| General information |
| Database: | DB00320 |
| Objective: | To evaluate feasibility, safety and outcome of cetuximab concurrent with radiotherapy in locally advanced headneck cancer. |
| Authors: | Dattatreya S, et al |
| Title: | Cetuximab plus radiotherapy in patients with unresectable locally advanced squamous cell carcinoma of head and neck regiona open labelled single armphase II study. |
| Journal: | Indian J Cancer. |
| Year: | 2011 |
| PMID: | 21768658 |
| 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: | 4 |
| Therapeutic Combination Content: | Cetuximab plus radiotherapy |
| Study Type: | openlabelled single armphase II study |
| Key Patients Feature: | locallyadvanced unresectable (Stage IV) squamous cell carcinoma of head and neck |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Cetuximab 400 mg/m 2 in week 1 followed by 250 mg/m 2 from weeks 2 to 8. This was administered alongwith concomitant radiotherapy from week 2 to 8 (200 cGy per fraction five days a week for 7 weeks totaling 70Gy) |
| Primary End Point: | the safety and toxicity. |
| Secondary End Point: | The response rate, duration of response, time to progression, and locoregional control at end of 2 years. |
| Patients Number: | 19 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | A total of 4 patients achieved complete response (CR), 9 had partial response (PR), 4 had stable disease (SD), and 2 developed progressive disease (PD). Thus, the overall response rate (ORR) was 68.42% (13/19 patients; [Table 2]), and disease control rate (DCR) was 89.47% (17/19). The response rate among the various tumor sites was as follows: Oropharynx 3 CR, 4 PR, 3 SD, 2 PD; Oral cavity CR 1, PR 2, SD 1; larynx both had PR; patient with primary in hypopharynx alsoachieved a PR. |
| Disease Control Rate: | 0.8947 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | the overall survival at 2 year was 84 % |
| Adverse Event(agent arm): | There were no grade 3/4 adverse events (AEs). A total of 7 patients had grade 1 and one patient had grade 2 dermatitis. Mucositis of grade 1 was seen in 10 patients. The patient with grade 2 dermatitis also developed post irradiation pigmentation and dry desquamation, 4 weeks after completion of treatment. |
| Conclusions: | Cetuximab concurrent with radiotherapy is a safe and effective option in advanced headneck cancer patients. |