Pearls and pitfalls of response evaluation criteria in solid tumors (RECIST) v1.1 non-target lesion assessment

Purpose Treating solid tumors with cancer immunotherapy (CIT) can result in unconventional responses and overall survival (OS) benefits that are not adequately captured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. We describe immune-modified RECIST (imRECIST) criteria, designed to better capture CIT responses. Patients and Methods Atezolizumab data from clinical trials in non–small-cell lung cancer, metastatic urothelial carcinoma, renal cell carcinoma, and melanoma were evaluated. Modifications to imRECIST versus RECIST v1.1 included allowance for best overall response after progressive disease (PD) and changes in PD definitions per new lesions (NLs) and nontarget lesions. imRECIST progression-free survival (PFS) did not count initial PD as an event if the subsequent scan showed disease control. OS was evaluated using conditional landmarks in patients whose PFS differed by imRECIST versus RECIST v1.1. Results The best overall response was 1% to 2% greater, the disease control rate was 8% to 13% greater, and the median PFS was 0.5 to 1.5 months longer per imRECIST versus RECIST v1.1. Extension of imRECIST PFS versus RECIST v1.1 PFS was associated with longer or similar OS. Patterns of progression analysis revealed that patients who developed NLs without target lesion (TL) progression had a similar or shorter OS compared with patients with RECIST v1.1 TL progression. Patients infrequently experienced a spike pattern (TLs increase, then decrease) but had longer OS than patients without TL reversion. Conclusion Evaluation of PFS and patterns of response and progression revealed that allowance for TL reversion from PD per imRECIST may better identify patients with OS benefit. Progression defined by the isolated appearance of NLs, however, is not associated with longer OS. These results may inform additional modifications to radiographic criteria (including imRECIST) to better reflect efficacy with CIT agents.

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Response Evaluation Criteria in Solid Tumors Response of the Primary Lesion in Metastatic Renal Cell Carcinomas Treated With Sunitinib: Does the Primary Lesion Have to Be Regarded as a Target Lesion?

Clinical Genitourinary Cancer ◽

10.1016/j.clgc.2012.12.005 ◽

2013 ◽

Vol 11 (3) ◽

pp. 276-282 ◽

Cited By ~ 1

Author(s):

Inkeun Park ◽

Kwonoh Park ◽

Seongjoon Park ◽

Yongcheol Ahn ◽

Jin-Hee Ahn ◽

...

Keyword(s):

Solid Tumors ◽

Renal Cell ◽

Evaluation Criteria ◽

Target Lesion ◽

Primary Lesion ◽

Response Evaluation ◽

Renal Cell Carcinomas ◽

Response Evaluation Criteria

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Practical consensus recommendations - Current role of immune response evaluation criteria in solid tumors criteria in the management of cancer patients receiving immunotherapy

International Journal of Molecular and Immuno Oncology ◽

10.25259/ijmio-6-2019 ◽

2019 ◽

Vol 4 ◽

pp. 21-23

Author(s):

Purvish M. Parikh ◽

T. P. Sahoo ◽

Randeep Singh ◽

Bahl Ankur ◽

Talvar Vineet ◽

...

Keyword(s):

Immune Response ◽

Solid Tumors ◽

Evaluation Criteria ◽

Supporting Evidence ◽

Response Evaluation ◽

Consensus Recommendation ◽

Current Role ◽

New Class ◽

Response Evaluation Criteria

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.

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Concordance of Carcinoembryonic Antigen Ratio and Response Evaluation Criteria in Solid Tumors as Prognostic Surrogate Indicators of Metastatic Colorectal Cancer Patients Treated with Chemotherapy

Annals of Surgical Oncology ◽

10.1245/s10434-014-4228-y ◽

2015 ◽

Vol 22 (7) ◽

pp. 2262-2268 ◽

Cited By ~ 16

Author(s):

Sheng-Chieh Huang ◽

Jen-Kou Lin ◽

Tzu-Chen Lin ◽

Wei-Shone Chen ◽

Shung-Haur Yang ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Carcinoembryonic Antigen ◽

Cancer Patients ◽

Solid Tumors ◽

Evaluation Criteria ◽

Response Evaluation ◽

Colorectal Cancer Patients ◽

Response Evaluation Criteria

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Chemosaturation durch perkutane hepatische Perfusion mit Melphalan bei hepatisch metastasiertem Aderhautmelanom: eine Überlebens- und Sicherheitsanalyse

TumorDiagnostik & Therapie ◽

10.1055/a-1557-6995 ◽

2021 ◽

Vol 42 (08) ◽

pp. 576-584

Author(s):

Cornelia Lieselotte Angelika Dewald ◽

Jan B. Hinrichs ◽

Lena Sophie Becker ◽

Sabine Maschke ◽

Timo C. Meine ◽

...

Keyword(s):

Disease Control ◽

Solid Tumors ◽

Overall Response Rate ◽

Response Rate ◽

Evaluation Criteria ◽

Progressionsfreies Überleben ◽

Response Evaluation ◽

Ischämischer Insult ◽

Kaplan Meier ◽

Response Evaluation Criteria

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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