Artigo Acesso aberto Revisado por pares

Activity of a specific inhibitor, gefitinib (Iressa™, ZD1839), of epidermal growth factor receptor in refractory non-small-cell lung cancer

2003; Elsevier BV; Volume: 15; Issue: 1 Linguagem: Inglês

10.1093/annonc/mdh010

ISSN

1569-8041

Autores

Alessandra Santoro, Raffaele Cavina, F Latteri, Paolo Andrea Zucali, V. Ginanni, Elisabetta Campagnoli, Benvenuto Ferrari, Emanuela Morenghi, Vittorio Pedicini, Massimo Roncalli, Marco Alloisio, G Ravasi, Héctor Soto Parrà,

Tópico(s)

HER2/EGFR in Cancer Research

Resumo

Gefitinib (Iressa(TM), ZD1839) is an orally active, selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. Phase I studies showed that it is well tolerated, with evidence of tumor regression in patients with advanced non-small-cell lung cancer (NSCLC). Therefore, we aimed to assess the antitumor activity and tolerability of gefitinib in a series of patients with previously treated, advanced NSCLC, as a part of a compassionate use program.To be eligible, all patients were required to have histologically or cytologically proven advanced or metastatic NSCLC, prior chemotherapy with at least one cisplatin-containing chemotherapy regimen or contraindication to cytotoxic drugs, Eastern Cooperative Oncology Group performance status < or =2, and adequate hematological, renal and hepatic parameters. All patients provided signed informed consent. Patient re-evaluation was performed every 4-6 weeks.Seventy-three consecutive patients were enrolled. Response rate, including complete and partial response, was 9.6%; an additional 43.8% of patients achieved stable disease, for an overall disease control of 53.4%. EGFR1 status was evaluated by immunocytochemistry in 25 patients. According to EGFR1 immunoreactivity all responses were observed with medium/strong imunoreactivity while three out of four responses were observed in high expressive patients. Median survival for all patients was 4 months while it reached 6 months for patients with disease control. The 1-year survival rate was 13.1% for the entire series and 23.2% for patients with disease control. Non-hematological toxicity was generally mild.Gefitinib has promising activity with a good toxicity profile in patients with progressive NSCLC who have received one or two prior chemotherapy regimens. A possible relationship within response and EGFR1 expression is suggested.

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