| Number of patients screened |
19 |
| Number of patients enrolled |
12 |
| Number of patients evaluable for toxicity |
12 |
| Number of patients evaluated for efficacy |
12 |
| Evaluation method |
RECIST 1.1 |
| Response assessment, CR |
1 (8.3%) |
| Response assessment, PR |
5 (41.6%) |
| Response assessment, SD |
5 (41.6%) |
| Response assessment, PD |
1 (1%) |
| Median duration assessment, PFS |
11.3 months (CI: 7.7-33.1 months) |
| Median duration assessment, response duration |
20.6 months (13.9-31.2 months) |
| Median duration assessment, duration of treatment |
19 months (4.4-31.2 months) |
| Outcome notes, efficacy |
The median follow-up time was 27.6 months (range 4.4-43.5 months), and the median duration of treatment was 19 months (range 4.4-31.2 months). The ORR was 50%, with one complete response (CR) and 5 partial responses (PR). The disease control rate was 92% (n = 11/12) of the patients (Fig. 2). One patient had PD due to new osseous metastasis, though target lesions decreased in size at the same time. Radiological PFS at 6 and 12 months was reported in 67.7% and 33.5% of patients, respectively. Treatment was continued in 5 patients beyond progression (41.7%) (Fig. 3). The median PFS was 11.3 months (95% CI: 7.7-33.1 months) (Fig. 4
). |