Abstract 3139
Background
Aflibercept (Af) significantly improves progression-free (PFS) and overall survival (OS) when added to FOLFIRI, in the overall population of patients (pts) pretreated with oxaliplatin-based therapy. A subset analysis of pts (>65years) included in the VELOUR trial, suggests a consistent benefit in OS in PFS, but increased grade 3-4 toxicity. Our hypothesis was that selected pts >70y with good PS could benefit from FA, provided they underwent a careful monitoring of toxicity.
Methods
Retrospective, multicenter, observational study of mCRC pts >70 years (y) treated with FA as part of routine clinical practice at 8 hospitals from the Galician Research Group on Digestive Tumours (GITuD).
Results
From 338 patients treated with FA between June 2013 to November 2018, 75 pts were recorded. Median age was 72.7 y (range 70-84 y), and 33.4% were >75y. 65.3% were male, 87.5% ECOG PS0-1, 42.5 % left-sided location, 76.0 % low grade, 59.5% RASmt and 77.3 % primary tumor resection. Prior therapy included bevacizumab (56%) and anti-EGFR agents (24%), only adjuvant treatment (5.3%). Median of FA cycles was 10 (range 1-35 cycles). Overall Response Rate (ORR) and disease control rate (DCR) were 30.7% and 65.4%, respectively. With a median follow-up of 27.1 months (m), median PFS was 6.6 m (95% CI, 5.3-7.9 m) and median OS was 15.1 m (95% CI, 12.5-17.8 m). The most common grade 3-4 toxicities overall were asthenia (21.3%), neutropenia (14.7%) and diarrhoea (14.7%). Af-related toxicities were hypertension (5.3%), dysphonia (5.3%) and proteinuria (2.7%). Two patients experienced grade 5 toxicity.This toxicity was managed with dose reduction of Af in 34.7% of cases, dose reduction of FOLFIRI on 56.0% and discontinuation of Af in 18.6%.
Conclusions
Older patients with mCRC are underrepresented in clinical trials. The VELOUR study included only 6.4% pts >75y of age and only 14% included in the substudy of patients >65y were >75y. Patients >65y treated with FA in the VELOUR trial experienced a high rate of G3-4 adverse events (89.3%). Our series confirms that with careful pt selection and dose adjustment based on toxicity, patients >70y can be treated with FA with a 52.0% of grade 3-4 toxicity, results that are comparable to those of younger patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Galician Research Group on Digestive Tumours (GITuD).
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3879 - Efficacy of derazantinib (DZB) in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) expressing FGFR2-fusion or FGFR2 mutations/amplifications
Presenter: Michele Droz Dit Busset
Session: Poster Display session 2
Resources:
Abstract
4679 - It’s Not Only About Weight Loss: Tackling Pancreatic Cancer-Associated Cachexia
Presenter: Ana Leonor Matos
Session: Poster Display session 2
Resources:
Abstract
2276 - Frequency and clinicopathological characteristics of biliary tract carcinomas harboring the FGFR2-fusion gene: a prospective observational study (PRELUDE study)
Presenter: Masafumi Ikeda
Session: Poster Display session 2
Resources:
Abstract
2773 - Post-hoc analyses of a subgroup of patients with advanced biliary tract cancer (BTC) who crossed over to treatment with etoposide toniribate (EDO-S7.1) in a randomized Phase II study
Presenter: Ulrich-Frank Pape
Session: Poster Display session 2
Resources:
Abstract
4479 - Capecitabine +Best supportive care (BSC) or Erlotinib +BSC has Overall survival (OS) benefit over BSC alone in unresectable/metastatic Gall bladder cancer(GBC) patients with ECOG PS-III. Results from a phase II Randomised controlled trial (RCT)
Presenter: Babita Kataria
Session: Poster Display session 2
Resources:
Abstract
4843 - FGFR2 fusions and its effect of patient (pt) outcomes in intrahepatic cholangiocarcinoma (iCCA)
Presenter: Daniel Almquist
Session: Poster Display session 2
Resources:
Abstract
2324 - The Clinical Outcomes of Systemic Chemotherapy in Patients with Unresectable or Metastatic Combined Hepatocellular-cholangiocarcinoma (HCC-CCA): Retrospective Study of 120 Patients
Presenter: Eojin Kim
Session: Poster Display session 2
Resources:
Abstract
3678 - High PD-L1 expression is associated with treatment response to pembrolizumab in patients with advanced biliary tract cancer.
Presenter: Gilhyang Kim
Session: Poster Display session 2
Resources:
Abstract
3901 - Genomic profiling in Chinese biliary tract cancer patients with PI3K/AKT/mTOR pathway and RAS gene mutations
Presenter: Jingyu Cao
Session: Poster Display session 2
Resources:
Abstract
4390 - Phase II trial of trifluridine/tipiracil (TAS-102) in patients with advanced refractory biliary tract cancer (BTC)
Presenter: Sakti Chakrabarti
Session: Poster Display session 2
Resources:
Abstract