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A treatment combination that includes Velcade and Rituxan helps improve responses and the safety profile in marginal zone lymphoma, according to a phase 2 trial.
Velcade (bortezomib), Rituxan (rituximab), cyclophosphamide, doxorubicin hydrochloride, prednisone and cytarabine hydrochloride (VR-CAP) generated improved responses with a tolerable safety profile for some patients with a type of lymphoma, according to findings from a phase 2 trial presented at the 2023 ESMO Congress.
Specifically, patients with marginal zone lymphoma (MZL), a type of slow-growing B-cell non-Hodgkin lymphoma that grows in the lymph tissue, benefited from VR-CAP when it was received as first-line treatment.
The phase 2 trial evaluated 23 patients with a median age of 55 years. Eighteen patients (78%) were under 60 years of age, and five patients (22%) were 60 years or older. The male-to-female ratio was 14 to nine. Of the 23 patients, most (65%) had stage 3 or 4 B-cell non-Hodgkin MZL (65%), and 35% of patients had stage 1 or 2 disease.
The two-year rate of progression-free survival (PFS; length of time during and after treatment when a patient’s cancer does not worsen) was 82.2%, and the overall response rate (ORR; percentage of patients who had a partial or complete response to treatment) was 82%.
As of February 2023, 15 patients completed the cumulative six-course treatment, six patients completed four courses of the total six, and two discontinued the treatment by choice, according to the study.
In 22 patients, a curative effect could be evaluated, and among them 16 (72.7%) experienced either a complete response (CR) or an unconfirmed complete response) and 5 patients (22.7%) experienced a partial response (PR).
“VR-CAP (as) first-line treatment of lymphoma in the marginal region has a good effect…and (is) well tolerated,” Dr. Junfeng Chu and co-authors wrote in a poster of the data.
READ MORE: Pharma Companies Pull Imbruvica Indication for Marginal Zone and Mantle Cell Lymphoma
Among the 23 total patients in the trial, two patients (8.7%) experienced B symptoms while undergoing treatment, compared with 21 patients (91.3%) who did not. B symptoms include fever, drenching night sweats and the loss of more than 10 percent of a patient’s body weight during a six-month period, according to the Leukemia and Lymphoma Society.
Patients receiving the full six treatment cycles had a CR rate of 66.7% and a partial response (PR) rate of 33.3%. Patients receiving four cycles of treatment had a CR rate of 33.3% and a PR rate of 57.1%.
Additionally, 4.8% of patients who received four cycles of treatment reported disease progression, and 4.8% had stable disease. Among patients treated for two cycles, investigators reported a PR rate of 68.2%, a CR rate of 27.3% and a stable disease rate of 4.5%.
The first-line treatment comprised six cycles, with each cycle lasting for three weeks. At the start of the treatment cycle, a dose of Rituxan was given through the vein, as well as a dose of cyclophosphamide and a dose of Ellence (epirubicin). On the first and fourth days, a dose of Velcade was given under the skin, and on the first and fifth days, a dose of prednisone was given orally.
The most common grade 1 or 2 (mild) side effects experienced by 13 patients who completed the six courses of treatment were anemia (73.9%), gastrointestinal reaction (52.2%), thrombocytopenia (low levels of platelets; 30.4%), pulmonary infection (21.7%, with 4.3% having severe reactions), neurotoxicity (disruption of normal nervous system activity; 87%) and Rituxan-related rash (8.7%).
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