Table 2.
Starting Combination Dose of Sunitinib, mg/day + IFN-α,* MU 3 Times Weekly (n) | Final† Combination Dose of Sunitinib, mg/day + IFN-α, MU 3 Times Weekly (n) |
---|---|
37.5 + 3 (13) | 37.5 + 6 (1) 37.5 + 3 (7) 37.5 + 0 (1) 25 + 3 (3) 25 + 0 (1) |
50 + 3 (12)‡ | 37.5 + 6 (4) 37.5 + 3 (3) 37.5 + 0 (1) 25 + 3 (2) 25 + 0 (2) |
Patients were subject to intrapatient dose escalation of IFN-α weekly, as tolerated, to a maximum dose of 9 MU, which, per a protocol amendment, was discontinued during cycle 1, making 6 MU the highest IFN-α dose thereafter. In addition, 6 patients, per the final protocol amendment, were newly enrolled on sunitinib 37.5 mg plus IFN-α 3 MU and not subject to dose escalation of IFN-α.
The combination dose received by patients as of the data cutoff.
One patient on sunitinib 50 mg/day mistakenly co-administered a starting dose of IFN-α 10 MU, necessitating a dose titration to 3 MU.
Abbreviation: IFN = interferon