A clinical trial result was announced that showed that the additional use of Ibrutinib, a targeted anticancer drug, in addition to chemotherapy for mantle cell lymphoma patients over 65 years of age, which cannot be treated, has a good therapeutic effect.
The research team at the University of Texas MD Anderson Cancer Center published this study in the New England Journal of Medicine on the 3rd (local time). The research team will present the results of this clinical study (SHINE phase 3 trial) at the American Society for Clinical Oncology (ASCO) held in Chicago, USA on the 3rd and 7th.
According to the results of the study, ‘progression-free survival’ was significantly increased when the targeted anticancer drug ‘ibrutinib’ was additionally administered to untreated mantle cell lymphoma patients over 65 years of age in addition to chemotherapy (standard chemoimmunotherapy). appeared to be extended.
Mantle cell lymphoma is an intractable hematologic malignancy, and it mainly occurs in the elderly. In addition, Ibrutinib, a drug used for anticancer treatment, is a targeted anticancer drug manufactured by Janssen (Korea Janssen Korea) and Pharmacyclics.
The research team administered ibrutinib in addition to standard chemotherapy to 261 elderly patients with mantle cell lymphoma (experimental group). In addition, 262 patients (control group) were additionally administered a placebo in addition to standard chemotherapy. All these patients were randomly assigned.
In principle, the standard chemotherapy is to administer bendamustine and rituximab for 6 cycles, but only rituximab is administered as maintenance therapy to patients who show an objective response.
According to the study results, the progression-free survival period (median) at follow-up (median 84.7 months) after the clinical trial was 80.6 months in the experimental group, which was about 27.7 months longer than that in the control group (52.9 months).
In addition, the proportion of patients who showed a complete response (complete remission) was 65.5% in the experimental group, which was 7.8% higher than that of the control group (57.6%). The overall survival of the two groups was similar. The incidence of adverse reactions (grade 3 or 4) was 81.5% in the experimental group and 77.3% in the control group.
Dr. Michael L. Wang, MD, Anderson Cancer Center, University of Texas, MD, and lead author of the study, said, “The combination therapy of bendamustine/rituximab and ibrutinib or the combination of rituximab (maintenance therapy) and ibrutinib was not effective until the age of 65. It has proven to be an effective first-line treatment for patients with mantle cell lymphoma considered unsuitable for autologous lymphoma treatment.”
On the other hand, progression-free survival (PFS) is a period in which cancer has not progressed further, and a complete response (CR) is a state in which there is no evidence of cancer in post-treatment tests.
The research team received funding from Janssen and Pharmacyclic, and the results of this study were introduced by the American health media ‘Health Day’.
By Kim Young-seop, staff reporter [email protected]
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