“Overall, the deterioration in quality of life, represented by patient-reported xerostomia, pain, and quality-of-life measures, should be interpreted in the context of the clinically meaningful disease control and survival outcomes observed in this heavily pretreated population,” noted lead study author Alin Chirindel, MD, who is affiliated with the Division of Nuclear Medicine at the University Hospital of Basel in Basel, Switzerland, and colleagues.
The study authors cautioned that grade 3 lymphopenia occurred in 21.1 percent of the cohort. However, the researchers also found that there were no cases of treatment-related death or secondary malignancies with administration of (177Lu)Lu-PSMA-I&T.
Three Key Takeaways
• Meaningful efficacy in a heavily pretreated population. More than 64 percent of patients had a PSA decline, with a 44% PSA50 response rate and median overall survival of 13.2 months—supporting (177Lu)Lu-PSMA-I&T as a viable option for mCRPC patients who've already exhausted other lines of therapy.
• Favorable renal safety profile, but hematologic toxicity warrants monitoring. No grade 3+ renal toxicity and no treatment-related deaths or secondary malignancies were observed, though grade 3 lymphopenia occurred in 21.1 percent of patients.
• Tolerability trade-offs are modest relative to benefit. Treatment discontinuation (5 percent) and dose reduction (7 percent) were relatively uncommon, and xerostomia was generally mild (15 percent), supporting the authors' view that quality-of-life impacts should be weighed against the disease control and survival benefits seen in this population.
The study results with (177Lu)Lu-PSMA-I&T revealed median PSA progression-free survival of 4.8 months and median overall survival of 13.2 months, according to the authors.
“These findings provide prospective evidence supporting the safety and clinical activity of (177Lu)Lu-PSMA-I&T in routine management of mCRPC,” posited Chirindel and colleagues.
(Editor’s note: For related content, see “FDA Expands Approval of Pluvicto in Combination with ARPI for PSMA-Positive mAPMN/S Prostate Cancer,” “SNMMI: Does Vaccination Enhance Pluvicto Efficacy in mCRPC?” and “Early SPECT/CT Response After Pluvicto May Help Predict Survival in Patients with mCRPC?”)
In regard to study limitations, the authors acknowledged a lack of standardization with imaging modalities and quantitative response thresholds, and no systematic collection of dosimetry data. The researchers also acknowledged no conclusions with respect to comparative efficacy due to the study’s single-arm registry design.
