Researchers affiliated with Leukemia Group B presented the results of a phase I-II clinical trial suggesting that a regimen of Gemzar®, Navelbine® and Doxil® (GND) was an effective salvage therapy for patients with Hodgkin Lymphoma who had failed chemotherapy or an autologous transplant. These results were presented at an oral session of the 39th annual meeting or the American Society of Clinical Oncology.

The optimal treatment for patients with Hodgkin lymphoma who have failed chemotherapy is high-dose therapy with autologous or allogeneic stem cell support. The results of high-dose therapy with stem cell support are improved if patients respond to salvage chemotherapy. Thus, the better the salvage chemotherapy, the more likely a patient will be cured with an autologous transplant. For patients who fail autologous transplant there is a need for palliative chemotherapy.

In this phase I-II study, the doses of GND that could be combined without excessive toxicity was determined. This study included two distinct groups of patients: those who had not received an autologous transplant (n=47) and those who had (n=28). For those who had not received an autologous transplant, the goal was to administer two cycles of GND and proceed to transplant. Two doses of MTD were determined: a lower those for those who had failed an autograft, and a higher dose for those who were undergoing treatment prior to an autograft. Patients were not excluded by the prior number of treatment regimens. However, the maximum dose of doxorubicin that was allowed was 400 mg per square meter.

Patients without a prior autologous transplant had a CR rate of 15% and a PR rate of 46%. Of the patients without a prior transplant, 68% were transplanted, resulting in a one-year OS of 90%. For those who had a prior autologous transplant, response rates were similar, but the median EFS was only 8.5 months. These researchers concluded that this was an active and well tolerated regimen but that an autologous transplant or other continued therapy was necessary.

Comments: This study suggests that the GND regimen is as good as or better than other salvage regimens for patients with relapsed Hodgkin lymphoma. Since the optimal therapy for patients is an autologous transplant this would be a good regimen to administer at first relapse followed by collection of stem cells and an immediate transplant. The 90% one-year survival of patients receiving autologous transplants following the GND regimen is very promising.

Reference: Bartlett N, Niedzwieki D, Johnson J, et al. A Phase I/II Study of Gemcitabine, Vinorelbine and Liposomal Doxorubicin for Relapsed Hodgkin’s Disease:Preliminary Results of CALGB 59804. Proceedings of the 39th annual meeting of the American Society of Clinical Oncology 2003;22:Abstract number 2275, page 566.