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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 ]. …

Evolving Paradigms in the Management of Multiple Myeloma: Novel Agents and Targeted Therapies.

Multiple myeloma (MM) is a clonal plasma cell disorder defined by bone marrow infiltration and osteolytic bone lesions and is the second most common hematologic malignancy after non-Hodgkin lymphoma. The landscape of MM treatment was transformed at the dawn of the twenty-first century by the introduction of novel agents including proteasome inhibitors (bortezomib) and immunomodulatory drugs (thalidomide, lenalidomide), which have prolonged the survival of MM patients. The recently revised International Myeloma Working Group diagnostic criteria for MM added validated biomarkers (clonal bone mar

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… The duration of response to each subsequent line of therapy decreases consistently [ 62 ]; therefore, retreatment with a prior regimen may be considered if remission off therapy has lasted more than 6 months. … A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma. Br J Haematol. 2013;160(5):649–659. doi: 10.1111/bjh.12198. 65. Ciechanover A. The ubiquitin-proteasome proteolytic pathway. …

Nirogacestat and its potential impact on desmoid tumor.

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The Rate of Infusion Represents an Important Aspect of Administering Anticancer Agents.

BackgroundInfusion rate is one of the essential elements that should be included in all intravenous orders. Patients may experience adverse consequences or risks associated with inappropriate infusion. Meanwhile, there is growing pressure on the chemotherapy unit to deliver treatment quickly, efficiently, and safely, and thus it is very necessary to improve the chemotherapy process and service to cancer patients. Clinicians should consider how to further standardize infusion therapy, and innovate new infusion strategies to increase efficacy, reduce toxicity, improve patient satisfaction and sa

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… prolonged 3-hour infusion of carboplatin with appropriate premedication could reduce the occurrence rate of HSRs compared with the standard 30-minute schedule in sequentially treated patients (3.4% versus 21%, P <0.001), indicating that prophylactic conversion to a prolonged infusion during carboplatin retreatment … The prophylactic conversion to an extended infusion schedule and use of premedication to prevent hypersensitivity reactions in ovarian cancer patients during carboplatin retreatment. Gynecol Oncol . 2010;116:326–331. doi: 10.1016/j.ygyno.2009.10.070 13. LaVigne K, Hyman DM, Zhou QC, et al. …

Bortezomib and dexamethasone for multiple myeloma: higher AST and LDH levels associated with a worse prognosis on overall survival.

BackgroundBortezomib offers a novel approach to the treatment of multiple myeloma producing rapid control. The aim of this study was to investigate the outcomes of bortezomib and dexamethasone-treated patients with multiple myeloma.MethodsWe conducted a retrospective study of 44 consecutively-treated multiple myeloma patients with bortezomib (1.3 mg/m(2) on days 1, 4, 8, and 11 of a 21-day cycle or 1.3 mg/m(2) intravenously 1, 8, 15, and 22 of every 35-day cycle) and dexamethasone.ResultsThe median time to progression, progression free survival time, and overall survival time in the treatment

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… Patients received a median of 1 therapy (range 0–8) prior to bortezomib retreatment and a median of 3 cycles of bortezomib (range 1–14) as retreatment; 86.4% received 1–6 cycles. Efficacy A total of 627 instances of chemotherapy were performed with a median of 11.5 instance (range 3–56). …

A review of recently published radiotherapy treatment guidelines for bone metastases: Contrasts or convergence?

Bone metastases are a common manifestation of malignancy, and external beam radiotherapy (EBRT) effectively and safely palliates the pain caused by this clinical circumstance. The myriad of EBRT dosing schemes and complexities involved with coordinating radiotherapy with other interventions necessitated the need for bone metastases treatment guidelines. Here we compare and contrast the bone metastases radiotherapy treatment guidelines recently published by the American Society for Radiation Oncology (ASTRO) and the American College of Radiology (ACR). These evaluations acknowledge current cont

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… Retreatment with radiotherapy for painful bone metastases. International Journal of Radiation Oncology, Biology, Physics. 1994;29(5):1011–1014. doi: 10.1016/0360-3016(94)90396-4. 17. Uppelschoten JM, Wanders SL, de Jong JM. Single-dose radiotherapy (6 Gy): palliation in painful bone metastases. … Single fraction radiotherapy is efficacious: a further analysis of the Dutch Bone Metastasis Study controlling for the influence of retreatment. International Journal of Radiation Oncology, Biology, Physics. 2004;59(2):528–537. doi: 10.1016/j.ijrobp.2003.10.006. 19. …

Discontinuation of maintenance therapy in multiple myeloma guided by multimodal measurable residual disease negativity (MRD2STOP).

MRD2STOP is a pragmatic trial evaluating maintenance therapy cessation guided by measurable residual disease (MRD) negativity in multiple myeloma (MM). Eligible patients had previous MRD -5, received ≥1 year of maintenance, and were prospectively confirmed to have undetectable disease by positron emission tomography, bone marrow (BM) flow cytometry (limit of detection [LoD] 10-5), and BM clonoSEQ (LoD 10-6). BM aspirates enriched for CD138+ cells were analyzed by clonoSEQ to achieve MRD 10-7 sensitivity. We evaluated the incidence of disease resurgence and progression-free survival (PFS), stra

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… All five patients successfully underwent retreatment, and three again reached MRD < 10 − 6 . One patient died due to complications related to a second hematologic malignancy. Overall survival (OS) is immature; the estimated 3-year OS was 97% (Fig. S4 ). … Encouragingly, all five patients with relapse were successfully retreated, and three had again achieved MRD < 10 − 6 . …

Transient increase in skeletal-related events after discontinuation of high-dose denosumab in cancer patients.

BACKGROUND: Denosumab is widely used to prevent skeletal-related events (SREs) in patients with bone metastases. However, rebound bone resorption after discontinuation is recognized. In osteoporosis, discontinuation of low-dose denosumab increases multiple vertebral fractures, but data on high-dose discontinuation remain limited. METHODS: Among 493 patients treated with high-dose denosumab at our institution (2014-2023), 78 met eligibility criteria. SREs during and after treatment were compared using each patient as their own control. SREs were defined as pathological fracture, spinal cord co

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… In one patient who restarted denosumab during follow-up, observation was censored at the time of retreatment. Patients who had received zoledronic acid or other bisphosphonates before denosumab initiation or after its discontinuation were not excluded and were allowed in this study. … In one patient who restarted denosumab 32 months after discontinuation, observation was censored at retreatment. The median follow-up was 365 days (mean, 692 days). The median overall survival was 601 days ( Supplementary figure 1 ). Data on the study endpoint were available for all 78 patients. …

Recent Clinical Trials Insights into the Treatment of Primary Membranous Nephropathy.

Immunosuppressive therapy is mandatory for primary membranous nephropathy with persistent nephrotic proteinuria or anti-phospholipase A2 receptor antibodies, reduced kidney function, or another risk factor for progression. Rituximab has demonstrated efficacy for proteinuria remission compared with renin-angiotensin system blockade or cyclosporine in two well-powered randomized controlled trials. More recently, STARMEN showed that alternating glucocorticoid-cyclophosphamide is superior to sequential tacrolimus-rituximab for proteinuria remission, although it was associated with a higher risk of

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… Table 6 Current research questions in the management of primary membranous nephropathy Optimization of current therapeutic options and incorporation of risk-based and response-based decision tools Optimal CYC regimen: consider low-dose short IV regimen Optimal RTX regimen, consider retreatment according … Optimization of RTX timing and dosing (e.g., retreatment at 6 months) could be the key to improving long-term efficacy. …

Challenges and opportunities in cancer immunotherapy: a Society for Immunotherapy of Cancer (SITC) strategic vision.

Cancer immunotherapy has flourished over the last 10-15 years, transforming the practice of oncology and providing long-term clinical benefit to some patients. During this time, three distinct classes of immune checkpoint inhibitors, chimeric antigen receptor-T cell therapies specific for two targets, and two distinct classes of bispecific T cell engagers, a vaccine, and an oncolytic virus have joined cytokines as a standard of cancer care. At the same time, scientific progress has delivered vast amounts of new knowledge. For example, advances in technologies such as single-cell sequencing and

CAR T-Cell Therapy for Patients with Multiple Myeloma: Current Evidence and Challenges.

The therapeutic landscape of multiple myeloma (MM) has benefited from an emergence of novel therapies over the last decade. By inducing T-cell kill of target cancer cells, chimeric antigen receptor (CAR) T-cell therapies have improved outcomes of patients with hematologic malignancies. B-cell maturation antigen (BCMA) is the current target antigen of choice for most CAR T-cell products under investigation for MM. However, their shortcomings deal with logistical and clinical challenges, including limited availability, manufacturing times, and toxicities. This article provides an overview of rec

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… Subsequent treatment with conventional therapies or BCMA-directed therapies demonstrated modest activity, with an associated PFS2 of 13.6 months and 15.5 months, respectively. 47 However, among the 28 patients retreated with ide-cel, activity seemed minimal with an ORR of only 21% (composed of 1 VGPR … and 5 PRs) and median PFS of only 1-month (range, 1–2.1 months). 17 Further, only 3 patients enrolled in the CARTITUDE-1 trial underwent cilta-cel retreatment. 16 Responses were also minimal, with 2 patients having stable disease and one with progressive disease, and none of the 3 patients having CAR …

A genetic variant study of bortezomib-induced peripheral neuropathy in Chinese multiple myeloma patients.

BackgroundBortezomib results in peripheral neuropathy (PN) in approximately 50% of patients, during multiple myeloma (MM) treatment, a complication known as Bortezomib-induced peripheral neuropathy (BIPN). The drug response varies among individuals. Genetic factor may play an important role in BIPN.MethodsA next-generation sequencing (NGS) panel containing 1659 targets from 233 genes was used to identify risk variants for developing BIPN in 204 MM patients who received bortezomib therapy. mRNA expression of MTHFR and ALDH1A1 in 62 peripheral blood samples was detected by real-time quantitative

Patient-reported utilities in advanced or metastatic melanoma, including analysis of utilities by time to death.

BackgroundHealth-related quality of life is often collected in clinical studies, and forms a cornerstone of economic evaluation. This study had two objectives, firstly to report and compare pre- and post-progression health state utilities in advanced melanoma when valued by different methods and secondly to explore the validity of progression-based health state utility modelling compared to modelling based upon time to death.MethodsUtilities were generated from the ipilimumab MDX010-20 trial (Clinicaltrials.gov Identifier: NCT00094653) using the condition-specific EORTC QLQ-C30 (via the EORTC-

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… These time points were pre-specified for the first 4 doses, however beyond this point quality of life instruments were only administered when patients received retreatment. … questionnaires (both EORTC QLQ-C30 and SF-36) were completed within the first 24 weeks of the trial (before and after patients were administered their initial course of ipilimumab), though observations are available for up to 4 years (5% of patients completed questionnaires after 12 months if receiving retreatment …

Management of mantle cell lymphoma in the elderly patient.

Mantle cell lymphoma is a relatively rare B-cell lymphoma with a specific genetic lesion and a typical immunophenotypic profile. The median age is 65 years. There is no curative treatment, except allogeneic stem cell transplantation for a selected group of patients. For the majority of patients, especially the elderly, the aim of therapy should therefore be a long progression-free survival. Age and comorbidity may hamper the use of the most active treatment regimen, such as high dose cytarabine and autologous stem cell transplantation. Therefore, it is a challenge to select the most appropriat

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… Lenalidomide | 15 | ORR 53% CR 20% | PFS 5.6 months DR 13.7 months | 66 Weigert et al 47 | R-HAD + B (rituximab, cytarabine, dexamethasone, bortezomib) | 8 | ORR 50% CR 25% | PFS 5.5 months OS 15 months | 65 Rituximab/bendamustine is an active regimen for MCL, and can be used in the relapsed setting. 36 Retreatment … Retreatment with bendamustine-containing regimens in patients with relapsed/refractory chronic lymphocytic leukemia and indolent B-cell lymphomas achieves high response rates and some long lasting remissions. Leuk Lymphoma. 2012 Dec 5; doi: 10.3109/10428194.2012.747679. Epub. 38. …

The changing landscape of relapsed and/or refractory multiple myeloma (MM): fundamentals and controversies.

The increase in the number of therapeutic alternatives for both newly diagnosed and relapsed/refractory multiple myeloma (RRMM) patients has widened the clinical scenario, leading to a level of complexity that no algorithm has been able to cover up to date. At present, this complexity increases due to the wide variety of clinical situations found in MM patients before they reach the status of relapsed/refractory disease. These different backgrounds may include primary refractoriness, early relapse after completion of first-line therapy with latest-generation agents, or very late relapse after

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… Approaches to the treatment of triple-class (PIs, IMiDs and monoclonal antibodies) RRMM patients, including CC, sASCT and retreatment, are currently limited. … Retreatment has been used with limited results when no other choice is available, but new drugs should now be used instead whenever possible. …

A qualitative evidence synthesis of healthcare professionals' experiences and views of palliative care for patients with a haematological malignancy.

IntroductionPatients with haematological malignancies may not be receiving appropriate referrals to palliative care and continuing to have treatments in the end stages of their disease. This systematic review of qualitative research aimed to synthesise healthcare professionals' (HCPs) views and experiences of palliative care for adult patients with a haematologic malignancy.MethodsA systematic search strategy was undertaken across eight databases. Thomas and Harden's approach to thematic analysis guided synthesis on the seventeen included studies. GRADE-GRADEQual guided assessment of confidenc

Non-Hematologic Toxicity of Bortezomib in Multiple Myeloma: The Neuromuscular and Cardiovascular Adverse Effects.

The overall approach to the treatment of multiple myeloma (MM) has undergone several changes during the past decade. and proteasome inhibitors (PIs) including bortezomib, carfilzomib, and ixazomib have considerably improved the outcomes in affected patients. The first-in-class selective PI bortezomib has been initially approved for the refractory forms of the disease but has now become, in combination with other drugs, the backbone of the frontline therapy for newly diagnosed MM patients, as well as in the maintenance therapy and relapsed/refractory setting. Despite being among the most widely

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… There is no evidence of new cumulative neurotoxicity upon retreatment with bortezomib [ 51 , 52 ]. … Evaluation of pre-existing neuropathy and bortezomib retreatment as risk factors to develop severe neuropathy in a mouse model J. Peripher. Nerv. Syst. 2011 16 199 212 10.1111/j.1529-8027.2011.00346.x 22003935 75. Shin Y.K. Jang S.Y. Lee H.K. Jung J. Suh D.J. Seo S.-Y. Park H.T. …

Emerging strategies and therapies for treatment of Paget's disease of bone.

Paget's disease of bone (PDB) is a progressive monostotic or polyostotic metabolic bone disease characterized by focal abnormal bone remodeling, with increased bone resorption and excessive, disorganized, new bone formation. PDB rarely occurs before middle age, and it is the second most frequent metabolic bone disorder after osteoporosis, affecting up to 3% of adults over 55 years of age. One of the most striking and intriguing clinical features is the focal nature of the disorder, in that once the disease is established within a bone, there is only local spread within that bone and no systemi

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… Monitoring and retreatment Serum total alkaline phosphatase is the most commonly used method of monitoring disease activity. 10 It should be measured every three months for the first six months after therapy and every six months thereafter. 10 Pretherapeutic serum total alkaline phosphatase is often … Retreatment is usually indicated when there are persistent symptoms of PDB or biochemical relapse. 10 Although there is no clinical trial evidence to guide clinicians, it is generally accepted that an increase of 25% above nadir indicates significant relapse requiring retreatment. 10 Mechanisms of action …

Safety and Tolerability of Antibody-Drug Conjugates in Cancer.

Antibody-drug conjugates are monoclonal antibodies attached to biologically active drugs through chemical linkers that deliver and release cytotoxic agents at the tumor site, reducing the likelihood of systemic exposure and therefore toxicity. Currently, there are about 110 ongoing studies implementing antibody-drug conjugates in the treatment of multiple human malignancies. Antibody-drug conjugates carry a feature of the specificity of a monoclonal antibody and the anti-neoplastic potential of a cytotoxin. The first antibody-drug conjugate was approved in 2001, and the field of antibody-drug

Long-term stabilisation of myeloma with curcumin.

Myeloma is a haematological malignancy which typically follows a relapsing-remitting course. While treatment can control the myeloma and improve quality of life for given periods of time, remissions generally become progressively shorter with subsequent relapses, and patients ultimately enter a final refractory phase. To help control symptoms and enhance quality of life, some patients use complementary therapies as an adjunct to their conventional therapy. Here, we describe a myeloma patient who started a daily dietary supplement of curcumin when approaching her third relapse. In the absence o

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… The patient achieved a partial response with CTD retreatment over the course of 17 cycles (M-protein 13 g/L) with no further episodes of idiosyncratic syndrome. However, attempts to harvest stem cells in February 2011 and again there months later, both failed. …