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Sysmex è attiva in diverse aree medico - scientifiche. In aggiunta alle informazioni disponibili per il personale medico qualificato, sono qui disponibili anche informazioni generali per le persone che cercano assistenza nelle nostre aree di competenza.

Al momento potrete trovare indicazioni e informazioni generali sul tumore al seno. Vi invitiamo a visitare il nostro sito al seguente link http://www.tumore-al-seno-diagnosi.it/

 

 

Pubblicazioni

Questo sito contiene studi scientifici e bibliografia relativi ai nostri prodotti. E’ possibile selezionare una di queste specifiche liste:

Oncologia

sentinel lymph node localisation

Breast Cancer Research and Treatment (2016): Karakatsanis A. et al. The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc99 and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies
Core message: “SPIO is an effective method for the detection of SN in patients with breast cancer. It is comparable to the standard technique and seems to simplify logistics.”

European Journal of Cancer (2016): Karakatsanis et al. The use of superparamagnetic iron oxide (SPIO) as sole method for the detection of sentinel node (SN) in breast cancer. The MONOS study
Core message: “SPIO is a safe and effective method in SN biopsy. It does not have the known drawbacks of the dual standard. … No adverse effects were noted; however, patients who will undergo breast conserving surgery should be informed about the possibility of skin staining.”

Annals of Surgical Oncology (2016): Teshome M. et al. Use of a Magnetic Tracer for Sentinel Lymph Node Detection in Early-Stage Breast Cancer Patients: A Meta-analysis
Core message: Sentinel Lymph node detection with Sienna+® revealed non-inferior performance to the standard method in breast cancer patients with clinically node-negative status.

Journal of Surgical Oncology (2015): Houpeau J.L. et al. Sentinel lymph node identification using superparamagnetic iron oxide particles versus radioisotope: The French Sentimag feasibility trial
Core message: Sentinel lymph node detection with Sienna+ is seen as a feasible method and a promising alternative to radiotracer. A beneficial potential was identified for ambulatory surgery or sites without nuclear medicine departments.

European Journal of Cancer Care (2015): Ghilli M. et al. The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment
Core message: Sentimag® was identified as safe with non-inferior performance compared to the radiotracer. The Sentimag® technique can be applied after a minimum learning curve. Especially when nuclear medicine units are not available, the magnetic detection provides an effective treatment of breast cancer patients.

European Journal of Surgical Oncology (2015): Piñero-Madrona et al. The superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: A comparative non-inferiority study
Core message: This study showed non-inferiority of the Sentimag technique compared to radiotracer. Ex-vivo and intraoperative detection rates at the node level were found to be slightly higher with Sentimag.

European Journal of Surgical Oncology (2014): Rubio I.T. et al. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer
Core message: Detection of SLNs with SPIO was not inferior to radiotracer. Procedure is safe, reliable and facilitates patients and OR management.

The Breast (2014): Thill M. et al.: The Central-European SentiMag study Sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope
Core message: “We obtained convincing results that magnetic SLNB can be performed easily, safely and equivalently well in comparison to the radiotracer method.”

Annals of Surgical Oncology (2013): Douek M. et al. Sentinel Node Biopsy Using a Magnetic Tracer Versus Standard Technique: The SentiMAG Multicentre Trial
Core message: Sentimag/Sienna+ is a feasible technique for SLNB. The identification rate is not inferior to the standard.

sentinel lymph node analysis

Breast Cancer

The Breast (2017): Peg V. et al. Role of total tumour load of sentinel lymph node on survival in early breast cancer patients
Core message: “SLN TTL permits the differentiation between two patient groups in terms of DFS and OS, independently of axillary staging (pN), age and tumour characteristics (size, grade, lymphovascular invasion). This new data confirms the clinical value of low axillary involvement and could partially replace the information that staging of the entire axilla provides in patients on whom no axillary lymph node dissection is performed.”

PLoS One  (2017): Terrenato I. et al. A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients
Core message: “Logistic regression models indicated that the cut-off of 2150 copies better discriminates patients with node negative or positive in comparison with the conventional OSNA cut-off (p<0.0001). This cut-off identifies false positive and false negative cases and true-positive and true negative cases very efficiently, and therefore better identifies which patients really need an ALND and which patients can avoid one. This is why we suggest that the negative cut-off should be raised from 250 to 2150. Furthermore, we propose that for patients with a copy number that ranges between 2150 and 5000, there should be a multidisciplinary discussion concerning the clinical and bio-morphological features of primary breast cancer before any decision is taken on whether to perform an ALND or not.”

Journal of Experimental & Clinical Cancer Research (2016): Di Filippo F et al. Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
Core message: ”The results of the study confirm that OSNA nomogram may help surgeons make an intraoperative decision on whether to perform ALND or not in case of positive sentinel nodes, and the patient to accept this decision based on a reliable estimation on the true percentage of NSN involvement. The use of this nomogram achieves two main gools: 1) the choice of the right treatment during the operation, 2) to avoid for the patient a second surgery procedure.”

Molecular and Clinical Oncology (2016): Parada D. et al. Intraoperative molecular analysis of sentinel lymph nodes following neoadjuvant chemotherapy in patients with clinical node negative breast cancer: An institutional study
Core message: “The OSNA assay is a highly sensitive, specific and reproducible diagnostic technique that can be used to analyse SLNs following NAC. The total tumoral load may assist with predicting additional non SLN metastases.”

The Breast (2016): Espinosa-Bravo M. et al. Intraoperative assessment of sentinel lymph node by one-step nucleic acid amplification in breast cancer patients after neoadjuvant treatment reduces the need for a second surgery for axillary lymph node dissection
Core message: The accurate and standardized intraoperative SLN analysis by OSNA decreases the need of a second surgery in 18.5% of breast cancer patients with a positive SLN after neoadjuvant therapy.

Surgery Today (2016): Shimazu K. et al. Clinical significance of breast cancer micrometastasis in the sentinel lymph node
Core message: The OSNA method shows the benefit of reproducibility among different institutions and the capability of analysing a whole lymph node in only 30-40 minutes.

Molecular and Clinical Oncology (2016): Kubota M et al. One-step nucleic acid amplification assay for intraoperative prediction of advanced axillary lymph node metastases in breast cancer patients with sentinel lymph node metastasis
Core message: The Total Tumour Load (TTL) determined by OSNA analysis can predict further axillary lymph node metastases in breast cancer patients. The TTL can be assessed intra-operatively, thus it can be used during surgery to determine the need for axillary lymph node dissection.

European Journal of Surgical Oncology (2016): Banerjee SM et al. The use of one-step nucleic acid amplification (OSNA) and tumour related factors in the treatment of axillary breast cancer: A predictive model
Core message: A predictive model combining Total Tumour Load (TTL) determined by OSNA analysis with lymphovascular invasion can identify breast cancer patients who require additional axillary treatment, i.e. axillary lymph node dissection or other adjuvant measures.

Histopathology (2016): Vieites B. et al. CK19 expression in breast tumours and lymph node metastasis after neoadjuvant therapy
Core message: The expression of CK19 protein is preserved after neoadjuvant therapy. This indicates that OSNA is a suited approach for lymph node analysis also upon neoadjuvant treatment.

Revista de Senología y Patología Mamaria (2015): Bernet L. et al. A multiparametric predictive model of axillary status in patients with breast cancer: total tumoral load and molecular signature. A multicenter study
Core message: “The inclusion of PM in the multivariate model improved the AUC, especially when the total number of sentinel nodes were included. Differences were observed in the impact of the CTT among the different molecular profiles subtypes.”

Journal of Experimental & Clinical Cancer Research (2015): Di Filippo F. et al. Elaboration of a nomogram to predict non sentinel node status in breast cancer patients with positive sentinel node, intra-operatively assessed with one step nucleic acid amplification method
Core message: The nomogram described by Di Filippo et al. is a very useful tool for predicting non-SLN status in breast cancer patients with positive SLNs assessed intra-operatively by OSNA.

The Breast (2014): Piñero-Madrona A. et al. Tumoral load quantification of positive sentinel lymph nodes in breast cancer to predict more than two involved nodes
Core message: In this study, the OSNA result clearly correlates with the risk of having two or more metastatic non-SLNs in breast cancer patients.

Breast Cancer Research and Treatment (2014): Rubio IT. et al. Nomogram including the total tumoral load in the sentinel nodes assessed by one-step nucleic acid amplification as a new factor for predicting nonsentinel lymph node metastasis in breast cancer patients
Core message: The nomogram described by Rubio et al. incorporates the Total Tumour Load (TTL) assessed by OSNA and can be used to predict non-SLN positivity. This useful tool can support clinicians in decision-making.

Journal of Clinical Pathology (2014): Deambrogio C. et al. A new clinical cut-off of cytokeratin 19 mRNA copy number in sentinel lymph node better identifies eligible for axillary lymph node dissection in breast cancer
Core message: The CK19 mRNA copy number represents a useful tool to predict the probability of nodal involvement and thus, it can be applied for the selection of patients in which axillary lymph node dissection could be recommended due to the high risk of further axillary lymph node metastases.

Annals of Oncology (2013): Klingler S. et al. Using one-step nucleic acid amplification (OSNA) for intraoperative detection of lymph node metastasis in breast cancer patients avoids second surgery and accelerates initiation of adjuvant therapy
Core message: The intraoperative SLN analysis by OSNA reduces the need of a second surgery in breast cancer patients and allows a prompt initiation of adjuvant therapy.

European Journal of Surgical Oncology (2013): Espinosa-Bravo M. et al. Prediction of non-sentinel lymph node metastasis in early breast cancer by assessing total tumoral load in the sentinel lymph node by molecular assay
Core message: Intraoperatively assessed Total Tumour load (TTL) in SLNs of clinically node negative breast cancer patients predicts for further non-SLN metastasis. TTL helps decision-making on performing or not axillary lymph node dissection.

European Journal of Cancer (2013): Osako T. et al. Sentinel node tumour burden quantified based on cytokeratin 19 mRNA copy number predicts non-sentinel node metastases in breast cancer: molecular whole-node analysis of all removed nodes
Core message: The CK19 mRNA copy number determined by OSNA predicts non-SLN metastases. This study further support the predictive value of the OSNA result.

British Journal of Cancer (2013): Osako T et al. Molecular detection of lymph node metastasis in breast cancer patients treated with preoperative systemic chemotherapy: a prospective multicentre trial using the one-step nucleic acid amplification assay
Core message: “The OSNA assay can detect the residual tumour burden as accurately as conventional pathology, although chemotherapy-induced histological changes are present.”

European Journal of Surgical Oncology (2013): Navarro-Cecilia J. et al. Intraoperative sentinel node biopsy by one-step nucleic acid amplification (OSNA) avoids axillary lymphadenectomy in women with breast cancer treated with neoadjuvant chemotherapy
Core message: The OSNA result can predict the axillary status with a high accuracy also in clinically node negative patients at initial presentation who underwent neoadjuvant therapy.

Breast Cancer Research and Treatment (2013): Peg V. et al. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients
Core message: The Total Tumour Load (TTL) determined by OSNA is an independent predictor of the nodal status and can support clinicians in personalising surgical treatment.

Journal of Breast Cancer (2013): Sagara Y. et al. Clinical application of the one-step nucleic acid amplification method to detect sentinel lymph node metastasis in breast cancer
Core message: The OSNA assay allows the accurate analysis of SLN and the prediction of non-SLN metastases. Moreover, applying this technique reduces pathologist’s workload.

Journal of Cancer Research and Clinical Oncology (2013): Helimann T. et al.: Intra-operative use of one-step nucleic acid amplification (OSNA) for detection of the tumor load of sentinel lymph nodes in breast cancer patients
Core message: OSNA is a very useful tool for supporting intra-operative decision-making about further axillary surgery, thus reducing the risk of second surgeries. Moreover, the CK19 copy number allows the prediction of further lymph node involvement and might help to find adequate adjuvant treatment options.

British Journal of Cancer (2012): Ohi Y. et al. Whole sentinel lymph node analysis by a molecular assay predicts axillary node status in breast cancer
Core message: The CK19 mRNA copy number in the SLN is the most significant predictor of non-SLN involvement.

International Journal of Cancer (2012): Le Frère-Belda MA. et al. Diagnostic performance of one-step nucleic acid amplification for intraoperative sentinel node metastasis detection in breast cancer patients
Core message: The OSNA method shows a higher sensitivity than intraoperative histological evaluation, and thus its use possibly leads to a decrease of the number of women who require a second surgical procedure for axillary lymph node dissection.

Journal of Clinical Pathology (2012): Cserni G. Intraoperative analysis of sentinel lymph nodes in breast cancer by one-step nucleic acid amplification
Core message: Cserni et al. describes in this review current literature and concerns related to the OSNA method.

Annals of Surgery (2012): Castellano I. et al. Reliability of whole sentinel lymph node analysis by one-step nucleic acid amplification for intraoperative diagnosis of breast cancer metastases
Core message: Whole SLN analysis by OSNA provides objective and reproducible results that help treatment decision making and accurate characterisation of SLN staging.

Journal of Breast Cancer Research and Treatment (2012): Godey F. et al. Sentinel lymph node analysis in breast cancer: contribution of one-step nucleic acid amplification (OSNA)
Core message: The intraoperative analysis of SLN by OSNA enables the surgeon to perform, when necessary, axillary lymph node dissection during the same procedure.

Histopathology (2011): Bernet L. et al. Diagnosis of the sentinel lymph node in breast cancer: a reproducible molecular method: a multicentric Spanish study
Core message: OSNA is a very sensitive, specific and reproducible method that enables standardisation of the SLN diagnostic procedure.

British Journal of Surgery (2011): Snook KL. et al. Multicentre evaluation of intraoperative molecular analysis of sentinel lymph nodes in breast carcinoma
Core message: OSNA allows accurate intraoperative evaluation of SLN and show excellent concordance with histology. This promising approach will become the standard method for analysis of SLN and axillary LNs.

Virchows Archiv (2009): Schem C. et al. One-step nucleic acid amplification – a molecular method for the detection of lymph node metastases in breast cancer patients; results of the German study group
Core message: OSNA is a reliable and standardized tool for the intraoperative detection of lymph node metastases and its adoption may lead to a benefit for the patients since unnecessary second surgeries are avoided.

International Journal of Cancer (2008): Visser M. et al. Intra-operative rapid diagnostic method based on CK19 mRNA expression for the detection of lymph node metastases in breast cancer
Core message: OSNA enables whole lymph node analysis and therefore, sampling errors, which are related to histological techniques, are avoided. Moreover, the automated procedure leads to a high degree of standardization and objectivity.

Clinical Cancer Research (2007): Tsujimoto M. et al. One-step nucleic acid amplification for intraoperative detection of lymph node metastasis in breast cancer patients
Core message: CK19 mRNA copy number cut-off values enable to distinguish among macrometastasis, micrometastasis, and non-metastasis. The clinical findings indicate that the OSNA assay is a useful intraoperative detection method for the detection of lymph node metastasis in breast cancer patients.

Performance Evaluations

Tsujimoto M, Nakabayashi K, Yoshidome K et al. One-step nucleic acid amplification for intraoperative detection of lymph node metastasis in breast cancer patients. Clin Can Res 2007 13: 4807-16.

Visser M, Jiwa M, Horstman A et al. Intra-operative diagnostic method based on CK19 mRNA expression for the detection of lymph node metastases in breast cancer. Int J Cancer 2008 122: 2562-67.

Schem C, Maass N, Bauerschlag D et al. One-step nucleic acid amplification – a molecular method of lymph node metastases in breast cancer patients; results of the German study group. Virchows Arch 2009 454: 203-10.

Snook KL, Layer GT, Jackson P et al. Multicentre evaluation of intraoperative molecular analysis of sentinel lymph nodes in breast carcinoma. Br J Surg. 2010 Dec 23. [Epub ahead of print].

Khaddage A, Berremila SA, Forest F, Clemenson A, Bouteille C, Seffert P, Peoc'h M.Implementation of Molecular Intra-operative Assessment of Sentinel Lymph Node in Breast Cancer. Anticancer Res. 2011 Feb;31(2):585-90.

Prediction of the axillary Status

Osako T, Iwase T, Kimura K, Horii R, Akiyama F. Sentinel node tumour burden quantified based on cytokeratin 19 mRNA copy number predicts non-sentinel node metastases in breast cancer: Molecular whole-node analysis of all removed nodes. Eur J Cancer. 2012 Dec 19. pii: S0959-8049(12)00918-5. doi: 10.1016/j.ejca.2012.11.022.

Ohi Y, Umekita Y, Sagara Y, Rai Y, Yotsumoto D, Matsukata A, Baba S, Tamada S, Matsuyama Y, Ando M, Sagara Y, Sasaki M, Tsuchimochi S, Tanimoto A, Sagara Y. Whole sentinel lymph node analysis by a molecular assay predicts axillary node status in breast cancer. Br J Cancer. 2012 Aug 28. doi: 10.1038/bjc.2012.387.

Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antúnez JR, de Salas MS, Delgado-Sánchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Téllez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013 Apr 11. [Epub ahead of print]

Deambrogio C, Castellano I, Paganotti A, Zorini EO, Corsi F, Bussone R, Franchini R, Antona J, Miglio U, Sapino A, Antonacci C, Boldorini R. A new clinical cut-off of cytokeratin 19 mRNA copy number in sentinel lymph node better identifies patients eligible for axillary lymph node dissection in breast cancer. J Clin Pathol. 2014 Jun 6. pii: jclinpath-2014-202384. doi: 10.1136/jclinpath-2014-202384

Rubio IT, Espinosa-Bravo M, Rodrigo M, Diaz MA, Hardisson D, Sagasta A, Dueñas B, Peg V. Nomogram including the total tumoral load in the sentinel nodes assessed by one-step nucleic acid amplification as a new factor for predicting nonsentinel lymph node metastasis in breast cancer patients. Breast Cancer Res Treat. 2014 Sep;147(2):371-380. Epub 2014 Aug 28.

 

Colon Cancer

Journal of Translational Medicine (2017): Rakislova N. et al. Lymph node pooling: a feasible and efficient method of lymph node molecular staging in colorectal carcinoma
Core message: “LN pooling makes it possible to analyze a high number of LNs from surgical colectomies with few molecular tests per patient. This approach enables a feasible means to integrate LN molecular analysis from CC specimens into pathology diagnosis and provides a more accurate LN pathological staging with potential prognostic implications.”

Virchows Archiv (2016) Aldecoa I. et al. Molecularly determined total tumour load in lymph nodes of stage I-II colon cancer patients correlates with high-risk factors. A multicentre prospective study
Core message: OSNA allows the identification of tumour burden (undetected by hystology) in lymph nodes of early colon cancer patients. Moreover, the Total Tumour Load (TTL) determined by OSNA correlates with high-risk factors and may be used for a better selection of stage I–II patients at risk of recurrence.

Surgical Endoscopy (2016): Aldecoa I. et al. Endoscopic tattooing of early colon carcinoma enhances detection of lymph nodes most prone to harbor tumor burden
Core message: Endoscopic tattooing clearly improves identification of lymph nodes. Moreover, this method allows the detection of those lymph nodes most prone to carry tumor burden as demonstrated by the Total Tumour Load (TTL) values.

Annals of Surgical Oncology (2016): Yamamoto H. et al. OSNA-Assisted Molecular Staging in Colorectal Cancer: A Prospective Multicenter Trial in Japan
Core message: High concordance between OSNA and histology. Besides, the TTL values determined by OSNA show to increase as the number of metastatic lymph node increases showing a trend compatible to the current pathological diagnosis system.

Annals of Surgical Oncology (2014): Vogelaar FJ. et al. The diagnostic value of one-step nucleic acid amplification (OSNA) for sentinel lymph nodes in colon cancer patients
Core message: The OSNA method shows a performance comparable to multilevel fine pathological examination. Since it enables whole lymph node analysis, sampling bias can be avoided leading to a more accurate tumour staging.

British Journal of Cancer (2014): Croner RS. et al. Molecular staging of lymph node-negative colon carcinomas by one-step nucleic acid amplification (OSNA) results in upstaging of a quarter of patients in a prospective, European, multicentre study
Core message: More than 25% of initially pN0 patients were upstaged by OSNA suggesting that this standardized and accurate method may improve staging.

 Japanese Journal of Clinical Oncology (2013): Yamamoto N. et al. An optimal mRNA marker for OSNA (One-step nucleic acid amplification) based lymph node metastasis detection in colorectal cancer patients
Core message: A CK19 mRNA copy number cut-off of 75-500 copies/µl leads to a high sensitivity and specificity of the OSNA method.

Cancer (2012): Güller U. et al. Molecular investigation of lymph nodes in colon cancer patients using one-step nucleic acid amplification (OSNA): a new road to better staging?
Core message: The OSNA method shows comparable performance such as intensive histopathological evaluation and may lead to upstaging of more than 15% of colon cancer patients.

Annals of Surgical Oncology (2011): Yamamoto H. et al. OSNA-based novel molecular testing for lymph node metastases in colorectal cancer patients: results from a multicenter clinical performance study in Japan
Core message: OSNA can be considered a novel molecular examination tool for the staging of colon cancer patients.

Journal of Translational Medicine (2010): Croner RS. et al. One step nucleic acid amplification (OSNA) - a new method for lymph node staging in colorectal carcinomas
Core message: The OSNA method allows the rapid analysis of the whole node and can applied as tool to determine nodal status in colon cancer patients.

scalp cooling

Journal of the American Medical Association (2017): Rugo HS. et al.: Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer
Core Message: 66.3% of breast cancer patients with scalp cooling under chemotherapy experienced at least 50% hair loss or better at the end of the chemotherapy. This result is significantly better compared to the control group with no scalp cooling (0%).

Journal of the American Medical Association (2017): Hershman DL: Scalp Cooling to Prevent Chemotherapy-Induced Alopecia: The Time Has Come
“Identifying interventions, such as scalp cooling for the prevention of chemotherapy-induced alopecia, that reduce or eliminate treatment-associated toxic effects will help ease the distress associated with chemotherapy and may, as a result, improve outcomes for patients with breast cancer.”

Current Oncology (2016): Fehr MK. et al.: Sensor-controlled scalp cooling to prevent chemotherapy-induced alopecia in female cancer patients
“The ability of scalp cooling to prevent chemotherapy-induced alopecia varies with the chemotherapy regimen and the age of the patient. Use of a compound endpoint with subjective and objective measures provides insightful and practical information when counselling patients.”

Journal of Clinical Oncology (2016): Schaffrin-Nabe D. et al. Hair-mass-index (HMI) as indicator for the efficacy of scalp cooling (SC) and the associated quality of life (EORTC QLQ C30)
Core message: All breast cancer patients treated with scalp cooling had significantly better hair results independently validated with a trichometer. Quality of life was improved and less psychological strain was reported compared to patients without scalp cooling.

Journal of Clinical Oncology (2016): Millastre E. et al. A scalp cooling system designated to prevent chemotherapy-induced alopecia: our experience with implementation at a Spanish public hospital
Core message: Dignicap was found to be feasible, effective and well-tolerated for patients in preventing chemotherapy-induced alopecia.

Oncology Research and Treatment (2015): Schaffrin-Nabe D. et al. The influence of various parameters on the success of sensor-controlled scalp cooling in preventing chemotherapy-induced alopecia
Core message: Sensor-controlled scalp cooling with DigniLife revealed an effective addition to supportive cancer therapy. The success of scalp cooling depends on various factors, of which different applied CT regimen, menopausal status, systemic comorbidities, medication and nicotine abuse were explored.

Journal of Clinical Oncology (2015): Rugo HS. et al. Clinical performance of the DigniCap System, a scalp hypothermia system, in preventing chemotherapy induced alopecia
Core message: The DigniCap System prevented significant hair loss in more than 70% of breast cancer patients under adjuvant CT, compared 6% of the control group. Treatment was well tolerated and no scalp metastases occurred. The DigniCap System is regarded highly effective in reducing chemotherapy-induced alopecia.

Springerplus (2014): Friedrichs K. et al. Successful reduction of alopecia induced by anthracycline and taxane containing adjuvant chemotherapy in breast cancer – clinical evaluation of sensor-controlled scalp cooling
Core message: “The evaluation demonstrates that feedback-controlled scalp cooling provides a good chance for breast cancer patients to keep their hair even during (neo-)adjuvant chemotherapies, which are known to cause severe to complete alopecia without scalp cooling.”

Molecular and Clinical Oncology (2013): Ekwall EM. et al. Determination of the most effective cooling temperature for the prevention of chemotherapy-induced alopecia
Core message: “A pre set temperature of 3°C in the DigniCap system is most efficient in achieving a hair follicle temperature of <22°C. A higher incidence of side effects was associated with the lower applied temperature level of 5°C and 3°C.

Liquid biopsy

Annals of Oncology (2017): Grasselli J. et al. Concordance of blood- and tumor-based detection of RAS mutations to guide anti-EGFR therapy in mCRC
Core message: “Tumor tissue from 146 mCRC patients was tested for RAS status with standard of care (SoC) PCR techniques, and Digital PCR (BEAMing) was used both in plasma and tumor tissue. Plasma RAS determination showed high overall agreement and captured a mCRC population responsive to anti-EGFR therapy with the same predictive level as SoC tissue testing. The feasibility and practicality of ctDNA analysis may translate into an alternative tool for anti-EGFR treatment selection.”

Annals of Oncology (2017): Vidal J. et al. Plasma ctDNA RAS mutation analysis for the diagnosis and treatment monitoring of metastatic colorectal cancer patients
Core message: RAS in tissue and plasma samples from 115 mCRC patients showed a 93% overall agreement using the OncoBEAM™ RAS CRC assay. Monitoring of RAS ctDNA in patients RAS wt showed that OncoBEAM was useful to detect RAS mutations during anti-EGFR treatment. It was finally concluded that the high overall agreement in RAS mutational assessment between plasma and tissue supports blood-based testing with OncoBEAM™ as a viable alternative for genotyping RAS of mCRC patients and that it is useful to monitor RAS in patients undergoing systemic therapy to detect potential treatment resistances.

ASCO (2016): Jones F.S. et al. Performance of Standardized BEAMing Platform for Detecting RAS Mutations in the Blood of Metastatic Colorectal Cancer (mCRC) Patients
Core message: “The high overall agreement of plasma and tissue RAS testing results (93.3%) demonstrates that blood-based OncoBEAMTM RAS CRC testing is a viable alternative to tissue-based RAS testing. Plasma RAS testing also provides an opportunity to monitor tumor RAS mutation dynamics during therapy in patients with systemic disease.”

ESMO (2016): Saunders M.P. et al. Performance assessment of blood based RAS mutation testing: concordance of results obtained from prospectively collected samples
Core message: “The high overall agreement of plasma and tissue RAS testing results (92.2%) shows that OncoBEAMTM RAS CRC testing is a viable alternative to tissue-based testing in this prospective study. Analysis of discordants shows that differences between plasma and tissue RAS results may arise from tumour heterogeneity, disease evolution, low ctDNA shedding, or low tumour burden.”

Molecular Oncology (2016): Schmiegel W. et al.Blood-based detection of RAS mutations to guide anti-EGFR therapy in colorectal cancer patients: Concordance of results from circulating tumor DNA and tissue-based RAS testing
Core message: ”The high concordance of plasma and tissue results demonstrates that blood-based RAS mutation testing is a viable alternative to tissue-based RAS testing.”

Oncotarget (2016): Toledo R.A. et al. Clinical validation of prospective liquid biopsy monitoring in patients with wild-type RAS metastatic colorectal cancer treated with FOLFIRI-cetuximab
Core message: ”The current study provides evidences, obtained for the first time in an unbiased and prospective manner, that reinforces the utility of LqB for monitoring mCRC patients.”

Annals of Oncology (2015): Morelli M.P. et al. Characterizing the patterns of clonal selection in circulating tumor DNA from patients with colorectal cancer refractory to anti-EGFR treatment
Core message: ”Monitoring treatment-induced genetic alterations by sequencing ctDNA could identify biomarkers for treatment screening in anti-EGFR-refractory patients.”

The Lancet Oncology (2015): Tabernero J. et al. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial
Core message: BEAMing of circulating tumour DNA allowed the non-invasive analysis of tumour genotype in real time and the detection of tumour-associated mutations.

Nature (2012): Misale S. et al. Emergence of KRAS mutations and acquired resistance to anti-EGFR therapy in colorectal cancer
Core message: “…our results suggest that blood-based non-invasive monitoring of patients undergoing treatment with anti-EGFR therapies for the emergence of KRAS mutant clones could allow for the early initiation of combination therapies that may delay or prevent disease progression.”

Nature Medicine (2008): Diehl F. et al. Circulating mutant DNA to assess tumor dynamics
Core message: “We found that ctDNA measurements could be used to reliably monitor tumor dynamics in subjects with cancer who were undergoing surgery or chemotherapy. We suggest that this personalized genetic approach could be generally applied to individuals with other types of cancer.”

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