Methadone was introduced in 2013 for the treatment of intractable cancer pain in Japan and is indicated for patients receiving opioid doses ≧60 mg/day as an oral morphine equivalent. Low-dose (≦10 mg/day) add-on methadone to prior opioids has been reported from European countries to successfully relieve various types of intractable cancer pain; however, there are few reports of such use in Japan. The aim of this study was to analyze more than a hundred cases with low-dose add-on methadone to treat intractable pain in Japanese cancer patients.

The optimal timing of surgery and the number of courses of perioperative chemotherapy for high-risk soft tissue sarcoma patients are still controversial. Tumour growth during neoadjuvant chemotherapy led to limb amputation in some patients. This study aims to confirm the non-inferiority of surgery and three courses of adjuvant chemotherapy with adriamycin (30 mg/m2, days 1 and 2) plus ifosfamide (2 g/m2, days 1-5) compared with our standard treatment of three courses of neoadjuvant chemotherapy and surgery followed by two courses of adjuvant chemotherapy with adriamycin plus ifosfamide for localized high-risk soft tissue sarcoma patients. This is a multi-center, two-arm, open-label, randomized phase III trial. The primary aim is to confirm the non-inferiority in overall survival (margin: hazard ratio of 1.61). This is the first randomized controlled trial to compare neoadjuvant chemotherapy and immediate surgery for soft tissue sarcoma. This trial was initiated on 16 November 2022 and registered with the Japan Clinical Trials Registry (jRCTs031220446).

Comprehensive genomic profiling (CGP) and specialized support for adolescent and young adult (AYA) cancer patients are crucial yet underexplored areas of healthcare in Japan. This study investigated awareness of CGP testing and support for AYA cancer patients among healthcare professionals in Osaka.

Surgical resection followed by adjuvant chemotherapy is currently the first choice for the treatment of clinical N1 (cN1) non-small cell lung cancer (NSCLC). However, diagnosing cN1 correctly can be difficult, even with current imaging diagnostic technologies. We aimed to analyze the diagnostic accuracy of preoperative nodal status and the predictive factors for nodal upstaging of cN1-NSCLC.

Consultation with palliative care specialists can be beneficial in addressing the numerous demands of patients with cancers and their families within communities. In settings lacking palliative care specialists, establishing a new community-based palliative care consultation system necessitates gathering evidence to support its development. This study aimed to identify the specific palliative care consultation needs and the consultation methods requested by Japanese physicians in settings without palliative care specialists.

The treatment options for differentiated thyroid cancer (DTC) are surgery, thyroid stimulating hormone suppression, radioactive iodine, and multitargeted tyrosine kinase inhibitors. The role of external-beam radiotherapy (EBRT) for DTC is controversial because of the lack of randomized controlled trials, but prospective single-arm studies and propensity score matching analyses have shown its efficacy and safety. This review discusses the role of EBRT after resection of gross disease, when there is a high risk of locoregional failure, as well as its role for locoregionally gross recurrent and unresectable disease. As in other tumor sites, EBRT has an important role in the palliative management and local control of patients with metastatic DTC, especially with bone and brain metastases.

Bladder preservation therapy for muscle-invasive bladder cancer is reported to yield outcomes comparable to those of radical cystectomy, although it receives a relatively low recommendation grade in Japanese guidelines. This study aims to compare the outcomes of trimodal therapy versus radical cystectomy in the treatment of muscle-invasive bladder cancer.

Survival prediction for patients with leptomeningeal metastasis (LM) is crucial for making proper management plans and counseling patients. Prognostic models in this patient domain have been limited, and existing models often include predictors that are not available in resource-limited settings. Our aim was to develop a practical, individualized survival prediction model for patients diagnosed with LM.

Patients with peripheral T-cell lymphoma demonstrated a poor prognosis after obtaining a complete response with induction treatment compared to those with B-cell lymphoma. Once it relapsed, curative treatment is frequently limited to invasive treatments with significant treatment-related mortality, including allogeneic stem cell transplantation. The limitations of these treatment choices indicate the necessity for developing optimal consolidation therapies to prevent relapse. This multicenter randomized phase III trial aims to confirm the superiority of the high-dose therapy with autologous stem cell transplantation over observation alone in terms of progression-free survival for patients with newly diagnosed peripheral T-cell lymphoma who achieved complete metabolic response after induction therapy. A total of 140 patients from 52 hospitals will be enrolled in Japan over 5.5 years. This trial is registered in the Japan Registry of Clinical Trials as jRCTs031240169 (https://jrct.niph.go.jp/latest-detail/jRCTs031240169).

We determined the optimal timing for initiating androgen receptor signaling inhibitor (ARSI) therapy in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) and assessed its impact on oncological outcomes.

Bone metastases are often associated with pain and can occur in various types of cancer, significantly affecting patients' quality of life. Despite the high response rates to initial conventional radiotherapy in patients with painful spinal metastases, recurrence and inadequate response still occur. Thus, the development of a highly effective strategy for pain recurrence is crucial to improving the quality of life in patients with advanced metastatic cancer. This randomized phase III trial aims to confirm the superiority of re-irradiation with stereotactic body radiotherapy (24 Gy in 2 fractions) over conventional radiotherapy (8 Gy in a single fraction) in achieving a complete pain response at 12 weeks in patients with previously irradiated painful spinal metastases. A total of 158 patients from 33 hospitals will be enrolled in Japan over 3.5 years. This trial has been registered in the Japan Registry of Clinical Trials as jRCTs1030240172 (https://jrct.niph.go.jp/latest-detail/jRCT1030240172).

In patients with non-small cell lung cancer (NSCLC) who present with radiologically undetermined malignant pleural dissemination or incidental surgical diagnosis of the same, surgery is generally not the preferred option; systemic therapy is favoured. However, there is no consensus on incorporating primary site resection into the treatment plan. Retrospective analyses hint at potential benefits of combining systemic therapy with primary site resection, but prospective studies have yet to confirm these findings. Consequently, we have planned a multicentre, open-label, randomized controlled phase III trial to assess the efficacy of adding primary site resection to standard systemic therapy for stage IVA (cT1-2bN0-1M1a) NSCLC patients with radiologically undetermined pleural dissemination. The primary endpoint is overall survival. We aim to enroll 170 patients from 71 institutions over 5 years. This trial is registered at the Japan Registry of Clinical Trials (jRCT) under study number jRCTs031220666.

The aim of this study was to compare prognostic outcomes of administering first- or second-generation androgen receptor signaling inhibitors in non-metastatic castration-resistant prostate cancer and to find prognostic indicators.

Malignant primary cardiac tumors require multimodal approaches including surgery, chemotherapy and radiotherapy, but these treatments can be associated with cardiovascular complications. However, few reports have described the cardiovascular complications related to primary cardiac tumor treatment because of their rarity.

Trastuzumab emtansine (T-DM1) is a novel therapy for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer, combining the targeted action of trastuzumab with the cytotoxic effects of emtansine. Although T-DM1 has demonstrated greater efficacy and safety compared to traditional therapies, concerns about hepatotoxicity and spleen-related complications have arisen.

Single-center studies or randomized controlled trials have evaluated the impact of radiotherapy for bone metastases on quality of life (QOL). We investigated the real-world impact of radiotherapy for bone metastases on QOL using nationwide multicenter cohort data.