| General information |
| Database: | DB00284 |
| Objective: | The combination of cisplatin and radiotherapy is a standard treatment for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Cetuximabradiotherapy is superior to radiotherapy alone in this population, validating epidermal growth factor receptor (EGFR) as a target. Erlotinib is a smallmolecule inhibitor of EGFR. Adding EGFR inhibition to standard cisplatinradiotherapy may improve efficacy. |
| Authors: | Martins RG, et al |
| Title: | Cisplatin and radiotherapy with or without erlotinib in locally advanced squamous cell carcinoma of the head and neck: a randomizedphase II trial. |
| Journal: | J Clin Oncol. |
| Year: | 2013 |
| PMID: | 23460709 |
| Trial Design |
| Clinical Trial Id: | NCT00410826 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | Cisplatin + radiotherapy¡Àerlotinib |
| Study Type: | a randomizedphase II trial |
| Key Patients Feature: | Eligible patients had biopsyconfirmed stage III, IVA, or IVB SCCHN with identified primary tumor in the nasopharynx (WHO type I), oral cavity, oropharynx, hypopharynx, or larynx |
| Biomarker: | p16 and EGFR |
| Biomark Analysis: | NA |
| Control Group Info: | Cisplatin and radiotherapy(arm A); Cisplatin and radiotherapy+erlotinib(arm B) |
| Treatment Info: | patients were randomly assigned to receive cisplatin 100 mg/m(2) on days 1, 22, and 43 combined with 70 Gy of radiotherapy (arm A) or the same chemoradiotherapy with erlotinib 150 mg per day, starting 1 week before radiotherapy and continued to its completion (arm B). Available tumors were tested for p16 and EGFR by fluorescent in situ hybridization. |
| Primary End Point: | complete response rate (CRR). |
| Secondary End Point: | progression free survival (PFS). |
| Patients Number: | 204 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Arm A had a CRR of 40% and arm B had a CRR of 52% (P = .08) when evaluated by central review. |
| Disease Control Rate: | 54 progression events |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | there was no difference in PFS (hazard ratio, 0.9; P = .71). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Patients on arm B had more rash, but treatment arms did not differ regarding rates of other grade 3 or 4 toxicities |
| Conclusions: | Erlotinib did not increase the toxicity of cisplatin and radiotherapy in patients with locally advanced HNSCC but failed to significantly increase CRR or PFS. |