TURKISH JOURNAL OF ONCOLOGY 2004 , Vol 19 , Num 1
Beşışık S. K.1, Saka B.2, Yücel S.3, Erten N.1, Vatansever S.1, Karan M. A.1, Taşçıoğlu C.1, Sargın D.1
1İç Hastalıkları Anabilim Dalı, İstanbul Tıp Fakültesi, İstanbul Üniversitesi, İstanbul
2İç Hastalıkları Uzmanı, Özel Derman Hastanesi, Zeytinburnu, İstanbul
3İç Hastalıkları Uzmanı, Okmeydanı Sosyal Sigortalar Kurumu Hastanesi, İstanbul
Introduction: In recent years, thalidomide was found effective in patients with refractory multiple myeloma. In this study, clinic success of thalidomide treatment in refractory multiple myeloma patients together with its side effects, and survival studies were evaluated and discussed.

Material and methods: Thalidomide and high dose dexamethasone treatment was given to 14 multiple myeloma patients for median 12 months (4-36 months), those were refractory to conventional treatment protocols. Daily thalidomide dosage was 200 mg at the beginning while it was increased to 400 mg at the end of the second week of the treatment. Dexamethasone dosage was daily 20 mg/m2 and given for 3 cycles. In first cycle, it was given at 1-4, 9-12, 17-20th days, and then only at 1-4th days of the next two cycles. Response was determined according to the amount of reduction in serum M-spike levels of the patients at the end of 8 weeks. Variables were compared with each other using linear regression analysis method. Overall survival rates were assessed with Kaplan-Meier statistical analysis.

Results: Patients received thalidomide for 14.2±7.7 months (4-36 months). After 8 weeks of the treatment, only one patient achieved remission (7%), however, clinical progression developed early in the follow-up, diagnosed with multiple plasmocytomas. Partial remission occurred in 5 patients (36%) and plateau was achieved in another 5 patients (36%). Unfortunately, 3 patients (21%) remained refractory to thalidomide treatment. Mean response time of those patients with partial remission or plateau was 14.6±7.6 months (4-33 months). No statistical significance was found between serum lactate dehydrogenase and beta-2 miroglobulin levels with clinical response time of the patients to thalidomide (p=0.7, p=0.8, respectively). Side effects occured in 10 patients (71%) during thalidomide treatment; constipation (43%), peripheral neuropathy (21%), deep venous thrombosis (14%), autonomic neuropathy (%7) and skin rash (%7). Five patients (36%) died because of the multi-organ failure secondary to increased myeloma activity. Overall and progression-free survival times were (± SE), 20±5.84 months (95% Confidence Interval: 8.56-31.44 months) and 10±3.42 months (%95 CI: 3.29-16.71 months) concurrently, and one year overall survival rate was (± SE), 70.13±12.57%.

Conclusion: Thalidomide and high dose dexamethasone combination is useful in the treatment of patients with relapsed and refractory multiple myeloma, however, our findings also indicated that long term sustained response is less probable. Keywords : Multiple myeloma, thalidomide