Table 1.
Recent trials of erlotinib and radiotherapy in head and neck squamous cell carcinoma.
| Trial | Year | Trial type | N | Treatment | Efficacy outcome | Safety outcomesa |
|---|---|---|---|---|---|---|
| Herchenhorn et al. (2010) | 2009 | Phase I/II single arm | 31 | Erlotinib + RT + cisplatin | Pathologic CR, 74.2% | Grade 3/4 toxicities: in-field dermatitis (52%), nausea (48%), vomiting (39%), dysphagia (35%), mucositis (29%), xerostomia (29%) |
| Savvides et al. (2006) | 2006 | Phase I dose-escalation | 23 | Erlotinib + RT + docetaxel | Of 18 patients, 15 achieved CRs | DLTs: grade 3/4 mucositis (n = 2), death (n = 1) |
| GICOR (Arias de la Vega et al., 2008) | 2008 | Phase I dose-escalation | 12 | Erlotinib + RT + cisplatin | MTD: erlotinib, 150 mg/day; cisplatin, 30 mg/m2 weekly; RT, 63 Gy | Grade 3/4 toxicities: mucositis (50%); anemia, welt, syncope, constipation, dysphonia, dermatitis, asthenia, respiratory infection (8% each) |
| Meluch et al. (2009) | 2009 | Phase II single arm | 48 | RT + chemotherapy + erlotinib + bevacizumab | 77% ORR; 18 month PFS: 85% | Grade 3/4 toxicities during induction: neutropenia (46%), mucositis (14%), diarrhea (14%), hand/foot syndrome (11%), neutropenic fever (6%). Local grade 3/4 toxicities during combined modality therapy: mucositis/ esophagitis (76%) |
CR, complete response; DLT, dose-limiting toxicity; GICOR, Grupo de Investigación Clínica en Oncología Radioterápica; MTD, maximum tolerated dose; ORR, overall response rate; PFS, progression-free survival; RT, radiotherapy.
aMost commonly reported moderate-to-severe adverse events.