Tesi etd-10182024-114308
Link copiato negli appunti
Tipo di tesi
Corso Ordinario Ciclo Unico 6 Anni
Autore
LANDI, MATTEO
URN
etd-10182024-114308
Titolo
The ERASE trial: optimizing adjuvant and post-adjuvant treatment in stage III and high-risk stage II colon cancer through liquid biopsy
Struttura
Classe Scienze Sperimentali
Corso di studi
SCIENZE MEDICHE - SCIENZE MEDICHE
Commissione
Tutor Prof. EMDIN, MICHELE
Relatore Prof.ssa CREMOLINI, CHIARA
Presidente Prof. PASSINO, CLAUDIO
Membro Dott.ssa durante, angela
Membro Prof. RECCHIA, FABIO ANASTASIO
Membro Prof. LIONETTI, VINCENZO
Membro Prof.ssa ANGELONI, DEBORA
Membro Prof. GIANNONI, ALBERTO
Relatore Prof.ssa CREMOLINI, CHIARA
Presidente Prof. PASSINO, CLAUDIO
Membro Dott.ssa durante, angela
Membro Prof. RECCHIA, FABIO ANASTASIO
Membro Prof. LIONETTI, VINCENZO
Membro Prof.ssa ANGELONI, DEBORA
Membro Prof. GIANNONI, ALBERTO
Parole chiave
- Nessuna parola chiave trovata
Data inizio appello
17/12/2024;
Disponibilità
parziale
Riassunto analitico
The combination of oxaliplatin and a fluoropyrimidine is considered standard treatment in the adjuvant setting for resected stage III and high-risk stage II colon cancer. In this population, approximately 60% of patients are cured by surgery alone and mortality is reduced in only 15-20% of cases by chemotherapy. This signifies that around 20% of patients will relapse despite adjuvant treatment.
Recently, circulating tumor DNA (ctDNA) analysis via liquid biopsy (LB) has emerged as a promising tool for detecting minimal residual disease (MRD) and guiding adjuvant treatment planning. Persistent ctDNA detection at the end of adjuvant treatment has been correlated with a higher risk of recurrence. Additionally, LB may refine subsequent treatment strategies, such as proposing post-adjuvant treatment and monitoring post-adjuvant ctDNA clearance as a surrogate marker of treatment efficacy.
The ERASE-CRC trial is a prospective, open-label, multicenter study, conducted in two parts. In ERASE-CRC1, resected stage III and high-risk stage II colon cancer patients are screened for ctDNA. If ctDNA is detected, patients are randomized to FOLFOX (12 cycles) / XELOX (8 cycles) versus FOLFOXIRI (12 cycles). Patients with RASwt and HER2+ tumors may be enrolled in the target-driven ERASE-CRC1 subtrial, receiving FOLFOX plus Trastuzumab plus Tucatinib (12 cycles). In ERASE-CRC2, patients from part 1 (or those treated as per clinical practice outside the trial) are tested for ctDNA at the end of adjuvant treatment. If ctDNA-positive, they are randomized to observation versus FTD/TPI (6 cycles).
This work presents preliminary data from ERASE-CRC1, analyzing early correlations between ctDNA positivity and patients’ clinical and pathological characteristics.
From March 1st, 2023, to September 30th, 2024, 448 patients were screened in ERASE-CRC1 and underwent liquid biopsy. Overall, 81 patients (18.08%) were ctDNA-positive, 350 (78.13%) ctDNA-negative, and 17 (3.79%) failed to have either a positive or negative result.
Out of the 289 patients whose clinical and pathological data is available, 49 (16.96%) had a high-risk stage II tumor and 14.29% of them (7 patients) were ctDNA-positive, 240 (83.04%) had a stage III tumor and 22.5% of them (54 patients) were ctDNA-positive. Out of all the 448 screened patients, 34 out of the 81 positive ones (41.98%) did non undergo randomization for various reasons, most frequently (in 67.65% of cases, 23 patients) because already metastatic.
Overall, ctDNA analysis was feasible and safe, especially given that two cycles of doublet chemotherapy were allowed for pending the result of the LB.
Recently, circulating tumor DNA (ctDNA) analysis via liquid biopsy (LB) has emerged as a promising tool for detecting minimal residual disease (MRD) and guiding adjuvant treatment planning. Persistent ctDNA detection at the end of adjuvant treatment has been correlated with a higher risk of recurrence. Additionally, LB may refine subsequent treatment strategies, such as proposing post-adjuvant treatment and monitoring post-adjuvant ctDNA clearance as a surrogate marker of treatment efficacy.
The ERASE-CRC trial is a prospective, open-label, multicenter study, conducted in two parts. In ERASE-CRC1, resected stage III and high-risk stage II colon cancer patients are screened for ctDNA. If ctDNA is detected, patients are randomized to FOLFOX (12 cycles) / XELOX (8 cycles) versus FOLFOXIRI (12 cycles). Patients with RASwt and HER2+ tumors may be enrolled in the target-driven ERASE-CRC1 subtrial, receiving FOLFOX plus Trastuzumab plus Tucatinib (12 cycles). In ERASE-CRC2, patients from part 1 (or those treated as per clinical practice outside the trial) are tested for ctDNA at the end of adjuvant treatment. If ctDNA-positive, they are randomized to observation versus FTD/TPI (6 cycles).
This work presents preliminary data from ERASE-CRC1, analyzing early correlations between ctDNA positivity and patients’ clinical and pathological characteristics.
From March 1st, 2023, to September 30th, 2024, 448 patients were screened in ERASE-CRC1 and underwent liquid biopsy. Overall, 81 patients (18.08%) were ctDNA-positive, 350 (78.13%) ctDNA-negative, and 17 (3.79%) failed to have either a positive or negative result.
Out of the 289 patients whose clinical and pathological data is available, 49 (16.96%) had a high-risk stage II tumor and 14.29% of them (7 patients) were ctDNA-positive, 240 (83.04%) had a stage III tumor and 22.5% of them (54 patients) were ctDNA-positive. Out of all the 448 screened patients, 34 out of the 81 positive ones (41.98%) did non undergo randomization for various reasons, most frequently (in 67.65% of cases, 23 patients) because already metastatic.
Overall, ctDNA analysis was feasible and safe, especially given that two cycles of doublet chemotherapy were allowed for pending the result of the LB.
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