Journal of Oncology / 2009 / Article / Tab 3

Review Article

Clinical Efficacy and Toxicity of Anti-EGFR Therapy in Common Cancers

Table 3

Selected clinical trials of cetuximab. EGFR, epidermal growth factor receptor; BSC, best supportive care; OS, overall survival; PFS, progression free survival; ORR, overall response rate; mCRC, metastatic colorectal cancer; FOLFIRI, 5 Flourouracil/Folinic Acid and Irinotecan; CapOx, capecitabine/oxaliplatin; SCC, squamous cell carcinoma; IHC, Immunohistochemistry; CR, complete response; PR, partial response; FISH, fluorescent in situ hybridization.

MalignancyRegimenNumber of patientsResultsComments

mCRCCetuximab vs. BSC [17]572 pts IHC EGFR+ mCRC Previously treated with chemotherapyCetuximab: 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)

mCRCCetuximab, Irinotecan vs. Cetuximab monotherapy [18]329 pts mCRC with progression after Irinotecan-based chemotherapyCetuximab, 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)

mCRCCetuximab, Irinotecan vs. Irinotecan [19]1298 pts EGFR+ mCRCCetuximab, 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

mCRCFOLFIRI +/ Cetuximab [20]1,217 pts EGFR+ mCRC First-line treatmentFOLFIRI + Cetuximab: PFS (8.9 mo) ORR (46.9%) FOLFIRI alone: PFS (8 mo) ORR (38.7%)15% relative risk reduction of progression

mCRCCapOx, bevacizumab +/ Cetuximab [21]775 pts Previously untreated mCRCCapOx, 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

mCRCFOLFOX +/ Cetuximab [22]337 pts 134 pts wild-type KRAS 99 pts mutant KRASWild-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, )

mCRCFOLFIRI +/ Cetuximab [23]1,217 pts 348 pts wild-type KRAS 192 pts mutant KRASWild-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 NeckPlatinum (cisplatin or carboplatin), fluorouracil +/ Cetuximab [25]442 pts Untreated recurrent or metastatic SCC of the head and neckPlatinum, 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 NeckCisplatin, Cetuximab vs. Cisplatin [26]117 pts Recurrent/metastatic SCC of the head and neckCisplatin, 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 NeckRadiation, Cetuximab vs. Radiation alone [27]424 pts Locoregionally advanced SCC of the head and neckRadiation, 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 cancerCetuximab, Gemcitabine vs. Gemcitabine alone [30]735 ptsCetuximab, 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

NSCLCCisplatin, Vinorelbine +/ Cetuximab [31]1,125 pts Only pts with EGFR detected by IHC were randomizedCisplatin, Vinorelbine, Cetuximab: Median OS (11.3 mo) Cisplatin, Vinorelbine: Median OS (10.1 mo)OS significantly improved in Cetuximab arm ( )

NSCLCSequential 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),

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