scholarly journals Modified Overall Immune Related Response Criterion, Stable Disease

2020 ◽  
Author(s):  
Keyword(s):  
Stable Disease ◽  
Response Criterion ◽  
Related Response

Clinical outcome of metastatic castration-resistant prostate cancer (mCRPC) patients (pts) with a post-treatment circulating tumor cell (CTC) of 0 vs CTC > 0: Post hoc analysis of COU-AA-301.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5015-5015 ◽  
Author(s):  
Howard I. Scher ◽  
Glenn Heller ◽  
Margaret K. Yu ◽  
Thian Kheoh ◽  
Weimin Peng ◽  
...  
Keyword(s):  
Disease Progression ◽  
Stable Disease ◽  
Lung Metastases ◽  
Objective Response ◽  
Response Assessment ◽  
Circulating Tumor Cell ◽  
Response Criterion ◽  
Castration Resistant Prostate Cancer ◽  
Radiographic Response ◽  
Measurable Disease

5015 Background: Assessment of radiographic response by RECIST in the majority of mCRPC pts is limited by the lack of measurable disease. Changes in CTC counts (CTCs) enumerated using Veridex CellSearch from unfavorable at baseline (BL [≥ 5 cells/7.5 mL]) to favorable (≤ 4) are prognostic for survival, and the test is FDA cleared as an aid in the monitoring of metastatic PC. The CTC cutpoint of ≥ 5 excludes many pts from response assessment. Examining CTCs alone and in combination with other biomarkers as a potential surrogate for clinical benefit was a secondary objective of COU-AA-301, a phase 3 trial of abiraterone acetate + prednisone vs prednisone alone in mCRPC. Methods: Pts from both treatment (tmt) groups with BL CTC > 0 were combined to assess CTC = 0 as a response criterion. Association between CTC response, defined as BL CTC > 0 and post-BL CTC = 0, and clinical outcomes was assessed. CTCs were determined at BL and 4, 8, and 12 wks. Pts with BL CTC > 0 and missing post-tmt CTCs were considered nonresponders. Radiographic response was first assessed at Wk 12. Overall survival (OS) was estimated using the Kaplan-Meier method. Results: Among739 pts with BL CTC > 0, 141 had measurable disease. At Wk 12, 19% (141/739) of pts were CTC responders and 81% (598/739) were CTC nonresponders. Among CTC responders, 74% (104/141) had stable disease or better by RECIST; 26% (37/141) were either not evaluable or had disease progression by RECIST. Median OS was 23.8 and 10.0 mos for CTC responders (n = 141) and nonresponders (n = 598), respectively. Among pts with liver and/or lung metastases, 86% (24/28) of CTC responders at Wk 12 had stable disease or better by RECIST; 14% (4/28) had disease progression by RECIST. Median OS was 19.9 and 7.1 mos for CTC responders (n = 28) and nonresponders (n = 127), respectively. Similar results were observed in Wk 8 CTC responders. Conclusions: For mCRPC pts with BL CTC > 0, CTC response on tmt (CTC = 0) is associated with longer survival and could be considered a response criterion. Additional analysis is required to fully characterize the relationship between CTC = 0 and objective response by RECIST in pts with measurable disease. Clinical trial information: NCT00638690.

RECIST 1.1 versus immune-related RECIST and immune-related response criteria in assessing response to nivolumab in patients with lung, renal, and head and neck cancers.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14609-e14609
Author(s):  
Surabhi Pathak ◽  
Marina Messinger ◽  
Michael Russell Mullane
Keyword(s):  
Head And Neck ◽  
Stable Disease ◽  
Evaluation Criteria ◽  
Cook County ◽  
Ease Of Use ◽  
Response Criteria ◽  
Fisher Exact Test ◽  
Response Evaluation ◽  
Recist 1.1 ◽  
Related Response

e14609 Background: Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is reported to underestimate response to immunotherapeutic drugs. Therefore, immune related RECIST (iRECIST) based on RECIST 1.1 and immune related response criteria (IRRC) based on WHO response criteria have been studied, mainly in patients with melanoma. Whether RECIST 1.1 underestimates responses in other cancers is not well known. Aim of the present study is to assess response rates to PDL-1 inhibitor Nivolumab in lung, renal and head and neck (H&N) cancers using RECIST 1.1, iRECIST and IRRC. Methods: We reviewed patients from 2012 to present with lung, renal, H&N cancers treated with Nivolumab at John h Stroger Jr. Hospital of Cook County. Incomplete charts and those treated for less than 4 cycles of Nivolumab were excluded. Data was analyzed using descriptive statistics and Fisher exact test. Results: 47 charts were reviewed, 27 met the inclusion criteria. 17 lung (14 adeno, 3 squamous), 7 renal (5 clear cell) and 3 H&N cancer patients were included. Average age was 58.2yrs, 20(74%) were male. Average treatment was for 13 cycles. Response was assessed after at least 4 cycles. Disease control rate for lung, renal, head and neck cancer was 70%,58%, 33% respectively with RECIST 1.1 criteria compared to 77%, 71% and 66% respectively using immune RECIST or IRRC (P > 0.05). No patient developed pseudoprogression. Two had progressive disease per RECIST 1.1 but stable disease with iRECIST and IRRC. 26 of the 27 patients showed concordance between iRECIST and IRRC. One patient had stable disease per iRECIST but partial response per IRRC. Average survival after treatment initiation was 8.3 months for lung, 9.1 months for renal and 5.6 months for H&N cancer. Treatment was discontinued in 2 patients based on progression per RECIST 1.1, both patients had stable disease per iRECIST& IRRC. Conclusions: Trend towards underestimation of treatment response using RECIST 1.1 criteria compared to iRECIST or IRRC was observed. Strong concordance was observed between iRECIST and IRRC. Given relative ease of use, iRECIST might be favored over IRRC in response evaluation for immunotherapeutic drugs.

GROWTH HORMONE AND RADIO-SULFATE INCORPORATION IN COSTAL CARTILAGE

1961 ◽  
Vol 37 (2) ◽  
pp. 176-182 ◽  
Author(s):  
Elliott J. Collins ◽  
Vernon F. Baker
Keyword(s):  
Growth Hormone ◽  
Costal Cartilage ◽  
Time Response ◽  
Hormone Activity ◽  
Reliable Estimation ◽  
Hypophysectomized Rats ◽  
Related Response ◽  
Sulfate Incorporation

ABSTRACT The characteristics and nature of the effect of growth hormone on the incorporation of radio-sulfate into the costal cartilage of hypophysectomized rats has been studied. The time-response studies indicate that a reliable estimation of growth hormone activity can be ascertained within a 24 hour period, and a reproducible dose-related response can be obtained at dosage levels ranging from 12-48 μg. Growth hormone stimulates the synthesis of organic sulfates and accumulation of inorganic sulfates within 48 hours.

scholarly journals Detection of EGFR Activating and Resistance Mutations by Droplet Digital PCR in Sputum of EGFR-Mutated NSCLC Patients

2021 ◽  
Vol 15 ◽  
pp. 117955492199307
Author(s):  
Klaus Hackner ◽  
Anna Buder ◽  
Maximilian J Hochmair ◽  
Matthaeus Strieder ◽  
Christina Grech ◽  
...  
Keyword(s):  
Stable Disease ◽  
Progressive Disease ◽  
Kinase Inhibitor ◽  
Diagnostic Yield ◽  
Resistance Mutation ◽  
Egfr Mutations ◽  
Plasma Samples ◽  
Percent Agreement ◽  
Nsclc Patients ◽  
Egfr Mutated

Background: Proof of the T790M resistance mutation is mandatory if patients with EGFR-mutated non-small cell lung cancer (NSCLC) progress under first- or second-generation tyrosine kinase inhibitor therapy. In addition to rebiopsy, analysis of plasma circulating tumor DNA is used to detect T790M resistance mutation. We studied whether sputum is another feasible specimen for detection of EGFR mutations. Methods: Twenty-eight patients with advanced EGFR-mutated NSCLC were included during stable and/or progressive disease. The initial activating EGFR mutations (exon 19 deletions or L858R mutations) at stable disease and at progressive disease (together with T790M) were assessed in simultaneously collected plasma and sputum samples and detected by droplet digital polymerase chain reaction (ddPCR). Results: Activating EGFR mutations were detected in 47% of the plasma samples and 41% of sputum samples during stable disease, and in 57% of plasma samples and 64% of sputum samples during progressive disease. T790M was detected in 44% of the plasma samples and 66% of the sputum samples at progressive disease. In ddPCR T790M-negative results for both specimens (plasma and sputum), negativity was confirmed by rebiopsy in 5 samples. Concordance rate of plasma and sputum for T790M was 0.86, with a positive percent agreement of 1.0 and a negative percent agreement of 0.80. Conclusions: We demonstrated that EGFR mutation analysis with ddPCR is feasible in sputum samples. Combination of plasma and sputum analyses for detection of T790M in NSCLC patients with progressive disease increases the diagnostic yield compared with molecular plasma analysis alone.

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