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
1049 - The Effect Of Multiple Interventions For Women At Risk For Cervical Cancer On Their Health Responsibility, Beliefs Regarding Cervical Cancer, And Having Screening: A Randomized Controlled Experiment
Presenter: Busra Altinel
Session: Poster Display session 2
Resources:
Abstract
1309 - Quantifying the Effects of the Korean National Cancer Screening Program on Cervical Cancer Mortality
Presenter: Nhung Bui
Session: Poster Display session 2
Resources:
Abstract
1346 - Spread of tumor and adverse events after modified radical hysterectomy for FIGO Stage IB1 cervical cancer patients with tumor diameter preoperatively estimated 2 cm or less: Japan Clinical Oncology Group trial (JCOG1101); exploratory analysis before primary analysis.
Presenter: Takahide Arimoto
Session: Poster Display session 2
Resources:
Abstract
5352 - Impact of Combined Interstitial and Intracavitary Brachytherapy in locally advanced Cervical cancer: A Survival and toxicity profile assessment
Presenter: Vibhay Pareek
Session: Poster Display session 2
Resources:
Abstract
2049 - Chemoradiotherapy response prediction model by proteomic expressional profiling in patients with locally advanced cervical cancer
Presenter: Chel Hun Choi
Session: Poster Display session 2
Resources:
Abstract
1923 - Disparities starting adjuvant chemotherapy for locally advanced cervix cancer in the international, academic, randomised, phase 3 OUTBACK trial (ANZGOG 0902, RTOG 1174, NRG 0274)
Presenter: Linda Mileshkin
Session: Poster Display session 2
Resources:
Abstract
3284 - Primary results from CECILIA, a global single-arm phase 2 study evaluating bevacizumab (BEV), carboplatin (C) and paclitaxel (P) for advanced cervical cancer (aCC)
Presenter: Andres Redondo
Session: Poster Display session 2
Resources:
Abstract
843 - Prognostic and clinicopathological significance of PD-L1 in patients with cervical cancer: a meta-analysis
Presenter: Xiaobin Gu
Session: Poster Display session 2
Resources:
Abstract
1020 - Clinical impact of molecular profiling of cervical cancer (CC) patients (pts) in a dedicated Phase I (P1) unit
Presenter: Mariana Scaranti
Session: Poster Display session 2
Resources:
Abstract
872 - Comparative proteomic profiles of cervical cancer and paried paracancerous tissue and the potential effects of DUSP7 over-expression through inhibiting RAS pathway on the biological characteristics of human cervical cancer cell line SIHA
Presenter: Xuan Jiang
Session: Poster Display session 2
Resources:
Abstract