Low-dose tamoxifen 5 mg/day (babytam) for 3 years can decrease the incidence of new breast cancer events in women with breast intraepithelial neoplasia by 42% with limited toxicity, which provides a new treatment option for these disorders. However, predictive biomarkers of babytam efficacy are lacking. We studied whether baseline levels of insulin-like growth factor-1 (IGF-I), IGF-binding protein-3 (IGFBP-3), estradiol, and sex hormone-binding globulin (SHBG) and their ratios predict babytam efficacy on breast cancer events in a preplanned secondary analysis.

The addition of targeted therapy (TT) to immune checkpoint inhibitors has been shown to transiently increase immune infiltration in melanoma. This formed the rationale for the IMPemBra trial, which showed a numerical increase in progression-free survival (PFS) in patients treated with short-term/intermittent TT and anti-PD1 compared to anti-PD1 alone. In this report, the final toxicity-analysis, 5-year PFS and exploratory analysis of overall survival (OS) will be reported, together with an analysis of subsequent therapies.

Background: To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex® in Chinese patients with premenopausal breast cancer. Methods: From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex® every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results: A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex®. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex®. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex® group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion: LY01005 is as effective as Zoladex® in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

This study aimed to compare the pharmacokinetic (PK) profiles, safety, and immunogenicity of the proposed A140 with those of cetuximab (Erbitux®) in healthy Chinese male subjects.

This study was to investigate the effects of psychological care with dietary care on the psychological state and quality of life of patients undergoing chemotherapy for advanced gastric cancer (GC).

Adjuvant pembrolizumab prolonged recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with resected stage IIB/IIC melanoma in KEYNOTE-716. Results of a post hoc 4-year analysis are reported, including progression/recurrence-free survival 2 (PRFS2).

To assess the efficacy of glutamine mouthwash versus standard oral hygiene protocol (SOHP) in reducing the overall incidence, duration and severity of oral mucositis in children with acute lymphoblastic leukemia (ALL) receiving High Dose Methotrexate (HDMTX).

UKALL 2011 randomly assigned children and young adults (younger than 25 years) with ALL or lymphoblastic lymphoma. The aims were to reduce induction toxicity (randomization 1 [R1]), CNS relapse risk (randomization 2 [R2]-interim maintenance [R2IM]), and maintenance morbidity (R2pulses).

Metastatic uveal melanoma (mUM) has a poor prognosis, with liver metastases typically presenting a therapeutic challenge. Melphalan/Hepatic Delivery System (Melphalan/HDS) is a drug/medical device combination used for liver-directed treatment of unresectable mUM patients. This study assessed efficacy and safety of Melphalan/HDS versus best alternative care (BAC).

In the phase 3 ponatinib-3001 trial (PhALLCON, NCT03589326), ponatinib demonstrated superior efficacy over imatinib with comparable safety in patients with newly diagnosed Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). This post hoc analysis evaluated the net benefits of ponatinib using a quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) approach.

The current standard treatment for chemotherapy-induced nausea and vomiting (CINV) with standard antiemetics is insufficient. Rikkunshito, a Japanese traditional herbal medicine, has been shown to improve cisplatin-induced anorexia and functional dyspepsia, and our exploratory study found that rikkunshito has an additive beneficial effect on CINV in patients with uterine corpus and cervical cancer receiving cisplatin containing chemotherapy (JORTC KMP-02).

The purpose of digital remote monitoring (DRM) is improving cancer care management. However, its effectiveness largely depends on the role of nurse navigators (NNs) within these systems to process data and lead action.

The potential benefit of adding photodynamic therapy (PDT) to intravitreal aflibercept injection (IAI) in eyes with polypoidal choroidal vasculopathy (PCV) remains unclear.

To evaluate secondary efficacy endpoints and safety for the ENGOT-OV16/NOVA (NCT01847274) trial of niraparib maintenance therapy after extended follow-up and vital-status-data retrieval. Previously reported analyses (data cutoff, October 1, 2020) indicated benefit of niraparib maintenance therapy beyond first progression, but overall survival (OS) analyses were limited by missing data.

In the phase 3 CheckMate 76 K trial, adjuvant nivolumab significantly improved recurrence-free survival and distant metastasis-free survival versus placebo in patients with resected stage IIB/C melanoma. We report patient-reported outcomes from CheckMate 76 K.

Advanced non-small cell lung cancer (NSCLC) with positive PD-L1 expression requires more effective therapeutic options. This study aims to evaluate the efficacy and safety of autologous cytokine-induced killer (CIK) cell therapy combined with the anti-PD-1 antibody toripalimab, with or without chemotherapy, as a first-line treatment for advanced NSCLC. This phase II trial enrolled 40 patients with PD-L1-positive, driver mutation-negative advanced NSCLC between July 2020 and December 2022. Patients were randomly assigned to Arm A (toripalimab + CIK cells + chemotherapy) or Arm B (toripalimab + CIK cells). Progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and safety profiles were evaluated. Subgroup analyses were conducted based on the number of CIK cell cycles received. Arm A showed a significantly longer median PFS compared to Arm B (20.0 vs. 6.0 months, p = 0.0038), while median OS was not reached in Arm A versus 17.0 months in Arm B (p = 0.0479). ORR was 47.4% in Arm A and 60.0% in Arm B. Patients receiving four or more cycles of CIK cells had significantly improved PFS and OS. No new safety concerns were identified. The combination of CIK cells and toripalimab, with or without chemotherapy, demonstrates promising efficacy and safety in patients with advanced PD-L1-positive NSCLC. The addition of chemotherapy may further enhance therapeutic outcomes, making it a potentially superior strategy compared to CIK cells combined with the anti-PD-1 antibody alone.

Oral mucositis is considered as one of the most prevalent complications of chemotherapy or radiation therapy in cancerous tumors, which can interrupt the patient's treatment and nutrition. This study therefore aimed to evaluate the efficacy of ginger-honey mouthwash on the prevention of chemotherapy-induced oral mucositis in patients suffering from various cancers.

Cisplatin-induced hearing loss (CIHL) remains a significant complication of pediatric cancer treatment. We evaluated the feasibility, safety, and trends of the efficacy of intratympanic injections of sustained-exposure dexamethasone thermosensitive gel (OTO-104) for otoprotection.

Prevention of chemotherapy-induced nausea and vomiting with currently recommended NK1 receptor antagonist-based triplet during carboplatin (AUC ≥4) chemotherapy appears inadequate. A comparative study between olanzapine and NK1 receptor antagonist-based combination is lacking.

Unsupervised machine learning (ML) approaches such as clustering have not been commonly applied to patient-reported data. This study describes ML methods to explore and describe patient-reported symptom trajectories in older adults receiving chemotherapy.