Shruti Rajesh Patel, Maya Ramachandran, Angela Ai, Christopher T Chen
{"title":"Redefining Available Therapy in Oncology Accelerated Approval Decisions.","authors":"Shruti Rajesh Patel, Maya Ramachandran, Angela Ai, Christopher T Chen","doi":"10.1200/JCO.24.00892","DOIUrl":"https://doi.org/10.1200/JCO.24.00892","url":null,"abstract":"<p><p>When weighing rapid approval for follow-on drugs, should @FDAOncology recognize the drugs that came before?</p>","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":" ","pages":"JCO2400892"},"PeriodicalIF":42.1,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142501184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Experimental, Theoretical, and Spectroscopic Analysis of Molecular Interactions in Binary Liquid Mixtures Comprising 4-Methyl-2-pentanol + CmH2m+1OCH2CH2OH (m = 2,3,4) at Different Temperatures","authors":"Gyan Prakash Dubey*, and , Rachana Singh, ","doi":"10.1021/acs.jced.4c0047110.1021/acs.jced.4c00471","DOIUrl":"https://doi.org/10.1021/acs.jced.4c00471https://doi.org/10.1021/acs.jced.4c00471","url":null,"abstract":"<p >In present communication, we report the experimental values of density (ρ), viscosity (η), and speed of sound (<i>u</i>) of binary mixtures of 4-methyl-2-pentanol with 2-ethoxyethanol, 2-propoxyethanol, and 2-butoxyethanol at <i>T</i> = (298.15, 303.15, and 308.15) K. The excess and deviation properties, such as excess molar volume (<i>V</i><sub><i>m</i></sub><sup>E</sup>), excess molar isentropic compressibility (<i>K</i><sub>s,m</sub><sup>E</sup>), excess speed of sound (<i>u</i><sup>E</sup>), deviation in viscosity (Δη), and excess Gibbs energy of activation for viscous flow (Δ<i>G</i><sup>*E</sup>) were evaluated using the experimentally measured values of density (ρ), viscosity (η), and speed of sound (<i>u</i>). The variations in these properties with composition and temperature were used to study the interactions due to physical and chemical effects between the unlike components of the binary mixtures. Further, density values were used to estimate partial molar volumes (<i></i><math><msub><mover><mi>V</mi><mo>¯</mo></mover><mrow><mi>m</mi><mo>,</mo><mi>i</mi></mrow></msub></math>), excess partial molar volumes (<i></i><math><msubsup><mover><mi>V</mi><mo>¯</mo></mover><mrow><mi>m</mi><mo>,</mo><mi>i</mi></mrow><mi>E</mi></msubsup></math>), and their limiting values at infinite dilution (<i></i><math><msubsup><mover><mi>V</mi><mo>¯</mo></mover><mrow><mi>m</mi><mo>,</mo><mi>i</mi></mrow><mrow><mi>E</mi><mo>,</mo><mi>∞</mi></mrow></msubsup></math>). The excess properties were fitted to the Redlich–Kister polynomial equation. The correlation ability of various semiempirical relations of viscosity was also compared using standard deviation. The excess volume data have also been rationalized by the Prigogine–Flory–Patterson theory. Fourier transform infrared spectra of these liquid mixtures were also recorded. Spectral analysis of these mixtures also supports the results obtained from calculated parameters.</p>","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":"69 11","pages":"3914–3929 3914–3929"},"PeriodicalIF":2.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Handles for complexity building","authors":"Francesco Zamberlan","doi":"10.1038/s41929-024-01244-y","DOIUrl":"10.1038/s41929-024-01244-y","url":null,"abstract":"","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":"7 10","pages":"1056-1056"},"PeriodicalIF":42.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142487871","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Scatter and conquer","authors":"Marcal Capdevila-Cortada","doi":"10.1038/s41929-024-01245-x","DOIUrl":"10.1038/s41929-024-01245-x","url":null,"abstract":"","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":"7 10","pages":"1057-1057"},"PeriodicalIF":42.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142487873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Synergistic role for CO","authors":"Estíbaliz Merino","doi":"10.1038/s41929-024-01226-0","DOIUrl":"10.1038/s41929-024-01226-0","url":null,"abstract":"Typically, active acyl intermediates are quenched with nucleophiles to complete carbonylation. Now, a visible-light-induced radical relay enables CO insertion and selective (hetero)aryl group migration without nucleophiles.","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":"7 10","pages":"1058-1059"},"PeriodicalIF":42.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142487904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Solubility of Perindopril l-Arginine in 10 Pure Solvents and 3 Binary Solvents from 278.15 to 323.15 K","authors":"Hongchen Cao, Yuntian Xiao, Yongkang Liu, Ling Zhou* and Qiuxiang Yin*, ","doi":"10.1021/acs.jced.4c0049910.1021/acs.jced.4c00499","DOIUrl":"https://doi.org/10.1021/acs.jced.4c00499https://doi.org/10.1021/acs.jced.4c00499","url":null,"abstract":"<p >The solubility of Perindopril <span>l</span>-Arginine was measured in ten pure solvents (water, methanol, ethanol, methyl ethyl ketone, isopropyl acetate, ethyl acetate, isobutyl acetate, <i>n</i>-propyl acetate, methyl <i>tert</i>-butyl ether, and methylcyclohexane) as well as in three binary solvent mixtures (methyl <i>tert</i>-butyl ether-water, methyl <i>tert</i>-butyl ether-methanol, and methyl <i>tert</i>-butyl ether-ethanol). These measurements were conducted using isothermal methods of the dynamic method across a temperature range of 278.15 to 323.15 K at a pressure of 0.1 MPa. The solubility data in pure solvents were analyzed using the modified Apelblat equation, Yaws equation, and Van’t Hoff equation. For the binary solvent mixtures, the data were correlated by using the improved Apelblat equation, the CNIBS/R-K model, and the Apelblat–Jouyban–Acree model. The calculated results from these models showed high agreement with the experimental data, confirming the reliability of these models.</p>","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":"69 11","pages":"4206–4215 4206–4215"},"PeriodicalIF":2.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Blowing in the tube","authors":"Davide Esposito","doi":"10.1038/s41929-024-01246-w","DOIUrl":"10.1038/s41929-024-01246-w","url":null,"abstract":"","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":"7 10","pages":"1053-1053"},"PeriodicalIF":42.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142487870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nicholas Turner, Cristina Saura, Philippe Aftimos, Evelyn van den Tweel, Mayke Oesterholt, Norbert Koper, Marco Colleoni, Emilie Kaczmarek, Kevin Punie, Xinni Song, Anne Armstrong, Giulia Bianchi, Agostina Stradella, Sylvain Ladoire, Joline Si Jing Lim, Nathalie Quenel-Tueux, Tira J Tan, Santiago Escrivá-de-Romaní, Joyce O'Shaughnessy
{"title":"Trastuzumab Duocarmazine in Pretreated Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Breast Cancer: An Open-Label, Randomized, Phase III Trial (TULIP).","authors":"Nicholas Turner, Cristina Saura, Philippe Aftimos, Evelyn van den Tweel, Mayke Oesterholt, Norbert Koper, Marco Colleoni, Emilie Kaczmarek, Kevin Punie, Xinni Song, Anne Armstrong, Giulia Bianchi, Agostina Stradella, Sylvain Ladoire, Joline Si Jing Lim, Nathalie Quenel-Tueux, Tira J Tan, Santiago Escrivá-de-Romaní, Joyce O'Shaughnessy","doi":"10.1200/JCO.24.00529","DOIUrl":"https://doi.org/10.1200/JCO.24.00529","url":null,"abstract":"<p><strong>Purpose: </strong>Human epidermal growth factor receptor 2 (HER2)-targeted therapy is standard of care for HER2-positive (HER2+) breast cancer, but most patients develop progressive disease with persistent HER2 expression. No definitive treatment guidance currently exists beyond second line. Trastuzumab duocarmazine (T-Duo) is a third-generation, HER2-targeted antibody-drug conjugate that demonstrated efficacy and acceptable safety in phase I studies of heavily pretreated patients with HER2+/HER2-low breast cancer.</p><p><strong>Methods: </strong>In this open-label, randomized, phase III trial, T-Duo was compared with physician's choice (PC) in patients with unresectable locally advanced/metastatic HER2+ breast cancer with progression during/after ≥2 HER2-targeted therapies or after trastuzumab emtansine (T-DM1). The primary endpoint was progression-free survival (PFS) by blinded independent central review.</p><p><strong>Results: </strong>In total, 437 patients were randomly assigned 2:1 to T-Duo (n = 291) or PC (n = 146). The median age was 56.0 years (range, 24-86); most patients (93.6%) had metastatic disease. The median time from diagnosis of metastatic disease to trial entry was 3.5 years; the median number of prior HER2-targeted therapies in metastatic setting was three. The median PFS was 7.0 months (95% CI, 5.4 to 7.2) with T-Duo versus 4.9 months (95% CI, 4.0 to 5.5; hazard ratio [HR], 0.64 [95% CI, 0.49 to 0.84]; <i>P</i> = .002) with PC. PFS benefit was maintained across most predefined subgroups. The median overall survival (first analysis) was 20.4 (T-Duo) versus 16.3 months (PC; HR, 0.83 [95% CI, 0.62 to 1.09]; <i>P</i> = .153). Objective response rate was 27.8% (T-Duo) versus 29.5% (PC); other efficacy end points-clinical benefit rate, duration of response, and reduction in target lesion measurement-tended to favor T-Duo. Grade ≥3 treatment-emergent adverse events occurred in 52.8% (T-Duo) versus 48.2% (PC).</p><p><strong>Conclusion: </strong>Treatment with T-Duo was manageable, but tolerability was affected by prevalent ocular toxicity, leading to a higher discontinuation rate in the T-Duo arm. T-Duo significantly reduced the risk of progression in patients with advanced HER2+ breast cancer who have progressed during/after ≥2 HER2-targeted therapies or after T-DM1.</p>","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":" ","pages":"JCO2400529"},"PeriodicalIF":42.1,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142501185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Post-translationally created hybrids","authors":"Jan-Stefan Voeller","doi":"10.1038/s41929-024-01243-z","DOIUrl":"10.1038/s41929-024-01243-z","url":null,"abstract":"","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":"7 10","pages":"1055-1055"},"PeriodicalIF":42.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142487869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maj-Britt Jensen, Eva Balslev, Ann Søegaard Knoop, Malgorzata K Tuxen, Inger Højris, Erik H Jakobsen, Søren Cold, Hella Danø, Vesna Glavicic, Julia Kenholm, Bent Ejlertsen
{"title":"Adjuvant Docetaxel and Cyclophosphamide With or Without Epirubicin for Early Breast Cancer: Final Analysis of the Randomized DBCG 07-READ Trial.","authors":"Maj-Britt Jensen, Eva Balslev, Ann Søegaard Knoop, Malgorzata K Tuxen, Inger Højris, Erik H Jakobsen, Søren Cold, Hella Danø, Vesna Glavicic, Julia Kenholm, Bent Ejlertsen","doi":"10.1200/JCO.24.00836","DOIUrl":"https://doi.org/10.1200/JCO.24.00836","url":null,"abstract":"<p><p>The primary analysis of the DBCG 07-READ trial reported in 2017 provided evidence of no overall benefit from adjuvant anthracyclines in patients with early <i>TOP2A</i> normal breast cancer in disease-free survival (DFS), distant disease-free survival (DDFS), or overall survival (OS). We performed a protocol-scheduled analysis of DDFS, DFS, and OS on the basis of 10-year follow-up. Full details on incident heart failure (HF) and second cancers were presented. Patients in the intention-to-treat population assigned to epirubicin and cyclophosphamide followed by docetaxel (EC-D) had longer DDFS (adjusted hazard ratio [HR], 0.79 [95% CI, 0.64 to 0.98]; <i>P</i> = .03) and DFS (HR<sub>Adjusted</sub>, 0.83 [95% CI, 0.69 to 0.99]; <i>P</i> = .04) than patients assigned to docetaxel and cyclophosphamide (DC). There was no statistically significant difference in mortality rates. The 10-year cumulative risk of HF was 2.1% (95% CI, 1.4 to 3.3) with EC-D and 1.1% (95% CI, 0.6 to 2.0) with DC (HR<sub>Unadjusted</sub>, 2.12 [95% CI, 1.03 to 4.35]; <i>P</i> = .04). In conclusion, anthracycline followed by docetaxel improved outcome compared with DC in patients with <i>TOP2A</i> normal early breast cancer, and no clinical value of <i>TOP2A</i> testing was shown. The risk of HF was doubled in patients receiving anthracycline; however, overall, the risk of HF was low.</p>","PeriodicalId":42,"journal":{"name":"Journal of Chemical & Engineering Data","volume":" ","pages":"JCO2400836"},"PeriodicalIF":42.1,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142501182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}