910O Primary results of the phase III JAVELIN head &amp; neck 100 trial: Avelumab plus chemoradiotherapy (CRT) followed by avelumab maintenance vs CRT in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN)

Cohen, Ezra E.W.; Ferris, Robert L.; Psyrri, Amanda; Haddad, Robert I.; Tahara, Makoto; Bourhis, Jean; Harrington, Kevin J.; Chang, Peter Mu Hsin; Lin, Ja‐Chen; Razaq, Mohammad; Teixeira, Margarida; Lövey, József; Chamois, J.; Domı́nguez, A.; Hu, Chaosu; Dvorkin, Mikhail; Beukelaer, S. De; Pavlov, Dmitri; Thurm, Holger; Lee, N.

doi:10.1016/j.annonc.2020.08.1025

Cited by 38 publications

(25 citation statements)

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“…Similarly, afatinib therapy for 18 months after definitive CRT in patients with intermediate- to high-risk unresected HNSCC did not improve DFS [ 30 ]. The phase III JAVELIN head and neck 100 trial (NCT02952586) showed that stage III/IVA/IVB HNSCC patients using avelumab plus CRT followed by avelumab maintenance failed to show a statistically significant improvement in PFS compared with CRT alone [ 31 ].…”

Section: Discussionmentioning

confidence: 99%

The Overall Efficacy and Outcomes of Metronomic Tegafur-Uracil Chemotherapy on Locally Advanced Head and Neck Squamous Cell Carcinoma: A Real-World Cohort Experience

Yeh

Chan

Tsai

et al. 2021

Biology

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Metronomic chemotherapy inhibits tumor growth by continuous administration of lower-dose chemotherapy. Our study aimed to demonstrate the outcomes of metronomic chemotherapy with tegafur–uracil in locally advanced head and neck squamous cell carcinoma (LA HNSCC). This was a retrospective study including 240 patients with LA HNSCC. After standard treatment, 96 patients were further treated with metronomic tegafur-uracil, and 144 patients were not. No statistical differences were found between both groups with regard to sex, clinical stage, or primary treatment choice. There were more hypopharyngeal cancers and more patients with poor clinicopathological features, including lymphovascular invasion, extranodal extension, and positive margins in the tegafur–uracil group. The median follow-up duration was 31.16 months. Overall survival (OS) was not reached in the tegafur–uracil group and was 54.1 months in the control group (p = 0.008). The median disease-free survival (DFS) was 54.5 months in the tegafur–uracil group and 34.4 months in the control group (p = 0.03). Neither group reached distant metastasis-free survival (DMFS, p = 0.02). In patients with LA HNSCC, adding tegafur–uracil as metronomic chemotherapy after either curative surgery with adjuvant chemoradiotherapy or definitive concurrent chemoradiotherapy significantly improved the OS, DFS, and DMFS with tolerable adverse events.

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Section: Discussionmentioning

confidence: 99%

The Overall Efficacy and Outcomes of Metronomic Tegafur-Uracil Chemotherapy on Locally Advanced Head and Neck Squamous Cell Carcinoma: A Real-World Cohort Experience

Yeh

Chan

Tsai

et al. 2021

Biology

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“…Studies in locally advanced HNSCC using pembrolizumab or nivolumab with cisplatin and radiation were shown to be safe without unexpected toxicities [ 68 , 69 ]. However, the results of the Phase III JAVELIN Head and Neck 100 trial evaluating avelumab (PD-L1 inhibitor) plus CRT followed by avelumab maintenance versus CRT in patients with locally advanced HNSCC did not show any survival benefits (PFS stratified HR 1.21, 95% CI 0.93–1.57; stratified p -value 0.92 and OS stratified HR 1.31, 95% CI 0.93–1.85; stratified p -value 0.94; ClinicalTrials.gov Identifier: NCT02952586) [ 70 ]. The use of ICI as well as other targeted agents as maintenance therapy after CRT (ClinicalTrials.gov Identifier: NCT03811015 and NCT00079053) is under investigation.…”

Section: Management Of Newly Diagnosed Locally Advanced Hnsccmentioning

confidence: 99%

Recent Advances and Future Directions in Clinical Management of Head and Neck Squamous Cell Carcinoma

Muzaffar

Bari

Kirtane

et al. 2021

Cancers

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Head and neck squamous cell carcinoma (HNSCC) is the most common cancer arising in the head and neck region. The most common risk factors are smoking, excessive drinking, and human papillomavirus (HPV) infection. While the overall incidence of smoking is decreasing, the incidence of HPV-related HNSCC is increasing in the United States and Western Europe, which led to a shift in understanding of the pathophysiology, treatment, and prognosis of this disease. The outcomes for non-metastatic HNSCC remains very encouraging and continues to improve. Advances in radiation technology and techniques, better organ preserving surgical options, and multidisciplinary treatment modalities have improved cure rates for locally advanced HNSCC patients. The treatment of metastatic disease, however, remains an area of need. The advancement of immune checkpoint inhibitors has provided significantly better outcomes, but only a small proportion of patients obtain benefits. Most recurrent and/or metastatic HNSCC patients continue to have poor survival. This has led to the vigorous investigation of new biomarkers and biomarker-based therapies. Novel therapeutic options including adaptive cellular therapy and therapeutic vaccines are also on the horizon. In this review, we highlight the latest advances in the field of HNSCC and the future direction of research.

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“…More recently, malignancies, in which ICIs have shown efficacy in metastatic setting such as head and neck cancer, were investigated in combination therapies consisting of ICI and RT. However, no added benefit was found after combined treatment compared to standard RT combined with chemotherapy or targeted drugs (cetuximab) in locally advanced setting, e.g., GORTEC 2015-01 “PembroRad” or JAVELIN Head and Neck 100 trials [ 174 , 175 ]. Another category, where the addition of ICI has not shown any added benefit, e.g., CheckMate 548 (NCT02667587), are stroma-rich but inherently immune-cold tumors, such as GBM and pancreatic cancer.…”

Section: Immunotherapeutic Options and Conventional Radiotherapymentioning

confidence: 99%

Charged Particle and Conventional Radiotherapy: Current Implications as Partner for Immunotherapy

Marcus

Lieverse

Klein

et al. 2021

Cancers

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Radiotherapy (RT) has been shown to interfere with inflammatory signals and to enhance tumor immunogenicity via, e.g., immunogenic cell death, thereby potentially augmenting the therapeutic efficacy of immunotherapy. Conventional RT consists predominantly of high energy photon beams. Hypofractionated RT regimens administered, e.g., by stereotactic body radiation therapy (SBRT), are increasingly investigated in combination with cancer immunotherapy within clinical trials. Despite intensive preclinical studies, the optimal dose per fraction and dose schemes for elaboration of RT induced immunogenic potential remain inconclusive. Compared to the scenario of combined immune checkpoint inhibition (ICI) and RT, multimodal therapies utilizing other immunotherapy principles such as adoptive transfer of immune cells, vaccination strategies, targeted immune-cytokines and agonists are underrepresented in both preclinical and clinical settings. Despite the clinical success of ICI and RT combination, e.g., prolonging overall survival in locally advanced lung cancer, curative outcomes are still not achieved for most cancer entities studied. Charged particle RT (PRT) has gained interest as it may enhance tumor immunogenicity compared to conventional RT due to its unique biological and physical properties. However, whether PRT in combination with immune therapy will elicit superior antitumor effects both locally and systemically needs to be further investigated. In this review, the immunological effects of RT in the tumor microenvironment are summarized to understand their implications for immunotherapy combinations. Attention will be given to the various immunotherapeutic interventions that have been co-administered with RT so far. Furthermore, the theoretical basis and first evidences supporting a favorable immunogenicity profile of PRT will be examined.

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910O Primary results of the phase III JAVELIN head & neck 100 trial: Avelumab plus chemoradiotherapy (CRT) followed by avelumab maintenance vs CRT in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN)

Cited by 38 publications

References 0 publications

The Overall Efficacy and Outcomes of Metronomic Tegafur-Uracil Chemotherapy on Locally Advanced Head and Neck Squamous Cell Carcinoma: A Real-World Cohort Experience

The Overall Efficacy and Outcomes of Metronomic Tegafur-Uracil Chemotherapy on Locally Advanced Head and Neck Squamous Cell Carcinoma: A Real-World Cohort Experience

Recent Advances and Future Directions in Clinical Management of Head and Neck Squamous Cell Carcinoma

Charged Particle and Conventional Radiotherapy: Current Implications as Partner for Immunotherapy

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