University Hospital A Coruña, A Coruña, Spain;
Nieves P. Martinez-Lago , Beatriz Alonso de Castro , Cristina Reboredo Rendo , Teresa Calleja , Martín Igor Gómez-Randulfe Rodríguez , Sofia Silva Diaz , Iria Parajó Vázquez , Maria Mateos Salvador , Fernando Busto Fernandez , Begona Grana Suarez , Juan De la camara , Margarita Reboredo Lopez
Background: TASBEV, compared with TAS-102, was associated with an improvement in progression-free survival (PFS) with tolerable toxicity in a randomized, open-label phase 2 trial. However, the subgroups of patients who may benefit from long-term TASBEV treatment are unknown. Methods: We conducted a retrospective, observational study of patients (pts) with mCRC refractory or intolerant to standard therapies treated with TAS-102 30-35 mg/m2 twice daily on days 1–5 and 8–12 every 28 days plus BEV 5 mg/kg on days 1 and 15 at University Hospital a Coruña (Spain). Results: We recorded 47 pts treated between July 2019 to June 2022. Median age was 65 years (range 41 – 82 years), 78.7% ECOG PS0-1, 51.1% RASmt, 78.7% of pts had liver and 23.4%, peritoneal metastases; 29.8% time since diagnosis of 1st metastases <18 months and 57.4% poor prognostic Tabernero Subgroup. Previous treatment included 94.3% previous antiVEGF treatment and 74.5% received TAS-102 BEV as 3rd line of treatment. Median of cycles received was 4 (range 1-15 cycles). ORR and DCR were 2.4% and 48.8%, respectively. With a median follow up of 15.7 months, median PFS was 4.3 months (95% CI, 3.4-5.1 months) and median OS was 9.8 months (95% CI, 7.3-12.3 months). Univariate analysis of prognostic factors for progression-free and overall survival are listed in the table. Conclusions: In our series identified that Tabernero's prognostic subgroups or the development of grade 3-4 neutropenia during treatment, among others; identify patients who may benefit from long-term TASBEV treatment.
Characteristic | PFS, months | HR (95% CI)a | p-valuea | OS, months | HR (95% CI)a | p-valuea |
---|---|---|---|---|---|---|
Metastatic sites | ||||||
< 3 | 7.9 | 2.206 (1.1–4.3) | 0.016 | 17.7 | 3.615 (1.5–8.5) | 0.002 |
> 3 | 3.0 | – | – | 8.1 | – | – |
Liver metastases | ||||||
No | 8.4 | 0.473 (0.2–1.1) | 0.085 | 17.7 | 0.608 (0.2–1.8) | 0.357 |
Yes | 4.0 | – | – | 9.8 | – | – |
Peritoneal metastases | ||||||
No | 5.1 | 0.336 (0.2–0.7) | 0.003 | 11.1 | 0.350 (0.2–0.8) | 0.009 |
Yes | 2.5 | – | – | 6.2 | – | – |
Time from metastatic disease diagnosis | ||||||
> 18 months | 4.3 | 0.995 (0.5–2.0) | 0.901 | 10.6 | 1.915 (0.9–4.2) | 0.103 |
< 18 months | 4.0 | – | – | 8.5 | – | – |
Tabernero prognostic classification | ||||||
Best | 10.0 | – | 0.021 | NR | – | <0.001 |
Good | 7.9 | – | – | 19.1 | – | – |
Poor | 3.3 | – | – | 7.7 | – | – |
Neutropenia during treatment | ||||||
Grade 1-2 | 4.0 | 2.353 (1.2-4.7) | 0.014 | 8.1 | 2.578 (1.1-5.8) | 0.018 |
Grade 3-4 | 7.9 | 11.5 |
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