817P - Sorafenib in patients with renal cell carcinoma and brain, bone or lung metastases: subanalysis of the non-interventional predict study

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Jozef Mardiak
Authors J. Mardiak1, J. Ma2, E. Korbenfeld3, M. Zemanova4, N. Leonhartsberger5, K. Stauch6, A. Boeckenhoff7, J. Yu8, B. Escudier9, D. Jäger10
  • 1Department Of Medical Oncology, National Cancer Institute, 833 10 - Bratislava/SK
  • 2Cancer Institute And Hospital, Chinese Academy of Medical Sciences, Beijing/CN
  • 3Oncology, Hospital Británico de Buenos Aires, Buenos Aires/AR
  • 4Department Of Oncology, Charles University, Prague/CZ
  • 5Department Of Urology, Medical University Innsbruck, Innsbruck/AT
  • 6Global Non-interventional Studies, Bayer HealthCare, Leverkusen/DE
  • 7Global Development - Global Clinical Development, Bayer HealthCare, Wuppertal/DE
  • 8Global Medical Affairs, Bayer HealthCare, Montville/US
  • 9Institut Gustave Roussy, 94805 - Villejuif/FR
  • 10National Center For Tumor Diseases, University Medical Center Heidelberg, Heidelberg/DE

Abstract

Background

Clinical trials in advanced renal cell carcinoma (RCC) tend to exclude patients (pts) with brain metastases (mets). We report safety and efficacy outcomes from a subanalysis of PREDICT (NCT 00895674), a large, non-interventional study of sorafenib in pts with advanced RCC, according to sites of mets.

Table: 817P

Metastases subsets
Event Brain (n = 121) Bone (n = 673) Lung, all (n = 1723) Lung, only (n = 779) Overall (n = 2599)
Any AE 77 (63.6) 401 (59.6) 1011 (58.7) 406 (52.1) 1479 (56.9)
Any drug-related AE 58 (47.9) 316 (47.0) 861 (50.0) 366 (47.0) 1240 (47.7)
Any SAE 39 (32.2) 156 (23.2) 297 (17.2) 90 (11.6) 477 (18.4)
Any drug-related SAE 12 (9.9) 42 (6.2) 89 (5.2) 30 (3.9) 140 (5.4)
Most frequent any grade drug-related AEs*
Hand–foot skin reaction 20 (16.5) 106 (15.8) 366 (21.2) 188 (24.1) 520 (20.0)
Diarrhea 19 (15.7) 111 (16.5) 306 (17.8) 114 (14.6) 443 (17.1)
Rash 8 (6.6) 58 (8.6) 155 (9.0) 65 (8.3) 220 (8.5)
Alopecia 5 (4.1) 36 (5.4) 96 (5.6) 44 (5.7) 145 (5.6)
Decreased appetite 7 (5.8) 24 (3.6) 44 (2.6) 12 (1.5) 76 (2.9)

Methods

Pts were eligible based on a diagnosis of advanced RCC and a decision by the investigator to prescribe sorafenib under compliance of the local product label. Physician assessments of efficacy and tolerability were collected for up to 12 months.

Results

Of the efficacy population (n = 2311), 1079 pts (47%) had mets in >1 organ. Sites included bone (n = 635), brain (n = 113), lung (n = 1639); 750 pts had mets only in the lung (‘lung only’). Baseline characteristics across disease-site subsets were: 69–74% male; 73–82% aged <70 years; 82–85% prior nephrectomy; and 82–89% clear cell histology. Baseline performance status (PS) tended to be worse in pts with bone/brain mets vs lung/lung only mets (pts with ECOG PS ≥2 according to disease sites: brain, 46%; bone, 40%; lung, 27%; lung only, 20%). Overall, median duration of therapy (DOT) was 7.3 months. Median DOT was numerically longer in pts with 1 disease site (8.4 months) vs >1 site (6.2 months). Median DOT was longest in pts with lung only mets (9.1 months); in the other subsets it was numerically similar to overall median DOT (brain, 7.0 months; bone, 6.4 months; lung, 7.5 months). Sorafenib was generally well tolerated (Table). Serious adverse event rates were numerically higher in pts with brain mets vs the other subsets, but no cerebrovascular events were reported.

Conclusions

In pts with RCC treated in clinical practice, sorafenib DOT was >6 months regardless of number or location of metastases, and sorafenib was generally well tolerated regardless of disease site. Number (%) patients with AEs (safety population).

Disclosure

J. Mardiak: Jozef Mardiak has received Research Grants from Novartis and has received honoraria from Pfizer and Pierre Fabre.

J. Ma: Jianhui Ma has received Research Grants from Bayer.

M. Zemanova: Milada Zemanova has received consulting and lecture fees from Glaxo Smith Kline and Roche.

N. Leonhartsberger: Nicolai Leonhartsberger has received honoraria from Bayer, Pfizer and Roche.

K. Stauch: Kathrin Stauch is an employee of Bayer HealthCare and owns stock in Bayer Pharma AG.

A. Boeckenhoff: Annette Boeckenhoff is an employee of Bayer HealthCare and owns stock in Bayer Pharma AG.

J. Yu: Jian Yu is an employee of Bayer HealthCare.

B. Escudier: Bernard Escudier has served in an advisory role for Pfizer, Novartis, Roche, GSK, Bayer and Aveo, and has received honoraria from Pfizer, Novartis, Roche, GSK, Bayer and Aveo.

D. Jäger: Dirk Jäger has received honoraria from Bayer, Amgen, Pfizer, Novartis, Roche, Fresenius Kabi and Hoffmann-La Roche.

All other authors have declared no conflicts of interest.