Reina Sofia Hospital, University of Cordoba, Maimonides Institute of Biomedical Research, Spanish Cancer Network, Instituto de Salud Carlos III, Cordoba, Spain
A. Gomez , Jose María Vieitez , Silvia Gil , Antonieta Salud Salvia , Begoña Graña Suárez , Pilar Garcia Alfonso , Eva Martínez de Castro , Guillermo Alfonso Quintero Aldana , Juan J Reina , Encarnación González Flores , Mercedes Salgado Fernández , Mercedes Rodríguez Garrote , Ma. José Flor Oncala , Maria Jose Safont , Adelaida La Casta Munoa , Rafael Lopez , Guillot Monica , Beatriz García-Paredes , Eduardo Diaz-Rubio , Enrique Aranda
Background: FOLFOXIRI plus bevacizumab has demonstrated a survival benefit compared with FOLFIRI plus bevacizumab (TRIBE Lancet Oncol 2015) in first-line mCRC. This schedule is not routinely recommended in all patient groups due to toxicity. VISNÚ-1 trial compared FOLFOX + Bevacizumab (arm A) vs FOLFOXIRI + Bevacizumab (arm B) in non-elderly patients(p) with ≥ 3CTCs at baseline as a poor prognostic factor. Preliminary safety analysis is presented here. Methods: This is an open, multicentric, randomized phase III trial. Patients aged ≤ 70 years, ECOG 0-1 were randomized to arm A or arm B, stratified per KRAS mutation. The data presented here were generated from a snapshot of the database from Oct-31st-2017. Results: 350 p have been included in the study, 347 p were available for safety analysis. General characteristics in arms A and B: Median age (59 vs 60.5 years), gender (Male/Female: 67.2/32.8 vs 69.4/30.1%), ECOG 0/1 (48/52 vs 47/53%), primary tumor unresected (32.2 vs 37.1%), previous adjuvant chemotherapy (4.0 vs 5.3%). Most common grade ≥3 toxicities and treatment modifications are shown in table 1. Only neutropenia, asthenia, diarrhea and mucositis were more frequent in arm B. Fourteen patients dead due to treatment-related adverse events (6 in the FOLFOX- BEV arm and 8 in the FOLFOXIRI-BEV arm): 7 sepsis, 5 bowel perforation, 2 pulmonary toxicity). Conclusions: In our study, the use of FOLFOXIRI + Bev in mCRC did not result in an increase in treatment delays, dose reductions or treatment interruptions as compared with FOLFOX+Bev despite an increased incidence of neutropenia, diarrhea, asthenia and mucositis. Clinical trial information: NCT01640405
FOLFOX+BEV (N=177) | FOLFOXIRI+BEV (N=173) | |
---|---|---|
Treatment | N (%) | N (%) |
Delayed | ||
No | 29 (16.4) | 23 (13.5) |
Yes | 148 (83.6) | 147 (86.5) |
Dose Reductions | ||
No | 83 (46.9) | 62 (36.5) |
Yes | 94 (53.1) | 108 (63.5) |
Interrupted | ||
No | 75 (42.4) | 74 (43.5) |
Yes | 102 (57.6) | 96 (56.5) |
Adverse Events related to treatment (%) | % | % |
Grade ≥3 | 62.2 | 76.5 |
Neutropenia | 24.3 | 34.7 |
Asthenia | 6.2 | 14.7 |
Diarrhea | 5.1 | 20 |
Neurotoxicity | 21.5 | 18.8 |
Mucositis | 3.4 | 8.8 |
Hypertension | 3.4 | 3.6 |
Bowel perforation | 4.5 | 2.35 |
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Abstract Disclosures
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First Author: Javier Sastre
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