| General information |
| Database: | DB00260 |
| Objective: | Complete response (CR) at the primary tumor site as assessed by clinical examination following induction chemotherapy with PF (cisplatin and 5fluorouracil [5FU]) is a favorable predictive factor for overall survival and disease control in patients with locally advanced squamous cell carcinoma of the head and neck. In most series, the rate of CR at the primary site after induction PF was 20% to 30%. This study evaluated the efficacy and feasibility of induction nabpaclitaxel and cetuximab given with PF (ACPF) followed by definitive chemoradiation (CRT) in a phase 2 trial. |
| Authors: | Adkins D, et al |
| Title: | a phase 2 trial of induction nabpaclitaxel and cetuximab given with cisplatin and 5fluorouracil followed by concurrent cisplatin and radiation for locally advanced squamous cell carcinoma of the head and neck. |
| Journal: | Cancer. |
| Year: | 2013 |
| PMID: | 22991252 |
| Trial Design |
| Clinical Trial Id: | NCT00736944 |
| 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 nabpaclitaxel+cetuximab+ PF (cisplatin + 5fluorouracil [5FU]) (ACPF) followed by definitive chemoradiation (CRT) |
| Study Type: | a phase II trial. |
| Key Patients Feature: | Eligible patients were 18 years of age or older with untreated HNSCC stages III and IVa/b (T1 excluded) originating in the oropharynx, larynx and oral cavity;of which 22 (73%) had large (T3/T4) primary tumors. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with ACPF (nabpaclitaxel 100 mg/m(2) /week; cetuximab 250 mg/m(2) /week; cisplatin 75 mg/m(2) on day 1; 5FU 750 mg/m(2) /day on days 1 through 3) every 21 days for 3 cycles followed by CRT (cisplatin 100 mg/m(2) on days 1, 22, and 43 of radiation therapy [RT]). |
| Primary End Point: | CR at the primary tumor site after 2 cycles of ACPF |
| Secondary End Point: | NA |
| Patients Number: | 30 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The CR rate at the primary tumor site after 2 cycles of ACPF was 53% and the overall response rate was 100%. 29 (96%) patients completed 3 cycles of ACPF, 26 (90%) completed definitive RT per protocol, and 22 of the 27 evaluable patients (81%) received > 2 of the 3 planned doses of cisplatin with RT. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The estimated 2year PFS for the whole group was 65%, and for the oropharynx and laryngeal cancer subsites were 62% and 64%, respectively. |
| Median OS A vs. C: | The estimated 2year OS for the whole group was 84%, and for the oropharynx and laryngeal cancer subsites were 80% and 86%, respectively. |
| Adverse Event(agent arm): | The proportion of the 30 patients who experienced maximum grade 3, 4, or 5 AEs were 33%(10), 3%(1) and 3%(1), respectively. Some patients experienced more than one > grade 3 AE. |
| Conclusions: | Induction ACPF resulted in a high CR rate (53%) at the primary tumor site even in large tumors and did not adversely affect delivery of definitive CRT. Further investigation of ACPF is warranted. |