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Background@#In China, secondary cytoreductive surgery (SCR) has been widely used in ovarian cancer (OC) over the past two decades. Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open. The preliminary data from our pre-SOC1 phase II study showed that selected patients with second relapse who never received SCR at recurrence may still benefit from surgery. Moreover, poly(ADP-ribose) polymerase inhibitors (PARPi) maintenance now has been a standard care for platinum sensitive relapsed OC. To our knowledge, no published or ongoing trial is trying to answer the question if patient can benefit from a potentially complete resection combined with PARPi maintenance in OC patients with secondary recurrence. @*Methods@#SOC-3 is a multi-center, open, randomized, controlled, phase II trial of SCR followed by chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance in patients with platinum-sensitive second relapsed OC who never received SCR at recurrence. To guarantee surgical quality, if the sites had no experience of participating in any OC-related surgical trials, the number of recurrent lesions evaluated by central-reviewed positron emission tomography–computed tomography image shouldn't be more than 3. Eligible patients are randomly assigned in a 1:1 ratio to receive either SCR followed by 6 cyclesof platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone. Patients who undergo at least 4 cycles of chemotherapy and must be, in the opinion of the investigator, without disease progression, will be assigned niraparib maintenance. Major inclusion criteria are secondary relapsed OC with a platinum-free interval of no less than 6 months and a possibly complete resection. Major exclusion criteria are borderline tumors and non-epithelial ovarian malignancies, received debulking surgery at recurrence and impossible to complete resection. The sample size is 96 patients. Primary endpoint is 12-month non-progression rate.
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Background@#Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice. @*Methods@#The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC).The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival.
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Background@#Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice. @*Methods@#The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC).The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival.
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Diabetic retinopathy (DR),which is a common complication of diabetic and the main cause of blindness,brings not only a heavy economic burden to society,but also seriously threatens to the patients'quality of life.Clinical researches on the therapies of DR are active at present,but how to perform a good clinical research with scientific design should be considered with high priority.The randomized controlled trial (RCT) is considered to be the gold standard for evidence-based medicine,but RCT is not always perfect.Limitations still exist in certain circumstance and the conclusions from RCTs also need to be interpreted by an objective point of view before clinical practice.Real world study (RWS) bridges the gap between RCT and clinical practice,in which the data can be easily collected without much cost,and results might be obtained within a short period.However,RWS is also faced with the challenge of not having standardized data and being susceptible to confounding bias.The standardized single disease database for DR and propensity score matching method can provide a wide range of data sources and avoid of bias for RWS in DR.
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Background and purpose:Cancer is a common disease. Multidisciplinary approach is the best model for cancer treatment. Cancer staging is the basis for diagnosis, treatments and prediction of prognosis.The survey is to give an overview of the current application of cancer multidisciplinary approach and UICC or other international cancer staging in mainland China. We made inquiries to our Chinese oncologists’ experience of using these staging and share their comments and recommendations. For those cancers common in China, Chinese oncologists and academic societies should provide more information of staging, therapies, outcome, prognostic predictors of prognosis, etc. to make international stage systems, like UICC or AJCC, a more appropriate, accurate and acceptable guide to individual patients’ staging and treatment, to predict outcome and to facilitate clinical trials better. Methods: This survey was done from 2012 to 2013 by questionnaires. The questions were answered for 10 major cancers in China (liver cancer, esophageal cancer, nasopharyngeal carcinoma, lung carcinoma, breast cancer, gastric cancer, colorectal cancer, gynecologic cancer, prostate cancer and lymphoma). Thirty-three questionnaires have been answered by national wide hospitals including provincial cancer hospitals, district cancer hospitals and departments of oncology in general hospitals. We also site visited 7 grade B hospitals. Results:Multidisciplinary approach is not widely used in the hospitals. UICC or AJCC stages have been widely used for 10 cancers, but for cancers that were uncommon in the West;while common in China (nasopharyngeal carcinoma, liver cancer) the staging proposed by Chinese society have also been used to replace UICC/AJCC. Conclusion:We suggest a wild implementation of multidisciplinary approach. For those cancers common in China Chinese oncologists and academic societies should provide more information of staging, therapies, outcome, prognostic predictors of prognosis etc. to make international stage systems, like UICC or AJCC, a more appropriate, accurate and acceptable guide to individual patients’ staging and treatments, to predict outcome and to facilitate clinical trials better.
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Objective To explore the main factors affecting medical expenses of patients with colorectal cancer(CRC)and reduce such expenses by optimizing the clinical pathway of CRC according to the influencing factors.Methods Data of 467 discharged and medical insured CRC patients at Shanghai Cancer Center,Fudan University,were collected from 2009 to 2010.A multiple linear regression model was applied to analyze the influencing factors of medical expenses.The clinical pathway of CRC was optimized,and medical expenses before and after optimization were compared.Results Our data found days of stay and complications had impact on the medical expenses.Also,medical expenses were decreased accordingly with optimization of clinical pathway of CRC.Conclusion This study provides evidence for decision-making on single disease payment and medical insurance compensation on CRC.It is also meaningful to reduce the economic burden of patients with CRC.