Clinical Trial Shows Benefits of Vinorelbine for Mesothelioma

Research & Clinical Trials

Mesothelioma specialist Dr. Dean Fennell has strongly endorsed the use of vinorelbine as a second-line treatment for patients with relapsed disease.

He was the lead investigator in a recent phase II clinical trial studying the efficacy of vinorelbine for patients whose pleural mesothelioma cancer had progressed after traditional platinum-based chemotherapy.

Fennell, who is chair of thoracic and medical oncology at University of Leicester and University Hospitals in the United Kingdom, has based his belief on the multicenter trial involving 154 mesothelioma patients with relapsed disease.

“Doctors should now feel more confident in offering vinorelbine to patients and expanding their choice of options past platinum-based chemotherapy,” Fennell told The Mesothelioma Center at “The study provides solid evidence to justify its use in a setting of unmet need.”

Clinical Trial Results End Debate

There currently is no second-line standard of care for pleural mesothelioma. Treatment can vary widely based upon the medical center and is often only palliative in nature.

Vinorelbine is a different type of chemotherapy and classified as an antineoplastic agent. It comes with relatively low toxicity and is used for different cancers, mostly after recurrence. It is approved by the U.S. Food and Drug Administration for use with non-small cell lung cancer.

Although it has been used for many years on an international level, there has been considerable debate on its worth in combating mesothelioma after first-line relapse.

Previous research supporting its use has been inconclusive.

“Until now there was no evidence from an appropriately designed randomized trial to robustly justify its use,” Fennell said. “Our study was designed to address this important gap in knowledge.”

Findings Released at ASCO Meeting

Fennell presented his findings at the American Society of Clinical Oncology annual meeting earlier this month.

Median progression-free survival, from time of randomization, was 4.2 months for those receiving vinorelbine along with active symptom control. By contrast, median progression-free survival was just 2.8 months for those receiving only the same active symptom control, which excludes disease-modifying treatment.

Stable disease rate was 62.2% in the vinorelbine group, but only 46.4% in the non-vinorelbine group. Median duration of response was 7.2 months compared to 4.2 months, respectively.

Doses were given orally once per week for 21 days, then escalated through the following two months.

Grade 3 and 4 side effects were low with vinorelbine compared to standard chemotherapy. The most common was neutropenia in 12.5% of the patients. Second-most common was dyspnea, or difficulty breathing, at 6.2%. Lower respiratory infection was third at 5.2%.

Mesothelioma Treatment Improvement Still Needed

The immunotherapy drug pembrolizumab, known by the brand name Keytruda, has been approved by the FDA for second-line treatment of mesothelioma, but only for certain types of the disease. Its effectiveness has been inconsistent.

Mesothelioma, which is caused by exposure to asbestos, remains a rare cancer with no definitive cure. Although the most effective first-line treatment has been a multimodality regimen that includes aggressive surgery, the vast majority of patients do not qualify.

Typically, patients are not diagnosed until late, when surgery is no longer an option. Most patients receive only standard chemotherapy, which eventually ends in a relapse.

This latest study has shown that vinorelbine can then delay progression of the disease by 40%.

“All patients with malignant pleural mesothelioma eventually relapse following standard chemotherapy with pemetrexed and cisplatin,” Fennell said. “Vinorelbine exhibits useful clinical activity. It should be considered a treatment option.”

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