I’ve written about both 225Ac-DOTATATE targeted alpha therapy (TAT) and Capecitabine before but never as a concomitant pair (combo). So, when this Indian study came up on my radar, I felt it was a useful addition to my website adding to my existing targeted alpha therapy portfolio of information. India appears to be using more of this type of PRRT than any other country.
Read more about targeted alpha therapy by clicking here or on the photo below.
Read more about Capecitabine (combo with Temozolomide) by clicking here or on the photo below.
The abstract from the Indian study is posted and cited below.
Rationale: Although the short-term results of targeted alpha therapy (TAT) with 225Ac-DOTATATE in gastroenteropancreatic neuroendocrine tumors (GEP-NETs) have proven effective, none have assessed the long-term outcome results. In this study, we aimed to evaluate the long-term outcome of 225Ac-DOTATATE targeted alpha therapy (TAT) in patients with somatostatin receptor (SSTR)-expressing advanced-stage metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Methods: Patients with 68Ga-DOTANOC PET/CT scans showing moderate-to-high SSTR expression were recruited. Systemic TAT was performed in 91 adults with GEP-NET [54 males, and 37 females] mean age 54 years (y) (range: 25-75y)] using 225Ac-DOTATATE (100-120 kBq/kg body weight). All patients were given capecitabine therapy as a radiosensitizer (dose 2 g/day) from day 0 to 14 of every 225Ac-DOTATATE treatment cycle. Patients were categorized into three groups based on the status of prior 177Lu-PRRT: prior 177Lu-PRRT-refractory-group; prior 177Lu-PRRT-disease-control group; and 177Lu-PRRT naïve group. Primary endpoints were overall survival (OS), and secondary endpoints included progression-free survival (PFS), objective tumour response, clinical response, and the assessment of treatment-related toxicities. Results: Among the 91 patients, 57 underwent prior 177Lu-DOTATATE therapy [24 disease controlled (PR/SD), 33 progressive diseases (PD)]. A total of 453 225Ac-DOTATATE TAT cycles were administered [median four cycles per patient; range 1-10] in a median follow-up duration of 24 months (range 5-41mo). Median OS was not attained with a 24-month overall survival probability of 70.8%. In multivariate analysis, prognostic factors associated with a poor OS included, the presence bone metastases [HR: 2.501; 95% CI: 1.826 – 5.791; P<0.032], and 225Ac-DOTATATE therapy refractory disease [HR: 8.781; 95% CI: 3.843 – 20.062; P<0.0001]. Median PFS was also not reached with a 24-month progression-free survival probability of 67.5%. The multivariate analysis revealed only 177Lu-PRRT refractory disease significantly associated with a reduced PFS. [HR: 14.338; 95% CI: 1.853 – 97.698; P = 0.011]. Two of 79 patients (2.5%) with assessable disease experienced complete response; 38 (48%) had a partial response, 23 (29%) had SD, and 16 (20.2%) had PD. PD was observed in more patients from the prior 177Lu-PRRT-refractory group (11/33; 34%) as compared to 177Lu-PRRT-naïve patients (4/24; 11%), P-0.056. Patients from the prior 177Lu-PRRT-refractory group had the highest risk of poor PFS [HR:13.91; 95% CI: 4.45 – 42.271; P = 0.0009]. A significant clinical benefit was achieved post 225Ac-DOTATATE therapy with minimal treatment-related toxicities. Conclusion: The long-term results reveal 225Ac-DOTATATE TAT has shown promising results and improves overall survival, even in patients refractory to prior 177Lu-DOTATATE treatment, with transient and acceptable adverse effects.
Survival Outcomes in Metastatic Gastroenteropancreatic Neuroendocrine Tumor Patients receiving Concomitant 225Ac-DOTATATE Targeted Alpha Therapy and Capecitabine: A Real-world Scenario Management Based Long-term Outcome Study | Journal of Nuclear Medicine (snmjournals.org)
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.
Inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
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