Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 6737
© 2004 American Society of Clinical Oncology

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Abstract

Samarium-¹⁵³Sm-EDTMP and zoledronic acid present synergistic action and are able to control pain and significantly improve QoL in elderly patients with MM. (Results of a phase II trial and 19 months follow up)

Hematology-Oncology Department, Catanzaro, Italy; Hematology-Oncology Department, Rome, Italy; Nuclear Medicine, Catanzaro, Italy

6737

Background: Previously, we reported results on the association of samarium-153 Ethilene Diamine Tetramethylene Phosphonate (¹⁵³Sm-EDTMP) and zoledronic acid in the treatment of symptomatic refractory elderly multiple myeloma patients.(Proc.ASCO 2003).In order to expand on these observations we would like to provide with detailed follow-up data obtained in a series accounting now for 8 patients. Methods: Inclusion criteria: refractory MM diagnosis on pain control.Normal liver and renal function.No cytopenia. Median age was 78.5 years (range 70–81 yrs) M:F=5:3;ECOG PS >= 2; median time from diagnosis to Rx = 2 years (range 4–36 months); IgG #3 pts, IgG #4 pts, IgA #1 pt M-component and DS stage IIIA for all.#3 received >2 previous chemotherapeutic treatments .None of the patients was allowed to receive additional treatment during Rx. ^99mTc-MDP bone scans and ¹⁵³Sm-EDTMP gamma camera imaging were equivalent Treatment consisted of zoledronic acid (4mg) every 28 days, while 2GBq of ¹⁵³Sm-EDTMP was given at enrolment and allowed to be repeated when the disease became symptomatic.All 8 patients complained of severe, persistent pain, requiring a combination of non-oppioid analgesics. Patients were asked to quantify their pain using a visual analogue scale (0–10) Results: :@ baseline, the median pain-rate was 7 (range 7–9). After treatment the median pain rate was reduced to 2 (range 0–3) with no need for analgesics (P=0.06) with a median FU time of 14 months (range 6–19 ). Two patients had transient grade 2 WHO hematologic toxicity. Only one patient suffered for pain flares.Interestingly, M-component decreased more than 25% in 4/8 patients and was still stable Median survival was 36 months ( range 13–50)). The median time to 2^{nd 153}Sm-EDTMP infusion was 6.5 months and the median survival time from the first Rx was 15 months . Conclusions: Our results support the idea that treatment with ¹⁵³Sm-EDTMP and zoledronic acid is synergistic and has a significant impact on the outcome of elderly myeloma patients.

No significant financial relationships to disclose.