Table 2.
Clinical trials of the approved EGFR antibody drugs.
| Tumor type | Drug X | Combination therapy drugs | Route, dose | Comparison (medication group and control group) | Efficacy (PR, OS, PFS et), survival benefit = months | Safety (list grade III and IV adverse events) | Phase I, II, III (n) |
References/ clinical trials |
|---|---|---|---|---|---|---|---|---|
| Metastatic colorectal cancer | Cetuximab | Irinotecan | Initially 400 mg/m2 followed by weekly 250 mg/m2 | Cetuximab combined with irinotecan (218) vs. irinotecan (111) | PR 22.9 vs. PR 10.8% | Grade III and IV adverse events 65.1 vs. 43.5% | Phase II (329) | (43) |
| Colorectal cancer | Cetuximab | BSC | Initially 400 mg/m2 to weekly infusions at 250 mg/m2 | Cetuximab plus BSC (287) vs. BSC (285) | OS = 6.1 vs. 4.6 KRAS wild type OS = 9.5 vs. 4.8 |
Grade III and IV adverse events 78.5 vs. 59.1% | Randomized Phase III (572) | (44) |
| Head and neck squamous cell cancer | Cetuximab | XRT | 400 mg/m2 initial dose to followed weekly doses at 250 mg/m2 | RT (213) vs. RT plus Cetuximab (211) | OS = 29.3 vs. 49.0 | Received cetuximab had a greater number of grade 3 and 4 infusion reactions (3%) | Phase III (424) | (45) |
| Head and neck squamous cell carcinoma | Cetuximab | Panitumab | Cetuximab 2.5, 25, 62.5 mg/m2 panitumumab-0.06, 0.5, and 1 mg/kg,. | Cetuximab (n = 12) vs. panitumab (n = 15) | NR | Cetuximab-IRDye800CW and panitumumab-IRDye800CW grade 1 adverse events, respectively, is 15 and 1 | Phase I (27) | (46) |
| Advanced NSCLC | Cetuximab | Carboplatin and paclitaxel | 250 mg/m2 weekly after loading dose | Cetuximab vs. control | Median OS = 5.4 vs. 4.8 | 210 [37%] in the cetuximab group vs. 158 [25%] in the control group | Phase 3 (277) | (47) |
| SCCHN | Cetuximab | Nivolumab | 250 mg/m2 weekly after loading dose | Cetuximab + IC vs. Nivolumab+ Cetuximab | OS = 5.1 vs. 7.1 | Favored nivolumab vs. IC | Phase 3 (361) | NCT02105636 |
| Metastatic colorectal cancer | Panitumumab | BSC | Panitumumab 6 mg/kg every 2 weeks | Panitumumab plus BSC (231) vs. BSC (232) |
PR = 8 vs. 0% | Skin Toxicity 3/414 vs. 0% | Phase III (463) | (48) |
| Metastatic colorectal cancer | Panitumumab | FOLFOX4 | Intravenously (IV) over 1 h at 6 mg/kg every 2 weeks on day | Panitumumab-FOLFOX4 vs. FOLFOX4 (1:1) | PFS = 9.6 vs. 8.0 OS = 23.9 vs. 19.7 |
Grade 3/4: 96 vs. 31% | Phase III (1,183) | (49) |
| KRAS wild-type biliary cancer. | Panitumumab | Cisplatin and gemcitabine | 9 mg/kg BW, i.v q3w | Cisplatin and gemcitabine + panitumumab (A) vs. cisplatin + gemcitabine (B) | PFS = 54 vs. 73% OS = 12.8 months (arm A) vs. 20.1 months (arm B) | Neutropenia26 (44%) vs. 13 (47%) | Phase II (90) | (50) |
| Confirmed metastatic colon or rectum adenocarcinoma | Panitumumab | BSC | 6.0 mg /kg | Panitumumab with BSC, n = 142; vs. BSC, n = 128 | PFS = 5.2 vs. 1.7 OS = 10.2 vs. 7.4 | PAN WITH BSC 46.4% vs. BSC18.7 | Phase III (270) | (51) |
| HNSCC | Nimotuzumab | Cisplatin | Nimotuzumab (200 mg/week) | CRT + nimotuzumab (20) vs. CRT (20) vs. RT + nimotuzumab (17) vs. RT groups (19) | CR = 90 vs. 70 vs. 70.59 vs. 31.01% PR = 10 vs. 0 vs. 5.88 vs. 5.26% |
Grade 3/4: 55 vs. 25 vs. 59 vs. 84% | Phase IIb (92) | (52) |
| Nasopharyngeal carcinoma. | Nimotuzumab | Chemoradiotherapy | 200 mg, iv weekly for 7 courses | Single-arm treated with induction chemotherapy, sequential Nimotuzumab plus concurrent chemoradiotherapy | OS = 85.6% LRC = 97.8% PFS = 79.5% | Neutropenia (35.5) Thrombocytopenia (17.7) |
Phase II (45) | (53) |
| Advanced esophageal squamous cell cancer | Nimotuzumab | Paclitaxel and cisplatin | Nimotuzumab 200 mg weekly | Single arm | RR = 51.8% DCR = 92.9% OS = 14.0 months | Alopecia (78.6%) Neutropenia (46.4%), nausea (48.3%) |
Phase II (56) | (54) |
| Non-small-cell lung cancer | Necitumumab | Paclitaxel-carboplatin chemotherapy | Necitumumab 800 mg, on days 1 and 8 | Neci with Pac-Carb (n = 110) vs. Pac-Carb (n = 57) | PFS = 5.4 vs. 5.6 OS = 13.2 vs. 11.2 |
Grade 3/4: 65.1% vs. 69.1% | Phase II (167) | (55) |
| Non-small-cell lung cancer | Necitumumab. | Gemcitabine and cisplatin | Administered IV on days 1 and 8 (necitumumab continuation arm) | Necitumumab Continuation (n = 261) vs. Gemcitabine-Cisplatin non-progressors (n = 215) | Median OS = 15.9 vs. 15.0 months; median PFS = 7.4 vs. 6.9 months; | 185 (70.9) 114 (53) | Phase III (476) | (56) |
BSC, best supportive care; EGFR, epidermal growth factor receptor; FOLFOX, folinic acid (leucovorin), fluorouracil, oxaliplatin; FU, fluorouracil; HNSCC, head and neck squamous-cell carcinoma; NR, not reported; NSCLC, non-small-cell lung cancer; PR, Response rate; OS: Median overall survival; DCR, disease control rate; LCR, locoregional control; PFS, Median progression free survival; XRT, X-ray Radiation Therapy; RT, Radiation Therapy; OR, Overall Response; IC, Investigator's choice.