Abstract 5472
Background
Trifluridine/tipiracil (FTD/TPI, also known as TAS-102) prolongs OS in patients with chemorefractory mCRC. Inspired by the results of C-TASK FORCE (Kuboki 2017), we designed an investigator-initiated randomized trial in the last setting in mCRC patients demonstrating improved PFS and OS in patients receiving bevazicumab combined with TAS-102 as compared to patients treated with TAS-102 alone (Pfeiffer WCGI 2019). In the last line setting half of patients will not benefit from therapy as they have PD at the first evaluation performed after 2 months of therapy. In the present study we included an early response evaluation after 1 month of therapy aiming to identify patients not having any effect of therapy. In addition, we evaluated plasma CEA as a marker of response.
Methods
The main inclusion criteria were: histologically confirmed and chemo-refractory mCRC; PD during or after therapy with FU, irinotecan, oxaliplatin, and EGFR-inhibitor (RASwt); prior treatment with bevacizumab was allowed; PS 0-1. In arm A: FTD/TPI 35 mg/m²/dose bid from days 1-5 and 8-12; in arm B the same dose of FTD/TPI with bevacizumab (5 mg/kg), days 1 and 15 of a 28-day cycle. Response evaluation performed during treatment at 4 weeks, 8 weeks, and every 8 weeks thereafter. CEA was tested at baseline and at every 2. cycle.
Results
93 patients with chemo-refractory mCRC were randomized from Sep. 2017 to Oct. 2018. The median PFS was significantly improved from 2.6 months (arm A) to 4.6 months (arm B) with a HR 0.45 (95% CI, 0.29-0.72; P = 0.001). Median OS was significantly prolonged from 6.7 months (arm A) to 9.4 months (arm B) with HR 0.55 (95% CI, 0.32-0.94; P = 0.03) (Pfeiffer WCGI 2019). Sub-group analyses including predictive markers for early progression will presented.
Conclusions
FTD/TPI in combination with bevacizumab prolong PFS and OS and is a new option in patients with chemo-refractory mCRC. Predictive markers for early progression are ongoing and will be presented.
Clinical trial identification
2016-005241-23.
Editorial acknowledgement
Legal entity responsible for the study
Per Pfeiffer.
Funding
Servier.
Disclosure
C. Qvortrup: Research grant / Funding (institution): Servier. P. Pfeiffer: Research grant / Funding (institution): Servier; Research grant / Funding (institution): Merck. All other authors have declared no conflicts of interest.
Resources from the same session
5124 - STAR_PAC: Phase I clinical trial repurposing all trans retinoic acid (ATRA) as stromal targeting agent in a novel drug combination for pancreatic cancer.
Presenter: Hemant Kocher
Session: Poster Display session 2
Resources:
Abstract
5257 - Outcomes of First Line FOLFIRINOX (FFX) Versus Gemcitabine and Nab-Paclitaxel (GN) in Patients with Advanced Pancreatic Cancer: Multi-Institutional Canadian Sites Experience
Presenter: Neha Papneja
Session: Poster Display session 2
Resources:
Abstract
1166 - Effect of prior cancer on survival outcomes for patients with pancreatic adenocarcinoma
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1169 - Association of combination of irreversible electroporation ablation and chemotherapy with outcomes of locally advanced pancreatic cancer: a large cohort study
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1222 - Results from phase I study of the oncolytic viral immunotherapy agent Canerpaturev (C-REV) in combination with gemcitabine plus nab-paclitaxel as first-line treatment of unresectable pancreatic cancer
Presenter: Yusuke Hashimoto
Session: Poster Display session 2
Resources:
Abstract
1698 - Multicenter retrospective study of gemcitabine plus nab-paclitaxel for elderly patients with advanced pancreatic cancer
Presenter: Masato Ozaka
Session: Poster Display session 2
Resources:
Abstract
2424 - Irinotecan Combined with Oxaliplatin and S1 in Patients with Metastatic Pancreatic Adenocarcinoma
Presenter: Keke Nie
Session: Poster Display session 2
Resources:
Abstract
2885 - Cancer-associated thrombosis in patients with pancreatic cancer and its correlation with plasma tissue factor level: A Japanese prospective cohort study
Presenter: Satoshi Kobayashi
Session: Poster Display session 2
Resources:
Abstract
3702 - A Phase I/Ib, multi-center trial of ARQ-761 (Beta-Lapachone) with gemcitabine/nab-Paclitaxel in patients with advanced pancreatic cancer
Presenter: Muhammad Beg
Session: Poster Display session 2
Resources:
Abstract
5185 - Systemic administration of the hyaluronidase-expressing oncolytic adenovirus VCN-01 in patients with advanced or metastatic pancreatic cancer: first-in-human clinical trial
Presenter: Rocio Garcia-Carbonero
Session: Poster Display session 2
Resources:
Abstract