Abstract 3524
Background
Cabazitaxel (CAB) was marketed in 2012 in Italy, based on overall survival (OS) benefit demonstrated on the TROPIC study in mCRPC post-docetaxel. The efficacy and tolerability of CAB is overlapping in all age groups, though for very elderly patients (pts) it has never really been verified.
Methods
We conducted a retrospective, observational real-life study in 57 octogenarian pts, treated with CAB in eleven Italian cancer centers from 2012 to 2018. Feasibility of treatment has been investigated by duration of treatment and its tolerability. Duration of treatment and toxicity profile were also evaluated according to ≥ 85 years, ECOG performance status (PS) ≥ 2 and comprehensive geriatric assessment (CGA) questionnaire.
Results
This retrospective cohort included 57 mCRPC pts (median age 83.5 years; 21% aged over 85 years), 24% with exclusive bone metastatic disease, 50% with high-volume bone disease, 15% with high volume bone disease and visceral disease. Thirty-nine (68%) received the CGA questionnaire assessment, 34 resulted fit and 5 vulnerable. Ten (14%) had an ECOG PS ≥ 2, 9% received CAB as second-line, 23 (40%) as third-line, 29 (51%) as forth or more line. CAB was administered at 25 mg/sqm in 30 (52%) pts, and 20 mg/sqm or adapted schedules in 27 (48%). These latter schedules were adopted mainly in the subgroups with age > 85 years (75%), PS ≥ 2 (87.5%) and vulnerable according CGA questionnaires (100%). The median duration of treatment with CAB in all pts was 4.8 months, range 1-19 months (mo); 4.5 mo in those aged > 85 years, 4.4 mo in the vulnerable pts and 3.5 mo in pts with PS ≥ 2. The most represented grade 3-4 toxicity in the whole cohort were neutropenia (14%) and diarrhea (10.5%). Six patients (10.5%) drop out the treatment for significant toxicities: 3 febrile neutropenia G4, 2 diarrhea G4 and 1 severe cardiotoxicity, 5 (83%) of these pts received the 25 mg/sqm schedule, and 4 pts (67%) aged between 80-84 yeras with ECOG PS = 0 did not performed the CGA assessment before treatment. One death due to intestinal perforation non-clearly treatment-related was reported.
Conclusions
Octogenarian patients may be treated with CAB with the 20 mg/sqm regimen associated with less treatment interruptions. The CGA could contribute to better select pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5043 - Comprehensive results of a Phase Ib study with a HER2/neu B-cell peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy show safety, immunogenicity and clinical response in patients with HER2/Neu overexpressing advanced gastric cancer
Presenter: Ursula Wiedermann
Session: Poster Display session 3
Resources:
Abstract
4506 - Single intravenous preoperative administration of the oncolytic virus Pexa-Vec to prime anti-tumor immunity
Presenter: Adel Samson
Session: Poster Display session 3
Resources:
Abstract
1631 - Randomized phase 2 clinical trial of NY-ESO-1 protein vaccine combined with cholesteryl pullulan (CHP-NY-ESO-1) in resected esophageal cancer patients
Presenter: Shinichi Kageyama
Session: Poster Display session 3
Resources:
Abstract
4244 - T cell repertoire sequencing reveals dynamics of response to dendritic cell vaccine plus dasatinib for checkpoint blockade resistant metastatic melanoma
Presenter: Luca Quagliata
Session: Poster Display session 3
Resources:
Abstract
5791 - Ixovex, a novel oncolytic E1B-mutated adenovirus
Presenter: Mohiemen Anwar
Session: Poster Display session 3
Resources:
Abstract
4170 - Anti-CSPG4 DNA vaccination as a promising strategy for the treatment of CSPG4+ tumors: a comparative oncology trial
Presenter: Federica Riccardo
Session: Poster Display session 3
Resources:
Abstract
5780 - Antitumor activity, immunogenicity and safety of a novel PD-1 vaccine in combination with two chimeric HER-2 peptide vaccine in syngeneic Balb/c, C57Bl/6 models and in beagle dogs
Presenter: Pravin Kaumaya
Session: Poster Display session 3
Resources:
Abstract
5860 - Maternal immunization against ALK as a weapon to fight neuroblastoma
Presenter: Giuseppina Barutello
Session: Poster Display session 3
Resources:
Abstract
4720 - Phase 1 study evaluating safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-428, first-in-class mesothelin (MSLN)-CD40 bispecific, in patients (pts) with advanced solid tumors
Presenter: Jason Luke
Session: Poster Display session 3
Resources:
Abstract
5717 - Anti-PD-L1/IL-15 fusion protein generates robust adaptive immune gene signatures in tumors leading to tumor inhibition and memory responses
Presenter: Stella Martomo
Session: Poster Display session 3
Resources:
Abstract