scholarly journals Proposing Response Evaluation Criteria in Solid Tumors Based on Genomic Profiling or Genomic RECIST: A Retrospective Study on the Liquid Biopsy Results of 29 Cancer Patients

Author(s):  
Khin Zay Yar Myint ◽  
Junichi Taguchi ◽  
Masamori Shimabuku ◽  
Kenichi Kashihara ◽  
Ruriko Horio ◽  
...  

Tumor response and disease progression are assessed using imaging technologies. However, these technologies fail to detect tumor responses at the molecular level and clonal evolution. A potential surrogate for such parameters is using circulating tumor DNA (ctDNA). This study aimed to examine the quantity and composition of the ctDNA results of 29 cancer patients before and after dendritic cell (DC) immunotherapy and develop criteria to evaluate the molecular response to treatment based on these results. We categorized the patients into four categories based on percent changes in the total ctDNA compared with the baseline ctDNA titers, and this response assessment was termed genomic response evaluation criteria in solid tumors or gRECIST. Even those who are clinically evaluated as having a good response might harbor unfavorable tumor responses at the molecular level. Newly formed ctDNA levels can be the most prognostic parameter in tumor progression or the treatment response, while ctDNA clearance and the decline or rise in existing ctDNA did not change significantly in genomic response categories (gRECIST). More research is needed to support the clinical use of ctDNA in precision oncology and personalized cancer treatment.

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6603-6603 ◽  
Author(s):  
K. Borradaile ◽  
R. Ford

6603 Background: RECIST suggests progression of non-target disease is rare in patients with stable or responding target disease. We reviewed outcomes by RECIST to determine the rate of non-target (NT) progressive disease (PD). Methods: Outcomes of RECIST-based blinded independent central review (BICR) of 962 breast and colon cancer patients were used to identify 514 patients that had a progression event in order to determine the incidence of NT-PD. The radiographs of the 55 patients that had NT-PD were further reviewed by the authors (KB, RF) to confirm the NT-PD was “unequivocal.” To be considered unequivocal, there had to be a definite, substantial increase in the size of one or more metastatic NT lesions that was clearly not related to differences in imaging technique. To confirm the subjective nature of the “unequivocal progression,” the lesion(s) upon which PD was assessed was measured and a 20% increase in the lesion(s) since nadir was required. Results: Of the patients with PD, 11% (55/514) progressed only on worsening of NT disease. In 82% (45/55) of cases where the NT-PD was unequivocal, either the target disease was increasing but had not met the quantitative requirement for progression or the increase in NT disease would have resulted in target progression had the NT site(s) of disease been included with the baseline target lesions. Of the remaining 18% (10/55) where the two criteria described above did not apply, and an additional evaluation was performed, the next evaluation confirmed PD. Conclusions: Progression on the basis of NT disease can be reliably assessed if the target disease has started to increase from the nadir or if the increase in NT disease is significant enough to have resulted in target disease progression if classified as such. If one of the above criteria is not met, it is recommended that treatment continue until progression can be confirmed at the next evaluation. No significant financial relationships to disclose.


2019 ◽  
Vol 4 ◽  
pp. 21-23
Author(s):  
Purvish M. Parikh ◽  
T. P. Sahoo ◽  
Randeep Singh ◽  
Bahl Ankur ◽  
Talvar Vineet ◽  
...  

Response evaluation criteria in solid tumors (RECIST) are a method used to evaluate and document the response to cancer treatment in solid tumors. The availability of a new class of immuneoncology drugs has resulted in the need to modify RECIST criteria methodology. The first leadership immuno-oncology network (LION) master course brought together experts in oncology and immuno-oncology. Six questions were put to the experts and their opinion, supporting evidence, and experience were discussed to arrive at a practical consensus recommendation. n this nascent field, the availability of a practical consensus recommendation developed by experts in the field is of immense value to the community oncologist and other health-care consultants.


2021 ◽  
Vol 42 (08) ◽  
pp. 576-584
Author(s):  
Cornelia Lieselotte Angelika Dewald ◽  
Jan B. Hinrichs ◽  
Lena Sophie Becker ◽  
Sabine Maschke ◽  
Timo C. Meine ◽  
...  

Ziel Die Chemosaturation mittels perkutaner hepatischer Perfusion mit Melphalan (CS-PHP) ist ein palliatives Therapieverfahren für Patienten mit nicht kurativ behandelbaren Lebertumoren. Die CS-PHP erlaubt eine selektive intrahepatische Anreicherung von hochdosiertem Melphalan bei minimaler systemischer Toxizität durch venöse Hämofiltration. Ziel dieser Studie war es, das Ansprechen und Überleben sowie die Sicherheit der CS-PHP-Prozedur bei Patienten mit leberdominant metastasiertem Aderhautmelanom zu evaluieren. Material und Methoden Gesamtansprechrate (overall response rate, ORR) und Krankheitskontrollrate (disease control rate, DCR) wurden anhand von Response Evaluation Criteria In Solid Tumors (RECIST1.1) ermittelt. Medianes Gesamtüberleben (mOS), medianes progressionsfreies Überleben (mPFS) und hepatisches mPFS (mhPFS) wurden mittels Kaplan-Meier-Schätzer ermittelt. Nebenwirkungen wurden entsprechend der einheitlichen Terminologie-Kriterien für Nebenwirkungen (CTCAE) v5 klassifiziert. Ergebnisse 30 Patienten wurden zwischen Oktober 2014 und Januar 2019 mit 70 Chemosaturationen behandelt. Die ORR betrug 42,3 % und die DCR 80,8 %. Das mOS betrug 12 (95 %-Konfidenzintervall (KI) 7–15) Monate, das mPFS 6 (95 %-KI 4–10) und das mhPFS ebenfalls 6 (95 %-KI 4–13) Monate. Signifikante, aber transiente hämatotoxische Nebenwirkungen waren häufig (87 % Grad-3/4-Thrombozytopenie), hepatische Toxizität bis Leberversagen (n = 1/70) sowie kardiovaskuläre Komplikationen (ischämischer Insult, n = 1/70) waren selten. Schlussfolgerung Das palliative Therapiekonzept der Chemosaturation ist bei Patienten mit hepatisch metastasiertem Aderhautmelanom effektiv. Die interventionelle Prozedur ist sicher, seltene, aber schwerwiegende kardiovaskuläre und hepatische Komplikationen erfordern eine sorgfältige Patientenselektion und intensive Aufmerksamkeit.


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