Table 2.
Efficacy data from clinical trials evaluating ErbB/HER family inhibitors as monotherapy in head and neck squamous cell carcinoma.
| Study | Phase (n) |
Therapy | Setting | RR (%) | TTP | PFS | OS | Ref. |
|---|---|---|---|---|---|---|---|---|
| Vermorkenet al. (2007) |
Phase II (n = 103) |
Cetuximab (mAb) |
Previously treated recurrent/metastatic HNSCC |
13 | 70 days | NR | 178 days | [30] |
| Machiels et al. (2011) |
Phase III (n = 286) |
Zalutumumab (mAb) + BSC versus BSC alone |
Previously treated recurrent/metastatic HNSCC |
6.3 versus 1.1 | NR | 9.9 versus 8.4 weeks (HR: 0.63; 95% CI: 0.47–0.84; p = 0.0012) |
6.7 versus 5.2 months (HR: 0.77; 97.06% CI: 0.57–1.05; p = 0.0648) |
[59] |
| Thomas et al. (2007) |
Phase II (n = 31) |
Erlotinib (TKI) | Neoadjuvant, nonmetastatic HNSCC |
29 | NR | NR | NR | [82] |
| Soulieres et al. (2004) |
Phase II (n = 115) |
Erlotinib (TKI) | Untreated or previ- ously treated recurrent/metastatic HNSCC |
4.3 | NR | 9.6 weeks (95% CI: 8 .1–12.1) |
6.0 months (95% CI: 4. 8 –7.0 ) |
[61] |
| Cohen et al. (2005) |
Phase II (n = 71) |
Gefitinib (TKI) | Untreated or previ- ously treated recurrent/metastatic HNSCC |
1.4 | NR | 1.8 months (95% CI: 1.7– 3.1) |
5.5 months (95% CI: 4.0–7.0) |
[36] |
| Cohen et al. (2003) |
Phase II (n = 52) |
Gefitinib (TKI) | Previously treated recurrent/metastatic HNSCC |
10.6 | 3.4 months (95% CI: 1.8 –3.6 ) |
NR | 8.1 months (95% CI: 5.2–9.4) |
[62] |
| Chua et al. (2008) |
Phase II (n = 19) |
Gefitinib (TKI) | Previously treated recurrent/metastatic nasopharyngeal carcinoma |
0 | 4 months (95% CI: 2.6–5.4) |
NR | 16 months | [83] |
| Ma et al. (2008) | Phase II (n = 16) |
Gefitinib (TKI) | Previously treated recurrent/metastatic nasopharyngeal carcinoma |
0 | 2.7 months |
NR | 12 months | [84] |
| Stewart et al. (2009) |
Phase III (n = 486) |
Gefitinib (TKI) 250 mg versus gefitinib 500 mg versus MTX |
Untreated recurrent/ metastatic HNSCC |
2.7 (OR vs MTX: 0.69; 95% CI: 0.19– 2.50; p = 0.57) versus 7.6 (OR vs MTX: 2.04; 95% CI: 0.74– 5.56; p = 0.17) versus 3.9 |
NR | NR | 5.6 months (HR vs MTX: 1.22; 95% CI: 0.95–1.57; p = 0.12) versus 6.0 months (HR vs MTX: 1.12; 95% CI: 0.87–1.43; p = 0.39) versus 6.7 months |
[34] |
| del Campo et al. (2011) |
Phase II (n = 107) |
Lapatinib (TKI) versus placebo |
Untreated locally advanced HNSCC |
17 versus 0† | NR | NR | NR | [65] |
| de Souza et al. (2012) |
Phase II (n = 45) |
Lapatinib (TKI) | Recurrent/metastatic HNSCC without (arm A) or with (arm B) prior EGFR inhibitor exposure |
A: 0; B: 0 | NR | A: 52 days; B: 52 days |
A: 288 days; B: 155 days |
[66] |
| Seiwert et al. (2011) |
Phase II (n = 124) |
Afatinib (TKI) versus cetuximab |
Previously treated recurrent/metastatic HNSCC |
19.2 versus 7.3 | NR | 15.9 versus 15.1 weeks |
NR | [71] |
| Siu et al. (2011) | Phase II (n = 69) |
Dacomitinib (TKI) |
Untreated recurrent/ metastatic HNSCC |
11 | NR | 2.8 months (95% CI: 2.6 – 4 .1) |
7.6 months (95% CI: 6 . 4 –12) |
[74] |
†
Independent evaluation (intent-to-treat).
BSC: Best supportive care; EGFR: EGF receptor; HER: Human EGFR; HNSCC: Head and neck squamous cell carcinoma; HR: Hazard ratio; mAb: Monoclonal antibody; MTX: Methotrexate; NR: Not reported; OR: Odds ratio; OS: Overall survival; PFS: Progression-free survival; RR: Response rate; TKI: Tyrosine kinase inhibitor; TTP: Time to progression.