Adding the monoclonal anti-EGFR antibody Panitumumab ( Vectibix ) to chemotherapy did not significantly improve overall survival for patients with recurrent and/or metastatic head and neck cancer.

The results come from the SPECTRUM trial, which included 657 patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Participants were randomly assigned to either Cisplatin and 5-Fluorouracil or Cisplatin and 5-Fluorouracil plus Panitumumab.

The primary endpoint, statistically better overall survival by adding Panitumumab to the chemotherapy regimen, was not reached.

Median overall survival was 11.1 months in the Panitumumab arm, compared to 9.0 months in the chemotherapy-alone arm. This difference was not statistically significant ( hazard ratio, HR=0.87; p=0.14 ).

Although overall survival was not significantly different between the treatment groups, patients receiving Panitumumab experienced a longer progression-free survival, with medians of 5.8 months for patients in the Panitumumab arm and 4.6 months for patients in the chemotherapy-alone arm ( HR = 0.78; descriptive p=0.004 ).
The overall response rate was 36% in the Panitumumab arm, compared to 25% for patients who received only chemotherapy ( descriptive p=0.007 ).
Since the primary endpoint was not met, secondary endpoints were not tested for statistical significance per the pre-specified statistical analysis plan.

The safety profile was as expected for Cisplatin and 5-Fluorouracil in combination with Panitumumab. Serious adverse events were seen in 48% of Panitumumab patients, compared to 43% of chemotherapy-alone patients.

Source: ESMO Meeting, 2010

XagenaMedicine2010


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