One of the most severe endocrine side effects of immune checkpoint inhibitors (ICI) is hypophysitis leading to adrenal insufficiency. Recovery is rare, although it has been reported after high-dose glucocorticoid treatment. This is the first randomised study to evaluate whether hormonal recovery differs in patients treated with high-dose glucocorticoids versus glucocorticoid replacement therapy.

Dysgeusia contributes to malnutrition and worsens the quality of life of patients with cancer. Despite the different strategies, there is no effective treatment for patients suffering from taste disorders provided by the pharmaceutical industry. Therefore, we developed a novel strategy for reducing side effects in cancer patients by providing a novel food supplement with the taste-modifying glycoprotein miraculin, which is approved by the European Union, as an adjuvant to medical-nutritional therapy.

The first-in-human, Phase 1 Study 101 showed antitumor activity and a tolerable safety profile of farletuzumab ecteribulin in Japanese patients with platinum-resistant ovarian and non-small cell lung cancer. A pharmacometric assessment evaluated farletuzumab ecteribulin pharmacokinetics and exposure-response (E-R) relationships for efficacy and safety to support dose optimization. Patients received 0.3-1.2 mg/kg of farletuzumab ecteribulin intravenously every 3 weeks. A pharmacokinetics (PK) model was developed and used for E-R analyses. Efficacy was assessed via tumor response and safety via known treatment-emergent adverse events (TEAEs) of farletuzumab ecteribulin, particularly pneumonitis/interstitial lung disease (ILD). Dosing scenarios were simulated to identify dosing that maximizes the probability of an objective response while minimizing the risk of ILD. The farletuzumab ecteribulin PK dataset included 1261 observations from 82 patients. The final model included an estimated population mean value for farletuzumab ecteribulin clearance of 0.0162 L/h. Body surface area (BSA) was a significant PK covariate and was included in the model. Body weight (BW) was associated with higher farletuzumab ecteribulin exposure. Using BW-based dosing, farletuzumab ecteribulin AUC (area under the serum concentration-time curve) was higher in patients with tumor response or stable disease versus patients with progressive disease and higher in patients with ILD and other TEAEs. Dosing simulations showed that BSA-based dosing (33 mg/m2) yielded similar tumor responses to BW-based dosing (0.9 mg/kg) and decreased ILD rates. This study showed that BW-based dosing resulted in higher risks of ILD events for patients with a high BW versus low BW, whereas BSA-based dosing is predicted to reduce this risk while maintaining clinical efficacy.

We report updated results with longer follow-up in patients with MSI-H/dMMR endometrial cancer (EC) in cohort D (advanced EC of any MSI/dMMR status) and cohort K (any MSI-H/dMMR advanced solid tumor, except colorectal) of the phase 2 KEYNOTE-158 study (NCT02628067) and the first results from patients with non-MSI-H/non-dMMR advanced EC (cohort D).

Leukemia is a prevalent cancer that severely affects children, and standard chemotherapy often leads to severe gastrointestinal symptoms and neutropenia. This study aimed to discover alternative treatments to prevent neutropenia in pediatric leukemia patients and minimize chemotherapy-related complications. This randomized, placebo-controlled trial was conducted on 52 children between the ages of 3 and 18 years who were suffering from acute leukemia and undergoing chemotherapy. The study included a case and control group. A traditional wheat bran product called "Wheat Saviq" was given to the case group with Jollab syrup, while refined wheat flour and a placebo were given to the control group. For 1 month, both groups received a daily dose. Symptoms, weight, and blood cell count were measured before and after the trial. After the intervention, the pain, constipation, and bloating scores in the intervention group were lower than in the control group. Furthermore, the intervention group significantly increased white blood cells (WBC) and red blood cells (RBC). These findings suggest that incorporating wheat bran into the diet of pediatric leukemia patients has great potential in alleviating gastrointestinal symptoms and enhancing immune function. This randomized trial showed that consuming Wheat "Saviq" and Jollab syrup effectively reduced gastrointestinal symptoms and improved certain laboratory findings in children with leukemia undergoing chemotherapy. Furthermore, the results align with traditional Persian medicine (TPM) texts and further support the potential benefits of wheat bran for digestion and immune system health. IRCT registration number: IRCT20220410054474N1. Registration date: 2022-05-24, 1401/03/03.

Intravesical instillation of chemotherapy (IIC) after radical surgery for upper urinary tract urothelial carcinoma (UTUC) reduces the risk of intravesical recurrence (IVR). However, compliance is low because of possible extravesical leakage after bladder cuff excision. The aim of this study was to evaluate the efficacy of preoperative IIC in reducing the risk of IVR.

To investigate the effects of compression therapy combined with exercise for cancer patients (EXCAP) in patients with peripheral neuropathy caused by breast cancer chemotherapy.

Radiotherapy (RT)/cetuximab (C) demonstrated superiority over RT alone for locally advanced squamous head and neck cancer. We tested this in completely resected, intermediate-risk cancer.

The primary objectives of this trial were aimed at exploring the pharmacokinetic profiles and the human bioequivalence of an intravenous liposomal injection of doxorubicin hydrochloride in comparison with a reference formulation in Chinese patients diagnosed with metastatic breast cancer.

Lasofoxifene, a novel endocrine therapy (ET), showed antitumor activity versus fulvestrant in women with ESR1-mutated, metastatic breast cancer (mBC) that progressed on prior ET (phase 2, ELAINE 1 study). We investigated changes in genitourinary syndrome of menopause (GSM) vulvar-vaginal symptoms with lasofoxifene and how patient/disease characteristics affect baseline vulvar-vaginal symptoms in ELAINE 1.

It remains unclear whether adding CTLA-4 blockade to PD-1/PD-L1 blockade improves clinical outcomes in cervical cancer (CC).

For patients with high-risk non-muscle-invasive bladder cancer (NMIBC) for whom bacillus Calmette-Guérin (BCG) treatment has failed, bladder preservation is a high priority. Immune checkpoint inhibitors have shown promise, but systemic administration is associated with substantial toxicity. In this single-arm phase 2 study, 30 patients with NMIBC after BCG failure were treated with intravesical durvalumab every 6 wk. The maximum tolerated dose in the run-in phase was 1000 mg. In phase 2, the high-grade relapse (HGR)-free rate at 1 yr after completing therapy was 39% (95% confidence interval [CI] 18-59%). HGR-free rates at 1, 3, and 6 mo after completing study treatment were 70% (95% CI 45-85%), 55% (95% CI 31-74%), and 39% (95% CI 18-59%), respectively. At 13 mo after completing enrolment, four patients in phase 2 had experienced progression to stage ≥T2; the 1-yr bladder-intact survival rate was 78% (95% CI 57-89%). The only treatment-related adverse event was grade 1 haematuria in five patients (17%). In conclusion, intravesical durvalumab 1000 mg every 6 wk is feasible after BCG failure in patients with high-risk NMIBC, with negligible toxicity and encouraging efficacy. Intravesical durvalumab may be more attractive than systemic administration of immune checkpoint inhibitors and warrants further investigation as a treatment for NMIBC. This trial is registered on ClinicalTrials.gov as NCT03759496.

Vascular endothelial growth factor (VEGF) is overexpressed in nasopharyngeal carcinoma and suppresses the anti-tumour immune response. Previous studies have shown that adding anti-VEGF treatment to PD-1 inhibition treatment strategies improves tumour response. We aimed to compare the efficacy of pembrolizumab, a PD-1 inhibitor, with or without bevacizumab, a VEGF inhibitor, in nasopharyngeal carcinoma.

Ribociclib + endocrine therapy (ET) showed significant progression-free survival (PFS) and overall survival (OS) benefits in the MONALEESA trials in patients with HR+ /HER2 - advanced breast cancer (ABC). We report efficacy, safety, and patient-reported outcomes (PROs) across age groups, including older patients, in these trials.

Numerous studies have demonstrated limited survival benefits of transarterial chemoembolization (TACE) alone in the treatment of intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria. The advent of immunotherapy, particularly immune checkpoint inhibitors (ICIs), has opened new avenues for HCC treatment. However, TACE combined with ICIs has not been investigated for patients with intermediate-stage HCC beyond the up-to-seven criteria. The study aims to evaluate the efficacy and safety of this treatment strategy for such patients.

The use of short hydration (SH) to prevent cisplatin-induced nephrotoxicity lacks substantive prospective evaluation. The aim of this study was to evaluate the safety and efficacy of SH, including those with head and neck cancer (HNC) who are at higher risks of mucositis that causes diminished oral intake.

To evaluate the efficacy, durability and safety of intravitreal faricimab versus aflibercept over 48 weeks in patients with neovascular age-related macular degeneration (nAMD) from the LUCERNE China subpopulation.

LIGHT (oLaparib In HRD-Grouped Tumor types; NCT02983799) prospectively evaluated olaparib treatment in patients with platinum-sensitive relapsed ovarian cancer (PSROC) assigned to cohorts by known BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: germline BRCAm (gBRCAm), somatic BRCAm (sBRCAm), HRD-positive non-BRCAm, and HRD-negative. At the primary analysis, olaparib treatment demonstrated activity across all cohorts, with greatest efficacy in terms of objective response rate and progression-free survival observed in the g/sBRCAm cohorts. The authors report final overall survival (OS).

Dordaviprone (ONC201) is a novel, small molecule imipridone with antitumor effects in glioma patients. This study evaluated the pharmacokinetics and safety of dordaviprone following single escalating doses (Part A), as a capsule content mixed with applesauce or Gatorade (sports drink) [Part B1]), and with or without food [Part B2]. The most common treatment-emergent adverse events pooled across study parts (Parts A, B1, and B2) were headache, dizziness, and headache, respectively; all were mild. Systemic dordaviprone exposure increased dose proportionally following administration of 125-625 mg of dordaviprone. Following dordaviprone capsule contents sprinkled on applesauce or dissolved in sports drink, the geometric mean ratios, and 90% confidence intervals (CIs) of the dordaviprone area under the concentration versus time curve (AUC) fell within the bioequivalence (BE) limits of 80.00%-125.00%; however, for Cmax the 90% CI lower limit (0.70) fell below BE limits when sprinkled on applesauce. The geometric mean ratios and 90% CIs of dordaviprone administered under fed versus fasted conditions fell within BE limits of 80.00%-125.00% for the AUC, indicating no food effect on total exposure; however, maximum concentration (Cmax) (90% CI 0.55, 0.67) fell below BE limits.

Patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer with residual invasive disease after neoadjuvant systemic therapy have a high risk of recurrence and death. The primary analysis of KATHERINE, a phase 3, open-label trial, showed that the risk of invasive breast cancer or death was 50% lower with adjuvant trastuzumab emtansine (T-DM1) than with trastuzumab alone.