Study of the Predictive and Prognostic Role of Pharmacogenetic and Radiogenic Variants on the Response to Neoadjuvant Chemoradiation Therapy in Patients With Locally Advanced Rectal Cancer

In locally advanced rectal cancer the pathological complete response (pCR) to neoadjuvant chemoradiation therapy (nCRT) is associated with a favourable long-term prognosis. The identification of markers predictive of response to therapy would therefore optimise treatment by allowing personalised therapy. It has been shown that the genetic profile of the patient could influence the activation of the immune system in combination with chemoradiation therapy in targeting tumour cells. In addition, genetic features of molecular pathways correlated with response to chemoradiotherapy, may in turn affect the probability of a good response to treatment in these patients, but also the occurrence of adverse events. The main objective of the study is to define the role of genetic markers related to immune system activation and other molecular pathways in predicting the complete pathological response to preoperative chemoradiation therapy in patients with locally advanced rectal cancer.

开始日期2024-10-03

申办/合作机构

Centro di Riferimento Oncologico

NCT06347354 / Not yet recruitingN/AIIT

Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Braast Cancer and Metastatic Lymph Nodes (FLUO)

In the case of a pre-operative diagnosis of ductal carcinoma in situ (DCIS), sentinel lymph node biopsy is generally not indicated whereas it is considered standard clinical practice for patients with clinical stage I-II infiltrating breast cancer who have clinically negative axillary lymph nodes or clinically suspicious lymph nodes with negative needle aspiration findings. It is not uncommon that, in patients with ductal carcinoma in situ at preoperative diagnosis, there may be an upgrade on definitive histological examination due to the identification of foci of infiltration (about one-fifth of cases), requiring axillary lymph node biopsy in a second surgery. Prospective studies have shown that the sentinel lymph node identification rate after recent breast-conserving surgery is suboptimal. With regard to the false negative rate (FNR), several studies demonstrated that it could be associated with different techniques used for lymph node identification. Lymph node biopsy by Indocyanine green (ICG) is capable of identifying the sentinel lymph node, however, there are no data in literature on the permanence of ICG in the lymph node system. The knowledge of this data would allow the application of this method, already considered safe for the identification of the sentinel lymph node at the time of breast surgery, also in those situations in which the sentinel lymph node biopsy is postponed due to the upgrade of definitive histological diagnosis from carcinoma in situ to infiltrating/micro-infiltrating carcinoma.The main objective of this trial is to evaluate the permanence of fluorescence at the level of axillary lymph nodes 3 weeks after subcutaneous injection in patients who are candidates to radical axillary surgery. Marking the sentinel lymph node before breast surgery in cases of DCIS with risk factors could reduce the false negative rate, allowing to increase the accuracy of the procedure in identifying the lymph node potentially involved by metastatic infiltration. In addition, the identification of the sentinel lymph node in patients who are candidates to radical axillary surgery, could increase the sensitivity of the surgery in staging axillary disease and could make the lymph node exeresis more targeted, reducing the morbidity of the surgery resulting in a better outcome for the patient.

开始日期2024-09-01

申办/合作机构

Centro di Riferimento Oncologico

NCT06639178 / RecruitingN/AIIT

Phase II Trial to Determine the Effectiveness of an N-acetylcysteine and Urea-based Cream in Prevention of Capecitabine-induced HAND-foot Syndrome in Breast Cancer Patients

Breast cancer (BC) is the most frequent tumour in women. To date, among the available treatments, the use of Capecitabine, an oral prodrug of fluorouracil, has been shown activity in different setting. In advanced disease, Capecitabine is often used as monotherapy in patients pretreated with anthracycline, taxane or both.
One of the most frequent toxicities reported by patients receiving capecitabine is hand-foot syndrome (HFS), with an incidence of grade 3 HFS of 28%. HFS, also known as palmar-plantar erythrodysesthesia syndrome, is initially characterized by palmoplantar numbness, tingling, or burning pain. These symptoms usually coincide with sharply demarcated erythema with or without edema, cracking, or desquamation. In advanced stages, blistering and ulceration may occur. Although HFS is not considered life threatening, it can be painful and interfere with daily activities, thusseriously compromising quality of life (QoL), therefore this toxicity is considered dose limiting.Moreover, consistent with the theory that Capecitabine and its metabolites induce an inflammatory effect, the use of COX-2 inhibitors is an emerging strategies, but more evidence are needed from largest study to confirm their efficacy.
Similarly, N-acetylcysteine (NAC), an antioxidant, mucolytic and nephroprotective agent, that affects pathways involved in inflammatory conditions and that has demonstrated to be effective in several dermatologic conditions, could be useful in the management of Capecitabine-induced HFS.
From this arises the present study that has the objective of evaluating the role of NAC plus urea-based cream in the prevention of Capecitabineinduced HFS in patient affected by breast cancer.

开始日期2024-08-01

申办/合作机构

Centro di Riferimento Oncologico

100 项与 Centro di Riferimento Oncologico 相关的临床结果

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项与 Centro di Riferimento Oncologico 相关的文献（医药）

2024-09-01·The Journal of Vascular Access

Safe Insertion of Arterial Catheters (SIA): An ultrasound-guided protocol to minimize complications for arterial cannulation

Review

作者: Spencer, Timothy R ; Lamperti, Massimo ; Mahoney, Keegan J ; Bardin-Spencer, Amy ; Imbriaco, Guglielmo ; Brescia, Fabrizio ; Pittiruti, Mauro

Direct puncture and cannulation of peripheral arteries is frequently performed in critical care and in emergency settings, mainly for hemodynamic monitoring and blood sampling. While there is abundant literature on peripheral arterial cannulation in children and adults, there is still scope for clinical improvements which may impact on patient safety. Although the radial artery is the most frequently utilized access site today, due to its superficial proximity, ease of access, and low risk of adverse events, other sites are sometimes chosen. The authors propose the Safe Insertion of Arterial Catheters (SIA) protocol, an ultrasound-guided insertion bundle applying a systematic approach to arterial cannulation, with a focus on improving insertion practices, reducing procedural complications, increasing the patient safety profile, and improving device performance.

2024-07-01·Journal of Nuclear Medicine

A Prospective Randomized Multicenter Study on the Impact of [¹⁸F]F-Choline PET/CT Versus Conventional Imaging for Staging Intermediate- to High-Risk Prostate Cancer

Article

作者: Novara, Giacomo ; Chierichetti, Franca ; Borsatti, Eugenio ; Gallan, Mauro ; Del Bianco, Paola ; Bartolomei, Mirco ; Trenti, Emanuela ; Magni, Giovanna ; Evangelista, Laura ; De Salvo, Gian Luca ; Baresic, Tanja ; Trifirò, Giuseppe ; Urso, Luca ; Panareo, Stefano ; Setti, Lucia ; Bertin, Daniele ; Donner, Davide ; Zattoni, Fabio ; Burei, Marta ; Farsad, Mohsen ; Brugola, Elisabetta

This study aimed to compare the efficacy of [¹⁸F]F-choline PET/CT with conventional imaging for staging and managing intermediate- to high-risk prostate cancer (PCa). The primary objective was to assess the ability of PET/CT with [¹⁸F]F-choline to identify lymph node and systemic involvement during initial staging. Secondary objectives included evaluating the impact of [¹⁸F]F-choline PET/CT on unnecessary local treatments and assessing the safety of [¹⁸F]F-choline agents. Additionally, the study aimed to analyze recurrence-free survival and overall survival 5 y after randomization. Methods: A prospective controlled, open, randomized multicenter phase III trial involving 7 Italian centers was conducted. Eligible patients with intermediate- to high-risk PCa were randomized in a 1:1 ratio. Two groups were formed: one undergoing conventional imaging (abdominopelvic contrast-enhanced CT and bone scanning) and the other receiving conventional imaging plus [¹⁸F]F-choline PET/CT. The study was terminated prematurely; however, all the endpoints were thoroughly analyzed and enriched. Results: Between February 2016 and December 2020, 256 patients were randomly assigned. In total, 236 patients (117 in the control arm and 119 in the experimental arm) were considered for the final assessment. In the experimental arm, the sensitivity for lymph node metastases, determined by final pathology and serial prostate-specific antigen evaluations, was higher than in the control arm (77.78% vs. 28.57% and 65.62% vs. 17.65%, respectively). The [¹⁸F]F-choline was tolerated well. The use of [¹⁸F]F-choline PET/CT resulted in an approximately 8% reduction in unnecessary extended lymphadenectomy compared with contrast-enhanced CT. Additionally, [¹⁸F]F-choline PET/CT had a marginal impact on 5-y overall survival, contributing to a 4% increase in survival rates. Conclusion: In the initial staging of PCa, [¹⁸F]F-choline PET/CT exhibited diagnostic performance superior to that of conventional imaging for detecting metastases. [¹⁸F]F-choline PET/CT reduced the rate of unnecessary extensive lymphadenectomy by up to 8%. These findings support the consideration of discontinuing conventional imaging for staging PCa.

2024-06-01·Journal of Clinical Oncology

Triplet chemotherapy combined with anti-EGFR treatment in RAS wild-type colon cancer: A network meta-analysis.

作者: de Scordilli, Marco ; Fumagalli, Arianna ; Rota, Simone ; Bortolot, Martina ; Di Nardo, Paola ; Basile, Debora ; Guardascione, Michela ; Torresan, Sara ; Foltran, Luisa ; Puglisi, Fabio ; Giudici, Fabiola ; Guglielmi, Alessandra ; Noto, Claudia ; Ongaro, Elena

e15592 Background: The optimal first-line treatment for RAS wild-type (wt) metastatic colorectal cancer (mCRC) remains undetermined. Recently, several studies have explored the efficacy of first-line treatment regimens, including triplet chemotherapy (CT) combined with an anti-EGFR antibody, in comparison to either doublet CT combined with an anti-EGFR antibody, triplet CT combined with an anti-VEGF treatment, or triplet CT alone. However, none of these trials yielded conclusive results. Hence, we conducted a systematic review and an explorative network meta-analysis (NMA) of the available data. Methods: A systematic review was conducted, encompassing all phase II/III randomized clinical trials (RCTs) that compared a regimen consisting of triplet CT associated with an anti-EGFR treatment against different first-line systemic regimens for RAS-wt mCRC patients. Both pairwise and NMA were performed to establish direct and indirect comparisons of overall response rate (ORR) using a random effects model within the frequentist framework. Results: 7 RCTs (TRIPLETE, VOLFI, TRICE, PANIRINOX, AIO-CELIM2, FOCULM, DEEPER), involving a total of 1283 patients, were included in the analysis. Overall, 4 arms were identified, encompassing all possible combinations of CT, anti-EGFR treatment, and anti-VEGF treatment: arm A (triplet + anti-EGFR), arm B (doublet + anti-EGFR), arm C (triplet alone), and arm D (triplet + anti-VEGF). A benefit was demonstrated for all treatments associated with targeted therapy when compared to triplet alone; no difference was observed among groups A, B and D. Results of selected NMA comparisons are shown in the table 1. Additionally, we conducted a pairwise meta-analysis for ORR, which, due to available comparisons, was only feasible for groups A vs. B, A vs. C, and A vs. D; the results of this analysis confirmed the NMA findings (group A vs. group C, pooled OR: 4.23 (2.06 – 8.68)). Conclusions: Through indirect comparisons, no significant ORR benefit was found for triplet CT associated with anti-EGFR treatment compared to doublet CT combined with anti-EGFR treatment or triplet CT combined with anti-VEGF. All regimens incorporating targeted treatment demonstrated superior performance compared to triplet CT alone. Our findings do not advocate for the routine use of triplet CT associated with anti-EGFR treatment in this patient population; however, we await mature OS data from a few of the trials included in our analysis. [Table: see text]

项与 Centro di Riferimento Oncologico 相关的新闻（医药）

2023-11-17

·PRNewswire

RaySearch Laboratories: Interim report January 1 - September 30, 2023

STOCKHOLM, Nov. 17, 2023 /PRNewswire/ -- THIRD QUARTER (JULY - SEPTEMBER 2023) Order intake SEK 240.7 M (219.1) Net sales SEK 252.9 M (210.9) Operating profit SEK 28.6 M (12.0) Profit after tax SEK 21.6 M (10.1) Earnings per share before/after dilution SEK 0.63 (0.29) Cash flow SEK 63.5 M (-48.0) Order backlog SEK 1,966.3 M (1,715.2) at the end of the period NINE MONTHS (JANUARY - SEPTEMBER 2023) Order intake SEK 686.5 M (704.1) Net sales SEK 722.5 M (579.3) Operating profit SEK 70.5 M (22.0) Profit after tax SEK 50.0 M (9.6) Earnings per share before/after dilution SEK 1.46 (0.28) Cash flow SEK 144.7 M (4.0) SIGNIFICANT EVENTS DURING THE THIRD QUARTER University Medical Center Groningen in the Netherlands purchased Micro-RayStation for pre-clinical research. RayCare in clinical use with CyberKnife at Lausanne University Hospital (CHUV) in Switzerland. RaySearch and MedAustron expand their partnership through a new strategic research agreement. Henrik Bergentoft leaves the position as CFO. Annika Blondeau Henriksson has been appointed interim CFO. RaySearch's business partner IBA has placed an order for RayStation and RayCare for installation at CRO National Cancer Institute (C.R.O.) in Aviano, Italy. Baptist Health Lexington in the US has placed an order for RayStation to two of its major centers. Oregon Health & Science University in the US has placed an order for RayStation. SIGNIFICANT EVENTS AFTER THE END OF THE REPORTING PERIOD RaySearch has received an order from Israel-based P-Cure and is deepening its collaboration focusing on advanced proton therapy solutions. The Paul Scherrer Institute in Switzerland has placed an order for RayStation. The Mass General Cancer Center in the US has placed an order and thereby plans to expand its use of RayStation to proton treatment planning. FOR FURTHER INFORMATION, PLEASE CONTACT: Johan Löf, CEO, +46 (0)8 510 530 00, [email protected] Annika Blondeau Henriksson, interim CFO, +46 (0)8 510 530 00, [email protected] The information contained in this interim report is such that RaySearch Laboratories AB (publ) is obliged to disclose under the EU Market Abuse Regulation and the Swedish Securities Market Act. The information was submitted for publication on November 17, 2023 at 7:45 a.m. CET. WEBCAST CEO Johan Löf and interim CFO Annika Blondeau Henriksson will present RaySearch's interim report for January - September 2023 at a webcast to be held in English on Friday, November 17, 2023 at 10:00-10:30 a.m. CET. Link to webcast: RaySearch Q3 2023 You can also join the webcast by phone: Sweden +46 (0) 8 505 100 31 UK: +44 (0) 207 107 06 13 US: +1 (1) 631 570 56 13 The following files are available for download: SOURCE RaySearch Laboratories

高管变更财报

2023-09-29

·PRNewswire

RaySearch receives order for RayStation and RayCare in Italy

STOCKHOLM, Sept. 29, 2023 /PRNewswire/ -- RaySearch Laboratories AB (publ) announces that Ion Beam Applications S.A. (IBA), market leader in proton therapy, has placed an order for RayStation®* treatment planning system and the oncology information system RayCare®* for installation at CRO National Cancer Institute (C.R.O.) in Aviano, Italy. RaySearch partnered with IBA for the public tender, with IBA serving as the main system integrator. The order includes implementation of both RayStation and RayCare at C.R.O. Aviano. The combination of RayStation and RayCare provides an integrated and unified solution throughout the complete workflow, when combined with an IBA proton therapy machine. IBA signed the contract with C.R.O. Aviano in November 2021 following a comprehensive vendor selection process. RaySearch partnered with IBA for the public tender and the center has now decided to select RayStation and RayCare. RayStation includes a complete set of licencs for pencil beam scanning, including automatic proton therapy planning using machine learning techniques. RayCare includes licences to cover the workflow management and the treatment delivery for all patients treated with proton therapy. C.R.O. Aviano is expected to start treating patients by the end of 2024. Johan Löf, founder and CEO, RaySearch, says: "We are very pleased to provide C.R.O. Aviano with RayStation and RayCare. The adoption of both RaySearch solutions at C.R.O. Aviano will enhance implementation efficiency as well as the possibility to optimize clinical excellence of proton therapy at this center. For RaySearch, this agreement further strengthens our prominent role in both treatment planning and oncology information systems for proton therapy centers in Europe." The total order value is EUR 1.7 million (approximately SEK 19 million). A service contract is not included but is expected to be added at a later stage. For more information, please contact: Johan Löf, founder and CEO, RaySearch Laboratories AB (publ) Telephone: +46 (0) 8 510 530 00 [email protected] The following files are available for download: SOURCE RaySearch Laboratories

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100 项与 Centro di Riferimento Oncologico 相关的转化医学

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