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|Title:||Analysis of Patient Survival in a Phase 1 Trial of Systemic Targeted Alpha Therapy for Metastatic Melanoma|
|Authors:||ALLEN B. J.; SINGLA A; RAJA C.; RIZVI S.; GRAHAM P.; BRUCHERTSEIFER Frank; APOSTOLIDIS Christos; MORGENSTERN Alfred|
|Citation:||IMMUNOTHERAPY vol. 3 no. 9 p. 1041-1050|
|Publisher:||FUTURE MEDICINE LTD|
|Type:||Articles in periodicals and books|
|Abstract:||Survival results are analysed from a Phase 1 study of Systemic Targeted Alpha Therapy for patients with metastatic melanoma. The effect of key parameters such as melanoma inhibitory activity (MIA) protein, age, sex, lactate dehydrogenase (LDH), metastatic disease stage and treatment dose were examined. The survival analysis is conducted on a previously reported open label phase 1 dose escalation study. Following intravenous administration of the alpha immunoconjugate, 213Bi‐cDTPA‐9.2.27, patients were monitored for response and toxicity over subsequent days, weeks and months. Responses were measured by physical examination, computed tomography scan (CT) and blood sampling, including serum melanoma inhibitory activity (MIA) protein. Responses were assessed using CT at 8 weeks. In addition to the above tools, toxicity was monitored by blood pathology, urine analysis and glomerular filtration rate (GFR) and human anti‐mouse antibody response (HAMA). Thirty eight patients with stage IV melanoma or in transit metastasis were treated with activities in the range 55‐1035 MBq. No adverse events of any type or level were observed, so the maximum tolerance dose was not achieved. An objective partial response rate (ORR) of 10% was observed, with 40% stable disease for 8 weeks and a median survival of 8.9 months. Survival analysis showed MIA, disease stage, LDH and treatment effect to be significant prognostic indicators for survival. These factors also proved significant on univariate analysis. However, further evaluation of the treatment effect using Cox proportional hazards analysis showed LDH and disease stage to be the significant factors.|
|JRC Directorate:||Nuclear Safety and Security|
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