Gy to 62% three months post-radiotherapy ( 18 , 19 ). In contrast, our study observed a complete response rate of 11.6%, aligning more closely with the lower end of this spectrum, specifically comparable to the rate observed at 40 Gy radiation but notably lower than the rate at 3 months post-radiotherapy.…”

Section: Discussionmentioning

confidence: 99%

Immune checkpoint inhibitors combined with concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma

Huang,

Liang,

Liu

et al. 2024

Front. Immunol.

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PurposeThis study aims to evaluate the efficacy of immune checkpoint inhibitors (ICIs) combined with concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with locally advanced esophageal squamous cell carcinoma.Materials and methodsThis retrospective cohort study included patients diagnosed with locally advanced esophageal squamous cell carcinoma who received either CCRT alone or CCRT combined with ICIs from April 2019 to February 2023. The primary endpoint was progression-free survival (PFS), and the secondary endpoint was overall survival (OS).ResultsA total of 101 patients were enrolled, with 58 undergoing CCRT alone and 43 receiving CCRT+ICI. The CCRT+ICI group demonstrated a higher complete response rate compared to the CCRT alone group (11.6% vs. 1.7%, P = 0.037). However, no significant difference was observed in 1-year PFS (58.9% vs. 55.2%; hazard ratio [HR] = 1.26, 95% confidence interval [CI]: 0.70-2.26; P = 0.445) or 1-year OS (70.8% vs. 75.9%; HR = 1.21, 95% CI: 0.58-2.53; P = 0.613) between CCRT+ICI and CCRT alone groups. The CCRT alone group experienced a higher incidence of leukopenia of any grade (93.1% vs. 76.7%, P = 0.039) but a lower incidence of pneumonitis of any grade (36.2% vs. 65.1%, P = 0.008).ConclusionCCRT+ICI may not lead to improved survival outcomes compared to CCRT alone in patients with locally advanced esophageal squamous cell carcinoma. These findings indicate the need for further investigation into this treatment approach.

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“…Concurrent administration of Camrelizumab with chemoradiotherapy has shown promising results, with 85.0% and 69.6% 12-month and 24-month OS rates respectively, and 80.0% and 65.0% 12-month and 24-month PFS rates respectively, albeit with 40% of patients experiencing serious treatment-related AEs ( 44 ). In the EC-CRT-001 study, 62% of patients receiving Toripalimab combined with chemoradiotherapy achieved complete remission, and the 1-year PFS and OS rates were 54.5% and 78.4%, respectively ( 46 ). The randomized, double-blinded, placebo-controlled, multicenter phase III ESCORT-CRT study has been launched to compare the efficacy and safety of Camrelizumab or placebo combined with definitive chemoradiotherapy ( 64 ).…”

Section: Clinical Trials Testing the Combination Of Radiotherapy With...mentioning

confidence: 99%

Radiotherapy combined with immune checkpoint inhibitors in locally advanced/metastatic esophageal squamous cell carcinoma: clinical trials, efficacy and future directions

Jiang

Liu

et al. 2023

Front. Immunol.

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Esophageal squamous cell carcinoma (ESCC) is a common malignancy worldwide and often diagnosed at advanced stages with poor prognosis. Combination of radiotherapy and immunotherapy seems to be a promising approach for treating ESCC. This comprehensive review article summarizes the current state of combination of radiotherapy and immunotherapy in locally advanced/metastatic ESCC, delineates the clinical trials that merit attention, and outlines unresolved issues and future research directions in this field. The clinical trial findings suggest that radio-immunotherapy combination may improve tumor response and overall survival with manageable side effects, highlighting the importance of patient selection and the necessity for further research to optimize treatment strategies. Issues such as irradiation dosage, fractionation regimen, irradiation site and technique of radiotherapy, as well as the timing, sequence and duration of combination therapy will all affect treatment outcomes, justifying further in-depth investigation.

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Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial

Cited by 43 publications

References 28 publications

First-Line Immunotherapy Combined with Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: A Real World Study

First-Line Immunotherapy Combined with Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: A Real World Study

Immune checkpoint inhibitors combined with concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma

Radiotherapy combined with immune checkpoint inhibitors in locally advanced/metastatic esophageal squamous cell carcinoma: clinical trials, efficacy and future directions

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