| General information |
| Database: | DB00315 |
| Objective: | To determine the efficacy and feasibility of induction chemotherapy (ICT) with docetaxel, cisplatin and 5fluorouracil followed by radiotherapy and cetuximab (C) in patients with locally advanced head and neck cancer. |
| Authors: | Keil F, et al |
| Title: | Induction chemotherapy with docetaxel, cisplatin and 5fluorouracil followed by radiotherapy with cetuximab for locally advanced squamous cell carcinoma of the head and neck. |
| Journal: | Eur J Cancer. |
| Year: | 2012 |
| PMID: | 22981499 |
| Trial Design |
| Clinical Trial Id: | NCT0050463 |
| 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 and 5fluorouracil followed by radiotherapy with cetuximab |
| Study Type: | phase II trial |
| Key Patients Feature: | patients withhistological proven, locally advanced stage III and IVSCCHN of the larynx, hypopharynx, oropharynx ornasopharynx documented by computer tomography(CT) and/or positron emission tomographycomputertomography (PET CT) were included in our study.Patients with an ECOG performance score of 0 or 1without severe comorbidities and with adequate hematopoietic, hepatic and renal functions were eligible. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:induction chemotherapy+radiotherapy plus C B:induction chemotherapy |
| Treatment Info: | pts received three courses of ICT consisting of docetaxel 75mg/m(2) day 1, cisplatin 75mg/m(2) day 1 and infusional 5fluorouracil 750mg/m(2)/day on days 15 followed by radiotherapy plus C at 250mg/m(2)/week (after an initial loading dose of 400mg/m(2)). |
| Primary End Point: | locoregional control; |
| Secondary End Point: | PFS and OS, the response rate and short and long term toxicities, respectively. |
| Patients Number: | 49 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | After completion of ICT 44 of 49 patients received radiotherapy plus C. Three months after therapy completion tumour response was observed in 33 patients and after two years, 25 patients were in complete remission (CR). The most common grade 4 toxicity during the whole treatment period was dermatitis (30%), followed by mucositis (27%) and neutropenia (17%) without fever. One toxic related death was observed during ICT. Twoyear progression free survival (PFS) rate was 59% and twoyear overall survival (OS) rate was 63%, respectively. |
| Disease Control Rate: | Locoregional control after one year was 0.72 (95% CI 0.58-0.85) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | progression free survival (PFS) rate was 59% |
| Median OS A vs. C: | twoyear overall survival (OS) rate was 63% |
| Adverse Event(agent arm): | The most common grade 4 toxicity during the whole treatment period was dermatitis (30%), followed by mucositis (27%) and neutropenia (17%) without fever. One toxic related death was observed during ICT. |
| Conclusions: | Concurrent radiotherapy plus C after three courses of ICT was feasible and was associated with promising CR, PFS and OS rates. Further optimisation of dose and sequence is warranted. |