medwireNews: Results from the phase 2 VIM trial support the use of vinorelbine in patients with malignant pleural mesothelioma (MPM) whose disease has progressed following platinum-based therapy.
“Vinorelbine exhibits useful clinical activity but has not been formally evaluated in a randomised clinical trial, despite its widespread off-label use worldwide,” and “this underpins the VIM study,” explained Dean Fennell (University of Leicester, UK) at the 2021 ASCO Annual Meeting.
In the UK-based trial, the median progression-free survival (PFS) was 4.2 months for the 98 patients who were randomly assigned to receive vinorelbine 80 mg/m2 (60 mg/m2 in the first cycle) on days 1, 8, and 15 of each 3-weekly cycle alongside active symptom control (ASC).
By comparison, the median PFS was 2.8 months among the 56 patients who received ASC alone, which equated to a significant 40% reduction in the risk for disease progression or death with the addition of vinorelbine.
Fennell explained that they assessed PFS by BRCA1 expression, as “BRCA1 regulates spindle assembly checkpoint in MPM and predicts vinorelbine sensitivity in preclinical models, suggesting that BRCA1 negative patients may be chemoresistant.”
But the addition of vinorelbine to ASC offered a significant PFS advantage regardless of whether patients were BRCA1 negative (hazard ratio [HR]=0.22) or positive (HR=0.35), and therefore BRCA1 does not appear to be a predictive biomarker for vinorelbine efficacy, said the presenter.
A total of 3.1% of patients in the vinorelbine group had a partial response, as did 1.8% of those in the control group, and responses lasted for a median of 7.2 and 4.2 months, respectively. The rate of stable disease was higher among vinorelbine-treated participants than their counterparts given ASC alone, at a respective 62.2% and 46.4%, reported Fennell.
However, the addition of vinorelbine did not significantly prolong overall survival, at a median of 9.3 months compared with 9.1 months with ASC.
The most common adverse event of grade 3 or 4 in the vinorelbine versus ASC alone group was neutropenia (12.5 vs 0.0%), followed by dyspnea (6.2 vs 0.0%), lower respiratory infection (5.2 vs 5.9%), lymphopenia (4.2 vs 0.0%), and fatigue (4.2 vs 0.0%). There were two deaths related to a serious adverse event in the vinorelbine arm versus none in the control arm.
Fennell therefore concluded that “vinorelbine appears to be a safe and effective treatment, and could be considered as a treatment option for patients with relapsed mesothelioma.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group