Bosutinib Apears to be Safe, with Low Cross Intolerance, in Patients Treated in 4th Line. Results of the Spanish Compassionate Use Program

Autor: Maria del Carmen García Garay, Concepción Ruiz, Alejandra Martinez-Trillo, Andrés Romo Collado, Ana Iglesias Pérez, María José Sánchez, Isabel Mata, Jose Luis Lopez Lorenzo, Guiomar Bautista, Juan Luis Steegmann, Beatriz Cuevas, Ana Sebrango, Alberto Alvarez, Guillermo Deben, Fernando Ortega, Esperanza Romero, Concepción Boqué, Maria Luisa Martin Mateos, Sandra Valencia, Angeles Fernandez, Angeles Portero, Pilar Giraldo, Sabela Bobillo, Natalia de las Heras, José Tallón, José María Guinea, Valentín García-Gutiérrez, Begoña Maestro
Rok vydání: 2014
Předmět:
Zdroj: Blood. 124:5523-5523
ISSN: 1528-0020
0006-4971
DOI: 10.1182/blood.v124.21.5523.5523
Popis: Second-generation TKIs have demonstrated efficacy and an acceptable tolerability in patients (pts) with chronic myeloid leukemia (CML); however, new data from so called “off target” side effects have been published. For example, serious concerns have been raised about cardiovascular (CV) events with ponatinib, and, in lesser degree with nilotinib (NI), impeding or difficulting the treatment in patients with previous CV risk factors. Besides, patients with previous history of pleural effusion or pulmonary hypertension should avoid dasatinib (DA) if possible. Bosutinib could be a good candidate for situations which preclude the use of other TKI’s. We have previously presented efficacy data of 29 patients treated with bosutinib in forth line. The aim of this study is to report safety data of heavily CML patients treated with bosutinib in 4th line. We have studied 30 pts previously treated with imatinib (IM), dasatinib and nilotinib and 5 pts previously treated with IM-DA or NI since 2012 under the Spanish Compassionate Use Program. Patient’s baseline characteristics and previous treatments are shown in table 1. We have classified patients in 2 groups regarding to investigator-driven cause of discontinuation: intolerant (INT) or resistant (RES). At the data cutoff on June 16, 2014, the median follow up was 11.47 months (range, 2.03-45.97 months). Median duration of BOS treatment across all cohorts was 9.23 months (range, 0.63-23.40 months). We observed no significant differences in terms of Index prognostic factors (Sokal, Hasford or Eutos), sex, median duration of TKIs treatment or comorbidities. However, patients with resistance where significantly older observed: 56 years vs. 67 years (p
Databáze: OpenAIRE
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