Open Access
Table 3
Description of studies using the PICO method
| Articles | Patients | Intervention | Comparison | Outcome |
|---|---|---|---|---|
| Widjaja et al. (2022), Germany | Twenty men with mCRPC undergoing 177Lu-PSMA therapy | A median dose of 7.32 GBq (interquartile range 7.28–7.37) of 177Lu-PSMA was given every cycle. Treatment followed established procedural parameters, with cycles repeated every 6-8 weeks (median 42 days). A routine laboratory panel was evaluated before and throughout each cycle, including blood cell counts, liver enzymes, and PSA levels. | Blood samples for DDR-marker analysis were taken before, an hour after, and 24 hours after the 177Lu-PSMA injection DDR markers associated with intact lymphocyte cells were added and divided by the total number of cells to determine the number of foci per cell. PSA levels were measured before and 6-8 weeks after two cycles of therapy, and the percentage change from baseline was analyzed. |
Low baseline DDR marker (gamma-H2AX foci) levels before therapy may represent low individual radiosensitivity and be associated with earlier PSA-PD and shorter PSA-PFS. |
| Derlin et al. (2021), Germany | Twenty-one patients with advanced gastroenteropancreatic neuroendocrine tumors (ten males and eleven females) | Eleven patients started peptide receptor radionuclide therapy (PRRT) with 7.4 GBq lutetium-177(177Lu) labeled 1,4,7,10 tetraazacyclododecane-N,N’,N”,N”-tetraacetic acid-d-Phe(1)-Tyr(3) octreotate (177Lu-DOTA-TATE), and 10 patients had previously received at least one PRRT cycle before (6±1). All patients suffered from grade 1 (G1) or grade 2 (G2) metastatic nonfunctioning gastroenteropancreatic neuroendocrine tumors. In addition, general laboratory examinations were performed, including hematology, liver enzymes, and serum CgA levels. | The reliability of the analysis was confirmed in lymphoblastoid cells irradiated with a dose of 2 Gy from healthy donors and ataxia-telangiectasia syndrome (A–T) patients, the latter of whom showed a radiosensitivity phenotype. Blood samples of patients undergoing PRRT with 177Lu-DOTA-TATE were irradiated with a dose of 2 Gy as positive controls |
The study found significant heterogeneity in gamma-H2AX foci induction and kinetics in PRRT patients’ PBLs, suggesting potential for stratification and treatment response prediction. However, the data was preliminary and called for larger prospective studies. |
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