Tarceva safety profile1
In a randomized double-blind study (BR.21; Tarceva administered as second line therapy), rash (75 %) and diarrhoea (54 %) were the most commonly reported adverse drug reactions. Most were Grade 1/2 in severity and manageable without intervention. Grade 3/4 rash and diarrhoea occurred in 9 % and 6 %, respectively in Tarceva-treated patients and each resulted in study discontinuation in 1 % of patients. Dose reduction for rash and diarrhoea was needed in 6 % and 1 % of patients, respectively. In study BR.21, the median time to onset of rash was 8 days, and the median time to onset of diarrhoea was 12 days. In general, rash manifests as a mild or moderate erythematous and papulopustular rash, which may occur or worsen in sun exposed areas. For patients who are exposed to sun, protective clothing, and/or use of sun screen (e.g. mineral-containing) may be advisable. Adverse reactions occurring more frequently (≥3 %) in Tarceva-treated patients than in the placebo group in the pivotal study BR.21, and in at least 10 % of patients in the Tarceva group, are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in the table below.
- In another double-blind, randomized, placebo-controlled Phase III study (BO18192, SATURN), Tarceva was administered as maintenance after first-line chemotherapy. SATURN was conducted in 889 patients with advanced, recurrent or metastatic NSCLC following first-line standard platinum based chemotherapy, no new safety signals were identified. The most frequent ADRs seen in patients treated with Tarceva in study BO18192 were rash and diarrhoea (any Grade 49% and 20%, respectively), most were Grade 1/2 in severity and manageable without intervention. Grade 3 rash and diarrhoea occurred in 6% and 2% of patients, respectively. No Grade 4 rash or diarrhoea was observed. Rash and diarrhoea resulted in discontinuation of Tarceva in 1% and <1% of patients, respectively. Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 8.3% and 3% of patients, respectively.
- In an open-label, randomized phase III study (ML 20650, EURTAC) conducted in 154 patients, the safety of Tarceva for first-line treatment of NSCLC patients with EGFR activating mutations was assessed in 75 patients; no new safety signals were observed in these patients. The most frequent ADRs seen in patients treated with Tarceva in study ML 20650 were rash and diarrhoea (any Grade 80% and 57%, respectively), most were Grade 1/2 in severity and manageable without intervention. Grade 3 rash and diarrhoea occurred in 9% and 4% of patients, respectively. No Grade 4 rash or diarrhoea was observed. Both rash and diarrhoea resulted in discontinuation of Tarceva in 1% of patients. Dose modifications (interruptions or reductions) for rash and diarrhea were needed in 11% and 7% of patients, respectively.
Dosing and side effect management guidelines can be found in the document "Tarceva: dosing guidelines and side effect management strategies"
Reference
- Tarceva® (erlotinib) Summary of Product Characteristics, F. Hoffmann-La Roche Ltd., 2011.
