Chemotherapy

In a phase III randomized trial of 442 patients with untreated metastatic or recurrent SCC of the head and neck, adding cetuximab to platinum plus fluorouracil (5-FU) improved overall survival (OS), compared with platinum plus 5-FU alone. The median survival was 10.1 months versus 7.4 months (hazard ratio [HR]death, 0.80; 95% confidence interval [CI], 0.64–0.99; P = .04).[10]Tumor EGFR gene copy number was not a predictive biomarker for the efficacy of cetuximab plus platinum and 5-FU as first-line therapy for patients with metastatic or recurrent SCC of the head and neck.[12][Level of evidence A1]

In a phase III randomized trial of 442 patients with untreated metastatic or recurrent SCC of the head and neck, adding cetuximab to platinum plus fluorouracil (5-FU) improved overall survival (OS), compared with platinum plus 5-FU alone. The median survival was 10.1 months versus 7.4 months (hazard ratio [HR]death, 0.80; 95% confidence interval [CI], 0.64–0.99; P = .04).[10]Tumor EGFR gene copy number was not a predictive biomarker for the efficacy of cetuximab plus platinum and 5-FU as first-line therapy for patients with metastatic or recurrent SCC of the head and neck.[12][Level of evidence A1]

Quality of life (QOL) was not adversely affected by adding cetuximab to this platinum-based regimen.[11]

An open-label, phase III, randomized trial demonstrated improved progression-free survival (PFS) for patients who received afatinib compared with patients who received methotrexate.[13]

An open-label, phase III, randomized trial demonstrated improved progression-free survival (PFS) for patients who received afatinib compared with patients who received methotrexate.[13]

After a median follow-up of 6.7 months, the median PFS was 2.6 months (95% CI, 2.0–2.7) for the afatinib group and 1.7 months (95% CI, 1.5–2.4) for the methotrexate group (HR, 0.80; 95% CI, 0.65–0.98; P = .030).

An open-label, phase III, randomized trial demonstrated improved progression-free survival (PFS) for patients who received afatinib compared with patients who received methotrexate.[13]

The most frequent grade 3 or grade 4 drug-related adverse events for patients treated with afatinib or methotrexate included:

An open-label, phase III, randomized trial demonstrated improved progression-free survival (PFS) for patients who received afatinib compared with patients who received methotrexate.[13] › The most frequent grade 3 or grade 4 drug-related adverse events for patients treated with afatinib or methotrexate included:

Rash or acne (10% for afatinib vs. 0% for methotrexate).

An open-label, phase III, randomized trial demonstrated improved progression-free survival (PFS) for patients who received afatinib compared with patients who received methotrexate.[13] › The most frequent grade 3 or grade 4 drug-related adverse events for patients treated with afatinib or methotrexate included:

Diarrhea (9% for afatinib vs. 2% for methotrexate).

An open-label, phase III, randomized trial demonstrated improved progression-free survival (PFS) for patients who received afatinib compared with patients who received methotrexate.[13] › The most frequent grade 3 or grade 4 drug-related adverse events for patients treated with afatinib or methotrexate included:

Stomatitis (6% for afatinib vs. 8% for methotrexate).

An open-label, phase III, randomized trial demonstrated improved progression-free survival (PFS) for patients who received afatinib compared with patients who received methotrexate.[13] › The most frequent grade 3 or grade 4 drug-related adverse events for patients treated with afatinib or methotrexate included:

Fatigue (6% for afatinib vs. 3% for methotrexate).

An open-label, phase III, randomized trial demonstrated improved progression-free survival (PFS) for patients who received afatinib compared with patients who received methotrexate.[13] › The most frequent grade 3 or grade 4 drug-related adverse events for patients treated with afatinib or methotrexate included:

Neutropenia (<1% for afatinib vs. 7% for methotrexate).

An open-label, phase III, randomized trial demonstrated improved progression-free survival (PFS) for patients who received afatinib compared with patients who received methotrexate.[13]

Overall, serious adverse events occurred in 14% of patients treated with afatinib and 11% of patients treated with methotrexate.