ArticleCancer2013
A phase 1 study of everolimus plus docetaxel plus cisplatin as induction chemotherapy for patients with locally and/or regionally advanced head and neck cancer.
Article in Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
21 citing papers in PubMed.
- Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- The Role of the PI3K/Akt/mTOR Axis in Head and Neck Squamous Cell Carcinoma.Biomedicines · 2024Review
- The Role of mTORC1 Pathway and Autophagy in Resistance to Platinum-Based Chemotherapeutics.International journal of molecular sciences · 2023Review
- First-line everolimus and cisplatin in patients with advanced extrapulmonary neuroendocrine carcinoma: a nationwide phase 2 single-arm clinical trial.Therapeutic advances in medical oncology · 2022Article
- Any Role of PIK3CA and PTEN Biomarkers in the Prognosis in Oral Squamous Cell Carcinoma?Life (Basel, Switzerland) · 2020Article
- Targeting AKT/mTOR in Oral Cancer: Mechanisms and Advances in Clinical Trials.International journal of molecular sciences · 2020Review
- mTOR inhibitor use in head and neck squamous cell carcinoma: A meta-analysis on survival, tumor response, and toxicity.Laryngoscope investigative otolaryngology · 2020Review
- Clinical Development of Molecular Targeted Therapy in Head and Neck Squamous Cell Carcinoma.JNCI cancer spectrum · 2019Article
- mTOR Signaling in Cancer and mTOR Inhibitors in Solid Tumor Targeting Therapy.International journal of molecular sciences · 2019Review
- AKT1 restricts the invasive capacity of head and neck carcinoma cells harboring a constitutively active PI3 kinase activity.BMC cancer · 2018Article
- Targeting phosphoinositide 3-kinase (PI3K) in head and neck squamous cell carcinoma (HNSCC).Cancers of the head & neck · 2018Review
- Dysregulations in the PI3K pathway and targeted therapies for head and neck squamous cell carcinoma.Oncotarget · 2017Review
- mTOR, metabolism, and the immune response in HPV-positive head and neck squamous cell cancer.World journal of otorhinolaryngology - head and neck surgery · 2016Review
- The CDK4/6 inhibitor LY2835219 has potent activity in combination with mTOR inhibitor in head and neck squamous cell carcinoma.Oncotarget · 2016Article
- Phase I Study of Everolimus in Combination with Gemcitabine and Split-Dose Cisplatin in Advanced Urothelial Carcinoma.Bladder cancer (Amsterdam, Netherlands) · 2016Article
- The effect of thymoquinone treatment on the combined renal and pulmonary toxicity of cisplatin and diesel exhaust particles.Experimental biology and medicine (Maywood, N.J.) · 2015Article
- Article
- Parallel phase Ib studies of two schedules of buparlisib (BKM120) plus carboplatin and paclitaxel (q21 days or q28 days) for patients with advanced solid tumors.Cancer chemotherapy and pharmacology · 2015Article
- Hedgehog signaling drives radioresistance and stroma-driven tumor repopulation in head and neck squamous cancers.Cancer research · 2014Article
- Sequencing the head and neck cancer genome: implications for therapy.Annals of the New York Academy of Sciences · 2014Review
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
backgroundActivation of the phosphatidylinositol-3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) pathway is common in head and neck cancers, and it has been demonstrated that inhibition of mTOR complex 1 sensitizes cell lines to platinum and taxane chemotherapy. The authors conducted a phase 1 study to evaluate the addition of oral everolimus to cisplatin and docetaxel as induction chemotherapy for head and neck cancer.
methodsIn this single-institution phase 1 study, 3 doses of daily everolimus were explored: 5 mg daily, 7.5 mg daily (administered as 5 mg daily alternating with 10 mg daily), and 10 mg daily of each 21-day cycle. Cisplatin and docetaxel doses were fixed (both were 75 mg/m(2) on day 1 of 21-day cycle) at each dose level with pegfilgrastim support. A standard 3 + 3 dose-escalation plan was used. After induction, patients were removed from protocol.
resultsEighteen patients were enrolled (15 men, 3 women), and their median Karnofsky performance status was 90. The most common toxicities were hyperglycemia, low hemoglobin, fatigue, and thrombocytopenia. Dose-limiting toxicities (DLTs) were neutropenic fever (1 event at dose level 2, 2 events at dose level 3), and all patients recovered fully from these DLTs. The maximum tolerated dose was exceeded at dose level 3. The progression-free survival rate at 1 year was 87.5% (95% confidence interval, 56.8%-96.7%); and, at 2 years, it was 76.6% (95% confidence interval, 41.2%-92.3%). Activating PI3K catalytic subunit α (PIK3CA) gene mutations were identified in 2 human papillomavirus-associated oropharyngeal cancers.
conclusionsThe phase 2 recommended dose was 7.5 mg daily for everolimus plus cisplatin and docetaxel (both at 75 mg/m(2) on day 1 of a 21-day cycle) given with pegfilgrastim support.
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Registered trials
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