In a multicenter, open-label, phase II study published in the Journal of Clinical Oncology, nearly three-quarters (73%) of patients with relapsed/refractory Hodgkin lymphoma (HL) treated with bendamustine plus gemcitabine and vinorelbine prior to autologous hematopoietic cell transplantation (AHCT) had a complete response. In addition, 10 percent of patients achieved a partial response, for an overall response rate of 83 percent (secondary endpoint).
“These findings provide a strong rationale for further development of the [bendamustine, gemcitabine, and vinorelbine] regimen,” the study authors, led by Armando Santoro, MD, wrote. “Because the number of novel agents that may be added in the pre-transplantation therapy setting is growing, direct comparisons of combinations incorporating novel agents with [bendamustine, gemcitabine, and vinorelbine] and other regimens will be necessary to identify the best salvage strategy for relapsed and refractory HL.”
Dr. Santoro, clinical research director, cancer center director, and head of the medical oncology and hematology unit at Humanitas Clinical and Research Center in Milan, Italy, and colleagues assessed outcomes in 59 patients who received the following treatment for four 21-day cycles:
- 800 mg/m2 of gemcitabine on days 1 and 4
- 20 mg/m2 of vinorelbine on day 1
- 90 mg/m2 of bendamustine on days 2 and 3
Patients also received 100 mg of prednisolone daily.
CD34+ cells were successfully harvested in 55 of 57 evaluable patients, and 43 of 49 responding patients underwent AHCT.
After a median follow-up of 29.1 months (range = 3.4-49.1 months), the two-year progression-free survival (PFS) was 62.2 percent and the overall survival (OS) was 77.6 percent. Among those undergoing AHCT, the PFS and OS rates were 80.8 percent and 89.3 percent, respectively.
The most common grade 3/4 non-hematologic adverse events (AEs) included febrile neutropenia (n=7) and infection (n=4), while the most common grade 3/4 hematologic AEs were thrombocytopenia (n=8) and neutropenia (n=8).
Source: Santoro A, Mazza R, Pulsoni A, et al. Bendamustine in combination with gemcitabine and vinorelbine is an effective regimen as induction chemotherapy before autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma: Final results of a multicenter phase II study. J Clin Oncol. 2016 July 5. [Epub ahead of print]