| Title |
Metronomic treatment of advanced non-small-cell lung cancer with daily oral vinorelbine – a Phase I trial
|
|---|---|
| Published in |
OncoTargets and therapy, February 2017
|
| DOI | 10.2147/ott.s122106 |
| Pubmed ID | |
| Authors |
Sylvia Guetz, Amanda Tufman, Joachim von Pawel, Achim Rittmeyer, Astrid Borgmeier, Pierre Ferré, Birgit Edlich, Rudolf Maria Huber |
| Abstract |
In a Phase I dose-finding study of metronomic daily oral vinorelbine in advanced non-small-cell lung cancer, a recommended dose was established for this therapeutic approach. In addition, this trial revealed promising efficacy data and an acceptable tolerability profile. The observed vinorelbine blood concentrations suggest continuous anti-angiogenic coverage. We present a Phase I dose-finding study investigating metronomic daily oral vinorelbine (Navelbine(®) Oral, NVBo) in advanced non-small-cell lung cancer (NSCLC). Patients with stage III/IV NSCLC received daily NVBo at fixed dose levels of 20-50 mg/d for 21 days of each 4-week cycle. Primary end point was the maximum tolerated dose. Secondary end points included tumor response, time to progression (TTP), overall survival (OS) and tolerability. Twenty-seven patients with advanced NSCLC were enrolled. Most of them were extensively pretreated. Daily NVBo was well tolerated up to 30 mg/d. At 40 mg/d, two of five patients experienced dose-limiting toxicities (DLTs). Three of six patients had DLTs at the 50 mg/d level. The recommended dose was established at 30 mg/d in cycle 1, with escalation to 40 mg/d in cycle 2, if tolerated. Pharmacokinetic analyses showed continuous blood exposure over 21 days and only marginal accumulation. The tolerability profile was acceptable (all dose levels - all grades: decreased appetite 33%, diarrhea 33%, leukopenia 33%, nausea 30%, vomiting 26%; ≥grade 3: leukopenia 30%, lymphopenia 19%, neutropenia 19%, febrile neutropenia 15%). Disease control rate, OS and TTP signaled a treatment effect. Daily metronomic NVBo therapy in extensively pretreated patients with advanced NSCLC is feasible and safe at the recommended dose of 30 mg/d. Escalation to 40 mg/d in the second cycle is possible. The blood concentrations of vinorelbine after daily metronomic dosing reached lower peaks than intravenous or oral conventional dosing. Blood concentrations were consistent with anti-angiogenic or immune modulating pharmacologic properties of vinorelbine. Further studies are warranted to evaluate the safety and efficacy of this novel approach in specific patient populations. |
Mendeley readers
The data shown below were compiled from readership statistics for 35 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 35 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 8 | 23% |
| Student > Master | 6 | 17% |
| Student > Doctoral Student | 3 | 9% |
| Researcher | 3 | 9% |
| Student > Ph. D. Student | 1 | 3% |
| Other | 3 | 9% |
| Unknown | 11 | 31% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 10 | 29% |
| Nursing and Health Professions | 4 | 11% |
| Computer Science | 3 | 9% |
| Biochemistry, Genetics and Molecular Biology | 3 | 9% |
| Neuroscience | 1 | 3% |
| Other | 1 | 3% |
| Unknown | 13 | 37% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 07 March 2017.
All research outputs
#22,764,772
of 25,382,440 outputs
Outputs from OncoTargets and therapy
#2,078
of 3,016 outputs
Outputs of similar age
#365,805
of 424,972 outputs
Outputs of similar age from OncoTargets and therapy
#63
of 77 outputs
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