White Paper Predicts: with Continued, Specific Efforts, Cancer Can Become Chronic & Manageable by 2022

Total Page:16

File Type:pdf, Size:1020Kb

White Paper Predicts: with Continued, Specific Efforts, Cancer Can Become Chronic & Manageable by 2022 ] ] [ News ] Analysis ] Commentary ] Controversy ] July 10, 2012 Vol. 34 No. 13 oncology-times.com Publishing for O34 Years NCoLoGY The Independent TIMES Hem/Onc News Source White Paper Predicts: With Continued, Specific Efforts, Cancer Can Become Chronic & Manageable by 2022 BY PEGGY EASTMAN hat was the conclusion of the docu- Tment by representatives from AACR, the Personalized Medicine Coalition, and Feinstein Kean Healthcare, distributed­ at this conference­ . Read what John Mendelsohn, Siddartha Mukherjee, Laura Esserman, and others had to say. Page 22 Key Takeaways! Free Instant • Personal Picks—ASCO President SANDRA SWAIN Access to • Hematologic (ALL, CML, CLL, Plasma Cell Dyscrasias)—RAVI VIJ OT on Your • GU–WALTER STADLER iPad! • Lung Cancer – RENALDO MARTINS • Plus: JOE SIMONE on ASCO Past, Present, & Future Starting on p. 7 [ALSO] SHOP TALK ������������������������������������������������������������������������������������������4 ALL: Confirmation that Adolescents & Young Adults Do Better on Pediatric Protocols ����������������23 Metastatic Breast Cancer: T-DM1 Superior to Capecitabine-Lapatinib ����������������������������������������26 Platinum-Resistant Ovarian Cancer: Bevacizumab Extends Survival ����������������������������������������������28 ASTRO Leader HOWARD SANDLER on PSA Screening ����������������������������������������������������������30 Controlling Intractable Pain Resistant to Opiates ��������������������������������������������������������������������������31 Debating PFS vs. OS as Trial Endpoint ����������������������������������������������������������������������������������������32 Facebook.com/ @OncologyTimes PERIODICALS OncologyTimesNews 7 Best of ASCO 2012: Hematological Malignancies oncology times Plasma Cell Dyscrasias, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, & Chronic Lymphocytic Leukemia BY RAVI VIJ, MD • july 10, 2012 his year’s ASCO Annual Meeting was generally well tolerated, and a 2 mg/ ­anti-IL-6 ­monoclonal antibody, plus bort- had several exciting presenta- m2 dose was established as the MTD on a ezomib versus bortezomib alone in patients tions focusing on a variety of twice weekly regimen. with relapsed/refractory multiple­ myeloma ­hematological malignancies. This drug has been found to have a (Abstract 8018). Although there was a THere, I ­review what I consider the most much longer terminal half life of four to trend for an increase in overall­ response significant developments in plasma cell six days, in comparison to bortezomib, rates, only marginal and non­significant dyscrasias, acute lymphoblastic ­leukemia, and despite being a boronate, no grade effects on progression-free survival were • chronic myelogenous leukemia, and 3 or 4 peripheral neuropathy was noted. noted. oncology-times.com chronic lymphocytic leukemia. Six out of 53 patients achieved a partial Plesner et al reported encouraging response or better. preliminary efficacy data from a multi- Plasma Cell Dyscrasias In another presentation, Kumar et center phase I/II study of daratumumab, The oral session on plasma cell dys- al reported on once-weekly dosing of a CD38 monoclonal antibody, in patients RAVI VIJ, MD, is Associate crasias had three presentations look- MLN9708 in patients with relapsed/ with relapsed/refractory disease (Abstract Professor of Medicine in ing at combination therapies with the refractory disease (Abstract 8034). 8019). The MTD of the drug has not yet the Section of Stem Cell novel proteosome inhibitor carfilzomib. Here, the maximally tolerated dose was been established. However, seven out of Transplant and Leukemia Philippe Moreau et al (first author Brigitte 2.97 mg/m2. In addition, Richardson 29 heavily pretreated patients had a par- at Washington University Kolb) reported­ on a phase I/II study of reported on a regimen of MLN9708, tial response, and four patients achieved a School of Medicine in ­carfilzomib plus melphalan and ­prednisone given weekly in combination with le- minimal response. St. Louis. in elderly patients with de novo multiple nalidomide and dexamethasone, in Moreau et al presented data from myeloma (Abstract 8009). Despite the patients with ­previously untreated mul- a randomized phase II study of elotu- phase I /II nature of the trial, a very prom- tiple myeloma. The maximally tolerated zumab with lenalidomide and low-dose ising overall response of 89 percent with a dose was ­determined to be 2.97 mg/m2 dexamethasone in patients with relapsed 40 percent very good partial response rate (Abstract 8033). disease (Abstract 8020). A 92% response was seen. I, on behalf of my co-investigators, rate in patients treated at the 10 mg/kg Joseph Mikhael reported on a phase ­presented the outcomes of patients dose was reported, with the median pro- I/II trial of cyclophosphamide, carfilzo- ­refractory to lenalidomide and bort- gression-free survival not being reached mib, thalidomide, and dexamethasone ezomib, treated with pomalidomide at a median follow-up of 17.2 months in (CYCLONE) in patients with newly diag- with or without low-dose dexametha- that arm. nosed multiple myeloma (Abstract 8010). sone (MM002 study) (Abstract 8016). Ghobrial et al presented long-term An overall response rate of 96 percent with In this study an overall response rate results of a phase II trial of the oral a 75 percent very good partial response of 30 percent was seen with pomalido- mTOR inhibitor everolimus (RAD001) rate was noted. mide and low-dose dexamethasone in in relapsed or refractory Waldenström’s the intention-to-treat population with a macroglobulinemia. In this 60-patient ex- “This year’s ASCO Annual median progression-free survival of 3.8 perience, a response rate of over 50 percent A trial, though months, and a median overall survival of was noted in a patient population that had Meeting had several 14.4 months at the time of data cutoff in received a median of three prior therapies, early, of the novel exciting presentations April 2011. suggesting high single-agent activity with A preplanned subset analysis of this this drug. proteosome inhibitor focusing on a variety study showed that the response rates were carfilzomib combined similar in patients who were refractory to Acute Lymphoblastic Leukemia of hematological lenalidomide, refractory to bortezomib, Topp et al presented results of the with melphalan and malignancies.” and refractory to both lenalidomide and ­anti-CD19 BiTE blinatumomab in bortezomib, including dual-refractory adult patients with relapsed/refrac- prednisone in elderly And Andrzej Jakubowiak presented an patients who had had a prior stem cell tory B precursor acute lymphoblastic patients with de novo update on his trial combining carfilzomib transplant. ­leukemia (Abstract 6500). This ­bispecific with lenalidomide and dexamethasone In addition, Rossi et al reported impres- T-cell engager (BiTE) is designed multiple myeloma, with a stringent complete remission rate sive overall response rates and very good to direct cytotoxic T-cells to CD19- of 42 percent (Abstract 8011). partial response rates with a three-drug expressive cancer cells. With that given showed a very In an elegant commentary on the combination of clarithromycin, pomalid- as a continuous IV infusion, the trial promising overall above three abstracts, Robert Orlowski omide, and dexamethasone in relapsed/ established 5 mcg/m2 per day in week 1, ­concluded that upfront combination refractory disease (Abstract 8036). and then 15 mcg/m2 per day thereafter, response rate of 89% therapies with carfilzomib showed very ASCO 2012 also saw the first presenta- four weeks on and two weeks off, for up high rates of ­response, and it seemed that tion of the data from the PANORAMA 2 to five cycles as the dose for the extension and a very good the depth of response was improved with trial by Alsina et al (Abstract 8012). In this phase of the study. partial response rate better ­tolerability in terms of ­neuropathy. phase II study panobinostat in combina- A 72 percent CR/CRH (CR with However, he highlighted that firm tion with bortezomib and dexamethasone partial hematological recovery) rate was of 40%. ­conclusions versus bortezomib could in patients with relapsed and bortezomib demonstrated, with all but two of the not be drawn given the higher number of refractory multiple myeloma resulted in an responders achieving a complete mo- doses of carfilzomib administered per cycle overall response rate of 33 percent. lecular remission, with a median dura- in combination regimens. At a clinical science symposium ti- tion of complete ­hematological remission Another exciting compound in tled “Immunotherapy for Myeloma,” of 8.9 months, and a median survival of ­development includes the oral ­proteosome there were presentations on three dif- nine months. The major side effects were inhibitor MLN9708. Lonial et al pre- ferent monoclonal antibodies in devel- a cytokine release syndrome in three out sented data from a phase I study of opment for the disease. Orlowski et al of the 36 patients enrolled, and CNS twice-weekly dosing of this agent in pa- presented the results of a phase II ran- adverse events in six patients, including tients with relapsed and/or refractory mul- domized ­double-blind placebo-controlled three patients with ­seizures and three with tiple myeloma (Abstract 8017). The drug study comparing siltuximab, a chimeric continued on page 8 8 • “Practice Consolidation Moves to New Level,” by Lola Butcher, 6/10/12 issue. • “Medical Home for Oncology: COA Coordinating Plans to Make
Recommended publications
  • Melphalan) for Injection, for Intravenous Use History of Serious Allergic Reaction to Melphalan Initial U.S
    HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------DOSAGE FORMS AND STRENGTHS----------------------- These highlights do not include all the information needed to use For Injection: 50 mg per vial, lyophilized powder in a single-dose vial for EVOMELA safely and effectively. See full prescribing information for reconstitution. (3) EVOMELA. ---------------------------CONTRAINDICATIONS---------------------------------- EVOMELA® (melphalan) for injection, for intravenous use History of serious allergic reaction to melphalan Initial U.S. Approval: 1964 WARNING: SEVERE BONE MARROW SUPPRESSION, ---------------------WARNINGS AND PRECAUTIONS-------------------------- HYPERSENSITIVITY, and LEUKEMOGENICITY See full prescribing information for complete boxed warning. • Gastrointestinal toxicity: Nausea, vomiting, diarrhea or oral mucositis may occur; provide supportive care using antiemetic and antidiarrheal • Severe bone marrow suppression with resulting infection or medications as needed. (2.1, 5.2) bleeding may occur. Controlled trials comparing intravenous (IV) • Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to melphalan to oral melphalan have shown more myelosuppression fetus and to avoid pregnancy . (5.6, 8.1, 8.3) with the IV formulation. Monitor hematologic laboratory • Infertility: Melphalan may cause ovarian function suppression or testicular parameters. (5.1) suppression. (5.7) • Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation
    [Show full text]
  • Refractory Multiple Myeloma Patients: a Meta-Analysis and Systematic Review
    OncoTargets and Therapy Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW Arsenic trioxide-based therapy in relapsed/ refractory multiple myeloma patients: a meta-analysis and systematic review Xuepeng He Abstract: Multiple myeloma (MM) is a clonal malignancy characterized by the proliferation of Kai Yang malignant plasma cells in the bone marrow and the production of monoclonal immunoglobulin. Peng Chen Although some newly approved drugs (thalidomide, lenalidomide, and bortezomib) demonstrate Bing Liu significant benefit for MM patients with improved survival, all MM patients still relapse. Arsenic Yuan Zhang trioxide (ATO) is the most active single agent in acute promyelocytic leukemia, the antitumor Fang Wang activity of which is partly dependent on the production of reactive oxygen species. Due to its multifaceted effects observed on MM cell lines and primary myeloma cells, Phase I/II trials have Zhi Guo been conducted in heavily pretreated patients with relapsed or refractory MM. Therapy regimens Xiaodong Liu varied dramatically as to the dosage of ATO and monotherapy versus combination therapy with Jinxing Lou For personal use only. other agents available for the treatment of MM. Although ATO-based combination treatment Huiren Chen was well tolerated by most patients, most trials found that ATO has limited effects on MM Department of Hematology, patients. However, since small numbers of patients were randomized to different treatment General Hospital of Beijing arms, trials have not been statistically powered to determine the differences in progression-free Military Area of PLA, Beijing, People’s Republic of China survival and overall survival among the experimental arms.
    [Show full text]
  • Evaluation of Melphalan, Oxaliplatin, and Paclitaxel in Colon, Liver, And
    ANTICANCER RESEARCH 33: 1989-2000 (2013) Evaluation of Melphalan, Oxaliplatin, and Paclitaxel in Colon, Liver, and Gastric Cancer Cell Lines in a Short-term Exposure Model of Chemosaturation Therapy by Percutaneous Hepatic Perfusion RAJNEESH P. UZGARE, TIMOTHY P. SHEETS and DANIEL S. JOHNSTON Pharmaceutical Research and Development, Delcath Systems, Inc., Queensbury, NY, U.S.A. Abstract. Background: The goal of this study was to candidates for use in the CS-PHP system to treat patients determine whether liver, gastric, or colonic cancer may be with gastric and colonic metastases, and primary cancer of suitable targets for chemosaturation therapy with the liver. percutaneous hepatic perfusion (CS-PHP) and to assess the feasibility of utilizing other cytotoxic agents besides Chemotherapeutic molecules exert beneficial clinical effects melphalan in the CS-PHP system. Materials and Methods: by inhibiting cell growth or by inducing cell death via Forty human cell lines were screened against three cytotoxic apoptosis. They can be divided into several categories based chemotherapeutic agents. Specifically, the dose-dependent on their mechanisms of action. The chemotherapeutic agent effect of melphalan, oxaliplatin, and paclitaxel on melphalan hydrochloride, which has been approved by the proliferation and apoptosis in each cell line was evaluated. US Food and Drug Administration and is used in the These agents were also evaluated for their ability to induce treatment of multiple myeloma and ovarian cancer, is a apoptosis in normal primary human hepatocytes. A high- derivative of nitrogen mustard that acts as a bifunctional dose short-term drug exposure protocol was employed to alkylating agent. Melphalan causes the alkylation of DNA at simulate conditions encountered during CS-PHP.
    [Show full text]
  • Leukemia Cells Are Sensitized to Temozolomide, Carmustine and Melphalan by the Inhibition of O6‑Methylguanine‑DNA Methyltransferase
    ONCOLOGY LETTERS 10: 845-849, 2015 Leukemia cells are sensitized to temozolomide, carmustine and melphalan by the inhibition of O6‑methylguanine‑DNA methyltransferase HAJIME ARAI, TAKAHIRO YAMAUCHI, KANAKO UZUI and TAKANORI UEDA Department of Hematology and Oncology, Faculty of Medical Sciences, University of Fukui, Eiheiji, Fukui 910-1193, Japan Received August 8, 2014; Accepted April 13, 2015 DOI: 10.3892/ol.2015.3307 Abstract. The cytotoxicity of the monofunctional alkylator, Introduction temozolomide (TMZ), is known to be mediated by mismatch repair (MMR) triggered by O6-alkylguanine. By contrast, the Alkylating agents comprise a major class of chemo- cytotoxicity of bifunctional alkylators, including carmustine therapeutic agents, widely used in various types of cancer, (BCNU) and melphalan (MEL), depends on interstrand cross- including leukemia (1,2). There are two types of alkyl- links formed through O6-alkylguanine, which is repaired by ating agents: monofunctional and bifunctional agents. nucleotide excision repair and recombination. O6-alkylguanine Bifunctional alkylating agents include cyclophosphamide, is removed by O6-methylguanine-DNA methyltransferase ifosfamide, melphalan (MEL) and carmustine (BCNU; (MGMT). The aim of the present study was to evaluate the cyto- also known as 1,3-bis(2-chloroethyl)-1-nitrosourea). toxicity of TMZ, BCNU and MEL in two different leukemic Monofunctional agents include temozolomide [TMZ; cell lines (HL-60 and MOLT-4) in the context of DNA repair. also known as 3,4-dihydro-3-methyl-4-oxoimidazo The transcript levels of MGMT, ERCC1, hMLH1 and hMSH2 (5,1-d)-as-tetrazine-8-carboxamide] and dacarbazine (1-3). were determined using reverse transcription-quantitative Alkylating agents form a variety of DNA adducts in polymerase chain reaction.
    [Show full text]
  • Targeting Autophagy Augments in Vitro and in Vivo Antimyeloma Activity of DNA-Damaging Chemotherapy
    Author Manuscript Published OnlineFirst on February 2, 2011; DOI: 10.1158/1078-0432.CCR-10-0890 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Targeting autophagy augments in vitro and in vivo antimyeloma activity of DNA-damaging chemotherapy Yaozhu Pan1,3, Ying Gao1,3, Liang Chen1,2, Guangxun Gao1, Hongjuan Dong1, Yang Yang1, Baoxia Dong1, Xiequn Chen1 1Department of Hematology, Xijing Hospital, Fourth Military Medical University; Xi’an, People’s Republic of China 2Department of Bioengineering, School of Life Science and Technology, Xi’an Jiaotong University, Xi’an, People’s Republic of China Running head: autophagy and DNA-damaging chemotherapy in MM 3These authors contributed equally to this work. Key words: multiple myeloma; autophagy; apoptosis; DNA damage; xenograft model Corresponding author: Xiequn Chen, Department of Hematology, Xijing Hospital, Fourth Military Medical University, No.17 Changle West Road, Xi’an 710032, China; e-mail: [email protected]; [email protected] 1 Downloaded from clincancerres.aacrjournals.org on September 28, 2021. © 2011 American Association for Cancer Research. Author Manuscript Published OnlineFirst on February 2, 2011; DOI: 10.1158/1078-0432.CCR-10-0890 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Translational Relavance Multiple myeloma (MM) is a hematologic malignancy resulting from a clonal proliferation of plasma cells in the bone marrow. Although there have been major advances in the treatment of MM in recent years, it remains incurable mostly because of the development of drug resistance. Herein, we demonstrates that DNA-damaging agents (such as doxorubicin and melphalan) induced autophagy as a prosurvival mechanism in MM cells by engaging Bcl-2/Beclin1/Class III phosphatidylinositol 3-kinase complex.
    [Show full text]
  • High-Dose Mitoxantrone + Melphalan (MITO/L-PAM)
    Leukemia (2001) 15, 256–263 2001 Nature Publishing Group All rights reserved 0887-6924/01 $15.00 www.nature.com/leu High-dose mitoxantrone + melphalan (MITO/L-PAM) as conditioning regimen supported by peripheral blood progenitor cell (PBPC) autograft in 113 lymphoma patients: high tolerability with reversible cardiotoxicity C Tarella1, F Zallio1, D Caracciolo1, A Cuttica1, P Corradini1,2, P Gavarotti1, M Ladetto1, V Podio3, A Sargiotto4, G Rossi5, AM Gianni6 and A Pileri1 1Dipartimento di Medicina e Oncologia Sperimentale, Divisione Universitaria di Ematologia; Serv. 3Univ. e 4Osped di Medicina Nucleare; 5Divisione Universitaria di Radioterapia-Azienda Ospedaliera S Giovanni Battista di Torino, Torino; and 6Unita` Trapianto Midollo, Ist Naz. Tumori, Milano, Italy Hematological and extrahematological toxicity of high-dose The ease deriving from the excellent tolerability of PBPC (hd) mitoxantrone (MITO) and melphalan (L-PAM) as condition- procedures probably slowed down the efforts aimed to look ing regimen prior to peripheral blood progenitor cell (PBPC) autograft was evaluated in 113 lymphoma patients (87 at dis- for innovative and possibly more effective conditioning regi- ease onset). Autograft was the final part of a hd-sequential mens. In fact, most autograft programs employed nowadays (HDS) chemotherapy program, including a debulkying phase are based on conditioning regimens designed several years (1–2 APO ± 2 DHAP courses) and then sequential adminis- ago, such as TBI + cyclophosphamide (CY), or regimens con- tration of hd-cyclophosphamide, methotrexate (or Ara-C) and taining nitrosurea or melphalan (L-PAM), such as BEAM, CBV etoposide, at 10 to 30 day intervals. Autograft phase included: or BEAC.17–21 Looking for a better conditioning regimen, one (1) hd-MITO, given at 60 mg/m2 on day −5; (2) hd-L-PAM, given at 180 mg/m2 on day −2; (3) PBPC autograft, with a median of should not only consider the antitumor activity of a given drug 11 × 106 CD341/kg, or 70 × 104 CFU-GM/kg, on day 0.
    [Show full text]
  • High-Dose Cyclophosphamide Or Melphalan with Escalating Doses of Mitoxantrone and Autologous Bone Marrow Transplantation for Refractory Solid Tumors Paula O
    [CANCER RESEARCH 49. 4654-4658. August 15. 1989] High-Dose Cyclophosphamide or Melphalan with Escalating Doses of Mitoxantrone and Autologous Bone Marrow Transplantation for Refractory Solid Tumors Paula O. M. Mulder,1 Dirk T. Sleijfer, Pax H. B. Willemse, Elisabeth G. E. de Vries, Donald R. A. Uges, and Nanno H. Mulder Divisions of Intensive Care [P. O. M. M.] and Medical Oncology-¡D.T. S., P. H. B. W., E. G. E. d. K, N. H. M.], Department of Internal Medicine, and Department of Pharmacy [D. R. A. U.J, University Hospital, 9713 EZ Groningen, The Netherlands ABSTRACT In the current clinical trial adult patients with disseminated As the dose-limiting toxicity of mitoxantrone is hematological, the solid tumors received a regimen of escalating doses of mito xantrone in combination with high-dose cyclophosphamide on drug is suitable for dose escalation and use in intensive chemotherapy three consecutive days followed by ABMT.2 followed by autologous bone marrow rescue. Adult patients with therapy- resistant solid tumors received a regimen of high-dose cyclophosphamide The objectives of our study were: determination of the max (7 g/m2) and escalating doses of mitoxantrone in dose steps of 30,45, 60, imum tolerated dose of mitoxantrone that can be given in and 75 mg/m2. Both drugs were given i.v. on 3 consecutive days. Despite combination with a fixed high-dose of cyclophosphamide; de the addition of mesnum (3.5 to 7 g/m2), hemorrhagic cystitis occurred on termination of the extramedullary toxicity; assessment of the the second day in four of eight patients, irrespective of the mesnum or antitumor activity of the regimen; and determination of the mitoxantrone dose.
    [Show full text]
  • Melphalan (Alkeran®) (“MEL Fa Lan”)
    Melphalan (Alkeran®) (“MEL Fa lan”) How drug is given: by mouth Purpose: to kill cancer cells in multiple myeloma, ovarian cancer, and other cancers How to take the drug by mouth • Take this medication on an empty stomach (at least 1 hour beFore or 2 hours after food). Taking it before a meal or at bedtime may decrease nausea. • Swallow each tablet whole; do not crush or chew them. If you are unable to swallow the tablet, the pharmacist will give you specific instructions • IF you miss a dose, take it as soon as possible. However, iF it is almost time For your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double dose. • Wash hands after taking the medication. Avoid handling crushed or broken tablets. Storage • Store this medicine in the refrigerator, away From light. Keep this medicine in its original container, out oF the reach oF children and pets. Things that may occur during treatment 1. You may have nausea, vomiting, and/or loss oF appetite. Nausea and vomiting may begin soon after the drug is given and may last more than 24 hours. You may be given medicine to help with this. 2. Your blood cell counts may drop. This is known as bone marrow suppression. This includes a decrease in your: • Red blood cells, which carry oxygen in your body to help give you energy • White blood cells, which Fight inFection in your body • Platelets, which help clot the blood to stop bleeding If you have a fever of 100.5°F (38°C) or higher, chills, a cough, or any bleeding problems, tell your doctor or nurse right away.
    [Show full text]
  • Efficacy and Tolerability of Hydroxyurea in the Treatment of the Hyperproliferative Manifestations of Myelofibrosis: Results in 40 Patients
    Efficacy and tolerability of hydroxyurea in the treatment of the hyperproliferative manifestations of myelofibrosis: results in 40 patients Alejandra Martínez-Trillos, Anna Gaya, Margherita Maffioli, Eduardo Arellano-Rodrigo, Xavier Calvo, Marina Díaz-Beyá, Francisco Cervantes To cite this version: Alejandra Martínez-Trillos, Anna Gaya, Margherita Maffioli, Eduardo Arellano-Rodrigo, Xavier Calvo, et al.. Efficacy and tolerability of hydroxyurea in the treatment of the hyperproliferative manifestations of myelofibrosis: results in 40 patients. Annals of Hematology, Springer Verlag, 2010, 89 (12), pp.1233-1237. 10.1007/s00277-010-1019-9. hal-00549428 HAL Id: hal-00549428 https://hal.archives-ouvertes.fr/hal-00549428 Submitted on 22 Dec 2010 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Editorial Manager(tm) for Annals of Hematology Manuscript Draft Manuscript Number: AOHE-D-10-00175R1 Title: Efficacy and tolerability of hydroxyurea in the treatment of the hyperproliferative manifestations of myelofibrosis: results in 40 patients Article Type: Original
    [Show full text]
  • Cancer Drug Costs for a Month of Treatment at Initial Food
    Cancer drug costs for a month of treatment at initial Food and Drug Administration approval Year of FDA Monthly Cost Monthly cost (2013 Generic name Brand name(s) approval (actual $'s) $'s) Vinblastine Velban 1965 $78 $575 Thioguanine, 6-TG Thioguanine Tabloid 1966 $17 $122 Hydroxyurea Hydrea 1967 $14 $97 Cytarabine Cytosar-U, Tarabine PFS 1969 $13 $82 Procarbazine Matulane 1969 $2 $13 Testolactone Teslac 1969 $179 $1,136 Mitotane Lysodren 1970 $134 $801 Plicamycin Mithracin 1970 $50 $299 Mitomycin C Mutamycin 1974 $5 $22 Dacarbazine DTIC-Dome 1975 $29 $125 Lomustine CeeNU 1976 $10 $41 Carmustine BiCNU, BCNU 1977 $33 $127 Tamoxifen citrate Nolvadex 1977 $44 $167 Cisplatin Platinol 1978 $125 $445 Estramustine Emcyt 1981 $420 $1,074 Streptozocin Zanosar 1982 $61 $147 Etoposide, VP-16 Vepesid 1983 $181 $422 Interferon alfa 2a Roferon A 1986 $742 $1,573 Daunorubicin, Daunomycin Cerubidine 1987 $533 $1,090 Doxorubicin Adriamycin 1987 $521 $1,066 Mitoxantrone Novantrone 1987 $477 $976 Ifosfamide IFEX 1988 $1,667 $3,274 Flutamide Eulexin 1989 $213 $399 Altretamine Hexalen 1990 $341 $606 Idarubicin Idamycin 1990 $227 $404 Levamisole Ergamisol 1990 $105 $187 Carboplatin Paraplatin 1991 $860 $1,467 Fludarabine phosphate Fludara 1991 $662 $1,129 Pamidronate Aredia 1991 $507 $865 Pentostatin Nipent 1991 $1,767 $3,015 Aldesleukin Proleukin 1992 $13,503 $22,364 Melphalan Alkeran 1992 $35 $58 Cladribine Leustatin, 2-CdA 1993 $764 $1,229 Asparaginase Elspar 1994 $694 $1,088 Paclitaxel Taxol 1994 $2,614 $4,099 Pegaspargase Oncaspar 1994 $3,006 $4,713
    [Show full text]
  • A Phase 2 Study of Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Patients with Relapsed/Refractory Multiple Myeloma
    Leukemia (2012) 26, 1675 --1680 & 2012 Macmillan Publishers Limited All rights reserved 0887-6924/12 www.nature.com/leu ORIGINAL ARTICLE A phase 2 study of pegylated liposomal doxorubicin, bortezomib, dexamethasone and lenalidomide for patients with relapsed/refractory multiple myeloma JR Berenson1,2,3, O Yellin1, T Kazamel1, JD Hilger1, C-S Chen4, A Cartmell5, T Woliver6, M Flam7, E Bravin8, Y Nassir2,9, R Vescio10 and RA Swift2 Our previous studies have shown that lowering the dose of pegylated liposomal doxorubicin (PLD) and bortezomib in combination with intravenous dexamethasone on a longer 4-week cycle maintained efficacy and improved tolerability in both previously untreated and relapsed/refractory (R/R) multiple myeloma (MM) patients. Lenalidomide has shown efficacy in combination with bortezomib and dexamethasone but this combination has been poorly tolerated. We conducted this phase 2 study (clinicaltrials.gov identifier: NCT01160484) to evaluate whether a longer 4-week schedule using modified doses and schedules of IV dexamethasone (40 mg), bortezomib (1.0 mg/m2) and PLD (4.0 mg/m2) administered on days 1, 4, 8, and 11 with lenalidomide 10 mg daily on days 1--14 (DVD-R) would be effective and tolerated for patients with R/R MM. A total of 40 heavily pretreated patients were enrolled and 84.6% showed clinical benefit (complete response, 20.5%; very good partial response, 10.3%; partial response, 17.9%; minimal response, 35.9%) to the combination regimen. An additional 10.3% showed stable disease and 5.1% progressed while on study. The regimen was well tolerated, with a low incidence of adverse events such as fatigue (40%), thrombocytopenia (35%), neutropenia (35%), anemia (30%), peripheral neuropathy (25%) and pneumonia (15%).
    [Show full text]
  • Melphalan Hydrochloride (Evomela) for Intravenous Use
    Corporate Medical Policy Melphalan Hydrochloride (Evomela) for Intravenous Use File Name: melphalan_hydrochloride_evomela_for_intravenous_use Origination: 7/2016 Last CAP Review: 3/2020 Next CAP Review: n/a Last Review: 3/2020 Description of Procedure or Service Multiple myeloma is a systemic malignancy of plasma cells that accumulate in the bone marrow, usually associated with monoclonal antibody secretion, and results in bone marrow failure and bone destruction. It is the second most common hematologic disease with nearly 30,000 new cases projected in the U.S. in 2016 and over 11,000 deaths annually. Melphalan hydrochloride (Evomela) is classified as an alkylating agent. Alkylating agents are a class of chemotherapy drugs that bind to DNA and prevent proper DNA replication. They have chemical components that can form permanent covalent bonds with nucleophilic substances in the DNA. Alkylating agents are used as part of chemotherapy in different types of cancers, including multiple myeloma. According to the National Cancer Institute, melphalan (Evomela) is used for palliative treatment in multiple myeloma patients who cannot take melphalan (Evomela) by mouth and as a conditioning treatment to prepare multiple myeloma patients for a stem cell transplant. Melphalan (Evomela) is also available in a tablet form. This policy only addresses intravenous use of Melphalan (Evomela). ***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician. Policy BCBSNC will provide coverage for Melphalan Hydrochloride (Evomela) for intravenous use when it is determined to be medically necessary because the medical criteria and guidelines shown below are met.
    [Show full text]