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[PMID]: 29244528
[Au] Autor:Johnston SRD; Hegg R; Im SA; Park IH; Burdaeva O; Kurteva G; Press MF; Tjulandin S; Iwata H; Simon SD; Kenny S; Sarp S; Izquierdo MA; Williams LS; Gradishar WJ
[Ad] Address:Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul Nat
[Ti] Title:Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE.
[So] Source:J Clin Oncol;36(8):741-748, 2018 Mar 10.
[Is] ISSN:1527-7755
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Purpose Human epidermal growth factor receptor 2 (HER2) targeting plus endocrine therapy (ET) improved clinical benefit in HER2-positive, hormone receptor (HR)-positive metastatic breast cancer (MBC) versus ET alone. Dual HER2 blockade enhances clinical benefit versus single HER2 blockade. The ALTERNATIVE study evaluated the efficacy and safety of dual HER2 blockade plus aromatase inhibitor (AI) in postmenopausal women with HER2-positive/HR-positive MBC who received prior ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy. Methods Patients were randomly assigned (1:1:1) to receive lapatinib (LAP) + TRAS + AI, TRAS + AI, or LAP + AI. Patients for whom chemotherapy was intended were excluded. The primary end point was progression-free survival (PFS; investigator assessed) with LAP + TRAS + AI versus TRAS + AI. Secondary end points were PFS (comparison of other arms), overall survival, overall response rate, clinical benefit rate, and safety. Results Three hundred fifty-five patients were included in this analysis: LAP + TRAS + AI (n = 120), TRAS + AI (n = 117), and LAP + AI (n = 118). Baseline characteristics were balanced. The study met its primary end point; superior PFS was observed with LAP + TRAS + AI versus TRAS + AI (median PFS, 11 v 5.7 months; hazard ratio, 0.62; 95% CI, 0.45 to 0.88; P = .0064). Consistent PFS benefit was observed in predefined subgroups. Overall response rate, clinical benefit rate, and overall survival also favored LAP + TRAS + AI. The median PFS with LAP + AI versus TRAS + AI was 8.3 versus 5.7 months (hazard ratio, 0.71; 95% CI, 0.51 to 0.98; P = .0361). Common adverse events (AEs; ≥ 15%) with LAP + TRAS + AI, TRAS + AI, and LAP + AI were diarrhea (69%, 9%, and 51%, respectively), rash (36%, 2%, and 28%, respectively), nausea (22%, 9%, and 22%, respectively), and paronychia (30%, 0%, and 15%, respectively), mostly grade 1 or 2. Serious AEs were reported similarly across the three groups, and AEs leading to discontinuation were lower with LAP + TRAS + AI. Conclusion Dual HER2 blockade with LAP + TRAS + AI showed superior PFS benefit versus TRAS + AI in patients with HER2-positive/HR-positive MBC. This combination offers an effective and safe chemotherapy-sparing alternative treatment regimen for this patient population.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1712
[Cu] Class update date: 180308
[Lr] Last revision date:180308
[St] Status:In-Data-Review
[do] DOI:10.1200/JCO.2017.74.7824

  2 / 1180 MEDLINE  
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[PMID]: 29506451
[Au] Autor:Bansal N; Walters HL; Kobayashi D
[Ad] Address:1 Division of Cardiology, Carman and Ann Adams Department of Pediatrics, Children's Hospital of Michigan, Wayne State University School of Medicine, Detroit, MI, USA.
[Ti] Title:Purulent Pericarditis Due to Paronychia in a 16-Month-Old Child: A Nail-Biting Story.
[So] Source:World J Pediatr Congenit Heart Surg;:2150135117742651, 2018 Jan 01.
[Is] ISSN:2150-136X
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Purulent pericarditis is a rare infectious disease with significant mortality, even in the modern antibiotic era. The presenting signs can often be subtle and patients can deteriorate rapidly with cardiac tamponade. We report a previously healthy 16-month-old female who developed purulent pericarditis associated with paronychia and sepsis caused by methicillin-sensitive Staphylococcus aureus. In addition to antibiotic treatment, she required emergent pericardiocentesis for cardiac tamponade, followed by two surgical interventions including full median sternotomy incision and partial pericardiectomy. At 4-month follow-up, she did well with no evidence of constrictive pericarditis on echocardiogram.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180306
[Lr] Last revision date:180306
[St] Status:Publisher
[do] DOI:10.1177/2150135117742651

  3 / 1180 MEDLINE  
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[PMID]: 29491117
[Au] Autor:Nasu S; Suzuki H; Shiroyama T; Tanaka A; Iwata K; Ryota N; Ueda Y; Takata SO; Masuhiro K; Morita S; Morishita N; Okamoto N; Hirashima T
[Ad] Address:Department of Thoracic Oncology, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Osaka, Japan hugurahoma@yahoo.co.jp.
[Ti] Title:Skin Rash Can Be a Useful Marker for Afatinib Efficacy.
[So] Source:Anticancer Res;38(3):1783-1788, 2018 03.
[Is] ISSN:1791-7530
[Cp] Country of publication:Greece
[La] Language:eng
[Ab] Abstract:BACKGROUND/AIM: Although afatinib has a strong efficacy, it can be toxic; hence, we aimed to determine markers of response to afatinib in order to assess prognosis. PATIENTS AND METHODS: Information on clinical background, therapeutic effects, and adverse events was collected retrospectively at one Institution from patients treated with afatinib as initial epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI). We examined the relationship between different adverse events and their effects on prognosis. RESULTS: Afatinib was used in 32 patients as the initial EGFR-TKI. Adverse events of grade 3 or higher including diarrhoea (12.5%), paronychia (6.3%), and stomatitis (3.1%) were experienced by patients. The median progression-free survival (PFS) was 15.4 months. A relationship between skin rash severity and PFS was observed. CONCLUSION: Grade 2 or higher skin rash might be a marker for long-term efficacy of afatinib when administered as a first-line treatment.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180305
[Lr] Last revision date:180305
[St] Status:In-Process

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[PMID]: 29363250
[Au] Autor:Kiura K; Yoh K; Katakami N; Nogami N; Kasahara K; Takahashi T; Okamoto I; Cantarini M; Hodge R; Uchida H
[Ad] Address:Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
[Ti] Title:Osimertinib in patients with epidermal growth factor receptor T790M advanced non-small cell lung cancer selected using cytology samples.
[So] Source:Cancer Sci;, 2018 Jan 24.
[Is] ISSN:1349-7006
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:Osimertinib is a potent, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) selective for EGFR-TKI sensitizing (EGFRm) and T790M resistance mutations. The primary objective of the cytology cohort in the AURA study was to investigate safety and efficacy of osimertinib in pretreated Japanese patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), with screening EGFR T790M mutation status determined from cytology samples. The cytology cohort was included in the Phase I dose expansion component of the AURA study. Patients were enrolled based on a positive result of T790M by using cytology samples, and received osimertinib 80 mg in tablet form once daily until disease progression or until clinical benefit was no longer observed at the discretion of the investigator. Primary endpoint for efficacy was objective response rate (ORR) by investigator assessment. Twenty-eight Japanese patients were enrolled into the cytology cohort. At data cut-off (February 1, 2016), 12 (43%) were on treatment. Investigator-assessed ORR was 75% (95% confidence interval [CI] 55, 89) and median duration of response was 9.7 months (95% CI 3.8, not calculable [NC]). Median progression-free survival was 8.3 months (95% CI 4.2, NC) and disease control rate was 96% (95% CI 82, 100). The most common all-causality adverse events were paronychia (46%), dry skin (46%), diarrhea (36%) and rash (36%). Osimertinib provided clinical benefit with a manageable safety profile in patients with pretreated EGFR T790M mutation-positive NSCLC whose screening EGFR T790M mutation-positive status was determined from cytology samples. (ClinicalTrials.gov number NCT01802632).
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1801
[Cu] Class update date: 180301
[Lr] Last revision date:180301
[Cl] Clinical Trial:ClinicalTrial
[St] Status:Publisher
[do] DOI:10.1111/cas.13511

  5 / 1180 MEDLINE  
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[PMID]: 29479729
[Au] Autor:Poveda-Montoyo I; Vergara-de Caso E; Romero-Pérez D; Betlloch-Mas I
[Ad] Address:Department of Dermatology, University General Hospital of Alicante, Alicante, Spain.
[Ti] Title:Retronychia a little-known cause of paronychia: A report of two cases in adolescent patients.
[So] Source:Pediatr Dermatol;, 2018 Feb 26.
[Is] ISSN:1525-1470
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Retronychia is a clinical condition resulting from embedding of the nail plate into the proximal nail fold. We report two adolescent girls, 14 and 16 years of age, with a history of chronic proximal paronychia of the great toe, one of them developing osteomyelitis. After failure of treatment with several systemic antibiotics, nail avulsion was performed, leading us to the diagnosis of retronychia and with rapid and complete resolution of symptoms in both cases. Delay in diagnosis of retronychia can lead to local complications and prolonged discomfort.
[Pt] Publication type:CASE REPORTS
[Em] Entry month:1802
[Cu] Class update date: 180226
[Lr] Last revision date:180226
[St] Status:Publisher
[do] DOI:10.1111/pde.13429

  6 / 1180 MEDLINE  
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[PMID]: 29469707
[Au] Autor:Robledo A; Godoy E; Manrique E; Manchado P
[Ad] Address:Department of Dermatology, Hospital Clínico Universitario de Valladolid, Spain. robledosanchezaitana@gmail.com.
[Ti] Title:Retronychia: an underdiagnosed disease.
[So] Source:Dermatol Online J;23(7), 2017 Jul 15.
[Is] ISSN:1087-2108
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Retronychia is a recently described cause of ingrowth of the nail plate on the ventral surface of the proximal nail fold. Clinical features are repeated episodes of proximal paronychia, nail plate thickening, and occasionally granulation tissue emergence. The usual treatments for paronychia such as antibiotics and antifungals are ineffective in these cases. Avulsion of the nail plate is the treatment of choice for these patients, but effective treatment is usually delayed owing to inadequate diagnosis. Herein, we describe a 28-year-old woman with a case of retronychia. She was treated for two months with oral and topical antifungal and antibiotics by her general practitioner. After proper diagnosis and avulsion of the nail she presented a normal and non-painful growth of the affected nail.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180222
[Lr] Last revision date:180222
[St] Status:In-Process

  7 / 1180 MEDLINE  
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[PMID]: 29462253
[Au] Autor:Hsu WH; Yang JC; Mok TS; Loong HH
[Ad] Address:Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
[Ti] Title:Overview of current systemic management of EGFR-mutant NSCLC.
[So] Source:Ann Oncol;29(suppl_1):i3-i9, 2018 Jan 01.
[Is] ISSN:1569-8041
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:Front-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy is the standard of care for lung cancer patients with sensitising EGFR mutations (exon 19 deletion or L858R mutation). Several phase III studies have demonstrated the superiority of gefitinib, erlotinib (first generation of TKIs) or afatinib (second generation) to chemotherapy in progression-free survival and response rates. Drug-related toxicities, such as diarrhoea, acneiform skin rash, mucositis, and paronychia, are frequently encountered in patients who receive EGFR TKIs. Other rare side-effects, such as hepatic impairment and interstitial lung disease, should be identified early and managed carefully. Patients with uncommon EGFR mutations, such as G719X, S768I, and L861Q, may require special selection of EGFR TKIs. The combination of erlotinib plus bevacizumab has been accepted in certain parts of the world as an alternative front-line treatment. This review article summarizes the studies leading to the establishment of EGFR TKIs in EGFR-mutant lung cancer patients. The side-effect profiles of the current EGFR TKIs in these large trials are listed, and the management of uncommon EGFR mutations is discussed. Finally, the potential role of combination front-line treatment is discussed.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180220
[Lr] Last revision date:180220
[St] Status:In-Data-Review
[do] DOI:10.1093/annonc/mdx702

  8 / 1180 MEDLINE  
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[PMID]: 29423683
[Au] Autor:Tanaka H; Taima K; Tanaka Y; Itoga M; Ishioka Y; Nakagawa H; Baba K; Hasegawa Y; Takanashi S; Tasaka S
[Ad] Address:Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, 5, Zaifu-cho, Hirosaki, 036-8562, Japan. xyghx335@gmail.com.
[Ti] Title:A phase I study of afatinib for patients aged 75 or older with advanced non-small cell lung cancer harboring EGFR mutations.
[So] Source:Med Oncol;35(3):34, 2018 Feb 08.
[Is] ISSN:1559-131X
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:This phase I trial was conducted to determine the maximum tolerated dose (MTD) and recommended dose of afatinib for phase II trial in elderly patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. The study used a standard 3 + 3 dose escalation design. Patients aged 75 years or older with advanced NSCLC harboring EGFR mutations were enrolled. The doses of afatinib, which were given once daily, were planned as follows: level 1, 20 mg/day; level 2, 30 mg/day; level 3, 40 mg/day. Dose-limiting toxicity (DLT) was defined as grade 4 hematologic, persistent grade > 2 diarrhea for > 2 days despite concomitant medications or grade 3 non-hematologic toxicity. DLT was evaluated during day 1-28. Fifteen patients were enrolled. Patient characteristics were: male/female 3/12; median age 79 (range 75-87); PS 0/1, 2/13. Six patients have been treated at levels 1 and 3, and three patients at level 2. At level 1, one of six patients experienced grade 3 rush, grade 3 anorexia, and grade 3 infection as DLTs. At level 2, none of three patients experienced a DLT. At level 3, two patients developed grade 3 diarrhea, one of whom also experienced grade 3 anorexia. Most frequent adverse events of any grade were diarrhea, paronychia, rush, and nausea. Most patients at level 2 and 3 required dose reduction in 3 months. MTD was defined as 40 mg/day, and recommended dose for phase II study in elderly patients was 30 mg/day.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180216
[Lr] Last revision date:180216
[St] Status:In-Process
[do] DOI:10.1007/s12032-018-1098-3

  9 / 1180 MEDLINE  
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[PMID]: 29390534
[Au] Autor:Liu H; Song K; Zhang M; Dong X; Liu S; Wang Y
[Ad] Address:Department of Plastic Surgery, Peking Union Medical College Hospital.
[Ti] Title:Toe keloid after nail extraction treated with surgical excision: A case report.
[So] Source:Medicine (Baltimore);96(51):e9373, 2017 Dec.
[Is] ISSN:1536-5964
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:RATIONALE: In this study, a case of toe keloid after nail extraction is presented, in which the keloids on both toes were resected by surgical excision. Keloids (from the Greek word meaning "crab's claw") are fibrous growths that extend beyond the original area of injury to involve the adjacent normal skin. In general, keloid tendencies appear to be regionally isolated to keloid-prone areas, such as the chest, ears, and deltoid regions, whereas the hands and feet are usually spared, which is why this case is meaningful. PATIENT CONCERNS: A 20-year-old Chinese man had paronychia on both halluxes when he was 16 years old. He underwent a nail extraction at the age of 17. The nails of both halluxes were removed by nail extraction. This operation was successful, and the postoperative course was uneventful. After 6 months, the scars of the nail extraction on both sides began to exhibit hyperplasia and became red and swollen with itching. Later, the scar expanded and eroded the tissue beyond the matrix unguis. The whole matrix unguis was destroyed, and the nails were distorted. The scars began to ulcerate after 2 years. The patient used potassium permanganate to clean his wounds, but the keloid scars did not improve. DIAGNOSES: The patient was diagnosed as toe keloid based on his history and symptoms. The biopsy result supported our diagnoses. INTERVENTIONS: The toe keloids were effectively cured by surgical excision and skin flap transplantation combined with postoperative irradiation and hyperbaric oxygen (HBO) treatment. OUTCOMES: No recurrence was detected during the period from 6 to 24 months of follow-up after the surgery. LESSONS: In this case, the trauma of the nail extraction was likely the key cause of the keloid. However, the patient was also predisposed to keloids, as we observed keloids on his chest. In general, keloid tendencies appear to be regionally isolated to keloid-prone areas such as the chest, ears, and deltoid regions, whereas the hands and feet are usually spared, which is why this case is meaningful.
[Mh] MeSH terms primary: Keloid/surgery
Paronychia/surgery
Postoperative Complications/surgery
Toes/surgery
[Mh] MeSH terms secundary: Humans
Keloid/etiology
Male
Skin Transplantation
Young Adult
[Pt] Publication type:CASE REPORTS; JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180214
[Lr] Last revision date:180214
[Js] Journal subset:AIM; IM
[Da] Date of entry for processing:180203
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009373

  10 / 1180 MEDLINE  
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[PMID]: 29191595
[Au] Autor:Yu HA; Ahn MJ; Cho BC; Gerber DE; Natale RB; Socinski MA; Giri N; Quinn S; Sbar E; Zhang H; Giaccone G
[Ad] Address:Memorial Sloan Kettering Cancer Center, 300 East 66th, Street, New York, NY 10065, USA. Electronic address: YuH@mskcc.org.
[Ti] Title:Phase 2 study of intermittent pulse dacomitinib in patients with advanced non-small cell lung cancers.
[So] Source:Lung Cancer;112:195-199, 2017 Oct.
[Is] ISSN:1872-8332
[Cp] Country of publication:Ireland
[La] Language:eng
[Ab] Abstract:BACKGROUND: Dacomitinib is a second-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Pre-clinical data suggest that intermittent pulsatile dosing of dacomitinib may result in inhibition of EGFR T790M. METHODS: We evaluated safety, pharmacokinetics and efficacy of intermittent pulsatile dacomitinib in both molecularly unselected patients and patients with lung cancers harboring EGFR T790M (Clinical Trial Registration Number NCT01858389). RESULTS: Thirty-eight patients were treated on study with pulse dacomitinib; sixteen with EGFR T790M in Cohort A and 22 who were not molecularly selected in Cohort B. One patient out of 16 patients in Cohort A had a partial response to study therapy (ORR 6.3%, 95% CI 0.2-30.2%). The median progression-free survival (PFS) in Cohort A was 2.3 months and median PFS in Cohort B was 1.6 months. The adverse event profile was similar to standard daily dose dacomitinib with the most frequent treatment-related toxicities occurring in >20% of patients being diarrhea, rash, stomatitis, nausea, dry skin, paronychia, fatigue, and decreased appetite. CONCLUSION: Intermittent pulsatile dacomitinib is safe and relatively well tolerated but is not effective in patients that harbor EGFR T790M or in unselected patients with non-small cell lung cancer.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1712
[Cu] Class update date: 180207
[Lr] Last revision date:180207
[Cl] Clinical Trial:ClinicalTrial
[St] Status:In-Process


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