|
| Malignancy | Regimen | Number of patients | Results | Comments |
|
| mCRC | Cetuximab vs. BSC
[17] | 572 pts
IHC EGFR+ mCRC Previously
treated with chemotherapy | Cetuximab: PR (8%)
SD (31.4%) BSC:
PR (0%) SD (10.9%) | Cetuximab was associated with
a significant improvement in OS ()
Cetuximab: OS (6.1 mo), BSC:
OS (4.6 mo) |
|
| mCRC | Cetuximab, Irinotecan vs.
Cetuximab monotherapy
[18] | 329 pts
mCRC with progression after
Irinotecan-based chemotherapy | Cetuximab, Irinotecan: ORR (22.9%)
Cetuximab: ORR (10.8%) | No difference in OS Median time to progression:
Cetuximab, Irinotecan (4.1 mo), Cetuximab (1.5 mo) |
|
| mCRC | Cetuximab, Irinotecan vs.
Irinotecan
[19] | 1298 pts
EGFR+ mCRC | Cetuximab, Irinotecan:
ORR (16.4%) PFS (4.0 mo)
Cetuximab: ORR (4.2%)
PFS (2.6 mo) | No significant difference in
OS, but large number of pts receiving Irinotecan eventually got cetuximab |
|
| mCRC | FOLFIRI +/ Cetuximab
[20] | 1,217 pts
EGFR+ mCRC First-line treatment | FOLFIRI + Cetuximab: PFS (8.9 mo)
ORR (46.9%) FOLFIRI alone:
PFS (8 mo) ORR (38.7%) | 15% relative risk reduction of
progression |
|
| mCRC | CapOx, bevacizumab +/
Cetuximab
[21] | 775 pts
Previously untreated mCRC | CapOx, bevacizumab:
ORR (40.6%) PFS (10.7 mo)
Cetuximab arm: ORR (43.9%)
PFS (9.8 mo) | Cetuximab combination was
worse in PFS
No difference in OS |
|
| mCRC | FOLFOX +/ Cetuximab [22] | 337 pts 134 pts wild-type KRAS
99 pts mutant KRAS | Wild-type KRAS response with
FOLFOX + Cetuximab (ORR 61%, PFS 7.7 mo)
Mutant KRAS response with
FOLFOX + Cetuximab (ORR 33%, PFS 5.5 mo) | Cetuximab only benefits
patients with wild-type KRAS (HR 0.448, ) |
|
| mCRC | FOLFIRI +/ Cetuximab [23] | 1,217 pts
348 pts wild-type KRAS 192 pts mutant KRAS | Wild-type KRAS response with
FOLFIRI + Cetuximab (ORR 59%, PFS 9.9 mo)
Mutant KRAS response with
FOLFIRI + Cetuximab (ORR 36%, PFS 7.6 mo) | Cetuximab only benefits
patients with wild-type KRAS and reduced risk for disease progression by 32%
() |
| SCC of the Head and Neck | Platinum (cisplatin or
carboplatin), fluorouracil +/ Cetuximab
[25] | 442 pts
Untreated recurrent or
metastatic SCC of the head and neck | Platinum, fluorouracil,
Cetuximab:
ORR (36%) PFS (5.6 mo)
Platinum, fluorouracil: ORR (20%)
PFS (3.3 mo) | Median OS was significantly
improved in the Cetuximab arm (10.1 mo vs. 7.4 mo), |
|
| SCC of the Head and Neck | Cisplatin, Cetuximab vs.
Cisplatin
[26] | 117 pts
Recurrent/metastatic SCC of
the head and neck | Cisplatin, Cetuximab: ORR (26%) Cisplatin ORR (10%) | No significant improvement in
OS or PFS
Enhanced response for patients
with EGFR staining less than 80% by IHC |
|
| SCC of the Head and Neck | Radiation, Cetuximab vs.
Radiation alone
[27] | 424 pts
Locoregionally advanced SCC of
the head and neck | Radiation, Cetuximab: PFS (17.1 mo)
OS (49 mo) Radiation alone:
PFS (12.4 mo) OS (29.3 mo) | OS benefit favoring Cetuximab
arm ()
Incidence in grade 3 or higher
side effects, including mucositis, did not differ significantly between the
groups |
|
| Pancreatic cancer | Cetuximab, Gemcitabine vs.
Gemcitabine alone
[30] | 735 pts | Cetuximab, Gemcitabine: ORR (14%)
PFS (3.5 mo) OS (6.4 mo)
Gemcitabine alone: ORR (12%)
PFS (3 mo) OS (5.9 mo) | The addition of Cetuximab did
not significantly improve ORR, PFS, or OS |
|
| NSCLC | Cisplatin, Vinorelbine +/
Cetuximab
[31] | 1,125 pts
Only pts with EGFR detected by
IHC were randomized | Cisplatin, Vinorelbine,
Cetuximab:
Median OS (11.3 mo) Cisplatin, Vinorelbine:
Median OS (10.1 mo) | OS significantly improved in
Cetuximab arm () |
|
| NSCLC | Sequential or concurrent
carboplatin and paclitaxel with cetuximab
[32] | 229 pts
EGFR by FISH assessable in 76 pts (positive in 59%) | FISH-positive: CR/PR (81%)
Median PFS (6 mo) FISH-negative:
CR/PR (55%) Median PFS (3 mo) | Median OS superior in
FISH-positive (15 mo vs. 7 mo), |
|
