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

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 patien...

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Main Authors: Madhav Prasad Yadav, Sanjana Ballal, Marian Meckel, Frank Roesch, Chandrasekhar Bal
Format: Article
Language:English
Published: SpringerOpen 2020-10-01
Series:EJNMMI Research
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13550-020-00709-y
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author Madhav Prasad Yadav
Sanjana Ballal
Marian Meckel
Frank Roesch
Chandrasekhar Bal
author_facet Madhav Prasad Yadav
Sanjana Ballal
Marian Meckel
Frank Roesch
Chandrasekhar Bal
author_sort Madhav Prasad Yadav
collection DOAJ
description 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.
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spelling doaj.art-f3c73abeaba1476fae4cd7f01051c4fe2022-12-21T23:10:53ZengSpringerOpenEJNMMI Research2191-219X2020-10-0110111310.1186/s13550-020-00709-y[177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety resultsMadhav Prasad Yadav0Sanjana Ballal1Marian Meckel2Frank Roesch3Chandrasekhar Bal4Department of Nuclear Medicine, Room No: 59-A, Thyroid Clinic, All India Institute of Medical Sciences (AIIMS)Department of Nuclear Medicine, Room No: 59-A, Thyroid Clinic, All India Institute of Medical Sciences (AIIMS)Department of Nuclear Chemistry, Johannes Gutenberg UniversityDepartment of Nuclear Chemistry, Johannes Gutenberg UniversityDepartment of Nuclear Medicine, Room No: 59-A, Thyroid Clinic, All India Institute of Medical Sciences (AIIMS)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.http://link.springer.com/article/10.1186/s13550-020-00709-y[177Lu]Lu-DOTA-ZOLPain palliationSkeletal metastases
spellingShingle Madhav Prasad Yadav
Sanjana Ballal
Marian Meckel
Frank Roesch
Chandrasekhar Bal
[177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results
EJNMMI Research
[177Lu]Lu-DOTA-ZOL
Pain palliation
Skeletal metastases
title [177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results
title_full [177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results
title_fullStr [177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results
title_full_unstemmed [177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results
title_short [177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results
title_sort 177lu lu dota zol bone pain palliation in patients with skeletal metastases from various cancers efficacy and safety results
topic [177Lu]Lu-DOTA-ZOL
Pain palliation
Skeletal metastases
url http://link.springer.com/article/10.1186/s13550-020-00709-y
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