DICER1 syndrome is a relatively recently identified hereditary tumor predisposition syndrome, strongly associated with pleuropulmonary blastoma (PPB) and other neoplasms, but its actual status in Japan is unclear.

Salivary gland cancer (SGC) is rare and has various histological types. This rarity and heterogeneity have hindered elucidation of the therapeutic contribution of systemic therapy, including immune checkpoint inhibitors, to recurrent or metastatic SGC (RM-SGC). The purpose of this trial was to investigate the efficacy and safety of nivolumab for platinum-refractory RM-SGC.

Germline pathogenic variants (GPVs) in cancer predisposition genes increase cancer risk, but their population-level prevalence in Japan remains unclear.

While nanoliposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) showed higher efficacy than 5-FU/LV in controlled settings, whether the availability of this regimen has truly improved real-world survival outcomes in unresectable pancreatic cancer remains unclear.

Risk-reducing mastectomy (RRM) and risk-reducing salpingo-oophorectomy (RRSO) are preventive options for women with hereditary breast and ovarian cancer (HBOC). The Japanese national medical insurance began covering RRM and RRSO for patients with HBOC in April 2020.

Messenger RNA (mRNA) offers a powerful platform for therapeutic cancer vaccines. Several clinical trials targeting tumor-associated antigens and neoantigens have demonstrated promising immunological and clinical responses. For effective cancer vaccination, technologies for in vivo mRNA delivery and mRNA molecular design are essential. mRNA delivery systems, typically based on synthetic nanoparticles, are designed to protect mRNA from enzymatic degradation, facilitate its delivery to lymphoid organs and antigen-presenting cells, and stimulate innate immune responses to serve as adjuvants. To maximize the potential of these delivery systems, molecular design of the delivered mRNA is also critical. Strategies such as nucleoside modification, self-amplifying RNA, circular RNA, and hybridization-based mRNA engineering are employed to modulate the immunostimulatory properties of mRNA, extend the duration of antigen presentation, and introduce additional functionalities to the delivery systems. While technological advances in these areas have significantly contributed to the recent progress of mRNA cancer vaccines, current formulations, including widely used lipid nanoparticles (iLNPs), still have considerable room for improvement in terms of safety and efficacy. This has prompted vigorous research efforts to redesign iLNPs and explore non-lipid-based approaches. In this context, this review outlines the established foundational technologies and highlights ongoing research in mRNA delivery and engineering, with a focus on their biological and functional aspects.

This multicenter, single-arm, Phase II study aimed to evaluate the efficacy and safety of fluorouracil, levofolinate, and irinotecan (150 mg/m2, standard dose in Japan) (FOLFIRI) plus ramucirumab (RAM) as second-line treatment for metastatic colorectal cancer (mCRC) in Japanese patients.

Immune checkpoint blockades (ICBs), particularly PD-1 pathway blockades, have significantly improved outcomes in advanced renal cell carcinoma (RCC). However, long-term ICB therapy imposes substantial financial and toxicity burdens. Retrospective data suggest that treatment responses plateau around 24 weeks, and some patients maintain disease control even after ICB pause. We initiated a multi-institutional, open-label, randomized controlled trial to confirm the non-inferiority of pausing PD-1 pathway blockade to its continuous administration in patients with advanced clear cell RCC without disease progression. The primary endpoint is overall survival and the secondary endpoint includes time to failure of strategy, progression-free survival, and adverse events. Conducted by the Urologic Oncology Study Group of the Japan Clinical Oncology Group (JCOG), this phase III trial was approved by Certified Review Board in February 2020, with patient enrollment beginning in July 2020. The trial is registered in the Japan Registry for Clinical Trials (JCOG1905; jRCT1031200071).

Immune checkpoint inhibitors (ICI) have recently been developed and launched in Japan, at the same time, soaring national healthcare costs have become one of the major social issues. We investigated the volume of prescriptions and the drug costs of ICIs using National Database (NDB) open data.

Immune checkpoint inhibitors (ICIs), which target immune regulatory molecules such as cytotoxic T-lymphocyte-associated protein 4 and programmed death-ligand 1, are widely used as standard treatments for various cancer types. However, by overcoming T-cell suppression, they can also trigger immune-related adverse events (irAEs) that may necessitate treatment discontinuation. Rechallenging with an ICI after irAE resolution remains a clinical dilemma. This review evaluates current evidence on the efficacy and safety of ICI rechallenge. Systematic reviews and meta-analyses have demonstrated notable efficacy, with pooled objective response rates (ORR) ranging from 21.8% to 43.1% and disease control rates from 62.0% to 71.9%. Efficacy appears higher among patients who initially discontinued treatment due to an irAE than among those who stopped because of disease progression. For instance, a recent phase II study of nivolumab rechallenge in non-small cell lung cancer patients who relapsed after an initial response reported a modest ORR of 8.5%. Nonetheless, this potential benefit must be balanced against the risk of toxicity recurrence. The recurrence rate of the same irAE is ~32%, with risk varying by organ systems. Safety comparisons between initial treatment and rechallenge yield mixed results, with some studies reporting higher and others similar rates of severe events. Although major guidelines recommend permanent discontinuation for severe (Grade ≥ 3) irAEs, emerging evidence-including class-switching strategies and organ-specific prophylaxis-suggests that rechallenge may be feasible in selected patients. A personalized risk-benefit assessment remains essential, considering the type and severity of the initial irAE and the reason for discontinuation.

The aim of this study was to compare survival and the incidence of complications between stereotactic body radiotherapy/proton beam therapy (SBRT/PBT) and sublobar resection for vulnerable elderly patients with clinical stage IA non-small cell lung cancer (NSCLC).

Postoperative delirium (POD) is a common and serious complication, especially among older adults. The economic burden of POD, particularly in patients undergoing highly invasive cancer resection who are at high risk of delirium, remains unclear. We aimed to clarify the economic burden of subsyndromal delirium (SSD) and severe delirium in this population.

Enfortumab vedotin plus pembrolizumab (EVP) has shown promising efficacy in locally advanced or metastatic urothelial carcinoma (la/mUC), but real-world data in Japanese patients are limited. We assessed the safety and early efficacy of EVP, with a focus on cutaneous adverse events (AEs).

Fluorescence cystoscopy (FL) using 5-aminolevulinic acid (ALA) enhances the detection of urothelial carcinoma compared to white-light endoscopy (WL). The location of bladder tumors may affect the diagnostic performance of FL; however, this issue has been underexplored. We analyzed the diagnostic performance of FL compared with that of WL across different bladder regions.

Anthracycline (A) and taxane (T)-based therapies improve breast cancer survival, with guidelines strongly recommending these regimens and dose-dense approaches. However, the real-world maintenance of optimal dose intensity, a critical prognostic factor, remains unclear. We aimed to clarify the current treatment situation regarding relative dose intensity (RDI), with a secondary focus on safety.

Extended waiting periods between cancer diagnosis and treatment initiation may impact patients' quality of life and prognosis. However, few studies have examined the current situation in Japan and the factors influencing these waiting periods.

Pazopanib is used to treat relapsed and refractory sarcomas. Pazopanib's role in pediatric, adolescent, and young adult populations remains unestablished.