VINORELBINE - AN ACTIVE-DRUG FOR THE MANAGEMENT OF PATIENTS WITH HEAVILY PRETREATED HODGKINS-DISEASE

Background: This study evaluated the therapeutic effect: of the weekly administration of vinorelbine (5'-nor-anhydrovinblastine), a semisynt hetic vinca alkaloid, in heavily pretreated patients with Hodgkin's di sease. Patients and methods: Twenty-four patients with Hodgkin's disea se 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 course s. All but two were considered evaluable for drug response. The reason s for their exclusion were early death due to pancytopenia and loss to follow-up after two courses. In complete responders, six additional c ourses were administered; in ah other patients, treatment was continue d until their diseases progressed. Toxicity was evaluated in 23 patien ts according to the Common Toxicity Criteria. Results: Eleven of 22 ev aluable patients (50%) showed objective response (complete 14% and par tial 36%). The median duration of response was six months for both com plete and partial responders (range 2-10 months). Thirteen patients ar e still alive and five are still on therapy. Grade 3-4 granulocytopeni a was documented in 53% of patients and grade 3 infections in 13%. Ane mia and thrombocytopenia were negligible. Nausea and vomiting were not observed; grade 2 alopecia occurred in only one patient. There were g rade 3 reactions at the injection site in the first five patients, so a venous central access was utilized in the subsequent patients. Two p atients had grade 1 constipation and only one developed an adynamic il eum. Although all patients had previously been treated with vinca alka loid analogs, peripheral neuropathy was mild. Conclusions: Our data in dicate that vinorelbine is active as a single agent in heavily pretrea ted patients with Hodgkin's disease. The efficacy in patients pretreat ed with at least two vinca alkaloids suggests a possible absence of cr oss-resistance between vinorelbine and other vinka analogs. Toxicity i s mild and reversible. The inclusion of vinorelbine in second-line com bination chemotherapy regimens for Hodgkin's disease is strongly recom mended.