International Journal of Clinical Oncology最新文献

Background: No clinical trials demonstrated anti-HER2 plus chemotherapy (anti-HER2 + ChT) was superior to anti-HER2 plus endocrine therapy (anti-HER2 + ET) in HR + /HER2 + MBC. This study aims to compare efficacy of anti-HER2 + ET with anti-HER2 + ChT in real-world clinical practice, and analyze clinical outcome of anti-HER2 + ET as maintenance therapy after benefiting from anti-HER2 + ChT.

Methods: This study retrospectively compared two regimens: anti-HER2 + ChT vs anti-HER2 + ET, utilizing chi-square tests for response rate comparisons and Kaplan-Meier approach for survival analysis.

Results: Totally, 241 eligible patients were included in this study. In first-line setting, 197 patients (81.7%) received anti-HER2 + ChT and 44 (18.3%) received anti-HER2 + ET. Objective response rate (54.3% vs 11.4%, P < 0.001) and clinical benefit rate (82.7% vs 68.2%, P = 0.029) of anti-HER2 + ChT group were higher than those of anti-HER2 + ET. PFS analysis showed there was no significant difference between anti-HER2 + ChT and anti-HER2 + ET in first-line (mPFS, 15.0 m [95%CI 12.1-17.9] vs 9.0 m [95%CI 0.5-17.5]; HR 1.32 [0.88-1.98]; P = 0.162) and the front two lines of treatment (PFS-2, 26.0 m [95%CI 23.0-29.0] vs 24.0 m [95%CI 15.9-32.1]; HR 1.03 [0.64-1.64]; P = 0.919). Notably, PFS of patients with anti-HER2 + ChT maintained by anti-HER2 + ET was superior to anti-HER2 + ET (24.0 m [95%CI 18.0-30.0] vs 17.0 m [95%CI 9.5-24.5]; HR 0.53 [0.32-0.89]; P = 0.005) and other anti-HER2 + ChT group (24.0 m vs 12.0 m [95%CI 9.1-15.0]; HR 0.52 [0.36-0.76]; P < 0.001).

Conclusion: While anti-HER2 + ChT showed superior disease control over anti-HER2 + ET, it didn't confer a survival advantage, possibly due to small sample size or retrospective design constraints. For patients deriving benefit from anti-HER2 + ChT, transitioning to maintenance therapy with anti-HER2 + ET may represent an optional strategy.

Background: Adult granulosa cell tumors (AGCTs) are rare low-grade malignant ovarian tumors, with 80-90% diagnosed at FIGO stage I. This study aimed to identify prognostic factors and refine management for stage I AGCT.

Methods: In this 30-year retrospective cohort study, patients with stage I AGCT between January 1988 and January 2024 were selected and reviewed in total cohort and subgroups according to tumor stage.

Results: This retrospective study analyzed 333 eligible AGCT cases, including 196 patients (58.9%) with FIGO stage IA and 137 (41.1%) with stage IC. After a median follow-up of 138.5 ± 108.0 months, recurrence occurred in 55 patients (40.1%) in the IC group, significantly higher than that in the IA group (38 patients, 19.4%; P < 0.001, FDR = 0.005). Approximately half of recurrences in both groups were intra-abdominal, with comparable median recurrence intervals. Multivariate logistic regression identified stage IC (P = 0.001), incomplete staging surgery (P = 0.015) and adjuvant chemotherapy (P = 0.002) independent predictors of increased recurrence. In the propensity-matched cohort (n = 188), adjuvant chemotherapy showed no significant association with recurrence (P = 0.067). Cox multivariate analysis revealed stage IC and incomplete staging surgery as independent prognostic factors for worse DFS in early-stage disease (P = 0.001 and 0.012, respectively). Notably, complete staging surgery was associated with improved DFS specifically in stage IC patients (P = 0.016).

Conclusions: Unilateral salpingo-oophorectomy instead of simple cystectomy demonstrated a favorable safety profile in reproductive patients with stage I AGCT. Comprehensive surgical staging without lymphadenectomy should be considered as a viable treatment strategy, especially in the stage IC disease, manifesting a significantly higher recurrence rate and shorter DFS compared to stage IA counterparts.

Background: The safety and efficacy of neoadjuvant FLOT (Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel) and DOS (Docetaxel, Oxaliplatin, S-1) regimens for locally advanced gastric cancer (LAGC) have not been compared.

Methods: Patients with histologically confirmed LAGC (stage ≥ cT3 or cN + , no metastasis) treated between 2017-2021 were retrospectively included and propensity-matched into FLOT (4 cycles, n = 72) and DOS (3 cycles, n = 72) groups. Outcomes included RECIST response, grade 3/4 adverse events, surgical/pathological results, and R0 resection rates, and long-term survival (overall survival [OS] and progression-free survival [PFS]).

Results: RECIST response rates were 41.7% (FLOT) vs. 47.2% (DOS); R0 resection rates were 63.9% vs. 72.2%. No significant differences were observed in operative time, blood loss, hospital stay, histopathological regression (TRG1a: 2.8% vs. 8.3%; TRG1b: 13.9% vs. 16.7%), postoperative morbidity (29.8% vs. 24.5%), or grade 3/4 toxicity (20.8% vs. 13.9%). The 5-year OS rates were 42.7% and 50.4% (p = 0.652), and the PFS rates were 33.7% and 41.4% (p = 0.548) for the FLOT and DOS groups, respectively.

Conclusion: DOS demonstrated no significant but favorable feasibility, safety, and efficacy compared to FLOT in LAGC. Shorter hospital stay with DOS may enhance patient comfort and reduce healthcare burden.

Background: Discussions on do-not-attempt-resuscitation (DNAR) orders are considered critical end-of-life discussions with patients with advanced cancer; however, patients are not necessarily involved in these discussions. Therefore, we aimed to clarify oncologists' practice, perceptions, values, and attitudes regarding DNAR orders and to identify factors associated with oncologists' attitudes toward confirming patients' preference for DNAR orders.

Methods: Oncologists in designated cancer hospitals in Japan were surveyed using a self-administered questionnaire. Multivariate analyses were performed to identify attributes to attitudes toward confirmation of patients' preferences.

Results: Among 688 participating oncologists, 477 (69%) indicated that they would confirm patients' preferences when issuing a DNAR order if they were competent. Independent variables for positive attitudes toward confirming patients' preferences before issuing DNAR orders included "Talking about DNAR is severely distressing for family" (Odds ratio (OR) = 2.459, p < 0.001) and "It is burdensome to prepare for discussions regarding DNAR orders" (OR = 1.450, p = 0.002) and the value "Non-maleficence" (OR = 1.384, p = 0.012). On the other hand, independent variables for negative attitudes included "Patients do not need to know about DNAR if their family members know about it" (OR = 0.329, p < 0.001) and "Talking about DNAR orders is severely distressing for patients" (OR = 0.443, p ≤ 0.001) and the values "Preference of family" (OR = 0.687, p = 0.012), "Lack of training and education on discussing DNAR orders," (OR = 0.731, p = 0.006), and "It is hard to talk about death" (OR = 0.758, p = 0.026).

Conclusion: Oncologists' discomfort talking about death and their perceived distress for patients and their families were associated with their attitudes towards discussions about DNAR orders.

Background: Chemotherapy-induced hiccups are one of the frequently appearing adverse events. Previous reports have suggested that cisplatin (CDDP) combined with dexamethasone and neurokinin 1 (NK1) receptor antagonists is particularly associated with these symptoms. Consequently, we aimed to identify additional factors involved in the development of problematic hiccups during the real-world treatment.

Methods: Patients with thoracic cancer first receiving CDDP-containing treatment (≥ 75 mg/m²) with dexamethasone, palonosetron, and aprepitant were retrospectively assessed (n = 286). The primary endpoint was the evaluation of risk factors for grade ≥ 2 hiccups during the first cycle. Secondary endpoints were the evaluation of factors for all-grade symptoms and the efficacy of rescue medication.

Results: The incidence of grade ≥ 2 hiccups was 32.9%, with all-grade symptoms of 44.8%. Grade 3 severe hiccups were observed in 5.2% of the patients. Most patients (96.8%) received metoclopramide as first-line treatment, and the efficacy of the first medication was confirmed in 59.6% of patients. Multivariate logistic regression analyses identified male sex, baseline hypoalbuminemia, and concomitant bevacizumab as significant risk factors for grade ≥ 2 problematic hiccups (adjusted odds ratio with 95% confidence interval 10.32 [4.38-24.32], P < 0.0001 for males; 2.41 [1.06-5.50], P = 0.04 for hypoalbuminemia; and 3.42 [1.25-9.36], P = 0.02 for concomitant bevacizumab). Moreover, male sex was identified as a singular risk factor for all-grade symptoms (7.94 [4.14-15.22], P < 0.0001).

Conclusion: Our study revealed that male sex, hypoalbuminemia, and concomitant bevacizumab use were significant risk factors for clinically problematic hiccups in patients receiving CDDP-containing treatment along with dexamethasone and NK1 receptor inhibitors for thoracic cancer.

Background: An increased risk of infection has been suggested for patients with triple-negative breast cancer (TNBC) treated with atezolizumab plus nab-paclitaxel based on the IMpassion130 trial.

Methods: This Japanese postmarketing study aimed to compare the incidence of severe infections in patients with TNBC treated with atezolizumab plus nab-paclitaxel versus nab-paclitaxel alone. Anonymized patient records regarding medical claims and laboratory tests were extracted from the Japanese Medical Data Vision database. Patients with a drug index date of November 27, 2019,-May 31, 2022, were included in the analysis. Based on the published literature, severe infections were declared when a patient had a confirmed diagnosis of infection, a hospitalization record, infection as the primary reason for hospitalization, and a record of immunological infection tests. In the sensitivity analysis, the definition of severe infections was modified as a combination of confirmed infection diagnosis and intravenous antibacterial drug prescription records.

Results: Overall, 321 and 319 patients were included in the exposure (atezolizumab plus nab-paclitaxel) and control (nab-paclitaxel alone) groups, respectively. After adjusting for standardized mortality/morbidity ratio weighting, the baseline characteristics were balanced between the groups. The incidence rate ratio (exposure/control) of severe infections was estimated at 3.29 (95% confidence interval [CI]: 0.93-13.53) originally and 1.05 (95% CI: 0.56-1.84) in the sensitivity analysis. Additional analyses supported the appropriateness of the revised definition of severe infections.

Conclusions: Overall, our results did not indicate a significant increase in the risk of severe infections with atezolizumab plus nab-paclitaxel in daily clinical practice. Further research is required.

Background: Hand-foot syndrome (HFS) and hand-foot skin reaction (HFSR) are adverse effects induced by cytotoxic chemotherapeutic agents, such as capecitabine, pegylated liposomal doxorubicin, and multi-kinase inhibitors. HFS/HFSR can significantly reduce patients' quality of life and impact cancer treatment intensity due to severe pain in the hands and feet. Although several recommendations and guidelines have been published, most focus on European and American populations, with no management guidelines specifically addressing Asian patients. Given that Asian skin types differ from those of Europeans and Americans, treatment recommendations tailored to Asian populations are needed.

Methods: A narrative review of published articles retrieved following a systematic search of PubMed, the Cochrane Library, Medical Online, and Ichushi-Web between January 2000 and March 2025 was conducted. The search strategy targeted clinical trials using keywords related to HFS, palmar-plantar erythrodysesthesia, HFSR, prevention, therapy, and relevant anticancer agents. The review adhered to the PRISMA 2020 guidelines; However, formal quality assessment tools such as GRADE or the Cochrane risk-of-bias tool were not applied.

Results: In total, 53 articles were included in this review, which found different recommendations from European countries due to the differences in skin type. Among the recommended treatments was topical diclofenac, suggested as a potential and novel prevention strategy for capecitabine-induced HFS. However, high potent topical steroids, such as lidocaine patches, or antiseptic solutions, were not recommended.

Conclusions: This review provides evidence-based recommendations for the prevention and treatment of HFS/HFSR in Asian patients, taking into account their unique skin characteristics.

Remote robotic-assisted surgery (RRAS), a form of telesurgery, offers a potential solution to Japan's surgeon shortage and regional disparities in care. Despite advances in robotic systems and modern communication technologies, including both 5G wireless and wired networks, clinical adoption remains limited due to regulatory, infrastructural, and institutional barriers. This review consolidates five years (2020-2025) of technical and operational validation of the hinotori™ Surgical Robot System-a domestically developed platform-in alignment with the 2022 Japanese Remote Surgery Guidelines. Based on over 30 remote-session evaluations by Kobe University, Medicaroid, and NTT DOCOMO, we summarize system performance across key domains: communication latency, QoS-based prioritization, VPN redundancy, fail-safe mechanisms, electromagnetic compatibility, human-system interaction, and legal compliance. Under optimized Sub6 5G SA conditions, the system consistently achieved a round-trip latency of approximately 100 ms and stable stereoscopic video transmission, even during simulated 1 Gbps congestion. Safety was ensured through automatic standby, dual-cockpit fallback, and real-time monitoring. Although hinotori™ meets technical and safety criteria, full-scale implementation remains constrained by legal requirements-particularly the mandate for an on-site physician under Article 20 of the Medical Practitioners Act. Supervised telesurgery, where remote surgeons assist on-site teams, is legally permissible and may serve as a transitional model. This review integrates technical findings with policy considerations, proposing a path toward safe, equitable, and sustainable RRAS deployment in Japan. To our knowledge, this is the first comprehensive review aligning domestic telesurgical validation with national policy benchmarks, offering a foundation for future regulation, accreditation, and digital surgical integration.