The longitudinal patterns of patient-reported outcomes and their association with mortality in routine oncology care are largely unexplored.

Renizgamglogene autogedtemcel (reni-cel) is an investigational clustered regularly interspaced short palindromic repeats (CRISPR)-Cas12a gene-edited autologous hematopoietic stem-cell therapy. The therapy was designed to disrupt the BCL11A binding sites in the HBG1 and HBG2 promoters to reactivate fetal hemoglobin production for the treatment of transfusion-dependent β-thalassemia.

Renizgamglogene autogedtemcel (reni-cel) is an investigational clustered regularly interspaced short palindromic repeats (CRISPR)-Cas12a gene-edited autologous hematopoietic stem-cell therapy. The therapy was designed to disrupt the BCL11A binding sites in the HBG1 and HBG2 promoters to reactivate fetal hemoglobin production for the treatment of sickle cell disease.

A novel 5 mg mini-tablet formulation of mercaptopurine (6-MP) was developed to provide flexible and accurate doses to treat children with acute lymphoblastic leukemia. We conducted two open-label, randomized, single-dose, four-period, two-sequence, full-replicate, crossover trials to characterize the pharmacokinetics and relative bioavailability of the novel 6-MP mini-tablet (N) compared to the reference 6-MP tablet (R) under both fasted and fed conditions. The 6-MP plasma concentrations were measured using ultra performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS). The Cmax, AUC0-t, and AUC0-inf were used to evaluate the relative bioavailability. The results showed that the 6-MP mini-tablet was bioequivalent to the reference formulation under fasting condition. Under the fasted condition, the geometric least-squares mean ratios (GLSMR) (90% CI) of Cmax, AUC0-t, and AUC0-inf of N over R were 91.71% (81.31%-103.44%), 97.53% (92.57%-102.76%), and 97.91% (93.17%-102.90%), respectively. The mean CL/F (238.4 vs 219.3 L/h), the mean Vd/F (523.4 vs 451.8 L), the median Tmax (1.50 vs 1.25 h), and the mean t1/2 (1.55 vs 1.44 h) of N and R showed similarity. Under fed condition, the GLSMR (90% CI) of Cmax, AUC0-t, and AUC0-inf of N over R were 68.16% (59.62%-77.93%), 86.22% (81.37%-91.37%), and 86.59% (81.88%-91.57%), respectively. Furthermore, a high-fat diet increased both CL/F and Vd/F of 6-MP and decreased exposure of 6-MP, with all changes exceeding two-fold. Both products exhibited a favorable safety profile without any SAE being observed. These results supported the marketing of 6-MP mini-tablets.

DHP107 is an oral paclitaxel enabling administration of paclitaxel without Cremophor EL, a vehicle used to improve the solubility of intravenous (IV) paclitaxel. The randomized phase II OPERA study investigated the efficacy and safety of DHP107 versus IV paclitaxel in patients with HER2-negative breast cancer.

LINKER-MM1 (NCT03761108) is a Phase 1/2 study of linvoseltamab, a human BCMA×CD3 bispecific antibody for patients with relapsed/refractory multiple myeloma (RRMM) who are triple-class exposed (TCE) with ≥ 3 prior lines of therapy (3L+), or triple-class refractory (TCR). To contextualize efficacy data from LINKER-MM1, the Phase 2 linvoseltamab 200 mg cohort (N = 105) was compared with an international external control arm (ECA) comprising 203 patients from participating International Myeloma Working Group sites who met LINKER-MM1 eligibility criteria based on chart reviews. The ECA reflected real-world standard-of-care (RW SOC). An independent data review committee assessed data relevance, quality, and cohort comparability, while a separate independent central review committee evaluated response data. Inverse probability of treatment weighting was used to balance baseline characteristics between the linvoseltamab arm and the ECA. Linvoseltamab had a higher objective response rate (weighted odds ratio 3.0 [95% confidence interval (CI): 1.9-4.1]) and longer median progression-free survival (weighted hazard ratio [wHR] 0.33 [95% CI: 0.28-0.40]), time to next treatment (wHR 0.34 [95% CI: 0.29-0.44]), and overall survival (wHR 0.72 [95% CI: 0.58-0.98]) than RW SOC. These findings highlight linvoseltamab's potential as an effective treatment for 3L+ and TCE/TCR RRMM.

Poly(ADP-ribose) polymerase (PARP) inhibition (PARPi) is a precision medicine strategy in advanced prostate cancer, with the greatest benefit seen in a subset of patients with homologous recombination repair (HRR) gene alterations. Combination approaches may expand activity beyond HRR-altered disease. We conducted a phase 2 study of the PARP inhibitor olaparib in combination with the anti-PD-L1 antibody durvalumab in an HRR-unselected population of men with metastatic castration-resistant prostate cancer (mCRPC).

Standard adjuvant chemotherapy for stage III colon cancer consists of a fluoropyrimidine-plus-oxaliplatin regimen. Whether the addition of atezolizumab (an anti-programmed death ligand 1 agent) to a modified FOLFOX6 regimen (fluorouracil, oxaliplatin, and leucovorin; called mFOLFOX6) would improve outcomes in patients with stage III colon cancer with mismatch repair-deficient (dMMR) status is unclear.

The KRAS p.G12D variant occurs in 5% of patients with non-small-cell lung cancer (NSCLC) and is the most common substitution variant in pancreatic ductal adenocarcinoma, occurring in 40% of patients, but no targeted therapies directed against this variant are currently approved for clinical use. Setidegrasib (ASP3082) is a first-in-class KRAS G12D-targeted protein degrader.

The discovery and therapeutic application of immune checkpoint inhibitors (ICIs) have significantly improved clinical outcomes in cancer treatment. However, the response rate is still low in gastrointestinal (GI) cancers. The gut microbiome's impact on immune modulation is a promising area for overcoming resistance to immunotherapy.

Advances in cancer treatment have led to improved survival rates, but challenges related to health-related quality of life (HRQoL) persist, often exacerbated by sleep disturbances. We present a pre-registered, secondary analysis of HRQoL from a trial of sleep interventions among women with early or advanced breast cancer receiving chemotherapy.

To assess the effectiveness of an electronic antiemetic device (EAD) stimulating the Neiguan acupoint (PC6) in preventing and alleviating chemotherapy-induced nausea and vomiting (CINV) in cancer patients, with a particular focus on delayed-phase CINV. The safety of the device was also assessed.

Chemotherapy and immunotherapy-induced peripheral neuropathy affects up to 68% of cancer patients and may persist long after treatment, substantially impairing daily functioning and quality of life. While exercise therapy has demonstrated benefits in lower-limb polyneuropathy (PNP), evidence for upper-extremity symptoms remains scarce. The VISCIPH B pilot study investigated the effect of two supervised exercise interventions for PNP of the upper extremities using exploratory analyses of symptom response.

This study compared Intraneural Facilitation (INF®) therapy and standard physical therapy (PT) in preventing chemotherapy-induced peripheral neuropathy (CIPN) in women with newly diagnosed breast and gynecologic cancer. Thirty-eight women undergoing platinum and/or taxane-based chemotherapy, without prior peripheral neuropathy, were randomized into INF® therapy (n = 20) and PT (n = 18). Treatments lasted 45 minutes, twice weekly, for 6 weeks. Neuropathy severity was evaluated using the Pain Quality Assessment Scale. Assessments were at baseline, 3 weeks, 6 weeks, and 3 months post-intervention. Acceptability, burden, and satisfaction were evaluated after 6 weeks. Among 38 patients, 12 (32%) experienced CIPN, with mean pain scores remaining mild (≤3) and no pharmacotherapy required until week 6. No adverse events were reported from the interventions. The INF® therapy arm showed significant changes in numbness (F = 6.030, P = .001, partial η2 = 0.262) after week 6, while the PT arm showed significant changes in numbness (Z = -2.39, P = .017), tingling (Z = -2.84, P = .004), cramping (Z = -2.120, P = .034), surface pain (Z = -2.75, P = .006), and deep pain (Z = -1.99, P = .046) between weeks 3 and 6. Nearly 80% of patients completed chemotherapy cycles with an average relative dose intensity of 90.4% (INF® therapy: 87.73% vs PT: 73.44%). Ninety-four percent of patients were satisfied with their care, accepted the treatments, and perceived them as a low burden. The results demonstrated that INF® therapy and PT are feasible options for CIPN, improving treatment adherence, outcomes, and quality of life for women with newly diagnosed breast and gynecological cancers.Trial Registration - The study was pre-registered on ClinicalTrials.gov (NCT03272919). August 8, 2017.

Chemotherapy-induced alopecia (CIA) is known to have a significant psychological and quality of life impact. Although cold caps have been shown to prevent CIA, expense and extension of treatment durations are barriers for routine clinical use. Keratinocyte growth factor (KGF) has been shown to have cytoprotective effects on human hair follicles and reduce alopecia in preclinical models. We hypothesized that KGF-hair serum (KGF-HS) will prevent CIA.

Chemotherapy-induced peripheral neuropathy (CIPN), characterized by loss of sensation and impaired physical function, is a prevalent and debilitating side effect of chemotherapy, affecting 30%-50% of breast cancer survivors (BCS) with effects lasting years after treatment completion. Mindfulness-based interventions are shown to be efficacious in reducing symptoms in neuropathies. This subgroup analysis examined the effect of Mindfulness-Based Stress Reduction on Breast Cancer (MBSR(BC)) compared to Breast Cancer Education Support (BCES) or Usual Care (UC) on CIPN among BCS who received chemotherapy or chemotherapy and radiation.

T-cell immunoglobulin and mucin-domain containing 3 (TIM-3) is an inhibitory receptor linked to decreased antitumor activity of immune cells. S095018 is a human anti-TIM-3 IgG2 antibody that blocks the binding of phosphatidyl serine to TIM-3. Sym021 is a humanized IgG1 antibody that inhibits the binding of programmed cell death protein-1 (PD-1) to its ligands programmed death-ligand 1 (PD-L1) and PD-L2.

PD-1 and PD-L1 inhibitors have been shown to synergise with anti-angiogenic agents in non-small-cell lung cancer (NSCLC). We aimed to compare benmelstobart plus anlotinib with pembrolizumab in patients with previously untreated, driver gene-negative, PD-L1-positive, advanced NSCLC.

Up to 75% of patients experience cancer-related cognitive impairment (CRCI) during treatment. CRCI often co-occurs with mental fatigue. Chemotherapy may cause cognitive impairment and mental fatigue by compromising systemic inflammatory responses, whereas exercise may induce a self-regulating inflammatory response and promote immunocompetence. Exercise-induced immunocompetence may lead to improvements in CRCI and mental fatigue. We examined the effects of exercise on CRCI and mental fatigue, as well as the relationships between exercise and CRCI and between inflammatory responses and CRCI, in patients receiving chemotherapy in a multicenter phase III randomized controlled trial.

This study aimed to report the incidence, common reasons, and associated risk factors for unplanned hospital presentations during chemotherapy treatment.