Randomized study of intravesical chemotherapy using pirarubicin in patients with non-muscle-invasive bladder cancer in Japan: Comparing one immediate postoperative intravesical chemotherapy with short-term adjuvant intravesical chemotherapy after TURBT: Subanalysis in patients with intermediate risk.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4536-4536
Author(s):  
Yoshio Naya ◽  
Kazuya Mikami ◽  
Natsuki Takaha ◽  
Koji Okihara ◽  
Tsuneharu Miki ◽  
...  

4536 Background: The objective is to evaluate the efficacy defining of 2-year tumor recurrence free rate of intravesical chemotherapy using pirarubicin (THP) for patients with intermediate risk. Methods: Between October 2010 and January 2015, 206 patients were enrolled in this study and finally 113 were randomized to one immediate postoperative intravesical instillation of THP 30mg (Group A), or additional intravesical instillation of THP 30mg weekly for 8 weeks after single postoperative instillation (Group B). The recurrent risk was stratified using EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder, the 2009 update. Of 113, 100 with intermediate risk were analyzed in this study. The patients were examined by cystoscopy and urine cytology every 3 months after trans urethral resection to determine bladder tumor recurrence. The primary endpoint was 2 year-recurrence-free survival rates. A statistical analysis was performed by SAS (SAS Institute Inc., Cary, USA). Results: The 2-year recurrence free survival rates were 66.2% in Group A and 86.1% in Group B, respectively (log rank test, p = 0.0043). In patients with recurrence score between 5 and 9, the 2-year recurrence free survival was 92.3% in Group B and 22.2% in Group A (log rank test, p = 0.0013). Cox regression analysis revealed that only additional instillation of THP was significant independent factor for recurrence free rate in patients with intermediate risk. There was no patient with progression during this period. Frequent adverse effects were frequent urination and micturition pain without severe adverse effect (Grade 3 or more). Limitation of this study is a failure to enroll sufficient number for statistical analysis. Conclusions: Additional instillation of THP 30mg weekly for 8 weeks reduced the risk of tumor recurrence without severe toxicity in NMIBC patients with intermediate recurrent risk.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 384-384
Author(s):  
Yutaka Kasejima ◽  
Wataru Takahashi ◽  
Yoshiaki Kawano ◽  
Takahiro Yamaguchi ◽  
Ken-ichiro Tanoue ◽  
...  

384 Background: Anthracyclines are recommended reagents for one immediate intravesical instillation after transurethral resection (TUR) and additional adjuvant instillation in intermediate risk NMIBC to reduce the risk of recurrence. Several studies have showed that Pirarubicin (THP), an anthracycline analogue, can rapidly penetrate tumor tissue after intravesical instillation. Therefore long instillation time (e.g. 120 min) may not be required for its prophylactic effect against recurrence without compromising its efficacy. Methods: This randomised, prospective, open-label trial intended to enroll 160 pts with primary NMIBC with intermediate risk based on EORTC criteria. Pts who seemed likely to be at intermediate risk were provisionally registered and then randomised into two groups with different intravesical THP retention times before TUR, (a) 30 min versus (b) 120 min. The registration was finally confirmed by pathology results of TUR. All registered pts received initial THP instillation within 24 hr after TUR and then intended to continue weekly repetitive THP instillation for a total of 9 treatments. Follow-up period is 4 years. Primary endpoint is change from baseline in quality of life measurements (e.g. OABSS and I-PSS), which were evaluated prior to each THP intravesical instillation. Secondary endpoint is recurrence-free survival. Results: 126 pts were enrolled for provisional registration. After excluding pts due to the result of pathology by TUR, 29 pts were assigned to group (a), and 26 pts to group (b). Although not statistically significant, there is a trend that group (a) is less prone to increase in OABSS after 3rd instillation compared to group (b). Log-rank test shows that there is no significant difference in recurrence-free survival between the groups during follow-up period (HR = 2.161, 95% C.I.: 0.4317-10.82, p= 0.3484). Conclusions: Shortening intravesical instillation period to 30 min has little effect on reducing the adverse effect of THP. However, it does not compromise the prophylactic effect on recurrence in intermediate risk NMIBC pts. Clinical trial information: UMIN000006861.


2002 ◽  
Vol 9 (5) ◽  
pp. 566-572 ◽  
Author(s):  
Ali F. AbuRahma ◽  
Mark C. Bates ◽  
John T. Wulu ◽  
Patrick A. Stone

Purpose: To compare the results of balloon angioplasty/stenting (BA/S) versus redo surgery in patients with early carotid restenosis. Methods: Sixty-one patients (35 women; mean age 69 years, range 46–82) with early restenosis (<24 months from the primary endarterectomy) in 63 carotid arteries were treated during a 5-year period; 41 patients (41 arteries) had redo surgery (group A) and 20 patients (22 arteries) had BA/S (group B). Patients were followed regularly with duplex ultrasound to detect ≥50% recurrent restenosis (RRS) after redo surgery or BA/S. Kaplan-Meier life-table analysis was used to estimate the stroke-free survival rates and freedom from ≥50% RRS. Results: The demographic and clinical characteristics were comparable for both groups, as were the perioperative stroke and death rates (2.4% and 0% for group A, respectively, versus 4.5% and 0% for group B, p=0.46). Group A had a 12% incidence of cranial nerve injury (all transient) versus 0% for group B (p=0.11); however, group B had a higher incidence of ≥50% RRS than group A (32% versus 0%, p=0.0003). The stroke-free survival rates for redo surgery at 6, 12, 24, 36, and 48 months were 100%, 100%, 100%, 100%, and 88% versus 95%, 95%, 84%, 84%, and 63% for BA/S (p=0.067). Redo surgery had a 100% freedom from ≥50% RRS at the same time intervals, while recurrent restenosis rates for the BA/S patients were 95%, 86%, 69%, 52%, and 52% (p<0.0001). Conclusions: BA/S and redo surgery have comparable stroke and death rates in the treatment of early RCS; however, redo surgery is associated with cranial nerve injuries (transient), while stent patients have a higher incidence of recurrent lesions. These considerations should be kept in mind when selecting the appropriate treatment for patients with early postsurgical restenosis.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14536-e14536
Author(s):  
Tomoharu Yoshizumi ◽  
Toru Ikegami ◽  
Shohei Yoshiya ◽  
Takashi Motomura ◽  
Yohei Mano ◽  
...  

e14536 Background: There is currently no consensus on how to manage patients with hepatocellular carcinoma (HCC) while awaiting liver transplantation (LT). The guideline published in UK states that locoregional therapy should be considered for all listed patients with HCC. Living donor LT (LDLT) is a choice for treating HCC patients in organ shortage era. The aim of the present study is to clarify the risk factors of tumor recurrence after LDLT in patients who had received pre-transplant treatments (pre-Tx) for HCC. Methods: One hundred two adult patients (39 females and 63 males) who had undergone LDLT due to end-stage liver disease with recurrent HCC after pre-Tx were enrolled. The primary end-point of this study was HCC recurrence after LDLT. Recurrence-free survival rates after LDLT were calculated. Risk factors of tumor recurrence were identified using univariate and multivariate analysis. Results: The 1-, 3-, and 5-year recurrence-free survival rates were 89.4%, 80.7%, and 78.8%, respectively. Seventy-four of 102 patients underwent pre-Tx more than twice. Moreover, the times of pre-Tx, the interval between the first treatment and LDLT, and the interval between the last treatment and LDLT did not affect the outcome of LDLT. On univariate analysis, the factors affecting recurrence-free survival were exceeding the up-to-seven criteria (p<0.0001), exceeding the Kyushu University criteria (p<0.0001), neutrophil-to-lymphocyte ratio (NLR) > 4 (p=0.0001), Alpha-fetoprotein > 400 ng/ml (p<0.0001), and bilobar tumor distribution (p=0.047). A multivariate analysis identified independent risk factors for post-LDLT tumor recurrence were exceeding the up-to-seven criteria (p=0.001) and NLR > 4 (p=0.002). The 1- and 3-year recurrence-free survival rates in the recipients with exceeding the up-to-seven criteria and NLR > 4 were 30.0% and 15.0%, respectively. Conclusions: The kind or duration of pre-Tx did not affect the outcome of LDLT, but LDLT should not be performed for the patients with exceeding the up-to-seven criteria and NLR more than 4 after pre-Tx for HCC to prevent tumor recurrence.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Nakano ◽  
K Suenari ◽  
K Suruga ◽  
H Takemoto ◽  
Y Hashimoto ◽  
...  

Abstract Background Currently, cryoballoon ablation (CBA) has proven to be highly effective in achieving free from atrial fibrillation (AF), especially paroxysmal AF. However, the optimal freezing protocol for each patient to achieve successful pulmonary vein isolation by only CBA is still uncertain. The aim of this study was to evaluate the clinical implications of a reduction in the freezing duration (<180s) during CBA guided by the time to target temperature. Methods From November 2015 to August 2018, 286 consecutive paroxysmal AF patients undergoing CBA were enrolled. We compared 107 patients undergoing a tailor-made CBA procedure (Group A; August 2017-August 2018) to 179 patients with a standard CBA procedure (Group B; November 2015–July 2017). In Group A, the freezing duration was reduced to 150s when the temperature reached ≤−40°C within 40s. Furthermore, we reduced it to 120s when it reached ≤−50°C within 60s. In the other patients, the freezing time was 180s except for excessive freezing over −60°C and/or emergent situations while monitoring the esophageal temperature and for phrenic nerve injury as in Group B. Results The baseline clinical characteristics were similar between two groups. In Group A, 89 patients (83%) underwent CBA with a reduction in the freezing time. The rate of having reduction time in left inferior PV (LIPV) and right inferior PV (RIPV) was lower compared with left superior PV (LSPV) and right superior PV (RSPV) (respectively 17%, 29%, 56%, and 63.5%). However, for right inferior PV, in 31 patients having the reduced freezing time, none of them required touch-up ablation. Although the procedure time and frequency of touch-up ablation did not differ between the 2 groups, total freezing time for each PV was significantly shorter in Group A than Group B as shown in figure (LSPV: 164±28s vs. 216±67s; p<0.001, LIPV: 187±44s vs. 218±69s; p<0.001, RSPV: 147±31s vs. 192±51s; p<0.001, RIPV: 180±50 vs. 218±73s; p<0.001). The AF free survival rate during the follow-up period (356±167 days) was similar between the 2 groups (log-rank test, p=0.38). Furthermore, the complication rate was similar 2 groups. The freezing time for each PV Conclusion The safety and efficacy of the new tailor-made CBA strategy were non-inferior to the standard procedure. This study showed that the unnecessary freezing time could be reduced in most of paroxysmal AF patients.


2020 ◽  
Vol 50 (12) ◽  
pp. 1412-1418
Author(s):  
Kenta Ishii ◽  
Yukihiro Yokoyama ◽  
Yoshihiro Nishida ◽  
Hiroshi Koike ◽  
Suguru Yamada ◽  
...  

Abstract Objective This study sought to investigate the characteristics of primary and repeated recurrent retroperitoneal liposarcoma. Methods Patients treated with primary or recurrent retroperitoneal liposarcoma between 2005 and 2018 were retrospectively reviewed. Survival time analysis of recurrence-free survival and overall survival was conducted using Kaplan–Meier analysis and log-rank test. Results Fifty-two patients with primary retroperitoneal liposarcoma were analysed. Amongst them, 46 patients (88%) had undergone surgery. Histologic grades included well-differentiated (n = 21), dedifferentiated (n = 21), myxoid (n = 3) and pleomorphic (n = 1) subtypes. The patients undergoing R0 resection in the first surgery had significantly higher recurrence-free survival rates compared with the patients undergoing non-R0 resection (3-year recurrence-free survival: 80 versus 38%; 5-year recurrence-free survival: 49 versus 29%, P = 0.033). Although overall survival rates tended to be higher in the patients undergoing R0 resection compared with the non-R0 resection, it did not reach to a statistical significant difference (5-year overall survival: 93 versus 75%; 10-year overall survival: 93 versus 59%, P = 0.124). The recurrence rates were 65, 67, 73 and 100%, and the median recurrence-free survival times were 46, 20, 9 and 3 months after the first, second, third and fourth surgeries, respectively. The 5-year overall survival rates were 82, 69, 40 and 0% after the first, second, third and fourth surgeries, respectively. Conclusions With repeated recurrence and surgeries, the time to recurrence decreased and the recurrence rate increased. R0 resection in the first surgery was considered the most important for longer recurrence-free survival and radical cure.


2021 ◽  
Vol 20 ◽  
pp. 153303382098587
Author(s):  
Yang Wu ◽  
Longzhen Zhang ◽  
Tianyou Tang ◽  
Liantao Li ◽  
Liang Li ◽  
...  

Background: Cervical lymph nodes metastases are one of the most significant prognostic factors in patients with laryngeal carcinoma, whether treatment by surgery or by radiotherapy. The current study retrospected the postoperative radiotherapy of locally advanced supraglottic and glottic laryngeal carcinoma (at a greater risk of lymph node metastasis) to determine the effect of radiotherapy excluding cervical level Ⅳ lymph nodes. Methods: Patients of supraglottic type and glottic type were irradiated with level Ⅳ from January 2012 to June 2013, without level Ⅳ from July 2013 to December 2014, according to physicians’ decision. Ninety-three patients were selective neck irradiation (SNI) of levels Ⅱ-Ⅳ (Group A) and 87 patients were SNI of levels Ⅱ and Ⅲ (Group B). The comparison between Group A and Group B was made with observation of clinical risk of recurrence and radiation complications, as well as overall survival (OS), progress-free survival (PFS) and regional nodal recurrence-free survival. Results: No remarkable difference was observed in the distribution of recurrence, levels of relapse, OS, PFS and regional nodal recurrence-free survival between the 2 groups (p > 0.05). Mean radiation dose at level Ⅳ, thyroid and cervical esophagus showed significant difference between the 2 therapeutic groups (p < 0.01). As regard radiation complications, no significant difference was found in radiation dermatitis of any grade between the 2 groups (p > 0.05). However, there was remarkable difference in clinical hypothyroidism and radiation esophagitis between Group A and Group B (p < 0.05). Conclusions: Radiotherapy after surgery omitting level Ⅳ may improve the quality of life in patients with locally advanced supraglottic and glottic laryngeal carcinoma, won’t worsen the prognosis as well.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18007-e18007
Author(s):  
Yu Fujiwara ◽  
Yasuyoshi Sato ◽  
Naoki Fukuda ◽  
Naomi Hayashi ◽  
Xiaofei Wang ◽  
...  

e18007 Background: Concurrent chemoradiotherapy (CCRT) with cisplatin (CDDP) is a standard treatment for locally advanced head and neck cancer (LAHNC) in the definitive setting. Three cycles of 100 mg/m2 CDDP for every three weeks (Q3W) are now recommended but compliance with CCRT is relatively low due to its severe toxicity. Therefore, the potential de-escalation strategies for LAHNC have been discussed to decrease the therapeutic toxicity. Methods: Patients with LAHNC who underwent definitive CCRT with CDDP between 2012 and 2018 at The Cancer Institute Hospital of Japanese Foundation for Cancer Research were analyzed. Patients were classified into two groups based on the planned CDDP dose: (A) 100 mg/m2 and (B) 80 mg/m2 Q3W for three times. One-to-one propensity score matching was performed to minimize bias between two groups. After patients in two groups were matched by using propensity score, the overall survival (OS), recurrence-free survival (RFS), local recurrence-free survival (LRFS), and metastatic recurrence-free survival (MRFS) were analyzed by the Kaplan-Meier method with the Cox proportional hazards model. The follow-up term was set as two years to evaluate the early survival benefit. The dose and density of CDDP and the objective adverse events were also assessed. Results: A total of 304 patients were included with the median age of 62 (Interquartile range [IQR]: 54-67) years. Among them, 249 patients (82%) were male. Patients were treated with 100 mg/m2 CDDP (n = 145) and 80 mg/m2 CDDP (n = 159) regimens. After the propensity score matching, 119 patients were included in each group, respectively. There were no significant differences in baseline characteristics between two propensity-matched cohorts. The median follow-up time was 24 months in each group. Two-year OS was 93.0% (95% confidence interval [CI]: 88.4-97.8) in group A and 94.9% (91.0-99.0) in group B. Two-year RFS was 86.5% (80.6-92.9) in group A and 83.1% (76.6-90.1) in group B, respectively. No significant difference was observed in OS (Hazard ratio [HR] = 1.42, 95% CI: 0.49-4.08, p = 0.52), RFS (HR = 0.81, 95% CI: 0.42-1.57, p = 0.54), LRFS (HR = 0.57, 95% CI: 0.24-1.36, p = 0.20), and MFS (HR = 1.32, 95% CI: 0.52-3.35, p = 0.56). The median cumulative dose of CDDP was significantly higher in group A (300 mg, interquartile range [IQR]: 240-300) than in group B (240 mg, IQR:160-240) but the frequency of hematological, hepatic, renal, electrolytic, and grade 3-5 any adverse events was not significantly different between two groups. Conclusions: Our study showed no survival difference at 2-year follow-up between 100 mg/m2 and 80 mg/m2 CDDP regimens of definitive CCRT for LAHNC. This result could support the tide of the de-escalation strategy in head and neck cancer treatment. Longer follow-up is necessary and further prospective trials comparing CDDP dosage are warranted.


2011 ◽  
Vol 21 (2) ◽  
pp. 332-336 ◽  
Author(s):  
Ingrid Vandenput ◽  
Jone Trovik ◽  
Ignace Vergote ◽  
Philippe Moerman ◽  
Karin Leunen ◽  
...  

Objective:To assess the impact of adjuvant chemotherapy in early surgically staged type II endometrial cancer (serous [S], clear cell carcinoma [CC]) and carcinosarcomas (CS) on recurrence and survival.Materials and Methods:Patients diagnosed with stages I-II S-CC and CS after comprehensive surgical staging were retrospectively collected. Surgical staging was defined as pelvic lymphadenectomy of more than 11 nodes harvested and exploration of the upper abdomen, with our without omentectomy. Groups with (group A) and without (group B) platinum-based chemotherapy were compared.Results:We identified 69 patients with a mean age of 66 years (range, 48-88 years). Both groups showed similar baseline characteristics. Group A consisted of 34 patients (23 S-CC, 11 CS) with 10 (29%) recurrences outside the pelvis (7 S-CC, 3 CS). Group B included 35 patients (28 S-CC, 7 CS) of which 10 (29%) developed recurrence outside the pelvis (7 S-CC, 3 CS). The median recurrence-free survival was 22 months (range, 13-51 months) for group A versus 10 months (range, 1-59 months) for group B (P= 0.437). Five patients (15%) of group A and 9 (26%) of group B died of disease after a median follow-up of 29 months (range, 20-59 months) and 17 months (range, 4-64 months), respectively (P= 0.168).Conclusion:Recurrences in early-stage type II endometrial cancer and carcinosarcomas occur irrespective of adjuvant chemotherapy, but recurrence-free survival is prolonged when adjuvant chemotherapy is administered. Only prospective randomized intergroup trials can address the benefit of adjuvant chemotherapy in early-stage high-risk endometrial cancer.


2021 ◽  
Vol 11 ◽  
Author(s):  
Zhongbao Zhou ◽  
Yuanshan Cui ◽  
Shuangfeng Huang ◽  
Zhipeng Chen ◽  
Yong Zhang

BackgroundDue to the poor prognosis, the treatment of high-risk bladder cancer (HRBC) remains controversial. This meta-analysis aims to access the efficacy of intra-arterial chemotherapy (IAC) combined with intravesical chemotherapy (IC) versus IC alone after bladder-sparing surgery in HRBC.MethodsA systematic search of PubMed, Cochrane Library databases, EMBASE (until June 2020) was conducted. PRISMA checklist was followed. The data were analyzed by RevMan v5.3.0.ResultsA total of five articles including 843 patients were studied. The analysis demonstrated that the IAC + IC group had a greater improvement of overall survival (P = 0.02) and significant reduction in terms of tumor recurrence rate (P = 0.0006) and tumor progression rate (P = 0.008) compared with the IC group. The recurrence-free survival in the IAC + IC group was significantly higher than that in the IC group (P = 0.004), but there was no significant difference in progression-free survival between the two groups (P = 0.32). In addition, the combination of IAC and IC significantly extended tumor recurrence interval (P = 0.0001) and reduced tumor-specific death rate (P = 0.01) for patients with HRBC compared with IC alone. For side effects related with IAC, although about half of the patients experienced some toxicities, most of them were mild and reversible (grades 1–2, 22.3% vs. grade 3–4, 2.7%), mainly including nausea/vomiting (P = 0.0001), neutropenia (P = 0.002), and alanine aminotransferase (P = 0.0001).ConclusionPatients with HRBC treated with IAC + IC after bladder-sparing surgery had a marked improvement in the overall survival, recurrence-free survival, time interval to first recurrence, tumor recurrence rate, tumor progression rate, and tumor-specific death rate than patients treated with IC alone. However, progression-free survival was not significantly correlated with treatment strategy. In addition, patients seemed to tolerate well the toxicities related with IAC. Systematic Review RegistrationPROSPERO, identifier CRD42021232679.


2020 ◽  
Vol 30 (4) ◽  
pp. 565-572
Author(s):  
Wenhan Weng ◽  
Xiao Li ◽  
Shushi Meng ◽  
Xianping Liu ◽  
Peng Peng ◽  
...  

Abstract OBJECTIVES Video-assisted thoracoscopic thymectomy is becoming the preferable approach for early-stage thymoma. However, large thymomas are still recognized as a relative contraindication due to the possible risk of incomplete resection or capsular disruption. Thus, the aim of this study is to evaluate the feasibility of video-assisted thoracoscopic thymectomy for large thymomas. METHODS Patients diagnosed with Masaoka stage I–IV thymoma between April 2001 and December 2018 were retrospectively reviewed. All patients were divided into 2 groups: thymoma &lt;5.0 cm (group A) and thymoma ≥5.0 cm (group B). Propensity score matching analysis was performed to compare postoperative results. Recurrence-free survival and overall survival were compared for oncological evaluation. RESULTS A total of 346 patients were included in this study. In the propensity score matching analysis, 126 patients were included both in group A and group B. There was no significant difference between these 2 groups in terms of the R0 resection rate (95.2% vs 94.4%, P = 1.000), conversion rate (1.6% vs 3.2%, P = 0.684), operation time (119.4 ± 48.4 vs 139.1 ± 46.6 min, P = 0.955), blood loss (93.2 ± 231.7 vs 100.5 ± 149.3 ml, P = 0.649), duration of chest drainage (2.7 ± 1.6 vs 2.8 ± 2.0 days, P = 0.184), length of hospitalization (5.0 ± 3.9 vs 5.2 ± 2.9 days, P = 0.628) or postoperative complications (5.9% vs 8.5%, P = 0.068). There was no significant difference between these 2 groups in terms of the overall survival (P = 0.271) and recurrence-free survival (P = 0.288). CONCLUSIONS Video-assisted thoracoscopic thymectomy is a safe and effective approach for large thymomas (≥5 cm) with comparable surgical and oncological results.


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