DOI 10.1007/s40261-017-0515-2
CASE REPORT
Paolo Marchetti1
1 Introduction
with other EGFR tyrosine kinase inhibitors (TKIs), the or bone metastases. Based on bronchoscopy with biopsy
most common adverse events with afatinib are diarrhea, findings, the patient was diagnosed with EGFR-mutated
skin rash, paronychia, and stomatitis. The grade and the (Exon 21, L858R) NSCLC adenocarcinoma, cT4 N2 M0,
severity of drug toxicity can lead to dosage reduction or stage IV according to the American Joint Committee on
permanent treatment discontinuation. According to label- Cancer staging system, 7th edition [8]. The patient under-
ing recommendations, the starting dosage of afatinib went palliative thoracentesis to manage dyspnea, from
should be 40 mg daily, although dosage reduction to 30 or which cytology examination detected NSCLC cells. Sur-
20 mg daily is possible if treatment is not tolerated [2–4]. gery was excluded because of bilateral lung metastases and
In the first-line treatment of EGFR-mutated NSCLC, pericardial involvement. Considering the tumor histologi-
randomized clinical studies have demonstrated the superior cal and biological features and the patient’s good Karnof-
efficacy of afatinib 40 mg daily in prolonging progression- sky Performance Status (KPS) score (70% at diagnosis),
free survival (PFS) compared with the first-generation first-line treatment with oral afatinib 40 mg daily was
EGFR TKI gefitinib [5] and cisplatin-based chemotherapy initiated.
[6, 7]. Although these studies permitted afatinib dosage After 2 months of afatinib 40 mg daily, the patient
reductions to 20 mg daily for treatment-related adverse presented with several adverse events based on Common
events of grade 3 or higher (or prolonged grade 2 events), Terminology Criteria for Adverse Events (4.03 version):
clinical data regarding the efficacy of afatinib 20 mg daily grade 3 skin rash (Fig. 2a, b), grade 3 mucositis, grade 2
in NSCLC are limited. diarrhea, and grade 2 paronychia. In accordance with
We report our experience with a patient with advanced labeling information, afatinib therapy was interrupted and
EGFR-mutated NSCLC who achieved complete tumor the patient was admitted to the oncology department for
response with afatinib 20 mg daily, after intolerable further treatment. During hospitalization, CT imaging
adverse events developed at higher afatinib dosages. showed partial response to afatinib therapy (Fig. 1b). After
dermatologic consultation, the patient started intravenous
and topical antibiotic (amoxicillin/clavulanic acid) and
2 Case Report antimycotic (fluconazole) treatment, as well as topical 3%
boric acid solution. Ten days later, her skin rash and
A 71-year-old female was admitted to an emergency mucositis had regressed to grade 2, with complete resolu-
department for dysphonia and dyspnea. The patient’s tion of gastrointestinal toxicities.
medical history included hypertension and osteoarthritis; Twenty days after treatment interruption, the patient
she had never smoked. Total body computed tomography restarted afatinib therapy at a reduced dosage of 30 mg
(CT) imaging showed a thoracic mass in the superior left daily. Eight months after starting afatinib therapy, CT
lobe, with multiple small bilateral nodules and pleural imaging showed further partial response compared with the
effusion (Fig. 1a), but was negative for abdominal, brain, previous scan, with resolution of the pleural effusion and
Fig. 1 Computed tomography (CT) imaging: a at diagnosis; b after therapy (dosage reduced to 20 mg daily) showing complete tumor
2 months of afatinib 40 mg daily showing partial tumor response; response. CT scans a and c were conducted with contrast, b was
c after 8 months of afatinib therapy showing further partial response performed at high resolution, and d is a low-dose CT scan of positron
(dosage reduced to 30 mg daily); and d after 11 months of afatinib emission tomography
Afatinib 20 mg Daily in Advanced EGFR-Mutated NSCLC
3 Discussion
12. Tani T, Naoki K, Asakura T, et al. Successful treatment of non- (EGFRm?) NSCLC (LUX-Lung 7): patient-reported outcomes
small-cell lung cancer with afatinib and a glucocorticoid fol- (PROs) and impact of dose modifications on efficacy and adverse
lowing gefitinib- and erlotinib-induced interstitial lung disease: a events (AEs). J Clin Oncol. 2016;34(Suppl):abstr 9046.
case report. Mol Clin Oncol. 2016;5(4):488–90.
13. Hirsh V, Yang JCH, Tan EH, et al. First-line afatinib (A) vs
gefitinib (G) for patients (pts) with EGFR mutation positive