21 results on '"Sakanaka, K."'
Search Results
2. Treatment strategy for early-stage esophageal cancer.
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Sakanaka K
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- Humans, Chemoradiotherapy methods, Esophagoscopy methods, Neoplasm Recurrence, Local, Esophageal Neoplasms therapy, Esophageal Neoplasms diagnostic imaging, Neoplasm Staging
- Abstract
Approximately 90% of esophageal cancers in Japan are squamous cell carcinomas, and they are often detected at earlier stages in Japan than in Western countries; superficial esophageal cancer without lymph node or distant metastasis comprises one-third of all esophageal cancers in Japan. Endoscopic resection is a minimally invasive treatment for superficial esophageal cancer; however, the risk of regional lymph node recurrence is negligible when it invades the submucosal layer or lymphovasculature. In such cases, surgical treatment is necessary to control regional lymph node recurrences, although the physical burdens and potential complications cannot be overlooked. Recently, clinical trials in Japan have shown promising clinical outcomes of organ preservation strategies. One strategy is initially performing endoscopic resection for superficial esophageal cancer, assessing the risk of lymph node metastasis based on pathological diagnosis for endoscopically resected specimens, and subsequently considering additional therapy (e.g., observation or prophylactic chemoradiotherapy)-another strategy aimed to cure superficial esophageal cancer through definitive chemoradiotherapy alone. The safety and efficacy of the two strategies have been evaluated in clinical trials, which showed that both organ preservation strategies are comparable to surgery in terms of overall survival. However, challenges include improving the accuracy of pretreatment endoscopic diagnosis and decreasing the local-regional recurrence after chemoradiotherapy. This review provides an overview of the latest standard treatment for early-stage esophageal cancer and its future perspectives., (© 2024. The Author(s).)
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- 2024
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3. Prognostic factors for overall survival in clinical node-positive patients with upper tract urothelial carcinoma.
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Sasahara T, Yanagisawa T, Sugaya S, Hisakane A, Sakanaka K, Hara S, Otsuka T, Takamizawa S, Yata Y, Takahashi Y, Takiguchi Y, Mori K, Tsuzuki S, Kimura S, Miki J, and Kimura T
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- Humans, Prognosis, Retrospective Studies, Nephroureterectomy, Carcinoma, Transitional Cell surgery, Carcinoma, Transitional Cell drug therapy, Urinary Bladder Neoplasms, Ureteral Neoplasms surgery
- Abstract
Background: There is sparse evidence regarding optimal management and prognosticators for oncologic outcomes in patients with clinical node-positive (cN+) upper tract urothelial carcinoma (UTUC)., Methods: We retrospectively analyzed the data from 105 UTUC patients with cN1-2M0 between June 2010 and June 2022 at multiple institutions affiliated with our university. At the time of diagnosis, all patients received standard-of-care treatment including radical nephroureterectomy (RNU), chemotherapy, and/or palliative care. We employed a Cox regression model to analyze the prognostic importance of various factors on overall survival (OS)., Results: Of 105 patients, 54 (51%) underwent RNU, while 51 (49%) did not. RNU was likely to be selected in patients with younger and higher G8 score, resulting in better median OS in patients who underwent RNU than in those who did not (42 months vs. 15 months, p < 0.001). Multivariable analysis among the entire cohort revealed that low G8 score (≤14) (hazard ratio [HR]: 2.07, 95% confidence interval [CI]: 1.08-3.99), elevated pretreatment C-reactive protein (CRP) (HR: 3.35, 95%CI: 1.63-6.90), and failure to perform RNU (HR: 2.16, 95%CI: 1.06-4.42) were independent prognostic factors for worse OS. In the subgroup analyses of cohorts who did not undergo RNU, elevated pretreatment CRP was the only independent prognostic factor for worse OS in cN+ UTUC patients., Conclusions: RNU seems to be a reasonable treatment option in cN+ UTUC patients where applicable. Elevated pretreatment CRP appears to be a reliable prognosticator of worse OS and may be helpful in optimizing candidate selection for intensified treatment in this setting., (© 2024 The Japanese Urological Association.)
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- 2024
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4. Effect of a variant histology on the oncological outcomes of Japanese patients with upper tract urothelial carcinomas after radical nephroureterectomy: a multicenter retrospective study.
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Uchida N, Urabe F, Suhara Y, Goto Y, Yoshihara K, Sadakane I, Yata Y, Kurawaki S, Miyajima K, Ishikawa M, Takahashi K, Iwatani K, Imai Y, Sakanaka K, Nakazono M, Hisakane A, Kurauchi T, Kayano S, Onuma H, Mori K, Aikawa K, Yanagisawa T, Tashiro K, Tsuzuki S, Miki J, Furuta A, Sato S, Takahashi H, and Kimura T
- Abstract
Background: An earlier systematic review and meta-analysis found that patients with a certain histological variant of upper tract urothelial carcinoma (UTUC) exhibited more advanced disease and poorer survival than those with pure UTUC. A difference in the clinicopathological UTUC characteristics of Caucasian and Japanese patients has been reported, but few studies have investigated the clinical impact of the variant histology in Japanese UTUC patients., Methods: We retrospectively enrolled 824 Japanese patients with pTa-4N0-1M0 UTUCs who underwent radical nephroureterectomy without neoadjuvant chemotherapy. Subsequently, we explored the effects of the variant histology on disease aggressiveness and the oncological outcomes. We used Cox's proportional hazards models to identify significant predictors of oncological outcomes, specifically intravesical recurrence-free survival (IVRFS), recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS)., Results: Of the 824 UTUC patients, 32 (3.9%) exhibited a variant histology that correlated significantly with a higher pathological T stage and lymphovascular invasion (LVI). Univariate analysis revealed that the variant histology was an independent risk factor for suboptimal RFS, CSS, and OS. However, significance was lost on multivariate analyses., Conclusions: The variant histology does not add to the prognostic information imparted by the pathological findings after radical nephroureterectomy, particularly in Japanese UTUC patients., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-23-561/coif). The authors have no conflicts of interest to declare., (2024 Translational Andrology and Urology. All rights reserved.)
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- 2024
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5. Definitive chemoradiotherapy for a patient with anal cancer after renal transplantation.
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Kashiwagi T, Sakanaka K, Inoo H, Hirashima H, Fujii K, and Mizowaki T
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Patients after renal transplantation are susceptible to secondary malignancies, including anal squamous cell carcinoma. Chemoradiotherapy is the standard treatment for anal squamous cell carcinoma; however, typical irradiation fields for anal cancer encompass a transplanted kidney located in the right iliac fossa, which causes complete renal dysfunction. Thus, typical irradiation fields are not feasible for this population. Additionally, standard concurrent chemotherapy demonstrates nephrotoxicity. Here, we report a case of modified definitive chemoradiotherapy for a 40-year-old patient with locally advanced perianal squamous cell carcinoma after renal transplantation whose abdominoperineal resection was difficult because of a history of repeated open surgeries and long-term steroids. We modified the cranial side of the elective nodal irradiation fields in this case to spare the transplanted kidney, considering the lymph chains of the perianal tumor. We then used continuous 5-fluorouracil to avoid nephrotoxicity of mitomycin C, considering his life expectancy. Modified definitive chemoradiotherapy achieved complete remission with expected toxicities. Now, approximately five years after the procedure, the patient remains disease-free, preserving anal and renal function. Definitive chemoradiotherapy using modified irradiation fields and chemotherapy may be an option for patients with anal squamous cell carcinoma after renal transplantation., Competing Interests: Conflict of interestThe authors declare no conflicts of interest., (© The Author(s) under exclusive licence to The Japan Society of Clinical Oncology 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.)
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- 2024
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6. Prognostic significance of subclassifying pathological T3 upper tract urothelial carcinoma: Results from a multicenter cohort study.
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Suhara Y, Urabe F, Yoshihara K, Kurawaki S, Fukuokaya W, Iwatani K, Imai Y, Sakanaka K, Hisakane A, Kurauchi T, Kayano S, Onuma H, Mori K, Kimura S, Tashiro K, Tsuzuki S, Miki J, Sato S, Takahashi H, and Kimura T
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- Humans, Prognosis, Retrospective Studies, Nephroureterectomy methods, Carcinoma, Transitional Cell pathology, Urinary Bladder Neoplasms, Urologic Neoplasms pathology
- Abstract
Objective: The population with pathological T3 (pT3) upper tract urothelial carcinoma (UTUC) is heterogeneous, thereby making prognostication challenging. We assessed the clinical ramifications of subclassifying pT3 UTUC after nephroureterectomy., Methods: We conducted a retrospective analysis including 308 patients who underwent nephroureterectomy for pT3N0-1M0 UTUC. pT3 was subclassified into pT3a and pT3b based on invasion of the peripelvic and/or periureteral fat. Cox's proportional hazard models were utilized to determine the significant prognosticators of oncological outcomes, encompassing intravesical recurrence-free survival, recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival., Results: Multivariate analysis elucidated that pT3b status, pathological N1 status, and lymphovascular invasion status were independent risk factors for an unfavorable RFS and CSS. Although the RFS and CSS of patients with pT3b UTUC were superior to those in patients with pT4 UTUC, no significant disparities were detected between patients with pT3a and pT2., Conclusion: Our findings demonstrate that pT3 UTUC with peripelvic/periureteral fat invasion is independently associated with metastasis and cancer-specific death after nephroureterectomy. These findings provide patients and physicians with invaluable insight into the risk for disease progression in pT3 UTUC patients., (© 2023 The Japanese Urological Association.)
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- 2024
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7. A phase III randomized controlled trial comparing local field with additional prophylactic irradiation in chemoradiotherapy for clinical-T1bN0M0 esophageal cancer: ARMADILLO trial (JCOG1904).
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Sasaki K, Nomura M, Kato K, Sakanaka K, Ito Y, Kadota T, Machida R, Kataoka T, Minashi K, Tsubosa Y, Kajiwara T, Fukuda H, Takeuchi H, Mizowaki T, Nishimura Y, and Kitagawa Y
- Subjects
- Humans, Neoplasm Recurrence, Local pathology, Chemoradiotherapy, Japan, Treatment Outcome, Salvage Therapy, Retrospective Studies, Esophageal Neoplasms pathology, Esophageal Squamous Cell Carcinoma therapy, Esophageal Squamous Cell Carcinoma pathology
- Abstract
Chemoradiotherapy has been considered as one of the standard treatment options for clinical T1bN0M0 esophageal squamous cell carcinoma with organ preservation. However, 20% of patients develop locoregional recurrence after chemoradiotherapy, which requires salvage treatment including salvage surgery and endoscopic resection. Salvage surgery can cause complications and treatment-related death. Interestingly, chemoradiotherapy with elective nodal irradiation has been reported to reduce the locoregional recurrence of advanced esophageal squamous cell carcinoma. Hence, we are conducting a clinical trial to confirm whether modified chemoradiotherapy with elective nodal irradiation was superiority to that without elective nodal irradiation for the patients with cT1bN0M0 esophageal squamous cell carcinoma. The primary endpoint is major progression-free survival, defined as the time from randomization to the date of death or disease progression, excluding successful curative resection through salvage endoscopic resection. We plan to enroll 280 patients from 54 institutions over 4 years. This trial has been registered in the Japan Registry of Clinical Trials (jRCTs031200067)., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2024
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8. Real-world outcomes of adjuvant immunotherapy candidates with upper tract urothelial carcinoma: results of a multicenter cohort study.
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Kagawa H, Urabe F, Kiuchi Y, Katsumi K, Yamaguchi R, Suhara Y, Yoshihara K, Goto Y, Sadakane I, Yata Y, Saito S, Kurawaki S, Ajisaka S, Miyajima K, Takahashi K, Iwatani K, Imai Y, Sakanaka K, Nakazono M, Kurauchi T, Kayano S, Onuma H, Aikawa K, Yanagisawa T, Tashiro K, Tsuzuki S, Furuta A, Miki J, and Kimura T
- Subjects
- Humans, Retrospective Studies, Nephroureterectomy methods, Prognosis, Chemotherapy, Adjuvant methods, Carcinoma, Transitional Cell drug therapy, Carcinoma, Transitional Cell pathology, Urologic Neoplasms drug therapy, Urologic Neoplasms surgery, Urinary Bladder Neoplasms drug therapy
- Abstract
Background: Recent clinical trials have reported improved disease-free survival rates of patients with stage pT3-4/ypT2-4 or pN + upper tract urothelial carcinoma (UTUC) on adjuvant nivolumab therapy. However, the appropriateness of the patient selection criteria used in clinical practice remains uncertain., Methods: We retrospectively analyzed 895 patients who underwent nephroureterectomy to treat UTUC. The patients were divided into two groups: grade pT3-4 and/or pN + without neoadjuvant chemotherapy (NAC) or grade ypT2-4 and/or ypN + on NAC (adjuvant immunotherapy candidates) and others (not candidates for adjuvant immunotherapy). Kaplan-Meier curves were drawn to assess the oncological outcomes, including recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS). Cox proportional hazards models were used to identify significant prognostic factors for oncological outcomes., Results: The Kaplan-Meier curves revealed notably inferior RFS, CSS, and OS of patients who were candidates for adjuvant immunotherapy. Multivariate analysis revealed that pathological T and N grade and lymphovascular invasion (LVI) status were independent risk factors for poor RFS, CSS, and OS., Conclusion: In total, 44.8% of patients were candidates for adjuvant immunotherapy. In addition to pathological T and N status, LVI was a significant predictor of survival, and may thus play a pivotal role in the selection of patients eligible for adjuvant immunotherapy., (© 2023. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.)
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- 2024
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9. Outcome of selective neck dissection for cervical lymph node recurrence or residual lymph node metastasis of oesophageal cancer.
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Kishimoto Y, Kawai Y, Fujimura S, Komurasaki A, Sakanaka K, Tsunoda S, Mizowaki T, Obama K, Muto M, and Omori K
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- Humans, Lymphatic Metastasis pathology, Lymph Nodes surgery, Lymph Nodes pathology, Neck surgery, Neck pathology, Retrospective Studies, Lymph Node Excision, Neoplasm Recurrence, Local pathology, Neck Dissection, Esophageal Neoplasms surgery
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- 2024
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10. Comparison of neoadjuvant and adjuvant chemotherapy for upper tract urothelial carcinoma in real-world practice: a multicenter retrospective study.
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Takahashi K, Urabe F, Suhara Y, Nakano J, Yoshihara K, Goto Y, Sadakane I, Koike Y, Yata Y, Suzuki H, Kurawaki S, Miyajima K, Iwatani K, Imai Y, Sakanaka K, Nakazono M, Kurauchi T, Kayano S, Onuma H, Aikawa K, Yanagisawa T, Tashiro K, Tsuzuki S, Koike Y, Furuta A, Miki J, and Kimura T
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- Humans, Retrospective Studies, Neoadjuvant Therapy, Chemotherapy, Adjuvant, Urinary Bladder Neoplasms pathology, Carcinoma, Transitional Cell drug therapy, Carcinoma, Transitional Cell surgery, Carcinoma, Transitional Cell pathology, Ureteral Neoplasms drug therapy, Ureteral Neoplasms surgery, Ureteral Neoplasms pathology
- Abstract
Background: Multiple studies have demonstrated the effectiveness of neoadjuvant chemotherapy and adjuvant chemotherapy in patients with upper tract urothelial carcinoma compared with surgery alone. However, no clinical trial has established the superiority of neoadjuvant chemotherapy or adjuvant chemotherapy in terms of perioperative outcomes., Methods: We conducted a retrospective analysis encompassing 164 upper tract urothelial carcinoma patients who underwent radical nephroureterectomy and received perioperative chemotherapy. Of these patients, 65 (39.6%) and 99 (60.4%) received neoadjuvant chemotherapy and adjuvant chemotherapy, respectively. Recurrence-free survival and cancer-specific survival were computed using the Kaplan-Meier method. Additionally, we conducted Cox regression analyses to evaluate the risk factors for recurrence-free survival and cancer-specific survival., Results: Pathological downstaging was seen in 37% of the neoadjuvant chemotherapy group. However, no pathological complete response was observed in this cohort. The Kaplan-Meier curves demonstrated significantly lower recurrence-free survival and cancer-specific survival in patients who received adjuvant chemotherapy. Multivariate Cox regression analysis revealed patients treated with adjuvant chemotherapy exhibited a marked association with inferior recurrence-free survival and cancer-specific survival., Conclusion: Our study has suggested that neoadjuvant chemotherapy would be more effective in high-risk upper tract urothelial carcinoma patients compared with adjuvant chemotherapy., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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11. Adjuvant treatments for locally advanced differentiated thyroid cancer: a nationwide survey in Japan.
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Kawamoto T, Yasuda K, Ito Y, Zenda S, Sakanaka K, Shikama N, Nakamura N, and Mizowaki T
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- Humans, Iodine Radioisotopes therapeutic use, Japan, Lymphatic Metastasis, Clinical Trials as Topic, Radiotherapy, Adjuvant, Thyroid Neoplasms radiotherapy, Thyroid Neoplasms pathology
- Abstract
The role of adjuvant external-beam radiotherapy (EBRT) for locally advanced differentiated thyroid cancer (DTC) is controversial because of the lack of prospective data. To prepare for a clinical trial, this study investigated the current clinical practice of adjuvant treatments for locally advanced DTC. A survey on treatment selection criteria for hypothetical locally advanced DTC was administered to representative thyroid surgeons of facilities participating in the Japan Clinical Oncology Group Radiation Therapy Study Group. Of the 43 invited facilities, surgeons from 39 (91%) completed the survey. For R1 resection or suspected residual disease, 26 (67%) facilities administered high-dose (100-200 mCi) radioactive iodine (RAI), but none performed EBRT. For R2 resection or unresectable primary disease, 26 (67%) facilities administered high-dose RAI and 7 (18%) performed adjuvant treatments, including EBRT. For complete resection with nodal extra-capsular extension, 13 (34%) facilities administered high-dose RAI and 1 (3%) performed EBRT. For unresectable mediastinal lymph node metastasis, 31 (79%) facilities administered high-dose RAI and 5 (13%) performed adjuvant treatments, including EBRT. Adjuvant EBRT was not routinely performed mainly because of the lack of evidence for efficacy (74%). Approximately 15% of the facilities routinely considered adjuvant EBRT for DTC with R2 resection or unresectable primary or lymph node metastasis disease. Future clinical trials will need to optimize EBRT for these patients.
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- 2023
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12. Combination of docetaxel versus nonsteroidal antiandrogen with androgen deprivation therapy for high-volume metastatic hormone-sensitive prostate cancer: a propensity score-matched analysis.
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Yanagisawa T, Kimura T, Hata K, Narita S, Hatakeyama S, Mori K, Sano T, Otsuka T, Iwamoto Y, Enei Y, Nakazono M, Sakanaka K, Iwatani K, Matsukawa A, Atsuta M, Nishikawa H, Tsuzuki S, Miki J, Habuchi T, Ohyama C, Shariat SF, and Egawa S
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- Male, Humans, Docetaxel therapeutic use, Androgen Antagonists therapeutic use, Androgens therapeutic use, Retrospective Studies, Propensity Score, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Prostatic Neoplasms pathology, Nonsteroidal Anti-Androgens therapeutic use, Prostatic Neoplasms, Castration-Resistant pathology
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Purpose: The aim of this study was to investigate the oncologic efficacy of combining docetaxel with androgen deprivation therapy (ADT) versus nonsteroidal antiandrogen (NSAA) with ADT in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) with focus on the effect of sequential therapy in a real-world clinical practice setting., Methods: The records of 382 patients who harbored high-volume mHSPC, based on the CHAARTED criteria, and had received ADT with either docetaxel (n = 92) or NSAA (bicalutamide) (n = 290) were retrospectively analyzed. The cohorts were matched by one-to-one propensity scores based on patient demographics. Overall survival (OS), cancer-specific survival (CSS), progression-free survival (PFS), including time to castration-resistant prostate cancer (CRPC), and time to second-line progression (PFS2) were compared. 2nd-line PFS defined as the time from CRPC diagnosis to progression after second-line therapy was also compared., Results: After matching, a total of 170 patients were retained: 85 patients treated with docetaxel + ADT and 85 patients treated with NSAA + ADT. The median OS and CSS for docetaxel + ADT versus NSAA + ADT were not reached (NR) vs. 49 months (p = 0.02) and NR vs. 55 months (p = 0.02), respectively. Median time to CRPC and PFS2 in patients treated with docetaxel + ADT was significantly longer compared to those treated with NSAA (22 vs. 12 months; p = 0.003 and, NR vs. 28 months; p < 0.001, respectively). There was no significant difference in 2nd-line PFS between the two groups., Conclusions: Our analysis suggested that ADT with docetaxel significantly prolonged OS and CSS owing to a better time to CRPC and PFS2 in comparison to NSAA + ADT in high-volume mHSPC., (© 2022. The Author(s).)
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- 2023
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13. En Bloc Resection Versus Conventional TURBT for T1HG Bladder Cancer: A Propensity Score-Matched Analysis.
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Yanagisawa T, Matsukawa A, Iwatani K, Sato S, Hayashida Y, Okada Y, Yorozu T, Fukuokaya W, Sakanaka K, Urabe F, Kimura S, Tsuzuki S, Shimoda M, Takahashi H, Miki J, Shariat SF, and Kimura T
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- Humans, Retrospective Studies, Propensity Score, Cystectomy, Urologic Surgical Procedures methods, Urinary Bladder Neoplasms surgery, Urinary Bladder Neoplasms pathology
- Abstract
Background: We aimed to assess the clinical, oncological, and pathological impact of en bloc resection of bladder tumors (ERBT) compared with conventional transurethral resection of bladder tumors (cTURBT) for pT1 high-grade (HG) bladder cancer., Patients and Methods: We retrospectively analyzed the record of 326 patients (cTURBT: n = 216, ERBT: n = 110) diagnosed with pT1 HG bladder cancer at multiple institutions. The cohorts were matched by one-to-one propensity scores based on patient and tumor demographics. Recurrence-free survival (RFS), progression-free survival (PFS), cancer-specific survival (CSS), and perioperative and pathologic outcomes were compared. The prognosticators of RFS and PFS were analyzed using the Cox proportional hazard model., Results: After matching, 202 patients (cTURBT: n = 101, ERBT: n = 101) were retained. There were no differences in perioperative outcomes between the two procedures. The 3-year RFS, PFS, and CSS were not different between the two procedures (p = 0.7, 1, and 0.7, respectively). Among patients who underwent repeat transurethral resection (reTUR), the rate of any residue on reTUR was significantly lower in the ERBT group (cTURBT: 36% versus ERBT: 15%, p = 0.029). Adequate sampling of muscularis propria (83% versus 93%, p = 0.029) and diagnostic rates of pT1a/b substaging (90% versus 100%, p < 0.001) were significantly better in ERBT specimen compared with cTURBT specimen. On multivariable analyses, pT1a/b substaging was a prognosticator of disease progression., Conclusions: In patients with pT1HG bladder cancer, ERBT had similar perioperative and mid-term oncologic outcomes compared with cTURBT. However, ERBT improves the quality of resection and specimen, yielding less residue on reTUR and yielding superior histopathologic information such as substaging., (© 2023. Society of Surgical Oncology.)
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- 2023
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14. Comparison of Quality of Life and Injection Site Reactions After Switching from Degarelix 80 mg to 480 mg in Advanced Prostate Cancer: A Prospective Trial.
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Miyajima K, Yanagisawa T, Suzuki H, Fukuokaya W, Sakanaka K, Obayashi K, Miki J, and Kimura T
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- Humans, Male, Activities of Daily Living, Gonadotropin-Releasing Hormone, Injection Site Reaction, Prospective Studies, Prostatic Neoplasms drug therapy, Quality of Life
- Abstract
Background/aim: Degarelix has been widely used for prostate cancer; however, injection site reactions (ISRs) can be a clinical issue. We assessed differences in ISR intensity and patient quality of life (QOL) between degarelix 80 mg and 480 mg, a three-month formulation launched in 2020 in Japan., Patients and Methods: We prospectively analyzed 25 patients with advanced prostate cancer. ISR intensity and patient QOL were evaluated before and after switching from degarelix 80 mg to 480 mg. A visual analogue scale (VAS) and faces rating scale (FRS) were applied to assess the ISRs. We applied a rating format from the M. D. Anderson Symptom Inventory (MDASI) to assess patient QOL., Results: For degarelix 80 mg and a first dose of 480 mg, the incidence rate of ISRs was 84% and 92%, respectively (p=0.083). ISR pain on the third day after injection scored by VAS was 2.7±2.8 and 5.2±2.7, respectively (p<0.001). Other ISR findings such as redness, induration, swelling, warmth, and itching were significantly worse for degarelix 480 mg than for 80 mg. In the category of patient QOL, interference with activities of daily living such as general activity was significantly worse after degarelix 480 mg (p=0.003). However, 80% of patients were able to continue degarelix 480 mg during the nine months of follow-up., Conclusion: Degarelix 480 mg seems to exacerbate pain and other ISR findings, and to reduce patient QOL, compared with degarelix 80 mg. Optimal management of ISRs is essential to maintain patient QOL when using degarelix 480 mg., (Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)
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- 2023
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15. A Single-Arm Confirmatory Study of Definitive Chemoradiation Therapy Including Salvage Treatment for Clinical Stage II/III Esophageal Squamous Cell Carcinoma (JCOG0909 Study).
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Takeuchi H, Ito Y, Machida R, Kato K, Onozawa M, Minashi K, Yano T, Nakamura K, Tsushima T, Hara H, Okuno T, Hironaka S, Nozaki I, Ura T, Chin K, Kojima T, Seki S, Sakanaka K, Fukuda H, and Kitagawa Y
- Subjects
- Antineoplastic Combined Chemotherapy Protocols therapeutic use, Chemoradiotherapy adverse effects, Chemoradiotherapy methods, Cisplatin, Fluorouracil, Humans, Salvage Therapy methods, Survival Rate, Treatment Outcome, Carcinoma, Squamous Cell pathology, Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma drug therapy
- Abstract
Purpose: Definitive chemoradiotherapy (CRT) is the standard treatment for patients with locally advanced esophageal cancer (EC) who refuse surgery as the initial therapy. However, poor survival, a high incidence of late toxicities, and severe complications after salvage surgery remain issues to be resolved. This single-arm multicenter trial (JCOG0909) aimed to confirm the efficacy of CRT modifications, including salvage treatment for reducing CRT-related toxicities and facilitating salvage treatment for improved survival., Methods and Materials: Patients with clinical stage II/III EC (International Union Against Cancer sixth edition, non-T4) were eligible. Chemotherapy comprised cisplatin (75 mg/m
2 on days 1 and 29) and 5-fluorouracil (1000 mg/m2 /d on days 1-4 and 29-32). Radiation therapy was administered at a total dose of 50.4 Gy. Good responders received 1 to 2 additional cycles of chemotherapy. For residual or recurrent disease, salvage endoscopic resection or salvage surgery was performed based on specific criteria. The primary endpoint was 3-year overall survival (OS). The calculated sample size was 95 patients, with a 1-sided alpha of 5% and a power of 80%. The expected and threshold 3-year OS were 55% and 42%, respectively., Results: Overall, 96 patients were enrolled, and 94 were included in the efficacy analysis. A complete response was achieved in 55 patients (59%). Salvage endoscopic resection and salvage surgery were performed in 5 (5%) and 25 patients (27%), respectively. R0 resection by salvage surgery was achieved in 19 patients (76%). Five patients (20%) showed grade 3 or 4 early operative complications, and 9 patients (9.6%) showed grade 3 late toxicities during the long-term follow-up. The 3-year OS was 74.2% (90% confidence interval, 65.9%-80.8%)., Conclusion: The combination of definitive CRT and salvage treatment has lower CRT-related toxicities and yields good OS, thus making it a promising novel treatment option for patients with locally advanced EC., (Copyright © 2022 Elsevier Inc. All rights reserved.)- Published
- 2022
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16. Association of volumetric-modulated arc therapy with radiation pneumonitis in thoracic esophageal cancer.
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Inoo H, Sakanaka K, Fujii K, Ishida Y, and Mizowaki T
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- Humans, Organs at Risk, Radiotherapy Dosage, Radiotherapy Planning, Computer-Assisted methods, Retrospective Studies, Esophageal Neoplasms complications, Esophageal Neoplasms radiotherapy, Radiation Pneumonitis etiology, Radiotherapy, Conformal adverse effects, Radiotherapy, Conformal methods, Radiotherapy, Intensity-Modulated adverse effects, Radiotherapy, Intensity-Modulated methods, Thoracic Neoplasms radiotherapy
- Abstract
The lung volume receiving low-dose irradiation has been reported to increase in volumetric-modulated arc radiotherapy (VMAT) compared with three-dimensional conformal radiotherapy (3DCRT) for thoracic esophageal cancer, which raises concerns regarding radiation pneumonitis (RP) risk. This single institutional retrospective cohort study aimed to explore whether VMAT for thoracic esophageal cancer was associated with RP. Our study included 161 patients with thoracic esophageal cancer, of whom 142 were definitively treated with 3DCRT and 39 were treated with VMAT between 2008 and 2018. Radiotherapy details, dose-volume metrics, reported RP risk factors and RP incidence were collected. The RP risk factors were assessed via multivariate analysis. Dose-volume analysis showed that VMAT delivered more conformal dose distributions to the target volume (P < 0.001) and reduced V30 Gy of heart (57% vs 41%, P < 0.001) but increased V5 Gy (54% vs 41%, P < 0.001) and V20 Gy (20% vs 17%, P = 0.01) of lungs compared with 3DCRT. However, the 1-year incidence rates of RP did not differ between the two techniques (11.3% in 3DCRT vs 7.7% in VMAT, P = 0.53). The multivariate analysis suggested that the presence of interstitial lung disease (ILD) (P = 0.01) and V20 Gy of lungs ≥20% (P = 0.008) were associated with RP. Conclusively, VMAT increased the lung volume receiving low to middle doses irradiation, although this might not be associated with RP. Further studies are needed to investigate the effect of using VMAT for delivering conformal dose distributions on RP., (© The Author(s) 2022. Published by Oxford University Press on behalf of The Japanese Radiation Research Society and Japanese Society for Radiation Oncology.)
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- 2022
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17. A case of a pregnant woman with locally advanced cervical esophageal cancer treated with definitive chemoradiotherapy.
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Tateishi Y, Sakanaka K, Hirashima H, Mukumoto N, Inoo H, Fujii K, Ono T, Nakamura M, Nakata M, Kawasaki K, Tani H, Mandai M, and Mizowaki T
- Abstract
The information of definitive radiotherapy for a pregnant woman with malignancy was limited; however, it was reported to be potentially feasible with minimal risks. We performed definitive chemoradiotherapy for a pregnant woman with locally advanced cervical esophageal cancer. Feasibility of radiotherapy and safety of fetus were confirmed by the phantom study estimating fetal dose, and monitoring it in each radiotherapy session. The planned chemoradiotherapy completely eradicated esophageal cancer while preserving her laryngopharyngeal function. A female infant was delivered by cesarian section after planned chemoradiotherapy, and she grew without any apparent disorders 2 years after chemoradiotherapy. Chemoradiotherapy might be one of the treatment options for a pregnant woman with cervical esophageal cancer especially wishing the preservation of laryngopharyngeal function., Competing Interests: Conflict of interestThe authors declare that they have no conflict of interest., (© The Author(s) under exclusive licence to The Japan Society of Clinical Oncology 2022.)
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- 2022
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18. Preoperative chemoradiotherapy for locally advanced low rectal cancer using intensity-modulated radiotherapy to spare the intestines: a single-institutional pilot trial.
- Author
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Sakanaka K, Fujii K, Ishida Y, Mukumoto N, Hida K, Inoo H, Sakai Y, and Mizowaki T
- Subjects
- Chemoradiotherapy methods, Humans, Intestines pathology, Pilot Projects, Radiotherapy Dosage, Radiotherapy, Conformal methods, Radiotherapy, Intensity-Modulated methods, Rectal Neoplasms pathology, Rectal Neoplasms radiotherapy
- Abstract
The irradiated volume of intestines is associated with gastrointestinal toxicity in preoperative chemoradiotherapy for rectal cancer. The current trial prospectively explored how much of the irradiated volume of intestines was reduced by intensity-modulated radiotherapy (IMRT) compared with 3-dimensional conformal radiotherapy (3DCRT) and whether IMRT might alleviate the acute gastrointestinal toxicity in this population. The treatment protocol encompassed preoperative chemoradiotherapy using IMRT plus surgery for patients with clinical T3-4, N0-2 low rectal cancer. IMRT delivered 45 Gy per 25 fractions for gross tumors, mesorectal and lateral lymph nodal regions, and tried to reduce the volume of intestines receiving 15 Gy (V15 Gy) < 120 cc and V45 Gy ≤ 0 cc, respectively, while keeping target coverage. S-1 and irinotecan were concurrently administered. Acute gastrointestinal toxicity, rates of clinical downstaging, sphincter preservation, local regional control (LRC) and overall survival (OS) were evaluated. Twelve enrolled patients completed the chemoradiotherapy protocol. The volumes of intestines receiving medium to high doses were reduced by the current IMRT protocol compared to 3DCRT; however, the predefined constraint of V15 Gy was met only in three patients. The rate of ≥ grade 2 gastrointestinal toxicity excluding anorectal symptoms was 17%. The rates of clinical downstaging, sphincter preservation, three-year LRC and OS were 75%, 92%, 92% and 92%, respectively. In conclusion, preoperative chemoradiotherapy using IMRT for this population might alleviate acute gastrointestinal toxicity, achieving high LRC and sphincter preservation; although further advancement is required to reduce the irradiated volume of intestines, especially those receiving low doses., (© The Author(s) 2021. Published by Oxford University Press on behalf of The Japanese Radiation Research Society and Japanese Society for Radiation Oncology.)
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- 2022
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19. Abiraterone acetate versus nonsteroidal antiandrogen with androgen deprivation therapy for high-risk metastatic hormone-sensitive prostate cancer.
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Yanagisawa T, Kimura T, Mori K, Suzuki H, Sano T, Otsuka T, Iwamoto Y, Fukuokaya W, Miyajima K, Enei Y, Sakanaka K, Matsukawa A, Onuma H, Obayashi K, Tsuzuki S, Hata K, Shimomura T, Miki J, and Egawa S
- Subjects
- Androgen Antagonists administration & dosage, Androgen Antagonists adverse effects, Antineoplastic Combined Chemotherapy Protocols, Comparative Effectiveness Research, Humans, Japan epidemiology, Liver Function Tests methods, Male, Middle Aged, Neoplasm Grading, Neoplasm Staging, Nonsteroidal Anti-Androgens administration & dosage, Nonsteroidal Anti-Androgens adverse effects, Prognosis, Retrospective Studies, Risk Assessment methods, Abiraterone Acetate administration & dosage, Abiraterone Acetate adverse effects, Anilides administration & dosage, Anilides adverse effects, Liver Neoplasms diagnosis, Liver Neoplasms secondary, Nitriles administration & dosage, Nitriles adverse effects, Prednisolone administration & dosage, Prednisolone adverse effects, Prostatic Neoplasms drug therapy, Prostatic Neoplasms epidemiology, Prostatic Neoplasms pathology, Prostatic Neoplasms, Castration-Resistant diagnosis, Prostatic Neoplasms, Castration-Resistant epidemiology, Prostatic Neoplasms, Castration-Resistant etiology, Tosyl Compounds administration & dosage, Tosyl Compounds adverse effects
- Abstract
Background: Although prostate cancer is a very common form of malignancy in men, the clinical significance of androgen deprivation therapy (ADT) with abiraterone acetate versus the nonsteroidal antiandrogen bicalutamide has not yet been verified in patients with high-risk metastatic hormone-sensitive prostate cancer (mHSPC). The present study was designed to initiate this verification in real-world Japanese clinical practice., Methods: We retrospectively analyzed the records of 312 patients with high-risk mHSPC based on LATITUDE criteria and had received ADT with bicalutamide (n = 212) or abiraterone acetate (n = 100) between September 2015 and December 2020. Bicalutamide was given at 80 mg daily and abiraterone was given at 1000 mg daily as four 250-mg tablets plus prednisolone (5-10 mg daily). Overall survival (OS), cancer-specific survival (CSS), and time to castration-resistant prostate cancer (CRPC) were compared. The prognostic factor for time to CRPC was analyzed by Cox proportional hazard model., Results: Patients in the bicalutamide group were older, and more of them had poor performance status (≧2), than in the abiraterone group. Impaired liver function was noted in 2% of the bicalutamide group and 16% of the abiraterone group (p < 0.001). Median follow-up was 22.5 months for bicalutamide and 17 months for abiraterone (p < 0.001). Two-year OS and CSS for bicalutamide versus abiraterone was 77.8% versus 79.5% (p = 0.793) and 81.1% versus 82.5% (p = 0.698), respectively. Median time to CRPC was significantly longer in the abiraterone group than in the bicalutamide group (NA vs. 13 months, p < 0.001). In multivariate analysis, Gleason score ≧9, high alkaline phosphatase, high lactate dehydrogenase, liver metastasis, and bicalutamide were independent prognostic risk factors for time to CRPC. Abiraterone prolonged the time to CRPC in patients with each of these prognostic factors., Conclusions: Despite limitations regarding the time-dependent bias, ADT with abiraterone acetate significantly prolonged the time to CRPC compared to bicalutamide in patients with high-risk mHSPC. However, further study with longer follow-up is needed., (© 2021 Wiley Periodicals LLC.)
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- 2022
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20. Clinical Significance of Horizontal and Vertical Margin of En Bloc Resection for Nonmuscle Invasive Bladder Cancer.
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Yanagisawa T, Miki J, Sakanaka K, Fukuokaya W, Iwatani K, Sato S, Obayashi K, Hirooka S, Kimura T, Takahashi H, and Egawa S
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Male, Margins of Excision, Neoplasm Invasiveness pathology, Neoplasm Staging, Retrospective Studies, Urinary Bladder Neoplasms pathology, Urinary Bladder Neoplasms surgery, Urologic Surgical Procedures methods
- Abstract
Purpose: The primary advantage of en bloc resection of bladder tumors is to provide better diagnostic accuracy. However, the clinical significance of horizontal and vertical margin has not been demonstrated. We evaluated the clinical importance of surgical margins in patients who underwent en bloc resection of bladder tumors., Materials and Methods: We retrospectively analyzed the records of 140 consecutive patients who underwent en bloc resection of bladder tumors for nonmuscle invasive bladder cancer. We analyzed perioperative and oncological outcome, and compared patient demographics and recurrence-free survival for horizontal findings. The relationship between surgical margin and second transurethral resection outcome in pT1 bladder cancer was also analyzed., Results: Mean tumor diameter was 17.2±9.8 mm. Pathological stages were 93 cases in pTa and 47 cases in pT1. Diagnostic rates for the horizontal and vertical margins were 63% and 99%, respectively. The rates of sessile, carcinoma in situ, high grade, and pT1 tumors were significantly higher in the horizontal margin positive group (41) than in the negative group (47). There was no significant difference in 2-year recurrence-free survival based on horizontal margin findings (negative: 72.4%, positive: 75.4%, p=0.87). A second transurethral resection was performed in 31 of the 47 pT1 patients; pT1 residue was seen only in vertical margin positive cases, and 5 pTa/pTis residues at the transurethral resection scar were seen in 15 horizontal margin positive patients., Conclusions: Horizontal margin positive findings were not associated with recurrence-free survival, but careful assessment is warranted regarding residue at the original site. A second transurethral resection should be considered in patients with horizontal and vertical margin positive pT1 bladder cancer.
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- 2021
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21. Reducing variability among treatment machines using knowledge-based planning for head and neck, pancreatic, and rectal cancer.
- Author
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Hirashima H, Nakamura M, Mukumoto N, Ashida R, Fujii K, Nakamura K, Nakajima A, Sakanaka K, Yoshimura M, and Mizowaki T
- Subjects
- Humans, Knowledge Bases, Radiotherapy Dosage, Radiotherapy Planning, Computer-Assisted, Radiotherapy, Intensity-Modulated, Rectal Neoplasms radiotherapy
- Abstract
Purpose: This study aimed to assess dosimetric indices of RapidPlan model-based plans for different energies (6, 8, 10, and 15 MV; 6- and 10-MV flattening filter-free), multileaf collimator (MLC) types (Millennium 120, High Definition 120, dual-layer MLC), and disease sites (head and neck, pancreatic, and rectal cancer) and compare these parameters with those of clinical plans., Methods: RapidPlan models in the Eclipse version 15.6 were used with the data of 28, 42, and 20 patients with head and neck, pancreatic, and rectal cancer, respectively. RapidPlan models of head and neck, pancreatic, and rectal cancer were created for TrueBeam STx (High Definition 120) with 6 MV, TrueBeam STx with 10-MV flattening filter-free, and Clinac iX (Millennium 120) with 15 MV, respectively. The models were used to create volumetric-modulated arc therapy plans for a 10-patient test dataset using all energy and MLC types at all disease sites. The Holm test was used to compare multiple dosimetric indices in different treatment machines and energy types., Results: The dosimetric indices for planning target volume and organs at risk in RapidPlan model-based plans were comparable to those in the clinical plan. Furthermore, no dose difference was observed among the RapidPlan models. The variability among RapidPlan models was consistent regardless of the treatment machines, MLC types, and energy., Conclusions: Dosimetric indices of RapidPlan model-based plans appear to be comparable to the ones based on clinical plans regardless of energies, MLC types, and disease sites. The results suggest that the RapidPlan model can generate treatment plans independent of the type of treatment machine., (© 2021 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals LLC on behalf of American Association of Physicists in Medicine.)
- Published
- 2021
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