| 【Objective】 Discussing the efficacy and safety of Granulocyte-colony Stimulating Factor(G-CSF) plus Bortezomib,Cyclonphosphamide and Dexamethasone on the treatment of non-transplant-naive multiple myeloma.【Mthods 】 From July 1 2013 to MAY 1, 2015, total of 33 patients with non-transplant- naive multiple myeloma according to the International Myeloma Working Group were enrolled in our study in the Second Affiliated Hospital of Soochow University. Induction therapy as granulocyte colony stimulating factor combined BCD(G-BCD, C linical Trials.gov Identifier NCT02027220). Dosing schedule consisted 28-day cycles of G-CSF 150 ug,intracutaneously injection(IC)on days 0,1,7,8,14,15,21 and 22;Bortezomib 1.0-1.3mg/㎡,intravenously injection(IV) on days 1,8,15 and 22; C yclonphosphamide 300mg/ ㎡,IV on days 1,8,15 and 22;and Dexamethasone 20mg/d,IV on days 1,2,8,9,15,16,22 and 23.Response was assessed by the 2009 IMWG criteria, and standard reference NCI CTCAE4.02 to judgment adverse reactions. According to the wishes and illness of patients after induction therapy,administered including T(thalidomide) single, TD(thalidomide plus dexamethasone), CTD(cyclophosphamide, thalidomide, and dexamethasone) or MTD(melphalan, thalidomide plus dexamethasone) program as consolidation and maintenance therapy every three months to assess the efficacy of therapeutic effect.【Results】 Collection of non-transplant-naive patients with multiple myeloma total of 33 cases, including 17 males and 16 females, male to female ratio was 1.06: 1, the median age was 62.9 years(44-84 years). All the patients received G-BCD regiment at least one cycle. After a course of treatment, achieved a partial remission(PR) or better 27 cases of patients, treatment response rate(RR) was 81.8%, which eight cases reached near complete remission / complete remission(n CR / CR), accounting for 24.2%. 17 patients have completed four courses of treatment and the efficacy evaluation, all patients reached better than PR response, treatment response was 100%, which strict complete remission(s CR) achieving in 2 cases, accounting for 11.8%; n C R / C R patients 8 cases, accounting for 47%; VGPR 5 patients, accounting for 29.4%; PR in 2 patients, accounting for 11.8%. Four patients completed six courses of treatment, 100% gain over VGPR remission, including C R 3 patients(75%); one case VGPR, accounting for 25%. Major adverse reactions in GBC D induction therapy course were fatigue 48.48%, Limb Edema 36.36%, thrombocytopenia 36.36%, neutropenia 24.24%, anemia 15.15%, Anorexia 30.30%,diarrhea 30.30%, constipation 9.09%, nausea / vomiting 9.09%,lung infection 24.24%, respiratory tract infection 18.18%, peripheral neuropathy 15.15%, SGOT / SGPT abnormal 18.18%, skin rash 12.12%, kidney dysfunction 3.03%, Herpes Zoster12.12%. Almost all of the side effects could be well tolerated, 3 grade is rarely,no discontinuation due to the side effects.Among the 33 cases of patients, four cases have not completed induction therapy and not entered the maintenance therapy, five cases losted, 20 patients receiving maintenance therapy,including s CR 13 cases, n CR 1 case, VGPR 4 cases, PR in 2 patients, 4 cases did not receive any maintenance treatment,among which 2 cases died after recurrence, one case recurrenced, 1 case achieved VGPR.【Conclusions】(1) G-CSF may enhance the sensitivity of patients with newly diagnosed multiple myeloma of bortezomib treatment.(2) All side effects during G-BCD induction therapy is well tolerable, rarely 3 grade side effects happened.(3) Consolidation and maintenance after induction therapy of G-BCD regimen is very important, you can further increase the depth of response, it may be beneficial in patients with long-term survival.(4) G-BC D program as an initial treatment of non-transplant patients with multiple myeloma induction programs are safe and effective. |
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