Kategorie: Genitourinární nádory
Téma: Poster session II: Genitourinary malignancies - Renal cancer
Číslo abstraktu: P-7123
Methods: Between June 2004 and October 2005, 649 nephrectomised pts with clear cell mRCC were randomised to IFN at a recommended dose of 9 MIU 3×/week for up to 52 weeks + BEV 10 mg/kg q2w or placebo until disease progression. The protocol specified that IFN should first be withheld and the dose then lowered to 6 or 3 MIU for grade ≥3 adverse events (AEs) attributable to IFN that did not resolve within 28 days or for other investigator-defined reasons.
Results: IFN dose was reduced in 131 and 97 pts in the BEV and placebo arms, respectively. Baseline characteristics, including MSKCC score, were similar in pts who reduced the dose of IFN compared with the overall population. Median OS in pts who received BEV + reduced doses of IFN (26.0 months) was consistent with the total BEV + IFN population (23.3 months). With longer follow up, no new safety signals were observed. A lower incidence of grade ≥3 IFN-related events, including fatigue, asthenia, influenza-like illness, pyrexia and malaise, was observed during the 6 weeks after IFN dose reduction (18%) than during the 6 weeks prior to dose reduction (44%) in pts treated with BEV + reduced doses of IFN.
Conclusions: The OS benefit of BEV + reduced doses of IFN (median 26 months) is comparable to that of the overall BEV + IFN population. These data suggest that reducing the dose of IFN used in combination with BEV is an effective measure to manage toxicity and improve tolerability without compromising efficacy.
Trial sponsored by F. Hoffmann-La Roche, Ltd.
Publikováno v: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 430
Datum přednesení příspěvku: 21. 9. 2009