scholarly journals Relationships between pathological factors and long-term outcomes in patients enrolled in two prospective randomized controlled trials comparing the efficacy of oral tegafur–uracil with CMF (N·SAS-BC 01 trial and CUBC trial)

2020 ◽  
Author(s):  
Shinji Ohno ◽  
Shigehira Saji ◽  
Norikazu Masuda ◽  
Hitoshi Tsuda ◽  
Futoshi Akiyama ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Receptors ◽  
Cox Model ◽  
Tumor Infiltrating Lymphocytes ◽  
Rank Test ◽  
Long Term Outcomes ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Purpose To evaluate the efficacies of cyclophosphamide, methotrexate, and fluorouracil (CMF) and tegafur–uracil (UFT) as adjuvant therapy in patients with resected stage I–IIIA breast cancer by immunohistochemistry (IHC)-based subtype and to determine the relationships between clinicopathological factors and long-term outcomes. Methods A pooled analysis of the randomized controlled N·SAS-BC 01 and CUBC studies was conducted. Expression of hormone receptors (HRs; estrogen and progesterone receptors), human epidermal growth factor receptor 2 (HER2), and Ki67were assessed by IHC. Tumor-infiltrating lymphocytes (TILs) and nuclear/histological grades were determined by hematoxylin and eosin staining. Relapse-free survival (RFS) and overall survival (OS) were estimated by Kaplan–Meier analysis and hazard ratios were determined by Cox model adjusted for baseline tumor size and nodal status. Results A total of 689 patients (342 CMF and 347 UFT) were included in the analyses with a median follow-up of 11.1 years. There was no significant difference in RFS or OS between the two cohorts (RFS: 0.96 [95% confidence interval: 0.71–1.30], log-rank test p = 0.80; OS: 0.93 [0.64–1.35], p = 0.70). There was no difference in RFS or OS between the two cohorts for HR+/HER2− and HR+/HER2+ subtypes. RFS was significantly longer in patients treated with UFT compared with CMF in patients with HR−/HER2+ subtype (0.30 [0.10–0.88], p = 0.03). A high TILs level was associated with a better OS compared with low TILs level (p = 0.02). Conclusions This long-term follow-up study showed that RFS and OS were similar in patients with luminal-type breast cancer treated with CMF and UFT.

scholarly journals A follow-up study of a randomized controlled study evaluating safety and efficacy of leuprorelin acetate every-3-month depot for 2 versus 3 or more years with tamoxifen for 5 years as adjuvant treatment in premenopausal patients with endocrine-responsive breast cancer

Breast Cancer ◽  
2021 ◽  
Vol 28 (3) ◽  
pp. 684-697
Author(s):  
Junichi Kurebayashi ◽  
Eiichi Shiba ◽  
Tatsuya Toyama ◽  
Hiroshi Matsumoto ◽  
Minoru Okazaki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Disease Free Survival ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Observation Study ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Premenopausal Patients

Abstract Background Previously, we conducted the 5-year open-label, randomized controlled trial (RCT) of leuprorelin adjuvant therapy in post-operative premenopausal patients with endocrine-responsive breast cancer, which was a pilot study to investigate the optimal duration of leuprorelin treatment. Since, however, long-term outcomes became required for the adjuvant endocrine therapy, we performed this follow-up observation study. Methods Follow-up observation study was performed up to 10th year after randomization, continuing RCT to evaluate the efficacy and safety of leuprorelin every 3 months for ≥ 3 versus 2 years, with daily tamoxifen for 5 years. Primary endpoints were disease-free survival (DFS) and 2-year landmark DFS. Results Eligible patients (N = 222) were randomly assigned to receive leuprorelin for either 2 years (N = 112) or ≥ 3 years (N = 110) with tamoxifen. Leuprorelin treatment for ≥ 3 years versus 2 years provided no significant difference in DFS (HR 0.944, 95% CI 0.486–1.8392) or 2-year landmark DFS (N = 99 and 102 in 2-year and ≥ 3-year groups, HR 0.834, 0.397–1.753). In small, higher-risk subgroup (n = 17); however, 2-year landmark DFS in ≥ 3-year group was significantly longer (HR 0.095, 0.011–0.850) than that in 2-year group. The incidence of bone-related adverse events was around 5% in both groups. Conclusions Adjuvant leuprorelin treatment for ≥ 3 years with tamoxifen only showed similar efficacy and safety profiles to those for 2 years in analyses among all patients but suggested greater benefit in higher-risk patients. No new safety signal was identified for long-term leuprorelin treatment. Trial registration number Not applicable. This was an observational study.

scholarly journals Conventional versus hypofractionated postmastectomy radiotherapy: a report on long-term outcomes and late toxicity

2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Imjai Chitapanarux ◽  
Pitchayaponne Klunklin ◽  
Attapol Pinitpatcharalert ◽  
Patumrat Sripan ◽  
Ekkasit Tharavichitkul ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Late Toxicity ◽  
Breast Cancer Patients ◽  
Long Term Outcomes ◽  
Postmastectomy Radiotherapy ◽  
Free Survival ◽  
Significant Difference

Abstract Objective We evaluated the long-term outcomes and late toxicity of conventional fractionated (CF) and hypofractionated (HF) postmastectomy radiotherapy (PMRT) in terms of locoregional recurrence-free survival (LRRFS), disease-free survival (DFS), overall survival (OS), and late toxicity. Methods A cohort of 1640 of breast cancer patients receiving PMRT between January 2004 and December 2014 were enrolled. Nine hundred eighty patients were treated with HF-PMRT: 2.65 Gy/fraction to a total of 42.4–53 Gy and 660 patients were treated with CF-PMRT: 2 Gy/fraction to a total of 50–60 Gy. Results The median follow-up time was 71.8 months (range 41.5–115.9 months). No significant difference was found in the rates of 5-year LRRFS, DFS, and OS of HF-PMRT vs CF-PMRT; 96% vs. 94% (p = 0.373), 70% vs. 72% (p = 0.849), and 73% vs. 74% (p = 0.463), respectively. We identified a cohort of 937 eligible breast cancer patients who could receive late toxicities assessment. With a median follow-up time of this patient cohort of 106.3 months (range 76–134 months), there was a significant higher incidence of grade 2 or more late skin (4% vs 1%) and subcutaneous (7% vs 2%) toxicity in patients treated with HF-PMRT vs CF-PMRT. Patients who received additional radiation boost were significantly higher in the HF-PMRT group. Grade 2 or more late RTOG/EORTC lung toxicity was significant lesser in HF-PMRT vs CF-PMRT (9% vs 16%). Grade 1 brachial plexopathy was also significant lesser in HF-PMRT vs CF-PMRT (2% vs 8%). Heart toxicity and lymphedema were similar in both groups. Conclusions HF-PMRT is feasible to deliver with comparable long-term efficacy to CF-PMRT. HF-PMRT had higher grade 2 or more skin and subcutaneous toxicity but less lung and brachial plexus toxicity.

scholarly journals Randomized Controlled Trial of the Clinical Recovery and Biodegradation of Polylactide-co-glycolide Implants Used in the Intramedullary Nailing of Children’s Forearm Shaft Fractures with at Least Four Years of Follow-Up

2021 ◽  
Vol 10 (5) ◽  
pp. 995
Author(s):  
Marja Perhomaa ◽  
Tytti Pokka ◽  
Linda Korhonen ◽  
Antti Kyrö ◽  
Jaakko Niinimäki ◽  
...  
Keyword(s):  
Intramedullary Nailing ◽  
Controlled Trial ◽  
Long Term Outcomes ◽  
Intramedullary Nails ◽  
Metal Implants ◽  
Shaft Fractures ◽  
Fractures In Children ◽  
Significant Difference

The preferred surgical fixation of forearm shaft fractures in children is Elastic Stable Intramedullary Nailing (ESIN). Due to known disadvantageous effects of metal implants, a new surgical method using biodegradable polylactide-co-glycolide (PLGA) intramedullary nails has been developed but its long-term outcomes are unclear. The aim of this study was to compare the long-term outcomes of Biodegradable Intramedullary Nailing (BIN) to ESIN and assess the biodegradation of the study implants via magnetic resonance imaging (MRI). The study population of the prospective, randomized trial consisted of paediatric patients whose forearm shaft fractures were treated with BIN (n = 19) or ESIN (n = 16). Forearm rotation at minimally four years’ follow-up was the main outcome. There was no clinically significant difference in the recovery of the patients treated with the BIN as compared to those treated with the ESIN. More than half of the implants (57.7%, n = 15/26) were completely degraded, and the rest were degraded almost completely. The PLGA intramedullary nails used in the treatment of forearm shaft fractures in this study resulted in good function and anatomy. No unexpected disadvantages were found in the degradation of the implants. However, two implant failures had occurred in three months postoperatively.

124Impact of intimal tracking for recanalization of CTO lesions on long-term clinical outcomes

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Kano ◽  
K Nasu ◽  
M Habara ◽  
T Shimura ◽  
M Yamamoto ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cox Regression ◽  
Target Lesion ◽  
Hazard Ratio ◽  
Rank Test ◽  
Total Occlusion ◽  
Significant Difference ◽  
The Impact

Abstract Background For recanalization of coronary chronic total occlusion (CTO) lesions, subintimal guidewire tracking in both antegrade and retrograde approaches are commonly used. Purpose This study aimed to assess the impact of subintimal tracking on long-term clinical outcomes after recanalization of CTO lesions. Methods Between January 2009 and December 2016, 474 CTO lesions (434patients) were successfully recanalized in our center. After guidewire crossing in a CTO lesion, those lesions were divided into intimal tracking group (84.6%, n=401) and subintimal tracking group (15.4%, n=73) according to intravascular ultrasound (IVUS) findings. Long-term clinical outcomes including death, target lesion revascularization (TLR), target vessel revascularization (TVR) were compared between the two groups. In addition, the rate of re-occlusion after successful revascularization was also evaluated. Results The median follow-up period was 4.7 years (interquartile range, 2.8–6.1). There was no significant difference of the rate of cardiac death between the two groups (intimal tracking vs. subintimal tracking: 7.0% vs. 4.1%; hazard ratio, 0.61; 95% confidence interval [CI], 0.19 to 2.00; p=0.41), TLR (14.3% vs. 16.2%; hazard ratio, 1.34; 95% CI, 0.71 to 2.53; p=0.37), and TVR (17.5% vs. 20.3%; hazard ratio, 1.27; 95% CI, 0.72 to 2.23; p=0.42). However, the rate of re-occlusion was significantly higher in the subintimal tracking group than intimal tracking group at 3-years re-occlusion (4.2% vs. 14.5%; log-rank test, p=0.002, Figure). In the multivariate COX regression, subintimal guidewire tracking was an independent predictor of re-occlusion after CTO recanalization (HR: 5.40; 95% CI: 2.11–13.80; p<0.001). Figure 1 Conclusions Subintimal guidewire tracking for recanalization of coronary CTO was associated with significantly higher incidence of target lesion re-occlusion during long-term follow-up period.

scholarly journals Liver Transplantation from Voluntary Organ Donor System in China: A Comparison between DBD and DCD Liver Transplants

2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
Wei Chen ◽  
Dipesh Kumar Yadav ◽  
Xueli Bai ◽  
Jianying Lou ◽  
Risheng Que ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Organ Donation ◽  
Survival Rates ◽  
Organ Donor ◽  
Long Term Outcomes ◽  
Significant Difference ◽  
Short And Long Term ◽  
Donor System

Background. In China, the cases of liver transplantation (LT) from donation after citizens’ death have rose year by year since the citizen-based voluntary organ donor system was initiated in 2010. The objective of our research was to investigate the early postoperative and late long-term outcomes of LT from donation after brain death (DBD) and donation after circulatory death (DCD) according to the current organ donation system in China. Methods. Sixty-two consecutive cases of LT from donation after citizens’ death performed in our hospital between February 2012 and June 2017 were examined retrospectively for short- and long-term outcomes. These included 35 DCD LT and 27 DBD LT. Result. Subsequent median follow-up time of 19 months and 1- and 3-year graft survival rates were comparative between the DBD group and the DCD group (81.5% and 66.7% versus 67.1% and 59.7%; P=0.550), as were patient survival rates (85.2% and 68.7% versus 72.2% and 63.9%; P=0.358). The duration of ICU stay of recipients was significantly shorter in the DBD group, in comparison with that of the DCD group (1 versus 3 days, P=0.001). Severe complication incidence (≥grade III) after transplantation was identical among the DBD and DCD groups (48.1% versus 60%, P=0.352). There was no significant difference in postoperative mortality between the DBD and DCD groups (3 of 27 cases versus 5 of 35 cases). Twenty-one grafts (33.8%) were lost and 18 recipients (29.0%) were dead till the time of follow-up. Malignancy recurrence was the most prevalent reason for patient death (38.8%). There was no significant difference in incidence of biliary stenosis between the DBD and DCD groups (5 of 27 cases versus 6 of 35 cases, P=0.846). Conclusion. Although the sample size was small to some extent, this single-center study first reported that LT from DCD donors showed similar short- and long-term outcomes with DBD donors and justified the widespread implementation of voluntary citizen-based deceased organ donation in China. However, the results should be verified with a multicenter larger study.

Psychosocial adjustment among women with breast cancer stages I and II: six-year follow-up of consecutive patients.

1994 ◽  
Vol 12 (9) ◽  
pp. 1778-1782 ◽  
Author(s):  
M Omne-Pontén ◽  
L Holmberg ◽  
P O Sjödén
Keyword(s):  
Breast Cancer ◽  
Psychosocial Adjustment ◽  
Social Adjustment ◽  
Negative Experience ◽  
Follow Up Study ◽  
Significant Difference ◽  
Long Term Follow Up ◽  
The Impact

PURPOSE To evaluate, in a long-term follow-up study of consecutive patients (N = 99), the impact of surgery--breast-conserving treatment (BCT) versus mastectomy (MT)--on psychosocial adjustment among women with breast cancer, pTNM stage I/II. PATIENTS AND METHODS Semistructured interviews were conducted at a median of 6 years (range, 5.8 to 8.1) after primary surgery. Sixty-six women were available for the long-term follow-up study. Twenty-six women had been treated with BCT and 40 with MT. RESULTS No statistically significant differences were found between the two groups concerning psychosocial adjustment, as measured by the Social adjustment Scale (SAS). In general, the levels of maladjustment were lower than at 13 months postoperatively, but 10% still showed maladjustment. Sixty percent of the women were unwilling to show themselves naked, and 22% felt that they had become less attractive because of the surgical treatment. In an explorative part of the interview, 68% of the women complained about how they had been informed of the diagnosis. A tendency toward a significant difference was found in the relation between previous maladjustment and a negative experience at the time of diagnosis (P = .07). CONCLUSION Few data are available on long-term follow-up results with regard to psychosocial adjustment among women after breast cancer surgery. This study provides the important information that there are no differences in patient psychosocial adjustment that can be ascribed to the type of surgery at 6-year follow-up evaluation.

Treatment of early breast cancer (EBC): A long-term follow-up study—GOCS experience

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11610-e11610
Author(s):  
J. Iturbe ◽  
A. Zwenger ◽  
J. A. Lacava ◽  
P. Perez Verdera ◽  
C. Vallejo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Therapy ◽  
Multivariate Regression ◽  
Hormone Receptors ◽  
Bilateral Breast Cancer ◽  
Distant Recurrence ◽  
Initial Diagnosis ◽  
Rank Test ◽  
Adjuvant Radiation

e11610 Background: Most cases of breast cancer are diagnosed at early stage of disease, therefore treatment is oriented to increase the relapse-free survival (RFS) and overall survival (OS). The prognosis, in comparison to other malignancies, has improved in the last decades as a result of mammographic screening. The objective of this study was to evaluate the incidence of local and distant recurrence, RFS and OS in women with EBC. Methods: From 01/1978 to 12/2004, 929 women with EBC were identified, 350 were stage I and 579 stage II (AJCC 2002). RFS was analyzed from the date of initial diagnosis to the date of local or distant recurrence. OS was estimated from the date of initial diagnosis to the last follow-up or date of death. Multivariate regression analyses were carried out using proportional hazard model proposed by Cox. RFS and OS were evaluated by the product-limit method of Kaplan and Meier, and differences between curves were assessed by means of log-rank test. Results: Median age was 51 years (28–92). Conservative surgery was performed in 69.7% of patients (pts). The median number of nodes examined was 17. Hormone receptors were ER+ in 65% and PR+ in 62% of pts. Adjuvant radiation therapy was administered to 73% of pts, whereas adjuvant chemotherapy to 29% and adjuvant hormone therapy to 18.5% of cases. Combined chemotherapy and hormone therapy was given to 34% of women. The median follow-up was 8.4 years (0.3–30). Local recurrence was documented in 37 pts (3.8%) whereas 269 developed metastatic disease (29%). Bilateral breast cancer was seen in 102 cases (10.9%) and 91 pts (9.7%) developed 2nd malignancies. RFS rate at 5, 10, 15, 20 and 25 years was 71%, 67%, 65%, 65% and 64% respectively. OS at 5, 10, 15, 20 and 25 years was 82%, 62%, 49%, 39% and 28% respectively. Factors that had an effect in OS demonstrated by the multivariate regression analysis were: histologic grade, tumor size, ER status, vascular and nodal involvement (p < 0.001). Conclusions: Clinical outcomes in EBC in our experience are similar to that reported in international literature. This group of pts continues to have a good prognosis as shown by the OS rate at 5, 10, 15, 20 and 25 years, although high percentage of pts continue to have recurrence and die from breast cancer after 5, 10, 15, 20 and 25 years of follow-up. No significant financial relationships to disclose.

Long-term cardiopulmonary mortality after radiation for locally advanced esophageal cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 99-99 ◽  
Author(s):  
Abigail Berman Milby ◽  
Andrzej Pawel Wojcieszynski ◽  
Smith Apisarnthanarax ◽  
James M. Metz ◽  
John Peter Plastaras
Keyword(s):  
Esophageal Cancer ◽  
Esophageal Carcinoma ◽  
Background Radiation ◽  
Univariate Analysis ◽  
Locally Advanced ◽  
Rank Test ◽  
Trimodality Therapy ◽  
Significant Difference

99 Background: Radiation (RT) is considered an integral component of trimodality therapy for locally-advanced esophageal carcinoma to improve locoregional control and potentially survival. However, the long-term risk of cardiopulmonary mortality (CPM) is not well-understood in this population. Methods: Patients age 20-85 with esophageal carcinoma with T3, T4 or node positive (N+) disease who underwent esophagectomy were identified within 17 Surveillance, Epidemiology, and End Results registries from 1988-2006. Patients with metastatic disease or <6 mo follow up were excluded. CPM was calculated for patients receiving vs not receiving RT and compared by the Kaplan-Meier method. The log-rank test was used for univariate associations and Cox proportional hazards model was used for multivariate analysis (MVA). Results: A total of 4,079 patients met the defined selection criteria of whom 2,408 were treated with RT, and 1,671 were not. Median age was 62.2 yrs (22-84) and follow-up was 22 mos (6-248). There was no significant difference in CPM in patients who received RT versus those who did not (p=0.8). At 10 yr, the majority of deaths were from esophageal cancer (73 with vs 78% without RT) compared to CPM (13.7 with vs 11.6% without RT). On univariate analysis ( table ), age <60, diagnosis era, and histology were significant independent predictors of CPM. On MVA, age <60 (HR 0.36) and diagnosis era (0.63 for 1994-2000 and 0.55 for 2000-2006) remained statistically significant for CPM. Conclusions: RT for esophageal cancer is not associated with an increased long-term risk of CPM in the overall population. Older age and earlier diagnosis era predict for CPM. Although survival in esophageal cancer is dominated by cancer deaths, advances in RT are still needed to prevent excess treatment-related mortality. [Table: see text]

scholarly journals Clinical outcomes and complications between FLACS and conventional phacoemulsification cataract surgery: a PRISMA-compliant Meta-analysis of 25 randomized controlled trials

2021 ◽  
Vol 14 (7) ◽  
pp. 1081-1091
Author(s):  
Li Chen ◽  
◽  
Xiao Lin ◽  
Hao-Yu Li ◽  
Yi Du ◽  
...  
Keyword(s):  
Cataract Surgery ◽  
Clinical Outcomes ◽  
Meta Analysis ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Long Term Follow Up ◽  
Distant Visual Acuity ◽  
Phacoemulsification Cataract Surgery

AIM: To update and investigate the clinical outcomes and complications between femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification cataract surgery (CPCS). METHODS: A Meta-analysis was performed using databases, including Pubmed, Embase, and the Cochrane library. At least one of the clinical outcomes and/or complications data in each included randomized controlled trials (RCT) was reported. The quality of the RCT was assessed with the Cochrane risk assessments tool. RESULTS: Overall, 25 RCTs including 3781 eyes were included. No statistically significant difference detected between FLACS and CPCS in terms of corrected distant visual acuity (CDVA), uncorrected distant visual acuity (UDVA), and central corneal thickness (CCT) at the long-term follow up, although FLACS showed better CDVA at 1wk postoperatively, and less increase in CCT at 1d and 1wk. FLACS had better postoperative endothelial cell count (ECC) at 1 and 4-6wk, while there was no significantly difference between FLACS and CPCS at 1d, 3 and 6mo [weighted mean difference (WMD): 51.54, 95% confidence interval (CI): -5.46 to 108.54, P=0.08; WMD: 48.52, 95%CI: -17.54 to 114.58, P=0.15; WMD: 12.17, 95%CI: -48.61 to 72.94, P=0.69, respectively]. Postoperative endothelial cell loss (ECL) of the FLACS was significantly lower than that of the CPCS at 1, 4-6wk, and 3mo (P=0.02, 0.008, 0.03, respectively). However, there was no significant difference between two groups at 6mo (WMD: -30.36, 95%CI: -78.84 to 18.12, P=0.22). No significant difference was discovered with respect to the macular edema [odds ratio (OR): 0.93, 95%CI: 0.42 to 2.05, P=0.85], capsular complication excluding posterior capsular tears (OR: 0.79, 95%CI: 0.42 to 1.50, P=0.47) and intraocular pressure change (OR: 0.82, 95%CI: 0.39 to 1.72, P=0.60). However, posterior capsular tears were more common in CPCS group (OR: 0.12, 95%CI: 0.01 to 0.98, P=0.05). The effective phacoemulsification times were significantly lower in the FLACS group compared to the CPCS group (WMD: -0.78, 95%CI: -1.23 to -0.34, P=0.0006). CONCLUSION: No statistically significant difference is discovered between FLACS and CPCS in clinical outcomes at the long-term follow up. However, higher rate of posterior capsular tears is detected in patients receiving CPCS.

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