Table 3.
Select characteristics of first‐line sunitinib patients in the IMDC database and first‐line sunitinib patients in phase III clinical trials
| Characteristics and outcomes | IMDC real‐world databasea | CheckMate 214 trialb | Sunitinib vs. IFN‐α trialc Overall | KEYNOTE‐426 triald Overall | JAVELIN Renal 101 triale Overall | ||
|---|---|---|---|---|---|---|---|
| Overall | Intermediate & poor | Overall | Intermediate & poor | ||||
| First‐line sunitinib treatment period | January 2010 to February 2018 | October 2014 to February 2016 | August 2004 to October 2005 | October 2016 January 2018 | March 2016 December 2017 | ||
| Number of patients, n (%) | |||||||
| Overall | 1,769 | 1,451 | 546 | 422 | 375 | 429 | 444 |
| IMDC favorable | 318 (18.0) | — | 124 (22.7) | — | 134 (35.7) | 131 (30.5) | 96 (21.6) |
| IMDC intermediate | 1,031 (58.3) | 1,031 (71.1) | 333 (61.0) | 333 (78.9) | 205 (54.7) | 246 (57.3) | 276 (62.2) |
| IMDC poor | 420 (23.7) | 420 (28.9) | 89 (16.3) | 89 (21.1) | 34 (9.1) | 52 (12.1) | 71 (16.0) |
| Prior nephrectomy, n (%) | |||||||
| Yes | 1,501 (84.9) | 1,186 (81.8) | 437 (80.0) | 319 (76.0) | 340 (90.7) | 358 (83.4) | 355 (80.0) |
| No | 267 (15.1) | 264 (18.2) | 109 (20.0) | 103 (24.0) | 35 (9.3) | 71 (16.6) | 89 (20.0) |
| Median OS, months | |||||||
| Overall | 28.6 | NR | — | — | — | ||
| IMDC favorable | 52.1 | 32.9 | NR | — | — | ||
| IMDC intermediate & poor | 23.2 | 26.0 | 20.3 | — | — | ||
| IMDC intermediate | 25.8 | — | 23.0 | — | — | ||
| IMDC poor | 9.8 | — | 5.1 | — | — | ||
| Median TTD or PFS,f months | |||||||
| Overall | 8.1 | 12.3 | — | 11.1 | 8.4 | ||
| IMDC favorable | 15.0 | 25.1 | 16.0 | 12.7 | — | ||
| IMDC intermediate & poor | 7.1 | 8.4 | 9.7 | — | — | ||
| IMDC intermediate | 8.5 | — | 10.7 | 9.5 | — | ||
| IMDC poor | 4.2 | — | 2.5 | 2.9 | — | ||
| ORR, % | |||||||
| Overall | 32.4 | 32.0 | 35.7 | 25.7 | |||
| IMDC favorable | 38.5 | 52.0 | 58.2 | — | 37.5 | ||
| IMDC intermediate & poor | — | 27.0 | 38.9 | — | — | ||
| IMDC intermediate | 34.6 | — | 42.4 | — | 25.4 | ||
| IMDC poor | 21.7 | — | 17.6 | — | 11.3 | ||
a
IMDC data for first‐line sunitinib was received on September 1, 2018.
b
Motzer et al. 4.
c
Rini et al. 5.
d
Rini et al. 23.
e
Motzer et al. 19.
f
TTD served as a proxy for PFS in the IMDC database.
Abbreviations: —, not available; IFN, interferon; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression‐free survival; TTD, time to treatment discontinuation.