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  • 1
    Online Resource
    Online Resource
    Randomized phase III study comparing FOLFOX + bevacizumab versus folfoxiri + bevacizumab (BEV) as 1st line treatment in patients with metastatic colorectal cancer (mCRC) with ≥3 baseline circulating tumor cells (bCTCs).
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. 3507-3507
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 3507-3507
    Abstract: 3507 Background: FOLFOXIRI+BEV has demonstrated a survival benefit compared with FOLFIRI plus BEV (TRIBE Lancet Oncol 2015) in first-line mCRC. Nevertheless, due to its safety profile, this schedule is not recommended for all pts. In addition, we have showed that the detection of ≥3 bCTCs is a poor prognostic factor for survival (MACRO The Oncologist 2012). The VISNU-1 trial compares FOLFOX + BEV vs FOLFOXIRI + BEV in pts with mCRC and ≥3 bCTCs. Progression-free survival (PFS) is the primary endpoint. Secondary endpoints included overall response rate (ORR) and overall survival (OS). Methods: This is an open, multicentric, randomized phase III trial. Patients with mCRC younger than 70 years, ECOG 0-1 were randomized to FOLFOX+BEV (arm A) or FOLFOXIRI+BEV (arm B), stratified per KRAS mutation (mutated vs WT) and number of involved organs (1 vs 〉 1). Results: 349 pts were included in the ITT population; 177 in group A and 172 in group B. Characteristics of the pts, molecular profiling and safety analysis have been previously presented at ASCO 2018 and showed that this schedule had an acceptable toxicity profile. Efficacy analysis in the ITT population is shown in the table. Conclusions: In this population with very bad prognosis, our study met its primary endpoint. Pts who received FOLFOXIRI + Bev benefit for a statistically significative PFS and ORR. OS showed a trend of benefit in the experimental arm. According to these results, FOLFOXIRI-Bev could be considered an adequate treatment option for pts with mCRC and ≥3 bCTCs. Clinical trial information: 2012-000846-37. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.3507
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    The CIRCULATE Spain study: Circulating tumor DNA based decision for adjuvant treatment in localized colon cancer.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. TPS3635-TPS3635
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. TPS3635-TPS3635
    Abstract: TPS3635 Background: A substantial proportion of colon cancer (CC) patients do not benefit from adjuvant chemotherapy, and almost 40% of them will develop metastases despite initial optimal treatment. We have designed the phase 2 CIRCULATE-SPAIN trial (EudraCT Number: 2021-000507-2) to prove the feasibility of using liquid biopsy detection of minimal residual disease to guide the post-surgical clinical management of localized CC patients. Moreover, it is important to define if conventional versus intensive adjuvant chemotherapy could convert plasma circulating tumor DNA (ctDNA) positive into a ctDNA negative status. Methods: CIRCULATE-SPAIN is a trial to prove the feasibility of using liquid biopsy detection of MRD to guide the post-surgical clinical management of early colon cancer patients. It is a multicenter, randomized, open-label phase II “Single-To-double ARm Transition (START)” study in which patients are firstly enrolled into a single arm (Phase IIa) study expandable to a randomized double arm (Phase IIb). The CIRCULATE-SPAIN trial involves two primary endpoints, one for the Phase IIa and a second one for the Phase IIb. The primary objective for Phase IIa is to analyze the potential effect of FOLFOXIRI as an intensive adjuvant treatment for ctDNA clearance as a surrogate biomarker of treatment efficacy. Only if the pre-fixed result of 14 out of 40 patients achieves ctDNA clearance, the trial will be expanded to a phase IIb in which patients will be enrolled to randomly receive intensive adjuvant treatment (FOLFOXIRI) versus conventional adjuvant therapy (CAPOX). The primary objective in this phase is to study differences on the conversion rate between both groups. An academic assay based on tumor informed approach is used for ctDNA determination. Tumor and germline samples analysis are carried out by an in-house-developed bioinformatics pipeline specialized in variant-calling analysis using a custom 29-gene panel. Somatic variants are identified by the germline mutations extraction. Different annotation databases and an internal pathological mutation database are used to rule out potential benign somatic variants. Those candidate somatic mutations with the highest allelic frequency are selected and a specific panel of amplicons is designed to monitor their presence in ctDNA using NGS. Plasma samples analysis is carried out by an in-house pipeline specialized in reducing potential background noise. To assess panel performance in both sample types, the bioinformatics pipelines include a set of methods to calculate and filter according to different quality control metrics. Recruitment for the Phase IIa is ongoing with a total of 67 pre-screened out of which two patients were eligible. Clinical trial information: 2021-000. 507-20 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.TPS3635
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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