Konference: 2010 35th Congress ESMO – účast ČR
Kategorie: Genitourinární nádory
Téma: Genitourinary tumors
Číslo abstraktu: 0928P
Autoři: Prof. Dr. Dirk Jäger; JH Ma; MD Ernesto Korbenfeld; Doc. MUDr. Milada Zemanová, Ph.D.; Nicolai Leonhartsberger; Kathrin Stauch; A. Bockenhoff; J. Yu; doc. MUDr. Jozef Mardiak, CSc., mim.Prof.
Background: Sorafenib (Sor) was shown to be
effective for treatment of metastatic renal cell carcinoma (mRCC)
in randomized controlled trials (RCT). Because patients (pts)
treated under daily-practice conditions have heterogeneous
characteristics that may differ from RCT pts, the
non-interventional study PREDICT was undertaken to evaluate
baseline (BL) characteristics of mRCC pts and the safety and
efficacy of Sor in community practice settings.
Methods: This is a prospective, open-label,
multicenter observational study, encompassing a broad multi-ethnic
population from 18 countries in Europe (EU), Asia/Pacific (AP), and
Latin America (LA). Clinicians followed mRCC pts who received Sor
for up to 12 months. Pt characteristics were recorded at BL; tumor
and pt status and adverse events (AEs) were documented at routine
follow-up visits. This is an update from an interim analysis (data
cutoff Jan. 15, 2010).
Results: 2038 pts were valid for BL
characteristics analysis. 97% of AP pts came from China. Compared
to the pivotal phase 3 study TARGET, there were more pts in the
PREDICT trial with poor ECOG performance status (PS) and higher
MSKCC risk scores, while fewer pts with prior systemic therapy or
cytoreductive nephrectomy. Regional differences in BL
characteristics in PREDICT are shown in the table. Pts from AP were
younger and more often had clear cell histology type. More pts from
EU had undergone nephrectomy than in AP or LA. IFN alpha was
commonly used in AP and LA, somewhat less often in EU. IL-2 was
commonly used in AP, but not in EU and LA. TKIs or mTOR inhibitor
(mTORi) were more commonly used in EU and LA than in AP.
Conclusions: Pts with mRCC had a worse BL
prognosis in the PREDICT study than in TARGET, in terms of ECOG PS
and MSKCC risk score. Among the regions, AP pts had a worse BL ECOG
PS and MSKCC score than pts from EU and LA. Prior systemic
treatment differed by region, with TKI or mTORi used mostly in EU
and LA as opposed to AP.
| BL characteristics | Overall N=2038 | EU N=1119 | AP N=742 | LA N=177 | TARGET N=451 |
| Male, N(%) | 1456(71) | 798(71) | 527(71) | 131(74) | 315(70) |
| Median age, y (range) | 61 (15-88) | 65 (19-88) | 53 (15-85) | 59 (22-88) | 58 (19-86) |
| Only clear-cell histology, | 1684 (83) | 884 (79) | 660 (89) | 140 (79) | 449 (99) |
| N (%) | |||||
| Prior nephrectomy, N (%) | 1724 (85) | 1003 (90) | 581 (78) | 140 (79) | 422 (94) |
| Last anti-cancer therapy, | 577 (45) 90 (7) 199 (15) | 272 (36) 18 (2) 176 (23) | 249 (58) 69 (16) 2 (0.5) | 56 (62) 3 (3) 21 (23) | 307 (68) 191 (42) |
| N (% of pts with | 181 (14) 7(05) 5 (0.4) | 158 (21) 7 (0.9) | 2 (05)--- | 21 (23)--- | 0 (0)---- |
| pre-treatment) IFN alpha | 6 (0.5) | 5 (0.7) 6 (0.8) | |||
| IL-2 TKI or mTORi | |||||
| Sunitinib Temsirolimus | |||||
| Bevacizumab Pazopanib | |||||
| ECOG PS, N (%) 0 | 400 (20) | 276 (25) | 66 (9) | 58 (33) | 219 (49) |
| 1 | 1040 (51) | 557 (50) | 397 (54) | 86 (49) | 219 (49) |
| 2 | 472 (23) | 237 (21) | 214 (29) | 21 (12) | 7 (2) |
| 2 | 118 (6) | 41 (4) | 65 (9) | 12 (7) | 0 (0) |
| Pts with metastases in | |||||
| Lung | 1454 (71) | 805 (72) | 549 (74) | 100 (57) | 348 (77) |
| Bone | 550 (27) | 340 (30) | 147 (20) | 63 (36) | 110 (24) |
| Liver | 434 (21) | 250 (22) | 152 (20) | 32 (18) | 116 (26) |
| Brain | 98 (5) | 50 (5) | 39 (5) | 9 (5) | 0 (0) |
| Memorial Sloan Kettering | 414 (20) | 235 (21) | 153 (21) | 26 (15) | 233 (52) |
| Cancer Center Prognostic | |||||
| Risk, N (%) Low | |||||
| Intermediate | 728 (36) | 365 (33) | 326 (44) | 37 (21) | 218 (48) |
| High | 214 (11) | 77 (7) | 122 (16) | 15 (9) | 0 (0) |
| Missing/not assessed | 682 (33) | 392 (35) | 141 (19) | 99 (56) | 0 (0) |
Disclosure: D. Jäger: Honoraria, Bayer; J. Ma:
Research Grant, Bayer; E. Korbenfeld: Honoraria, Bayer; N.
Leonhartsberger: Honoraria, Bayer and Pfizer; K. Stauch:
Employment, Bayer HealthCare; A. Bockenhoff: Employment, Bayer
HealthCare; J. Yu: Employment, Bayer HealthCare. All other authors
have declared no conflicts of interest.
Datum přednesení příspěvku: 10. 9. 2010
