iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

Seymour, Lesley; Bogaerts, Jan; Perrone, Andrea; Ford, Robert; Schwartz, Lawrence H.; Mandrekar, Sumithra J.; Lin, Nancy U.; Litière, Saskia; Dancey, Janet; Chen, Alice; Hodi, F. Stephen; Therasse, Patrick; Hoekstra, Otto S.; Shankar, Lalitha; Wolchok, Jedd D.; Ballinger, Marcus; Caramella, Caroline; Vries, Elisabeth G.E. de

doi:10.1016/s1470-2045(17)30074-8

Cited by 1,760 publications

(1,524 citation statements)

References 35 publications

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“…Consequently, antitumor response to immunotherapy may be significantly longer compared to that of targeted therapies [26]. To address this issue, immune RECIST (iRECIST) were developed, which provide better assessment of the effect of therapy [27]. Here, the bar will be reset if RECIST progressive disease is followed at the next timepoint by tumor shrinkage.…”

Section: Response Assessment Of Icpismentioning

confidence: 99%

Implications of Immunotherapy in Hepatobiliary Tumors

2019

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Hepatocellular carcinoma (HCC) remains one of the leading causes of cancer-related death worldwide. Upon ineligibility for resection, liver transplantation, or locoregional therapies, sorafenib has been the only systemic treatment option of advanced HCC for more than a decade. Immunotherapy is an evolving HCC treatment option that has shown promise in treatment efficacy at an acceptable safety profile during several preceding phase I/II trials. Numerous clinical trials of immune checkpoint inhibitors (ICPIs) alone, in combination of two, or combined with other targeted or locoregional therapies are ongoing. Encouraging results of two-phase III trials testing pembrolizumab or nivolumab versus standard care therapy even resulted in Food and Drug Administration approval for second-line treatment of advanced HCC. ICPIs may open new avenues to the treatment of hepatobiliary tumors, alone or in combination.

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Section: Response Assessment Of Icpismentioning

confidence: 99%

Implications of Immunotherapy in Hepatobiliary Tumors

2019

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“…Bei anderen Krebsarten wurde unter der Immuntherapie eine Pseudoprogression spinaler Metastasen beschrieben, darunter auch ein Fallbericht über einen Patienten mit Melanom, der mit Immuncheckpoint-Inhibitoren und Bestrahlung behandelt wurde [25]. Aufgrund solcher atypischer Ansprechmuster wurden neue Kriterien zur Beurteilung des Ansprechens wie die Immune-related Response Criteria (irRC) und die modifizierten Response Evaluation Criteria in Solid Tumors (iRECIST) vorgeschlagen, allerdings bislang noch nicht vollständig umgesetzt [21,26]. …”

Section: Diskussionunclassified

Atypisches Ansprechen mit Pseudoprogression im Knochen unter Nivolumab bei einem Patienten mit fortgeschrittenem kutanem Plattenepithelkarzinom

et al. 2019

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Derzeit existiert keine etablierte Standardtherapie für Patienten mit metastasiertem cSCC. Wegen der Pathomechanismen, die bei der Karzinogenese des kutanen Plattenepithelkarzinoms eine Rolle spielen, wurde postuliert, dass diese Tumoren möglicherweise durch eine PD-1/PD-L1-Blockade beeinflussbar sind. Der vorliegende Bericht beschreibt den Fall eines Patienten, der wegen eines kutanen Plattenepithelkarzinoms mit Lymphknotenbeteiligung und Lungenmetastasen, das gegenüber 2 Therapielinien mit platinbasierten Schemata und Salvage-Operation refraktär war, eine Behandlung mit Nivolumab erhielt. Der klinische Verlauf war durch ein atypisches Ansprechmuster mit initialem Rückgang der Weichteilläsionen/viszeralen Läsionen bei gleichzeitig neu auftretenden Knochenläsionen gekennzeichnet. In den anschließenden bildgebenden Untersuchungen zeigten sich insgesamt eine Verbesserung und eine anhaltende Krankheitskontrolle unter Fortführung der Therapie. Im vorliegenden Fall erhielt der Patient mit metastasiertem therapierefraktärem cSCC eine Immuntherapie und entwickelte ein atypisches Ansprechmuster.

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“…RECIST response is likely not a reliable marker of response to immunotherapy. Recent studies support using iRECIST and 6 month PFS as having a greater association with survival for immunotherapies [80,81]. Patients with stable disease by RECIST criteria may also be clinically significant and should be taken into account, particularly if durable.…”

Section: Measurable Tumor Response Rates In Positive and Negative Phamentioning

confidence: 99%

Can RECIST response predict success in phase 3 trials in men with metastatic castration-resistant prostate cancer?

Brown

Sonpavde

Armstrong

2018

Prostate Cancer Prostatic Dis

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Background Intermediate endpoints are needed in early phase studies of men with metastatic castration-resistant prostate cancer (mCRPC) that can reliably predict success in phase 3 trials. Among men with measurable disease, objective response may provide information as to whether a treatment is likely to be successful. Methods We conducted a systematic review of systemic agents that have proceeded to phase 3 trials in men with mCRPC and examined the relationship between improvements in measurable disease response in phase 2 trials and successful phase 3 trials leading to regulatory approval. Only trials that included men with radiographically measurable disease were included. Results We examined 31 eligible mCRPC phase 3 trials between 1992 and 2017 and 29 of the preceding phase 2 trials for RECIST responses. Measurable tumor responses in phase 2 trials were higher for successful therapies in phase 3 trials in chemotherapy-naive men with mCRPC, but were less correlated with success in trials investigating docetaxel combination regimens or the post chemotherapy mCRPC setting. Many failed agents did not produce higher than expected response rates over control arms; however, several agents such as anti-angiogenic therapies or orteronel produced higher than expected responses without survival benefit. Conclusions Objective responses in men with mCRPC may be associated with prolonged survival, but this association is mechanism dependent and inconsistent across trials or disease states. These data support considering RECIST response as a supportive but not sole endpoint in phase 2 trials to support launching phase 3 trials.

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iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

Cited by 1,760 publications

References 35 publications

Implications of Immunotherapy in Hepatobiliary Tumors

Implications of Immunotherapy in Hepatobiliary Tumors

Atypisches Ansprechen mit Pseudoprogression im Knochen unter Nivolumab bei einem Patienten mit fortgeschrittenem kutanem Plattenepithelkarzinom

Can RECIST response predict success in phase 3 trials in men with metastatic castration-resistant prostate cancer?

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