Table 3.
Response to Treatment in Asymptomatic Patients
| Patients (n = 101) | |||
|---|---|---|---|
| Intracranial | Extracranial | Global | |
| Best overall response, No. (%)a | |||
| Complete response | 29 (28.7) | 11 (10.9) | 11 (10.9) |
| Partial response | 26 (25.7) | 38 (37.6) | 40 (39.6) |
| Stable disease ≥ 6 months | 4 (4.0) | 6 (5.9) | 4 (4.0) |
| Progressive disease | 27 (26.7) | 16 (15.8) | 29 (28.7) |
| Not evaluable for CBR: | 15 (14.9) | 30 (29.7) | 17 (16.8) |
| Death prior to first on-study assessment | 3 (3.0) | 3 (3.0) | 2 (2.0) |
| Early discontinuation due to toxicity | 1 (1.0) | 1 (1.0) | 1 (1.0) |
| Stable disease <6 months | 8 (7.9) | 15 (14.8) | 9 (8.9) |
| No extracranial disease at baseline | NA | 7 (6.9) | NA |
| Otherb | 3 (3.0) | 4 (10.9) | 5 (5.0) |
| ORR, no./No. (%; 95% CI) | 55/101 (54.4; 44.2-64.4) | 49/101 (48.5; 38.4-58.7) | 51/101 (50.5; 40.4-60.6) |
| CBRc, no./No. (%; 95% CI) | 59/101 (58.4; 48.2-68.1) | 55/101 (54.4; 44.2-64.4) | 55/101 (54.4; 44.2-64.4) |
| Median time to response, months (range) | 1.61 (1.1-12.5) | 1.4 (1.1-23.2) | 1.4 (1.1-7.0) |
| Median duration of response, months (95% CI) | Not reached | Not reachedd (18.1-not reached) | Not reached |
| Ongoing response, no./No. (%) | 48/55 (87.3) | 39/48d (81.2) | 43/51 (84.3) |
Abbreviations: CBR, clinical benefit rate; CI, confidence interval; CR, complete response; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
aTwo patients had a response preceded by initial progressive disease.
bTotal of 5 patients for all 3 response categories (intracranial, extracranial, and global): 1 patient withdrew consent (all 3 categories), 2 patients stopped study (all 3 categories), 1 patient for EC lesion procedure not done (just global), 1 patient for gamma knife therapy (global).
cClinical benefit rate = complete response + partial response + stable disease ≥ 6 months.
dOne additional patient had a response, but was not included as no response date was recorded by the investigator.