Dataset Information

IRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.

ABSTRACT: Tumours respond differently to immunotherapies compared with chemotherapeutic drugs, raising questions about the assessment of changes in tumour burden-a mainstay of evaluation of cancer therapeutics that provides key information about objective response and disease progression. A consensus guideline-iRECIST-was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent design and data collection, facilitate the ongoing collection of trial data, and ultimate validation of the guideline. This guideline describes a standard approach to solid tumour measurements and definitions for objective change in tumour size for use in trials in which an immunotherapy is used. Additionally, it defines the minimum datapoints required from future trials and those currently in development to facilitate the compilation of a data warehouse to use to later validate iRECIST. An unprecedented number of trials have been done, initiated, or are planned to test new immune modulators for cancer therapy using a variety of modified response criteria. This guideline will allow consistent conduct, interpretation, and analysis of trials of immunotherapies.

SUBMITTER: Seymour L

PROVIDER: S-EPMC5648544 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Seymour Lesley L Bogaerts Jan J Perrone Andrea A Ford Robert R Schwartz Lawrence H LH Mandrekar Sumithra S Lin Nancy U NU Litière Saskia S Dancey Janet J Chen Alice A Hodi F Stephen FS Therasse Patrick P Hoekstra Otto S OS Shankar Lalitha K LK Wolchok Jedd D JD Ballinger Marcus M Caramella Caroline C de Vries Elisabeth G E EGE

The Lancet. Oncology 20170302 3

Tumours respond differently to immunotherapies compared with chemotherapeutic drugs, raising questions about the assessment of changes in tumour burden-a mainstay of evaluation of cancer therapeutics that provides key information about objective response and disease progression. A consensus guideline-iRECIST-was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent desi ...[more]

PMID: 28271869

Similar Datasets

Project description:BackgroundFor clinically appropriate early-stage breast cancer patients, reflex criteria for Oncotype DX ordering ("the intervention") were implemented at our comprehensive cancer center, which reduced time-to-adjuvant chemotherapy initiation. Our objective was to evaluate Oncotype DX ordering practices and chemotherapy use before and after implementation of the intervention.Materials and methodsWe examined medical records for 498 patients who had definitive breast cancer surgery at our center. The post-intervention cohort consisted of 232 consecutive patients who had Oncotype DX testing after reflex criteria implementation. This group was compared to a retrospective cohort of 266 patients who were diagnosed and treated prior to reflex criteria implementation, including patients who did and did not have Oncotype DX ordered. Factors associated with Oncotype DX ordering pre- and post-intervention were examined. We used multivariate logistic regression to evaluate factors associated with chemotherapy receipt among patients with Oncotype DX testing.ResultsThe distribution of Oncotype DX scores, the proportion of those having Oncotype DX testing (28.9% vs. 34.1%) and those receiving chemotherapy (14.3% vs. 19.4%), did not significantly change between pre- and post-intervention groups. Age ≤65 years, stage II, grade 2, 1-3+ nodes, and tumor size >2 cm were associated with higher odds of Oncotype DX testing. Among patients having Oncotype DX testing, node status and Oncotype DX scores were significantly associated with chemotherapy receipt.ConclusionOur criteria for reflex Oncotype DX ordering appropriately targeted patients for whom Oncotype DX would typically be ordered by providers. No significant change in the rate of Oncotype DX ordering or chemotherapy use was observed after reflex testing implementation.Implications for practiceThis study demonstrates that implementing multidisciplinary consensus reflex criteria for Oncotype DX ordering maintains a stable Oncotype DX ordering rate and chemotherapy rate, mirroring what was observed in a specific clinical practice, while decreasing treatment delays due to additional testing. These reflex criteria appropriately capture patients who would likely have had Oncotype DX ordered by their providers and for whom the test results are predicted to influence management. This intervention serves as a potential model for other large integrated, multidisciplinary oncology centers to institute processes targeting patient populations most likely to benefit from genomic assay testing, while mitigating treatment delays.

Project description:Purpose of reviewBecause of the epidemiological incidence of anterior cruciate ligament (ACL) injuries, the high reinjury rates that occur when returning back to sports, the actual number of patients that return to the same premorbid level of competition, the high incidence of osteoarthritis at 5-10-year follow-ups, and the effects on the long-term health of the knee and the quality of life for the patient, individualizing the return to sports after ACL reconstruction (ACL-R) is critical. However, one of the challenging but unsolved dilemmas is what criteria and clinical decision making should be used to return an athlete back to sports following an ACL-R. This article describes an example of a functional testing algorithm (FTA) as one method for clinical decision making based on quantitative and qualitative testing and assessment utilized to make informed decisions to return an athlete to their sports safely and without compromised performance. The methods were a review of the best current evidence to support a FTA.Recent findingsIn order to evaluate all the complicated domains of the clinical decision making for individualizing the return to sports after ACL-R, numerous assessments need to be performed including the biopsychosocial concepts, impairment testing, strength and power testing, functional testing, and patient-reported outcomes (PROs). The optimum criteria to use for individualizing the return to sports after ACL-R remain elusive. However, since this decision needs to be made on a regular basis with the safety and performance factors of the patient involved, this FTA provides one method of quantitatively and qualitatively making the decisions. Admittedly, there is no predictive validity of this system, but it does provide practical guidelines to facilitate the clinical decision making process for return to sports. The clinical decision to return an athlete back into competition has significant implications ranging from the safety of the athlete, to performance factors and actual litigation issues. By using a multifactorial FTA, such as the one described, provides quantitative and qualitatively criteria to make an informed decision in the best interests of the athlete.

Dataset Information

IRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets