Tolerability and efficacy of afatinib at a low starting dosage in 10 elderly or low performance status patients with advanced refractory non-small-cell lung cancer.

Background: Whether a full dosage of afatinib is tolerable and effective for elderly or low performance status (PS) patients with advanced refractory non-small-cell lung cancer (NSCLC) is unclear.

Methods: We retrospectively evaluated the tolerability and efficacy of afatinib in 10 patients (the majority elderly) with a low PS score (2 or 3), who had advanced refractory adenocarcinoma and were carrying active epidermal growth factor receptor mutations. Afatinib was administered at a starting dosage of 20 or 30mg/day, followed by 10mg increases in dose up to a maximum dosage of 40mg/day.

Results: The median patient age was 76 years and 50% of the patients had a PS of 3. The patients had previously been treated with gefitinib and/or erlotinib, with a median number of three chemotherapy regimens. All the patients received at least 30mg/day of afatinib. Eight patients did not receive the 40mg/day dosage because of patient refusal due to grade 2 diarrhea (n=6) or the judgment of the doctor (n=2). One patient discontinued the treatment because of drug-induced interstitial lung disease. The most frequent adverse event was grade 2 diarrhea. The objective response rate was 11% and the PS score of five cases improved after afatinib therapy. The median progression-free survival and overall survival periods were 3.6 months and 5.8 months, respectively.

Conclusions: A low starting dosage of afatinib might enable elderly or low PS patients with advanced refractory NSCLC to receive this drug as salvage therapy.