RECIST 1.1, mRECIST 1.1: RADIOLOGICAL ASSESSMENT OF TUMOR RESPONSE TO CHEMOTHERAPY (literature review)

Vestnik ◽  
2021 ◽  
pp. 291-295
Author(s):  
Ж.Ж. Жолдыбай ◽  
Г.И. Хуснутдинова ◽  
Ж.К. Жакенова ◽  
С.Е. Есентаева ◽  
А.Н. Ахмульдинова ◽  
...  

Определение изменений опухолевого роста является важной характеристикой клинической оценки терапии рака - как уменьшение размеров опухоли (объективный ответ), так и прогрессирование заболевания являются полезными конечными точками клинических исследований. Критерии RECIST были впервые опубликованы в 2000 г. и с тех пор начали применяться в мировой онкологической практике для оценки эффективности лечения. В 2009 году критерии RECIST 1.0 были пересмотрены и дополнены новыми данными RECIST 1.1 (2009 г.). Учитывая применение химиотаргетной терапии и особенности ответа на нее опухоли, предложены SACT критерии, модифицированные критерии RECIST (mRECIST) как способ адаптации критериев RECIST. Современные знания критериев оценки лечения солидных опухолей поможет лучевым диагностам правильно интерпретировать результаты исследований. В работе представлен обзор научных исследований по критериям оценки опухолевого ответа на лечение по данным радиологических исследований. Determining of tumor changes is an important characteristic of the clinical evaluation of cancer therapy - both tumor shrinkage (objective response) and disease progression are useful endpoints of clinical trials. The RECIST criteria were first published in 2000 and since then have been used in the global oncological practice to assess the effectiveness of treatment. In 2009, the RECIST 1.0 criteria were revised and supplemented with new data from RECIST 1.1 (2009). Taking into account the use of target chemotherapy and the peculiarities of the tumor response to it, the SACT criteria and modified RECIST criteria (mRECIST) are proposed as a way to adapt the RECIST criteria. Modern knowledge of the criteria for ASSESSMENT OF TUMOR RESPONSE will help radiologyst to correctly interpret the research results. The paper provides an overview of scientific studies on the criteria for evaluating tumor response to treatment based on radiological studies.

1997 ◽  
Vol 2 (3) ◽  
pp. E1
Author(s):  
Roger J. Packer ◽  
Joanne Ater ◽  
Jeffrey Allen ◽  
Peter Phillips ◽  
Russell Geyer ◽  
...  

The optimum treatment of nonresectable low-grade gliomas of childhood remains undecided. There has been increased interest in the use of chemotherapy for young children, but little information concerning the long-term efficacy of such treatment. Seventy-eight children with a mean age of 3 years (range 3 months-16 years) who had newly diagnosed, progressive low-grade gliomas were treated with combined carboplatin and vincristine chemotherapy. The patients were followed for a median of 30 months from diagnosis, with 31 patients followed for more than 3 years. Fifty-eight children had diencephalic tumors, 12 had brainstem gliomas, and three had diffuse leptomeningeal gliomas. Forty-four (56%) of 78 patients showed an objective response to treatment. Progression-free survival rates were 75 ± 6% at 2 years and 68 ± 7% at 3 years. There was no statistical difference in progression-free survival rates between children with neurofibromatosis Type 1 and those without the disease (2-year, progression-free survival 79 ± 11% vs. 75 ± 6%, respectively). The histological subtype of the tumor, its location, and its maximum response to chemotherapy did not have an impact on the duration of disease control. The only significant prognostic factor was age: children 5 years old or younger at the time of treatment had a 3-year progression-free survival rate of 74 ± 7% compared with a rate of 39 ± 21% in older children (p < 0.01). Treatment with carboplatin and vincristine is effective, especially in younger children, in controlling newly diagnosed progressive low-grade gliomas.


2018 ◽  
Vol 104 (2) ◽  
pp. 88-95 ◽  
Author(s):  
Alessandro Inno ◽  
Giuseppe Lo Russo ◽  
Matteo Salgarello ◽  
Giulia Corrao ◽  
Raffaella Casolino ◽  
...  

The objective response is an important endpoint to evaluate clinical activity of new anticancer drugs. Standardized criteria for evaluating response are needed for comparing results of different trials and represent the basis for advances in cancer therapy. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 are the most used in clinical practice and in clinical trials; however, they are not able to capture atypical responses seen with immunotherapy drugs. We describe the evolution of response criteria with a special focus on the immune-related criteria.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12651-e12651
Author(s):  
John A Cole ◽  
Joseph R Peterson ◽  
Tyler M Earnest ◽  
Micahel J Hallock ◽  
John R Pfeiffer ◽  
...  

e12651 Background: Nutrient and drug penetration into any solid tumor are critical determinants of the tumor's response to treatment. They depend on both the density of microvasculature within the tumor microenvironment, as well as the exchange rates of nutrients between the microvasculature and the extracellular space. But these parameters are heterogenous, varying considerably from location to location within the tumor and surrounding tissues. The Toft's model and its analogues date back to the early 1990s, and have been used to estimate vascular density, exchange rates, and extracellular-extravascular volume in a spatially-resolved manner using dynamic contrast enhaced (DCE) MRI's. Unfortunately, accurately extracting kinetic parameters from a DCE time-series requires the images to have a time-resolution of just a few seconds, which is rarely done in clinical practice. Methods: We employ a custom designed parallel algorithm to fit DCE MRI data to an exactly-solved ODE model of tissue perfusion kinetics. Results: Here we describe a simplified model of tissue perfusion that can be fit to DCE time traces with temporal resolutions of 90 seconds or more. We show that for many breast tumors, the vascular density and tissue-vascular exchange rate are such that they give rise to a halo of fast-perfusing tissue on the tumor periphery, and slower-perfusing tissue inside. We then use this model as part of a more comprehensive tumor simulation methodology to predict how different patients will respond to neoadjuvant chemotherapy (NACT). We find that the incorporation of our microvascular model gives rise to significantly more accurate predictions of post-treatment tumor volume. Conclusions: Performing perfusion kinetics analyses on clinical MRIs is both challenging, but critical for accurately predicting how a patient will respond to treatment. Our model, which relaxes the requirement for fine DCE temporal resolution, allows for these analyses to be performed on a larger swath of patients without the need for small volumes of interest, or ultra-fast MRI techniques. Moreover, when used within a broader tumor-modeling framework, our model increases the accuracy of predictions of tumor response to NACT.


1997 ◽  
Vol 86 (5) ◽  
pp. 747-754 ◽  
Author(s):  
Roger J. Packer ◽  
Joanne Ater ◽  
Jeffrey Allen ◽  
Peter Phillips ◽  
Russell Geyer ◽  
...  

✓ The optimum treatment of nonresectable low-grade gliomas of childhood remains undecided. There has been increased interest in the use of chemotherapy for young children, but little information concerning the long-term efficacy of such treatment. Seventy-eight children with a mean age of 3 years (range 3 months—16 years) who had newly diagnosed, progressive low-grade gliomas were treated with combined carboplatin and vincristine chemotherapy. The patients were followed for a median of 30 months from diagnosis, with 31 patients followed for more than 3 years. Fifty-eight children had diencephalic tumors, 12 had brainstem gliomas, and three had diffuse leptomeningeal gliomas. Forty-four (56%) of 78 patients showed an objective response to treatment. Progression-free survival rates were 75 ± 6% at 2 years and 68 ± 7% at 3 years. There was no statistical difference in progression-free survival rates between children with neurofibromatosis Type 1 and those without the disease (2-year, progression-free survival 79 ± 11% vs. 75 ± 6%, respectively). The histological subtype of the tumor, its location, and its maximum response to chemotherapy did not have an impact on the duration of disease control. The only significant prognostic factor was age: children 5 years old or younger at the time of treatment had a 3-year progression-free survival rate of 74 ± 7% compared with a rate of 39 ± 21% in older children (p < 0.01). Treatment with carboplatin and vincristine is effective, especially in younger children, in controlling newly diagnosed progressive low-grade gliomas.


2019 ◽  
Vol 8 (1) ◽  
pp. 1
Author(s):  
Stanislaw R. Burzynski ◽  
Tomasz Janicki ◽  
Samuel Beenken

Treatment of recurrent glioblastoma multiforme (rGBM) poses a difficult challenge. Therefore, the purpose of this report was to evaluate objective response (OR), progression-free survival (PFS), overall survival (OS), and the incidence of adverse events (AEs) in rGBM patients, age 19-70 years, who were treated with antineoplaston AS2-1 (Astugenal) plus targeted therapy. A retrospective analysis was performed. Tumor response was assessed by gadolinium-enhanced magnetic resonance imaging (MRI). Twenty-nine adult rGBM patients were treated between 9/11/2015 and 06/23/2018. Seven had no prior treatment with bevacizumab elsewhere, had radiologic evidence of rGBM, and had MRI assessment of tumor response. The median treatment time was 101 days (range: 55-208 days). OR was seen in six patients (85.7%) with complete disappearance of gadolinium enhancement in four patients (57.1%) and a 50% or greater reduction in gadolinium enhancement in two patients (28.6%). Progressive disease was seen in one patient (14.3%). The median time to first response was 29 days (range: 22-96 days) while the median duration of response was 141 days (range 55-739+ days). Six- and 12-month PFS was 57% and 19%, respectively while 6- and 12-month OS at was 86% and 54%, respectively. Treatment was well-tolerated with no patients experiencing grade 3 or 4 antineoplaston-related toxicity. Regarding response to treatment and toxicity, AS2-1 plus targeted therapy compares favorably with other reported rGBM therapies. Duration of response was shortened by the ill-advised decision of some patients to discontinue treatment after a tumor response was achieved. &nbsp;


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 766-766
Author(s):  
Jung Han Kim ◽  
Hyun Joo Jang ◽  
Hyeong Su Kim ◽  
Hun Ho Song ◽  
Dae Young Zang

766 Background: The Response Evaluation Criteria in Solid Tumors Guidelines version 1.1 (RECIST 1.1) adopted a total of five target lesions to be measured, with a maximum of two lesions per organ. To the best of our knowledge, the criterion of two target lesions per organ in the RECIST 1.1 is arbitrary and has not been supported by any objective evidence. We hypothesized that measuring the single largest lesion in each organ (modified RECIST 1.1; mRECIST 1.1) might show almost the same response classification as measuring two target lesions per organ (RECIST 1.1). Methods: We compared tumor responses according to the modified RECIST 1.1 and RECIST 1.1 using computed tomography in patients with advanced gastric cancer (GC) or colorectal cancer (CRC) who received a first-line chemotherapy. Results: A total of 89 patients who had at least two target lesions in any organ according to the RECIST 1.1 were included: 51 with GC and 38 with CRC. Regardless of the primary sites, the number of target lesions according to the modified RECIST 1.1 was significantly lower than that according to the RECIST 1.1 (p < 0.001). The assessment of tumor responses showed a high concordance between the two criteria, with a kappa value of 0.906 (95% CI, 0.826-0.986). Only five patients (5.6%) showed disagreement in the tumor response assessment between the two criteria: 3 in GC and 2 in CRC. Four patients showed disagreement between PR and SD, and one showed disagreement between SD and PD. The overall response rates of chemotherapy, which were calculated regardless of the primary sites and anti-cancer treatment, were not significantly different between the two criteria (42.7% versus 42.7%, p = 1.0) (Table). Conclusions: The modified RECIST 1.1, with a decreased number of target lesions, was comparable to the original RECIST 1.1 in the assessment of tumor response in patients with advanced GC or CRC. Our results suggest that it may be possible to measure the single largest lesion per organ for assessing tumor response. [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18053-e18053
Author(s):  
Stephen Raskin ◽  
Eyal Klang ◽  
Tehila Kharizman ◽  
Eli Konen ◽  
Raanan Berger ◽  
...  

e18053 Background: RECIST, among methodologies designed to provide an objective assessment of tumor response to therapy, is based on the measurement of Target Lesions (TLs) and classification of response according to an objective scale of beneficial response or progressive disease (PD). The “PD point” (the time-point at which RECIST 1.1 first classifies the trial as PD) is a common end-point in clinical trials and is defined as that point when the objective response rate is > 20%. However, RECIST also allows for the subjective assessment of non-TL lesions (NTLs) and new lesions (NLs) to determine the PD point. We sought to determine which of these parameters was most influential in determining PD. Methods: We evaluated the formal RECIST 1.1 assessments for consecutive patient enrollments in randomized clinical trials prepared by two senior radiologists at our institution from 2013 through 2018. Data was evaluated at the “PD point.” Results: There were 1260 patients, with 4499 CT or MRI scans. Of these, 581 trials concluded with PD. There were seven groups (+/-/-, -/+/-, -/-/+ . . . +/+/+) according to the status of TLs, NTLs, and NLs at the PD point. In 538 patients (92.6%), TLs were unnecessary in determining the PD point. Two-thirds of these had objective response rates of < 40%. Measurable and non-measurable NTLs were equally responsible for PD, and the strongest determinant of PD was the unequivocal appearance of new lesions. Conclusions: In this study, subjective parameters, as defined by RECIST 1.1, were far more likely to result in a determination of PD than objective ones. These findings may have relevance for considering the value of RECIST 1.1 as a scientific standard for therapeutic efficacy as well as in the design of new methodologies for the assessment of tumor response.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS5596-TPS5596
Author(s):  
Evan Y. Yu ◽  
David Laidley ◽  
Frederic Pouliot ◽  
Stephan Probst ◽  
Robert Sabbagh ◽  
...  

TPS5596 Background: PSMA is a transmembrane glycoprotein expressed in normal human prostate epithelium at low levels, but highly upregulated in metastatic prostate cancer (PC). 18F-DCFPyL is a novel PSMA-targeted PET imaging agent that has shown highly promising diagnostic performance for detection of metastatic disease, with potential to identify disease amenable to theranostic targeting. 1095 is a novel PSMA-targeted small molecule that binds to the extracellular domain of PSMA selectively with high affinity. The complex is internalized, allowing the beta emitter, I-131, to kill PC cells. Methods: ARROW is an open-label, randomized (2:1) trial of enza plus 1095 or enza alone in pts with progressive mCRPC who previously received abi. ~120 pts (80: 1095 + enza; 40: enza alone) will be treated at ~40 sites in the US and Canada. Eligible male pts must be at least 18 yo with metastatic disease documented by bone scan or soft tissue lesions measurable per RECIST 1.1 on CT/MRI, be PSMA-avid as determined by 18F-DCFPyL PET/CT, have evidence of biochemical or radiographic progression on abi, and be ineligible for or refuse to receive chemotherapy. Pts will receive enza (prescribed per approved labeling) with or without 1095 (100 mCi dose, followed by up to 3 additional dose(s) administered at least 8 weeks apart, as determined by dosimetry evaluation and occurrence of dose-limiting events). The primary objective is to determine the efficacy of 1095 plus enza compared to enza alone, based on PSA response (confirmed PSA decline ≥50%) rate according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria. Additional objectives include objective response rate based on PCWG3-modified RECIST 1.1, progression-free survival (PFS) defined as the first occurrence of radiographic progression (PCWG3-modified RECIST 1.1), unequivocal clinical progression, or death from any cause, duration of response, overall survival, and the safety and tolerability of 1095 radioligand therapy. Clinical trial information: NCT03939689 .


2020 ◽  
Vol 38 (6_suppl) ◽  
pp. TPS260-TPS260
Author(s):  
Evan Y. Yu ◽  
David Laidley ◽  
Frederic Pouliot ◽  
Stephan Probst ◽  
Fred Saad ◽  
...  

TPS260 Background: PSMA is a transmembrane glycoprotein expressed in normal human prostate epithelium at low levels, but highly upregulated in metastatic prostate cancer (PC). 18F-DCFPyL is a novel PSMA-targeted PET imaging agent that has shown highly promising diagnostic performance for detection of metastatic disease, with potential to identify disease amenable to theranostic targeting. 1095 is a novel PSMA-targeted small molecule that binds to the extracellular domain of PSMA selectively with high affinity. The complex is internalized, allowing the beta emitter, I-131, to kill PC cells. Methods: ARROW is an open-label, randomized (2:1) trial of enza plus 1095 or enza alone in pts with progressive mCRPC who previously received abi. ~120 pts (80: 1095 + enza; 40: enza alone) will be treated at ~40 sites in the US and Canada. Eligible male pts must be at least 18 yo with metastatic disease documented by bone scan or soft tissue lesions measurable per RECIST 1.1 on CT/MRI, be PSMA-avid as determined by 18F-DCFPyL PET/CT, have evidence of biochemical or radiographic progression on abi, and be ineligible for or refuse to receive chemotherapy. Pts will receive enza (prescribed per approved labeling) with or without 1095 (100 mCi dose, followed by up to 3 additional dose(s) administered at least 8 weeks apart, as determined by dosimetry evaluation and occurrence of dose-limiting events). The primary objective is to determine the efficacy of 1095 plus enza compared to enza alone, based on PSA response (confirmed PSA decline ≥50%) rate according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria. Additional objectives include objective response rate based on PCWG3-modified RECIST 1.1, progression-free survival (PFS) defined as the first occurrence of radiographic progression (PCWG3-modified RECIST 1.1), unequivocal clinical progression, or death from any cause, duration of response, overall survival, and the safety and tolerability of 1095 radioligand therapy. Clinical trial information: NCT03939689.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7548-7548
Author(s):  
P. Bruzzi ◽  
M. Sormani ◽  
M. Tiseo ◽  
L. Boni ◽  
R. Rosell ◽  
...  

7548 Background: In order to assess the validity of objective response to chemotherapy (CT) as a surrogate endpoint of survival in advanced non-small cell lung cancer (NSCLC), we applied the four Prentice criteria to the data collected in the CISCA meta-analysis, comparing the efficacy of carboplatin and cisplatin in the first-line treatment of advanced NSCLC. Methods: Nine trials including 2,968 patients (pts) were analyzed in the CISCA meta-analysis. The prognostic effect of tumor response on survival was analyzed setting a landmark at two months after randomization (time of response recording), in order to eliminate early death from the analysis. After this landmark correction, pts included in the validation analysis were 2,525 with complete data on tumor response and survival. Results: Cisplatin-based CT was associated with a significantly higher tumor response rate compared with carboplatin-based CT (OR = 1.39; 95% CI: 1.18–1.64; p < 0.001). Carboplatin regimens also led to a numerically higher risk of death as compared to cisplatin (HR = 1.06; 95% CI: 0.98–1.16; p = 0.15). Tumor response was a highly significant predictor of survival (HR = 0.50; 95% CI: 0.46–0.55; p < 0.001). When tumor response was introduced in the Cox model (as a four level variable), the hazard ratio in favour of cisplatin treatment changed from 1.06 to 1.004 (95% CI: 0.922–1.093; p = 0.94), indicating that no residual effect of the cisplatin treatment on survival was present once tumor response was adjusted for. This suggests that the overall survival benefit of cisplatin CT was a result of the increase in response rate. The median survival time of patients with complete and partial response was 19.5 months (95% CI: 11.5–27.5 months) and 14.0 months (95% CI: 13.1–14.9 months), respectively; whereas, the median survival time of patients with no response was 7.8 months (95% CI: 7.5–8.1 months). Conclusions: These results support the hypothesis that the achievement of an objective response to CT in advanced NSCLC is associated with a survival benefit. The potential role of objective response as a surrogate endpoint for survival in CT trials of advanced NSCLC warrants further investigation. No significant financial relationships to disclose.


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