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Andras G. Lacko - One of the best experts on this subject based on the ideXlab platform.

  • Superparamagnetic reconstituted high-density lipoprotein nanocarriers for magnetically guided drug delivery.
    International journal of nanomedicine, 2017
    Co-Authors: Sarika Sabnis, Sangram Raut, Nirupama Sabnis, Andras G. Lacko
    Abstract:

    Current cancer chemotherapy is frequently associated with short- and long-term side effects, affecting the quality of life of cancer survivors. Because malignant cells are known to overexpress specific surface antigens, including receptors, targeted drug delivery is often utilized to reduce or overcome side effects. The current study involves a novel targeting approach using specifically designed nanoparticles, including encapsulation of the anti-cancer drug Valrubicin into superparamagnetic iron oxide nanoparticle (SPION) containing reconstituted high-density lipoprotein (rHDL) nanoparticles. Specifically, rHDL-SPION-Valrubicin hybrid nanoparticles were assembled and characterized with respect to their physical and chemical properties, drug entrapment efficiency and receptor-mediated release of the drug Valrubicin from the nanoparticles to prostate cancer (PC-3) cells. Prussian blue staining was used to assess nanoparticle movement in a magnetic field. Measurements of cytotoxicity toward PC-3 cells showed that rHDL-SPION-Valrubicin nanoparticles were up to 4.6 and 31 times more effective at the respective Valrubicin concentrations of 42.4 µg/mL and 85 µg/mL than the drug Valrubicin alone. These studies showed, for the first time, that lipoprotein drug delivery enhanced via magnetic targeting could be an effective chemotherapeutic strategy for prostate cancer.

  • Photophysical characterization of anticancer drug Valrubicin in rHDL nanoparticles and its use as an imaging agent
    Journal of photochemistry and photobiology. B Biology, 2015
    Co-Authors: Sunil Shah, Rahul Chib, Sangram Raut, Jaclyn Y. Bermudez, Nirupama Sabnis, Divya Duggal, Andras G. Lacko, Zygmunt Gryczynski, Joseph Kimball, Ignacy Gryczynski
    Abstract:

    Nanoparticles are target-specific drug delivery agents that are increasingly used in cancer therapy to enhance bioavailability and to reduce off target toxicity of anti-cancer agents. Valrubicin is an anti-cancer drug, currently approved only for vesicular bladder cancer treatment because of its poor water solubility. On the other hand, Valrubicin carrying reconstituted high density lipoprotein (rHDL) nanoparticles appear ideally suited for extended applications, including systemic cancer chemotherapy. We determined selected fluorescence properties of the free (unencapsulated) drug vs. Valrubicin incorporated into rHDL nanoparticles. We have found that upon encapsulation into rHDL nanoparticles the quantum yield of Valrubicin fluorescence increased six fold while its fluorescence lifetime increased about 2 fold. Accordingly, these and potassium iodide (KI) quenching data suggest that upon incorporation, Valrubicin is localized deep in the interior of the nanoparticle, inside the lipid matrix. Fluorescence anisotropy of the rHDL Valrubicin nanoparticles was also found to be high along with extended rotational correlation time. The fluorescence of Valrubicin could also be utilized to assess its distribution upon delivery to prostate cancer (PC3) cells. Overall the fluorescence properties of the rHDL: Valrubicin complex reveal valuable novel characteristics of this drug delivery vehicle that may be particularly applicable when used in systemic (intravenous) therapy.

  • Abstract B54: SR-B1 directed nanoparticles in targeted therapy for the treatment of metastatic triple-negative breast cancer
    Organ Site Research, 2015
    Co-Authors: Rebecca Johnson, Andras G. Lacko
    Abstract:

    This study endeavors to fill a void in the treatment of metastatic triple negative breast cancer (TNBC) with the use of scavenger receptor class B type 1 (SR-B1) targeted reconstituted high-density lipoprotein (rHDL) nanoparticles. Though new therapies are being evaluated in clinical trials, TNBC remains an incurable disease. Accordingly, the 5-year survival rate for women with metastatic TNBC is less than 30%. The overall goal of this study is to evaluate the efficacy of Lapatinib (an EGFR inhibitor) and Valrubicin (a topoisomerase II inhibitor) encapsulated rHDL nanoparticles in the treatment of metastatic TNBC. Selective uptake of anticancer agents delivered by rHDL nanoparticles via the SR-B1 is being evaluated using H3 cholesterol ester labeled rHDL nanoparticles in the presence and absence of a chemical inhibitor of SR-B1. Anti-proliferative effects of Lapatinib and Valrubicin encapsulated nanoparticles were evaluated using CCK-8 kits. The findings from these studies revealed that the rHDL encapsulated forms of Lapatinib and Valrubicin had enhanced efficacy when used in combination than the free drugs. In particular, rHDL encapsulated Lapatinib had a 55% increase in efficacy in MDA-MB-231 cell line over the un-encapsulated form as a single agent. The ultimate goal of these studies is to assess the impact of rHDL encapsulated Lapatinib and Valrubicin, alone or in combination against TNBC. One of the major barriers to successful cancer chemotherapy is the development of multidrug resistance (MDR) by malignant tumors. rHDL nanoparticles provide a cytosolic drug delivery mechanism for malignant cells and will likely help to overcome drug resistance by TNBC tumors. In addition, the tumor selective delivery of the drug payload via the rHDL nanoparticles is anticipated to reduce or eliminate off target toxicity to normal tissues upon clinical application. Citation Format: Rebecca Johnson, Andras Lacko. SR-B1 directed nanoparticles in targeted therapy for the treatment of metastatic triple-negative breast cancer. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr B54.

  • A Comparison of Photophysical Characteristics of rHDL Encapsulated Anti-Cancer Drug Valrubicin and Free Valrubicin
    Biophysical Journal, 2015
    Co-Authors: Sunil Shah, Rahul Chib, Sangram Raut, Jaclyn Y. Bermudez, Nirupama Sabnis, Divya Duggal, Andras G. Lacko, Zygmunt Gryczynski, Ignacy Gryczynski
    Abstract:

    Drug delivery via nanotechnology is one of the rapidly developing fields in cancer therapeutics. Targeted drug delivery has the advantage of having minimal interaction with healthy tissue, thereby reducing the toxicity of the drug to the rest of the body. rHDL nanoparticles are an efficient method of drug delivery for highly lipophilic anti-cancer drugs. Scavenger receptors class B type I (SR-BI), which are highly expressed on cancer cells interact with rHDL nanoparticles for effective drug delivery to the cancer cell and tumor. Valrubicin is an anti-cancer drug, with intrinsic fluorescence. In this experiment, we compared the photophysical properties of free Valrubicin and rHDL Valrubicin via steady state and time resolved fluorescence measurements. The steady-state anisotropy of rHDL Valrubicin is higher as compared to free Valrubicin, suggesting its encapsulation in rHDL nanoparticles. A longer rotational correlation time was observed for rHDL Valrubicin in time resolved anisotropy measurements compared to free Valrubicin, further supporting steady state anisotropy data.. We also studied the cellular internalization of free Valrubicin and rHDL Valrubicin using confocal microscopy. This could help track the movement of rHDL nanoparticles within the cancer cells.

  • Maya Nair 1
    2013
    Co-Authors: Nirupama Sabnis, Walter J Mcconathy, Andras G. Lacko
    Abstract:

    Enhanced solubility and functionality of Valrubicin (AD-32) against cancer cells upon encapsulation into biocompatible nanoparticle

Gary D. Steinberg - One of the best experts on this subject based on the ideXlab platform.

  • Emerging therapies in the management of high-risk non-muscle invasive bladder cancer (HRNMIBC)
    World Journal of Urology, 2019
    Co-Authors: Ryan P. Werntz, Brittany Adamic, Gary D. Steinberg
    Abstract:

    Purpose BCG is the gold standard in management of high-risk non-muscle invasive bladder cancer (HRNMIBC). However, in patients who fail BCG, there are few effective intrasvesical options. This review aims to explore standard and emerging therapies in HRNMIBC. Methods A non-systematic literature review was performed using Medline and PubMed. Literature focused on HRNMIBC and BCG failure studies, with particular attention to Phase II and III clinical trials. Results The only FDA approved therapy for BCG failure patients in Valrubicin. Patients with HRNMIBC and BCG failure patients are at increased risk for progression and death from bladder cancer. There are a variety of clinical trials exploring different therapeutic approaches such as immunotherapy, vaccines, radiotherapy, and gene therapy. These trials are showing some promise in the early reporting phase. Conclusion Despite limited intravesical treatment options in BCG failure patients, there are several promising therapies currently being developed and several with promising early results.

  • Emerging therapies in the management of high-risk non-muscle invasive bladder cancer (HRNMIBC).
    World journal of urology, 2018
    Co-Authors: Ryan P. Werntz, Brittany Adamic, Gary D. Steinberg
    Abstract:

    BCG is the gold standard in management of high-risk non-muscle invasive bladder cancer (HRNMIBC). However, in patients who fail BCG, there are few effective intrasvesical options. This review aims to explore standard and emerging therapies in HRNMIBC. A non-systematic literature review was performed using Medline and PubMed. Literature focused on HRNMIBC and BCG failure studies, with particular attention to Phase II and III clinical trials. The only FDA approved therapy for BCG failure patients in Valrubicin. Patients with HRNMIBC and BCG failure patients are at increased risk for progression and death from bladder cancer. There are a variety of clinical trials exploring different therapeutic approaches such as immunotherapy, vaccines, radiotherapy, and gene therapy. These trials are showing some promise in the early reporting phase. Despite limited intravesical treatment options in BCG failure patients, there are several promising therapies currently being developed and several with promising early results.

  • intravesical Valrubicin in patients with bladder carcinoma in situ and contraindication to or failure after bacillus calmette guerin
    Urologic Oncology-seminars and Original Investigations, 2013
    Co-Authors: Colin P Dinney, Richard E. Greenberg, Gary D. Steinberg
    Abstract:

    Abstract Objectives Evaluate the efficacy and safety of Valrubicin for bacillus Calmette-Guerin (BCG)–refractory carcinoma in situ (CIS) of the bladder based on updated phase III pivotal trial efficacy data together with efficacy and safety data from a supportive phase II/III study. Materials and Methods In a phase II/III open-label study (A9303), BCG refractory/intolerant adults with CIS (≥1 previous course of BCG or could not complete a BCG course owing to toxicity or contraindication) were randomized to receive 6 or 9 weekly intravesical Valrubicin (800 mg) instillations. In the pivotal phase III open-label study, BCG-refractory/recurrent adults with CIS (≥2 previous courses of intravesical therapy, including ≥1 BCG course) received 6 weekly intravesical Valrubicin (800 mg) instillations. Patients with muscle-invasive disease were excluded. Patients underwent a primary disease evaluation (PDE) at 3 months (∼6 weeks after last dose) that included cytoscopy, biopsy, and cytology. Disease recurrence was monitored at 3-month intervals. Complete response (CR) was defined as no evidence of disease at the PDE (month 3) and follow-up (month 6). Efficacy data from the pivotal trial reflect updated information based on US Food and Drug Administration review. Safety assessments in A9303 included local bladder adverse events (LBAEs) and other adverse events (AEs). Results Eighty patients enrolled and 78 completed treatment and underwent the PDE in study A9303; in the pivotal trial, the respective numbers were 90 and 87 patients. In study A9303, 39% of patients had received ≥2 previous courses of BCG and 11% had received ≥3 courses vs. 70% and 28%, respectively, in the pivotal trial. In both studies, the CR rate was 18%. In A9303, LBAEs were the most common AEs, reported by 86% of patients during treatment and 45% during follow-up; most treatment-related LBAEs were mild to moderate. 2 serious AEs in 1 patient (azotemia/reflux nephropathy) were judged as definitely or possibly treatment related; none of the patient deaths were judged to be related to Valrubicin. Conclusions Two trials of Valrubicin in patients with CIS demonstrate a consistent degree of efficacy in highly pretreated patients (pivotal trial; BCG-refractory patients) and those with fewer previous therapies (A9303; BCG-refractory/intolerant patients).

  • Factors affecting Valrubicin response in patients with bacillus Calmette-Guérin-refractory bladder carcinoma in situ.
    Postgraduate medicine, 2011
    Co-Authors: Gary D. Steinberg, Norm D. Smith, Kevin Ryder, Nicole M. Strangman, Simon J. Slater
    Abstract:

    AbstractObjective: Patients with bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the bladder are candidates for intravesical (IVe) Valrubicin. This post-hoc analysis of data from the pivotal phase 3, prospective, open-label study of Valrubicin evaluated the effects of patient characteristics and past treatments on the response to Valrubicin. Methods: Enrolled patients had non-muscle-invasive CIS with or without concurrent papillary disease stage Ta and/or T1 for which papillary tumors had been resected before treatment, and had previously received ≥ 2 courses of IVe therapy (≥ 1 BCG course). Patients received a course of Valrubicin, which consisted of 6 weekly IVe treatments of Valrubicin (800 mg). Complete response was defined as no evidence of disease by urine cytology, cystoscopy, and biopsy at 3 and 6 months posttreatment. Patient characteristics, baseline urinary symptoms, and number and type of previous treatment courses and instillations were compared for complete versus nonres...

  • Marker Lesion Experiments in Bladder Cancer—What Have We Learned?
    The Journal of urology, 2010
    Co-Authors: Ofer N. Gofrit, Kevin C. Zorn, Sergey Shikanov, Gary D. Steinberg
    Abstract:

    Purpose: In marker lesion experiments a single bladder tumor is deliberately left unresected for later ablation by intravesical instillation of a novel agent. While the benefits are clear, eg the opportunity to examine the effect of therapy on measurable disease, the safety and medical ethics of these experiments are less obvious. We review the goals, inclusion criteria, definition of success, agents used, effectiveness, safety and ethics of marker lesion studies, and suggest a framework for future experiments.Materials and Methods: Published bladder cancer studies using the marker lesion concept were identified with a MEDLINE® search through March 2009.Results: A total of 23 well documented marker lesion studies were identified involving more than 1,200 patients. Most agents studied were cytotoxins (mitomycin-C, epirubicin, gemcitabine, Valrubicin, apaziquone) or immune response modifiers (bacillus Calmette-Guerin, tumor necrosis factor-α, interferon-α, granulocyte-macrophage colony-stimulating factor). ...

Yuanjiang Pan - One of the best experts on this subject based on the ideXlab platform.

Karin Stenderup - One of the best experts on this subject based on the ideXlab platform.

  • Exploring Valrubicin’s effect on Propionibacterium acnes-induced skin inflammation in vitro and in vivo
    Dermatology reports, 2015
    Co-Authors: Louise Rottboell, Cecilia Rosada, Sarah De Foenss, Kenneth Thomsen, Helle Christiansen, Stine Andersen, Thomas N. Dam, Karin Stenderup
    Abstract:

    Acne is a common skin disease involving colonization with Propionibacterium acnes ( P . acnes ), hyperproliferation of the follicular epithelium and inflammatory events. Valrubicin is a second-generation anthracycline, non-toxic upon contact, and available in a topical formulation. Valrubicin’s predecessor doxorubicin possesses antibacterial effects and previously we demonstrated that Valrubicin inhibits keratinocyte proliferation and skin inflammation suggesting beneficial topical treatment of acne with Valrubicin. This study aims to investigate Valrubicin’s possible use in acne treatment by testing Valrubicin’s antibacterial effects against P . acnes and P. acnes -induced skin inflammation in vitro and in vivo . Valrubicin was demonstrated not to possess antibacterial effects against P. acnes . Additionally, Valrubicin was demonstrated not to reduce mRNA and protein expression levels of the inflammatory markers interleukin (IL)-1β, IL-8, and tumor necrosis factor (TNF)-α in vitro in human keratinocytes co-cultured with P . acnes . Moreover, in vivo , Valrubicin, applied both topically and intra-dermally, was not able to reduce signs of inflammation in mouse ears intra-dermally injected with P . acnes . Taken together, this study does not support beneficial antibacterial and anti inflammatory effects of topical Valrubicin treatment of acne.

  • exploring Valrubicin s effect on propionibacterium acnes induced skin inflammation in vitro and in vivo
    Dermatology Reports, 2015
    Co-Authors: Louise Rottboell, Cecilia Rosada, Sarah De Foenss, Kenneth Thomsen, Helle Christiansen, Stine Andersen, Thomas N. Dam, Karin Stenderup
    Abstract:

    Acne is a common skin disease involving colonization with Propionibacterium acnes ( P . acnes ), hyperproliferation of the follicular epithelium and inflammatory events. Valrubicin is a second-generation anthracycline, non-toxic upon contact, and available in a topical formulation. Valrubicin’s predecessor doxorubicin possesses antibacterial effects and previously we demonstrated that Valrubicin inhibits keratinocyte proliferation and skin inflammation suggesting beneficial topical treatment of acne with Valrubicin. This study aims to investigate Valrubicin’s possible use in acne treatment by testing Valrubicin’s antibacterial effects against P . acnes and P. acnes -induced skin inflammation in vitro and in vivo . Valrubicin was demonstrated not to possess antibacterial effects against P. acnes . Additionally, Valrubicin was demonstrated not to reduce mRNA and protein expression levels of the inflammatory markers interleukin (IL)-1β, IL-8, and tumor necrosis factor (TNF)-α in vitro in human keratinocytes co-cultured with P . acnes . Moreover, in vivo , Valrubicin, applied both topically and intra-dermally, was not able to reduce signs of inflammation in mouse ears intra-dermally injected with P . acnes . Taken together, this study does not support beneficial antibacterial and anti inflammatory effects of topical Valrubicin treatment of acne.

  • Valrubicin activates PKCa in keratinocytes: a conceivable mode of action in treating hyper-proliferative skin diseases.
    Journal of drugs in dermatology : JDD, 2013
    Co-Authors: Ina Groenkjaer Laugesen, Karin Stenderup, Elisabeth De Darkó, Tomas Norman Dam, Stine Andersen, Eva Hauge, Cecilia Rosada
    Abstract:

    Background Valrubicin is a semisynthetic anthracycline developed as an anti-cancer drug able to ameliorate psoriasis and non-melanoma skin cancer (NMSC) by topical application in animal models. Valrubicin decreases cell proliferation, and induces apoptosis; however its mode of action is still unknown. Valrubicin localizes in the cytoplasm and its valerate moiety resembles diacylglycerol, an activator of protein kinase C (PKC) α, which belongs to the PKC family of cytoplasmic serine/threonine protein kinases. PKCα is observed in the suprabasal layers of normal skin and is associated to keratinocyte growth arrest and differentiation processes. In hyper-proliferative skin diseases the presence of PKCα is altered. Objective The aim of the present study was to investigate Valrubicin's mode of action in keratinocytes by studying its possible effect on PKCα activation. Methods PKCα's characteristic to translocate from the cytoplasm to the cellular membrane when activated was assessed by measuring the amount of PKCα in the soluble and membrane-bound protein fractions isolated from Valrubicin stimulated keratinocytes and by visualizing PKCα in stimulated cells over time. Downstream signaling was investigated by measuring the amount of phosphorylated Myristoylated Alanine-rich C-kinase substrate (MARCKS) and extracellular signal-regulated kinases (ERK) 1/2 of Valrubicin-stimulated keratinocytes. To investigate whether there was a direct interaction between Valrubicin and PKCα, an activity assay employing purified PKCα protein was used. Results Valrubicin activates PKCα in vitro as shown by PKCα's translocation and phosphorylation of downstream signaling molecules. Conclusion Valrubicin stimulates PKCα activity and downstream signaling which may contribute to its beneficial effect in psoriasis and NMSC.

  • Topical Valrubicin application reduces skin inflammation in murine models
    The British journal of dermatology, 2012
    Co-Authors: E. Hauge, Cecilia Rosada, Tomas Norman Dam, H. Christiansen, E. De Darkó, Karin Stenderup
    Abstract:

    Summary Background  Valrubicin is a cytostatic anthracycline analogue, lacking toxicity by skin and tissue contact, and represents a new drug with potential for topical treatment of psoriasis and nonmelanoma skin cancer (NMSC); the beneficial effects have been partly explained by its antiproliferative and proapoptotic characteristics. Objectives  To assess the effect of Valrubicin on skin inflammation as inflammation also plays a key role in psoriasis and NMSC. Methods  The effect of topical Valrubicin treatment on skin inflammation in vivo was addressed in skin inflammation mouse models, where 12-O-tetradecanoylphorbol 13-acetate was used to induce irritant contact dermatitis. An acute and a chronic model were included, to investigate the effect of Valrubicin in short-term inflammation and in more persistent inflammation. Inflammation-associated ear oedema was evaluated by measuring ear thickness, infiltration of neutrophil cells, and expression of inflammatory cytokines, interleukin (IL)-1β and IL-6. Results  Topical Valrubicin treatment effectively reduced the inflammatory response in the acute and the chronic models. Conclusions  The present data document an anti-inflammatory effect of Valrubicin, and may suggest an interesting new role for Valrubicin in other debilitating skin diseases in which inflammation is a significant factor.

  • Topical application of Valrubicin has a beneficial effect on developing skin tumors.
    Carcinogenesis, 2010
    Co-Authors: Stine Andersen, Cecilia Rosada, Elisabeth De Darkó, Frederik Dagnæs-hansen, Tomas Norman Dam, Ina Groenkjaer Laugesen, Karin Stenderup
    Abstract:

    Valrubicin is a second generation anthracycline characterized by an excellent safety profile presenting no skin toxicity or necrosis upon contact. In its current liquid formulation (Valstar; Indevus Pharmaceuticals, Lexington, MA), it is approved solely for the treatment of bladder cancer. Recently, Valrubicin was incorporated in a cream formulation rendering this drug available for topical application. The cytostatic property of Valrubicin can, thus, be employed for treating hyperproliferative skin diseases as was recently described for psoriasis. In the present study, the effect of topical application of Valrubicin was investigated in skin tumor development; we hypothesized that Valrubicin may be employed in treating actinic keratosis, a hyperproliferative skin condition that may transform into malignancy. A two-stage chemical mouse skin carcinogenesis model that represents the multistage etiology of human skin cancer-from developing papillomas to squamous cell carcinoma (SCC) was used. Moreover, two human skin SCC cell lines: DJM-1 and HSC-1 were cultured, to further investigate the effect of Valrubicin in vitro. Cell viability was assessed by adenosine triphosphate presence, proliferation as proliferative cell nuclear antigen expression and apoptosis as cytokeratin 18 cleavage, caspase activation, poly-adenosine diphosphate-ribose-polymerase cleavage and bax and bcl-2 regulation. Valrubicin significantly inhibited tumor formation in the mouse skin carcinogenesis model and significantly decreased cell viability of the cultured human skin SCC cells. In both mouse skin and SCC cells, proliferation was significantly decreased. Apoptosis was significantly increased in SCC cells but unchanged in the treated mouse skin at study completion. This study demonstrated that topical application of Valrubicin has a beneficial effect in treating developing skin tumors.

Michael S. Cookson - One of the best experts on this subject based on the ideXlab platform.

  • Use of intravesical Valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma in situ of the bladder:
    Therapeutic advances in urology, 2014
    Co-Authors: Michael S. Cookson, Sam S. Chang, Samira Q. Harper, Zhihui Lang, Christine Francis Lihou, Ronald F. Tutrone
    Abstract:

    Objectives:The objective was to conduct a US multicenter, retrospective medical record study examining the effectiveness, safety, and patterns of use of Valrubicin for treatment of nonmuscle-invasi...

  • Use of intravesical Valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma of the bladder
    SAGE Publishing, 2014
    Co-Authors: Michael S. Cookson, Sam S. Chang, Christine Lihou, Samira Q. Harper, Zhihui Lang, Ronald F. Tutrone
    Abstract:

    Objectives: The objective was to conduct a US multicenter, retrospective medical record study examining the effectiveness, safety, and patterns of use of Valrubicin for treatment of nonmuscle-invasive bladder cancer (NMIBC) by clinicians since the 2009 reintroduction of Valrubicin. Methods: Patients ≥ 18 years with NMIBC who received had one or more instillations of Valrubicin (October 2009– September 2011) were eligible. The primary endpoint was event-free survival (EFS). Safety and tolerability were also assessed. Results: The medical records of 113 patients met the inclusion criteria; 100 patients (88.5%) completed Valrubicin treatment. The median age was 75 years (range 42–95 years). The median NMIBC duration was 31 months since diagnosis: 51.3% (58/113) had carcinoma in situ (CIS) alone, and 31.9% (36/113) had unspecified NMIBC. Most patients, 94.7% (107/113), had more than three Valrubicin instillations and 70.8% (80/113) completed a full course. The EFS rate (95% confidence interval) was 51.6% (40.9–61.3%), 30.4% (20.4–41.1%), and 16.4% (7.9–27.5%) at 3, 6, and 12 months, respectively. Median time to an event was 3.5 (2.5–4.0) months after the first Valrubicin instillation. Local adverse reactions (LARs) were experienced by 49.6% (56/113) of patients; most LARs were mild (93.6%). The most frequent LARs were hematuria, pollakiuria, micturition urgency, bladder spasm, and dysuria. In total, 4.4% (5/113) of patients discontinued Valrubicin because of adverse events or LARs. Conclusions: Data from the present retrospective study are consistent with previous prospective clinical trials that demonstrated Valrubicin effectiveness and tolerability for select patients with CIS, before considering cystectomy. Additional prospective studies are warranted to evaluate Valrubicin safety and efficacy in the broader patient population with NMIBC

  • Efficacy and safety of Valrubicin in non–muscle-invasive bladder cancer in older and younger patients.
    Journal of Clinical Oncology, 2013
    Co-Authors: Michael S. Cookson, Samira Q. Harper, Christine Francis Lihou, Surya Chitra, Ronald Tutrone
    Abstract:

    309 Background: Valrubicin was approved in the United States in 1998, removed from the market in 2002 because of manufacturing issues, and reintroduced in 2009. We report the effectiveness and safety of Valrubicin, stratified by patient age, from a US multicenter, observational, retrospective study. Methods: Medical records of adults with non–muscle-invasive bladder cancer (NMIBC) who used Valrubicin were abstracted between March and September 2011. The median age (75 [range 42–95] years) was the stratification cutoff. Kaplan-Meier analyses were performed for event-free survival (EFS), worsening-free survival (WFS), and progression-free survival (PFS). Results: 113 patients (mean age, 73.7 years) received intravesical Valrubicin (median, 6 [range, 2–18] instillations). Median EFS, WFS, and PFS were similar in patients ≤75 vs >75 years old (see Table); 1-year rates were 17.8% vs 15.4%, respectively, for EFS; 16.1% vs 14.3% for WFS; and 80.2% vs 81.4% for PFS. 11 (19%) patients aged ≤75 years vs 4 (7%) aged...

  • efficacy and safety of Valrubicin in non muscle invasive bladder cancer in older and younger patients
    Journal of Clinical Oncology, 2013
    Co-Authors: Michael S. Cookson, Samira Q. Harper, Christine Francis Lihou, Surya Chitra, Ronald Tutrone
    Abstract:

    309 Background: Valrubicin was approved in the United States in 1998, removed from the market in 2002 because of manufacturing issues, and reintroduced in 2009. We report the effectiveness and safety of Valrubicin, stratified by patient age, from a US multicenter, observational, retrospective study. Methods: Medical records of adults with non–muscle-invasive bladder cancer (NMIBC) who used Valrubicin were abstracted between March and September 2011. The median age (75 [range 42–95] years) was the stratification cutoff. Kaplan-Meier analyses were performed for event-free survival (EFS), worsening-free survival (WFS), and progression-free survival (PFS). Results: 113 patients (mean age, 73.7 years) received intravesical Valrubicin (median, 6 [range, 2–18] instillations). Median EFS, WFS, and PFS were similar in patients ≤75 vs >75 years old (see Table); 1-year rates were 17.8% vs 15.4%, respectively, for EFS; 16.1% vs 14.3% for WFS; and 80.2% vs 81.4% for PFS. 11 (19%) patients aged ≤75 years vs 4 (7%) aged...

  • Effectiveness and safety of Valrubicin in non–muscle-invasive bladder cancer following reintroduction: Results from a medical chart review study.
    Journal of Clinical Oncology, 2013
    Co-Authors: Michael S. Cookson, Samira Q. Harper, Christine Francis Lihou, Surya Chitra, Ronald Tutrone
    Abstract:

    296 Background: Valrubicin was approved in the United States in 1998, removed from the market in 2002 because of manufacturing issues, and reintroduced in 2009. We report secondary outcomes and concomitant medication use from a US multicenter, observational, retrospective study. Methods: Medical records of adult patients with non–muscle-invasive bladder cancer (NMIBC) who used Valrubicin were abstracted (March–September 2011). Kaplan-Meier analyses were performed for disease-free survival (DFS), progression-free survival (PFS), worsening-free survival (WFS), cystectomy-free survival (CFS), and time to cystectomy. Results: 113 patients (mean age, 73.7 years) received intravesical Valrubicin (median, 6 instillations [range, 2–18]). 107 patients (94.7%) received >3 instillations; 97 (85.8%) completed the full course of therapy (≥6 instillations). DFS was 51.6% (95% CI, 40.9%–61.3%) at 3 months, 30.4% (95% CI, 20.4%–41.1%) at 6 months, and median DFS was 3.5 months (95% CI, 2.5–4.0). PFS was 97.6% (95% CI, 90...

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