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Poster Display session 2

5472 - Early response evaluation and CEA response in patients treated in a Danish randomized study comparing trifluridine/tipiracil (TAS-102) with or without bevazicumab in patients with chemorefractory metastatic colorectal cancer (mCRC)

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Colon and Rectal Cancer

Presenters

Camilla Qvortrup

Citation

Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246

Authors

C. Qvortrup1, M. Yilmaz2, S. Möller3, D. Zitnjak4, L. Maltha1, M. Krogh5, L. Noergaard Petersen1, F. Hejlesen2, S.B. Winther5, K.G. Thomsen5, P. Pfeiffer5

Author affiliations

  • 1 Department Of Oncology, Rigshospitalet, University of Copenhagen, 2100 - Copenhagen/DK
  • 2 Department Of Oncology, Aalborg University Hospital, 9000 - Aalborg/DK
  • 3 Open Patient Data Explorative Network (open), Odense University Hospital, Odense/DK
  • 4 Department Of Oncology, Hospital of Southern Jutland, Soenderborg/DK
  • 5 Department Of Oncology, Odense University Hospital, 5000 - Odense C/DK

Resources

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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.

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