TEMHEAD: a single-arm multicentre phase II study of temsirolimus in platin- and cetuximab refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) of the German SCCHN Group (AIO)

Grünwald, Viktor; Keilholz, Ulrich; Boehm, Andreas; Guntinas‐Lichius, Orlando; Hennemann, B.; Schmoll, Hans Joachim; Ivanyi, Philipp; Abbas, M. Nazim; Lehmann, U.; Koch, Andreas; Karch, Annika; Zörner, A.; Gauler, Thomas

doi:10.1093/annonc/mdu571

Cited by 58 publications

(40 citation statements)

References 25 publications

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“…Mutational analysis in our study revealed a low incidence of PIK3CA (9%) without a correlation with treatment efficacy [13]. Clearly, other predictive biomarkers are needed in order to individualise therapy in R/M SCCHN.…”

Section: Discussionmentioning

confidence: 60%

“…Patients' sera were collected within the TEMHEAD phase II study (NCT01172769), which tested temsirolimus as a weekly intravenous infusion until death, progression or intolerance [13]. From a total of 40 eligible patients, 29 had assessable sera for this preplanned substudy.…”

Section: Patientsmentioning

confidence: 99%

“…The use of temsirolimus has improved survival in metastatic renal cell carcinoma, but data for SCCHN remain limited [12]. We recently showed that the use of temsirolimus is efficacious in SCCHN [13].…”

Section: Introductionmentioning

confidence: 99%

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Baseline caspase activity predicts progression free survival of temsirolimus-treated head neck cancer patients

John

Rösner

Keilholz

et al. 2015

European Journal of Cancer

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Section: Discussionmentioning

confidence: 60%

Section: Patientsmentioning

confidence: 99%

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Baseline caspase activity predicts progression free survival of temsirolimus-treated head neck cancer patients

John

Rösner

Keilholz

et al. 2015

European Journal of Cancer

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“…Therefore, these phase II results should be viewed with caution but could represent the beginning of a new treatment strategy targeting the PI3K pathway. Mechanistic target of rapamycin (mTOR) represents another potential target in the PI3K pathway, and mTOR inhibitors have shown preliminary efficacy preclinically and clinically, including in the TEMHEAD phase II study [24,25,26]. Other trials were negative including another phase II trial with the pan-PI3K inhibitor PX-866 and a phase II trial with the mTOR inhibitor everolimus as monotherapy [27,28].…”

Section: Targeted Therapies In Head and Neck Cancermentioning

confidence: 99%

“…Generally, PIK3CA mutations, amplifications, or PTEN loss could mechanistically be expected to predict sensitivity to PI3K pathway inhibitors. In clinical studies in HNSCC, these aberrations were infrequently or not at all identified, and the small sample size did not allow for correlative analyses [26,27,28]. In a retrospective study in 549 patients with breast cancer, mutations in PIK3CA or AKT and PTEN loss were associated with an improved response to everolimus compared to the ‘PI3K normal pathway' [58].…”

Section: Predictive Biomarkersmentioning

confidence: 99%

Targeted Therapy of Head and Neck Cancer

2016

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Head and neck squamous cell carcinoma (HNSCC) is one of the most common solid cancers worldwide. It is mainly caused by exposure to tobacco smoke and alcohol as well as infection with the human papilloma virus (HPV). The prognosis is poor, especially once it recurs or metastasizes. Current therapeutic options include surgery, radio- and chemotherapy. Epidermal growth factor receptor (EGFR) inhibitors are so far the only targeted agents that have been approved in head and neck cancer. Primary or secondary resistance is frequent or will eventually develop. Several driver mutations and other genomic aberrations have been described in HNSCC including EGFR overexpression and amplification. Yet, no predictive biomarkers for the application of EGFR inhibitors have been identified. Further targeted agents are in development for HNSCC, of which inhibitors of the PI3K pathway are the closest to clinical application. In recent years, the incidence of HPV-driven HNSCC has risen in Western countries. HPV-positive and -negative HNSCC are distinct molecular tumor entities, and consequences for targeted therapies have been discussed. This review looks at approved and investigational targeted treatment strategies as well as potential predictive biomarkers such as the HPV status to guide treatment.

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A systematic literature review of the human papillomavirus prevalence in locally and regionally advanced and recurrent/metastatic head and neck cancers through the last decade: The “ALARM” study

Agelaki,

Boukovinas,

Athanasiadis

et al. 2024

Cancer Medicine

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AimsThe aim of this systematic literature review was to provide updated information on human papillomavirus (HPV) prevalence in locally and regionally advanced (LA) and recurrent/metastatic (RM) head and neck cancer (HNC) worldwide.MethodsElectronic searches were conducted on clinicaltrials.gov, MEDLINE/PubMed, Embase, and ASCO/ESMO journals of congresses for interventional studies (IS; Phase I–III trials) as well as MEDLINE and Embase for non‐interventional studies (NIS) of LA/RM HNC published between January 01, 2010 and December 31, 2020. Criteria for study selection included: availability of HPV prevalence data for LA/RM HNC patients, patient enrollment from January 01, 2010 onward, and oropharyngeal cancer (OPC) included among HNC types. HPV prevalence per study was calculated as proportion of HPV+ over total number of enrolled patients. For overall HPV prevalence across studies, mean of reported HPV prevalence rates across studies and pooled estimate (sum of all HPV+ patients over sum of all patients enrolled) were assessed.ResultsEighty‐one studies (62 IS; 19 NIS) were included, representing 9607 LA/RM HNC cases, with an overall mean (pooled) HPV prevalence of 32.6% (25.1%). HPV prevalence was 44.7% (44.0%) in LA and 24.3% (18.6%) in RM. Among 2714 LA/RM OPC patients from 52 studies with available data, mean (pooled) value was 55.8% (50.7%). The majority of data were derived from Northern America and Europe, with overall HPV prevalence of 46.0% (42.1%) and 24.7% (25.3%) across studies conducted exclusively in these geographic regions, respectively (Northern Europe: 31.9% [63.1%]). A “p16‐based” assay was the most frequently reported HPV detection methodology (58.0%).ConclusionOver the last decade, at least one quarter of LA/RM HNC and half of OPC cases studied in IS and NIS were HPV+. This alarming burden is consistent with a potential implication of HPV in the pathogenesis of at least a subgroup of HNC, underscoring the relevance of HPV testing and prophylaxis to HNC prevention and management.

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TEMHEAD: a single-arm multicentre phase II study of temsirolimus in platin- and cetuximab refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) of the German SCCHN Group (AIO)

Abstract: NCT01172769.

Cited by 58 publications

References 25 publications

Baseline caspase activity predicts progression free survival of temsirolimus-treated head neck cancer patients

Baseline caspase activity predicts progression free survival of temsirolimus-treated head neck cancer patients

Targeted Therapy of Head and Neck Cancer

A systematic literature review of the human papillomavirus prevalence in locally and regionally advanced and recurrent/metastatic head and neck cancers through the last decade: The “ALARM” study

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