| General information |
| Database: | DB00882 |
| Objective: | Previous trials have shown that antiEGFR monoclonal antibodies can improve clinical outcomes of patients with recurrent or metastatic squamouscell carcinoma of the head and neck (SCCHN). they assessed the efficacy and safety of panitumumab combined with cisplatin and fluorouracil as firstline treatment for these patients. |
| Authors: | Vermorken JB, et al |
| Title: | Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamouscell carcinoma of the head and neck (SPECTRUM): an openlabelphase 3 randomised trial. |
| Journal: | Lancet Oncol. |
| Year: | 2013 |
| PMID: | 23746666 |
| Trial Design |
| Clinical Trial Id: | NCT00460265 |
| Agent: | panitumumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced squamous cell carcinoma of the head and neck |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Cisplatin + fluorouracil with panitumumab |
| Study Type: | an openlabelphase III randomised trial |
| Key Patients Feature: | Eligible patients were aged at least 18 years; had histologically or cytologically confirmed SCCHN; had distant metastatic or locoregionally recurrent disease, or both, that was deemed to be incurable by surgery or radiotherapy; had an Eastern Cooperative Oncology Group performance status of 1 or less; and had adequate haematological, renal, hepatic, and cardiac function. |
| Biomarker: | tumour human papillomavirus (HPV) status |
| Biomark Analysis: | p16 status could be a prognostic and predictive marker in patients treated with panitumumab and chemotherapy |
| Control Group Info: | Cisplatin and fluorouracil versus Cisplatin and fluorouracil with panitumumab |
| Treatment Info: | patients were randomly assigned according to a computergenerated randomisation sequence (1:1; stratified by previous treatment, primary tumour site, and performance status) to one of two groups. Patients in both groups received up to six 3week cycles of intravenous cisplatin (100 mg/m(2) on day 1 of each cycle) and fluorouracil (1000 mg/m(2) on days 14 of each cycle); those in the experimental group also received intravenous panitumumab (9 mg/kg on day 1 of each cycle). Patients in the experimental group could choose to continue maintenance panitumumab every 3 weeks |
| Primary End Point: | overall survival and was analysed by intention to treat. |
| Secondary End Point: | NA |
| Patients Number: | 657 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 36% in the panitumumab group, 25% in the control group. |
| Disease Control Rate: | 82% in the panitumumab group, 72% in the control group. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.8 months (95% CI 5.66.6) in the panitumumab group and 4.6 months (4.15.4) in the control group (HR 0.780, 95% CI 0.6590.922; p=0.0036). |
| Median OS A vs. C: | 11.1 months (95% CI 9.812.2) in the panitumumab group and 9.0 months (8.111.2) in the control group (hazard ratio [HR] 0.873, 95% CI 0.7291.046; p=0.1403). |
| Adverse Event(agent arm): | Grade 3 or 4 treatmentemergent adverse events were generally more common in the panitumumab group than in the control group |
| Conclusions: | Although the addition of panitumumab to chemotherapy did not improve overall survival in an unselected population of patients with recurrent or metastatic SCCHN, it improved progression free survival and had an acceptable toxicity profile. p16 status could be a prognostic and predictive marker in patients treated with panitumumab and chemotherapy. Prospective assessment will be necessary to validate our biomarker findings. |