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
2670 - Molecular subtypes of metastatic(met) gastric cancer(GC) (MoTriGastric): new biomarkers closer to the clinics
Presenter: Maria Alsina Maqueda
Session: Poster Display session 2
Resources:
Abstract
3797 - Exploring candidate signal transduction pathways for targeted therapy in esophageal cancer
Presenter: Aafke Creemers
Session: Poster Display session 2
Resources:
Abstract
5485 - Clinical implication of CLDN18, RhoGAP, and E-cadherin in gastric signet ring cell carcinoma
Presenter: Hyunho Kim
Session: Poster Display session 2
Resources:
Abstract
1970 - Identification of a spectrum of germline mutations for hereditary diffuse gastric cancer in the Russian population by next-generation sequencing.
Presenter: IRINA EFIMOVA
Session: Poster Display session 2
Resources:
Abstract
4989 - The molecular profiling and prognostic value of Chinese gastric signet ring cell carcinoma patients
Presenter: Jia Wei
Session: Poster Display session 2
Resources:
Abstract
7145 - A phase 2 basket study of MCLA-128, a bispecific antibody targeting the HER3 pathway, in NRG1 fusion-positive advanced solid tumors
Presenter: Alison Schram
Session: Poster Display session 2
Resources:
Abstract
1406 - Simultaneous Resection of Pancreatic Cancer and Liver Oligometastases After Induction Chemotherapy in Stage IV Patients:an Open-Label Prospective Randomized Multicenter phase 3 trial(CSPAC-1)
Presenter: Miaoyan Wei
Session: Poster Display session 2
Resources:
Abstract
1530 - Multicenter randomized phase II trial of 5-Fluorouracil/leucovorin (5-FU/LV) with or without liposomal irinotecan (nal-IRI) in metastatic biliary tract cancer (BTC) as second-line therapy after progression on gemcitabine plus cisplatin (GemCis): NIFTY trial
Presenter: Changhoon Yoo
Session: Poster Display session 2
Resources:
Abstract
1563 - A randomized phase II study of Maintenance therapy with multiepitope vaccine Tedopi (OSE2101) ± nivolumab or FOLFIRI after induction chemotherapy (CT) with FOLFIRINOX in patients (Pts) with advanced Pancreatic ductal adenocarcinoma (aPDAC) (TEDOPaM – PRODIGE 63 GERCOR study)
Presenter: Cindy Neuzillet
Session: Poster Display session 2
Resources:
Abstract
2780 - A phase 3, randomized, double-blind, placebo-controlled, international study of durvalumab in combination with gemcitabine plus cisplatin for patients with advanced biliary tract cancers: TOPAZ-1
Presenter: Do-Youn Oh
Session: Poster Display session 2
Resources:
Abstract