Long term treatment with Pamidronate (PMD), a second generation bisphosphonate, reduces skeletal events in advanced myeloma. Some evidences also suggest that PMD could have a direct anti-neoplastic activity on myelomatous plasma cells. However, it is still not known whether PMD treatment is able to prevent or at least to delay skeletal-related events or progression of the disease in asymptomatic, initial phases of monoclonal gammapathies, which usually do not require specific therapy. Thus, we treated with PMD (AREDIA, Novartis, 60 to 90 mg, as 4-hours infusion every four weeks for one year, then every three months, until progression) 38 patients with asymptomatic, stage IA or smoldering myeloma. In particular, criteria for inclusion were: serum M-component >2 g/dl; bone marrow plasmocytosis > 10%; good performance status; no presence of bone lesions, anemia, hypercalcemia, renal failure, bone pain or recurrent infections; no concomitant treatment with steroids. In doubtful cases, the absence of skeletal lesions was confirmed by MR and/ or MIBI-scintigraphy studies. Routine hemato-chemical parameters were evaluated at least every three months. Bone rx-survey, MR and MIBI-scan were repeated every year or when clinically indicated. No significant reduction of M-component (> 25%) was observed in PMD treated patients during the period of the study. These patients were compared with 38 historical controls showing similar characteristics and matched for age, sex, M-component and bone marrow plasmocytosis, who had never received PMD or other bisphosphonates. After a median follow-up of 36 months (range 12-60), there have been 9 progressions to overt MM in the PMD group. The same number of progressions (9) was seen within the control group. However, among 18 patients who required chemo-radiotherapy for progressive disease, osteolytic bone lesions developed in 7/9 controls, but only in 3 out of 9 of PMD treated patients. Although larger and, possibly, randomized studies are required for drawing definitive conclusions, the results of this study suggest that "prophylactic" administration of PMD in asymptomatic, initial phases of myeloma does not seem to prevent the progression of the disease, but could limit bone disease expression in these patients.
|Issue number||11 PART II|
|Publication status||Published - 2000|
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