Drug Therapy:
• Panitumumab (Vectibix)
• 5-Fluorouracil (5-FU)
• Cisplatin
Regimen 2
Drug Therapy:
• 5-Fluorouracil (5-FU)
• Cisplatin
Participating Institution
Multicenter (n=130)
Cancer Indication
head and neck cancer
Clinical
Indication
head and neck cancer, squamous
cell carcinoma, metastatic or recurrent
Clinical
Status
Phase III (begin 5/07, closed
5/09) USA, Argentina, Australia, Brazil, Europe (Belgium, Bulgaria,
France, Germany, Hungary, Ireland, Italy, Poland, Portugal, Romania,
Russia, Sweden, Switzerland, Ukraine, UK), India, Japan, Mexico, Peru,
Singapore, South Korea
Clinical
Trial Title
A Phase III Randomized Trial of
Chemotherapy With or Without Panitumumab in Patients With Metastatic
and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Trial
Acronym
SPECTRUM
Clinical
Trial Objective
The trial’s primary objective is
to determine OS. Secondary objectives include PFS, overall response
rate, duration of response, time to progression (TTP), time to
response, patient reported outcomes and safety.
According
to the protocol, patients in arm 1 are treated with panitumumab (9
mg/kg) plus cisplatin and 5-FU while patients in arm 2 are treated with
cisplatin and 5-FU administered every 3 weeks. Treatment continues for
6 cycles.
Administration
Route
intravenous (IV)
Biomarkers
One of the trial's secondary
objectives is to investigate potential biomarker development.
The most frequently reported
adverse events in the Vectibix plus chemotherapy arm included nausea,
rash, neutropenia and vomiting, as anticipated for this combination
therapy.
Result
Summary
In August 2010, according to top-line results, SPECTRUM
failed to meet its primary endpoint of OS. The addition of Vectibix to
platinum-based chemotherapy did not result in a statistically
significant improvement in OS compared to chemotherapy alone; median
survival was 11.1 months with Vectibix compared to 9.0 months with
chemotherapy alone for a hazard ratio (HR) of 0.87. In addition,
secondary endpoints of median progression-free survival (PFS) of 5.8
months versus 4.6 months (HR=0.78), respectively, and objective
response rate of 36% versus 25%, respectively, although numerically
improved they were not tested for statistical significance. Detailed
results from the trial will be presented at the 35th European Society
for Medical Oncology (ESMO) Congress scheduled for October 8-12 in
Milan, Italy.
Result
- Overall Response
36% with Vectibix compared to 25%
with chemotherapy alone
Result
- PFS
5.8 months with Vectibix compared
to 4.6 months with chemotherapy alone (HR=0.78)
Result
- Overall Survival
Median OS is 11.1 months with
Vectibix compared to 9.0 months with chemotherapy alone (HR=0.87).
