Abstract
Afatinib is an oral, irreversible, tyrosine kinase inhibitor (TKI) of EGFR, HER2 and HER4. According to phase I studies, the recommended dose of afatinib was 50. mg daily. Rash, acne, diarrhea and stomatitis were the most common adverse events. Afatinib failed to demonstrate an improvement in overall survival in unselected heavily pretreated NSCLC patients (Lux-Lung-1). On the contrary, the Lux-Lung-3 and -6 trials met the primary end point, demonstrating a significant increase in terms of PFS with afatinib compared with chemotherapy in the first line treatment of EGFR mutant patients. Moreover, in both studies, afatinib improved overall survival in patients with exon 19 EGFR deletion (31.7 vs 20.7 months; HR: 0.59, p= 0.0001). The results of ongoing randomized trials should further clarify the efficacy of afatinib compared with first-generation TKIs in advanced NSCLC, its activity in the adjuvant and neoadjuvant settings, as well as its efficacy in other tumors.
| Original language | English |
|---|---|
| Pages (from-to) | 143-151 |
| Number of pages | 9 |
| Journal | Critical Reviews in Oncology/Hematology |
| Volume | 97 |
| DOIs | |
| Publication status | Published - Jan 1 2016 |
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Keywords
- Afatinib
- Clinical trials
- EGFR
- Head-neck
- NSCLC
ASJC Scopus subject areas
- Oncology
- Hematology
- Geriatrics and Gerontology
Cite this
Afatinib : An overview of its clinical development in non-small-cell lung cancer and other tumors. / Giordano, Pasqualina; Manzo, Anna; Montanino, Agnese; Costanzo, Raffaele; Sandomenico, Claudia; Piccirillo, Maria Carmela; Daniele, Gennaro; Normanno, Nicola; Carillio, Guido; Rocco, Gaetano; Bianco, Roberto; Perrone, Francesco; Morabito, Alessandro.
In: Critical Reviews in Oncology/Hematology, Vol. 97, 01.01.2016, p. 143-151.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Afatinib
T2 - An overview of its clinical development in non-small-cell lung cancer and other tumors
AU - Giordano, Pasqualina
AU - Manzo, Anna
AU - Montanino, Agnese
AU - Costanzo, Raffaele
AU - Sandomenico, Claudia
AU - Piccirillo, Maria Carmela
AU - Daniele, Gennaro
AU - Normanno, Nicola
AU - Carillio, Guido
AU - Rocco, Gaetano
AU - Bianco, Roberto
AU - Perrone, Francesco
AU - Morabito, Alessandro
PY - 2016/1/1
Y1 - 2016/1/1
N2 - Afatinib is an oral, irreversible, tyrosine kinase inhibitor (TKI) of EGFR, HER2 and HER4. According to phase I studies, the recommended dose of afatinib was 50. mg daily. Rash, acne, diarrhea and stomatitis were the most common adverse events. Afatinib failed to demonstrate an improvement in overall survival in unselected heavily pretreated NSCLC patients (Lux-Lung-1). On the contrary, the Lux-Lung-3 and -6 trials met the primary end point, demonstrating a significant increase in terms of PFS with afatinib compared with chemotherapy in the first line treatment of EGFR mutant patients. Moreover, in both studies, afatinib improved overall survival in patients with exon 19 EGFR deletion (31.7 vs 20.7 months; HR: 0.59, p= 0.0001). The results of ongoing randomized trials should further clarify the efficacy of afatinib compared with first-generation TKIs in advanced NSCLC, its activity in the adjuvant and neoadjuvant settings, as well as its efficacy in other tumors.
AB - Afatinib is an oral, irreversible, tyrosine kinase inhibitor (TKI) of EGFR, HER2 and HER4. According to phase I studies, the recommended dose of afatinib was 50. mg daily. Rash, acne, diarrhea and stomatitis were the most common adverse events. Afatinib failed to demonstrate an improvement in overall survival in unselected heavily pretreated NSCLC patients (Lux-Lung-1). On the contrary, the Lux-Lung-3 and -6 trials met the primary end point, demonstrating a significant increase in terms of PFS with afatinib compared with chemotherapy in the first line treatment of EGFR mutant patients. Moreover, in both studies, afatinib improved overall survival in patients with exon 19 EGFR deletion (31.7 vs 20.7 months; HR: 0.59, p= 0.0001). The results of ongoing randomized trials should further clarify the efficacy of afatinib compared with first-generation TKIs in advanced NSCLC, its activity in the adjuvant and neoadjuvant settings, as well as its efficacy in other tumors.
KW - Afatinib
KW - Clinical trials
KW - EGFR
KW - Head-neck
KW - NSCLC
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U2 - 10.1016/j.critrevonc.2015.08.016
DO - 10.1016/j.critrevonc.2015.08.016
M3 - Article
VL - 97
SP - 143
EP - 151
JO - Critical Reviews in Oncology/Hematology
JF - Critical Reviews in Oncology/Hematology
SN - 1040-8428
ER -