Meeting
2023 ASCO Annual Meeting
Trifluridine/tipiracil (FTD/TPI) in extensively pre-treated metastatic colorectal cancer (mCRC) patients: Evaluation of prognostic subgroups of the TALLISUR study.
Authors
Meinolf Karthaus
Department of Hematology and Oncology, Munich Hospital Neuperlach, Munich, Germany
Meinolf Karthaus , Lena Weiss , Jorge Riera-Knorrenschild , Albrecht Kretzschmar , Manfred Welslau , Ursula Vehling-Kaiser , Henning Pelz , Thomas Jens Ettrich , Swantje Held , Linde Kehrmann , Juergen Hess , Timo Reislaender , Volker Heinemann
Organizations
Department of Hematology and Oncology, Munich Hospital Neuperlach, Munich, Germany, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany, Universitätsklinikum Marburg, Klinik für Innere Medizin, Marburg, Germany, Hematology and Oncology Practice MVZ Mitte, Leipzig and Zentrum für Integrative Onkologie, Glarus, Switzerland, Leipzig, Germany, Praxis Aschaffenburg, Aschaffenburg, Germany, Praxis Vehling-Kaiser, Landshut, Germany, Ambulantes Therapiezentrum fuer Haematologie und Onkologie, Offenburg, Germany, Ulm University, Ulm, Germany, Clinassess Inc., Leverkusen, Germany, Servier, Munich, Germany, Servier Deutschland GmbH, München, Germany, University of Munich, Munich, Germany
Research Funding
Pharmaceutical/Biotech Company
Servier
Background: Compared to placebo, FTD/TPI significantly improved overall survival (OS) in patients (pts) with pre-treated mCRC in the pivotal phase III RECOURSE trial. Subgroup analyses indicated that all subgroups benefitted from FTD/TPI. Of note, FTD/TPI prolonged survival even more in pts ≥ 65 years old. To evaluate these observations with data from daily clinical practice, we performed a subgroup analysis of the TALLISUR study. Methods: In this prospective, multi-center, German, open-label, phase IV study, pts with extensively pre-treated mCRC chose between best supportive care (BSC) or oral FTD/TPI (35 mg/m2bid on days 1 – 5 and 8 – 12 of each 28-day cycle). Duration of treatment and OS were analyzed for various subgroups. Based on a post-hoc analysis of the RECOURSE trial, 3 subgroups were defined according to: best, good and poor prognostic characteristics (BPC, GPC, PPC). Pts with < 3 metastatic sites at inclusion and ≥ 18 months from diagnosis to inclusion were considered to have GPC. GPC pts without liver metastasis at inclusion were considered to have BPC. All remaining pts were considered to have PPC. Results: Of 195 eligible pts, 186 pts chose treatment with FTD/TPI, while 9 pts decided to receive BSC only. Median OS was 6.9 (95% CI 6.1 – 8.3) months. Mean duration of treatment with FTD/TPI was 14.6 (range 0.1 – 102.7) weeks. Results of the subgroup analysis are summarized in the table. Pts ≥ 65 years old presented a longer median OS (7.2 vs 6.2 months). Conclusions: When given the choice between treatment and BSC in late-stage CRC, the vast majority of pts opted for treatment. Low metastatic burden and indolent disease were factors of good prognosis for FTD/TPI therapy regarding OS. Independent of baseline characteristics such as age, sidedness, and time of onset of metastases, virtually all pts benefitted from therapy with FTD/TPI. Albeit not statistically significant, elderly pts tend to have improved survival with FTD/TPI, consistent with results from RECOURSE. Clinical trial registration number: EudraCT No 2017-000292-83.
| Subgroup | Median OS (95% CI) [months] | Mean duration of treatment (range) [weeks] |
|---|---|---|
| BPC (n = 20) | 12.2 (6.0 – 18.2) | 16.3 (0.4 – 83.7) |
| GPC (n = 65) | 7.9 (6.2 – 13.3) | 15.1 (0.4 – 102.7) |
| PPC (n = 121) | 6.8 (5.4 – 8.1) | 14.3 (0.1 – 102.7) |
| Age < 65 years (n = 74) | 6.2 (4.8 – 8.6) | 13.7 (0.1 – 102.7) |
| Age ≥ 65 years (n = 112) | 7.2 (6.3 –11.1) | 15.2 (0.7 – 102.7) |
| Synchronous metastases (n = 102) | 6.9 (6.2 – 10.1) | 12.4 (0.1 – 72.7) |
| Metachronous metastases (n = 63) | 7.3 (5.3 – 12.4) | 16.8 (1.3 – 102.7) |
| Left sided tumor (n = 138) | 6.8 (6.0 – 8.3) | 13.9 (0.1 – 102.7) |
| Right sided tumor (n = 42) | 8.1 (5.9 – 12.8) | 16.9 (0.4 – 72.7) |
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Abstract Details
Session Type
Poster Session
Session Title
Gastrointestinal Cancer—Colorectal and Anal
Track
Gastrointestinal Cancer—Colorectal and Anal
Sub Track
Colorectal Cancer–Advanced Disease
Clinical Trial Registration Number
EudraCT No 2017-000292-83
Citation
J Clin Oncol 41, 2023 (suppl 16; abstr 3556)
DOI
10.1200/JCO.2023.41.16_suppl.3556
Abstract #
3556
Poster Bd #
256
Abstract Disclosures
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