Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 (Afatinib)
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
1. Advanced NSCLC has a poor prognosis and the positive impact of chemotherapy is limited
by the development of intrinsic and acquired resistance.
2. Over the past decade, less toxic agents such as the innovative targeted therapies, i.e.
erlotinib or gefitinib, have the potential to improve the effectiveness and keep a good
quality of life with a low toxicity
3. BIBW2992 (afatinib), an aniline-quinazoline, is an epidermal growth factor receptor
(EGFR) and human epidermal growth factor receptor 2 (HER-2) irreversible inhibitor, and
it has activity against erlotinib-resistant isoforms having mutations in EGFR and HER-2.
4. This molecule has shown benefits as a single agent in pre-treated patients who have
progressed despite platinum-based chemotherapy, with a minimal toxicity compared to
chemotherapy.
5. BIBW2992 is associated with adverse effects similar to those for erlotinib and
gefitinib, such as rash and diarrhea. These symptoms can reduce the quality of life (QL)
in patients and lead to inconsistent EGFR inhibitor dose administration
6. There is not a standard treatment for rash. However, case reports have tried to
demonstrate the benefit in the treatment of these cutaneous injuries obtained with
alcohol-free emollients, sunscreen with titanium dioxide or antibiotic (topic or oral)
treatment regimens that include clindamycin or doxycycline, as well as anti-inflammatory
drugs such as steroids and isotretinoin.
7. In order to reduce the incidence and severity of cutaneous toxicities, we will compare
the prophylactic antibiotic treatment using tetracycline and general dermatological
recommendations versus using only dermatological recommendations, in patients initiating
the treatment with BIBW2992.