| General information |
| Database: | DB00317 |
| Objective: | To determine the potential activity and tolerability of sequential treatment in head and neck cancer, they conducted a phase II trial based on induction chemotherapy of two cycles of taxotere, cisplatin and 5fluorouracil followed by radiotherapy plus weekly cetuximab. |
| Authors: | Rampino M, et al |
| Title: | Efficacy and feasibility of induction chemotherapy and radiotherapy plus cetuximab in head and neck cancer. |
| Journal: | Anticancer Res. |
| Year: | 2012 |
| PMID: | 22213307 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| 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: | induction chemotherapy and radiotherapy plus cetuximab |
| Study Type: | phaseII trial from 6 centres in Italy |
| Key Patients Feature: | patients were required to have nonmetastatic, histologically proven, stage III or IV squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx; age between 18 and 75 years old;measurable disease according to World Health Organization criteria(11); an Eastern Cooperative Oncology Group Performance Status02; adequate haematological, hepatic, cardiac and renal functions. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | ICT consisted of docetaxel at a dose of 75 mg/m2 intravenously (i.v.), cisplatin at a dose of 25 mg/m2 i.v. on days 1 to 3; and fluorouracil at a dose of 250 mg/m2 per day, as an i.v. bolus, on days 1 to 3 every 21 days. After completion of the ICT, an interval of 21 days was scheduled before the loading dose of Cet (400 mg/m2 i.v. in 120 min) that was delivered 1 week before the start of RT. weekly Cet (250 mg/m2) was administered during RT for at least six weeks. RT treatment was delivered using a 5 or 6 MV linear accelerator. The prescribed mean dose was 70 Gy to clinical target volume including the primary tumour and the metastatic lymph nodes. |
| Primary End Point: | efficacy, as measured by the objective response rate; Local and locoregional control rates (LC, LRC), progression free survival (PFS) and overall survival (OS) analyses were performed. |
| Secondary End Point: | NA |
| Patients Number: | 36 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Eightyone percent of patients had stage IV disease and 42% had hypopharyngeal and oral cavity primaries. The overall response rate was 81.8%, with 60.6% complete response and 33.3% partial response. Severe toxicities were febrile neutropenia (6%) during induction chemotherapy and dermatitis (48%), mucositis (33%) and dysphagia (12%) during the concurrentphase. |
| Disease Control Rate: | local control: 58%; locoregional control: 49% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | PFS rates were 45.5% (95% CI=26.2%62.9%) |
| Median OS A vs. C: | Twentyfourmonth OS rates were 53% (95% CI=28.9%72.3%) |
| Adverse Event(agent arm): | Severe toxicities were febrile neutropenia (6%) during induction chemotherapy and dermatitis (48%), mucositis (33%) and dysphagia (12%) during the concurrentphase. |
| Conclusions: | Their protocol proved to be feasible, effective and well tolerated. This sequential strategy should be further investigated. |