863P - Non pegylated liposomal doxorubicin (npld, myocettm) + carboplatin (cb) in patients (pts) with ovarian cancer in late relapse (oclr): a phase 2 gin...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Ovarian Cancer
Presenter Benoît You
Citation Annals of Oncology (2016) 27 (6): 296-312. 10.1093/annonc/mdw374
Authors B. You1, F. Joly2, I.L. Ray-Coquard3, C. El Kouri4, A. Mercier-Blas5, D. Berton-Rigaud6, E. Kalbacher7, O. Cojocarasu8, M. Fabbro9, J. Cretin10, A. Zannetti11, S. Abadie-Lacourtoisie12, D. Mollon13, A. Hardy-Bessard14, M. Provansal15, G. Freyer1
  • 1Oncologie Médicale, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR
  • 2Oncologie, Centre Francois Baclesse, Caen/FR
  • 3Service 2b Nord, Centre Léon Bérard, Lyon/FR
  • 4Oncologie Médicale, Centre Catherine de Sienne, Nantes/FR
  • 5Oncologie Médicale, Centre Hospitalier Privé de Saint-Grégoire, Saint-Grégoire/FR
  • 6Oncology, ICO Centre René Gauducheau, Saint-Herblain/FR
  • 7Radiothérapie - Oncologie, CHU Besançon, Hôpital Jean Minjoz, Besançon/FR
  • 8Médecine Interne Et Oncologie Médicale, Pavillon Reilly, Centre Hospitalier Du Mans, 72037 - Le Mans/FR
  • 9Médecine B2, ICM Val d'Aurelle, Montpellier/FR
  • 10Oncologie - Radiothérapie, Polycliniques Kenval - Site Valdegour, Nimes/FR
  • 11Oncologie Médicale, CH Cholet, Cholet/FR
  • 12Oncologie Médicale, ICO Paul Papin, Angers/FR
  • 13Service Radiothérapie Et Oncologie Médicale, Centre Hospitalier Intercommunal de Cornouaille, Quimper/FR
  • 14Oncologie Médicale, Centre CARIO - HPCA, Plerin-sur-Mer/FR
  • 15Oncologie Médicale, Institute Paoli Calmettes, 13274 - Marseille/FR

Abstract

Background

Cb + pegylated liposomal doxorubicin (PLD) is standard in OCLR. Because of recurrent PLD shortage, we explored the efficacy and tolerance of Cb-NPLD

Methods

From 11/2012 to 07/2014, 86 pts with OCLR received Cb AUC 5 mg.min/ml and NPLD 50 mg/m2, day 1 q4weeks with prophylactic G-CSF support. Primary objective was disease control rate (DCR) at 12 mos. Disease progression was defined according to GCIG criteria including RECIST, CA125 or clinical deterioration.

Results

A total of 69 pts (80%) completed 6 cycles and 7 (9%) continued up to 9 cycles, with G-CSF support (96%). Pts characteristics were: median age 67 years (range 60-75); serous histology (90%); prior platinum (100%), taxane (94%) and bevacizumab (33%); platinum-free interval 6-12 (PFI) (44%) or > 12 mos (56%); 67 (78%) pts had 1 previous line of chemotherapy (CT) and 19 (22%) had 2. DCR at 12 mos was 40%. Median PFS was 11.4 mos (95% CI: 10.2-13.1). OS is not mature (33% events). Complete response rate was 21% and objective response rate was 58% (95% CI: 47-68), 49% (95% CI: 32-65) and 64% (95% CI: 50-78) in the global population, in pts with 6-12 or > 12 mos PFI, respectively. Grade (G) 3/4 neutropenia, thrombocytopenia and anemia were observed in 23, 13 and 11% respectively with febrile neutropenia in 6%. Non hematological toxicities were the followings: G3 fatigue (13%), nausea (8%), vomiting (6%), hand-foot syndrome (1%), pulmonary embolism (1%); G2 alopecia (39%). Junctional tachycardia (JT) in a pt with JT history was the only cardiac event observed. One pt who did not receive prophylactic G-CSF support died from febrile neutropenia.

Conclusions

Cb + NPLD is an alternative carboplatin-based regimen for OC in late relapse. Activity and toxicity profile are in the range of other regimens, but prophylactic G-CSF support is required.

Clinical trial identification

NCT01705158

Legal entity responsible for the study

ARCAGY-GINECO

Funding

Teva

Disclosure

F. Joly: For consulting or advisory role : Roche, Sanofi, Pfizer For Research funding : Astellas, Pfizer For travel, accomodations, expenses : Roche, Janssen, Novartis. I.L. Ray-Coquard: For consulting or advisory role: Pharmamar, Roche, AstraZeneca, MSD For travel, accomodations, expenses: Pharmamar, Roche. A-C. Hardy-Bessard: For Travel, accomodation, expenses: Astrazeneca, Novartis, Roche G. Freyer: For consulting or advisory role: Teva. All other authors have declared no conflicts of interest.