ArticleCancer2010
Phase 1 and pharmacokinetic study of everolimus, a mammalian target of rapamycin inhibitor, in combination with docetaxel for recurrent/refractory nonsmall cell lung cancer.
Article in Cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 39 citations in OpenAlex.
- A phase II study of temsirolimus and erlotinib in patients with recurrent and/or metastatic, platinum-refractory head and neck squamous cell carcinoma.Oral oncology · 2013Trial
- Phase II study of docetaxel in combination with everolimus for second- or third-line therapy of advanced non-small-cell lung cancer.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2013Trial
- HighOncotarget · 2021Article
- Targeted drug delivery strategies for precision medicines.Nature reviews. Materials · 2021Article
- An update: emerging drugs to treat squamous cell carcinomas of the head and neck.Expert opinion on emerging drugs · 2018Review
- Race-, Age-, and Gender-Based Characteristics and Toxicities of Targeted Therapies on Phase I Trials.Oncology · 2018Article
- Safety and Efficacy of Docetaxel, Bevacizumab, and Everolimus for Castration-resistant Prostate Cancer (CRPC).Clinical genitourinary cancer · 2017Article
- A Translational, Pharmacodynamic, and Pharmacokinetic Phase IB Clinical Study of Everolimus in Resectable Non-Small Cell Lung Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2015Article
- 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
- Feasibility of adding everolimus to carboplatin and paclitaxel, with or without bevacizumab, for treatment-naive, advanced non-small cell lung cancer.Investigational new drugs · 2014Article
- Oncogenic driver mutations in lung cancer.Translational respiratory medicine · 2013Review
- A phase-1b study of everolimus plus paclitaxel in patients with small-cell lung cancer.British journal of cancer · 2013Article
- Targeted therapies in non-small cell lung carcinoma: what have we achieved so far?Therapeutic advances in medical oncology · 2013Article
- Article
- The Biological Role of PI3K Pathway in Lung Cancer.Pharmaceuticals (Basel, Switzerland) · 2012Article
- Article
- Rapamycin potentiates cytotoxicity by docetaxel possibly through downregulation of Survivin in lung cancer cells.Journal of experimental & clinical cancer research : CR · 2011Article
- Exploring long-term protection of normal human fibroblasts and epithelial cells from chemotherapy in cell culture.Oncotarget · 2011Article
- Inhibitors of mTOR.The oncologist · 2010Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundEverolimus is a novel inhibitor of the mammalian target of rapamycin pathway, which is aberrantly activated in nonsmall cell lung cancer (NSCLC). The authors conducted a phase 1 and pharmacokinetic study of everolimus and docetaxel for recurrent NSCLC.
methodsPatients with advanced stage NSCLC and progression after prior platinum-based chemotherapy were eligible. Sequential cohorts were treated with escalating doses of docetaxel (Day 1) and everolimus (orally daily, Days 1-19) every 3 weeks. Pharmacokinetic sampling of everolimus and docetaxel was done in Cycle 1. The primary endpoint was determination of the recommended phase 2 doses of the combination.
resultsTwenty-four patients were enrolled (median age, 62 years; women, 11; number of prior regimens, 1 [n=13], 2 [n=6], >or=3 [n=5]; Eastern Cooperative Oncology Group performance status, 0 [n=6], 1 [n=17]). The dose-limiting toxicities (DLTs) were fever with grade 3/4 neutropenia, grade 3 fatigue, and grade 3 mucositis. None of the 7 patients treated at the recommended phase 2 dose (docetaxel 60 mg/m2 and everolimus 5 mg daily) experienced DLT. Everolimus area under the concentration time curve (AUC) was not different with 60 or 75 mg/m2 docetaxel. Mean+/-standard deviation AUC-based accumulation factors for everolimus on Days 8 and 15 were 1.16+/-0.37 and 1.42+/-0.42, respectively. Docetaxel Day 1 half-life was 9.4+/-3.4 hours. Among 21 patients evaluable, 1 had a partial response, and 10 had disease stabilization.
conclusionsThe recommended phase 2 doses of docetaxel and everolimus for combination therapy are 60 mg/m2 and 5 mg orally daily, respectively. Promising anticancer activity has been noted.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.