This combined treatment, which includes bendamustine, ofatumumab, carboplatin and etoposide, may serve as an effective bridge to stem cell transplantation.
Salvage chemotherapy, or treatment for cancer nonresponsive to other chemotherapy regimens, with bendamustine, ofatumumab, carboplatin and etoposide in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) served as a safe and effective regimen to bridge patients to stem cell transplantation.
“In the era of high value, cost-conscious medicine, delivering high-quality care in the outpatient setting is becoming crucial to allow delivery of cost-effective care,” the study authors wrote. “(Bendamustine, ofatumumab, carboplatin and etoposide) offers a safe and effective outpatient alternative to currently available inpatient salvage chemotherapy regimens and has the potential to minimize hospitalizations and thus lower health care costs.”
Aggressive salvage treatments commonly used in these patients are often administered in an inpatient or outpatient setting. A more ideal regimen, according to the study authors, would be administered in an outpatient setting, provide a favorable toxicity profile and high disease response rate and offer an alternative to CD20-targeted therapy, which focuses on a protein on the surface of B cells that also be found in bone marrow.
In this phase 1/2 study, 35 patients (median age, 62 years; 15 women) with relapsed or refractory aggressive B-cell NHL were treated with a salvage chemotherapy regimen including bendamustine, ofatumumab, carboplatin and etoposide. In particular, 57% of patients had de novo large cell or grade 3B follicular lymphoma, 26% had transformed de novo large cell lymphoma, 9% had grade 3A follicular lymphoma and 3% had mantle cell lymphoma.
The first cycle of this treatment was administered in an inpatient setting to monitor for infusion-related reactions. If toxicities of grade 3 or higher did not occur, which included severe, life-threatening events, subsequent cycles were given in an outpatient setting.
The primary objective of this study was to assess the tolerability and safety of this regimen and to determine its overall response rate (ORR). In addition, secondary end points included overall survival (OS), progression-free survival (PFS), duration of response and the number of patients who advanced to stem cell transplantation. Follow-up was conducted for a median of 24.1 months.
The ORR in all patients was 69%, with 49% of patients having a complete response and 20% of patients having a partial response. When patients with de novo large cell lymphoma and grade 3B follicular lymphoma were assessed, the ORR was 70%, with 50% of patients having a complete response and 20% of patients having a partial response.
Patients in the study had a median PFS of 5.1 months and OS of 26.2 months. Twelve patients moved on to undergo stem cell transplantation.
The most common grade 3-4 nonhematologic toxicities, or those not related to cancer originating in the bone marrow or blood, included hypophosphatemia and neutropenic fever. Hypophosphatemia refers to an electrolyte disorder resulting from low phosphate levels in blood, whereas neutropenic fever occurs when a patient has a temperature of 100.4° F or greater while having low counts of a type of white blood cell called neutrophil.
“While the protocol mandated inpatient monitoring after the first cycle for (infusion-related reactions), we found that (infusion-related reactions) were all grade 1-2,” the study authors wrote. “Therefore, (bendamustine, ofatumumab, carboplatin and etoposide) should be safe for outpatient administration, which is our current institutional practice when using it outside of a clinical trial setting.”
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