Entry Detail
| General information | |
| Database: | DB00382 |
| Objective: | This study sought to determine the efficacy and safety profile of lapatinib in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). |
| Authors: | de Souza JA, et al |
| Title: | a phase II study of lapatinib in recurrent/metastatic squamous cell carcinoma of the head and neck. |
| Journal: | Clin Cancer Res. |
| Year: | 2012 |
| PMID: | 22371453 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | lapatinib |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 |
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | openlabel, uncontrolled, multicenterphase II study |
| Key Patients Feature: | Patients were required to have histologically orcytologically confirmed R/M SCCHN with measurable disease, 18 years or older withEastern Cooperative Oncology Group (ECOG) performance status < 2 and intact organfunction, as previously described.1 |
| Biomarker: | The biologic effects of lapatinib on tumor growth and survival pathways were assessed in paired tumor biopsies obtained before and after therapy. |
| Biomark Analysis: | Correlative analyses revealed an absence of EGFR inhibition in tumor tissue. |
| Control Group Info: | A:those without exposure to an epidermal growth factor receptor (EGFR) inhibitor(arm A) B:those with (arm B) exposure to an epidermal growth factor receptor (EGFR) inhibitor |
| Treatment Info: | All subjects were treated with lapatinib 1, 500 mg daily. |
| Primary End Point: | response rate (arm A) and progression free survival (PFS; arm B). |
| Secondary End Point: | NA |
| Patients Number: | 45 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | In an intenttotreat analysis, no complete or partial responses were observed, and stable disease was the best response observed in 41% of arm A (median duration, 50 days, range, 34159) and 17% of arm B subjects (median, 163 days, range, 135195). |
| Disease Control Rate: | 0.41 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 52 days (95% CI, 34-109 days) in both arms |
| Median OS A vs. C: | 288 (95% CI, 62-374) and 155 (95% CI, 75-242) days for arms A and B, respectively. |
| Adverse Event(agent arm): | Diarrhea was the most frequent toxicity occurring in 49% of patients. Seven patients experienced related grade 3 toxicity (3 fatigue, 2 hyponatremia, 1 vomiting, 1 diarrhea). |
| Conclusions: | Lapatinib as a single agent in recurrentmetastatic SCCHN, although well tolerated, appears to be inactive in either EGFR inhibitor naive or refractory subjects. |