What is the impact of subsequent antineoplastic therapy on overall survival (OS) following first-line bevacizumab (BEV)/interferon-alpha2a (IFN) in metastatic renal cell carcinoma (mRCC)? - Experience from AVOREN

Konference: 2009 34st Congress ESMO a 15th Congress ECCO - účast ČR

Kategorie: Genitourinární nádory

Téma: Poster session II: Genitourinary malignancies - Renal cancer

Číslo abstraktu: P-7126

Autoři: Sergio Bracarda; MD Joaquim Bellmunt; S.N. Negrier; prof. MUDr. Bohuslav Melichar, Ph.D.; Prof. MD Alain Ravaud, PhD; S. Jethwa; V. Sneller; MD Bernard J. Escudier

Background: BEV (Avastin®) directly inhibits VEGF, the key mediator of angiogenesis. The phase III AVOREN trial (BO17705F) compared 1st-line BEV + IFN with IFN + placebo in patients (pts) with mRCC. The duration of OS, the primary endpoint, was increased in pts receiving 1st-line BEV + IFN compared with IFN + placebo (Escudier et al ASCO 2009). Given the recent availability of four new agents, sequencing of therapy in mRCC is of interest. We analysed OS data in subgroups of pts who received ≥1 dose of subsequent therapy following initial study medication.

Methods: Nephrectomised pts with clear cell mRCC, KPS of ≥70%, no CNS metastases and adequate organ function received IFN (×3/week at a recommended dose of 9 MIU for up to 1 year) plus BEV (10 mg/kg q2w) or placebo until PD. Use of subsequent therapies was recorded and OS calculated in these subgroups.

Results: Between 06/04 and 10/05, 649 pts (641 treated) were randomised to BEV + IFN (n = 327) or IFN + placebo (n = 322). Post-protocol therapy was received by 180 (55%) pts in the BEV + IFN and 202 (63%) in the IFN + placebo arm; the majority (148 and 171) received 1 or 2 subsequent therapies. Pt characteristics, including MSKCC score, were similar in pts who received subsequent therapy and the overall population. The results of sequencing with different post-protocol therapies are shown below.

Conclusions: Although the AVOREN trial was not designed to examine the effect of 2nd-line therapy on OS, this retrospective exploratory analysis suggests a potential improvement in OS (greater than 30 months) in pts who receive BEV + IFN followed by subsequent therapies such as TKIs. The overall sequence of therapies should be considered when selecting 1st-line therapy for pts with mRCC, but prospective studies are required to confirm these findings.

Trial sponsored by F. Hoffmann-La Roche, Ltd.

Publikováno v: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 431

Datum přednesení příspěvku: 21. 9. 2009