Correlation of Computed Tomography and Positron Emission Tomography in Patients With Metastatic Gastrointestinal Stromal Tumor Treated at a Single Institution With Imatinib Mesylate: Proposal of New Computed Tomography Response Criteria

Choi, Haesun; Charnsangavej, C.; Faria, Silvana C.; Macapinlac, Homer A.; Burgess, Michael A.; Patel, Shreyaskumar; Chen, Lei L.; Podoloff, Donald A.; Benjamin, Robert S.

doi:10.1200/jco.2006.07.3049

Cited by 1,346 publications

(1,012 citation statements)

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“…This is in line with the results from the standard statistical analysis by Schiavon et al .,26 which showed that 3D criteria (based on a categorization of tumor response) seemed to overall better correlate to OS than 1D criteria when assessed after ∼6 or 12 months of treatment. Contrasting results have been reported regarding the predictive ability of Choi's criteria, a combination of size and density responses, on clinical outcome 5, 8, 9, 10, 11, 12. Here, none of the density‐related metrics could predict OS or PFS when tested alone or in addition to size‐related predictors.…”

Section: Discussioncontrasting

confidence: 77%

“…Choi et al 4, 5. proposed novel criteria combining tumor size and density changes that reflect morphological and structural changes, respectively, to assess response of gastrointestinal stromal tumors (GIST) to imatinib, a multitargeted tyrosine kinase inhibitor 4, 5.…”

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confidence: 99%

“…proposed novel criteria combining tumor size and density changes that reflect morphological and structural changes, respectively, to assess response of gastrointestinal stromal tumors (GIST) to imatinib, a multitargeted tyrosine kinase inhibitor 4, 5. In imatinib‐treated GIST, the Choi criteria correlated with time‐to‐tumor progression and disease‐specific survival 6.…”

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confidence: 99%

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Pharmacometric Modeling of Liver Metastases' Diameter, Volume, and Density and Their Relation to Clinical Outcome in Imatinib‐Treated Patients With Gastrointestinal Stromal Tumors

Schindler

Krishnan

Mathijssen

et al. 2017

CPT Pharmacom & Syst Pharma

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Three‐dimensional and density‐based tumor metrics have been suggested to better discriminate tumor response to treatment than unidimensional metrics, particularly for tumors exhibiting nonuniform size changes. In the developed pharmacometric modeling framework based on data from 77 imatinib‐treated gastrointestinal patients, the time‐courses of liver metastases' maximum transaxial diameters, software‐calculated actual volumes (Vactual) and calculated ellipsoidal volumes were characterized by logistic growth models, in which imatinib induced a linear dose‐dependent size reduction. An indirect response model best described the reduction in density. Substantial interindividual variability in the drug effect of all response assessments and additional interlesion variability in the drug effect on density were identified. The predictive ability of longitudinal tumor unidimensional and three‐dimensional size and density on overall survival (OS) and progression‐free survival (PFS) were compared using parametric time‐to‐event models. Death hazard increased with increasing Vactual. This framework may guide early clinical interventions based on three‐dimensional tumor responses to enhance benefits for patients with gastrointestinal stromal tumors (GIST).

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Section: Discussioncontrasting

confidence: 77%

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confidence: 99%

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confidence: 99%

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Pharmacometric Modeling of Liver Metastases' Diameter, Volume, and Density and Their Relation to Clinical Outcome in Imatinib‐Treated Patients With Gastrointestinal Stromal Tumors

Schindler

Krishnan

Mathijssen

et al. 2017

CPT Pharmacom & Syst Pharma

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“…This may be expected, as it is likely that the tumor size measurement used, sum of longest tumor diameter (SLD) of five largest target lesions, does not necessarily reflect the complete tumor burden, and that nontarget lesions may differ from target lesions in growth dynamics and response to drug. It is also known that a tumor may become less metabolically active (therefore less harmful) without necessarily decreasing in size 37. Furthermore, OS is correlated not only with tumor size in the dataset (target lesions), but also to other factors such as nontarget lesions, metastases, and general well‐being, which are not related to the target lesion in the analyses.…”

Section: Discussionmentioning

confidence: 99%

Exposure-Response Analysis of Necitumumab Efficacy in Squamous Non-Small Cell Lung Cancer Patients

Cosson

Wallin³

2017

CPT Pharmacometrics Syst. Pharmacol.

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We sought to describe the exposure–response relationship of necitumumab efficacy in squamous non‐small cell lung cancer patients and evaluate intrinsic and extrinsic patient descriptors that may guide dosing. SQUIRE was a phase III study comparing necitumumab in combination with gemcitabine and cisplatin vs. gemcitabine and cisplatin alone in 1,014 patients. An integrated model for tumor size dynamics and overall survival was developed, where reduction in tumor size results in a decrease in survival hazard. The change in tumor size was characterized using linear growth and first‐order shrinkage. Overall survival was described using a combination of a Weibull function and Gompertz function for the hazard, with dynamic tumor size being a predictor for the hazard. Although body weight resulted in higher clearance and lower exposure, simulations showed that an 800 mg flat dose provided optimal response regardless of body weight.

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“…Patients had to have received at least four cycles of therapy to be evaluable. Tumor response was evaluated using CHOI criteria 10 and RECIST 1.1 11 (response evaluation criteria in solid tumors) criteria by computerized tomography (CT)-scan. Patients were followed until tumor progression.…”

Section: Methodsmentioning

confidence: 99%

Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study

et al. 2018

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In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy.Eligible patients had unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria.Thirty two patients with metastatic colorectal cancer were enrolled. Five patients demonstrated response (Choi criteria) and 22 patients had stable disease as the best 2-month overall response. Median progression-free and overall survival were 5.4 (95% CI, 3.6–6.6) and 14.5 months (95% CI, 9–20.6) respectively. Twenty patients experienced grade 3 toxicity. No grade 4 or 5 toxicity related to therapy occurred. The most common grade 3 adverse events were neutropenia in 8 (25%) patients, digestive side effects in 7 (21.9%) patients and hypertension in 6 (18.75%) patients. No treatment-related deaths or serious adverse events were reported.5-FU plus bevacizumab and anakinra has promising activity and a manageable safety profile, suggesting that this combination might become a potential treatment option for patients with refractory mCRC.

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Correlation of Computed Tomography and Positron Emission Tomography in Patients With Metastatic Gastrointestinal Stromal Tumor Treated at a Single Institution With Imatinib Mesylate: Proposal of New Computed Tomography Response Criteria

Abstract: Small changes in tumor size or density on CT are sensitive and specific methods of assessing the response of GISTs. If the prognostic value of our proposed CT response criteria can be confirmed prospectively, the criteria should be employed in future studies of patients with GIST.

Cited by 1,346 publications

References 12 publications

Pharmacometric Modeling of Liver Metastases' Diameter, Volume, and Density and Their Relation to Clinical Outcome in Imatinib‐Treated Patients With Gastrointestinal Stromal Tumors

Pharmacometric Modeling of Liver Metastases' Diameter, Volume, and Density and Their Relation to Clinical Outcome in Imatinib‐Treated Patients With Gastrointestinal Stromal Tumors

Exposure-Response Analysis of Necitumumab Efficacy in Squamous Non-Small Cell Lung Cancer Patients

Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study

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