DOCSLIB.ORG

Bladder Cancer

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Bladder Cancer NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Bladder Cancer Version 4.2019 — July 10, 2019 For important information regarding the BCG shortage NCCN.org see MS-11. Also see the AUA BCG Shortage Notice. Continue Version 4.2019, 07/10/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 4.2019 Table of Contents Bladder Cancer Discussion *Thomas W. Flaig, MD †/Chair Christopher Hoimes, MD † Anthony Patterson, MD ϖ University of Colorado Cancer Center Case Comprehensive Cancer Center/ St. Jude Children’s Research Hospital/ University Hospitals Seidman Cancer Center The University of Tennessee *Philippe E. Spiess, MD, MS ϖ/Vice Chair and Cleveland Clinic Taussig Cancer Institute Health Science Center Moffitt Cancer Center *Brant A. Inman, MD, MSc ϖ Elizabeth R. Plimack, MD, MS † Neeraj Agarwal, MD ‡ † Duke Cancer Institute Fox Chase Cancer Center Huntsman Cancer Institute at the University of Utah Masahito Jimbo, MD, PhD, MPH Þ Kamal S. Pohar, MD ϖ University of Michigan Rogel Cancer Center The Ohio State University Comprehensive Rick Bangs, MBA Cancer Center - James Cancer Hospital Patient Advocate ϖ A. Karim Kader, MD, PhD and Solove Research Institute UC San Diego Moores Cancer Center Stephen A. Boorjian, MD ϖ Michael Porter, MD, MS ϖ Mayo Clinic Cancer Center Subodh M. Lele, MD ≠ Fred Hutchinson Cancer Research Center/ Fred & Pamela Buffett Cancer Center Mark K. Buyyounouski, MD, MS § Seattle Cancer Care Alliance Stanford Cancer Institute ϖ Joshua J. Meeks, MD, PhD Mark A. Preston, MD, MPH ϖ Robert H. Lurie Comprehensive Cancer *Sam Chang, MD, MBA ¶ Dana-Farber/Brigham and Women’s Center of Northwestern University Vanderbilt-Ingram Cancer Center Cancer Center Jeff Michalski, MD, MBA § Tracy M. Downs, MD ϖ Wade J. Sexton, MD ϖ Siteman Cancer Center at Barnes- University of Wisconsin Moffitt Cancer Center Jewish Hospital and Washington Carbone Cancer Center University School of Medicine Arlene O. Siefker-Radtke, MD † Jason A. Efstathiou, MD, DPhil § The University of Texas Jeffrey S. Montgomery, MD, MHSA ϖ Massachusetts General Hospital MD Anderson Cancer Center University of Michigan Rogel Cancer Center Cancer Center Jonathan Tward, MD, PhD § Lakshminarayanan Nandagopal, MD † Terence Friedlander, MD † Huntsman Cancer Institute University of Alabama at Birmingham UCSF Helen Diller Family at the University of Utah Comprehensive Cancer Center Comprehensive Cancer Center Jonathan Wright, MD ϖ Lance C. Pagliaro, MD † *Richard E. Greenberg, MD ϖ Fred Hutchinson Cancer Research Center/ Mayo Clinic Cancer Center Fox Chase Cancer Center Seattle Cancer Care Alliance Sumanta K. Pal, MD † Khurshid A. Guru, MD ϖ NCCN City of Hope National Medical Center Roswell Park Comprehensive Cancer Center Lisa Gurski, PhD Alyse Johnson-Chilla, MS Harry W. Herr, MD ϖ Memorial Sloan Kettering Cancer Center ‡ Hematology/Hematology § Radiotherapy/Radiation Continue oncology oncology NCCN Guidelines Panel Disclosures Þ Internal medicine ¶ Surgery/Surgical Oncology † Medical oncology ϖ Urology ≠ Pathology * Discussion writing committee member Version 4.2019, 07/10/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 4.2019 Table of Contents Bladder Cancer Discussion NCCN Bladder Cancer Panel Members Summary of the Guidelines Updates Clinical Trials: NCCN believes that the best management for any patient Introduction with cancer is in a clinical trial. Bladder Cancer Participation in clinical trials is • Clinical Presentation and Initial Evaluation (BL-1) especially encouraged. • Noninvasive or Tis, Primary Evaluation/Surgical Treatment (BL-1) To find clinical trials online at NCCN Secondary Surgical Treatment, Adjuvant Intravesical Treatment, Follow-up (BL-2) Member Institutions, click here: Posttreatment cTa, cT1, Tis Recurrent or Persistent Cancer (BL-3) nccn.org/clinical_trials/clinicians.aspx. • Muscle Invasive or Metastatic, Primary Evaluation/Surgical Treatment, Additional Workup (BL-1) Stage II (cT2, N0) Primary and Adjuvant Treatment (BL-4) NCCN Categories of Evidence and All recommendations Stage IIIA (cT3, N0; cT4a, N0; cT1-cT4a, N1) Primary and Adjuvant Treatment (BL-6) Consensus: are category 2A unless otherwise Stage IIIB (cT1-cT4a, N2,3) Primary and Subsequent Treatment (BL-7) indicated. Stage IVA (cT4b, Any N, M0; Any T, Any N, M1a) Primary and Subsequent Treatment (BL-8) Metastatic Disease, Additional Workup, Primary Treatment (BL-9) See NCCN Categories of Evidence Follow-up, Recurrent or Persistent Disease (BL-10) and Consensus. • Principles of Imaging for Bladder/Urothelial Cancer (BL-A) NCCN Categories of Preference: • Principles of Surgical Management (BL-B) All recommendations are considered • Principles of Pathology Management (BL-C) appropriate. • Bladder Cancer: Non-Urothelial and Urothelial with Variant Histology (BL-D) • Follow-up (BL-E) See NCCN Categories of Preference. • Principles of Intravesical Treatment (BL-F) • Principles of Systemic Therapy (BL-G) • Principles of Radiation Management of Invasive Disease (BL-H) Upper GU Tract Tumors: • Renal Pelvis (UTT-1) • Urothelial Carcinoma of the Ureter (UTT-2) • Urothelial Carcinoma of the Prostate (UCP-1) • Primary Carcinoma of the Urethra (PCU-1) Staging (ST-1) The NCCN Guidelines® are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network® (NCCN®) makes no representations or warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in any way. The NCCN Guidelines are copyrighted by National Comprehensive Cancer Network®. All rights reserved. The NCCN Guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. ©2019. Version 4.2019, 07/10/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 4.2019 Table of Contents Bladder Cancer Discussion Updates in Version 4.2019 of the NCCN Guidelines for Bladder Cancer from Version 3.2019 include: MS-1 • The discussion section was updated to reflect the changes in the algorithm. Updates in Version 3.2019 of the NCCN Guidelines for Bladder Cancer from Version 2.2019 include: BL-7 • Additional Workup, Molecular/genomic testing, footnote w is new: "Including FGFR RGQ RT-PCR for FGFR3 or FGFR2 genetic alterations." Also for BL-8. BL-9 • "including FGFR RGQ RT-PCR for FGFR3 or FGFR2 genetic alterations." was added to footnote bb. BL-G (3 of 5) • Subsequent systemic therapy for locally advanced or metastatic disease: Erdafitinib was added as an alternative preferred regimen for patients with FGFR3 or FGFR2 genetic alterations with appropriate reference. Updates in Version 2.2019 of the NCCN Guidelines for Bladder Cancer from Version 1.2019 include: Global • Note added directing user to the discussion section and a link to the AUA notice for more information regarding the BCG shortage. BL-F (1 of 3) • Induction (Adjuvant) Intravesical Chemotherapy or BCG: The third bullet and sub bullets are new. • Maintenance Intravesical BCG: The second bullet and sub bullet are new. MS-11 • A section with additional information on the BCG shortage was added. Updates in Version 1.2019 of the NCCN Guidelines for Bladder Cancer from Version 4.2018 include: Bladder Cancer INTRO BL-2 • This is a new page. • Footnote j was updated: "The most commonly used options for intravesical chemotherapy are gemcitabine (preferred) and BL-1 mitomycin." • Primary Evaluation/Surgical Treatment: "Preferred" added to BL-3 gemcitabine. • "Cystoscopy positive" and "cystoscopy suspicious for recurrence • Footnote c was updated: "Immediate intravesical chemotherapy post-intravesical therapy; no more than 2 consecutive cycles," reduces the recurrence rate by 35%. not immunotherapy, has been evaluation: "Preferred" added to gemcitabine. shown to decrease recurrence for patients with suspected non- • Top pathway, treatment updated: "Based on tumor stage and grade: muscle invasive bladder cancer based on cystoscopic appearance. Adjuvant intravesical therapy or Cystectomy based on tumor stage See Principles of Intravesical Treatment (BL-F)." (Also for BL-3) and grade." Continued Version 4.2019, 07/10/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. UPDATES NCCN Guidelines Index NCCN Guidelines Version 4.2019 Table of Contents Bladder Cancer Discussion Updates in Version 1.2019 of the NCCN Guidelines for Bladder Cancer from Version 4.2018 include: BL-3 (continued) Principles of Imaging for Bladder/Urothelial Cancer • Bottom pathway, Tis or cTa: "(preferred for cT1, high grade)" was BL-A (2 of 5) added to cystectomy.
Load more

Recommended publications
  • Bladder Cancer Early Detection, Diagnosis, and Staging Detection and Diagnosis
    cancer.org | 1.800.227.2345 Bladder Cancer Early Detection, Diagnosis, and Staging Detection and Diagnosis Finding cancer early, when it's small and hasn't spread, often allows for more treatment options. Some early cancers may have signs and symptoms that can be noticed, but that's not always the case. ● Can Bladder Cancer Be Found Early? ● Bladder Cancer Signs and Symptoms ● Tests for Bladder Cancer Stages and Outlook (Prognosis) After a cancer diagnosis, staging provides important information about the extent (amount) of cancer in the body and the likely response to treatment. ● Bladder Cancer Stages ● Survival Rates for Bladder Cancer Questions to Ask About Bladder Cancer Here are some questions you can ask your cancer care team to help you better understand your cancer diagnosis and treatment options. ● Questions To Ask About Bladder Cancer 1 ____________________________________________________________________________________American Cancer Society cancer.org | 1.800.227.2345 Can Bladder Cancer Be Found Early? Bladder cancer can sometimes be found early -- when it's small and hasn't spread beyond the bladder. Finding it early improves your chances that treatment will work. Screening for bladder cancer Screening is the use of tests or exams to look for a disease in people who have no symptoms. At this time, no major professional organizations recommend routine screening of the general public for bladder cancer. This is because no screening test has been shown to lower the risk of dying from bladder cancer in people who are at average risk. Some providers may recommend bladder cancer tests for people at very high risk, such as: ● People who had bladder cancer before ● People who had certain birth defects of the bladder ● People exposed to certain chemicals at work Tests that might be used to look for bladder cancer Tests for bladder cancer look for different substances and/or cancer cells in the urine.
    [Show full text]
  • MASCC/ESMO ANTIEMETIC GUIDELINE 2016 with Updates in 2019
    1 ANTIEMETIC GUIDELINES: MASCC/ESMO MASCC/ESMO ANTIEMETIC GUIDELINE 2016 With Updates in 2019 Organizing and Overall Meeting Chairs: Matti Aapro, MD Richard J. Gralla, MD Jørn Herrstedt, MD, DMSci Alex Molassiotis, RN, PhD Fausto Roila, MD © Multinational Association of Supportive Care in CancerTM All rights reserved worldwide. 2 ANTIEMETIC GUIDELINES: MASCC/ESMO These slides are provided to all by the Multinational Association of Supportive Care in Cancer and can be used freely, provided no changes are made and the MASCC and ESMO logos, as well as date of the information are retained. For questions please contact: Matti Aapro at [email protected] Chair, MASCC Antiemetic Study Group or Alex Molassiotis at [email protected] Past Chair, MASCC Antiemetic Study Group 3 ANTIEMETIC GUIDELINES: MASCC/ESMO Consensus A few comments on this guideline set: • This set of guideline slides represents the latest edition of the guideline process. • This set of slides has been endorsed by the MASCC Antiemetic Guideline Committee and ESMO Guideline Committee. • The guidelines are based on the votes of the panel at the Copenhagen Consensus Conference on Antiemetic Therapy, June 2015. • Latest version: March 2016, with updates in 2019. 4 ANTIEMETIC GUIDELINES: MASCC/ESMO Changes: The Steering Committee has clarified some points: 2016: • A footnote clarified that aprepitant 165 mg is approved by regulatory authorities in some parts of the world ( although no randomised clinical trial has investigated this dose ). Thus use of aprepitant 80 mg in the delayed phase is only for those cases where aprepitant 125 mg is used on day 1. • A probable modification in pediatric guidelines based on the recent Cochrane meta-analysis is indicated.
    [Show full text]
  • Combining Paclitaxel and Lapatinib As Second-Line Treatment for Patients with Metastatic Transitional Cell Carcinoma: a Case Series
    ANTICANCER RESEARCH 32: 3949-3952 (2012) Combining Paclitaxel and Lapatinib as Second-line Treatment for Patients with Metastatic Transitional Cell Carcinoma: A Case Series STÉPHANE CULINE, ZINEB SELLAM, LINDA BOUAITA, ELIAS ASSAF, CATHERINE DELBALDO, MURIEL VERLINDE-CARVALHO and DAMIEN POUESSEL Department of Medical Oncology, Henri Mondor Hospital, Créteil, France Abstract. Background: Current first-line cisplatin-based trial comparing vinflunine with best supportive care (BSC) combination chemotherapy regimens provide interesting to BSC alone, an estimated difference in overall survival response rates but limited impact on survival for patients with (OS) of 2 months was reached in the intent-to-treat metastatic transitional cell carcinoma of the urothelium. Such population. However, a significant difference in OS was only results leave a significant patient population in need of salvage seen after removing patients who had major protocol therapy. Patients and Methods: As the epidermal growth factor violations (2). Therefore therapy for patients who fail first- receptors 1 and 2 (EGFR and HER2) are frequently line cisplatin-based chemotherapy remains a highly unmet overexpressed in urothelial carcinoma, we explored the medical need. feasibility of a combination of paclitaxel (80 mg/m2/week) and In a phase II study led by the French Genito-Urinary lapatinib (1,500 mg orally daily) for six patients who were Tumor group (GETUG), the activity of weekly paclitaxel as treated after failure of first-line platinum-based chemotherapy. second-line chemotherapy was assessed in 45 patients with Results: Only one out of six patients was able to receive the MTCCU. A low objective response rate (9%) along with a full doses during the first six weeks of treatment, while grade high rate of stabilization (38%) suggested limited impact as 2 or 3 diarrhea events required lapatinib dose reduction (one a single agent (3).
    [Show full text]
  • Topotecan, Pegylated Liposomal Doxorubicin Hydrochloride
    Topotecan, pegylated liposomal doxorubicin hydrochloride and paclitaxel for second-line or subsequent treatment of advanced ovarian cancer (report contains no commercial in confidence data) Produced by Centre for Reviews and Dissemination, University of York Authors Ms Caroline Main, Research Fellow, Systematic Reviews, Centre for Reviews and Dissemination, University of York, YO10 5DD Ms Laura Ginnelly, Research Fellow, Health Economics, Centre for Health Economics, University of York, YO10 5DD Ms Susan Griffin, Research Fellow, Health Economics, Centre for Health Economics, University of York, YO10 5DD Dr Gill Norman, Research Fellow, Systematic Reviews, Centre for Reviews and Dissemination, University of York, YO10 5DD Mr Marco Barbieri, Research Fellow, Health Economics, The Economic and Health Research Centre, Universitat Pompeu Fabra, Barcelona, Spain Ms Lisa Mather, Information Officer, Centre for Reviews and Dissemination, University of York, YO10 5DD Dr Dan Stark, Senior Lecturer in Oncology and Honorary Consultant in Medical Oncology, Department of Oncology, Bradford Royal Infirmary Mr Stephen Palmer, Senior Research Fellow, Health Economics, Centre for Health Economics, University of York, YO10 5DD Dr Rob Riemsma, Reviews Manager, Systematic Reviews, Centre for Reviews and Dissemination, University of York, YO10 5DD Correspondence to Caroline Main, Centre for Reviews and Dissemination, University of York, YO10 5DD, Tel: (01904) 321055, Fax: (01904) 321041, E-mail: [email protected] Date completed September 2004 Expiry date September 2006 Contributions of authors Caroline Main Lead reviewer responsible for writing the protocol, study selection, data extraction, validity assessment and writing the final report. Laura Ginnelly Involved in the cost-effectiveness section, writing the protocol, study selection, data extraction, development of the economic model and report writing.
    [Show full text]
  • Package Insert
    BCG LIVE (FOR INTRAVESICAL USE) TICE® BCG WARNING TICE® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION). BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG (see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS). DESCRIPTION TICE® BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.1 The TICE® strain was developed at the University of Illinois from a strain originated at the Pasteur Institute. The medium in which the BCG organism is grown for preparation of the freeze-dried cake is composed of the following ingredients: glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, and iron ammonium citrate. The final preparation prior to freeze drying also contains lactose. The freeze-dried BCG preparation is delivered in glass vials, each containing 1 to 8 x 108 colony forming units (CFU) of TICE® BCG which is equivalent to approximately 50 mg wet weight. Determination of in- vitro potency is achieved through colony counts derived from a serial dilution assay. A single dose consists of 1 reconstituted vial (see DOSAGE AND ADMINISTRATION).
    [Show full text]
  • Primary Melanoma of the Bladder at Puerperium
    ISSN: 2469-5742 Rubio et al. Int Arch Urol Complic 2020, 6:073 DOI: 10.23937/2469-5742/1510073 Volume 6 | Issue 1 International Archives of Open Access Urology and Complications CASE REPORT Primary Melanoma of the Bladder at Puerperium: Case Report Rubio Galisteo JM1*, Gomez Gomez E1, Valero Rosa J1, Salguero Segura J1, Pineda Reyes B2, Gonzalez T3, Barbudo Merino J4, Ruiz Garcia JM1 and Requena Tapia MJ1 1Urology Department, Hospital Universitario Reina Sofia, Spain 2Ginecology Department, Hospital Universitario Reina Sofia, Spain 3 Check for Pathological Anatomy Department, Hospital Universitario Reina Sofia, Spain updates 4Emergency Department, Hospital Universitario Reina Sofia, Spain *Corresponding author: Rubio Galisteo JM, Urology Department, Hospital Universitario Reina Sofía, Av Menendez Pidal S/N, UGC Urología, Córdoba, CP: 14004, Spain, Tel: +3460-004-5566 of urinary bladder in a 39-years-old postpartum wom- Abstract an. Primary malignant melanoma of the urinary bladder is a sporadic disease and very little described in the literature. Case Presentation A 39-years-old female at the end of her pregnancy without previous history of skin disease was presented with hema- A healthy 39-years-old female is presented at the turia after cesarean and with constitutional syndrome. After end of her first pregnancy. The patient gives a history of the study, the patient was diagnosed with metastatic blad- 10 kg lost at the last months, and urinary tract infection der melanoma. Other locations of primary injury were ruled out. The patient died a month and a half after the diagnosis. treated with antibiotics with a urine culture positive to E.
    [Show full text]
  • Clinical Radiation Oncology Review
    Clinical Radiation Oncology Review Daniel M. Trifiletti University of Virginia Disclaimer: The following is meant to serve as a brief review of information in preparation for board examinations in Radiation Oncology and allow for an open-access, printable, updatable resource for trainees. Recommendations are briefly summarized, vary by institution, and there may be errors. NCCN guidelines are taken from 2014 and may be out-dated. This should be taken into consideration when reading. 1 Table of Contents 1) Pediatrics 6) Gastrointestinal a) Rhabdomyosarcoma a) Esophageal Cancer b) Ewings Sarcoma b) Gastric Cancer c) Wilms Tumor c) Pancreatic Cancer d) Neuroblastoma d) Hepatocellular Carcinoma e) Retinoblastoma e) Colorectal cancer f) Medulloblastoma f) Anal Cancer g) Epndymoma h) Germ cell, Non-Germ cell tumors, Pineal tumors 7) Genitourinary i) Craniopharyngioma a) Prostate Cancer j) Brainstem Glioma i) Low Risk Prostate Cancer & Brachytherapy ii) Intermediate/High Risk Prostate Cancer 2) Central Nervous System iii) Adjuvant/Salvage & Metastatic Prostate Cancer a) Low Grade Glioma b) Bladder Cancer b) High Grade Glioma c) Renal Cell Cancer c) Primary CNS lymphoma d) Urethral Cancer d) Meningioma e) Testicular Cancer e) Pituitary Tumor f) Penile Cancer 3) Head and Neck 8) Gynecologic a) Ocular Melanoma a) Cervical Cancer b) Nasopharyngeal Cancer b) Endometrial Cancer c) Paranasal Sinus Cancer c) Uterine Sarcoma d) Oral Cavity Cancer d) Vulvar Cancer e) Oropharyngeal Cancer e) Vaginal Cancer f) Salivary Gland Cancer f) Ovarian Cancer & Fallopian
    [Show full text]
  • Drug Name Plate Number Well Location % Inhibition, Screen Axitinib 1 1 20 Gefitinib (ZD1839) 1 2 70 Sorafenib Tosylate 1 3 21 Cr
    Drug Name Plate Number Well Location % Inhibition, Screen Axitinib 1 1 20 Gefitinib (ZD1839) 1 2 70 Sorafenib Tosylate 1 3 21 Crizotinib (PF-02341066) 1 4 55 Docetaxel 1 5 98 Anastrozole 1 6 25 Cladribine 1 7 23 Methotrexate 1 8 -187 Letrozole 1 9 65 Entecavir Hydrate 1 10 48 Roxadustat (FG-4592) 1 11 19 Imatinib Mesylate (STI571) 1 12 0 Sunitinib Malate 1 13 34 Vismodegib (GDC-0449) 1 14 64 Paclitaxel 1 15 89 Aprepitant 1 16 94 Decitabine 1 17 -79 Bendamustine HCl 1 18 19 Temozolomide 1 19 -111 Nepafenac 1 20 24 Nintedanib (BIBF 1120) 1 21 -43 Lapatinib (GW-572016) Ditosylate 1 22 88 Temsirolimus (CCI-779, NSC 683864) 1 23 96 Belinostat (PXD101) 1 24 46 Capecitabine 1 25 19 Bicalutamide 1 26 83 Dutasteride 1 27 68 Epirubicin HCl 1 28 -59 Tamoxifen 1 29 30 Rufinamide 1 30 96 Afatinib (BIBW2992) 1 31 -54 Lenalidomide (CC-5013) 1 32 19 Vorinostat (SAHA, MK0683) 1 33 38 Rucaparib (AG-014699,PF-01367338) phosphate1 34 14 Lenvatinib (E7080) 1 35 80 Fulvestrant 1 36 76 Melatonin 1 37 15 Etoposide 1 38 -69 Vincristine sulfate 1 39 61 Posaconazole 1 40 97 Bortezomib (PS-341) 1 41 71 Panobinostat (LBH589) 1 42 41 Entinostat (MS-275) 1 43 26 Cabozantinib (XL184, BMS-907351) 1 44 79 Valproic acid sodium salt (Sodium valproate) 1 45 7 Raltitrexed 1 46 39 Bisoprolol fumarate 1 47 -23 Raloxifene HCl 1 48 97 Agomelatine 1 49 35 Prasugrel 1 50 -24 Bosutinib (SKI-606) 1 51 85 Nilotinib (AMN-107) 1 52 99 Enzastaurin (LY317615) 1 53 -12 Everolimus (RAD001) 1 54 94 Regorafenib (BAY 73-4506) 1 55 24 Thalidomide 1 56 40 Tivozanib (AV-951) 1 57 86 Fludarabine
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2006/0024365A1 Vaya Et Al
    US 2006.0024.365A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0024365A1 Vaya et al. (43) Pub. Date: Feb. 2, 2006 (54) NOVEL DOSAGE FORM (30) Foreign Application Priority Data (76) Inventors: Navin Vaya, Gujarat (IN); Rajesh Aug. 5, 2002 (IN)................................. 699/MUM/2002 Singh Karan, Gujarat (IN); Sunil Aug. 5, 2002 (IN). ... 697/MUM/2002 Sadanand, Gujarat (IN); Vinod Kumar Jan. 22, 2003 (IN)................................... 80/MUM/2003 Gupta, Gujarat (IN) Jan. 22, 2003 (IN)................................... 82/MUM/2003 Correspondence Address: Publication Classification HEDMAN & COSTIGAN P.C. (51) Int. Cl. 1185 AVENUE OF THE AMERICAS A6IK 9/22 (2006.01) NEW YORK, NY 10036 (US) (52) U.S. Cl. .............................................................. 424/468 (22) Filed: May 19, 2005 A dosage form comprising of a high dose, high Solubility active ingredient as modified release and a low dose active ingredient as immediate release where the weight ratio of Related U.S. Application Data immediate release active ingredient and modified release active ingredient is from 1:10 to 1:15000 and the weight of (63) Continuation-in-part of application No. 10/630,446, modified release active ingredient per unit is from 500 mg to filed on Jul. 29, 2003. 1500 mg, a process for preparing the dosage form. Patent Application Publication Feb. 2, 2006 Sheet 1 of 10 US 2006/0024.365A1 FIGURE 1 FIGURE 2 FIGURE 3 Patent Application Publication Feb. 2, 2006 Sheet 2 of 10 US 2006/0024.365A1 FIGURE 4 (a) 7 FIGURE 4 (b) Patent Application Publication Feb. 2, 2006 Sheet 3 of 10 US 2006/0024.365 A1 FIGURE 5 100 ov -- 60 40 20 C 2 4.
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 9,101,662 B2 Tamarkin Et Al
    USOO91 01662B2 (12) United States Patent (10) Patent No.: US 9,101,662 B2 Tamarkin et al. (45) Date of Patent: *Aug. 11, 2015 (54) COMPOSITIONS WITH MODULATING A61K 47/32 (2013.01); A61 K9/0014 (2013.01); AGENTS A61 K9/0031 (2013.01); A61 K9/0034 (2013.01); A61 K9/0043 (2013.01); A61 K (71) Applicant: Foamix Pharmaceuticals Ltd., Rehovot 9/0046 (2013.01); A61 K9/0048 (2013.01); (IL) A61 K9/0056 (2013.01) (72) Inventors: Dov Tamarkin, Macabim (IL); Meir (58) Field of Classification Search Eini, Ness Ziona (IL); Doron Friedman, CPC ........................................................ A61 K9/12 Karmei Yosef (IL); Tal Berman, Rishon See application file for complete search history. le Ziyyon (IL); David Schuz, Gimzu (IL) (56) References Cited (73) Assignee: Foamix Pharmaceuticals Ltd., Rehovot U.S. PATENT DOCUMENTS (IL) 1,159,250 A 11/1915 Moulton (*) Notice: Subject to any disclaimer, the term of this 1,666,684 A 4, 1928 Carstens patent is extended or adjusted under 35 1924,972 A 8, 1933 Beckert 2,085,733. A T. 1937 Bird U.S.C. 154(b) by 0 days. 2,390,921 A 12, 1945 Clark This patent is Subject to a terminal dis 2,524,590 A 10, 1950 Boe claimer. 2,586.287 A 2/1952 Apperson 2,617,754 A 1 1/1952 Neely 2,767,712 A 10, 1956 Waterman (21) Appl. No.: 14/045,528 2.968,628 A 1/1961 Reed 3,004,894 A 10/1961 Johnson et al. (22) Filed: Oct. 3, 2013 3,062,715 A 11/1962 Reese et al.
    [Show full text]
  • Valrubicin (Valstar) Reference Number: CP.PHAR.439 Effective Date: 09.04.18 Last Review Date: 11.20 Line of Business: Medicaid, HIM Revision Log
    Clinical Policy: Valrubicin (Valstar) Reference Number: CP.PHAR.439 Effective Date: 09.04.18 Last Review Date: 11.20 Line of Business: Medicaid, HIM Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Valrubicin (Valstar®) is an anthracycline. FDA Approved Indication(s) Valstar is indicated for the intravescial therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Valstar is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Bladder Cancer (must meet all): 1. Diagnosis of recurrent or persistent CIS of the urinary bladder; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Member meets one of the following (a or b)*: a. Failure of intravesical BCG treatment, unless contraindicated or clinically significant adverse effects are experienced; b. Adjuvant intravesical chemotherapy for non-muscle invasive bladder cancer in the event of a BCG shortage (see Appendix D for information on BCG shortage); *Prior authorization may be required for BCG immunotherapy 5. Request meets one of the following (a or b):* a. Dose does not exceed 800 mg per week; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    [Show full text]
  • Transitional Cell Carcinoma: Options Beyond Nsaids Julie Marie Gillem, DVM, DACVIM (Oncology) Overview
    Transitional Cell Carcinoma: Options Beyond NSAIDs Julie Marie Gillem, DVM, DACVIM (Oncology) Overview ✦ Background ✦ Surgical Options ✦ Pathology ✦ Medical Options ✦ Location and staging ✦ Radiation Therapy ✦ Behavior Options ✦ Etiology and risk factors ✦ Palliative care ✦ Work up and diagnosis ✦ What about cats? Objectives ✦ How do we determine when NSAIDs fail? ✦ When should we intervene with surgery, chemotherapy, radiation therapy, and additional palliative care? Pathology ✦ ~2% of canine cancer ✦ Invasive transitional cell carcinoma (TCC) most common ✦ Others: SCC, adenocarcinoma, undifferentiated carcinoma, rhabdomyosarcoma, fibroma, and other mesenchymal tumors Location and Staging ✦ TCC in dogs most often found in the trigone of the bladder ✦ Series of 102 dogs at PUVTH ✦ Urethra and bladder in 56% ✦ Prostate involvement in 29% male dogs ✦ Lymph node mets in 16% at diagnosis ✦ Distant mets in 14% at diagnosis ✦ Distant mets in 50% at death Location ✦ TCC in dogs most often is found in the trigone region of the bladder. ✦ In a series of dogs with TCC examined at the PUVTH, the tumor involved the urethra as well as the bladder in 57 of 102 dogs (56%), and it involved the prostate in 11 of 38 (29%) male dogs. WHO Staging ✦ 78% T2 tumors ✦ 20% T3 tumors Biological Behavior ✦ At diagnosis: ✦ Regional lymph node metastasis in 12-46 % (Norris et al 1992, Knapp et al 2000, Blackburn et al 2013) ✦ Distant metastasis in 16- 23% (Norris et al 1992, Blackburn et al 2013) ✦ Distant metastasis in 50% at death (Norris et al 1992, Knapp et al
    [Show full text]