Clinical Efficacy and Safety Comparison of 177Lu-EDTMP with 153Sm-EDTMP on an Equidose Basis in Patients with Painful Skeletal Metastases.

Abstract

UNLABELLED:

This prospective study compared 177Lu-ethylene diamine tetramethylene phosphonate (EDTMP) with 153Sm-EDTMP for painful skeletal metastases.

METHODS:

Half of the 32 patients were treated with 177Lu-EDTMP and half with 153Sm-EDTMP, at 37 MBq/kg of body weight. Analgesic, pain, and quality-of-life scores (EORTC, Karnofsky, ECOG) and bone proliferation marker were used to examine efficacy. Hematologic toxicity was evaluated using NCI-CTCAE and compared between groups at baseline and each month till 3 mo after therapy. Pain relief was categorized as complete, partial, minimal, or none.

RESULTS:

Pain relief with 177Lu-EDTMP was 80%: 50% complete, 41.67% partial, and 8.33% minimal. Pain relief with 153Sm-EDTMP was 75%: 33.33% complete, 58.33% partial, and 8.33% minimal. The difference was not significant (P=1.000). Quality of life at 3 mo after therapy improved significantly in both groups as per ECOG score (P=0.014 and 0.005 for 177Lu-EDTMP and 153Sm-EDTMP, respectively), Karnofsky index (P=0.007 and 0.023 for 177Lu-EDTMP and 153Sm-EDTMP, respectively), and EORTC score (P=0.004 and <0.001 for 177Lu-EDTMP and 153Sm-EDTMP, respectively). Bone proliferation marker in responders of both groups dropped significantly (P=0.008 for 177Lu-EDTMP and P=0.019 for 153Sm-EDTMP), parallel to clinical response. For 177Lu-EDTMP, anemia, leukopenia, and thrombocytopenia were nonserious (grade I/II) in 46.67%, 46.67%, and 20%, respectively, and serious (grade III/IV) in 20%, 6.67%, and 0%, respectively. For 153Sm-EDTMP, anemia, leukopenia, and thrombocytopenia were nonserious (grade I/II) in 62.5%, 31.25%, and 18.75%, respectively, and serious (grade III/IV) in 18.75%, 0%, and 6.25%, respectively. One patient treated with 153Sm-EDTMP had grade IV thrombocytopenia but required no blood transfusion. Differences between groups were not significant for either nonserious or serious toxicity. For 177Lu-EDTMP, 3 of 12 responders experienced the flare phenomenon on the third day after therapy and one on the fifth day, showing no response to therapy. For 153Sm-EDTMP, 2 of 12 responders experienced the flare phenomenon, both on the third day after therapy.

CONCLUSION:

177Lu-EDTMP has pain response efficacy similar to that of 153Sm-EDTMP and is a feasible and safe alternative, especially in centers with no nearby access to 153Sm-EDTMP.

• Authors: Pradeep Thapa, Dilip Nikam, Tapas Das, Geeta Sonawane, Jai Prakash Agarwal, Sandip Basu
• Journal: Journal of nuclear medicine : official publication, Society of Nuclear Medicine (J Nucl Med) Vol. 56 Issue 10 Pg. 1513-9 (Oct 2015) ISSN: 1535-5667 [Electronic] United States
• PMID: 26315829 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: © 2015 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Chemical References

• Organometallic Compounds
• Organophosphorus Compounds
• Radiopharmaceuticals
• lutetium ethylenediaminetetramethylene phosphonic acid
• samarium Sm-153 lexidronam
• Alkaline Phosphatase

Topics

• Adult
• Aged
• Aged, 80 and over
• Alkaline Phosphatase (analysis, metabolism)
• Bone Neoplasms (complications, radiotherapy)
• Bone and Bones (enzymology)
• Female
• Humans
• Karnofsky Performance Status
• Male
• Middle Aged
• Neoplasm Metastasis
• Organometallic Compounds (adverse effects, therapeutic use)
• Organophosphorus Compounds (adverse effects, therapeutic use)
• Pain (etiology)
• Pain Management (methods)
• Pain Measurement
• Prospective Studies
• Quality of Life
• Radiopharmaceuticals (adverse effects, therapeutic use)
• Retrospective Studies
• Safety