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Yang L.-Y.,Biostatistics and Informatics Unit | Yang L.-Y.,Gynecologic Cancer Research Center | Lai C.-H.,Chang Gung University
Journal of Biopharmaceutical Statistics

In recent years, quantitative evaluation for biosimilarity has been taken seriously due to the development of biosimilar products. The concept for assessment of biological products is very different from that of small-molecule drug products because of the variability with respect to the manufacturing process and environmental factors of the biological products. In this article, we propose an estimate method for a biosimilar index and the related lower bound based on the concept of reproducibility probability by assessing power. In addition, some approximations are proposed and compared in regard to simplicity and accuracy. Copyright © 2014 Taylor & Francis Group, LLC. Source

Chung I.-H.,Chang Gung University | Wu T.-I.,Chang Gung University | Wu T.-I.,Taipei Medical University | Liao C.-J.,Chang Gung University | And 6 more authors.

Cervical carcinoma is the third-most common cause of cancer-related deaths in women worldwide. However, the molecular mechanisms underlying the metastasis of cervical cancer are still unclear. Oligonucleotide microarrays coupled with bioinformatics analysis show that cytoskeletal remodeling and epithelial-to- mesenchymal transition (EMT) are significant pathways in clinical specimens of cervical cancer. In accord with clinical observations demonstrating ectopic expression of lipocalin 2 (LCN2), an oncogenic protein associated with EMT, in malignant tumors, was significantly upregulated in cervical cancer and correlated with lymph node metastasis. Overexpression of LCN2 enhanced tumor cell migration and invasion both in vitro and in vivo. Conversely, knockdown or neutralization of LCN2 reduced tumor cell migration and invasion. LCN2-induced migration was stimulated by activation of the EMT-associated proteins, Snail, Twist, N-cadherin, fibronectin, and MMP-9. Our findings collectively support a potential role of LCN2 in cancer cell invasion through the EMT pathway and suggest that LCN2 could be effectively utilized as a lymph node metastasis marker in cervical cancer. Source

Huang C.-Y.,Gynecologic Cancer Center | Huang C.-Y.,National Taiwan University Hospital | Huang C.-Y.,National Taiwan University | Tang Y.-H.,Chang Gung University | And 14 more authors.
Gynecologic Oncology

Objective To investigate the clinical and pathological characteristics and the management of uterine papillary serous carcinoma (UPSC) in relation to patients' outcomes. Methods Clinicopathological data and the management of patients treated between 1991 and 2010 at 11 member hospitals of the Taiwanese Gynecologic Oncology Group (TGOG) were retrospectively reviewed. The Kaplan-Meier method was used to generate survival curves, and factors predictive of outcome were compared using the log-rank test and Cox regression analysis. Results A total of 119 pure UPSC patients were recruited. Stages I, II, III, and IV were identified in 34.5%, 2.5%, 36.1%, and 26.9% of the patients, respectively. The recurrence rate was 20.5% in FIGO stage I/II disease and 55.2% in FIGO stage III/IV disease. The 5-year overall survival rates for the patients with stage I, II, III, and IV disease were 92.0%, 66.7%, 34.2%, and 17.3%, respectively. Multivariate analysis showed that tumor stage (stage III/IV hazard ratio [HR] 8.65, 95% confidence interval [CI] 3.00-24.9) and optimal cytoreduction (HR 0.40, 95% CI 0.22-0.73) independently influenced the overall survival rate of UPSC patients. In addition, optimal cytoreduction (HR 0.36, 95% CI 0.17-0.78) and the combination of chemotherapy and radiation (HR 0.11, 95% CI 0.04-0.37) improved the overall survival of the advanced stage (FIGO stage III/IV) UPSC patients. Conclusions UPSC represents an aggressive subtype of endometrial cancer commonly accompanied by extra-uterine disease. Comprehensive surgical staging with cytoreductive surgery is mandatory and beneficial for UPSC patients. Systemic chemotherapy combined with radiation should be considered as an adjuvant therapy for advanced stage UPSC patients. © 2014 Elsevier Inc. Source

Chen T.-C.,Mackay Memorial Hospital | Chen T.-C.,Taipei Medical University | Chen T.-C.,Tatung University | Huang H.-J.,Linkou Medical Center | And 18 more authors.
Gynecologic Oncology

Objective: To evaluate the role of surgery, radiation therapy and chemotherapy in the management of small cell carcinoma of the uterine cervix (SCCC) through a retrospective study of Taiwanese Gynecologic Oncology Group. Methods: We reviewed the medical records and histological files of 144 patients with FIGO stages IA-IIB SCCC treated in 11 main hospitals in Taiwan from 1987 to 2009. Results: There were 110 patients receiving primary surgery and 34 primary radiation therapy. Most patients in each group also received chemotherapy as part of primary treatment. A lower loco-regional failure rate was observed in patients who received primary radiation therapy than in those who had primary surgery (6% vs. 27%; P = 0.009). The 5-year overall survival (OS) was 89% for 13 surgically treated patients with cervical tumor â‰2 cm and no lymphovascular space involvement (LVSI) in whom recurrence was noted in 2 of 4 patients without receiving adjuvant chemotherapy and none in the 9 patients who had chemotherapy. Excluding these 13 patients, primary radiation therapy with at least 5 cycles of platinum-based chemotherapy (n = 14, including 12 stages IB2-IIB) resulted in a 5-year OS of 78%, better than that of 46% by primary surgery (n = 97, including 40 stages IB2-IIB) (P = 0.046). Conclusions: None of the 9 patients with cervical tumor 2 cm and no LVSI showed disease recurrence after primary surgery and adjuvant chemotherapy. For most patients with stages I-II, primary radiation therapy with aggressive chemotherapy was associated with better survival than surgery. © 2015 Elsevier Inc. All rights reserved. Source

Wang C.-J.,Chang Gung University | Chao A.,Chang Gung University | Chao A.,Gynecologic Cancer Research Center | Yang L.-Y.,Gynecologic Cancer Research Center | And 11 more authors.
International Journal of Gynecological Cancer

Objective: Growing evidence suggests that fertility-preserving treatment is feasible for young women with early-stage, low-grade endometrial carcinoma. However, published data on their long-term outcomes and prognostic factors remain scanty. We aimed to investigate the outcomes of young women receiving fertility-preserving treatment. Methods: Between 1991 and 2010, the outcomes of young women with grade 1 endometrioid endometrial carcinoma at presumed stage IA (without myometrial invasion) who underwent fertility-preserving treatment of megestrol acetate 160 mg/d with or without other hormonal agents were retrospectively analyzed. Results: We identified 37 eligible patients (median age, 32 years; range, 18-40 years). The median follow-up time was 78.6 months (range, 19.1-252.8 months). Complete response (CR) lasting more than 6 months was achieved in 30 (81.1%) women. Responders were significantly younger than nonresponders (P = 0.032). Of the 30 women who had a CR, 15 (50.0%) had disease recurrence. The 5-, 10-, and 15-year cumulative recurrence-free survival rates were 51.0%, 51.0%, and 34.0%, respectively. Notably, those recurred were significantly older (P = 0.003), and the time to CR was significantly longer (P = 0.043) than those without recurrence. One patient developed late recurrences at 156 months, and 2 patients developed ovarian metastasis (6 and 137 months from diagnosis). All the patients are currently alive. Conclusions: This study demonstrates the feasibility of high-dose megestrol acetate-based therapy for fertility preservation. The substantial risk of late recurrences highlights the need for long-term follow-up studies of large sample sizes with in-depth tumor and host molecular signatures. Copyright © 2014 by IGCS and ESGO. Source

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