Table 2.
Results of a univariate analysis of PFS
| Subgroup | Median time PFS (weeks) | Cox Hazard Model | CBR Week 24 | TGR (0-Last) | |||
|---|---|---|---|---|---|---|---|
| Subgroup | Category | N | Median (95% CI) | HR (95% CI) | P-Value | % (n/N) | Mean ± SD |
| Age (years) | ≤65 | 16 | 36.29 (12.29, 53.14) | 1.00 | 0.632 | 68.8 (11/16) | 5.41 ± 11.34 |
| >65 | 12 | 36.64 (12.14, NC) | 0.80 (0.32, 1.98) | 58.3 (7/12) | 5.44 ± 10.34 | ||
| Sex | Male | 19 | 36.14 (12.29, 49.14) | 1.00 | 0.428 | 63.2 (12/19) | 6.71 ± 11.07 |
| Female | 9 | 53.14 (12.00, NC) | 0.68 (0.26, 1.78) | 66.7 (6/9) | 2.71 ± 10.00 | ||
| Presence or absence of progressive disease at baseline (based on RECIST standards) | Present | 11 | 25.14 (12.00, 37.14) | 2.54 (1.04, 6.20) | 0.041 | 45.5% (5/11) | 10.74 ± 13.84 |
| Absent | 17 | 53.14 (24.14, NC) | 1.00 | 76.5% (13/17) | 1.99 ± 6.50 | ||
| Presence or absence of prior treatment for NET (drug or treatment method) | Present | 22 | 36.22 (12.29, 49.14) | 3.99 (0.91, 17.40) | 0.066 | 54.5 (12/22) | 6.72 ± 11.55 |
| Absent | 6 | NC (33.00, NC) | 1.00 | 100.0 (6/6) | 0.69 ± 5.09 | ||
| Classification of primary tumor site (based on embryological classification in CLARINET study) | Pancreas | 12 | 36.79 (24.14, 59.43) | 1.00 | 0.615 | 83.3 (10/12) | 0.43 ± 7.83 |
| Foregut (except for pancreas) | 1 | 12.00 (NC, NC) | 960,261.8 (0.00, NC) | 0.0 (0/1) | 0.32 ± NC | ||
| Midgut | 2 | NC (NC, NC) | 0.00 (0.00, NC) | 100.0 (2/2) | -2.77 ± NC | ||
| Hindgut | 8 | 22.65 (12.14, 49.14) | 2.19 (0.80, 6.00) | 25.0 (2/8) | 16.35 ± 11.02 | ||
| Other/ Unknown | 5 | 36.14 (12.00, NC) | 0.97 (0.26, 3.58) | 80.0 (4/5) | 4.23 ± 6.12 | ||
| Grade of tumor | Grade 1 | 9 | NC (12.00, NC) | 1.00 | 0.195 | 55.6 (5/9) | 1.65 ± 5.95 |
| Grade 2 | 19 | 36.29 (21.29, 49.14) | 2.07 (0.69, 6.25) | 68.4 (13/19) | 7.21 ± 12.09 | ||
| Ki67 index (%) | ≤ 2 | 8 | NC (12.00, NC) | 1.00 | 0.016 | 62.5 (5/8) | 1.82 ± 6.34 |
| >2 and ≤5 | 8 | 42.72 (12.00, NC) | 1.85 (0.44, 7.75) | 62.5 (5/8) | 5.55 ± 8.50 | ||
| >5 and <10 | 9 | 36.29 (21.29, 53.14) | 3.22 (0.85, 12.15) | 88.9 (8/9) | 4.63 ± 11.81 | ||
| ≥10 and <20 | 2 | 12.07 (12.00, 12.14) | 46.04 (4.37, 484.62) | 0.0 (0/2) | 7.19 ± NC | ||
| Unknown | 1 | 12.14 (NC, NC) | 28.29 (1.95, 410.48) | 0.0 (0/1) | 36.90 ± NC | ||
| Hepatic tumor load (%) | ≥0 and ≤10 | 18 | 36.36 (21.29, 59.43) | 1.00 | 0.835 | 66.7 (12/18) | 4.09 ± 9.60 |
| >10 and ≤25 | 6 | 35.79 (12.00, NC) | 1.01 (0.33, 3.10) | 66.7 (4/6) | 8.10 ± 15.47 | ||
| >25 and ≤50 | 3 | 25.14 (24.14, 37.14) | 1.81 (0.50, 6.55) | 33.3 (1/3) | 9.49 ± 9.98 | ||
| >50 | 1 | NC (NC, NC) | 0.00 (0.00, NC) | 100.0 (1/1) | 1.17 ± NC | ||
| Baseline TGR (%/month) | <10 | 13 | 59.43 (24.00, NC) | 1.00 | 0.078 | 76.9 (10/13) | 3.41 ± 9.43 |
| ≥10 | 15 | 35.29 (12.14, 37.14) | 2.31 (0.91, 5.83) | 53.3 (8/15) | 7.17 ± 11.76 | ||
This analysis of PFS time considers as events centrally assessed disease progressions (using RECIST 1.1 standards) and any deaths reported during the study. PFS, progression-free survival; CBR, clinical benefit rate; TGR, tumor growth rates; CI, confidence interval; HR, hazard rate; SD, standard deviation; NC, not calculated; RECIST, Response Evaluation Criteria in Solid Tumors