Vinorelbine

A multicenter, open-label, randomized, phase II trial (VIM [NCT02139904]) included 154 patients with malignant pleural mesothelioma and disease progression after previous platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either active symptom control (ASC) with oral vinorelbine (n = 98) or ASC alone (n = 56) every 3 weeks until disease progression, unacceptable toxicity, or withdrawal. The primary end point was PFS.[13] The clinical impact of vinorelbine monotherapy for treatment of relapsed malignant pleural mesothelioma is limited, with a modest improvement in PFS and no difference in OS. This clinical impact should be weighed against the potential impact on quality of life caused by treatment-related adverse events.

A multicenter, open-label, randomized, phase II trial (VIM [NCT02139904]) included 154 patients with malignant pleural mesothelioma and disease progression after previous platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either active symptom control (ASC) with oral vinorelbine (n = 98) or ASC alone (n = 56) every 3 weeks until disease progression, unacceptable toxicity, or withdrawal. The primary end point was PFS.[13] The clinical impact of vinorelbine monotherapy for treatment of relapsed malignant pleural mesothelioma is limited, with a modest improvement in PFS and no difference in OS. This clinical impact should be weighed against the potential impact on quality of life caused by treatment-related adverse events.

The median PFS was 4.2 months in the ASC-plus-vinorelbine group and 2.8 months in the ASC-alone group (adjusted HR, 0.60; 80% CI [upper limit, 0.70]; one-sided adjusted log-rank P < .001).[13][Level of evidence B1]

A multicenter, open-label, randomized, phase II trial (VIM [NCT02139904]) included 154 patients with malignant pleural mesothelioma and disease progression after previous platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either active symptom control (ASC) with oral vinorelbine (n = 98) or ASC alone (n = 56) every 3 weeks until disease progression, unacceptable toxicity, or withdrawal. The primary end point was PFS.[13] The clinical impact of vinorelbine monotherapy for treatment of relapsed malignant pleural mesothelioma is limited, with a modest improvement in PFS and no difference in OS. This clinical impact should be weighed against the potential impact on quality of life caused by treatment-related adverse events.

The median OS did not differ significantly between the two groups (9.3 months in ASC-plus-vinorelbine group vs. 9.1 months in the ASC-alone group).

A multicenter, open-label, randomized, phase II trial (VIM [NCT02139904]) included 154 patients with malignant pleural mesothelioma and disease progression after previous platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either active symptom control (ASC) with oral vinorelbine (n = 98) or ASC alone (n = 56) every 3 weeks until disease progression, unacceptable toxicity, or withdrawal. The primary end point was PFS.[13] The clinical impact of vinorelbine monotherapy for treatment of relapsed malignant pleural mesothelioma is limited, with a modest improvement in PFS and no difference in OS. This clinical impact should be weighed against the potential impact on quality of life caused by treatment-related adverse events.

The objective response rate was 3% in the ASC-plus-vinorelbine group and 2% in the ASC-alone group.

A multicenter, open-label, randomized, phase II trial (VIM [NCT02139904]) included 154 patients with malignant pleural mesothelioma and disease progression after previous platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either active symptom control (ASC) with oral vinorelbine (n = 98) or ASC alone (n = 56) every 3 weeks until disease progression, unacceptable toxicity, or withdrawal. The primary end point was PFS.[13] The clinical impact of vinorelbine monotherapy for treatment of relapsed malignant pleural mesothelioma is limited, with a modest improvement in PFS and no difference in OS. This clinical impact should be weighed against the potential impact on quality of life caused by treatment-related adverse events.

Although BRCA1 expression is required for vinorelbine-induced apoptosis in preclinical models, and loss of expression may correlate with vinorelbine resistance, low BRCA1 expression did not correlate with clinical activity in this study.

A multicenter, open-label, randomized, phase II trial (VIM [NCT02139904]) included 154 patients with malignant pleural mesothelioma and disease progression after previous platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either active symptom control (ASC) with oral vinorelbine (n = 98) or ASC alone (n = 56) every 3 weeks until disease progression, unacceptable toxicity, or withdrawal. The primary end point was PFS.[13] The clinical impact of vinorelbine monotherapy for treatment of relapsed malignant pleural mesothelioma is limited, with a modest improvement in PFS and no difference in OS. This clinical impact should be weighed against the potential impact on quality of life caused by treatment-related adverse events.

Vinorelbine was generally well tolerated and most treatment-related adverse events in both groups were mild to moderate in severity. The most common serious adverse events in the ASC-plus-vinorelbine group versus the ASC-alone group were dyspnea (5% vs. 0%), lower respiratory tract infection (5% vs. 6%), unspecified infection (3% vs. 0%), and febrile neutropenia (3% vs. 0%). Treatment-related deaths were reported in two patients in the ASC-plus-vinorelbine group (caused by pneumonia and lower respiratory tract infection) and in one patient in the ASC-alone group (caused by lower respiratory tract infection).