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Article: Early-stage anaplastic lymphoma kinase (

Chen, Monica F / Chaft, Jamie E

2023 Volume 12, Issue 2, Page(s) 337–345

Abstract: Background and objective: While anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) are standard of care treatment for metastatic : Methods: We identified the references for this narrative review through a literature search of papers ... ...

Abstract	Background and objective: While anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) are standard of care treatment for metastatic Methods: We identified the references for this narrative review through a literature search of papers about early stage Key content and findings: The incidence of oncogenic Conclusions: Attempts at large, randomized trials to evaluate the benefit of ALK TKIs in the adjuvant and neoadjuvant has been hampered by slow recruitment given the rarity of
Language	English
Publishing date	2023-02-17
Publishing country	China
Document type	Journal Article ; Review
ZDB-ID	2754335-3
ISSN	2226-4477 ; 2218-6751
ISSN (online)	2226-4477
ISSN	2218-6751
DOI	10.21037/tlcr-22-631
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Article ; Online: Brief Report: Tyrosine Kinase Inhibitors for Lung Cancers That Inhibit MATE-1 Can Lead to "False" Decreases in Renal Function.

Chen, Monica F / Harada, Guilherme / Liu, Dazhi / DeMatteo, Ray / Falcon, Christina / Wilhelm, Clare / Kris, Mark G / Drilon, Alexander / Gutgarts, Victoria

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

2023 Volume 19, Issue 1, Page(s) 153–159

Abstract: Introduction: Select tyrosine kinase inhibitors (TKIs) used to treat oncogene-driven lung cancers also inhibit MATE-1. When MATE-1 is blocked, creatinine is retained in the serum. Elevated creatinine levels raise the specter of drug-induced intrarenal ... ...

Abstract	Introduction: Select tyrosine kinase inhibitors (TKIs) used to treat oncogene-driven lung cancers also inhibit MATE-1. When MATE-1 is blocked, creatinine is retained in the serum. Elevated creatinine levels raise the specter of drug-induced intrarenal insufficiency despite the lack of true renal injury. We conducted a systematic analysis of MATE-1 inhibitor (MATEi)-treated patients to comprehensively characterize this phenomenon. Methods: Patients with oncogene-driven lung cancer treated with a wide variety of MATEi TKIs (brigatinib, cabozantinib, capmatinib, crizotinib, entrectinib, lorlatinib, pralsetinib, selpercatinib, and tepotinib) were eligible for an analysis of renal dysfunction. Acute kidney injury was classified on the basis of creatinine levels (Kidney Disease: Improving Global Outcomes criteria) as stage 1 (≥1.5× but <2× baseline), stage 2 (≥2× but <3× baseline), or stage 3 (>3× baseline). When available, cystatin C, a marker of kidney function unaffected by MATE-1, was used to evaluate the glomerular filtration rate (GFR). Results: We identified 863 patients receiving MATEi TKIs including crizotinib (39%, n = 333), lorlatinib (17%, n = 144), cabozantinib (10%, n = 87), selpercatinib (10%, n = 82), capmatinib (9%, n = 77), brigatinib (6%, n = 53), entrectinib (5%, n = 45), tepotinib (5%, n = 41), and pralsetinib (0.1%, n = 1). Of the 90 patients (10%) with acute kidney injury, Kidney Disease: Improving Global Outcomes stages 1, 2, and 3 were observed in 72% (n = 65), 21% (n = 19), and 7% (n = 6) of patients, respectively. Concurrently drawn creatinine and cystatin C levels on TKI therapy were available for 17 patients. In most cases (n = 15 of 17), the calculated GFR was higher using cystatin C versus creatinine. The percentage of patients whose GFR was higher using cystatin C versus creatinine by less than 10 mL/min, 10 to 19 mL/min, 20 to 29 mL/min, and more than or equal to 30 mL/min was 27% (n = four of 15), 20% (n = three of 15), 20% (n = three of 15), and 33% (n = five of 15), respectively. Long-term data in three patients that spanned 3 years revealed that GFR was higher using cystatin C versus creatinine in 96% (n = 49 of 51) of all time points. Using a virtual clinical trial GFR cutoff of 40 mL/min, the percentage of eligible patients rose from 41% (n = seven of 17) using creatinine calculations to 71% (n = 12 of 17) using cystatin C calculations. Conclusions: The calculated GFR in patients with cancer receiving MATEi TKIs was higher in almost all cases when using cystatin C. When serum creatinine level seems elevated in patients receiving MATE-1 inhibitors, we recommend recalculating GFR using cystatin C before searching for other etiologies of kidney injury and reducing or stopping TKI therapy.
MeSH term(s)	Humans ; Cystatin C ; Tyrosine Kinase Inhibitors ; Creatinine ; Lung Neoplasms/drug therapy ; Crizotinib ; Glomerular Filtration Rate ; Kidney ; Acute Kidney Injury ; Biomarkers
Chemical Substances	entrectinib (L5ORF0AN1I) ; Cystatin C ; capmatinib (TY34L4F9OZ) ; brigatinib (HYW8DB273J) ; cabozantinib (1C39JW444G) ; lorlatinib (OSP71S83EU) ; Tyrosine Kinase Inhibitors ; Creatinine (AYI8EX34EU) ; Crizotinib (53AH36668S) ; Biomarkers
Language	English
Publishing date	2023-09-23
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2432037-7
ISSN	1556-1380 ; 1556-0864
ISSN (online)	1556-1380
ISSN	1556-0864
DOI	10.1016/j.jtho.2023.09.1444
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Article ; Online: Cyclodestructive procedures for refractory glaucoma.

Chen, Monica F / Kim, Carole H / Coleman, Anne L

The Cochrane database of systematic reviews

2019 Volume 3, Page(s) CD012223

Abstract: Background: Cyclodestructive procedures are often used in patients with refractory glaucoma who have failed to achieve lower intraocular pressure (IOP) from filtration procedures and maximal medical therapy. Destruction of the ciliary body helps to ... ...

Abstract	Background: Cyclodestructive procedures are often used in patients with refractory glaucoma who have failed to achieve lower intraocular pressure (IOP) from filtration procedures and maximal medical therapy. Destruction of the ciliary body helps to lower IOP by reducing aqueous humor formation. Of the many types of cyclodestructive procedures, laser cyclophotocoagulation (CPC) has become the most common surgical method for reducing aqueous inflow. Options for CPC are wide-ranging: they can be performed using a neodymium:yttrium-aluminum-garnet (Nd:YAG) or diode laser and laser energy can be delivered by either the contact or non-contact method. Another cyclodestructive procedure is endoscopic cyclophotocoagulation (ECP), which the ophthalmologist can use selectively to target the ciliary epithelium and ablate ciliary body tissue. There is debate regarding which cyclodestructive method is best and how they compare to other glaucoma surgeries. Objectives: To assess the relative effectiveness and safety of cyclodestructive procedures compared with other procedures in people with refractory glaucoma of any type and to assess the relative effectiveness and safety of individual cyclodestructive procedures compared with each other. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2018, Issue 9); Ovid MEDLINE; Embase.com; PubMed; LILACS BIREME; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 21 September 2018. Selection criteria: We included randomized controlled trials or quasi-randomized trials in which participants underwent a secondary procedure for refractory glaucoma. We included trials with any laser type, route of administration, and laser settings. The primary comparison was any cyclodestructive procedure versus another glaucoma treatment, and the secondary comparisons were individual cyclodestructive procedures versus another cyclodestructive procedure. Data collection and analysis: Two review authors independently reviewed the titles and abstracts from the database searches, and after retrieving the full-text reports of those that were potentially relevant, classified the full-text articles as included or excluded. Two review authors independently extracted data from the included studies and assessed the risk of bias. Discrepancies were resolved by discussion or by consultation with a third review author when necessary. Main results: We included five trials reporting data for 330 eyes (326 participants). One study to had a low risk of bias for most domains and the other studies had an overall unclear risk of bias. This review includes four different comparisons: 1) ECP versus Ahmed implant, 2) micropulse CPC versus continuous-wave CPC; 3) CPC with a diode versus Nd:YAG laser; and 4) CPC with an Nd:YAG laser emitting 8J versus 4J.No study reported data for our primary outcome, change from baseline in pain severity as reported by the participant or change in number of pain medications.For our primary comparison, we included one trial that compared ECP with the Ahmed implant. At 12-month follow-up, the mean difference (MD) in IOPs between groups was -1.14 mmHg (95% confidence interval (CI) -4.21 to 1.93; 58 participants; low-certainty evidence (LCE)). At 24 months postintervention, we found very LCE suggesting that visual acuity may be better among participants in the ECP group than in the Ahmed implant group (MD -0.24 logMAR, 95% CI -0.52 to 0.04; 54 participants), and the difference in the mean number of glaucoma medications used by participants in each group was unclear (MD -0.50, 95% CI -1.17 to 0.17; 54 participants; very LCE). Reported adverse events in the ECP group (34 participants) were one case each of hypotony, phthisis bulbi, retinal detachment, and choroidal detachment; in the Ahmed implant group (34 participants) there was one case of endophthalmitis, two cases of retinal detachment, and six cases of choroidal detachment.Three types of comparisons from four included studies provided data for our secondary comparisons. In the study that compared micropulse with continuous-wave CPC, median IOP was reported to be similar between the two groups at all time points. At 18 months postintervention, the median number of IOP-lowering medications was reduced from two to one in both groups. One participant in the micropulse and two in the continuous group exhibited worsened visual acuity. One case of prolonged inflammation was seen in the micropulse group (23 participants). Seven cases of prolonged inflammation, five cases of hypotony, and one case of phthisis bulbi were seen in the continuous group (23 participants).Two studies compared CPC using a semiconductor diode versus an Nd:YAG laser. At 12 months postintervention, the MD in IOP was 1.02 mmHg (95% CI -1.49 to 3.53) in one study (LCE). The second study did not report mean IOP beyond three months of follow-up. Neither study reported the mean change in best-corrected visual acuity or number of glaucoma medications. Both studies reported hypotony as an adverse event in three participants in each study.One study compared different energy settings of the same Nd:YAG laser. At 12-month follow-up, visual acuity was unchanged or improved in 21 of 33 participants in the 8J group and 20 of 27 participants in the 4J group (risk ratio 0.86, 95% CI 0.61 to 1.21; very LCE). More participants in the 8J group reduced the number of medications taken compared with the 4J group (RR 1.49, 95% CI 0.76 to 2.91; 50 participants; very low-certainty evidence). The presence of fibrin or hyphema were seen in five participants who received 8J and none who received 4J. There was a severe anterior chamber reaction in 11 of 26 (42%) participants who received 8J of energy and 2 of 21 (10%) participants who received 4J of energy. Authors' conclusions: Evidence from five studies included in this review was inconclusive as to whether cyclodestructive procedures for refractory glaucoma result in better outcomes and fewer complications than other glaucoma treatments, and whether one type of cyclodestructive procedure is better than another. The most commonly reported adverse events across all five studies were hypotony and phthisis bulbi. Large, well-designed randomized controlled trials are needed. Patient-reported outcomes such as pain and quality of life should be considered as primary outcomes or important secondary outcomes of future trials.
MeSH term(s)	Aqueous Humor ; Ciliary Body/surgery ; Endoscopy ; Glaucoma/surgery ; Glaucoma Drainage Implants/adverse effects ; Humans ; Intraocular Pressure ; Laser Coagulation/adverse effects ; Laser Coagulation/methods ; Lasers, Solid-State/therapeutic use ; Randomized Controlled Trials as Topic ; Visual Acuity
Language	English
Publishing date	2019-03-10
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Systematic Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD012223.pub2
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Article ; Online: Long-Term Patient-Reported Outcomes of Visual Field Defects and Compensatory Mechanisms in Patients After Cerebral Hemispherectomy.

Meer, Elana A / Chen, Monica F / Jones, Monika / Mathern, Gary W / Pineles, Stacy L

Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society

2020 Volume 41, Issue 2, Page(s) 147–153

Abstract: Background: In cases of intractable epilepsy resistant to drug therapy, hemispherectomy is often the only treatment option to mitigate seizures; however, the true long-term subjective visual outcomes are relatively unexplored. In this study, we sought ... ...

Abstract	Background: In cases of intractable epilepsy resistant to drug therapy, hemispherectomy is often the only treatment option to mitigate seizures; however, the true long-term subjective visual outcomes are relatively unexplored. In this study, we sought to determine and characterize patient-reported visual function years after hemispherectomy. Methods: This was an observational study conducted on a large cohort of children with seizure disorder treated with cerebral hemispherectomy. An online survey was sent to parents with questions to assess subjective visual function with a variety of questions from presence of visual field defects after hemispherectomy, to improvement over time, compensatory mechanisms used, and development of strabismus. Results: This survey was emailed to 248 parents of previously evaluated children who agreed to be re-surveyed, 48 (20%) of which responded. The average age at hemispherectomy was approximately 5 (±4) years, and the average time after hemispherectomy was 7 (±5) years. Thirty-nine patients (81%) were seizure-free after 1 surgery and 85% (n = 41) were seizure-free after ≥1 surgeries. Thirty-four (71%) experienced a visual field defect after surgery, but 25 (52%) experienced subjective improvement over time. Thirty-eight (79%) used compensatory mechanisms, such as head tilting, with 16 (33%) patients experiencing subjective improvement over time. Twenty-seven (56%) patients experienced a decrease in visual acuity after surgery with 12 (25%) experiencing subjective improvement over time. Conclusion: In a large cohort examining patient-reported visual outcomes years after hemispherectomy, most patients experienced strabismus and/or visual field defects. However, more than half reported improvements and compensatory mechanisms (exotropic strabismus and ipsilateral esotropic strabismus) over time, presumably to enhance visual field function. By exploring subjective visual and cognitive function, this paper uniquely characterizes patient-reported improvements over time, and provides motivation for larger longitudinal studies using more quantitative measures of visual function and improvement after hemispherectomy.
MeSH term(s)	Adolescent ; Child ; Child, Preschool ; Female ; Follow-Up Studies ; Hemispherectomy/adverse effects ; Humans ; Male ; Patient Reported Outcome Measures ; Postoperative Complications/etiology ; Postoperative Complications/physiopathology ; Scotoma/etiology ; Scotoma/physiopathology ; Seizures/surgery ; Time Factors ; Visual Acuity ; Visual Field Tests ; Visual Fields/physiology
Language	English
Publishing date	2020-08-08
Publishing country	United States
Document type	Journal Article ; Observational Study
ZDB-ID	1189901-3
ISSN	1536-5166 ; 1070-8022
ISSN (online)	1536-5166
ISSN	1070-8022
DOI	10.1097/WNO.0000000000000998
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Article ; Online: Response to Repotrectinib After Development of

Chen, Monica F / Yang, Soo-Ryum / Shia, Jinru / Girshman, Jeffrey / Punn, Sippy / Wilhelm, Clare / Kris, Mark G / Cocco, Emiliano / Drilon, Alexander / Raj, Nitya

JCO precision oncology

2023 Volume 7, Page(s) e2200697

MeSH term(s)	Humans ; Pyrazoles/pharmacology ; Pyrazoles/therapeutic use ; Receptor, trkA/genetics ; Protein Kinase Inhibitors/pharmacology ; Protein Kinase Inhibitors/therapeutic use ; Mutation
Chemical Substances	repotrectinib (08O3FQ4UNP) ; Pyrazoles ; Receptor, trkA (EC 2.7.10.1) ; Protein Kinase Inhibitors
Language	English
Publishing date	2023-05-24
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2473-4284
ISSN (online)	2473-4284
DOI	10.1200/PO.22.00697
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Article ; Online: Adjunctive steroid therapy versus antibiotics alone for acute endophthalmitis after intraocular procedure.

Kim, Carole H / Chen, Monica F / Coleman, Anne L

The Cochrane database of systematic reviews

2017 Volume 2, Page(s) CD012131

Abstract: Background: Endophthalmitis refers to severe infection within the eye that involves the aqueous humor or vitreous humor, or both, and threatens vision. Most cases of endophthalmitis are exogenous (i.e. due to inoculation of organisms from an outside ... ...

Abstract	Background: Endophthalmitis refers to severe infection within the eye that involves the aqueous humor or vitreous humor, or both, and threatens vision. Most cases of endophthalmitis are exogenous (i.e. due to inoculation of organisms from an outside source), and most exogenous endophthalmitis is acute and occurs after an intraocular procedure. The mainstay of treatment is emergent administration of broad-spectrum intravitreous antibiotics. Due to their anti-inflammatory effects, steroids in conjunction with antibiotics have been proposed to be beneficial in endophthalmitis management. Objectives: To assess the effects of antibiotics combined with steroids versus antibiotics alone for the treatment of acute endophthalmitis following intraocular surgery or intravitreous injection. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 11), MEDLINE Ovid (1946 to 8 December 2016), Embase Ovid (1980 to 8 December 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 8 December 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 8 December 2016, ClinicalTrials.gov (www.clinicaltrials.gov); searched 8 December 2016, and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 8 December 2016. We did not use any date or language restrictions in the electronic searches for trials. Selection criteria: We included randomized controlled trials comparing the effectiveness of adjunctive steroids with antibiotics alone in the management of acute, clinically diagnosed endophthalmitis following intraocular surgery or intravitreous injection. We excluded trials with participants with endogenous endophthalmitis unless outcomes were reported by source of infection. We imposed no restrictions on the method or order of administration, dose, frequency, or duration of antibiotics and steroids. Data collection and analysis: Two review authors independently screened the search results, assessed risk of bias, and extracted data using methods expected by Cochrane. We contacted study authors to try to obtain missing information or information to clarify risk of bias. We conducted a meta-analysis for any outcomes that were reported by at least two studies. Outcomes reported from single studies were summarized in the text. We assessed the certainty of the evidence using GRADE. Main results: We included three trials with a total of 95 randomized participants in this review and identified one ongoing trial. The studies were conducted in South Africa, India, and the Netherlands. Out of the 92 analyzed participants, 91 participants were diagnosed with endophthalmitis following cataract surgery. In the remaining participant, endophthalmitis was attributable to penetrating keratoplasty. All studies used intravitreous dexamethasone for adjunctive steroid therapy and a combination of two intravitreous antibiotics that provided gram-positive and gram-negative coverage for the antibiotic therapy. We judged one trial to be at overall low risk of bias and two studies to be at overall unclear risk of bias due to lack of reporting of study methods. None of the three trials had been registered in a clinical trial register.While none of the included studies reported the primary outcome of complete resolution of endophthalmitis as defined in our protocol, one study reported combined anatomical and functional success (i.e. proportion of participants with intraocular pressure of at least 5 mmHg and visual acuity of at least 6/120). Very low-certainty evidence suggested no difference in combined success when comparing adjunctive steroid antibiotics alone (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.80 to 1.45; 32 participants). Low-certainty evidence from two studies showed that a higher proportion of participants who received adjunctive dexamethasone had a good visual outcome (Snellen visual acuity 6/6 to 6/18) at three months compared with those in the antibiotics-alone group (RR 1.95, 95% CI 1.05 to 3.60; 60 participants). Similarly, low-certainty evidence from one study suggested that more participants in the dexamethasone group had a good visual outcome at 12 months compared to those who did not receive dexamethasone (RR 2.00, 95% CI 0.98 to 4.08; 28 participants). Investigators of one study reported improvement in visual acuity, but we could not estimate the effect of adjunctive steroid therapy because the study investigators did not provide standard deviations or standard errors. Two studies reported adverse events (retinal detachment, hypotony, proliferative vitreoretinopathy, and seclusion of pupil). The total numbers of adverse events were 8 out of 30 (26.7%) for those who received dexamethasone versus 6 out of 30 (20.0%) for those who did not. We could only perform a pooled analysis for the occurrence of retinal detachment; any difference between the two treatment groups was uncertain (RR 1.57, 95% CI 0.50 to 4.90; 60 participants) (very low-certainty evidence). No study reported intraocular pressure or cost outcomes. Authors' conclusions: Current evidence on the effectiveness of adjunctive steroid therapy versus antibiotics alone in the management of acute endophthalmitis after intraocular surgery is inadequate. We found no studies that had enrolled cases of acute endophthalmitis following intravitreous injection. A combined analysis of two studies suggests adjunctive steroids may provide a higher probability of having a good visual outcome at three months than not using adjunctive steroids. However, considering that most of the confidence intervals crossed the null and that this review was limited in scope and applicability to clinical practice, it is not possible to conclude whether the use adjunctive steroids is effective at this time. Any future trials should examine whether adjunctive steroids may be useful in certain clinical settings such as type of causative organism or etiology. These studies should include outcomes that take patient's symptoms and clinical examination into account, report outcomes in a uniform and consistent manner, and follow up at short- and long-term intervals.
MeSH term(s)	Acute Disease ; Anti-Bacterial Agents/administration & dosage ; Anti-Bacterial Agents/therapeutic use ; Cataract Extraction/adverse effects ; Chemotherapy, Adjuvant ; Dexamethasone/administration & dosage ; Dexamethasone/therapeutic use ; Endophthalmitis/drug therapy ; Endophthalmitis/etiology ; Glucocorticoids/administration & dosage ; Glucocorticoids/therapeutic use ; Humans ; Intravitreal Injections/adverse effects ; Keratoplasty, Penetrating/adverse effects ; Postoperative Complications/drug therapy
Chemical Substances	Anti-Bacterial Agents ; Glucocorticoids ; Dexamethasone (7S5I7G3JQL)
Language	English
Publishing date	2017-02-22
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD012131.pub2
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Article ; Online: Lorlatinib Tolerability and Association With Clinical Outcomes in Patients With Advanced

Thummalapalli, Rohit / Choudhury, Noura J / Ehrich, Fiona / Beardslee, Tyler / Brazel, Danielle / Zhang, Shannon S / Merchant, Shelby / Chen, Monica F / Heller, Glenn / Ramalingam, Suresh S / Ou, Sai-Hong Ignatius / Mileham, Kathryn F / Riely, Gregory J

JTO clinical and research reports

2023 Volume 4, Issue 8, Page(s) 100546

Abstract: Introduction: Treatment with lorlatinib for patients with advanced : Methods: We reviewed the course of 144 patients with advanced : Results: A total of 58 patients (40%) had TRAE-related dose reductions, most (59%) owing to neurocognitive AEs or ... ...

Abstract	Introduction: Treatment with lorlatinib for patients with advanced Methods: We reviewed the course of 144 patients with advanced Results: A total of 58 patients (40%) had TRAE-related dose reductions, most (59%) owing to neurocognitive AEs or neuropathy. Among all patients, the median PFS was 8.1 months (95% confidence interval [CI]: 6.4-11.8); the median OS was 20.7 months (95% CI: 16.3-30.5). Among patients who were started on lorlatinib 100 mg/d (n = 122), a Cox regression model with the occurrence of a dose reduction as a time-dependent covariate indicated no association between dose reduction and PFS (hazard ratio = 0.86, 95% CI: 0.54-1.39) or OS (hazard ratio = 0.78, 95% CI: 0.47-1.30). Conclusions: Lorlatinib dose reductions were not associated with inferior clinical outcomes in this multicenter analysis. Prompt identification of lorlatinib TRAEs and implementation of dose reductions may help maximize tolerability without compromising outcomes.
Language	English
Publishing date	2023-06-30
Publishing country	United States
Document type	Journal Article
ISSN	2666-3643
ISSN (online)	2666-3643
DOI	10.1016/j.jtocrr.2023.100546
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Article ; Online: Phase II Study of Osimertinib in Patients With Epidermal Growth Factor Receptor Mutations: Results From the NCI-MATCH ECOG-ACRIN (EAY131) Trial Subprotocol E.

JCO precision oncology

2024 Volume 8, Page(s) e2300454

Abstract: Purpose: The National Cancer Institute Molecular Analysis for Therapy Choice trial is a signal-finding genomically driven platform trial that assigns patients with any advanced refractory solid tumor, lymphoma, or myeloma to targeted therapies on the ... ...

Abstract	Purpose: The National Cancer Institute Molecular Analysis for Therapy Choice trial is a signal-finding genomically driven platform trial that assigns patients with any advanced refractory solid tumor, lymphoma, or myeloma to targeted therapies on the basis of next-generation sequencing results. Subprotocol E evaluated osimertinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with Methods: Eligible patients had Results: A total of 19 patients were enrolled: 17 were evaluable for toxicity and 13 for efficacy. The median age of the 13 included in the efficacy analysis was 63 years, 62% had Eastern Cooperative Oncology Group performance status 1, and 31% received >three previous systemic therapies. The most common tumor type was brain cancers (54%). The ORR was 15.4% (n = 2 of 13; 90% CI, 2.8 to 41.0) and 6-month PFS was 16.7% (90% CI, 0 to 34.4). The two confirmed RECIST responses were observed in a patient with neuroendocrine carcinoma not otherwise specified ( Conclusion: In this pretreated cohort, osimertinib did not meet the prespecified end point threshold for efficacy, but responses were seen in a neuroendocrine carcinoma with an
MeSH term(s)	United States ; Humans ; Middle Aged ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; Carcinoma, Non-Small-Cell Lung/genetics ; ErbB Receptors/genetics ; National Cancer Institute (U.S.) ; Antineoplastic Agents/adverse effects ; Protein Kinase Inhibitors/adverse effects ; Mutation ; Carcinoma, Neuroendocrine/drug therapy ; Acrylamides ; Aniline Compounds ; Indoles ; Pyrimidines
Chemical Substances	osimertinib (3C06JJ0Z2O) ; ErbB Receptors (EC 2.7.10.1) ; Antineoplastic Agents ; Protein Kinase Inhibitors ; Acrylamides ; Aniline Compounds ; Indoles ; Pyrimidines
Language	English
Publishing date	2024-04-09
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article
ISSN	2473-4284
ISSN (online)	2473-4284
DOI	10.1200/PO.23.00454
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Article ; Online: Etiology and Age Modifies Subjective Visual Function After Cerebral Hemispherectomy.

Chen, Monica F / Meer, Elana / Velez, Federico G / Jones, Monika / Mathern, Gary W / Pineles, Stacy L

Journal of child neurology

2019 Volume 34, Issue 8, Page(s) 446–451

Abstract: Background: Cerebral hemispherectomy is typically used to treat patients with pharmacoresistant epilepsy. Visual-related outcomes are relatively unstudied in this population, aside from the knowledge that patients develop a complete homonymous ... ...

Abstract	Background: Cerebral hemispherectomy is typically used to treat patients with pharmacoresistant epilepsy. Visual-related outcomes are relatively unstudied in this population, aside from the knowledge that patients develop a complete homonymous hemianopia contralateral to the side of the hemispherectomy. The purpose of this study was to determine and characterize parent-reported functional visual, oculomotor, and postural changes in a large population of patients following cerebral hemispherectomy. Methods: An online survey was sent to parents of children who had undergone hemispherectomy for seizure control. Families were recruited by the Brain Recovery Project: Childhood Epilepsy Surgery Foundation. Parent-reported subjective visual function was assessed by the presence of peripheral field defects, ocular misalignment and anomalous head posture. Results: A total of 196 (12.5%) participants responded. Postoperative follow-up was 92±78 months (range: 1-382). Ninety-three percent of parents reported the child had difficulties with peripheral vision. Torticollis was present postoperatively in 122 (62%) patients. Strabismus was noted in 93 (49%). Fifty-five (59%) of the strabismus patients demonstrated exotropia with the majority of exotropia patients demonstrating the exo-deviated eye in the direction contralateral to the hemispherectomy (74.5%). Both torticollis and strabismus were most frequently seen immediately after surgery. Sixty-six patients (34%) underwent strabismus treatment. Patients with younger age of seizure onset, younger age of surgery, and certain epilepsy etiologies (hemimegencephaly, Sturge-Weber syndrome) were more likely to develop strabismus and torticollis. Conclusions: Torticollis and strabismus are common after hemispherectomy and appear to be influenced by etiology and age at surgery. Preoperative discussion with parents and patients regarding those compensatory mechanisms is recommended, and postoperative ophthalmologic assessments are also encouraged.
MeSH term(s)	Adolescent ; Age Factors ; Brain/physiopathology ; Brain/surgery ; Child ; Child, Preschool ; Electroencephalography ; Epilepsy/surgery ; Female ; Follow-Up Studies ; Hemispherectomy/adverse effects ; Humans ; Infant ; Male ; Postoperative Complications/etiology ; Postoperative Complications/physiopathology ; Vision Disorders/etiology ; Vision Disorders/physiopathology ; Vision Tests ; Vision, Ocular/physiology ; Young Adult
Language	English
Publishing date	2019-04-07
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639288-x
ISSN	1708-8283 ; 0883-0738
ISSN (online)	1708-8283
ISSN	0883-0738
DOI	10.1177/0883073819834430
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Article ; Online: Superior sulcus non-small cell lung cancers (Pancoast tumors): Current outcomes after multidisciplinary management.

McLaughlin, Kaitlin / Tan, Kay See / Dycoco, Joe / Chen, Monica F / Chaft, Jamie E / Mankuzhy, Nikhil P / Rimner, Andreas / Aly, Rania G / Fanaroff, Rachel E / Travis, William D / Bilsky, Mark / Bains, Manjit / Downey, Robert / Huang, James / Isbell, James M / Molena, Daniela / Park, Bernard J / Jones, David R / Rusch, Valerie W

The Journal of thoracic and cardiovascular surgery

2023 Volume 166, Issue 6, Page(s) 1477–1487.e8

Abstract: Objective: Despite neoadjuvant chemoradiotherapy, Pancoast tumors still present surgical and oncologic challenges. To optimize outcomes, we used a multidisciplinary care paradigm with medical and radiation oncology, and involvement of spine neurosurgery ...

Abstract	Objective: Despite neoadjuvant chemoradiotherapy, Pancoast tumors still present surgical and oncologic challenges. To optimize outcomes, we used a multidisciplinary care paradigm with medical and radiation oncology, and involvement of spine neurosurgery for most T3 and all T4 tumors. Spine neurosurgery permitted resection of transverse process for T3 and vertebral body resection for T4 tumors. Methods: Retrospective analysis of single institution, prospective database of patients undergoing resection for cT3 4M0 Pancoast tumors. Patients were grouped as cT3 with combined resection with spine neurosurgery (T3 Neuro), cT3 without spine neurosurgery (T3 NoNeuro), and cT4. Overall survival, progression-free survival were analyzed by Kaplan-Meier and compared between groups using log-rank test. Cumulative incidence of local-regional and distant recurrence were compared using Gray test. P value <.05 was considered significant. Results: From 2000 to 2021, 155 patients underwent surgery: median age was 58 years, and 81 were (52%) men. Most patients received neoadjuvant platinum-based neoadjuvant chemoradiotherapy (n = 127 [82%]). Operations were 48 cT3 Neuro, 41 cT3 NoNeuro, 66 cT4. R0 resection was achieved in 49 (94%) cT3 NoNeuro, 35 (85%) cT3 Neuro, and 57 (86%) cT4 patients (P = .4). Complete or major pathologic response occurred in 71 (55%) patients. Lower local-regional cumulative incidence was seen in cT3 Neuro versus cT3 NoNeuro (P = .05) and after major pathologic response. Overall survival and progression-free survival were associated with complete response, pathologic stage, and nodal status but not cT category. Conclusions: This treatment paradigm was associated with a high frequency of R0 resection, complete response, and major pathologic response. cT3 and cT4 tumors had similar outcomes. Novel therapies are needed to improve complete response.
MeSH term(s)	Male ; Humans ; Middle Aged ; Female ; Carcinoma, Non-Small-Cell Lung/pathology ; Lung Neoplasms/pathology ; Retrospective Studies ; Neoplasm Staging ; Neoadjuvant Therapy/adverse effects ; Neoplasm Recurrence, Local/pathology
Language	English
Publishing date	2023-08-22
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	3104-5
ISSN	1097-685X ; 0022-5223
ISSN (online)	1097-685X
ISSN	0022-5223
DOI	10.1016/j.jtcvs.2023.08.023
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