Background Two prevailing, totally implantable venous access ports are routinely utilized in oncology: chest port or arm port. This systematic review with meta-analysis was conducted to compare safety and efficiency of the two techniques. Methods We performed evidence acquisition intensively from PubMed, Embase, and Cochrane Library. Available comparative studies that evaluated both techniques were identified. The outcomes of interest included total complication events, procedure-related infections, thrombosis, intra-operative complications, mechanical complications, conversion rate, early port removal, and operating time. Results Thirteen comparative studies including 3,896 patients (2,176 for chest ports, and 1,720 for arm ports) were identified. The present study showed that arm port was associated with higher procedure conversion rate (2.51% in chest port group and 8.32% in arm port group; odd ratios [OR] 0.27, 95% confidence interval [CI] 0.15-0.46; p <0.001), but lower incidence of intra-operative complications (1.38% in chest port group and 0.41% in arm port group; OR 2.38, 95% CI 1.07–5.29; p =0.03). There were no between-group differences with respect to total complication events, procedure-related infections, thrombosis, mechanical complications, early port removal, and operating time. Subgroup analysis of patients under 60 years revealed that no significant difference was detected in intra-operative events (1.19% in chest port group and 0.02% in arm port group, OR 2.59, 95% CI 0.74–9.08; p <0.14), indicating that age may be a risk factor for intra-operative events. Sensitivity analysis did not change conclusions of all endpoints of interest. Conclusion Arm port is associated with higher procedure conversion rate, but lower incidence of intra-operative complications, and age may be a risk factor for intra-operative events.

No abstract

A 7 1 9 -A 8 1 3 chemotherapy. Methods: We performed a systematic literature search of the EMBASE, MEDLINE, Cochrane Library, Google Scholar, ABI/Inform, and the Web of Science using such search terms "filgrastim," "pegfilgrastim," "cost analysis," and "economic evaluation." Studies were limited to primary research in patients with solid tumor cancer, specifically, studies comparing filgrastim with pegfilgrastim and resulting in full manuscripts. Identified studies were evaluated by the Drummond checklist 6 and characterized by study perspectives, time horizon, data sources, and funding. Results: Six studies fulfilled the inclusion criteria. Most studies modeled hypothetical cohorts of women aged 30-80 years with breast cancer (Stages I-III) from a payer's perspective. The median Drummond score was 9 of 10 (range, 8-9). Methodological and reporting variations were common. Key assumptions were made about FN-related deaths during chemotherapy, hospitalization and outpatient management, chemotherapy costs, and data sources. All six studies were funded by the drug manufacturer. Pegfilgrastim was found to be cost-saving compared to 11-day filgrastim. However, when compared to 6-day filgrastim, the choice of intervention depends on the decision-maker's willingnessto-pay. ConClusions: Variations in methodology, reporting, and assumptions made comparisons between studies difficult and may explain in part the observed results reported in EEs. Studies independent of industry sponsor are needed to make conclusive interpretations. PCN22objeCtives: Cost-effectiveness analysis and cost-utility analysis were adopted to evaluate the tertiary breast cancer screening and diagnosis system in Guangdong province. Methods: Using data from Guangdong project to evaluate the validity and reliability of screening strategies. The intervention group received tertiary screening and diagnosis system, while control group received routine screening. The actual cost, detection rate and cost-effectiveness ratio were calculated. The Markov simulation model was constructed based on the natural history of breast cancer with TreeAge Pro 2011. The model was running over thirty years (each cycle represents one year). The sensitivity analysis was performed for incidence of breast cancer and health state utility. Results: The intervention group involved 26224 females while the control group involved 24282. The detection rate of breast cancer (1/10 million) was 91.54 and 28.86. The percentage of early stage breast cancer was 45.83% and 28.57%, respectively. The highest detection rate was found in women aged from 45 to 65. In order to detection one case of breast cancer, the number need to invite for screening program was 1595. Cost-effectiveness analysis was 6152.37yuan per detection rate of breast cancer (1/10 million). During the following 30 years, comparing to the control group, the tertiary breast cancer screening and diagnosis system for 100 thousand women will reduce 61 cases of breast cancer, and save 557.00 LYs, 649.05 QALYs. With the discount ra...

In SOFT study, subgroup analysis for hormone receptor-positive (HR+) breast cancer women younger than 35 years indicated better 5-year DFS in OFS+exemestane arm than OFS+tamoxifen. Since only about 11% of women included were younger than 35 years of age, this subgroup analysis result is underpowered. In addition, there still no specific randomized clinical trial focusing on endocrine treatment in women younger than 35 years of age. The purpose of this study is to compare the efficacy of gonadotropin releasing hormone agonists (GnRHa)+tamoxifen versus GnRHa+AIs in HR+ early breast cancer patients under age 35 with intermediate or high risk for disease recurrence. Study design This is a prospective, open label, multicentre, randomized controlled trial that compared the efficacy of GnRHa+tamoxifen versus GnRHa+AIs in HR+ early breast cancer patients under age 35 with intermediate or high risk for disease recurrence. This study was initiated by the first affiliated hospital of Sun Yat-sen university in 2016. Twenty-four hospitals in China participate in this trial. The protocol was approved by the appropriate regulatory and ethics authorities for each centre. This trial has been registrated at ClinicalTrials.gov. The NCT Number is NCT02914158. Criteria for patient eligibility: 1. Written informed consent must be signed. 2. ECOG≤2. 3. Histologically proven HR+ (ER≥1% by IHC) invasive breast cancer. 4. Age≤35, premenopausal. 5. No distant metastatic disease. 6. T≥2cm or with at least 1 axillary lymph node involved. 7. Patient must accept proper surgery, systemic therapy and radiation therapy if necessary. 8. Laboratory exam criteria for enrollment: hemoglobin ≥10g/dl, white blood cell ≥4,000/mm3, platelets ≥100,000/mm3, glutamic oxalacetic transaminase, glutamic-pyruvic transaminase, alkaline phosphatase ≤2 times upper limit of normal (ULN), total bilirubin, creatinine clearance rate ≤1.5 times ULN. Criteria for patient ineligibility: 1. Patients who are pregnant or lactating at the time of randomization or refuse to contraception.2. Patients who received organ transplantation. 3. Patients who have other malignant diseases within 5 years. 4. Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study. 5. Patients with sever hepatic, renal, cardiovascular, respiratory, digestive diseases or uncontrolled diabetes. 6. Patients who participate in other clinical trials. 7. Patients who allergy to goserelin, leuprorelin, tamoxifen or AIs. Statistical analysis According to previous results, 5-year DFS for OFS+tamoxifen in HR+ breast cancer patients under age 35 with intermediate or high risk of disease recurrence was 73% vs. 81% for OFS+AIs. This trial designed 80% power to detect a between-group difference using a two-sample log-rank test (two-sided a=0.05). To allow for missing 10% data, the study planned to enroll 680 patients (340 patients for each group) in 5 years. The statistical design assumed that 197 primary end point events should occur during 5-year follow-up and OFS+AIs should decrease 30% DFS relative risk. The calculations were performed using PASS 11. Treatment details Patients enrolled are randomized 1:1 to two arms in 8 weeeks after surgery, adjuvant chemotherapy or radiation therapy. Goserelin 3.6mg or leuprorelin 3.75mg is injected subcutaneously every 28 days for 5 years. Arm A: Tamoxifen 20mg orally daily. Arm B: Exemestane 25mg, letrozole 2.5mg or anastrozole 1mg orally daily. Stratification Stratified by HER2 and axillary lymph node status. Primary end point: Disease free survival. Secondary end point: Overall survival. Invasive Breast Cancer Recurrence-Free Interval. Adverse Effects Rate. Citation Format: Zhen Shan, Nan Shao, Zhongyu yuan, Qianjun Chen, Anqin Zhang, Kun Wang, Ailing Zhang, Li Cai, Yuhua Song, Herui Yao, Hongmin Ma, Heng Huang, Jianwen Li, Yuanqi Zhang, Lehong Zhang, Jincai Zhong, Hui Liu, Zhiyong Wu, Li Zhao, Feihai Ling, Weixiong Yang, Rui Zhuo, Xiangyang Song, Ying Lin. Adjuvant ovarian suppression plus aromatase inhibitor or tamoxifen for hormone receptor-positive breast cancer in women younger than 35 (ASPAIT): A multicenter randomized clinical trial [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT1-04-01.