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.MethodsIn 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.ResultsIn 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.
Highlights
Bone is the most common site of metastases in the majority of the solid cancers
Eligibility criteria Eligibility criteria for the [177Lu]Lu-DOTA-ZOL pain palliation treatment included: histologically confirmed breast, prostate, or lung cancers, progressive pain or pain requiring escalation of analgesics, patients with more than one site of pain corresponding to the avid uptake on [68Ga]Ga-DOTA-ZOL Positron emission tomography/ computed tomography (PET/CT) scan, patients with no prior history of radionuclide pain palliation therapy, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 4, Karnofsky performance status (KPS) ≥ 50, patient on or with history of prior bisphosphonates, patients with haematological, kidney, and liver function parameters within normal limits which included baseline haemoglobin of < 9 g/dL, platelet counts: < 75,000/μL, leukocyte counts: ≥ 4 × 109/L, serum creatinine: > 1.4 mg/dL, serum bilirubin > 3 mg%, glomerular filtration rate (GFR): < 50 mL/ min per 1.73 m2 body surface area (BSA)
Breast cancer (23/40, 57.5%) accounted for the maximum number of cases followed by prostate cancer (11/40, 27.5%)
Summary
Bone is the most common site of metastases in the majority of the solid cancers. The typical clinical symptom of skeletal metastases is bone pain. Apart from pain, other skeletal-related events (SREs), albeit to a lesser extent, are swelling, nerve compression, Yadav et al EJNMMI Res (2020) 10:130 immobility, or pathological fractures. Several algorithms have been evolved over the last 3 decades for the management of metastatic bone pain and SREs [2] in which a range of systemic to locoregional therapies are advocated. The most common approaches in clinical practice are chemotherapy, hormonal therapy, bisphosphonates, monoclonal antibody, namely denosumab and analgesics like non-steroidal anti-inflammatory drugs and opioids, molecules signalling growth factors, antidepressants, and endothelin receptor antagonists. Locoregional therapies are offered only for patients with oligo-metastases, namely, external beam radiotherapy (EBRT). Even though the list seems vast, none of them are curative in practice, with a majority of patients limited to palliative care, and involve a multidisciplinary approach
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