Chemo Mix Using Treanda Before HSCT Seen of Benefit in Phase 2 Study

Chemo Mix Using Treanda Before HSCT Seen of Benefit in Phase 2 Study

According to the results of a Phase 2 clinical trial, the triple combination of Treanda (bendamustine), Gemzar (gemcitabine), and Navelbine (vinorelbine) effectively induced complete remission in a large percentage of patients with relapsed or refractory Hodgkin’s lymphoma before undergoing autologous stem cell transplant (HSCT).

The study, “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,” published in the Journal of Clinical Oncology, was led by researchers at the Humanitas Cancer Center in Italy.

In patients with advanced-stage Hodgkin’s lymphoma, first-line chemotherapy induces cure rates close to 80 percent. Patients who fail to respond to treatment, or in whom the disease progresses despite an initial response, usually have a worse prognosis, and require second-line therapies as soon as possible to lower their risk of treatment failure.

Recently, the research team developed the Ifex (ifosfamide), Gemzar, and Navelbine pre-transplantation regimen, which was seen to result in an overall response rate of 84% and a complete response rate of 54%, with no toxicity concerns.

Because other studies indicated that Treanda can increase complete response rates when used in combination regimens as second-line therapy in patients with relapsed or refractory Hodgkin lymphoma patients, the researchers replaced Ifex with Treanda. The study enrolled 59 patients, with a median age of 33, 27 of which had primary refractory disease (failed to respond to initial therapy), and 32 with relapsed disease (progressed despite initial response to treatment).

Patients received Treanda (90 mg/m2) on days two and three, Gemzar (800 mg/m2) on days one and four, and Navelbine (20 mg/m2) on day one of four, 21-day cycles. Patients also received prednisolone (100 mg) on days one and four. The study’s primary endpoint was complete response rate after four cycles of therapy, and secondary endpoints were overall response rate, stem-cell mobilization activity, and toxicity.

After a median follow-up of 29.1 months, the researchers found that the triple therapy induced a complete response in 73% of patients, and a partial response in 10%, accounting for an overall response rate of 83%. For complete response, this was higher than what had been observed with the combination therapy containing Ifex.

Investigators also found that patients who had relapsed disease were significantly more likely to achieve complete response than those with refractory disease (84% versus 59%).

Among the responders, 43 patients received HSCT. In those patients, the two-year progression-free survival (PFS) and overall survival (OS) were found to be higher than in those who did not receive HSCT.

Severe adverse events to treatment, including febrile neutropenia and infection, were observed in eight patients.

“These findings provide a strong rationale for further development of the [Treanda, Gemzar and Navelbine] regimen,” the authors wrote. “Because the number of novel agents that may be added in the pretransplantation therapy setting is growing, direct comparisons of combinations incorporating novel agents with [Treanda, Gemzar and Navelbine] and other regimens will be necessary to identify the best salvage strategy for relapsed and refractory Hodgkin lymphoma.”

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