Or Irinotecan-Based Chemotherapy After Curative Resection of Synchronous Liver Metastases from Colorectal Cancer
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Regimen Reference Order – GAST – FOLFIRI
ADULT Updated: January 8, 2018 Regimen Reference Order – GAST – FOLFIRI ARIA: GAST – [FOLFIRI] Planned Course: Every 14 days until disease progression or unacceptable toxicity Indication for Use: Colorectal Cancer Metastatic CVAD: Required (Ambulatory Pump) Proceed with treatment if: ANC equal to or greater than 1.5 x 109/L AND Platelets equal to or greater than 100 x 109/L Contact Physician if parameters not met SEQUENCE OF MEDICATION ADMINISTRATION Pre-treatment Requirements Drug Dose CCMB Administration Guideline Not Applicable Treatment Regimen – GAST - FOLFIRI Establish primary solution 500 mL of: normal saline Drug Dose CCMB Administration Guideline ondansetron 16 mg Orally 30 minutes pre-chemotherapy dexamethasone 12 mg Orally 30 minutes pre-chemotherapy atropine 0.6 mg IV Push over 2 – 3 minutes pre-irinotecan May be repeated once if diarrhea occurs during irinotecan infusion irinotecan 180 mg/m2 IV in 500 mL D5W over 90 minutes irinotecan can be infused at the same time as leucovorin through a Y site leucovorin 400 mg/m2 IV in 500 mL D5W over 90 minutes fluorouracil 400 mg/m2 IV Push over 5 minutes fluorouracil 2400 mg/m2 IV in D5W continuously over 46 hours by ambulatory infusion device All doses will be automatically rounded that fall within the DSG Approved Dose Bands. See GAST DSG – Dose Banding document for more information Flush after each medication: 50 mL over 6 minutes (500 mL/hr) In the event of an infusion-related hypersensitivity reaction, refer to the ‘Hypersensitivity Reaction Standing Order’ Please refer to CCMB -
Assessment of Overall Survival, Quality of Life, And
Supplementary Online Content Salas-Vega S, Iliopoulos O, Mossialos E. Assesment of overall survival, quality of life, and safety benefits associated with new cancer medicines [published online December 29, 2016]. JAMA Oncol. doi:10.1001/jamaoncol.2016.4166 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 eTable 2. Regulatory evidence in support of classification of drug clinical benefits eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits eTable 3. Interagency agreement–Krippendorff’s alpha coefficients eMethods This supplementary material has been provided by the authors to give readers additional information about their work. Online-Only Supplement © 2016 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/25/2021 Clinical value of cancer medicines Contents eExhibits ......................................................................................................................................................... 3 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 (Summary of eTable 2) ................................................................................................................... 3 eTable 2. Regulatory evidence in support of classification of drug clinical benefits ....................... 6 eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits -
In the United States Court of Appeals for the Federal Circuit
Case: 18-1959 Document: 16 Page: 1 Filed: 08/20/2018 No. 18-1959 In the United States Court of Appeals for the Federal Circuit GENENTECH, INC., APPELLANT v. HOSPIRA, INC., APPELLEE ON APPEAL FROM THE UNITED STATES PATENT AND TRADEMARK OFFICE PATENT TRIAL AND APPEAL BOARD IN NO. IPR2016-01771 BRIEF OF APPELLANT GENENTECH, INC. PAUL B. GAFFNEY ADAM L. PERLMAN THOMAS S. FLETCHER WILLIAMS & CONNOLLY LLP 725 Twelfth Street, N.W. Washington, DC 20005 (202) 434-5000 Case: 18-1959 Document: 16 Page: 2 Filed: 08/20/2018 CERTIFICATE OF INTEREST Pursuant to Federal Circuit Rule 47.4, undersigned counsel for appellant certifies the following: 1. The full name of the party represented by me is Genentech, Inc. 2. The name of the real party in interest represented by me is the same. 3. Genentech, Inc. is a wholly-owned subsidiary of Roche Holdings Inc. Roche Holdings Inc.’s ultimate parent, Roche Holdings Ltd, is a publicly held Swiss corporation traded on the Swiss Stock Exchange. Upon information and belief, more than 10% of Roche Holdings Ltd’s voting shares are held either directly or indirectly by Novartis AG, a publicly held Swiss corporation. 4. The following attorneys appeared for Genentech, Inc. in proceedings below or are expected to appear in this Court and are not already listed on the docket for the current case: Teagan J. Gregory and Christopher A. Suarez of Williams & Connolly LLP, 725 Twelfth Street, N.W., Washington, D.C. 20005. 5. The title and number of any case known to counsel to be pending in this or any other court or agency that will directly affect or be directly affected by this court’s decision in this pending appeal are Genentech, Inc. -
1053.Full.Pdf
ANTICANCER RESEARCH 33: 1053-1060 (2013) Comparative Effectiveness of 5-Fluorouracil with and without Oxaliplatin in the Treatment of Colorectal Cancer in Clinical Practice EMMA HEALEY1, GILLIAN E. STILLFRIED2, SIMON ECKERMANN3, JAMES P. DAWBER3, PHILIP R. CLINGAN4 and MARIE RANSON1,5 1School of Biological Sciences, 2Center for Health Initiatives, 3Australian Health Services Research Institute, 4Graduate School of Medicine, and 5Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia Abstract. Background: First-line chemotherapeutic suggested no survival benefit with the addition of treatment of colorectal cancer (CRC) typically comprises oxaliplatin to 5-FU modalities in treating CRC in practice. oral (capecitabine) or intravenous 5-fluorouracil (5-FU) This raises questions as to the net benefit of oxaliplatin, plus leucovorin (LV), in combination with oxaliplatin given its known toxicity profile and expense. (XELOX or FOLFOX, respectively), although debate exists regarding the best course of treatment by modality in Since the late 1950s, chemotherapeutic treatment of clinical practice. Evidence from practice comparisons is colorectal cancer (CRC) has centred on the use of important in considering the net benefit of alternative fluoropyrimidine 5-fluorouracil (5-FU), with varying chemotherapy regimens, given expected differences in administration and scheduling regimens, ranging from bolus survival associated with compliance and age of patients injection to continuous infusion, as well as oral -
FOLFOX-4) Combination Chemotherapy As a Salvage Treatment in Advanced Gastric Cancer
Cancer Res Treat. 2010;42(1):24-29 DOI 10.4143/crt.2010.42.1.24 Oxaliplatin, 5-fluorouracil and Leucovorin (FOLFOX-4) Combination Chemotherapy as a Salvage Treatment in Advanced Gastric Cancer Young Saing Kim, M.D.1 Purpose Junshik Hong, M.D.1 This study was designed to determine the efficacy and safety of FOLFOX-4 chemotherapy as a salvage treatment for patients with advanced gastric cancer (AGC). Sun Jin Sym, M.D.1 Se Hoon Park, M.D.2 Materials and Methods Jinny Park, M.D.1 The AGC patients with an ECOG performance status of 0�1 and progressive disease after Eun Kyung Cho, M.D.1 prior treatments were registered onto this phase II trial. The patients received oxaliplatin (85 2 2 2 Jae Hoon Lee, M.D.1 mg/m on day 1), leucovorin (200 mg/m on days 1 and 2) and 5-fluorouracil (400 mg/m as a bolus and 600 mg/m2 as a 22-hour infusion on days 1 and 2) every 2 weeks. Dong Bok Shin, M.D.1 Results For the 42 treated patients, a total of 228 chemotherapy cycles (median: 5, range: 1�12) Division of Hematology/Oncology, were administered. Twenty-nine patients (69%) received FOLFOX-4 chemotherapy as a third- Department of Internal Medicine, (50 ) or fourth-line (19 ) treatment. On the intent-to-treat analysis, 9 patients (21 ) 1Gachon University Gil Hospital, % % % Incheon, 2Samsung Medical Center, achieved a partial response, which was maintained for 4.6 months. The median progression- Sungkyunkwan University School of free survival and overall survival were 3.0 months and 6.2 months, respectively. -
Situation De La Chimiothérapie Des Cancers Rapport 2012
Chimiotherapie-2012_44 pages 19/07/13 10:35 Page1 Mesure 21 SOINS Situation de la chimiothérapie COLLECTION des cancers États des lieux & des connaissances RAPPORT 2012 ANALYSE DES TENDANCES RÉCENTES DE LA PRATIQUE ET DES DÉPENSES DE LA CHIMIOTHÉRAPIE DES CANCERS EN FRANCE CYTOTOXIQUES, AUTRES ANTICANCÉREUX, THÉRAPIES CIBLÉES (INHIBITEURS DE TYROSINES KINASES ET APPARENTÉS, ANTICORPS MONOCLONAUX) ET HORMONOTHÉRAPIES www.e-cancer.fr Chimiotherapie-2012_44 pages 19/07/13 10:35 Page2 2 SITUATION DE LA CHIMIOTHÉRAPIE DES CANCERS RAPPORT 2012 L’Institut national du cancer est l’agence nationale sanitaire et scientifique chargée de coordonner la lutte contre le cancer en France. Ce document est téléchargeable sur le site : www.e-cancer.fr CE DOCUMENT S’INSCRIT DANS LA MISE EN ŒUVRE DU PLAN CANCER 2009-2013. Mesure 21 : Garantir un égal accès aux traitements et aux innovations Action 21.1 : Faciliter l’accès aux traitements par molécules innovantes. Intégrer dans le rapport annuel de l’INCa un rapport de situation sur les molécules anticancéreuses. COORDINATION DU RAPPORT l Dr Natalie HOOG LABOURET, Pôle Recherche et Innovation, responsable de la Mission Réforme du Médicament l Thomas MORTIER, Pôle Recherche et Innovation, Mission Réforme du Médicament ANALYSE DES DONNÉES l Dr Christine LE BIHAN-BENJAMIN, Pôle Santé Publique et Soins, Département Observation, Veille et Innovation l Mathieu ROCCHI, Pôle Santé Publique et Soins, Département Observation, Veille et Innovation l Natalie VONGMANY, Pôle Santé Publique et Soins, Département Observation, -
Advances in Targeted Therapies for Metastatic Colorectal Cancer
REVIEW Advances in targeted therapies for metastatic colorectal cancer Colorectal cancer is one of the most frequently diagnosed malignancies in men and women and despite recent advances the prognosis of metastatic colorectal cancer remains poor. A better understanding of the molecular pathways that characterize tumor growth has provided novel targets in cancer therapy. Several proteins have been implicated as having a crucial role in metastatic colorectal cancer. Targets are defined according to their cellular localization, such as membrane receptor targets, intracellular signaling targets and protein kinases that regulate cell division. In the last 5 years, cetuximab, panitumumab and bevacizumab have been approved for the treatment of metastatic colorectal cancer and emerging data on the clinical development of new drugs, other than EGF-receptor and VEGF inhibitors, are likely to provide novel opportunities in the treatment of this malignancy. KEYWORDS: metastatic colorectal cancer molecular cancer biology Jose Perez-Garcia, targeted therapies Jaume Capdevila, Teresa Macarulla, Colorectal cancer (CRC) is one of the most fre- factors. One of the most important regulators Francisco Javier Ramos, quent diagnosed cancers in men and women. In of this process is VEGF and VEGFR. VEGF is Elena Elez, recent years, CRC mortality has progressively a 45-kDa homodimer that belongs to a family Manuel Ruiz-Echarri & decreased, probably owing to the availability of of growth factors comprising six different gly- Josep Tabernero† earlier diagnosis through screening, improve- coproteins: VEGF-A (commonly referred to as †Author for correspondence: ments in surgical therapies and both chemo- VEGF), -B, -C, -D, -E, and PlGF. Owing to its Medical Oncology Department, therapy and radiotherapy approaches. -
FOLFIRI (Irinotecan / Modified De Gramont)
FOLFIRI (Irinotecan / Modified De Gramont) DRUG ADMINISTRATION SCHEDULE Day Drug Dose Route Diluent & Rate Glucose 5% 500ml Infusion Fast Running for Line Flush Ondansetron 8mg IV bolus Via glucose drip Dexamethasone 8mg Oral /Slow bolus/15 min infusion Calcium Leucovorin 250ml Glucose 5% over 2 hours 300mg IV Infusion (folinic acid) concurrent with irinotecan Day 1 2 IV 250ml Glucose 5% over 2 hours 180mg/m Irinotecan Infusion concurrent with folinic acid Glucose 5% 500ml Infusion Line Flush 2 5 Fluorouracil 400 mg/m IV bolus Over 5 minutes via Sodium Chloride 0.9% over 46 2400 mg/m2 5 Fluorouracil infusor hours Day 3 Attend ward/clinic for removaldevice of 5-FU infusor device *Ondansetron IV must be infused over 15 minutes in patients over 65 years of age. PREMEDICATION *If acute cholinergic syndrome appears atropine sulphate 250micrograms should be administered by subcutaneous injection unless clinically contraindicated. The manufacturer recommends the use of prophylactic atropine sulphate with subsequent doses of irinotecan. CYCLE LENGTH AND NUMBER OF DAYS Every 14 days APPROVED INDICATIONS First line for advanced colorectal cancer RECOMMENDED TAKE HOME MEDICATION Ondansetron 8mg twice daily for 2 days Dexamethasone 4mg twice daily for 1 day Metoclopramide 10mg three times daily as required Loperamide as required (4mg after first loose stool and 2mgs every 2 hours, to a maximum of 16 (2mg) tablets in 24 hours. For diarrhoea lasting greater than 24 hours give ciprofloxacin 250mg BD. Suggested antiemetic regimen - may vary with local practice. See CINV policy for more details INVESTIGATIONS / MONITORING REQUIRED FBC, U&E, LFT’s & tumour markers as appropriate prior to each course of chemotherapy FBC on the day of chemotherapy Where CEA is elevated this should be measured before each cycle (no need to await result before proceeding with treatment). -
FOLFOX Enables High Resectability and Excellent Prognosis for Initially Unresectable Colorectal Liver Metastases
ANTICANCER RESEARCH 30: 1015-1020 (2010) FOLFOX Enables High Resectability and Excellent Prognosis for Initially Unresectable Colorectal Liver Metastases TORU BEPPU, NAOKO HAYASHI, TOSHIRO MASUDA, HIROYUKI KOMORI, KEI HORINO, HIROMITSU HAYASHI, HIROHISA OKABE, YOSHIFUMI BABA, KOICHI KINOSHITA, CHIKAMOTO AKIRA, MASAYUKI WATANEBE, HIROSHI TAKAMORI and HIDEO BABA Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan Abstract. Background/Aim: To evaluate the efficacy of therapy (1-5). Another phase III study has shown survival oxaliplatin plus fluorouracil and leucovorin (FOLFOX) on improvement using oxaliplatin plus 5-FU/LV over irinotecan initially unresectable colorectal liver metastases (CRLM). plus 5-FU/leucovorin (LV) as a bolus administration (6). Patients and Methods: From May 2005 to December 2008, In a phase III study to investigate two sequences of folinic FOLFOX was administered to 71 patients with initially acid, 5-FU, and irinotecan (FOLFIRI) followed by folinic acid, unresectable CRLM. Hepatic resection was performed 5-FU, and oxaliplatin (FOLFOX6), and FOLFOX6 followed promptly after CRLM became resectable. Results: Twenty-six by FOLFIRI, hepatic resection of liver metastases was patients (37%) were downstaged as being resectable. The performed in 9% of patients after FOLFIRI versus 22% of mean interval between the first FOLFOX and hepatic patients in FOLFOX6 (p=0.02). R0 resection was performed resection was six months (range, 3-7 months), and 7.1 in 7% of patients after FOLFIRI versus 13% after FOLFOX6 courses (range, 2-12). Operative morbidity was 12% and (3). Oxaliplatin-based chemotherapy, including the FOLFOX mortality was nil. The median progression-free survival time regimen, can lead to tumors being downstaged in some was 19 and 7 months, and the median survival time was over patients with initially unresectable colorectal liver metastases 48 and 20 months, in finally resectable and unresectable (CRLM), and allowed hepatic resection in 16-38 per cent patients, respectively. -
Mucocutaneous Manifestations in Patients Receiving Cancer
MUCOCUTANEOUS MANIFESTATIONS IN PATIENTS RECEIVING CANCER CHEMOTHERAPY IN REGIONAL CANCER CENTRE OF TIRUNELVELI MEDICAL COLLEGE Dissertation Submitted to THE TAMILNADU DR.M.G.R. MEDICAL UNIVERSITY IN PARTIAL FULFILMENT FOR THE AWARD OF THE DEGREE OF DOCTOR OF MEDICINE IN DERMATOLOGY, VENEREOLOGY & LEPROSY BRANCH XII-A APRIL 2019 DEPARTMENT OF DERMATOLOGY VENEREOLOGY & LEPROSY TIRUNELVELI MEDICAL COLLEGE TIRUNELVELI -11 BONAFIDE CERTIFICATE This is to certify that the dissertation titled as “MUCOCUTANEOUS MANIFESTATIONS IN PATIENTS RECEIVING CANCER CHEMOTHERAPY IN REGIONAL CANCER CENTRE OF TIRUNELVELI MEDICAL COLLEGE” submitted by DR. P. SULOCHANA to the Tamil Nadu Dr. M.G.R Medical University, Chennai, in partial fulfilment of the requirement for the award of the Degree of DOCTOR OF MEDICINE in DERMATOLOGY, VENEREOLOGY & LEPROSY during the academic period 2016-2019 is a bonafide research work carried out by her under direct supervision & guidance. PROFESSOR & HEAD DEAN Department of Dermatology, Venereology & Leprosy Tirunelveli Medical college Tirunelveli Medical college Tirunelveli Tirunelveli. CERTIFICATE This is to certify that the dissertation titled as “MUCOCUTANEOUS MANIFESTATIONS IN PATIENTS RECEIVING CANCER CHEMOTHERAPY IN REGIONAL CANCER CENTRE OF TIRUNELVELI MEDICAL COLLEGE” submitted by DR. P. SULOCHANA is an original work done by her in the Department of Dermatology Venereology & Leprosy, Tirunelveli Medical college, Tirunelveli for the award of the Degree of DOCTOR OF MEDICINE in DERMATOLOGY, VENEREOLOGY & LEPROSY during the academic period 2016-2019. Place: Tirunelveli GUIDE Date: PROFESSOR & HEAD Department of Dermatology, Venereology & Leprosy, Tirunelveli Medical college, Tirunelveli. DECLARATION I solemnly declare that the dissertation titled “MUCOCUTANEOUS MANIFESTATIONS IN PATIENTS RECEIVING CANCER CHEMOTHERAPY IN REGIONAL CANCER CENTRE OF TIRUNELVELI MEDICAL COLLEGE” is done by me in the Department of Dermatology, Venereology & Leprosy, Tirunelveli Medical College, Tirunelveli. -
Impact and Relevance of the Unfolded Protein Response in HNSCC
International Journal of Molecular Sciences Review Impact and Relevance of the Unfolded Protein Response in HNSCC Olivier Pluquet 1,* and Antoine Galmiche 2,3,* 1 Institut Pasteur de Lille, Université de Lille, CNRS, UMR8161–M3T–Mechanisms of Tumorigenesis and Targeted Therapies, F-59000 Lille, France 2 Service de Biochimie, Centre de Biologie Humaine (CBH), CHU Sud, 80054 Amiens, France 3 EA7516, Université de Picardie Jules Verne (UPJV), 80054 Amiens, France * Correspondence: [email protected] (O.P.); [email protected] (A.G.) Received: 30 April 2019; Accepted: 27 May 2019; Published: 30 May 2019 Abstract: Head and neck squamous cell carcinomas (HNSCC) encompass a heterogeneous group of solid tumors that arise from the upper aerodigestive tract. The tumor cells face multiple challenges including an acute demand of protein synthesis often driven by oncogene activation, limited nutrient and oxygen supply and exposure to chemo/radiotherapy, which forces them to develop adaptive mechanisms such as the Unfolded Protein Response (UPR). It is now well documented that the UPR, a homeostatic mechanism, is induced at different stages of cancer progression in response to intrinsic (oncogenic activation) or extrinsic (microenvironment) perturbations. This review will discuss the role of the UPR in HNSCC as well as in the key processes that characterize the physiology of HNSCC. The role of the UPR in the clinical context of HNSCC will also be addressed. Keywords: Head and Neck Squamous Cell Carcinoma (HNSCC); Unfolded Protein Response (UPR); therapy; biomarkers; prognosis 1. Introduction Head and Neck Squamous Cell Carcinomas (HNSCCs) are a group of tumors that arise from the mucosal epithelia of the head and neck. -
Download FOLFIRI Chemotherapy
Mouth sores You mouth may become sore or dry after your treatment. Mouth problems can be caused by the chemo. Tell your nurse or doctor if you have this FOLFIRI Chemotherapy problem, as they can prescribe special mouthwashes and medicine to help. It is important to avoid hot, spicy or acidic foods. Steps to provide good mouth care: What is chemotherapy? • Use a soft toothbrush when brushing your teeth to prevent sore gums Chemotherapy is a method of treating cancer by using drugs. and bleeding. Combinations of chemotherapy drugs are often used in treating cancer. Use toothpaste for sensitive teeth if normal toothpaste bothers you. • • Floss gently, avoid rough flossing as your gums may be very sensitive and can easily bleed. What is FOLFIRI? • Brush and rinse your dentures after eating. Remove your dentures while sleeping. FOLFIRI is a combination of chemotherapy (chemo) drugs used in • Rinse your mouth at least 4 times a day. Use baking soda or salt and the treatment of cancer of the bowel. water solution. Mix a teaspoonful baking soda or salt into 1 cup (250ml) FOLFIRI chemo is given through an intravenous line (IV). The type of IV is of water. You may also use commercial mouthwash such as Biotene. called a PICC line. PICC stands for Peripherally Inserted Central Catheter. DO NOT use products which contain alcohol such as Listerine or Scope The PICC line is put in your upper arm and stays in place for your entire because the alcohol will worsen pain if there are any open sores. chemo treatment. More information about the PICC line and how it is put into your arm will be provided to you by your primary team.