| General information |
| Database: | DB00268 |
| Objective: | E2303 evaluated cetuximab, paclitaxel, and carboplatin used as induction therapy and concomitant with radiation therapy in patients with stage III/IV head and neck squamous cell carcinoma (HNSCC) determining pathologic complete response (CR), eventfree survival (EFS), and toxicity. |
| Authors: | Wanebo HJ, et al |
| Title: | Induction cetuximab, paclitaxel, and carboplatin followed by chemoradiation with cetuximab, paclitaxel, and carboplatin for stage III/IV head and neck squamous cancer: a phase II ECOGACRIN trial (E2303). |
| Journal: | Ann Oncol. |
| Year: | 2014 |
| PMID: | 25009013 |
| Trial Design |
| Clinical Trial Id: | NCT 00089297 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | cetuximab, paclitaxel, + carboplatin used as induction therapy + concomitant with radiation therapy |
| Study Type: | a phase II ECOGACRIN trial (EIIIII0III) |
| Key Patients Feature: | Eligible patients had biopsy confirmed, resectable stage III or IV squamous carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, measureable disease, ECOG performance status 0-1, normal values for neutrophil and platelet counts, serum creatinine, and bilirubin. |
| Biomarker: | p16 status |
| Biomark Analysis: | p16 AQUA score was not associated with response/survival. |
| Control Group Info: | single arm |
| Treatment Info: | pts underwent induction therapy with planned primary site restaging biopsies (at week 8 in clinical complete responders and at week 14 if disease persisted). Chemoradiation (CRT) began week 9. If week 14 biopsy was negative, patients completed CRT (6872 Gy); otherwise, resection was carried out. |
| Primary End Point: | PFS, EFS, CR, OS, toxicity |
| Secondary End Point: | NA |
| Patients Number: | 74 |
| Trial Results |
| DLT_MTD: | There were no treatmentrelated deaths. |
| Objective Response Rate: | Following induction, 41 (23 CR) underwent week 8 primary site biopsy and 24 (59%) had no tumor (pathologic CR). |
| Disease Control Rate: | Disease progression in 23 patients (37%) was local only in 10 (16%), regional in 5 (8%), local and regional in 2 (3%), and distant in 5 patients (8%). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | EFS at 3 years was 55% |
| Median OS A vs. C: | OS at 3 years was 78%. |
| Adverse Event(agent arm): | Toxicity was primarily hematologic or radiationrelated. |
| Conclusions: | Induction cetuximab, paclitaxel, and carboplatin followed by the same drug CRT is safe and induces high primary site response and promising survival. |