Peripheral neuropathy is a major adverse effect of Vincristine (VCR) in pediatric acute lymphoblastic leukemia (ALL) patients. Curcumin can prevent the development of many neurological diseases.

The aim of this study was to assess differences between Chinese and White patients in pharmacokinetics (PK) of, and clinical response to, acalabrutinib and its pharmacologically active major metabolite, ACP-5862, to support recommended dosing in Chinese patients with B-cell malignancies.

With the rising survival rate among children and adolescents with acute lymphoblastic leukemia (ALL), prioritizing patient-centered care to address the long-term effects of chemotherapy through tailored rehabilitation interventions is essential for optimizing their quality of life. The purpose of this study was to investigate the impact of an 8-week intervention using adaptive variable-resistance training (Adaptive-VRT) on chemotherapy-induced sarcopenia, fatigue, and functional restrictions in pediatric survivors of ALL.

The phase 2 trial KEYNOTE-158 ( NCT02628067 ) evaluated pembrolizumab in microsatellite-instability-high and mismatch-repair-deficient (MSI-H/dMMR) noncolorectal tumors. With 373 participants (95% with baseline MSI/dMMR documentation) and 4.5 years of follow-up, the primary endpoint of overall response rate was 33.8%. Secondary endpoints of duration of response, overall survival and progression-free survival were 63.2, 19.8 and 4.0 months, respectively. Grade ≥3 treatment-related adverse events occurred in 50 (13%) participants. These results further support pembrolizumab use in MSI-H/dMMR tumors.

Even with antiemetic prophylaxis, patients undergoing cancer chemotherapy often still experience chemotherapy-induced nausea and vomiting (CINV). Neurokinin-1 (NK-1) receptor antagonists will prevent CINV effectively but are not affordable for patients of low socioeconomic status.

Fruquintinib is a selective, oral tyrosine kinase inhibitor of all three vascular endothelial growth factor receptors 1, 2, and 3, which is approved for patients with previously treated metastatic colorectal cancer regardless of biomarker status. This population pharmacokinetic (PK) analysis characterized sources of interpatient variability on the PK of fruquintinib and its major metabolite M11 using data from 557 subjects who received fruquintinib in five phase I/Ib studies and the FRESCO-2 phase III study. The integrated model was a one-compartment model with first-order absorption, lag time in absorption, and linear elimination for fruquintinib and a one-compartment model with linear elimination for M11. The half-life of fruquintinib and M11 were estimated to be 43.2 and 54 h, respectively. Fruquintinib PK demonstrated dose proportionality. Fruquintinib oral clearance and apparent volume of distribution (V/F) increased with increasing body weight. Fruquintinib absorption rate constant was 60.7% lower with concurrent use of proton-pump inhibitors (PPIs), and fruquintinib V/F was 9.08% lower in healthy subjects versus patients with cancer. Magnitudes of the covariate effects of body weight, concurrent use of PPIs, and health status on fruquintinib exposures were estimated to be <20%, which is not considered clinically meaningful. Age (18.0-82.0 years), sex, race (Asian, Black, and White), ethnicity (Hispanic vs non-Hispanic), Eastern Cooperative Oncology Group performance status score, tumor type, mild or moderate renal impairment, and mild hepatic impairment had no clinically meaningful impact on fruquintinib or M11 PK. This analysis supports the same fruquintinib starting dosage, without need for adjustments, for these patient-specific factors.

Hand-foot syndrome (HFS) is a common adverse event of capecitabine causing treatment modifications. Topical urea cream can reduce sorafenib-induced hand-foot skin reaction. However, its benefit in preventing capecitabine-associated HFS was not seen early in the course and had been unknown with long-term use. The aim of this study was to evaluate the efficacy of urea cream for HFS prophylaxis throughout capecitabine treatment.

Data on exposure-response or exposure-toxicity relationships of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) are limited and inconclusive. We aimed to investigate whether there is an association between palbociclib exposure and progression-free survival (PFS), adverse events (AEs) and dose reductions.

PARP inhibitors may work synergistically to improve the efficacy of immunotherapy in patients with epithelial ovarian cancer (EOC). We performed a parallel-arm study of tremelimumab, alone or with olaparib, in patients with recurrent EOC.

Tamoxifen, a common treatment for estrogen receptor (ER)‑positive breast cancer, is associated with an increased risk of developing nonalcoholic fatty liver disease (NAFLD). Curcumin, a compound in turmeric, has shown potential in mitigating liver disease progression. This study aims to evaluate the efficacy and safety of curcumin in preventing NAFLD in breast cancer patients initiating tamoxifen therapy.In this 6‑month triple‑blind, randomized placebo‑controlled trial, 44 ER+ breast cancer patients scheduled to receive tamoxifen were assigned to receive either curcumin (500 mg daily) or a placebo. NAFLD grade was assessed via ultrasound at baseline and after 6 months. Laboratory values and demographic data were collected, and adverse effects were monitored. Statistical analyses was performed using SPSS version 16.Data of a total of 44 participants (22 participants in each group, mean age: 47.1 ± 6.0 years) were analyses. There were no significant differences between the placebo and curcumin groups regarding the demographic and baseline laboratory values. At study completion, significantly fewer patients in the curcumin group showed an increased NAFLD grade compared to the placebo group (13.6% vs. 54.5%; p = 0.03). Additionally, the prevalence of NAFLD grade ≥ 2 was lower in the curcumin group (13.6% vs. 40.9%; p = 0.04). No adverse effects related to curcumin were reported. Curcumin supplementation demonstrated a protective effect against tamoxifen‑induced NAFLD in ER+ breast cancer patients, suggesting its potential as a prophylactic adjunct to tamoxifen therapy. Larger multi‑centric trials are warranted to confirm these findings.

Immune checkpoint inhibitors (ICIs) are widely used cancer drugs. We developed "UPLIFT," a video and question prompt list (QPL) intervention to educate patients about ICI risks and benefits.

To evaluate the safety and efficacy of aromatherapy on symptom burden and associated outcomes.

We conducted a multicenter, open-label, randomized phase 2 study to assess the efficacy of nivolumab (Nivo) as maintenance therapy for patients with acute myeloid leukemia (AML) in first complete remission (CR) or CR with incomplete hematologic recovery who were not candidates for stem cell transplant. Patients were stratified and randomized to observation (Obs) or Nivo (3 mg/kg IV every 2 weeks for 46 doses). The primary end point was progression-free survival (PFS) defined as time to disease relapse or death due to any reason. Secondary end points included overall survival (OS), and evaluation of adverse events (AEs) after Nivo administration. Eighty patients were enrolled with median duration of follow-up of 24 months (33 months among survivors). PFS was 13.2 months in the Nivo arm and 10.9 months in the Obs arm. Overall PFS curves were not statistically significantly different. The median OS was 53.9 months in the Nivo arm and 30.9 months in the Obs arm. There were more AEs of any type (regardless of attribution) on the Nivo arm; 27 patients (71%) on the Nivo arm had a grade ≥3 AE compared with 5 patients (12%) on the Obs arm (P < .001). Nivo maintenance after AML chemotherapy failed to improve the PFS and OS in this randomized phase 2 study. There were increased AEs and serious AEs (SAEs) with Nivo, but these AEs and SAEs were expected and manageable. This trial was registered at www.ClinicalTrials.gov as #NCT02275533.

The addition of immune checkpoint inhibitors to standard-of-care chemoradiation (CRT) is established as the new standard of care in high-risk, locally advanced cervical cancer. However, the optimal sequencing of therapies is unknown. Defining safety and feasibility of the combination was a primary objective of this study examining concurrent versus sequential schedules.

This study aimed to compare the efficacy and safety of rezivertinib (BPI-7711) and gefitinib as first-line therapies in patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC).

In the ARIEL4 trial of rucaparib versus standard-of-care chemotherapy in patients with relapsed BRCA-mutated ovarian carcinoma, the primary endpoint was met, showing improved investigator-assessed progression-free survival with rucaparib. Here, we present the final overall survival analysis of the trial and other post-progression outcomes.

Given the suffering experienced by cancer patients, effective solutions must be found to prevent painful and debilitating side effects of anti-cancer treatment. This trial aims to study the effect of preconditioning with photobiomodulation in preventing oral mucositis and xerostomia in cancer patients undergoing chemotherapy alone for the first time, and to examine its role in improving patients' quality of life.

IMscin001 is a two-part dose-finding (Phase Ib) and -confirmation (Phase III) study to evaluate atezolizumab pharmacokinetics of subcutaneous (SC) compared with intravenous (IV) administration in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The objectives of the current analyses were to characterize the population pharmacokinetics (popPK) of atezolizumab and to determine the relationship between atezolizumab exposure and safety and efficacy endpoints in IMscin001. A previously validated IV popPK model was extended to add SC absorption parameters using SC and IV data from Phase Ib and Phase III of IMscin001 (N = 435), and covariate effects were investigated on the SC absorption parameters. The exposure-response (ER) investigation was performed using SC data following 1875 mg every three weeks (q3w) administration in the Phase III portion of IMscin001 (N = 246). The clinical endpoints were objective response rate, progression-free survival, or overall survival for efficacy, serious adverse events, special interest adverse events, Grades 3-5 adverse events, infusion-related reaction, or injection site reactions for safety. Atezolizumab SC absorption was characterized by a first-order absorption with a bioavailability of 71.8% and an absorption rate constant of 0.304 day-1. The extended popPK model was adequate to predict atezolizumab PK after IV and SC administrations and to predict individual exposure metrics. For all efficacy and safety endpoints, atezolizumab exposure was not statistically significant (p-value > 0.05) in the ER models. The non-inferior popPK exposure and flat ER results supported atezolizumab SC dose at 1875 mg q3w.

Mogamulizumab demonstrated improved outcomes vs. vorinostat across a range of disease and patient characteristics in patients with mycosis fungoides or Sézary syndrome in the MAVORIC trial.

Inotuzumab ozogamicin (InO) is approved for treatment of relapsed/refractory acute lymphoblastic leukemia (R/R ALL). Previous studies reported higher rates of post-hematopoietic stem cell transplant (HSCT) hepatic sinusoidal obstruction syndrome (SOS) in patients receiving InO than in those receiving chemotherapy prior to HSCT. It is unknown whether a lower InO dose would reduce the risk of post-HSCT SOS or affect efficacy. This study evaluated efficacy and safety of the currently approved InO starting dose and a lower dose in adults with R/R ALL who were eligible for HSCT and were identified as being at higher risk of post-HSCT SOS. This open-label, phase IV study (NCT03677596) had two phases: in the run-in phase patients received InO at 1.2 mg/m2/cycle (N=22); in the randomized phase patients received InO starting at dose levels of 1.8 mg/m2/cycle (N=38) or 1.2 mg/m2/cycle (N=42). Primary endpoints were rate of SOS and rate of hematologic remission. Overall, SOS was reported in ten patients (9.8%) and in all cases was post-HSCT SOS. In patients who proceeded to HSCT, post-HSCT SOS rates were 20%, 28.6%, 25.8%, and 16.7% in 1.2 mg/m2/cycle (run-in), 1.2 mg/m2/cycle (randomized), 1.2 mg/m2/cycle (run-in and randomized), and 1.8 mg/m2/cycle (randomized) InO dosing subgroups, respectively. The rates of complete remission with or without complete hematologic recovery were 50.0%, 83.3%, 71.9%, and 68.4% in the respective subgroups. The study found that a starting dose of the 1.2 mg/m2/cycle demonstrated efficacy and safety consistent with those of the recommended 1.8 mg/m2/ cycle dose in adults with R/R ALL who were eligible for HSCT and had a higher risk of post-HSCT SOS.