| General information |
| Database: | DB00318 |
| Objective: | Cetuximab plus radiotherapy (RT) may be an effective alternative to chemoradiation in locally advanced head and neck squamous cell carcinoma (LASCCHN) patients. They analyzed a group of patients treated at our institute with cetuximab plus volumetric modulation arc therapy (VMAT) with the RapidArc technique in a simultaneous integrated boost (SIB) regime. The primary end point was the assessment of acute toxicity and the feasibility of the combined approach. |
| Authors: | Alongi F, et al |
| Title: | Prospectivephase II trial of cetuximab plus VMATSIB in locally advanced head and neck squamous cell carcinoma. Feasibility and tolerability in elderly and chemotherapyineligible patients. |
| Journal: | Strahlenther Onkol. |
| Year: | 2012 |
| PMID: | 22194030 |
| 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: | 2 |
| Therapeutic Combination Content: | cetuximab plus VMAT(volumetric modulation arc therapy)SIB |
| Study Type: | Prospective phase II trial |
| Key Patients Feature: | primary tumor in oropharynx, hypopharynx, larynx, oral cavity, histopatological confirmation ofsquamous cell carcinoma, F stage III or IV head and neck disease, according to the American JointCommittee on Cancer 2002 stagingsystem, F performance status of 0-2 accordingto ECOG, F patient older than 18 years, F functional marrow, liver, and kidneyactivity not limiting for the feasibilityof combined treatment, F unsuitable for surgery, F unsuitable for chemoradiotherapy; patients excluded because of agemore than and equal to 70 years old (elderly) and/or excluded for comorbidities and/or limitingperformance status (unfit), andF signed informed consent for treatment. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | All patients underwent planning CT (additional image modalities were acquired for contouring purposes in the same treatment position: MRI in 12 and FDGPET in 4 out of 22 patients). VMAT, by means of RapidArc, and SIB with two dose levels of 54.45 Gy and 69.96 Gy in 33 fractions were adopted. All patients included in the analysis were concomitantly treated with cetuximab: administration of the drug was initiated 1 week before RT at a loading dose of 400 mg/m(2) body surface area over a period of 120 min, follow by a weekly 60 min infusion of 250 mg/m(2) for the duration of RT. |
| Primary End Point: | the assessment of acute toxicity and the feasibility of the combined approach. |
| Secondary End Point: | NA |
| Patients Number: | 22 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | All but 2 patients completed treatment and achieved the minimum followup of 12 months after the end of the treatment. Of the 22 patients, 18% (4 patients) showed grade 1, 36% (8 patients) grade 2, and 36% (8 patients) showed grade 3 dermatitis, while 9% (2 patients) had grade 1, 36% (8 patients) grade 2, and 45% (10 patients) had grade 3 mucositis/stomatitis. No grade 4 toxicities were recorded. Considering blood parameters, 3 cases of grade 1 anemia and 1 case of grade 2 thrombocytopenia were observed. Nobody required feeding tube placement during treatment. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | 18% (4 patients) showed grade 1, 36% (8 patients) grade 2, and 36% (8 patients) showed grade 3 dermatitis, while 9% (2 patients) had grade 1, 36% (8 patients) grade 2, and 45% (10 patients) had grade 3 mucositis/stomatitis. No grade 4 toxicities were recorded. Considering blood parameters, 3 cases of grade 1 anemia and 1 case of grade 2 thrombocytopenia were observed. Nobody required feeding tube placement during treatment. |
| Conclusions: | The here reported toxicity data are promising and encouraging in regard to the adoption of moderate hypofractionation with VMATSIB techniques, when cetuximab is concomitantly administered. |