RT Journal Article
SR Electronic
T1 <sup>177</sup>Lu-DOTATATE Plus Capecitabine Versus <sup>177</sup>Lu-DOTATATE Alone in Patients with Advanced Grade 1/2 Gastroenteropancreatic Neuroendocrine Tumors (LuCAP): A Randomized, Phase 2 Trial
JF Journal of Nuclear Medicine
JO J Nucl Med
FD Society of Nuclear Medicine
SP jnumed.124.268617
DO 10.2967/jnumed.124.268617
A1 Satapathy, Swayamjeet
A1 Aggarwal, Piyush
A1 Sood, Ashwani
A1 Chandekar, Kunal R.
A1 Das, Chandan K.
A1 Gupta, Rajesh
A1 Khosla, Divya
A1 Das, Namrata
A1 Kapoor, Rakesh
A1 Kumar, Rajender
A1 Singh, Harmandeep
A1 Shukla, Jaya
A1 Kumar, Ajay
A1 Mittal, Bhagwant Rai
YR 2025
UL http://jnm.snmjournals.org/content/early/2025/01/07/jnumed.124.268617.abstract
AB 177Lu-DOTATATE has emerged as a viable treatment strategy for advanced well-differentiated grade 1/2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Few retrospective studies have shown concomitant 177Lu-DOTATATE with radiosensitizing low-dose capecitabine to be effective in advanced NETs. However, this has not been validated in prospective randomized-controlled trials. Methods: In this investigator-initiated, parallel-group, open-label, phase 2 trial, patients with grade 1/2 GEP-NETs, having progressive somatostatin receptor–positive, locally advanced, or metastatic disease on 68Ga-DOTANOC PET/CT, were randomly assigned in a 1:1 ratio to 177Lu-DOTATATE plus capecitabine (experimental arm) or 177Lu-DOTATATE only (control arm). 177Lu-DOTATATE was administered at approximately 7.4 GBq/cycle intravenously, for up to 4 cycles, at 8 wk intervals, whereas capecitabine was given at 1,250 mg/m2/d orally from day 0 to day 14 of each cycle of 177Lu-DOTATATE. The primary endpoint was the objective response rate. Secondary endpoints included the disease control rate, progression-free survival, overall survival, and adverse events. Results: Seventy-two patients (median age, 53 y; range, 18–79 y) were enrolled. The objective response rate was 33.3% (95% CI, 18.6–50.9%) in the experimental arm versus 30.6% (95% CI, 16.4–48.1%) in the control arm (P = 0.800). The disease control rate was 88.9% (95% CI, 73.9–96.9%) and 91.7% (95% CI, 77.5–98.2%) in the experimental and control arms, respectively (P = 1.000). The estimated median progression-free survival in the experimental arm was 29 mo (95% CI, 22–29 mo) versus 31 mo (95% CI, 29–32 mo) in the control arm (P = 0.401). The median overall survival was not reached in either arm (P = 0.876). Overall, adverse events of at least grade 3 were noted in 7 patients in the experimental arm versus 6 patients in the control arm (P = 0.759). Conclusion: Based on the results of this trial, the addition of low-dose capecitabine to 177Lu-DOTATATE in advanced grade 1/2 GEP-NETs did not lead to superior radiographic responses. Further studies are needed to evaluate its potential role in high-grade NETs.