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
5134 - Early prediction of the platinum-resistant relapse risk using the CA125 modeled kinetic parameter KELIM: a pooled analysis of AGO-OVAR 7 & 9; ICON 7 (AGO/GINECO/ MRC CTU/GCIG trials).
Presenter: OLIVIER COLOMBAN
Session: Poster Display session 2
Resources:
Abstract
4410 - Mirvetuximab soravtansine, a folate receptor alpha (FRa)-targeting antibody-drug conjugate (ADC), in combination with carboplatin and bevacizumab: Initial results from a Phase 1b study in patients (pts) with ovarian cancer
Presenter: David Omalley
Session: Poster Display session 2
Resources:
Abstract
5077 - Response to Pegylated Liposomal Doxorubicin (PLD) and Weekly Paclitaxel (wpac) in Platinum Resistant (PR) Ovarian Cancer (OC) by BRCA mutation status
Presenter: Louise Bremer
Session: Poster Display session 2
Resources:
Abstract
3483 - Impact of prior pegylated liposomal doxorubicin (PLD) treatment in recurrent ovarian cancer (ROC): Sub-group analysis from a randomized, open-label study comparing trabectedin (T) and PLD versus PLD alone in ROC (ET743-OVC-3006)
Presenter: Bradley Monk
Session: Poster Display session 2
Resources:
Abstract
5423 - OCTAVE - A phase I study of enadenotucirev, an oncolytic group B adenovirus, in combination with weekly paclitaxel in platinum-resistant epithelial ovarian cancer
Presenter: Iain McNeish
Session: Poster Display session 2
Resources:
Abstract
1385 - Phase I study of low dose whole abdominal radiation therapy (LDWART) in combination with weekly paclitaxel (wP) for platinum resistant ovarian cancer (PROC)
Presenter: Natalie Ngoi
Session: Poster Display session 2
Resources:
Abstract
2090 - Phase 1b/2a study assessing the safety and efficacy of adding AL3818 (Anlotinib) to standard platinum-based chemotherapy in subjects with recurrent or metastatic endometrial, ovarian or cervical carcinoma
Presenter: David Miller
Session: Poster Display session 2
Resources:
Abstract
1960 - Phase I Study of Intraperitoneal TRX-E-002-1 in Subjects with Persistent or Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer: Three-month Follow-up Results of the Dose Escalation Phase
Presenter: Jermaine Coward
Session: Poster Display session 2
Resources:
Abstract
4288 - Hybrid capture-based genomic profiling of circulating tumor DNA (ctDNA) from patients with ovarian cancer
Presenter: Mi Yang
Session: Poster Display session 2
Resources:
Abstract
3433 - Tumor Microvessel Density for predicting Nintedanib activity: data from the randomized CHIVA trial (a GINECO study)
Presenter: Maud Villemin
Session: Poster Display session 2
Resources:
Abstract