Real-world effectiveness and safety of trifluridine-tipiracil (FTD/TPI) and bevacizumab (BEV) in refractory metastatic colorectal cancer (mCRC): The BeTAS trial.

Authors

null

Nieves Martinez Lago

Complexo Hospitalario Universitario de Ferrol, Ferrol, Spain

Nieves Martinez Lago , Borja Gonzalez , Elena Gallardo Martin , Ana Fernandez Montes , Antia Cousillas Castiñeira , Begona Grana Suarez , Alberto Carral Maseda , Maria Luz Pellon Augusto , Paula Gonzalez Villarroel , Juan De La Camara Gomez , Mercedes Salgado Fernández , Margarita Reboredo Lopez

Organizations

Complexo Hospitalario Universitario de Ferrol, Ferrol, Spain, Hospital Universitario Lucus Augusti, Lugo, Spain, Alvaro Cunqueiro Hospital, Vigo, Spain, Department of Medical Oncology. Complexo Hospitalario Universitario de Ourense (CHUO), Ourense, Spain, Medical Oncology Department-Complejo Hospitalario de Pontevedra, Pontevedra, Spain, University Hospital A Coruña, A Coruña, Spain, Medical Oncology Department, Hospital Universitario Lucus Augusti, Lugo, Spain, Complexo Hospitalario Universitario de Ourense, Ourense, Spain

Research Funding

No funding sources reported

Background: In the Sunlight Trial, the combination of FTD/TPI + BEV demonstrated significantly extended Overall Survival (OS) and Progression-Free Survival (PFS), along with an improved Disease Control Rate (DCR), compared to FTD/TPI alone in patients with refractory mCRC. The BeTAS trial aimed to evaluate the real-world effectiveness and safety of the FTD/TPI + BEV combination in patients with refractory mCRC. Methods: We conducted a multicenter, retrospective, observational study involving patients with mCRC who were refractory or intolerant to standard therapies (including oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF, and anti-EGFR if RAS/BRAF wild-type) and were treated with FTD/TPI + BEV at six university hospitals affiliated with the Galician Research Group on Digestive Tumors (GiTUD) in Northwest Spain. Results: A total of 110 patients were enrolled in the BeTAS trial between July 2019 and August 2023. The median age was 66 years (range 33-88 years), with 62.7% being male. Notably, 18.2% of patients had an ECOG performance status of 2, 50.9% had RAS mutations, 27.3% had three or more metastatic locations, and 72.7% had liver metastases. Additionally, 26.4% had a time since the diagnosis of the first metastases of less than 18 months, and 46.4% were categorized as the poor prognostic Tabernero´s Subgroup. Most patients (77.3%) received FTD/TPI + BEV as a third-line treatment, with 88.9% having received previous anti-VEGF therapy. Notably, 13.6% received FTD/TPI at a dose of 30 mg/m2, and 6.4% received prophylactic GCSF. The median number of cycles received was 4 (range 1-21 cycles). Among 97 evaluable patients, the overall response rate (ORR) was 2.1%, and the disease control rate (DCR) was 46.4%. With a median follow-up of 15.5 months, the median PFS was 4.2 months (95% CI, 3.5-4.9 months), and the median OS was 9.9 months (95% CI, 7.3 - 12.5 months). The most common grade 3-4 toxicities included neutropenia (41.8%), asthenia (7.3%), and hepatic toxicity (5.5%). No treatment-related deaths were reported. Conclusions: The BeTAS trial findings affirm the real-world effectiveness and safety of FTD/TPI + BEV in the context of routine clinical practice, even in a population with a poor prognosis and extensive prior treatment history.

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Abstract Details

Meeting

2024 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Colorectal Cancer,Anal Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Citation

J Clin Oncol 42, 2024 (suppl 3; abstr 51)

DOI

10.1200/JCO.2024.42.3_suppl.51

Abstract #

51

Poster Bd #

D14

Abstract Disclosures