| General information |
| Database: | DB00256 |
| Objective: | Induction TPF regimen is a standard treatment option for squamous cell carcinoma (SCC) of the oropharynx. The efficacy and safety of adding cetuximab to induction TPF (ETPF) therapy was evaluated. |
| Authors: | Chibaudel B, et al |
| Title: | Induction therapy with cetuximab plus docetaxel, cisplatin, and 5fluorouracil (ETPF) in patients with resectable nonmetastatic stage III or IV squamous cell carcinoma of the oropharynx. A GERCORphase II ECHO07 study. |
| Journal: | Cancer Med |
| Year: | 2015 |
| PMID: | 25684313 |
| Trial Design |
| Clinical Trial Id: | NCT00665392 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced squamous cell carcinoma of the oropharynx |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab+docetaxel, cisplatin, + 5fluorouracil(ETPF) |
| Study Type: | A GERCORphase II ECHO07 study. |
| Key Patients Feature: | Patients with nonmetastatic resectable stage III/IV SCC of the oropharynx |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with weekly cetuximab followed the same day by docetaxel and cisplatin and by a continuous infusion of 5fluorouracil on days 15 (every 3 weeks, 3 cycles). |
| Primary End Point: | clinical and radiological complete response (crCR) of primary tumor at 3 months. |
| Secondary End Point: | crCR rates, overall response, pathological CR, progression free survival, overall survival, and safety. |
| Patients Number: | 42 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The all nine planned cetuximab doses and the full three doses of planned chemotherapy were completed in 31 (76%) and 36 (88%) patients, respectively. Ttheylve (29%) patients required dose reduction. The crCR of primary tumor at the completion of therapy was observed in nine (22%) patients. ETPF was associated with a tumor objective response rate (ORR) of 58%. |
| 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): | The most frequent grade 34 toxicities were as follows: nonfebrile neutropenia (39%), febrile neutropenia (19%), diarrhea (10%), and stomatitis (12%). Eighteen (44%) patients experienced acnelike skin reactions of any grade. One toxic death occurred secondary to chemotherapyinduced colitis with colonic perforation. |
| Conclusions: | Thisphase II study reports an interesting response rate for ETPF in patients with moderately advanced SCC of the oropharynx. The schedule of ETPF evaluated in this study cannot be recommended at this dosage. |