[177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results

Madhav Prasad Yadav; Sanjana Ballal; Marian Meckel; Frank Roesch; Chandrasekhar Bal

doi:10.1186/s13550-020-00709-y

[¹⁷⁷Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results

EJNMMI Res. 2020 Oct 28;10(1):130. doi: 10.1186/s13550-020-00709-y.

Authors

Madhav Prasad Yadav¹, Sanjana Ballal¹, Marian Meckel², Frank Roesch², Chandrasekhar Bal³

Affiliations

¹ Department of Nuclear Medicine, Room No: 59-A, Thyroid Clinic, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi, 110029, India.
² Department of Nuclear Chemistry, Johannes Gutenberg University, Fritz-Strassmann-Weg 2, 55126, Mainz, Germany.
³ Department of Nuclear Medicine, Room No: 59-A, Thyroid Clinic, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi, 110029, India. csbal@hotmail.com.

Abstract

Background: [¹⁷⁷Lu]Lu-DOTA-ZOL has shown promising results from the dosimetry and preclinical aspects, but data on its role in the clinical efficacy are limited. The objective of this study is to evaluate the efficacy and safety of [¹⁷⁷Lu]Lu-DOTA-ZOL as a bone pain palliation agent in patients experiencing pain due to skeletal metastases from various cancers.

Methods: In total, 40 patients experiencing bone pain due to skeletal metastases were enrolled in this study. The patients were treated with a mean cumulative dose of 2.1 ± 0.6 GBq (1.3-2.7 GBq) [¹⁷⁷Lu]Lu-DOTA-ZOL in a median follow-up duration of 10 months (IQR 8-14 months). The primary outcome endpoint was response assessment according to the visual analogue score (VAS). Secondary endpoints included analgesic score (AS), global pain assessment score, Eastern Cooperative Oncology Group Assessment performance status (ECOG), Karnofsky performance status, overall survival, and safety assessment by the National Cancer Institute's Common Toxicity Criteria V5.0.

Results: In total, 40 patients (15 males and 25 females) with a mean age of 46.6 ± 15.08 years (range 24-78 years) were treated with either 1 (N = 15) or 2 (N = 25) cycles of [¹⁷⁷Lu]Lu-DOTA-ZOL. According to the VAS response assessment criteria, complete, partial, and minimal responses were observed in 11 (27.5%), 20 (50%), and 5 patients (12.5%), respectively with an overall response rate of 90%. Global pain assessment criteria revealed complete, partial, minimal, and no response in 2 (5%), 25 (62.5%), 9 (22.5%), and 4 (10%) patients, respectively. Twenty-eight patients died and the estimated median overall survival was 13 months (95% CI 10-14 months). A significant improvement was observed in the VAS, AS, and ECOG status when compared to baseline. None of the patients experienced grade III/IV haematological, kidney, or hepatotoxicity due to [¹⁷⁷Lu]Lu-DOTA-ZOL therapy.

Conclusion: [¹⁷⁷Lu]Lu-DOTA-ZOL shows promising results and is an effective radiopharmaceutical in the treatment of bone pain due to skeletal metastases from various cancers.

Keywords: Pain palliation; Skeletal metastases; [177Lu]Lu-DOTA-ZOL.