Cetuximab EGFR inhibitors

Description Results

OS 0.89 [0.75; 1.05] median 9.69 mo vs. 8.38 mo

PFS 0.90 [0.76; 1.07] median 4.40 mo vs. 4.24 mo

OS 0.87 [0.76; 1.00] median 11.3 mo vs. 10.1 mo

cetuximab (400 mg/m(2) on day 1, 250 mg/m(2) weekly) was administered until progression or unacceptable toxicity plus taxane/carboplatin (n=-9)

vs.

paclitaxel (225 mg/m(2)) or docetaxel (75 mg/m(2)), at the investigator's discretion, and carboplatin (area under the curve = 6) on day 1 every 3 weeks for < or = six cycles (n=-9)

open-label

Sample size: -9/-9

Primary endpoint: progression-free survival

FU duration:

phase III

Cetuximab-at a starting dose of 400 mg/m(2) intravenous infusion over 2 h on day 1, and from day 8 onwards at 250 mg/m(2) over 1 h per week-was continued after the end of chemotherapy until disease progression or unacceptable toxicity + CT (n=557)

vs.

cisplatin 80 mg/m(2) intravenous infusion on day 1, and vinorelbine 25 mg/m(2) intravenous infusion on days 1 and 8 of every 3-week cycle) for up to six cycles (n=568)

open-label

Sample size: 557/568

Primary endpoint: overall survival

FU duration:

cetuximab treatment (initial dose 400 mg/m(2), followed by 250 mg/m(2) weekly thereafter) + same CT (n=43)

vs.

for a maximum of eight cycles, patients received three-weekly cycles of cisplatin (80 mg/m(2), day 1) and vinorelbine (25 mg/m(2) on days 1 and 8) alone (n=43)

Sample size: 43/43

Primary endpoint:

FU duration:

cetuximab (400 mg/m2 i.v (n=65)

vs.

cisplatin (75 mg/m2 i.v., every 3 weeks) or carboplatin (area under the concentration-versus-time curve of 5 intravenously [i.v.], every 3 weeks), and gemcitabine (1,250 or 1,000 mg/m2 i.v., days 1 and 8) (n=66)

Sample size: 65/66

Primary endpoint: Response rate

FU duration:

phase II