Abiraterone acetate (AA) is a potent, selective androge (CYP17) biosynthesis inhibitor, which showed to improve overall survival (HR = 0.646) in mCRPC patients progressing after docetaxel. In this retrospective analysis we assessed the safety and efficacy of AA in patients affected with mCRPC progressing after chemotherapy, treated in the normal clinical practice, in several Italian Oncologic Units, after the approval of the drug from the Italian Drug Agency (AIFA)

A., Giuli

A., Pellegrino

D., Santini

E. M., Ruggeri

E., Cortesi

F., Angelini

F., Longo

F., Primi

I., Sperduti

M. A., Fabbri

M. G., Chilelli

M. L., Mancini

Marchetti, Paolo

Milano, Annalisa

R., Ratta

S., Quadrini

T., Gamucci

English

M. A. Fabbri

E. Cortesi

MARCHETTI, PAOLO

D. Santini

T. Gamucci

F. Angelini

F. Longo

MILANO, ANNALISA

M. L. Mancini

A. Giuli

S. Quadrini

I. Sperduti

A. Pellegrino

R. Ratta

F. Primi

M. G. Chilelli

E. M. Ruggeri

Archivio della ricerca- Università di Roma La Sapienza

S490 Abstracts2543 POSTERWeekly cabazitaxel in “unfit” metastatic castration resistant prostatecancer patients (mCRPC) progressing after docetaxel (D) treatment.CABASEM-SOGUG phase II trialE.M. Fernandez Parra1, M. Ochoa2, D. Castellano15, L. Munielo3,M.J. Juan4, B. Perez Valderrama5, B. Mellado6, O. Fernandez Calvo7,U. Anido8, M. Domenech9, S. Hernando10, J.A. Arranz11, C. Caballero12,M. Campayo6, P. Estevez5, L. Leon13, M.A. Climent14. 1Hospital de Valme,Servicio de Oncologı´a Me´dica, Sevilla, Spain; 2Hospital Duran i Reynals,Servicio de Oncologı´a Me´dica, Barcelona, Spain; 3Complejo HospitalarioUniversitario de Santiago, Laboratorio de Oncologı´a Traslacional,Santiago de Compostela, Spain; 4Fundacio´n Instituto Valenciano deOncologı´a, Oncologı´a Me´dica, Valencia, Spain; 5Hospital UniversitarioVirgen del Rocı´o, Servicio de Oncologı´a Me´dica, Sevilla, Spain; 6HospitalClinic, Servicio de Oncologı´a Me´dica, Barcelona, Spain; 7ComplejoHospitalario de Ourense, Servicio de Oncologı´a Me´dica, Ourense,Spain; 8Hospital Clinico Universitario de Santiago, Servicio de Oncologı´aMe´dica, Santiago de Compostela, Spain; 9Hospital Althaia de Manresa,Servicio de Oncologı´a Me´dica, Barcelona, Spain; 10Hospital UniversitarioFundacio´n de Alcorco´n, Servicio de Oncologı´a Me´dica, Madrid, Spain;11Hospital General Universitario Gregorio Maran˜o´n, Servicio de Oncologı´aMe´dica, Madrid, Spain; 12Hospital General Universitario de Valencia,Servicio de Oncologı´a Me´dica, Valencia, Spain; 13Complexo HospitalarioUniversitario de Pontevedra, Servicio de Oncologı´a Me´dica, Pontevedra,Spain; 14Fundacio´n Instituto Valenciano de Oncologia, Oncologı´a Me´dica,Valencia, Spain; 15Hospital 12 de Octubre, Madrid, SpainBackground: Cabazitaxel (C), a novel taxane developed to overcome Dresistance, showed an overall survival improvement after D in mCRPC ina three-weekly schedule. Its main toxicity is hematological, especially inunfit patients (Pts). We aimed to evaluate efficacy and safety of weeklyC/prednisone (P) schedule in “unfit” mCRPC previously treated with D.Possible relation of CTC counts and its early response with efficacy isanalyzed.Methods: Pts with mCRPC progressing after D treatment with adequatebone marrow, liver and kidney functions were included in this open-labelnon-comparative trial. Unfit pts defined as ECOG 2, dose reduction due tofebrile neutropenia during D treatment or radiation therapy affecting morethan 25% of bone marrow reserve. C 10mg/m2 was administered on days1, 8, 15 and 22 of 5-week cycles with P (5mg b.i.d.). Radiological andPSA response were evaluated according to the PCWG2 criteria and toxicityaccording NCI-CTC AE.Results: 70 pts have been enrolled and 1 of them is still on treatment.Median age was 73 y (range 54−85), 71% pts had ECOG 2, 81% hadbone, 16% liver and 11% lung metastases. Treatment: 302 cycles (median:3; range: 1−14); 1116 weekly infusions (median 11; range 1−54). Mediandose intensity was 89%. Twenty-two of 59 pts (37.3%) achieve 50%PSA response and 7 (11.9%) 80% PSA response. Radiological responsewas evaluable in 62 pts. PR was observed in 4 pt (6.5%) and SDin 33 pts (53.2%). Median PSA PFS was 6.7 months and 12 weeksPSA PFS was 78.7%. Median OS was 12.6 months. Most frequenttoxicities of all grades and grade 3−4 as % of pts were: anemia (68.6–15.7%), asthenia (60.0–15.7%), thrombocytopenia (15.7−8.6%), diarrhea(35.7−1.4%), nauseas (27.1−1.4%), neutropenia (12.9−4.3%), peripheralneuropathy (8.6−0.0%), and anorexia (25.7−2.9%). Neither grade IVdiarrhea nor febrile neutropenia were observed.Sixteen pts had basal CTC <5 cells/7.5mL (A) and 40 5 cells/7.5mL (B).Ten pts had early CTC response (conversion from B to A at 4 weeks),1 CTC progression and 29 did not change CTC group. Results show afavorable association between basal CTC and PFS (median 10.5 (A) vs 4.6(B) months; p = 0.035). Association between basal CTC and OS (median14.6 (A) vs 10.9 (B) months; p = 0.088) and CTC early response and OS(median 17.9 (responders) vs 12.7 months (non-responders); p = 0.190)did not reached statistical significance.Conclusions: Weekly cabazitaxel plus P administered to unfit pts seemsas effective as 3-weekly standard treatment but with much lesser toxicity.Basal CTC seems to be related with PFS and OS.Funding by Sanofi. NCT01518283.No conflict of interest.2544 POSTERAbiraterone acetate in metastatic castration-resistant prostate cancerafter chemotherapy. A retrospective “Real Life” analysis of activityand safetyM.A. Fabbri1, E. Cortesi2, P. Marchetti3, D. Santini4, T. Gamucci5,F. Angelini6, F. Longo7, A. Milano3, M.L. Mancini2, A. Giuli7, S. Quadrini5,I. Sperduti8, A. Pellegrino9, R. Ratta4, F. Primi1, M.G. Chilelli1,E.M. Ruggeri1. 1Ospedale Belcolle, UOC Oncology, Viterbo, Italy;2Policlinico Umberto I, UOC Oncology B, Rome, Italy; 3OspedaleSant’Andrea, UOC Oncology, Rome, Italy; 4Campus Biomedico, UOCOncology, Rome, Italy; 5Ospedale SS Trinita`, UOC Oncology, Sora,Italy; 6Regina Apostolorum, UOC Oncology, Albano Laziale, Italy;7Policlinico Umberto I, UOC Oncology A, Rome, Italy; 8 Istituto ReginaElena, Biostatistics Unit, Rome, Italy; 9San PIetro FBF, UOC Oncology,Rome, ItalyBackground: Abiraterone acetate (AA) is a potent, selective androgen(CYP17) biosynthesis inhibitor, which showed to improve overall survival(HR = 0.646) in mCRPC patients progressing after docetaxel. In thisretrospective analysis we assessed the safety and efficacy of AA inpatients affected with mCRPC progressing after chemotherapy, treated inthe normal clinical practice, in several Italian Oncologic Units, after theapproval of the drug from the Italian Drug Agency (AIFA).Material and Methods: We retrospectively reviewed the clinical dataof patients affected with mCRCP progressive after chemotherapy whoreceived AA (1000mg/d) plus prednisone (5mg/twice daily). Pts wereconsidered eligible if they had received docetaxel as prior chemotherapy.A total of 189 patients were included in the analysis. Main patientcharacteristics were: median age: 70 years (range 44−89), Gleasonscore >7: 84%; median PSA at AA start: 35 (range 0.36–2100); duration ofprior hormonal therapy <12 vs 12 months: 38 vs 62%; no. of metastaticsites: 1 vs 2: 73 vs 27%; bone only 48%, presence of visceral disease51%; symptomatic vs non-symptomatic: 53 vs 47%; median number of priordocetaxel courses: 6 (range 1−15); second-line cabazitaxel: 14%. Forty-four percent of patients received bisphosphonates during AA treatment.Results: AA was well tolerated and no relevant toxicity were observed.After a median follow-up of 8.5 months (range 1−51) the medianprogression-free survival (PFS) and the median overall survival (OS) were10 months (95%CI: 7−13) and 26 months (95%CI: 17−35) respectively.No differences in PFS and OS were found based on the response todocetaxel. Patients who received hormonal treatment for 12 months hada statistically significant longer PFS (13 vs 7 months, p = 0.009) and OS(28 vs 17 months, p = 0.03 months). The median decrease in the PSA level>50% was observed in 36% of patients. Patients with only bone metastasishad a PFS of 13 (95%CI: 7.18) and OS 28 months (95%CI:16−40). Twelvepatients (6%) presented a scheletal-related event (SRE).Conclusions: The results achieved in this analysis although retrospective,confirms the activity and safety of AA in these subset of patients.No conflict of interest.2545 POSTERReal-world treatment with abiraterone acetate in metastaticcastration-resistant prostate cancer (mCRPC) patients in thepost-chemotherapy setting in EuropeL. Dearden1, P. Musingarimi1, N. Shalet1, D. Demuth2, L. Garcia Alvarez2,A. Muthutantri2, A. Venerus2, R. Lasry2, M. Hankins2, T. Maher3.1Janssen, EMEA HEMAR, High Wycombe, United Kingdom; 2IMS Health,Real World Evidence Solutions, London, United Kingdom; 3Janssen,Medical Affairs, High Wycombe, United KingdomBackground: In the COU-AA-301 trial, abiraterone acetate plus low doseprednisone (AA) was found to extend survival in metastatic castrateresistant prostate cancer (mCRPC) patients progressing after docetaxelchemotherapy compared to placebo plus low dose prednisone. However,limited data related to AA treatment and outcomes is available in thereal-world. The primary objective of this study was to evaluate treatmentduration associated with AA treatment in routine clinical practice in mCRPCpatients in the post-chemotherapy setting across four European countries:Belgium, France, Germany and the Netherlands. Other clinical data suchas treatment sequencing and survival were assessed to place the treatmentduration into context.Material and Methods: The study was designed as a retrospective chartreview. Patients were identified through treating oncologists and urologistsregistered in the IMS Health Medical Radar physician database. EligiblemCRPC patients were aged 18 years at AA initiation (i.e. baseline),previously treated with docetaxel and naı¨ve to prior AA treatment. Baselinepatient characteristics were described using summary statistics. Kaplan–

Abiraterone acetate in metastatic castration-resistant prostate cancer after chemotherapy. A retrospective “Real Life” analysis of activity and safety

https://iris.uniroma1.it/bitstream/11573/862090/1/Fabbri_%20Abstract-2544-Abiraterone_2015.pdf

Abiraterone acetate in metastatic castration-resistant prostate cancer after chemotherapy. A retrospective “Real Life” analysis of activity and safety

Abstract

Similar works

Full text

Available Versions

Archivio della ricerca- Università di Roma La Sapienza