ABSTRACT
Objective: To analyze the treatment effect of the number of bortezomib, cyclophosphamide, and dexamethasone (BCD) chemotherapy courses for newly diagnosed multiple myeloma. Methods: We retrospectively analyzed data of patients with newly diagnosed multiple myeloma from January 2014 to July 2016 in Peking University People's Hospital. All 70 patients received two or more courses of BCD chemotherapy. Patients with extramedullary disease or amyloidosis were excluded. Patients completed their follow-up, and the treatment effects were studied in those who only received two, four, and six chemotherapy courses. Results: Among the 70 patients, the ratio of male to female was 36 :34, the median age of disease onset was 58.4 y (range: 33-81 y), and the number of patients with ISS stagesⅠ,Ⅱ, and Ⅲ was 16, 18, and 36, respectively. The number of patients who received two, four, and six chemotherapy courses was 14, 20, and 36, respectively. The percentages of complete remission, equal or more than very good partial remission, equal or more than partial remission for patients who received two courses were 14.28%, 42.86%, and 71.42%, those for four courses were 30.00%, 60.00%, 80.00%, and those for six courses were 38.89%, 75.00%, 83.33%, respectively. During the median 15.37 (range: 2-32) months follow up, the estimated progression free survival (PFS) was 21.96 months (95% CI: 19.26-24.70). No statistically significant difference for PFS was observed among the three groups (P=0.700). Conclusions: For the BCD chemotherapy regimen, the maximum therapeutic effect occurred after four or more courses. As the number of induction courses after four chemotherapies increased, the depth of disease relief increased but overall remission did not show substantial improvement. Therefore, four or more BCD chemotherapies can be used for the first line of induction therapy.
ABSTRACT
Objective To evaluate the efficacy and safety of lenalidomide in a real-world clinical practice in Chinese patients with multiple myeloma (MM).Methods It was a prospective,multi-center,observational study.A total of 165 consecutive patients with MM treated with lenalidomide-based regimens were enrolled in 12 hospitals from June 2013 to November 2015.Relevant information was recorded,such as baseline clinical data,cytogenetic abnormalities,treatment regimens,and duration of treatment,safety,and survival.Results (1)There were 126 relapsed and refractory MM (RRMM) patients,25 newly diagnosed patients and 19 maintenance patients.The evaluable RRMM patients accounted for 120 cases,among which 74 cases(61.7％) reached the partial response (PR) or above,and a very good partial response (VGPR) in 16 patients (13.3％),a complete response (CR) in 14 cases (11.7％),a strictly complete response (sCR) in 4 cases (3.3％).Thus,a VGPR or above in 34 patients accounted for 28.3％.(2)The median follow-up was 13 months,the median time to progression 12 months.The median survival after receiving lenalidomide was 19 months,and the median overall survival (OS) was 62 months.(3) The univariate analysis in 120 RRMM patients suggested that prognostic factors for significant improvement in PFS included normal karyotype,international staging system (ISS) Ⅰ-Ⅱ,t(4;14) negative (detected by fluorescence in situ hybridization),non-bortezomib resistance and response to previous regimens.As to OS,nonbortezomib resistance,response to previous regimens and non-primary refractoriness were positive factors.Multivariate analysis showed that the response to previous regimens (PR or better) was an independent good prognostic factor for progress-free survival (PFS),non-bortezomib resistance and non-primary refractoriness for OS.(4) Grade 3 or 4 adverse events that occurred in more than 10％ of all enrolled patients were neutropenia (12.7％),leukocytosis (11.5％) and thrombocytopenia (12.7％).Owing to intolerance of toxic side effects,7 cases withdrew lenalidomide.Conclusions No matter what combination,regimens containing lenalidomide are effective to RRMM patients with overall response rate 61.7％,a time to progression 12 months and an overall survival 62 months.The toxicity is quite tolerable and manageable.In addition,the response to previous treatment (reached PR or above) is the independent good prognostic factor for PFS,non-bortezomib resistance and non-primary refractoriness for OS.Clinical trail registration Clinicaltrials.gov,NCT01947309