| General information |
| Database: | DB00323 |
| Objective: | To report the mature data of a prospectivephase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT). |
| Authors: | Suntharalingam M, et al |
| Title: | Phase II study evaluating the addition of cetuximab to the concurrent delivery of weekly carboplatin, paclitaxel, and daily radiotherapy for patients with locally advanced squamous cell carcinomas of the head and neck. |
| Journal: | Int J Radiat Oncol Biol Phys. |
| Year: | 2011 |
| PMID: | 21601372 |
| 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: | cetuximab plus the concurrent delivery of weekly carboplatin, paclitaxel, and daily radiotherapy |
| Study Type: | prospectivephase II trial |
| Key Patients Feature: | Eligibility criteria included age >18 years, no prior chemotherapy or headandneck RT, Karnofsky Performance Status more than and equal to 70, and normal hematopoietic, hepatic, and renal functions.All patients were required to undergo a physical examination, panedoscopy, andradiographic studies that included computed tomography (CT) scans. In addition, a majorityof patients underwent positron emission tomography (PET)/CT for staging and 3 monthsafter therapy |
| Biomarker: | HPV status |
| Biomark Analysis: | The 3year OS of HPVpositive vs. HPVnegative patients were 100% and 43% (p = 0.032), respectively |
| Control Group Info: | single arm |
| Treatment Info: | The weekly IV dose schedules were CTX 250 mg/m(2) (400 mg/m(2) IV loading dose 1 week before RT), paclitaxel 40 mg/m(2), and carboplatin AUC 2. RT was given at 1.8 Gy per day to 70.2 Gy. Intensitymodulated RT was used in 70% of cases. |
| Primary End Point: | locoregional control rate assessed 3 months after completion of protocol therapy. |
| Secondary End Point: | diseasefree survival (DFS) and OS. |
| Patients Number: | 43 |
| Trial Results |
| DLT_MTD: | Toxicity included Grade 3 mucositis (79%), rash (9%), leucopenia (19%), neutropenia (19%), and RT dermatitis (16%). |
| Objective Response Rate: | The complete response (CR) rate at the completion of therapy was 84%. The estimated 3year local regional control rate was 72%. Six patients with an initial CR subsequently experienced a local recurrence, 10 patients experienced distant progression |
| Disease Control Rate: | The 1, 2, and 3year locoregional control rates were 77%, 72%, and 72%, respectively |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median DFS for the study population was 48 months, with the 1, 2, and 3year rates being 63%, 58%, and 58%, respectively |
| Median OS A vs. C: | NR(not reached). The 1, 2, and 3year OSs were 88%, 65% and 59%, respectively; The 3year OS of HPVpositive vs. HPVnegative patients were 100% and 43% (p = 0.032), respectively |
| Adverse Event(agent arm): | NA |
| Conclusions: | The addition of CTX to weekly PC and daily RT was well tolerated and resulted in encouraging local control and survival rates. |