[Clinical Study of Bortezomib in the Treatment of Multiple Myeloma at Different Dose-frequency Schedule].

ABSTRACT

OBJECTIVE: To evaluate the clinical effect of bortezomib with different dose-frequency in the treatment of multiple myeloma. METHODS: 86 patients with multiple myeloma in our hospital from February 2011 to February 2017 were included in the study. The patients were randomly divided into the experimental group (43 cases) and the control group (43 cases). The patients in the control group were treated with high dose bortezomib (1.6 mg/m2) on day 1, day 8, day 15 and day 22, with 35 d as a chemotherapy cycle. The patients in experimental group was treated with low dose bortezomib (1.0-1.3 mg/m2) on day 1, day 4, day 8 and day 11, with 21 d as a chemotherapy cycle. The patients in both groups were given dexamethasone(40 mg/d) and doxorubicin (10 mg/m2) from day 1 to day 4, and thalidomide was given orally at the intervals of 6 chemotherapy cycles. The clinical effect and the incidence of adverse drug reactions were compared between the two groups. RESULTS: The overall response rate (ORR) and disease control rate (DCR) were 88.37% and 95.35% respectively in the experimental group, while those of the control group were 81.40% and 90.70% respectively. There was no significant difference in ORR and DCR between the two groups. In the incidence of leukopenia, thrombocytopenia and neutropenia showed no significant difference between the two groups. The incidences of grade Ⅲ to grade Ⅳ peripheral neuropathy, herpes zoster, fatigue and abdominal distension in the experimental group were 2.33%, 4.65%, 13.95% and 2.33% respectively, while those of the control group were 16.28%, 27.91%, 34.88% and 18.60% respectively. The differences of the above incidences between the two groups were significant (P < 0.05). All the patients were followed up for 24 months. There was no significant difference in the overall survival (OS) rate, progression-free survival (PFS) rate and cumulative recurrence rate between the two groups. CONCLUSIONS: The effect of bortezomib in the treatment of multiple myeloma was similar at different dose-frequency group. The patients treated with low dose bortezomib (day 1, day 4, day 8 and day 11) had the better tolerance and lower incidences of adverse drug reactions.