Adjuvant durvalumab for esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy: a placebo-controlled, randomized, double-blind, phase II study

Park, Seo-Young; Sun, Jong‐Mu; Choi, Yoon‐La; Oh, Dongryul; Kim, H.K.; Lee, T.; Chi, Sangah; Lee, S.-H.; Jung, Sin Ho; Ahn, Myung‐Ju; Ahn, Yong Chan; Park, K.; Shim, Young Mog

doi:10.1016/j.esmoop.2022.100385

Cited by 22 publications

(21 citation statements)

References 16 publications

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“…Mamdani et al 5 reported that for patients with locally advanced esophageal and GEJ adenocarcinoma with pathologically residual disease after R0 resection following nCRT, there was a clinically meaningful improvement in the 1‐year recurrence‐free survival rate with adjuvant durvalumab when compared with historical data. However, the result of another study reported by Park et al . 6 is different from the Checkmate 577 and Mamdani's.…”

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confidence: 75%

“…Some reasons may explain the different results of aforementioned studies. First, the Checkmate 577 trial was a global phase III study with a higher level of evidence ( n = 794; ESCC, 21%), whereas Park et al's 6 study was a Korean single‐center phase II study with only 86 patients enrolled. Second, most of the neoadjuvant chemotherapy regimens in Checkmate577 were paclitaxel combined with carboplatin (PC), whereas the regimen of Park et al's 6 study was 5‐FU combined with cisplatin (CF).…”

mentioning

confidence: 99%

“…First, the Checkmate 577 trial was a global phase III study with a higher level of evidence ( n = 794; ESCC, 21%), whereas Park et al's 6 study was a Korean single‐center phase II study with only 86 patients enrolled. Second, most of the neoadjuvant chemotherapy regimens in Checkmate577 were paclitaxel combined with carboplatin (PC), whereas the regimen of Park et al's 6 study was 5‐FU combined with cisplatin (CF). The PC regiment combined with irradiation might lead to higher pCR rate for ESCC patients (CROSS trial, 49% vs. Park's trial, 31% vs. JCOG1109, 36.7%).…”

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confidence: 99%

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Is adjuvant immunotherapy a new standard for non‐pathological complete response patients with resectable esophageal squamous cell carcinoma?

2022

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Is adjuvant immunotherapy a new standard for non‐pathological complete response patients with resectable esophageal squamous cell carcinoma?

2022

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“…The findings of this trial have now been endorsed by treatment guidelines, which indicate that adjuvant treatment with nivolumab significantly prolongs DFS compared with placebo and has an adequate overall safety profile. However, a clinical study conducted by Park et al in 2022 (European Society for Medical Oncology—ESMO) contrasted with Checkmate577 (NCT02520453) [ 31 ]. This placebo-controlled, randomized, double-blind, phase II clinical study included 86 ESCC patients undergoing neoadjuvant chemoradiotherapy, staged T3-4N0M0 or T1-4N1-3M0 according to the American Joint Committee on Cancer (AJCC) 7th edition, and it evaluated the efficacy of adjuvant durvalumab compared to placebo.…”

Section: Icis For Locally Advanced Resectable Esccmentioning

confidence: 99%

“…However, the predictive value of PD-L1 expression in patients with locally advanced esophageal cancer is controversial. According to the subgroup analysis of the NCT02520453 study, the three-year OS was longer with durvalumab treatment than with placebo in the PD-L1 combined positive score (CPS) ≥ 1% group (94% versus 64%), but it was shorter in the PD-L1-negative group (42% vs. 55%) [ 31 ]. Nevertheless, in the CheckMate-577 study, nivolumab treatment showed similar clinical benefits regardless of tumor cell PD-L1 expression, indicating that this biomarker was not predictive of clinical benefit in this trial [ 30 ].…”

Section: Predictors Of Efficacy For Tumor Immunotherapymentioning

confidence: 99%

Recent Advances in Combination of Immunotherapy and Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Wang

Liu

Chen

et al. 2022

Cancers

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Esophageal cancer has a high mortality rate and a poor prognosis, with more than one-third of patients receiving a diagnosis of locally advanced cancer. Esophageal squamous cell carcinoma (ESCC) is the dominant histological subtype of esophageal cancer in Asia and Eastern Europe. Although neoadjuvant or definitive chemoradiotherapy (CRT) has been the standard treatment for locally advanced ESCC, patient outcomes remain unsatisfactory, with recurrence rates as high as 30–50%. The combination of immune checkpoint inhibitors (ICIs) and CRT has emerged as a novel strategy to treat esophageal cancer, and it may have a synergistic action and provide greater efficacy. In the phase III CheckMate-577 trial, one year of adjuvant nivolumab after neoadjuvant CRT improved disease-free survival in patients with residual disease on pathology. Moreover, several phase I and II studies have shown that ICIs combined with concurrent CRT may increase the rate of pathologic complete response for resectable ESCC, but they lack long-term follow-up results. In unresectable cases, the combination of camrelizumab and definitive CRT showed promising results against ESCC in a phase Ib trial. Phase III randomized trials are currently ongoing to investigate the survival benefits of ICIs combined with neoadjuvant or definitive CRT, and they will clarify the role of immunotherapy in locally advanced ESCC. Additionally, valid biomarkers to predict tumor response and survival outcomes need to be further explored.

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Monoclonal antibodies for the treatment of squamous cell carcinoma: A literature review

Tamimi

Sorkheh

et al. 2023

Cancer Reports

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Background Squamous cell carcinoma (SCC) is a relatively common and heterogenous malignancy of different organs, such as the skin, esophagus, and lungs. Although most cases experience good survival with surgical methods, management of advanced types of the disease remains challenging. Several modalities, including different chemotherapy regimens and immunotherapies, have been investigated in this matter, among which Monoclonal antibodies (Mabs) are one of the most promising ones. Since the development of Mabs, they have been widely used to treat different diseases. Mabs have shown significant efficacy with high specificity along with acceptable safety, which makes them a favorable option in cancer therapy. In this article, we aimed to review the different aspects of using Mabs in SCC therapy. Recent Findings We found that treating with different Mabs has shown excellent efficacy accompanied by acceptable safety in treating SCC of different organs. Therefore, Mabs are considered great options in the treatment of SCC, especially in advanced cases. Overall, two highly potent types of Mabs in SCC therapy are anti‐EGFR Mabs and checkpoint inhibitors, especially Cetuximab, Nimotuzumab, and PD‐1 inhibitors. Bevacizumab is also a promising option as adjuvant therapy to other modalities. Conclusion Although some Mabs have shown promising outcomes in SCC therapy, their application as a part of cancer treatment depends on further investigations regarding cost‐effectiveness and predictors of response. FDA has approved several Mabs in SCC therapies, and Mabs may have a crucial role in this era in the near future, especially in treating head and neck and esophageal SCC and metastatic lung cancer.

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Adjuvant durvalumab for esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy: a placebo-controlled, randomized, double-blind, phase II study

Cited by 22 publications

References 16 publications

Is adjuvant immunotherapy a new standard for non‐pathological complete response patients with resectable esophageal squamous cell carcinoma?

Is adjuvant immunotherapy a new standard for non‐pathological complete response patients with resectable esophageal squamous cell carcinoma?

Recent Advances in Combination of Immunotherapy and Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Monoclonal antibodies for the treatment of squamous cell carcinoma: A literature review

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