Radiotherapy plus camrelizumab and irinotecan for oligometastatic esophageal squamous cell carcinoma patients after first-line immunotherapy plus chemotherapy failure: An open-label, single-arm, phase II trial

Zhao, Wenyu; Shi, Ke; Cai, Xueting; Zuo, Zhentao; Shi, Wei; Qiu, Hu; Cai, Gaoke; Gong, Yi; Wu, Yong; Ruan, Su; Chen, Yongshun

doi:10.1016/j.radonc.2023.109679

Cited by 13 publications

(6 citation statements)

References 32 publications

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“…With the advent of the era of combined immunotherapy, multiple randomized phase III trials suggested improved survival bene ts with the addition of immunotherapy to chemotherapy for advanced ESCC patients [31][32][33]. However, the response rate is only about 30%, and primary and secondary resistance may be the underlying disruptive factors [34]. Radiotherapy may be considered a hopeful combination treatment option.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Radiotherapy Plus Immunochemotherapy in Patients with Oligometastatic Esophageal Cancer

duan,

cheng,

qin

et al. 2023

Preprint

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Background and purpose: Immunotherapy had revolutionized the treatment of metastatic esophageal cancer. Oligometastasis is a limited-metastatic state, and patients at this stage may benefit from metastatic-directed local treatments, which may increase their chances of survival. As an immunomodulator, radiotherapy (RT) might achieve a synergistic effect when combined with immunotherapy. Compared to immunochemotherapy alone, this study assessed the efficacy and safety of radiotherapy plus immunochemotherapy in de-novo oligometastatic esophageal cancer (EC). Materials and methods: In this trial, we retrospectively collected esophageal cancer patients with de-novo oligometastases and received immunochemotherapy. The primary endpoints were progression-free survival (PFS) and overall survival (OS).Secondary endpoints were objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and treatment-related adverse events (TREAs). Results: Between Jan 2019 and Jan 2022, 226 patients were included, which consisted of 108 cases in the RT plus immunochemotherapy (iCRT) group, and 118 cases in the immunochemotherapy (iCT) group. With a median follow-up of 22.2 months, the median PFS (mPFS) was 13.0 months for the iCRT group and 7.7 months for the iCT group (P＜0.001, HR=0.520, 95% CI, 0.388-0.696). In terms of OS, the median OS (mOS) was 27.5 months for the iCRT group and 21.7 months for the iCT group (P=0.026, HR=0.670, 95% CI, 0.468-0.958). The iCRT group compared with the iCT group was associated with a higher risk of ≥ grade 3 myelosuppression. No other grade 5 TRAEs or new safety signals were observed. Through univariate and multivariate analysis, we also found that, besides local radiotherapy, oligometastatic esophageal cancer (OMEC) patients with a history of alcohol consumption, more metastatic lesions, and second-line and above treatment had inferior PFS. And a lower KPS score, a greater number of metastatic lesions, and second-line and above treatment were found to have inferior OS. Conclusion: Compared to immunochemotherapy alone, radiotherapy plus immunochemotherapy showed survival benefits with manageable safety for oligometastatic esophageal cancer patients. It deserves to be validated in a larger trial.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Radiotherapy Plus Immunochemotherapy in Patients with Oligometastatic Esophageal Cancer

duan,

cheng,

qin

et al. 2023

Preprint

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“…For metastatic and recurrent esophageal cancer, immunotherapy combined with chemotherapy is the current first-line standard of care. Additionally, several clinical trials have investigated the potential benefits of adding irradiation to the primary lesion ( 50 , 79 – 85 ). These trials typically enrolled patients with oligometastases (no more than 3-5 metastases in less than 2 organs/lymphatic drainage regions) in good physical status to receive radiation regimens using conventional fractionation with 40-60GY ( 50 , 79 – 85 ).…”

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

confidence: 99%

“…Additionally, several clinical trials have investigated the potential benefits of adding irradiation to the primary lesion ( 50 , 79 – 85 ). These trials typically enrolled patients with oligometastases (no more than 3-5 metastases in less than 2 organs/lymphatic drainage regions) in good physical status to receive radiation regimens using conventional fractionation with 40-60GY ( 50 , 79 – 85 ). Although preclinical studies suggest that hypo fractionated radiotherapy with relatively high daily doses may induce stronger immunostimulating signals, it may not be practical for serial organ like the esophagus.…”

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

confidence: 99%

“…The PALEO study developed a protocol integrating Durvarlumab with chemotherapy and two courses of radiotherapy, giving hypo fractionated radiotherapy (30GY/10F) for primary esophageal lesion in week 1-2, and stereotactic body radiation therapy (SBRT, 24GY/3F) for a single metastasis in week 7 ( 87 ). Stage IVB ESCC patients who had failed first-line immunochemotherapy received primary tumor radiotherapy (40GY/20F)/metastatic lesions radiotherapy (30GY/10F) combined with Camrelizumab and irinotecan achieved an ORR of 40.8%, a DCR of 75.5%, with median PFS and OS of 6.9 and 12.8 months, respectively ( 50 ). For locoregional recurrent ESCC without distant metastasis, several studies have evaluated the efficacy and safety of Camrelizumab combined with concurrent chemoradiotherapy ( 80 , 88 ).…”

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

confidence: 99%

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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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“…Since the approval of immune checkpoint inhibitors (ICIs), immunotherapy has made an indelible mark in the field of cancer treatment[ 9 ]. With the widespread application of programmed death protein (PD)-1/PD ligand (PD-L)1 and cytotoxic lymphocyte-associated antigen-4 inhibitors in various indications, these ICI drugs have brought about transformative responses in advanced solid tumors over the past decade[ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Present situation and prospect of immunotherapy for unresectable locally advanced esophageal cancer during peri-radiotherapy

Wang,

Mo,

Yan

et al. 2024

World J Gastrointest Oncol

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Four major studies (Checkmate577, Keynote-590, Checkmate649 and Attraction-4) of locally advanced esophageal cancer published in 2020 have established the importance of immunotherapy, represented by anti-programmed death protein (PD)-1 in postoperative adjuvant treatment and advanced first-line treatment of locally advanced or advanced esophageal cancer and esophagogastric junction cancer, from the aspects of proof of concept, long-term survival, overall survival rate and progression-free survival. For unresectable or inoperable nonmetastatic esophageal cancer, concurrent radiotherapy and chemotherapy is the standard treatment recommended by various guidelines. Because its curative effect is still not ideal, it is necessary to explore radical radiotherapy and chemotherapy in the future, and it is considered to be promising to combine them with immunotherapeutic drugs such as anti-PD-1. This paper mainly discusses how to combine radical concurrent radiotherapy and chemotherapy with immunotherapy for unresectable local advanced esophageal cancer.

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Radiotherapy plus camrelizumab and irinotecan for oligometastatic esophageal squamous cell carcinoma patients after first-line immunotherapy plus chemotherapy failure: An open-label, single-arm, phase II trial

Cited by 13 publications

References 32 publications

Efficacy and Safety of Radiotherapy Plus Immunochemotherapy in Patients with Oligometastatic Esophageal Cancer

Efficacy and Safety of Radiotherapy Plus Immunochemotherapy in Patients with Oligometastatic Esophageal Cancer

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

Present situation and prospect of immunotherapy for unresectable locally advanced esophageal cancer during peri-radiotherapy

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