Table 2.
Best response, PFS, OS, and DSS of the TPK cohort
| Gemcitabine | nab‐paclitaxel + gemcitabine (n = 489) | FOLFIRINOX | All regimens | |||||
|---|---|---|---|---|---|---|---|---|
| (n = 272) | (n = 284) | (n = 1,174) | ||||||
| Best response | n | % | n | % | n | % | n | % |
| CR/PR | 19 | 7.0% | 82 | 16.8% | 59 | 20.8% | 175 | 14.9% |
| SD | 66 | 24.3% | 118 | 24.1% | 67 | 23.6% | 286 | 24.4% |
| PD | 50 | 18.4% | 70 | 14.3% | 54 | 19.0% | 195 | 16.6% |
| Not yet evaluable1 | 137 | 50.4% | 219 | 44.8% | 104 | 36.6% | 518 | 44.1% |
| Number of cycles | n | Mean ± StD | n | Mean ± StD | n | Mean ± StD | n | Mean ± StD |
| 235 | 4.3 ± 3.9 | 415 | 4.3 ± 3.0 | 239 | 7.3 ± 7.3 | 1,002 | 5.0 ± 4.8 | |
| Progression‐free survival | n | % | n | % | n | % | n | % |
| Events | 178 | 65.4% | 317 | 64.8% | 154 | 54.2% | 740 | 63.0% |
| Median PFS | Months | 95% CI | Months | 95% CI | Months | 95% CI | Months | 95% CI |
| 4.6 | 3.7–5.2 | 5.6 | 5.0–6.2 | 6.3 | 5.5–6.9 | 5.3 | 5.0–5.7 | |
| Survival rate | % | 95% CI | % | 95% CI | % | 95% CI | % | 95% CI |
| 6 months | 33.1% | 26.7–39.6 | 46.6% | 41.5–51.6 | 52.7% | 45.8–59.2 | 43.6% | 40.3–46.8 |
| 12 months | 16.1% | 10.9–22.2 | 17.6% | 13.4–22.2 | 24.3% | 17.6–31.7 | 18.4% | 15.6–21.5 |
| Overall survival | n | % | n | % | n | % | n | % |
| Events | 151 | 55.5% | 296 | 60.5% | 147 | 51.8% | 670 | 57.1% |
| Median OS | Months | 95% CI | Months | 95% CI | Months | 95% CI | Months | 95% CI |
| 6.8 | 6.1–9.0 | 9.1 | 8.2–10.1 | 11.3 | 10.5–12.5 | 9.2 | 8.5–10.0 | |
| Survival rate | % | 95% CI | % | 95% CI | % | 95% CI | % | 95% CI |
| 6 months | 57.6% | 50.6–64.0 | 65.1% | 60.1–69.6 | 80.0% | 74.2–84.7 | 66.2% | 63.1–69.1 |
| 12 months | 28.4% | 21.6–35.6 | 36.6% | 31.4–41.8 | 43.6% | 36.2–50.8 | 35.8% | 32.4–39.3 |
| Disease‐specific survival | n | % | n | % | n | % | n | % |
| Events | 128 | 47.1% | 231 | 47.2% | 124 | 43.7% | 548 | 46.7% |
| Median DSS | Months | 95% CI | Months | 95% CI | Months | 95% CI | Months | 95% CI |
| 9.0 | 6.6–10.4 | 10.6 | 9.3–11.6 | 11.9 | 11.2–13.4 | 10.7 | 9.8–11.3 | |
| Age at start of therapy | Median | Min‐Max | Median | Min‐Max | Median | Min‐Max | Median | Min‐Max |
| Years | 78 | 45–94 | 71 | 40–87 | 60 | 39–79 | 70 | 39–94 |
| Performance status2 | n | % | n | % | n | % | n | % |
| ECOG ≥ 1 | 198 | 72.8% | 314 | 64.2% | 148 | 52.1% | 749 | 63.8% |
Abbreviations: CR, complete response; DSS, disease‐specific survival; OS, overall survival; PD, progressive disease; PFS, progression‐free survival; PR, partial response; SD, stable disease; StD, standard deviation.
1
Due to the high number of ongoing treatments and assessment of response as per local site standard (noninterventional design without independent review), a high percentage of responses is not yet evaluable.
2
At enrolment.