Phase II trial of vinorelbine and oxaliplatin as first-line therapy in malignant pleural mesothelioma.

UNLABELLED: The incidence of malignant pleural mesothelioma (MPM) is increasing. Treatment options are limited, although recently published data have offered cause for optimism. We reported a response rate of 24% with low toxicity for single agent vinorelbine. Here we report a phase II trial of vinorelbine with oxaliplatin (VO) in patients with untreated MPM. Chemotherapy consisted of vinorelbine 30 mg/m(2), days 1 and 8 of a 21-day-cycle, and oxaliplatin 130 mg/m(2), day 1. Treatment continued up to six cycles. The primary endpoint was objective response. Secondary endpoints were toxicity, progression-free and overall survival. Responses were assessed by modified RECIST criteria. Twenty-six patients were enrolled. There were six partial remissions, 17 patients with stable disease, and three patients with PD. Response rate was 23% (95% confidence interval 9-44%). Median number of cycles delivered was four. Progression-free survival from first treatment was 4.7 months, and overall survival was 8.8 months. One-year-survival was 27%. Toxicity (% of patients with at least one episode of grade 3 or 4 toxicity): neutropenia 18%, phlebitis 12%, malaise 12%, anorexia 12%, nausea and vomiting 12%, constipation 6%. Quality of life assessed by Rotterdam symptom checklist was associated with stabilization or improvement of psychological well-being and lung symptoms in the majority of patients, but deterioration in physical symptoms. CONCLUSION: VO has activity in MPM with most patients responding or having stable disease, although this doublet is associated with significant toxicity.

Management of asymptomatic patients on follow-up for ovarian cancer with rising CA-125 concentrations.

In most women who have been treated for ovarian cancer, serum concentrations of the tumour marker cancer antigen (CA)-125 will serially rise on average 4 months before they develop symptoms or signs of relapse. Whether or not early reintroduction of treatment produces a survival advantage is unclear. Although a high chance exists that tumour response can be achieved with chemotherapy, complete cure of these patients is rarely possible. Potential advantages of early treatment of relapse include delaying cancer-related symptoms; psychological reassurance; and, possibly, improved survival. Potential disadvantages include loss of time without treatment and the associated toxic effects. Patients should be counselled on these advantages and disadvantages before deciding whether to have their CA-125 concentrations routinely measured during follow-up. In this review, we make suggestions, on the basis of the extent and duration of response to previous treatment, as to how to manage patients once their CA-125 concentrations start rising. Our suggestions range from close observation if scans are clear to various chemotherapy regimens, hormonal treatment, and surgery. Asymptomatic patients with rising CA-125 concentrations provide an ideal group in which to test new investigational agents that might have potential as maintenance treatment.