Glossary:
Progression-free survival: the length of time during and after treatment that a patient lives with the disease without it getting worse.
Overall survival: the length of time from diagnosis or treatment start that patients are still alive.
Complete response: the disappearance of all signs of cancer in response to treatment.
Overall response: the proportion of patients who have a complete or partial response to treatment.
Progressive disease: the worsening or growth of a disease despite treatment.
Thrombocytopenia: a condition characterized by low platelet count in the blood.
Neutropenia: an abnormally low count of neutrophils, a type of white blood cell.
Febrile neutropenia: a medical emergency characterized by fever and a low neutrophil count, often resulting from chemotherapy.
Adverse prognostic factor: any condition or factor that may negatively affect a patient’s disease outcome or survival.
Extranodal involvements: the spread of cancer beyond the lymph nodes to other organs or tissues.
In addition, thirty-one patients (64.6%) remain in CR, while 12 patients (25%) experienced progressive disease (PD), including three who died due to PD after six treatment cycles. One patient died from cardiovascular disease after the second cycle at a non-research clinical center, and an autopsy was not performed, leaving it unclear whether the death was due to sudden death related to side effects. One patient died from a COVID-19 infection after eight cycles of treatment; this patient's efficacy evaluation remained CR.
Furthermore, next-generation sequencing results from 33 patients showed TP53, MYD88 and PIM1 were the most commonly mutated genes. Multivariate analysis found BCL-6 gene rearrangement was an adverse prognostic factor for both progression-free survival (75.3% lower risk) and overall survival (94.3% lower risk). The number of extranodal involvements also significantly affected overall survival (15.12 times higher risk).
Regarding safety, grade 3 (severe) side effects were shown in 23 of 48 (47.9%) patients. Neutropenia was the most common grade 3 or worse side effect, occurring in 18 patients (37.5%), followed by pulmonary infection in 11 (22.9%), febrile neutropenia in three (6.3%), anemia in four (8.3%) and thrombocytopenia in four (8.3%). Treatment was well tolerated with no dose reductions or interruptions, the study stated.
“The regimen is well tolerated, especially for patients [at least] 60 years old, who did not benefit from [ibrutinib R‐CHOP] in the Phoenix study,” study authors wrote.
In this multicenter, prospective, singe-arm, phase 2 clinical study, a total of 48 newly diagnosed patients were enrolled between November 2020 and July 2022. Patients received Brukinsa (160 milligrams [mg] orally, twice daily) for six months and rituximab (375 mg per square meter [mg/m²], day 0), cyclophosphamide (750 mg/m², day 1), doxorubicin (50 mg/m², day 1), vincristine (1.4 mg/m², day 1) and prednisone (100 mg, days 1 to 5) in repeated 21-day cycles for six to eight cycles.
The study's primary end goals are progression-free survival and overall survival, and secondary end goals included complete response rate, overall response rate and side effects.
Reference:
“Zanubrutinib plus R‐CHOP for the treatment of newly diagnosed double‐expressor lymphoma: A phase 2 clinical study,” by Xia Yin, et al., Cancer.
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