Vinorelbine combined with active supportive care conferred superior [ progression-free survival (PFS) ] compared with active supportive care alone among patients with relapsed malignant pleural mesothelioma, according to phase 2 study results.
“All patients with malignant pleural mesothelioma eventually relapse following standard chemotherapy with pemetrexed and cisplatin. However, there is no standard treatment option in this patient setting,” Dean A. Fennell, FRCP, PhD, chair of thoracic medical oncology at University of Leicester and University Hospitals of Leicester NHS Trust in the U.K., said during his presentation at the virtual ASCO Annual Meeting. “Vinorelbine exhibits useful clinical activity but has not been formally evaluated in a randomized clinical trial, despite its widespread off-label use worldwide.”
The randomized, investigator-led, phase 2 VIM trial enrolled 154 patients with malignant pleural mesothelioma across 10 U.K. sites between May 2016 and October 2018. Researchers randomly assigned the patients, all of whom progressed after first-line chemotherapy, 2:1 to vinorelbine dosed at 60 mg/m² weekly every 21 days, then escalating to 80 mg/m² from cycle two, plus active supportive care (n = 98; median age, 70.5 years; 81.6% men; 36.7% BRCA1-positive) or active supportive care alone (n = 56 median age, 70.7 years; 80.4% men; 26.8% BRCA1-positive) until disease progression, unacceptable toxicity or withdrawal of consent. Researchers noted that BRCA1 status could not be obtained for 50% of study participants.
[ Progression-free survival (PFS) ] defined as the time from randomization to any progression or death served as the primary outcome. Secondary endpoints included OS, tolerability and safety.Two patients assigned active supportive care alone crossed over to the vinorelbine group and 22 patients (39.3%) assigned active supportive care alone proceeded to another clinical trial.
Median duration of vinorelbine treatment was 2.8 months (range, 1.2-5.1).
Results of the intention-to-treat analysis showed that after 129 events occurred, median [ progression-free survival (PFS) ] was 4.2 months (90% CI, 3.5-4.8) in the vinorelbine group compared with 2.8 months (90% CI, 2.5-2.9) with active supportive care alone (HR = 0.6; 95% CI, 0.41-0.86).
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