Konference: 2012 37th Congress ESMO – účast ČR
Kategorie: Genitourinární nádory
Téma: Poster, Poster presentation I
Číslo abstraktu: 809P
Autoři: prof. MUDr. Bohuslav Melichar, Ph.D.; Sergio Bracarda; Vsevolod Matveev; Prof.MD Andrey Kaprin; MD Boris Alekseev; Dr. R. Janciauskiene; Beatrix Lutiger; Prof. Martin E. Gore; Prof. Gerald H. Mickisch; MD Joaquim Bellmunt
In the AVOREN trial, first-line BEV + IFN (9 MIU three times in a week [tiw]) was effective in patients (pts) with mRCC. A retrospective analysis found that efficacy was maintained and IFN-related toxicity was improved in pts with IFN dose reduced to 6 or 3 MIU. BEVLiN (MO21609) prospectively assesses the safety and efficacy of BEV with low-dose IFN (3 MIU) in mRCC.
BEVLiN is an open-label single arm, multinational phase 2 study. Nephrectomized, treatment-naive pts with clear cell mRCC and favourable/intermediate Motzer scores were treated with BEV 10mg/kg q2w + IFN 3 MIU tiw until disease progression. BEVLiN was designed to allow descriptive, cross-trial comparison with the BEV + IFN 9 MIU-treated favourable/intermediate Motzer score AVOREN subgroup. Primary end points are safety (specific grade [Gr] ≥3 IFN-associated adverse events [AEs]) and progression-free survival (PFS). Secondary end points are overall survival (OS); overall response rate (ORR); any Gr ≥3, overall, and serious AEs.
147 pts were enrolled in BEVLiN. Baseline pt characteristics were similar to the comparator AVOREN subgroup. The median follow-up was 29.4 months. Pts received a median of 22.5 cycles of BEV (18.0 in the AVOREN subgroup). Median PFS was 15.3 mos (95% CI: 11.7; 18.0) vs 10.5 mos (95% CI: 10.1; 12.9); median OS was 30.7 mos (95% CI: 25.7; not reached) vs 25.8 mos (95% CI: 22.7; 29.4); and ORR was 29% vs 36% in BEVLiN and the AVOREN subgroup, respectively. The rates of any-Gr and Gr ≥3 IFN-associated AEs were markedly lower in BEVLiN than in the AVOREN subgroup (Table). Overall rates of AEs of special interest were similar between studies, despite longer BEV duration in BEVLiN.
|AE, % (95% CI)||BEVLiN n = 146a||AVOREN subgroup n = 283a|
|Any Gr||Gr ≥3||Any Gr||Gr ≥3|
|Any IFN-related AE||53 (45–62)||10 (6–16)||89 (85–92)||27 (22–32)|
|· Asthenia/fatigue||37 (29–45)||10 (5–16)||63 (57–68)||21 (16–26)|
|· Pyrexia||19 (13–27)||0 (0–2)||45 (39-51)||2 (1–4)|
|· Nausea||9 (5–15)||1 (0–4)||29 (23–34)||1 (0–3)|
|· Anorexia||0 (0–2)||0 (0–2)||36 (30–42)||3 (1–5)|
|Any BEV-related AE of special interestb||59 (50–67)||23 (17–31)||60 (54–66)||23 (18–28)|
aTreated pts. bIncludes hypertension, proteinuria, bleeding, and other AEs.
Use of low-dose IFN with BEV in BEVLiN resulted in a reduction in IFN-related AEs without compromising efficacy outcomes compared with a control AVOREN subgroup.
B. Melichar: Dr. Bohuslav Melichar has received honoraria for lectures from Roche and participated in an advisory board meeting.
S. Bracarda: Dr. Sergio Bracarda is an Advisory Board Member for Novartis, Pfizer, GSK, Bayer, Aveo/Astellas, Jannsen &Jannsen and Sanofi-Aventis. He has received honoraria for lectures from Novartis, Sanofi-Aventis and Pfizer.
R. Janciauskiene: Dr. Janciauskiene has been principal investigator in a Hoffmann-La Roche sponsored trial and has been an invited speaker for Hoffmann-La Roche.
B. Lutiger: Beatrix Lutiger is an employee of F. Hoffmann-La Roche AG.
M.E. Gore: Dr. Martin Gore has participated advisory board meetings and is on the speaker's bureau for Roche.
G. Mickisch: Dr. Gerald Mickisch is a member of the BEVLiN Steering Committee.
J. Bellmunt: Dr. Joaquim Bellmunt has participated in an advisory board meeting, and received a lectures fee from Roche.
All other authors have declared no conflicts of interest.
Datum přednesení příspěvku: 29. 9. 2012