Table 3.
Summary of anti-HER2-DOTA-PRIT efficacy and toxicity studies.
| DOTA-PRIT treatment (number of mice/group) | Control groups (number of mice/group) |
Tumor sizes (range, mm3) |
Tumor dose (Gy) |
Blood dose (Gy) |
Kidney dose (Gy) |
Median survivala | Therapeutic outcome/study endpoint |
|---|---|---|---|---|---|---|---|
| Single-cycle treatment with 55.5 MBq (5) | No treatment (5); BsAb only (5); 55.5 MBq of 177Lu-DOTA-Bn alone (5) | Small; palpable-30 | 22 | 0.8 | 0.3 | No treatment: 7 d; BsAb only: 16 d, 55.5 MBq of 177Lu-DOTA-Bn alone: 7 d, and undefined for 55.5 MBq. | No CRs in no treatment or 55.5 MBq of 177Lu-DOTA-Bn alone; BsAb only: 1/5 CR and 1/1 cure/85 d. For 55.5 MBq 5/5 CR, and 3/4 cures/85 d |
| Single-cycle treatment with 11.1, 33.3 or 55.5 MBq (5) | No treatment (5); 33.3 MBq of 177Lu-DOTA-Bn alone (5) |
Medium; ~100-400 | 4.4, 13, or 22 | 0.2, 0.5, or 0.8 | 0.6, 1.9, 3.1 | No treatment: 6 d; 33.3 MBq of 177Lu-DOTA-Bn alone: 25 d; for 11.1 MBq: 21 d; for 33.3 MBq: 42 d; for 55.5 MBq: 108 d. | No CRs in no treatment or 33.3 MBq of 177Lu-DOTA-Bn alone; for 11.1 MBq: 1/5 CR, and 1/5 regression to palpable; for 33.3 MBq: 0/5 CR; for 55.5 MBq: 1/5 CR. Overall: 2/15 CR and 1/15 regression to palpable; 2/6 curesb/200 d |
| Triple-cycle fractionated treatment with 55.5 MBq (total IA: ~167 MBq) (8) | No treatment (6); BsAb only (5)d; IgG-DOTA-PRIT (6)d | Medium; ~100-400 | 66 | 2.3 | 9.3 | No treatment: 35.5 d; BsAb only: 18 d; control IgG-DOTA-PRIT: 30 d; anti-HER2-DOTA-PRIT: undefined. | No CRs in controls; 2/8 CR, 6/8 regression to palpable, 5/8 cures/85 d |
aSurvival was defined as time to tumor doubling or death by any other cause.
bOne each in 11.1 and 55.5 MBq DOTA-PRIT-treated groups.
dTotal BsAb mass administered per mouse was 0.75 mg (3.57 nmol).