| General information |
| Database: | DB00391 |
| Objective: | Based on the convenient oral dosing of erlotinib and the promising results of biologic therapy, they undertook a phase II study with 21 patients with locally advanced (T34) lesions combining radiation with intraarterial (IA) cisplatin and oral daily erlotinib for a 7week therapy. |
| Authors: | Rao K, et al |
| Title: | a phase II study of intraarterial cisplatin with concurrent radiation and erlotinib for locally advanced head and neck cancer. |
| Journal: | Cancer Chemother Pharmacol |
| Year: | 2013 |
| PMID: | 23884559 |
| Trial Design |
| Clinical Trial Id: | NCT00304278 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | squamous cell carcinoma of the oropharynx, hypopharynx, or larynx |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | intraarterial cisplatin with concurrent radiation and erlotinib |
| Study Type: | openlabel, nonrandomized, phase II study |
| Key Patients Feature: | biopsyproven, previously untreated, squamous cell carcinoma of the oropharynx, hypopharynx, or larynx withlocally advanced stage III or IV disease with T3-T4 primary lesions and N0-N2 neck nodal disease. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Treatment for the primary tumor and upper neck was given to a total dose of 70 Gy. Chemotherapy with IA cisplatin (150 mg/m(2)) was given on days 1, 8, 15, and 22 concurrently with radiotherapy. During the 7week treatment period, patients were given erlotinib 150 mg/day. |
| Primary End Point: | the safety and tolerability of the combination of erlotinib andchemoradiation. |
| Secondary End Point: | disease free and overall survival. |
| Patients Number: | 21 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | A total of 89.5 % of patients achieved a complete remission (CR), while 10.5 % achieved a partial remission. Five of the 17 patients who achieved a CR relapsed, yielding a 26.3 % relapse rate. Two of the five patients were successfully salvaged with surgery; four out of five patients ultimately expired from disease. The locoregional and distant disease control rate stand at 63.2 and 94.7 %, respectively. |
| Disease Control Rate: | 0.368 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Among the 19 evaluable patients with a median followup of 22 months and with a minimum followup of 1 year, the diseasefree survival is 57.89 % |
| Median OS A vs. C: | Among the 19 evaluable patients with a median followup of nearly 22 months and with a minimum followup of 1 year, overall survival is 63.2 % |
| Adverse Event(agent arm): | Among the grade 3-4 toxicities, prolonged hospitalization was the most common (38 %) followed by nausea (26 %), diarrhea (16 %), dehydration (16 %), weight loss (11 %), vomiting (11 %), and fever (11 %). Other grade 3-4 side effects occurring at less than a 10 % rate included anemia, thrombocytopenia, hypothermia, arterial bleeding, pain, and stridor. Longterm side effects included xerostomia, most likely related to radiation, and ototoxicity, most likely related to cisplatin. |
| Conclusions: | Their study and several others now demonstrate the feasibility of combining antiepidermal growth factor receptor (EGFR) therapy with chemoradiation, hint at improved survival outcomes with reduced distant metastatic rates, and suggest that maintenance therapy with antiEGFR agent may be beneficial. |