nab-Sirolimus for Patients With Malignant Perivascular Epithelioid Cell Tumors
Andrew J. WagnerVinod RaviRichard F. RiedelKristen N. GanjooBrian A. Van TineRashmi ChughLee D. CranmerErlinda M. GordonJason L. HornickHeng DuBerta GrigorianAnita N. SchmidShihe HouKatherine E. HarrisDavid J. KwiatkowskiNeil DesaiMark A. Dickson
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Abstract:
Malignant perivascular epithelioid cell tumor (PEComa) is a rare aggressive sarcoma, with no approved treatment. To our knowledge, this phase II, single-arm, registration trial is the first prospective clinical trial in this disease, investigating the safety and efficacy of the mammalian target of rapamycin inhibitorKeywords:
Clinical endpoint
Sirolimus
Purpose To determine the relationship between target lesion selection with use of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and classification of therapeutic response in patients with metastatic cancer undergoing systemic cytotoxic and/or targeted therapies. Materials and Methods This prospective multireader study was conducted between July 2015 and July 2017. Three hundred sixteen consecutive participants with metastatic cancer underwent 932 CT examinations to monitor systemic treatment. CT studies were independently read by three radiologists. Readers identified a maximum of five lesions total (and a maximum of two lesions per organ). Dedicated oncology tumor response software was used. The Fleiss κ statistic was used to analyze interreader agreement in the assignment of individual response classes (complete response, partial response, progressive disease, or stable disease) and in the differentiation between progressive and nonprogressive disease. Results Readers selected the same set of target lesions in 128 of the 316 participants (41%) and selected a different set in 188 (59%). When target lesion selection was concordant, agreement was high (assignment of treatment response category: κ = 0.97; 95% confidence interval [CI]: 0.91, 1.0; differentiation between progressive and nonprogressive disease: κ = 0.98; 95% CI: 0.90, 1.0). When target lesion selection was discordant, agreement was significantly reduced (assignment of treatment response category: κ = 0.58; 95% CI: 0.54, 0.62; differentiation between progressive and nonprogressive disease: κ = 0.6; 95% CI: 0.59, 0.70). With concordant target lesion selection, readers agreed regarding diagnosis of progression in 97.7% of participants (95% CI: 95.4%, 100.0%); with discordant target lesion selection, readers agreed in only 55.3% (95% CI: 47.9%, 62.6%) (P < .01). Conclusion In patients with metastatic cancer undergoing systemic treatment, different cancer sites may appear similarly suitable and thus likely to be selected as target lesions but may yield inconsistent or even conflicting results with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. This indicates that the current, limited set of target lesions in RECIST 1.1 may not reflect overall tumor load or response to therapy. © RSNA, 2018 See also the editorial by Sosna in this issue.
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Objective
To investigate the value of circulating tumor cells (CTCs) in the evaluation of chemotherapeutic effect in non-small cell lung cancer (NSCLC).
Methods
A total of 23 cases of patients with NSCLC receiving chemotherapy were enrolled in this study from January 2015 to June 2017 in the First Affiliated Hospital of the Fourth Military Medical University.Venous blood (5 ml) was extracted from 23 patients prior to chemotherapy, 24h before the first, second, and third cycles of chemotherapy, CTCs were analyzed by CanPatrol™.In the meantime, the tumors were monitored by computed tomography at baseline, and 6 weeks after the first cycle of chemotherapy.According to the response evaluation criteria in solid tumors (RECIST), the patients at the time of 6 weeks after the first cycle of chemotherapy were divided into the effective group [partial response (PR)] and the ineffective group [progressive disease (PD) and stable disease (SD)].
Results
The effect of chemotherapy was determined according to RECIST at the time of 6 weeks after the first cycle of chemotherapy, among the 23 patients who went under chemotherapy, the outcomes consisted of partial response in 12 cases (52.2%), stable disease in 1 case (4.3%) and progressive disease in 10 cases (43.5%); the effect of chemotherapy was determined according to the changes of CTCs at the time of 6 weeks after the first cycle of chemotherapy too, and the outcomes consisted of complete response and partial response in 13 cases (56.5%), progressive disease in 10 cases (43.5%). As the results of the Fisher′s exact test showed, there were no significant differences between the two methods in the evaluation of curative effect (P=1.0). Spearman correlation analysis showed that the changes of CTCs number at the time of 6 weeks after the first cycle of chemotherapy were correlated with the curative effect (r=0.861, P=0.000). In the effective group, the number of CTCs of patients at the time of 3 weeks [5.5(4.3, 14.0)CTCs/5 ml] and 6 weeks [3.0(1.3, 5.8)CTCs/5 ml] after the first cycle of chemotherapy were lower than that of before chemotherapy [10.5(7.0, 26.3)CTCs/5 ml], the difference was statistically significant (Z=-2.941, -3.065, both P<0.05); conversely, in the ineffective group the number of CTCs of patients at the time of 3 weeks [7.0(3.0, 9.0)CTCs/5 ml] and 6 weeks [11.0(3.0, 13.0)CTCs/5 ml] after the first cycle of chemotherapy were higher than that of before chemotherapy [3.0(2.0, 5.0)CTCs/5 ml], the difference was statistically significant (Z=-2.687, -2.803, both P<0.05).
Conclusions
In patients with NSCLC, the therapeutic effect can be evaluated in early stage according to the changes of CTCs number in peripheral blood after chemotherapy.CTCs detection may be a useful supplement to the evaluation system of RECIST.
Key words:
Non-small cell lung cancer; Circulating tumor cells; Chemotherapy; Evaluation
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Abstract BACKGROUND: A significant improvement in overall survival (OS) was demonstrated in patients with advanced hepatocellular carcinoma (HCC) who received sorafenib (Sor) in the Sorafenib HCC Assessment Randomized Protocol (SHARP) study, in contrast to a response rate (RR) of 2% assessed according to Response Evaluation Criteria in Solid Tumors (RECIST). Modified RECIST (mRECIST) were developed to assess the response in patients with HCC, based on measurement of viable tumor with arterial enhancement on a computed tomography (CT) scan. In the current study, mRECIST were evaluated and were compared with RECIST in patients who received Sor for advanced HCC. METHODS: The authors retrospectively analyzed 53 patients who received Sor for advanced HCC. Patients must to have undergone a 4‐phase CT scan before treatment and repeatedly thereafter. CT scans were analyzed using RECIST 1.1 and mRECIST. RESULTS: The rates of objective response (OR), stable disease (SD), and progressive disease (PD) were 2%, 79%, and 19%, respectively, according to RECIST and 23%, 57%, and 21%, respectively, according to mRECIST ( P < .001). Patients who achieved an OR according to mRECIST had a longer OS than nonresponding patients with SD or PD (median OS, 18 months and 8 months, respectively; P = .013). In the 42 patients who achieved SD according to RECIST, OS differed depending on tumor response according to mRECIST, with a median OS of 17 months, 10 months, and 4 months for patients who achieved an OR (n = 11), SD (n = 29), and PD (n = 2), respectively ( P = .016). CONCLUSIONS: The current series validated mRECIST in patients who received Sor for advanced HCC. The majority of patients who had SD according to RECIST had a different prognosis according to mRECIST. The results indicated that, for patients with HCC, mRECIST should be used for the standard assessment of treatment efficacy, particularly in patients who are receiving antiangiogenic drugs. Cancer 2012;. © 2011 American Cancer Society.
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Objective To compare the concordance among RECIST, EASL and modified RECIST criteria for the evaluation of tumor response after transarterial chemoembolization of primary liver cancer.Methods Fifty patients with primary liver cancer underwent 2 TACE cycles separated by 30-40 days.Triphasic helical CT or MRI scans were performed at baseline, at 4 weeks after TACE procedure, and 2 independent radiologists evaluated tumor response according to above-mentioned three different criteria. Chisquare test was used to compare the response rate, and kappa coefficients were used to evaluate the coherence. Results When tumor responses were evaluated using the RECIST-EASL and modified RECIST criteria, the numbers of the patients achieved complete response, partial response, stable disease,progressive disease were 0, 10, 30, 10; 6,21,14,9; 6,21,13,10 respectively. The objective response rates for three different criteria were 20%, 54%, 54% respectively ( P ＜ 0. 01 ). Kappa coefficients between RECIST and EASL, between RECIST and modified RECIST, between EASL and modified RECIST were 0. 382, 0. 170, and 0. 857 (P = 0. 000). Conclusions RECIST criteria underestimates the extent of tumor response after TACE in primary liver cancer. Both EASL and modified RECIST criteria appear to agree with each other in determining treatment response. Furthermore, the modified RECIST is more convenient in clinical practice compared with EASL criteria.
Key words:
Liver neoplasms; Chemoembolization, therapeutic; Evaluation studies
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e21121 Background: Treatment response to anti-cancer therapies for advanced lung cancer is usually assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST), which is not generally applied in real-world settings. With real-world evidence increasingly being used to support promising treatment, this study evaluated the feasibility of assessing real-world lung cancer response by RECIST-based measurement of lesions on archived radiologic films and assessed its concordance with treatment response based on oncologist narratives in electronic health record (EHR). Methods: This retrospective study included 30 randomly selected metastatic non-small cell lung cancer (mNSCLC) patients diagnosed between January 2015 and December 2019 from the Syapse Learning Health Network of US community health systems. Eligible patients were ≥18 years, histologically confirmed mNSCLC; no other malignancy within 2 years prior to diagnosis; initiated index systemic treatment subsequent to progression on a platinum or anti-PD(L)-1-containing therapy; and had a baseline scan followed by at least one additional scan during the index period. Patients were followed from the initiation of index treatment until the initiation of a post-index line of treatment, death, or date of last contact, whichever occurred first. Tumor response was established using response documented in the medical oncologists’ narratives and compared to a radiologist’s assessment of archived images using RECIST v1.1 criteria. Best overall response was characterized as complete or partial response (CR/PR), stable disease (SD), progressive disease (PD), and not evaluable (NE). Results: The median age at mNSCLC diagnosis was 62 years; 22/30 (73%) were male; 28/30 (93%) were White and 2/30 (7%) were Black. Of the 22/30 (73%) patients with a documented Eastern Cooperative Oncology Group performance status, 21 (95%) had a status of 0 or 1. Patients had a median of 8 months follow-up with the majority surviving (63%) until the end of study. Table shows good concordance of best overall response between medical oncologist-reported and radiologist re-assessed responses; CR/PR was 67%, SD 79% and PD 80%. Causes of discordance were lack of CR/PR confirmation in medical oncologists’ narratives, absence of narratives, or presence of clinical symptoms. Conclusions: This study is an important step in demonstrating the potential to approximate real-world RECIST-based treatment response using EHR abstraction of oncologists’ documentation. Future studies should validate this approach, and improve upon it, by exploring additional real-world data elements as surrogates for clinically relevant responses to anti-cancer therapies. [Table: see text]
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