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Antibodies to watch in 2013: Mid-year update.

The transitions of antibody therapeutics to late-stage clinical development, regulatory review and the market are proceeding at a rapid pace in 2013. Since late 2012, two monoclonal antibody (mAb) therapeutics (itolizumab, trastuzumab emtansine) received their first approvals, first marketing applications for three mAbs (vedolizumab, ramucirumab, obinutuzumab) were submitted to regulatory agencies, and five mAbs (brodalumab, MABp1, moxetumomab pasudotox, tildrakizumab, rilotumumab) entered their first Phase 3 studies. The current total of commercially-sponsored antibody therapeutics undergoing

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… The AMAGINE-1 study ( NCT01708590 ) is evaluating the efficacy, safety, and effect of withdrawal and retreatment with brodalumab in patients with moderate-to-severe plaque psoriasis. … Patients are retreated at return of disease. The estimated primary completion date for the study is March 2014. …

Long-Term Follow up of Blinatumomab in Older Patients with B-Cell Acute Lymphoblastic Leukemia.

Older adults who are diagnosed with acute lymphoblastic leukemia (ALL) and are treated with chemotherapy generally have poor outcomes. Blinatumomab is a CD19/CD3 bispecific T-cell engager that has been approved for the treatment of B-cell ALL in the relapsed/refractory setting or in patients with minimal residual disease (MRD) positivity. We previously reported on a small cohort of older adults with newly diagnosed Philadelphia chromosome negative B-cell ALL who were treated with blinatumomab monotherapy in the first line setting. This is a long-term follow up of those patients and their clini

A multidisciplinary bone metastases clinic at Toronto Sunnybrook Regional Cancer Centre - A review of the experience from 1999 to 2005.

Our objective in this study was to review the experience of a one-stop multidisciplinary bone metastases clinic (BMC) that offers a coordinated multidisciplinary approach to the care of cancer patients with bone metastases in a tertiary cancer centre. Patients with symptomatic bone metastases were referred to BMC and assessed by a team of specialists in various disciplines - interventional radiology, orthopedic surgery, palliative medicine, and radiation oncology. At initial consultation, patient demographics, reasons for referral, and case disposition were recorded. From January 1999 to Febru

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… Retreatment is often also required when the effects of radiotherapy wears off. In a large RCT ( Steenland et al 1999 ), 16% of all patients required re-treatment. … The rate of retreatment was significantly more pronounced in patients who previously received a single fraction than those who received multiple fractions regimens (25% vs 7%). …

Stereotactic body radiotherapy for treatment of spinal metastasis: A systematic review of the literature.

BACKGROUND: Advances in local and systemic therapies continue to improve overall survival for patients with cancer, increasing the incidence of spine metastases. Up to 15% of patients with solid tumors develop spinal metastases. Spinal metastases can be particularly devastating for quality of life given the potential pain, neurological deficits from spinal cord compression or cauda equina syndrome, spinal instability, and pathological fractures that may result. Stereotactic body radiotherapy (SBRT) with or without adding less invasive surgical techniques for stabilization or separation has gai

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… and 89% for initial treatment at 12 months | Pain control rate was 86% for retreatment and 93% for initial at 6 months, 81% for retreatment and 89% for initial at 12 months, and 86% for treatment and 90% for initial at 2-y follow-up. … Local tumor control after retreatment of spinal metastasis using stereotactic body radiotherapy; comparison with initial treatment group . Acta Oncol. 2012 ; 51 ( 5 ): 589 – 595 . 22414095 10.3109/0284186X.2012.666637 52. Lee S , Chun M. …

Нейропатия, вызванная Бортезомибами, в множестве миэломы проявляется как падение ступни из-за перонеального нервного паралича.

Мы представляем пример человека в возрасте 50 лет с множественной миэломой, который развился после того, как получил комбинацию химиотерапии бортезомиб-дексаметасона. Для подтверждения диагноза и оценки степени нейропатии были проведены диагностические оценки, включая гематологические параметры, исследования в области нерва и съемки. У него была консервативная анальгетика и витаминные добавки, а бортезомиб временно удерживался. Нейропатия постепенно улучшалась, и бортезомиб был успешно восстановлен без повторного падения ног. Падение ног, вызванное борезомибом, является редким осложнением лече

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… Velcade (Bortezomib) Receives 2 New FDA Indications: For Retreatment of Patients with Multiple Myeloma and for First-Line Treatment of Patients with Mantle-Cell Lymphoma. Am Health Drug Benefits. 2015;8:135–40. 7. Zajączkowska R, Kocot-Kępska M, Leppert W, et al. … An observational, retrospective analysis of retreatment with bortezomib for multiple myeloma. Clin Lymphoma Myeloma. 2008;8:140–5. doi: 10.3816/CLM.2008.n.016. 15. Richardson PG, Briemberg H, Jagannath S, et al. …

Targeted approaches in the treatment of osteoporosis: differential mechanism of action of denosumab and clinical utility.

Denosumab is a breakthrough biological drug approved by the Food and Drug Administration and European Medicines Agency for the treatment of osteoporosis in 2010. It is a fully human monoclonal antireceptor activator of nuclear factor kappa-B ligand antibody, which inhibits the activity of osteoclasts, resulting in an antiresorptive effect with a significant increase in bone mineral density. The FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis every 6 Months) trial, comparing denosumab with no treatment in 7868 women with postmenopausal osteoporosis, showed an important reduc

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… Bone turnover marker levels increased with discontinuation of denosumab and decreased with retreatment. … Effects of teriparatide retreatment in osteoporotic men and women. J Clin Endocrinol Metab. 2009;94(7):2495–2501. doi: 10.1210/jc.2009-0154. 52. Eastell R, Nickelsen T, Marin F, et al. …

Daratumumab монотерапия для рецидива AL Amiloidosis: ретроспективный анализ в одном центре.

ЦЕЛЬ: Лечение рецидива АЛ-Амилоидоз по-прежнему сопряжено с трудностями, поскольку пациенты часто страдают серьезными расстройствами органов. Даратумумаб, коренной наркотик в множестве миеломы и недавно диагностированный AL амилоидоз, также продемонстрировал свои надежды на рецидив AL амилоидоз. Для оценки эффективности Daratumumumab мы провели ретроспективное исследование 40 пациентов, которые получили монотерапию Daratumumab в нашей будущей группе амилоидозов. Результаты: Средний возраст когорты составлял 67 лет, 31 пациент был отнесен к категории III/IV в соответствии с руководящими принцип

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… Real-world treatment patterns and outcomes of daratumumab retreatment in multiple myeloma in the United States. Blood. 2022;140(Supplement 1):5266–7. 24. Tan CRC, Rueda C, Shekarkhand T, Derkach A, Korde N, Maclachlan K, et al. … Clinical outcomes of retreatment with daratumumab-based regimens in anti-CD38 refractory multiple myeloma. J Clin Oncol. 2024;42(16_suppl):7570. 25. Rosenbaum C, Liedtke M, Christos P, Kim H, Pogonowski K, Agudo N, et al. …

Помимо CAR-T: Предотвращение и лечение релапса в гематологических злодеяниях B-Cell.

Цимерическая антигенная лейкемия (КАР) Т-клетотерапия произвела революцию в области лечения рентгеновской/рефракторной (R/R) острой лимфоболической лейкемии (B-LAL), неходгкинской лимфомы (NHL) и множественной миеломы (MM); однако значительная часть пациентов в конечном итоге, несмотря на первоначальные ответные меры, вновь заболела. В настоящем обзоре содержится краткий обзор клеточной терапии CAR-T, включая ее производственный процесс и связанные с этим токсичные свойства, до изучения биологических механизмов, лежащих в основе рецидива после CAR-T в B-ALL, NHL-особенно большой лимфомы B-клет

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… Gauthier et al. reported a complete remission rate of only 21% after reinfusion of the original CD19 CAR-T product, despite administration of a higher CAR-T cell dose, highlighting the challenges associated with CAR-T retreatment [ 53 ]. … Similarly, Ortiz-Maldonado et al. explored retreatment with CD19 CAR-T cells following rituximab-containing lymphodepletion aimed at reducing humoral anti-CAR immune responses. …

Patient reported change in pain outcome among stage IV cancer patients with bone metastases following palliative radiotherapy: A prospective study from Ethiopia.

BackgroundCancer is reported to be on the rise in low-income countries where most patients present in either locally advanced or metastatic … in status following palliative radiotherapy at two, four, and eight weeks (wks.), when compared to pretreatment pain status.MethodsA total of forty-four cancer patients with fifty sites of bone metastases were enrolled in the study. An observational cohort study was conducted to investigate the effectiveness of palliative RT towards alleviating pain due to bo …

Preformed crowns for decayed primary molar teeth.

BACKGROUND: Crowns for primary molars are preformed and come in a variety of sizes and materials to be placed over decayed or developmentall … . Some of our outcomes of interest were not measured in the studies: time to restoration failure or retreatment, patient satisfaction and costs. Crowns versus fillingsAll studies in this comparison used PMCs. One study reported outcomes in the short term and found no reports of major failure or pain in either group. There was moderate quality evidence that th …

CAR T cells and T cell engagers for autoimmunity-lessons from hematology.

Autoimmune diseases are driven by dysregulated immune responses against self-antigens, resulting in chronic inflammation and progressive tissue damage. Chimeric antigen receptor (CAR) T cell therapy and T cell engagers, initially developed for the treatment of hematologic malignancies, have demonstrated that they can mediate profound and sustained depletion of pathogenic B cells, leading to long-term remissions in otherwise refractory diseases. In this review, we explore key insights gained from hematologic applications of CAR T cells and T cell engagers, and discuss how these lessons can guid

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… Optimal CAR T-cell dose, fractionation, and retreatment remain undefined for autoimmune indications. Allogeneic or off-the-shelf CAR T products expand access but raise rejection concerns | Exploratory. Early trials show feasibility; long-term immune reconstitution and safety data are awaited. … Biomarkers guide intervention and retreatment | Critical unmet need. Predictive and mechanistic biomarkers remain underdeveloped for autoimmune CAR T and bispecific approaches. …

How should we choose optimal salvage treatments following BCMA-directed CAR T-cell therapy?

B-cell maturation antigen (BCMA) directed chimeric antigen receptor T-cell therapy (CAR-T) has transformed the treatment of relapsed/refractory multiple myeloma (RRMM), yet relapse is still common for most patients. A variety of different salvage treatment strategies have been studied in the last several years to address several resistance mechanisms that lead to relapse after BCMA CAR-T. To date, there are no clear guidelines regarding treatment sequencing strategies for salvage therapy. This review will investigate the current landscape of available salvage therapies and data supporting thei

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… The ORR was 21.4% and the median PFS was only 1-month (DOR 1.9–6.8 months) after retreatment with the same product [ 1 ]. All responders received a higher cell dose during their second infusion. Only 3 patients were retreated with cilta-cel in CARTITUDE-1. … Salvage therapies including retreatment with BCMA-directed approaches after BCMA CAR-T relapses for multiple myeloma. …

Ocular complications with the use of radium-223: a case series.

BackgroundRadium-223 is used for the treatment of osseous metastases in castrate-resistant prostate cancer, and has been shown to increase time to the first skeletal-related event, reduce the rate of hospitalization, and improve quality of life. It is well tolerated, with hematologic toxicity as the main adverse event. Thus far, no ocular complication has been reported in the literature after initial administration of radium-223 with a single case reported of ocular complications after a patient's second course of radium-223.Case presentationsWe present three cases of ocular complications afte

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… To our knowledge, only one previous study has demonstrated ocular sequalae in patients who received Ra-223, although this was after retreatment with Ra-223 [ 11 ]. … In this phase I/II study assessing retreatment with Ra-223 for mCRPC, ocular AEs including cataract formation, cataract worsening, iritis, uveitis, glaucoma, and photopsia occurred in 11% (5/44) of patients. …

Teprotumumab for patients with active thyroid eye disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomised, double-masked, placebo-controlled, multicentre trials.

BACKGROUND: Thyroid eye disease manifests inflammation and treatment-resistant proptosis and diplopia. Teprotumumab, an insulin-like growth … , with most patients maintaining responses in the long-term. Analyses of the effect of teprotumumab retreatment on non-responders and those who flare after response, as well as further studies in a broader population of thyroid eye disease are ongoing. FUNDING: Horizon Therapeutics.

Belantamab mafodotin, pomalidomide, and dexamethasone in Japanese patients with RRMM in the phase 3 DREAMM-8 trial.

The phase 3 DREAMM-8 (NCT04484623) trial assessed belantamab mafodotin + pomalidomide + dexamethasone (BPd) vs bortezomib + Pd (PVd) in lenalidomide-exposed patients with relapsed/refractory multiple myeloma (RRMM) and ≥ 1 prior therapy. Here, we present findings from Japanese patients (data cutoff: 27-May-24). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall response rate (ORR), duration of response (DoR), and safety. Overall, 21 patients were randomized 1:1 to BPd (N = 10) and PVd (N = 11). Median follow-up was 13.8 months (range 0.23-26.71). For

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… Furthermore, retreatment with anti-CD38-based therapies in patients with RRMM has shown variable clinical outcomes and limited clinical benefit [ 9 ]. Overall, this highlights the need for novel treatments that target different mechanisms of action for patients with RRMM. … Clinical outcomes associated with anti-CD38-based retreatment in relapsed/refractory multiple myeloma: a systematic literature review. Front Oncol. 2025;15:1550644. 40144211 10.3389/fonc.2025.1550644 PMC11938063 10. …

Immunogenicity to biological drugs in psoriasis and psoriatic arthritis.

Monoclonal antibodies or fusion proteins, defined as biological drugs, have modified the natural history of numerous immune-mediated disorders, allowing the development of therapies aimed at blocking the pathophysiological pathways of the disease, providing greater efficacy and safety than conventional treatment strategies. Virtually all therapeutic proteins elicit an immune response, producing anti-drug antibodies (ADAs) against hypervariable regions of immunoglobulins. Immunogenicity against biological drugs can alter their pharmacokinetic and pharmacodynamic properties, thereby reducing the

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… On the other hand, the presence of antibodies against IFX was associated with infusion-related adverse reactions only in the retreated group of patients and after an interval of 20 weeks from the last administration (23% in patients positive for ADAs, compared to 8% in patients without ADAs). … In a recent publication, Bagel et al. analyzed data from phase I, II and III studies on the use of BDL in PsO, with the objective of evaluating the potential effects of anti-BDL antibodies regarding safety, efficacy and percentage of retreatment during an observation period at 12 and 52 weeks. …

The Role of Post-Operative Radiotherapy for Non-Spine Bone Metastases (NSBMs).

Non-spine bone metastases (NSBMs) can cause significant morbidity and deterioration in the quality of life of cancer patients. This paper reviews the role of post-operative radiotherapy (PORT) in the management of NSBMs and provides suggestions for clinical practice based on the best available evidence. We identified six retrospective studies and several reviews that examined PORT for NSBMs. These studies suggest that PORT reduces local recurrence rates and provides effective pain relief. Based on the literature, PORT was typically delivered as 20 Gy in 5 fractions or 30 Gy in 10 fractions wit

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… The doses used for retreatments vary, but 8 Gy in 1 fraction is commonly used and is recommended in the ESTRO guideline [ 13 ]. … A systematic review of palliative bone radiotherapy based on pain relief and retreatment rates Crit. Rev. Oncol. 2018 123 132 137 10.1016/j.critrevonc.2018.01.006 29482774 10. Ahmad I. Ahmed M.M. Ahsraf M.F. Naeem A. Tasleem A. Ahmed M. Farooqi M.S. …

Recursive Partitioning Analysis for Local Control Achieved With Stereotactic Body Radiation Therapy for the Liver, Spine, or Lymph Nodes.

PurposeThis study aims to develop a local control risk stratification using recursive partitioning analysis (RPA) for patients receiving stereotactic body radiation therapy (SBRT) for metastatic cancer.Methods and materialsA single institutional database of 397 SBRT treatments to the liver, spine, and lymph nodes was constructed. All treatments required imaging follow-up to assess for local control. Cox proportional hazards analysis was implemented before the decision tree analysis. The data were split into training (70%), validation (10%), and testing (20%) sets for RPA to optimize the traini

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… 21 , 22 , 23 Even so, a recent multi-institutional study demonstrated encouraging local control rates, especially with smaller tumor volumes and higher biologically effective dose (BED). 24 For spinal metastases, SBRT offers high rates of local control, and it even serves as an effective option in retreatment … Local tumor control after retreatment of spinal metastasis using stereotactic body radiotherapy: Comparison with initial treatment group. Acta Oncologica. 2012;51:589–595. doi: 10.3109/0284186X.2012.666637. 26. Al-Omair A., Masucci L., Masson-Cote L. …

Belantamab Mafodotin: From Clinical Trials Data to Real-Life Experiences.

Despite the recent approval of novel immunotherapies, such as immunomodulatory drugs, proteasome inhibitors and anti-CD38 monoclonal antibodies, Multiple Myeloma (MM) remains incurable, and the acquisition of triple-refractoriness leads to really dismal outcomes in even earlier lines of therapy. More recently, innovative therapeutic strategies targeting B cell maturation antigen (BCMA), highly expressed on the plasma cell surface, are drawing different future landscapes in terms of effectiveness and outcomes. Belantamab Mafodotin, a first-in-class anti-BCMA antibody-drug conjugate, demonstrate

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… Interestingly, both ORR and outcomes did not seem worse in penta-refractory patients than the overall cohort, encouraging anti-BCMA retreatment in the challenging setting of penta-refractory patients. … Moreover, while retreatment with anti-CD38 mAb is not effective, the other anti-BCMA immunotherapies can be administered after belamaf leading to a significant duration of response in very heavily pretreated MM patients [ 52 ]. …

Monoclonal Antibodies to Treat Multiple Myeloma: A Dream Come True.

Immunotherapy is increasingly used in the treatment of multiple myeloma (MM). Monoclonal antibodies (mAbs) are safe and effective ways to elicit immunotherapeutic responses. In 2015, daratumumab has become the first mAb approved by the Food and Drug Administration for clinical use in MM and, in the last 5 years, a lot of clinical and preclinical research has been done to optimize the use of this drug class. Currently, mAbs have already become part of standard-of-care combinations for the treatment of relapsed/refractory MM and very soon they will also be used in the frontline setting. The succ

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… Initial reports of the suboptimal efficacy of retreatment with anti-CD38 mAbs in a small series of patients are beginning to emerge [ 93 ] and will require prospective confirmation in a significant number of patients. … Nevertheless, the most relevant issue limiting retreatment with anti-CD38 mAbs is the long-lasting downregulation of CD38 on plasma cell surfaces after anti-CD38 therapy [ 97 ]. …