| General information |
| Database: | DB00286 |
| Objective: | To replace 5fluorouracil with capecitabine within a trial of induction chemotherapy followed by cetuximab plus radiotherapy (RT) in patients with locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN). Also, to replace cisplatin with cetuximab after induction chemotherapy. |
| Authors: | Perri F, et al |
| Title: | Induction chemotherapy with docetaxel, cisplatin and capecitabine, followed by combined cetuximab and radiotherapy in patients with locally advanced inoperable squamous cell carcinoma of the head and neck: a phase III study. |
| Journal: | Oncology. |
| Year: | 2013 |
| PMID: | 23428719 |
| 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 with docetaxel, cisplatin + capecitabine, followed by combined cetuximab + radiotherapy |
| Study Type: | a phase III study |
| Key Patients Feature: | Histological or cytological confirmation of LA SCCHN (stage IIIIVA) was required. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Docetaxel and cisplatin were given at 75 mg/m(2), while capecitabine was initially given at 500 mg/m(2) twice a day and subsequently escalated. |
| Primary End Point: | The maximum tolerated dose |
| Secondary End Point: | NA |
| Patients Number: | 7 |
| Trial Results |
| DLT_MTD: | At dose level 1, two doselimiting toxicities were observed in the first 4 patients (grade 4 neutropenia and grade 3 diarrhea). In both patients, capecitabine was withdrawn and toxicities resolved. Dose escalation was halted and a lotheyr capecitabine dose (750 mg/m(2) daily) was selected. |
| Objective Response Rate: | Two complete responses and five partial responses were observed after induction chemotherapy. Four patients were evaluable for response after cetuximabRT (3 complete response and 1 partial response). |
| 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): | main toxicity was grade 3 skin rash; the most frequent late side effects were grade 2 xerostomia (5 patients), grade 1 taste alteration (3 patients) and subcutaneous fibrosis (2 patients). One patient experienced a laryngopharyngeal dysfunction requiring feeding tube application and enteral nutrition. |
| Conclusions: | Combined chemoradiotherapy is still the gold standard in LA SCCHN and no studies currently support the use of early induction chemotherapy. Our study did not contribute toward addressing this issue since it was discontinued early because of toxicity. |