Ceritinib compassionate use for patients with crizotinib-refractory, anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer

Giulio Metro, Antonio Passaro, Giuseppe Lo Russo, Laura Bonanno, Raffaele Giusti, Vanesa Gregorc, Enrica Capelletto, Olga Martelli, Fabiana L Cecere, Diana Giannarelli, Andrea Luciani, Alessandra Bearz, Alessandro Tuzi, Vieri Scotti, Giuseppe Tonini, Domenico Galetta, Annamaria Carta, Hector Soto Parra, Alberto Rebonato, Alessandro Morabito & 1 others Rita Chiari

Research output: Contribution to journalArticle

Abstract

AIM: Ceritinib was evaluated within a compassionate use program of Italian patients.

PATIENTS & METHODS: 70 patients with anaplastic lymphoma kinase-positive crizotinib-refractory advanced non-small-cell lung cancer received ceritinib.

RESULTS: Overall response was 40.6%, median progression-free survival was 8.2 months and median survival was 15.5 months. Dose reduction due to treatment-related adverse events occurred in 50.8% of patients starting at 750 mg/day. No significantly different progression-free survival was observed between patients who underwent any time dose reduction (n = 38) versus those who remained on the recommended dose of 750 mg/day (n = 32; p = 0.07).

CONCLUSION: The efficacy of ceritinib compassionate use program resembled that of clinical trials. Dose reductions and adjustments did not appear to negatively affect clinical outcome.

Original languageEnglish
Pages (from-to)353-361
Number of pages9
JournalFuture Oncology
Volume14
Issue number4
DOIs
Publication statusPublished - Feb 2018

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Compassionate Use Trials
Non-Small Cell Lung Carcinoma
Disease-Free Survival
Clinical Trials
Survival
ceritinib
crizotinib
anaplastic lymphoma kinase

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Ceritinib compassionate use for patients with crizotinib-refractory, anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer. / Metro, Giulio; Passaro, Antonio; Lo Russo, Giuseppe; Bonanno, Laura; Giusti, Raffaele; Gregorc, Vanesa; Capelletto, Enrica; Martelli, Olga; Cecere, Fabiana L; Giannarelli, Diana; Luciani, Andrea; Bearz, Alessandra; Tuzi, Alessandro; Scotti, Vieri; Tonini, Giuseppe; Galetta, Domenico; Carta, Annamaria; Soto Parra, Hector; Rebonato, Alberto; Morabito, Alessandro; Chiari, Rita.

In: Future Oncology, Vol. 14, No. 4, 02.2018, p. 353-361.

Research output: Contribution to journalArticle

Metro, G, Passaro, A, Lo Russo, G, Bonanno, L, Giusti, R, Gregorc, V, Capelletto, E, Martelli, O, Cecere, FL, Giannarelli, D, Luciani, A, Bearz, A, Tuzi, A, Scotti, V, Tonini, G, Galetta, D, Carta, A, Soto Parra, H, Rebonato, A, Morabito, A & Chiari, R 2018, 'Ceritinib compassionate use for patients with crizotinib-refractory, anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer', Future Oncology, vol. 14, no. 4, pp. 353-361. https://doi.org/10.2217/fon-2017-0441
Metro, Giulio ; Passaro, Antonio ; Lo Russo, Giuseppe ; Bonanno, Laura ; Giusti, Raffaele ; Gregorc, Vanesa ; Capelletto, Enrica ; Martelli, Olga ; Cecere, Fabiana L ; Giannarelli, Diana ; Luciani, Andrea ; Bearz, Alessandra ; Tuzi, Alessandro ; Scotti, Vieri ; Tonini, Giuseppe ; Galetta, Domenico ; Carta, Annamaria ; Soto Parra, Hector ; Rebonato, Alberto ; Morabito, Alessandro ; Chiari, Rita. / Ceritinib compassionate use for patients with crizotinib-refractory, anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer. In: Future Oncology. 2018 ; Vol. 14, No. 4. pp. 353-361.
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T1 - Ceritinib compassionate use for patients with crizotinib-refractory, anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer

AU - Metro, Giulio

AU - Passaro, Antonio

AU - Lo Russo, Giuseppe

AU - Bonanno, Laura

AU - Giusti, Raffaele

AU - Gregorc, Vanesa

AU - Capelletto, Enrica

AU - Martelli, Olga

AU - Cecere, Fabiana L

AU - Giannarelli, Diana

AU - Luciani, Andrea

AU - Bearz, Alessandra

AU - Tuzi, Alessandro

AU - Scotti, Vieri

AU - Tonini, Giuseppe

AU - Galetta, Domenico

AU - Carta, Annamaria

AU - Soto Parra, Hector

AU - Rebonato, Alberto

AU - Morabito, Alessandro

AU - Chiari, Rita

PY - 2018/2

Y1 - 2018/2

N2 - AIM: Ceritinib was evaluated within a compassionate use program of Italian patients.PATIENTS & METHODS: 70 patients with anaplastic lymphoma kinase-positive crizotinib-refractory advanced non-small-cell lung cancer received ceritinib.RESULTS: Overall response was 40.6%, median progression-free survival was 8.2 months and median survival was 15.5 months. Dose reduction due to treatment-related adverse events occurred in 50.8% of patients starting at 750 mg/day. No significantly different progression-free survival was observed between patients who underwent any time dose reduction (n = 38) versus those who remained on the recommended dose of 750 mg/day (n = 32; p = 0.07).CONCLUSION: The efficacy of ceritinib compassionate use program resembled that of clinical trials. Dose reductions and adjustments did not appear to negatively affect clinical outcome.

AB - AIM: Ceritinib was evaluated within a compassionate use program of Italian patients.PATIENTS & METHODS: 70 patients with anaplastic lymphoma kinase-positive crizotinib-refractory advanced non-small-cell lung cancer received ceritinib.RESULTS: Overall response was 40.6%, median progression-free survival was 8.2 months and median survival was 15.5 months. Dose reduction due to treatment-related adverse events occurred in 50.8% of patients starting at 750 mg/day. No significantly different progression-free survival was observed between patients who underwent any time dose reduction (n = 38) versus those who remained on the recommended dose of 750 mg/day (n = 32; p = 0.07).CONCLUSION: The efficacy of ceritinib compassionate use program resembled that of clinical trials. Dose reductions and adjustments did not appear to negatively affect clinical outcome.

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