TABLE 2

Studies of 131I-MIBG Therapy for Pheochromocytoma and PGL

131I-MIBG therapyOverall response
ReferenceNo. of patientsDisease statusActivityNo. of dosesTotal activityObjective*BiochemicalSymptomatic responseSurvivalComments
10948Metastatic PHEO/PGLHigh specific activity: 3.7–14.8 GBq (1.32–5.69 mCi)/kg1–4NA1 PR, no CRNANA; no significant decrease in BP in patients with high systolic BPNANo significant toxicity
107Group 1: 129/12 secreting555 MBq/dose every 3–4 moMaximum: 10; median: 7Maximum: 66.6 GBq; median: 39.41 CR, 3 PR (33%)5 PR (42%)NA1.9 yNo grade 3–4 hematologic toxicity
107Group 2: 169/16 secreting7.4–12.95 GBq/dose every 6–8 moMaximum: 6; median: 257.2 GBq (median: 24.1)2 CR, 3 PR (31%)2 CR, 3 PR (31%)NA3 y6 patients had grade 3–4 thrombocytopenia
11610Metastatic; symptomatic5.6 GBq/dose (n = 9); 3.7 GBq every 4–12 mo (n = 1)1–4 (mean: 2)10–13.2 GBq (mean 11.6 ± 1.6) (310 ± 44.0 mCi)3 PR (30%)5 patients (50%)5 patients (50%)Mean PFS: 17.5 mo (2–47 mo)No grade 3–4 hematologic toxicity
11850Metastatic; 50% with SDHB mutationPhase 2: high dose; 222–333 MBq (6–9 mCi)/kg1–318,204–145,003 GBq (492–3,919 mCi)27% after first treatment; 50% after second treatment35% after first dose; 71% after second doseNAOS at 5 y: 64%Grade 3–4 hematologic toxicity in up to 87%
11133Metastatic PGL/PHEOMean first dose: 14.47 ± 4.8 GBq (391 ± 130 mCi)1–6Mean: 20.3 ± 11.24 GBq (549 ± 304 mCi); maximum: 1,22338%60%86%Median OS: 56 mo; median survival: 4.7 yBone marrow suppression in 12%
106116 (compilation of data from multiple studies at 10 institutions)Metastatic PGL/PHEOMean dose: 158 (96–300)1–11 (mean: 3.3)Mean: 490 (96–2,322)30%45%76%5 patients had CR lasting up to 16–58 mo; better responses were seen in those with soft-tissue diseaseMild adverse effects in 41%; 1 patient had fatal marrow aplasia; 45% of the responders had median PFS of 19 mo
  • * Complete response (CR) plus partial response (PR).

  • NA = not available; BP = blood pressure; PFS = progression-free survival; OS = overall survival.