Abstract Objective To observe thalidomide in combination with dexamethasone in the treatment of multiple myeloma efficacy and adverse. Method Thalidomide, oral, daily starting dose of 50mg, 50mg per night Dayton service weekly increase, according to the patient tolerated dose of 50 mg / d, up to a maximum dose of 400mg / d. Dexamethasone 40mg / d, 1 to 4, 9 to 12, 17 to 20, respectively, intravenous or oral administration, every 28 days for a course of treatment. The regimen for at least 3 months. Results of complete remission in 4 cases (16%), partial remission in 6 cases (24%), progress in 10 cases (40%), ineffective in 5 cases (20%), with a total efficiency of 80%. Common adverse effects such as constipation, drowsiness, fatigue, edema, finger numbness. Conclusion Thalidomide in combination with dexamethasone is an effective treatment regimens for previously untreated multiple myeloma, and adverse reactions.
Key words multiple myeloma thalidomide ground dexamethasone naive
Thalidomide has to inhibit tumor angiogenesis, slow down the growth of tumor cells and immunomodulatory role in recent years for the treatment of multiple myeloma (multiple myeloma, MM) to achieve a certain effect , the study by observing the Sarit amines in combination with dexamethasone (TD program) in the treatment of newly diagnosed MM efficacy, to investigate its clinical value.
1 Materials and Methods
1.1 General information on 25 cases from our hospital Hematology October 2003 to June 2007 diagnosed MM patients, including 14 males and 11 females, aged 48 to 67 years, with a median age of 59 years old. All cases were confirmed by clinical, bone marrow cytology, serum M protein and X-ray examination, diagnosis, diagnostic criteria meet the the Zhang Nan editor “blood disease diagnosis and efficacy standards" , according to Durie Salmon staging system staging, Ⅰ A four cases, Ⅱ A, 5 cases, II B of 7 cases, Ⅲ A, Ⅲ B 4 cases. Patient visit average hemoglobin 61.30 (35.70 to 105.50) g / L, the average percentage of plasma cells in the bone marrow of 30.70% (10% to 65%), which associated with bone destruction in 22 cases, renal dysfunction in 13 cases.
1.2 treatment with thalidomide in combination with dexamethasone programs. Thalidomide (Changzhou Pharmaceutical Factory production), oral starting dose daily 50mg, the night Dayton clothing, according to the patient tolerated week to increase the dose of 50 mg / d, up to a maximum dose of 400mg / d. Dexamethasone 40mg / d, 1 to 4, 9 to 12, 17 to 20, respectively, intravenous or oral administration, every 28 days for a course of treatment. The regimen for at least 3 months. Disease progression or drug can not tolerate the side effects are disabled. If the treatment effect is reached complete remission (CR), continuous observed after four months of treatment to accept the program, does not require maintenance therapy. Instead the maximum tolerated dose of thalidomide used alone or used in combination with dexamethasone treatment effect for three months in the program receive continuous treatment progress and less than CR, 40mg / d, 1 to 4 days.
1.3 Efficacy and assessed before and after treatment, pay attention to the changes in the clinical manifestations observed blood count, erythrocyte sedimentation rate, 24 h urinary protein excretion, liver and kidney function, serum calcium, protein electrophoresis, serum M protein, bone marrow, routine head, chest and pelvic X ray. Reference  assessed the efficacy of the blood disease diagnosis and efficacy standards. Efficiency = (number of cases of complete remission + partial remission in a number of cases + progress in the number of cases) / total number of cases × 100%.
1.4 statistical method in patients with various clinical and hematological parameters before and after treatment with the t test.
2.1 clinical efficacy shown in Table 1. Average hemoglobin concentration, the proportion of plasma cells before and after treatment were significantly improved, the difference was statistically significant (P <0.05, <0.01), as shown in Table 2. Table 1 patients after treatment efficacy
Total efficiency progress complete remission partial remission invalid hemoglobin and bone marrow plasma cells in 20 patients (80%) and 4 patients (16%) 6 (24%) of 10 cases (40%) and 5 cases (20%) Table 2 patients before and after treatment compare
2.2 13 cases of adverse reactions finger numbness (52%), 16 patients (64%) constipation, drowsiness in 15 cases (60%), 15 patients (60%) appeared tired rash, 1 patient (4%), 10 cases (40%), edema, mild to symptomatic treatment could be tolerated without reduction or withdrawal. Course of medication were not the liver and kidney dysfunction, bone marrow suppression and deep vein thrombosis.
2.3 followed up each of the above cases March 1 follow-up, and each should be followed up routine blood, bone marrow, serum immunoelectrophoresis and head, chest, pelvis X films.
MM pathogenesis is not yet clear, the current lack of effective treatment. Recent studies prove that thalidomide treatment of MM, widely used in clinical. Thalidomide, also known as thalidomide, the main mechanism of the treatment of MM [3 5]: (1) direct role in myeloma cells or bone marrow stromal cells inhibit its growth; (2) inhibition of myeloma cells or bone marrow stromal cells adhesion between the change of tumor cell growth, survival and drug resistance; (3) inhibit the secretion of cytokines that promote the growth and survival of myeloma cells, or to reduce the biological activity (IL-6, IL 1B, IL 10 TNFa); (4) inhibition of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor-2 (BFGF-2) of the active and myeloma angiogenesis; (5) immunomodulatory effects: induction of Th1 cell responses and produce IFN r and IL 2.
Reported in the literature, patients with newly diagnosed MM Thalidomide response rate was 36% , the efficacy of Thalidomide and dexamethasone combination was significantly better than with Thalidomide or single dexamethasone efficacy dexamethasone the Thalidomide antiproliferative effect is increased by 35%, the thalidomide dexamethasone-resistant MM cells can induce apoptosis .
No large sample TD program in the treatment of newly diagnosed MM reported.
TD application program to the treatment of 25 cases of primary MM: efficiency of 80%, 16% complete remission, in line with the results reported in the literature. This indicates that the TD program is primary a treatment the MM more effective method.
Thalidomide adverse reactions such as drowsiness, dry mouth, loneliness, constipation and peripheral neuritis, the group adverse reaction to constipation, drowsiness, fatigue, edema, fingertip numbness main, the extent of reaction were mild given symptomatic treatment can be tolerated.
Summary, thalidomide in combination with dexamethasone side effects, efficacy, can be used as the preferred program for the treatment of newly diagnosed MM. Of course, our small sample size, the need to continue to expand the cases were observed.