Resultados :
*.- 1 Paciente con Respuesta Completa .
*.- 3 Pacientes con Respuestas Parciales .
*.- 40 Pacientes Estabilizados .
La Tasa de Beneficio Clínico (CBR: CR + PR + SD) fue del 69.8% en General y del 71.05% en Pacientes con Cáncer de Ovario.
16 September 2018 . |
| PHASE II STUDY TO EVALUATE THE EFFICACY, TOLERABILITY, AND BIOMARKERS OF PM01183 WITH OLAPARIB IN PATIENTS WITH ADVANCED a TUMORS. |
| Background and Aims:PM01183 (Lurbinectedin) is a new anticancer drug that inhibits trans-activated transcription and modulates tumor microenvironment. Olaparib (AZD2281), is a PARP inhibitor with proven efficacy in homologous recombination deficient tumors. The combination of PM01183 and olaparib in short course has been previously evaluated in patients with metastatic solid tumors showing to be feasible. Methods:This study evaluates the efficacy of PM1183 1.5 mg/m2 iv d1 in combination with short course of Olaparib tablets 250 mg BID on d1-5 in 21-day cycle in patients with a relapsed high-grade serous or endometroid platinum resistant ovarian -not refractory-, fallopian tube or primary peritoneal cancer, endometrial cancer or triple negative breast cancer. Primary endpoint: Response Rate (RR). Secondary endpoints: Progression and overall survival, pharmacokinetic safety and a translational study to evaluate the predictive and prognostic significance of different biomarkers. Results:63 patients were enrolled from 15/03/2017 to 19/12/2017. With a median age of 65 years. a median number of 3 prior lines, the most frequent tumor type was ovarian (60%) followed by endometrial (31%). Best response (R) at 12 weeks includes one complete (CR) ; 3 partial (PR) and 40 stabilizations (SD). The clinical benefit rate (CBR: CR+PR+SD) was 69.8% overall and 71.05% in patients with ovarian cancer. At the moment of the data cutoff, 20 SAEs were reported, no toxic death was seen and only one patient withdrew treatment. Conclusions:PM01183 and Olaparib short course showed an interesting efficacy in the entire population, with a good safety profile. |
| Co-authors |
| P. Andres 1, O. Ana 2, R. Andres 3, R. Maria Jesus 4, G. Eva 5, D.J. Ana 6, R. Victor 2, G. Alejandro 3, S. Raquel 4, C. Alfonso 5, F.M. Lorena 2, M. Pedro 7, I. Romero 1 1Instituto Valenciano de Oncología, Clinical Area Gynecologic Oncology, Valencia, Spain 2Vall Hebron Institute Oncology, Medical Oncology, Barcelona, Spain 3Hospital La Paz, Medical Oncology, Madrid, Spain 4Hospital Reina Sofia, Medical Oncology, Cordoba, Spain 5Hospital Ramon y Cajal, Medical Oncology, Madrid, Spain 6Hospital Marques de Valdecilla, Medical Oncology, Santander, Spain 7Instituto Valenciano de Oncología, Clinical trial Department, Valencia, Spain |