| General information |
| Database: | DB00259 |
| Objective: | They previously reported that nabpaclitaxelbased induction chemotherapy (IC) and concurrent chemoradiotherapy resulted in low relapse rates (13%) and excellent survival in head and neck squamous cell carcinoma (HNSCC). They compare the diseasespecific survival (DSS) and overall survival (OS) between patients given nabpaclitaxel, cisplatin, and fluorouracil with cetuximab (APFC) and historical controls given docetaxel, cisplatin, and fluorouracil with cetuximab (TPFC). |
| Authors: | Schell A, et al |
| Title: | Nabpaclitaxelbased compared to docetaxelbased induction chemotherapy regimens for locally advanced squamous cell carcinoma of the head and neck. |
| Journal: | Cancer Med. |
| Year: | 2015 |
| PMID: | 25619559 |
| 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: | 2 |
| Therapeutic Combination Content: | nabpaclitaxel, cisplatin, + fluorouracil+ cetuximab (APFC) |
| Study Type: | a prospective singleinstitutionphase II trial |
| Key Patients Feature: | untreated Stage III and IVa/b HNSCC, ECOG performance status of 0-1, T2-4 classification, and plan to receive three cycles of IC followed by cisplatin concurrent with definitive RT; T and N classification and smoking history were similar between the two groups and within p16positive and p16negative subsets. |
| Biomarker: | p16, a surrogate for human papillomavirus (HPV) |
| Biomark Analysis: | as in the conclusion |
| Control Group Info: | docetaxel, cisplatin, and fluorouracil+cetuximab (TPFC) |
| Treatment Info: | Patients with locally advanced HNSCC were treated with APFC (n = 30) or TPFC (n = 38). After 3 cycles of IC, patients were scheduled to receive cisplatin concurrent with definitive radiotherapy. |
| Primary End Point: | diseasespecific survival (DSS) and overall survival (OS) |
| Secondary End Point: | NA |
| Patients Number: | 68 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2year PFS was 89.3% for APFC and 55.7% for TPFC (P = 0.0019). Twoyear PFS for patients with p16positive OPSCC was 93.8% for APFC and 68.4% for TPFC (P = 0.034). The 2year PFS for patients with p16 negative HNSCC was 81.8% for APFC, and 51.2% with TPFC (P = 0.091). |
| Median OS A vs. C: | The 2year DSS for patients treated with APFC was 96.7% [95% CI: 85.2%, 99.8%] and with TPFC was 77.6% (CI: 62.6%, 89.7%) (P = 0.0004). Disease progression that resulted in death was more frequent in the TPFC group (39%) compared with the APFC group (3%) when adjusted for competing risks of death from other causes (Gray's test, P = 0.0004). In p16 positive OPSCC, the 2year DSS for APFC was 100% and for TPFC was 74.6% (CI: 47.4%, 94.6%) (P = 0.0019) and the 2year OS for APFC was 94.1% (CI: 65.0%, 99.2%) and for TPFC was 74.6% (CI: 39.8%, 91.1%) (P = 0.013). In p16 negative HNSCC, the 2year DSS for APFC was 91.7% (CI: 67.6%, 99.6%) and for TPFC was 82.6% (CI: 64.4%, 94.8%) (P = 0.092). A 2year DSS and OS were significantly better with a nabpaclitaxelbased IC regimen (APFC) compared to a docetaxelbased IC regimen (TPFC) in p16positive OPSCC. |
| Adverse Event(agent arm): | Neuropathy and creatinine elevation were more frequent with APFC, although most were grade 1-2. |
| Conclusions: | 2year DSS and OS they were significantly better with a nabpaclitaxelbased IC regimen (APFC) compared to a docetaxelbased IC regimen (TPFC) in p16positive OPSCC. The outcomes support further research of nabpaclitaxelbased IC regimens in HNSCC. |