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25 juli 2011: bron: Medscape en The Lancet

Opnieuw bewijzen gerandomiseerde studies uit dat Tarceva - Erlotinib een belangrijk medicijn is voor mensen met niet-klein-celiige longkanker die een positieve tumorexpressie hebben voor EGFR remmers zoals Tarceva en Iressa. Nu kwam een Chinese studie met resultaten die een verdriedubbeling te zien geven van de mediane overlevingstijd van patienten met vergevorderde longkanker. De mediane overlevingstijd ging van 4,8 naar 13,1 maanden. Eerder al zijn afgelopen jaren verschillende grote gerandomieerde studies met vergelijkbare goede resultaten gepubliceerd, zie linkerkolom.

Een zo grote mediane verlenging van de overlevingstijd is voor vergevorderde longkanker heel uitzonderlijk, aldus longkankerspecialisten in Medscape over deze studies, die ook in The Lancet zijn gepubliceerd. Hier het abstract van de studie. Het totale artikel plus studierapport kunt u inzien tegen betaling als u hier op de website van The Lancet klikt.

Compared with standard chemotherapy, erlotinib conferred a significant progression-free survival benefit in patients with advanced EGFR mutation-positive NSCLC and was associated with more favourable tolerability.

Bron: The Lancet

The Lancet Oncology, Early Online Publication, 22 July 2011

doi:10.1016/S1470-2045(11)70184-X

Cite or Link Using DOI

Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study

Prof Caicun Zhou MD ‡a

, Prof Yi-Long Wu MD ‡b, Prof Gongyan Chen PhD c, Prof Jifeng Feng MD d, Prof Xiao-Qing Liu MD e, Prof Changli Wang MD f, Prof Shucai Zhang MD g, Prof Jie Wang MD i, Songwen Zhou MD a, Shengxiang Ren MD a, Prof Shun Lu PhD j, Prof Li Zhang MD l, Prof Chengping Hu PhD m, Prof Chunhong Hu MD n, Prof Yi Luo MD o, Prof Lei Chen MD p, Prof Ming Ye MD k, Prof Jianan Huang MD q, Prof Xiuyi Zhi MD h, Prof Yiping Zhang MD r, Prof Qingyu Xiu MD s, Prof Jun Ma MD t, Prof Li Zhang MD u, Prof Changxuan You MD v

Summary

Background

Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor (TKI) therapy in non-small-cell lung cancer (NSCLC). The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus standard chemotherapy in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC.

Methods

We undertook an open-label, randomised, phase 3 trial at 22 centres in China. Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) received either oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects, or up to four cycles of gemcitabine plus carboplatin. Patients were randomly assigned (1:1) with a minimisation procedure and were stratified according to EGFR mutation type, histological subtype (adenocarcinoma vs non-adenocarcinoma), and smoking status. The primary outcome was progression-free survival, analysed in patients with confirmed disease who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov, number NCT00874419, and has completed enrolment; patients are still in follow-up.

Findings

83 patients were randomly assigned to receive erlotinib and 82 to receive gemcitabine plus carboplatin; 82 in the erlotinib group and 72 in the chemotherapy group were included in analysis of the primary endpoint. Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy (13.1 [95% CI 10.58—16.53] vs 4.6 [4.21—5.42] months; hazard ratio 0.16, 95% CI 0.10—0.26; p<0.0001). Chemotherapy was associated with more grade 3 or 4 toxic effects than was erlotinib (including neutropenia in 30 [42%] of 72 patients and thrombocytopenia in 29 [40%] patients on chemotherapy vs no patients with either event on erlotinib); the most common grade 3 or 4 toxic effects with erlotinib were increased alanine aminotransferase concentrations (three [4%] of 83 patients) and skin rash (two [2%] patients). Chemotherapy was also associated with increased treatment-related serious adverse events (ten [14%] of 72 patients [decreased platelet count, n=8; decreased neutrophil count, n=1; hepatic dysfunction, n=1] vs two [2%] of 83 patients [both hepatic dysfunction]).

Interpretation

Compared with standard chemotherapy, erlotinib conferred a significant progression-free survival benefit in patients with advanced EGFR mutation-positive NSCLC and was associated with more favourable tolerability. These findings suggest that erlotinib is important for first-line treatment of patients with advanced EGFR mutation-positive NSCLC.