Salvage Therapy with Vinorelbine in Advanced Non-Small-Cell Lung Cancer: A Retrospective Review of the Fox Chase Cancer Center Experience and a Review of the Literature

Devlin, John G.; Langer, Corey J.

doi:10.3816/clc.2007.n.011

Cited by 3 publications

(1 citation statement)

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“…In the second-line setting, vinorelbine was one of the comparators (along with ifosfamide) of a phase III trial of second line docetaxel [ 20 ] in which docetaxel (75 mg/m2) led to better overall survival than the comparators, thus establishing it as the standard choice for second-line treatment. A retrospective study that evaluated 39 patients with stage IIIb or IV treated with vinorelbine after a median of two prior lines of treatment, showed a partial response rate of 7.7 % and stable disease in 25.6 % of patients [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

A phase Ia/Ib clinical trial of metronomic chemotherapy based on a mathematical model of oral vinorelbine in metastatic non-small cell lung cancer and malignant pleural mesothelioma: rationale and study protocol

et al. 2016

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BackgroundMetronomic oral vinorelbine is effective in metastatic NSCLC and malignant pleural mesothelioma, but all the studies published thus far were based upon a variety of empirical and possibly suboptimal schedules, with inconsistent results. Mathematical modelling showed by simulation that a new metronomic protocol could lead to a better safety and efficacy profile.DesignThis phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patients with metastatic NSCLC or malignant pleural mesothelioma in whom standard treatments failed and who exhibited ECOG performance status 0–2 and adequate organ function will be eligible. Our mathematical PK-PD model suggested an alternative weekly D1, D2 and D4 schedule (named Vinorelbine Theoretical Protocol) with a respective dose of 60, 30 and 60 mg. Trial recruitment will be two-staged, as 12 patients are planned to participate in phase Ia to confirm safety and consolidate the calibration of the model parameters. Depending on the phase Ia results and after a favourable decision from a consultative committee, the extension phase (phase Ib) will be an efficacy study including 20 patients who will receive the Optimal Vinorelbine Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC v4.0) for the phase Ia and the objective response according to RECIST 1.1 for phase Ib.An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial.DiscussionThis ongoing trial is the first to prospectively test a mathematically optimized schedule in metronomic chemotherapy. As such, this trial can be considered as a proof-of-concept study demonstrating the feasibility to run a computational-driven protocol to ensure an optimal efficacy/toxicity balance in patients with cancer.Trial registrationEudraCT N°: 2015-000138-31

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Section: Introductionmentioning

confidence: 99%