Background: This study evaluated the therapeutic effect: of the weekly administration of vinorelbine (5'-nor-anhydrovinblastine), a semisynthetic vinca alkaloid, in heavily pretreated patients with Hodgkin's disease. Patients and methods: Twenty-four patients with Hodgkin's disease refractory or resistant to at least two chemotherapy regimens were enrolled in this study. Vinorelbine was administered in a weekly dose of 30 mg/m(2) i.v. bolus and patients were evaluated after four courses. All but two were considered evaluable for drug response. The reasons for their exclusion were early death due to pancytopenia and loss to follow-up after two courses. In complete responders, six additional courses were administered; in ah other patients, treatment was continued until their diseases progressed. Toxicity was evaluated in 23 patients according to the Common Toxicity Criteria. Results: Eleven of 22 evaluable patients (50%) showed objective response (complete 14% and partial 36%). The median duration of response was six months for both complete and partial responders (range 2-10 months). Thirteen patients are still alive and five are still on therapy. Grade 3-4 granulocytopenia was documented in 53% of patients and grade 3 infections in 13%. Anemia and thrombocytopenia were negligible. Nausea and vomiting were not observed; grade 2 alopecia occurred in only one patient. There were grade 3 reactions at the injection site in the first five patients, so a venous central access was utilized in the subsequent patients. Two patients had grade 1 constipation and only one developed an adynamic ileum. Although all patients had previously been treated with vinca alkaloid analogs, peripheral neuropathy was mild. Conclusions: Our data indicate that vinorelbine is active as a single agent in heavily pretreated patients with Hodgkin's disease. The efficacy in patients pretreated with at least two vinca alkaloids suggests a possible absence of cross-resistance between vinorelbine and other vinka analogs. Toxicity is mild and reversible. The inclusion of vinorelbine in second-line combination chemotherapy regimens for Hodgkin's disease is strongly recommended.
