P15. Crizotinib in metastatic ALK-positive lung cancer—results from clinical practice in Slovakia
Peter Berzinec1, Peter Kasan2, Lukas Plank3, Igor Andrasina4, Robert Godal5, Juraj Mazal6, Andrea Cipkova4, Lucia Denkova2, Gabriela Chowaniecova1, Iveta Kuliskova3
Background: Crizotinib was approved and authorized for use in the European Union in October 2012. Since then crizotinib has been available in Slovakia for treatment of advanced metastatic non-small cell lung cancer (NSCLC) after failure of standard chemotherapy only, based on the wording of the therapeutic indications by the European Medicines Agency. Purpose of this study was to assess results achieved with crizotinib in the treatment of advanced, metastatic NSCLC in clinical practice in Slovakia.
Methods: In this multicentre retrospective study, approved by the Ethical Committee of the Specialised Hospital of St Zoerardus Zobor, the data of 29 ALK-positive patients were reviewed. FISH with break-apart probes was used for the confirmation of ALK rearrangement in all cases. MedCalc version 14.8.1 was used for the statistical analyses.
Results: Between October 2012 and August 2014, 19 out of 29 ALK-positive patients were treated with crizotinib. Ten patients did not receive crizotinib: five due to on-going first-line chemotherapy, five due to other reasons. Characteristics of the treated patients: M/W: 5/14, age (years) median 57, range 23-77, PS (ECOG/WHO): 0/1/2/3: 1/9/4/5, Histology: 18 patients adenocarcinoma, 1 NSCLC, NOS. Treatment results: RR was evaluable in 17 patients: PR + CR: 12 (11+1), 71% (95% CI: 44-90), PD: 3, 18% (95% CI: 4-44), SD: 2, 12% (95% CI: 1-38), DCR: 14, 82% (95% CI: 56-96), PFS (in 19 patients) Kaplan-Meier estimate: 10 months (95% CI: 6 -15), PS (in 19 patients): significant improvement within 2 months (mean dif. –0.89, P=0.007), toxicities grade 3/4 occurred in 10 of 19 patients (53%), hematologic: 0, non-hematologic: hepatotoxicity 3/1, pneumonitis: 1/0, diarrhoea 1/0, nausea: 3/0, vomiting: 1/1, vision disorder: 1/0, peripheral oedema: 1/0. Crizotinib was permanently discontinued due to toxicity in only two patients. There was no statistically significant difference in the RR, grade 3/4 toxicities rate, and PFS between this study and the crizotinib arm in the PROFILE 1007 (Shaw AT et al., NEJM 2013).
Conclusions: Treatment results seen in this retrospective study are encouraging and consistent with those seen in the key phase III trial with crizotinib.
Keywords: Non-small cell lung cancer (NSCLC); crizotinib; ALK
doi: 10.3978/j.issn.2218-6751.2014.AB027
