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Modified intestinal isolation bag as promising tool in promoting bowel resumption after ovarian cancer cytoreductive surgery: a randomized clinical trial.
Perutelli, A, Ferrandina, G, Domenici, L, Cubeddu, A, Garibaldi, S, Aretini, P, Mazzanti, CM, Salerno, MG
Archives of gynecology and obstetrics. 2021;(3):733-742
Abstract
PURPOSE Postoperative ileus (POI) impairs patient recovery, prolonging hospital stay after major surgery in ovarian cancer (OvCa) patients. Thus, intraoperative bowel isolation is expected to reduce manipulation-related impairment. The aim of this study was to investigate the impact of intraoperative intestinal isolation bag on POI in OvCa patients submitted to primary surgery. METHODS A randomized trial including patients managed with or without isolation bag during OvCa primary surgery was conducted. Patients were selected by consecutive randomization. Primary endpoints were the time between surgery and resumption of bowel motility (as passage of first/continued flatus), assessing of postoperative nausea or vomiting and return to regular diet. Secondary endpoint was the impact of intestinal isolation bag on length of hospitalization in the two groups. RESULTS Ninety-two patients respecting inclusion criteria were eligible to be enrolled in the study (48 patients as Group 1 and 44 patients as Group 2). Thirty-eight (79.2%) patients, in which intraoperative isolation bag was used, experienced first/continued flatus within 3 days from surgery and they were susceptible to be discharged within 5 days, compared, respectively, to 34.3% of Group 2 (n = 15). Advantages were more evident in patients whose surgery took over 220 min (OR 0.02, CI 95% 0.001-0.57; p < 0.001) despite the type of surgical effort made. CONCLUSION Despite the small sample size, our study showed that the use of intestinal isolation bag can reduce incidence of POI and length of stay in OvCa patients submitted to primary cytoreductive surgery.
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FORWARD I: a Phase III study of mirvetuximab soravtansine versus chemotherapy in platinum-resistant ovarian cancer.
Moore, KN, Vergote, I, Oaknin, A, Colombo, N, Banerjee, S, Oza, A, Pautier, P, Malek, K, Birrer, MJ
Future oncology (London, England). 2018;(17):1669-1678
Abstract
Mirvetuximab soravtansine, an antibody-drug conjugate that binds with high affinity to folate receptor-α to provide tumor-directed delivery of the potent microtubule-disrupting agent DM4, has emerged as a promising investigational agent for the treatment of ovarian cancer, particularly in the setting of platinum-resistant disease. Here we describe the rationale and design of FORWARD I (NCT02631876), the first randomized, multicenter Phase III study to compare the safety and efficacy of mirvetuximab soravtansine versus investigator's choice of chemotherapy in women with folate receptor-α-positive, platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer. Patients will be randomized in a 2:1 ratio. The primary end point is progression-free survival, and key secondary objectives include comparison of overall response rates, overall survival and duration of response.
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Changing trends in reproductive/lifestyle factors in UK women: descriptive study within the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).
Gentry-Maharaj, A, Glazer, C, Burnell, M, Ryan, A, Berry, H, Kalsi, J, Woolas, R, Skates, SJ, Campbell, S, Parmar, M, et al
BMJ open. 2017;(3):e011822
Abstract
OBJECTIVE There has been considerable interest in the impact of reproductive factors on health but there are little data on how these have varied over time. We explore trends in reproductive/lifestyle factors of postmenopausal British women by analysing self-reported data from participants of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). DESIGN Prospective birth cohort analysis. SETTING Population cohort invited between 2001 and 2005 from age-sex registers of 27 Primary Care Trusts in England, Wales and Northern Ireland and recruited through 13 National Health Service Trusts. PARTICIPANTS 202 638 postmenopausal women aged 50-74 years at randomisation to UKCTOCS between April 2001 and October 2005. INTERVENTIONS Women were stratified into the following six birth cohorts (1925-1929, 1930-1934, 1935-1939, 1940-1944, 1945-1949, 1950-1955) based on year of birth. Self-reported data on reproductive factors provided at recruitment were explored using tabular and graphical summaries to examine for differences between the birth cohorts. OUTCOME MEASURES Trends in mean age at menarche and menopause, use of oral contraceptives, change in family size, infertility treatments, tubal ligation and hysterectomy rates. RESULTS Women born between 1935 and 1955 made up 86% of the cohort. Median age at menarche decreased from 13.4 for women born between 1925 and 1929 to 12.8 for women born between 1950 and 1955. Increased use of the oral contraceptives, infertility treatments and smaller family size was observed in the younger birth cohorts. Tubal ligation rates increased for those born between 1925 and 1945, but this increase did not persist in subsequent cohorts. Hysterectomy rates (17-20%) did not change over time. CONCLUSIONS The trends seen in this large cohort are likely to reflect the reproductive history of the UK female postmenopausal population of similar age. Since these are risk factors for hormone-related cancers, these trends are important in understanding the changing incidence of these cancers. TRIAL REGISTRATION NUMBER International Standard Randomised Controlled Trial Number: 22488978.
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Effect of Red Ginseng on Genotoxicity and Health-Related Quality of Life after Adjuvant Chemotherapy in Patients with Epithelial Ovarian Cancer: A Randomized, Double Blind, Placebo-Controlled Trial.
Kim, HS, Kim, MK, Lee, M, Kwon, BS, Suh, DH, Song, YS
Nutrients. 2017;(7)
Abstract
We evaluated the effect of red ginseng on toxicity, health-related quality of life (HRQL) and survival after adjuvant chemotherapy in patients with epithelial ovarian cancer (EOC). A total of 30 patients with EOC were randomly assigned to placebo (n = 15) and red ginseng groups (n = 15). All patients took placebo or red ginseng (3000 mg/day) for three months. Then, we compared changes of genotoxicity, HRQL and survival between the two groups. As a result, red ginseng reduced micronuclei yield in comparison with placebo despite no difference of binucleated cells index. Although red ginseng increased serum levels of alanine aminotransferase and aspartate aminotransferase significantly, they were within the normal value. Moreover, there were no differences in adverse events between placebo and red ginseng groups. In terms of HRQL, red ginseng was associated with improved emotional functioning and decreased symptoms of fatigue, nausea and vomiting, and dyspnea, reduced anxiety and interference affecting life and improved daytime somnolence. However, there was no effect of red ginseng on prognosis of EOC. Conclusively, red ginseng may be safe and effective to reduce genotoxicity and improve HRQL despite no benefit of survival in patients with EOC who received chemotherapy.
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Randomized phase II trial of sorafenib alone or in combination with carboplatin/paclitaxel in women with recurrent platinum sensitive epithelial ovarian, peritoneal, or fallopian tube cancer.
Schwandt, A, von Gruenigen, VE, Wenham, RM, Frasure, H, Eaton, S, Fusco, N, Fu, P, Wright, JJ, Dowlati, A, Waggoner, S
Investigational new drugs. 2014;(4):729-38
Abstract
BACKGROUND/PURPOSE This study was designed to evaluate the response and toxicity of sorafenib alone or when combined with carboplatin and paclitaxel in patients with platinum-sensitive, recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (EOC). METHODS Patients with recurrent platinum-sensitive EOC with no more than 2 prior courses of chemotherapy were randomized to single-agent sorafenib 400 mg twice daily or combination sorafenib 400 mg bid (days 2-19) with IV carboplatin (AUC 6) and IV paclitaxel 175 mg/m(2) (S+C/T) every 3 weeks. Single agent sorafenib could cross over to combination upon progression. RESULTS Patients were initially randomized to either arm, however, due to poor accrual, sorafenib arm was prematurely closed. A total of 13 patients were evaluable for response to sorafenib and 23 patients were evaluable for response to S+C/T. Objective response rate (RR) was 15 % for patients on sorafenib vs. 61 % for patients on S+C/T (p = 0.014); stable disease was seen in 62 % and 35 %, respectively. Clinical benefit rate (CBR) at 4 months (mos.) was 69 % for S and 65 % for S+C/T. The median progression free survival was 5.6 months on sorafenib vs. 16.8 months on S+C/T (p = 0.012) and there was no significant difference of overall survival between two arms (p = 0.974) with median overall survival 25.6 months under sorafenib vs. 25.9 months on S+C/T. Patients remained on trial for a median of 7.8 cycles on sorafenib and 5.4 cycles on S+C/T. CONCLUSION Sorafenib, alone or in combination with carboplatin and paclitaxel, has activity in patients with platinum-sensitive EOC. Sorafenib in combination with carboplatin and paclitaxel improved RR and PFS; however, there were increased grade and frequencies of toxicities.
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Use of dairy products, lactose, and calcium and risk of ovarian cancer - results from a Danish case-control study.
Faber, MT, Jensen, A, Søgaard, M, Høgdall, E, Høgdall, C, Blaakaer, J, Kjaer, SK
Acta oncologica (Stockholm, Sweden). 2012;(4):454-64
Abstract
BACKGROUND A number of epidemiological studies have examined the association between use of dairy products and risk of ovarian cancer, but results are conflicting. Using data from a large Danish population-based case-control study we here further examined the association between dairy consumption, lactose, and calcium and risk of overall ovarian cancer and histological types of ovarian cancer. MATERIAL AND METHODS In the period 1995-1999 we included 554 women with epithelial ovarian cancer and 1554 randomly selected age-matched controls (35-79 years). All women participated in a detailed personal interview that included questions about dairy consumption. Data were analysed using multiple logistic regression models. RESULTS Total dairy intake was associated with ovarian cancer risk (OR = 1.11; 95% CI: 1.07-1.15 per 100 ml/day). The association was strongest for milk [OR = 1.14; 95% CI: 1.03-1.27 per glass (200 ml)/day], soured milk products [OR = 1.49; 95% CI: 1.22-1.81 per portion (250 ml)/day] and yoghurt [OR = 1.65; 95% CI: 1.22-2.23 per portion (250 ml)/day]. In contrast, intake of cheese was associated with a decreased risk [OR = 0.70; 95% CI: 0.55-0.89 for > 1 portion (100 ml)/day compared with no intake]. Intake of lactose, but not calcium, was also associated with an increased ovarian cancer risk (OR = 1.24; 95% CI: 1.10-1.40 per 10 g of lactose/day). Similar risk patterns were observed for the different histological types of ovarian cancer, indicating virtually identical aetiologies with regard to dairy intake, lactose, and calcium. CONCLUSIONS Our results indicate that intake of dairy products is associated with a modest increased risk of ovarian cancer. In addition, ovarian cancer development was associated with lactose intake.
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Iron homeostasis and distal colorectal adenoma risk in the prostate, lung, colorectal, and ovarian cancer screening trial.
Cross, AJ, Sinha, R, Wood, RJ, Xue, X, Huang, WY, Yeager, M, Hayes, RB, Gunter, MJ
Cancer prevention research (Philadelphia, Pa.). 2011;(9):1465-75
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Abstract
Red meat consumption has been positively associated with colorectal cancer; however, the biological mechanism underlying this relationship is not understood. Red meat is a major source of iron, which may play a role in colorectal carcinogenesis via increased crypt cell proliferation, cytotoxicity, and endogenous N-nitrosation. In a nested case-control study within the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, we prospectively evaluated multiple iron exposure parameters, including dietary intake and serum measures of iron, ferritin, transferrin, total iron binding capacity (TIBC), and unsaturated iron binding capacity (UIBC) in relation to incident colorectal adenoma in 356 cases and 396 matched polyp-free controls. We also investigated variation in eight key genes involved in iron homeostasis in relation to colorectal adenoma in an additional series totaling 1,126 cases and 1,173 matched controls. We observed a positive association between red meat intake and colorectal adenoma [OR comparing extreme quartiles (OR(q4-q1)) = 1.59, 95% CI = 1.02-2.49, P(trend) = 0.03]. Serum TIBC and UIBC were inversely associated with colorectal adenoma (OR(q4-q1) = 0.57, 95% CI = 0.37-0.88, P(trend) = 0.03; and OR(q4-q1) = 0.62, 95% CI = 0.40-0.95, P(trend) = 0.04, respectively). Colorectal adenoma was not associated with serum ferritin, iron, or transferrin saturation or with polymorphisms in genes involved in iron homeostasis. Serum TIBC and UIBC, parameters that have a reciprocal relationship with overall iron load, were inversely related to colorectal adenoma, suggesting that individuals with lower iron status have a reduced risk of developing colorectal adenoma.
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Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m2) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel: follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial.
Markman, M, Liu, PY, Moon, J, Monk, BJ, Copeland, L, Wilczynski, S, Alberts, D
Gynecologic oncology. 2009;(2):195-8
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Abstract
OBJECTIVES A SWOG/GOG phase 3 trial exploring the impact of 12-monthly cycles of paclitaxel given to patients with advanced ovarian cancer who achieved a complete response to primary chemotherapy was discontinued by the Data Safety and Monitoring Committee when a prospectively defined interim analysis revealed a highly statistically significant improvement in progression-free survival (PFS). At study closure, it was too early to assess the impact on overall survival. METHODS Patients (n=296) received either 3 or 12 monthly cycles of paclitaxel (175 mg/m(2) over 3 h). RESULTS Of the 146 patients on the 3-cycle arm, 9 (6%) received >3 cycles. Median (12 versus 3 cycles; intention-to-treat analysis) updated PFS (all pts) 22 versus 14 months, p=0.006; overall survival (all pts) 53 versus 48 months, p=0.34. CONCLUSION Twelve cycles of single agent maintenance paclitaxel significantly improves PFS. Explanations for the lack of a favorable influence on overall survival include: (a) treatment at relapse equalized outcome; (b) the sample size was insufficient to reveal a difference; (c) "crossover" of patients from 3 cycles to longer treatment masked a potential difference. An ongoing phase 3 trial will hopefully provide a definitive answer to the question of the impact of this maintenance strategy on overall survival.
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Vitamin B6 points PC6 injection during acupuncture can relieve nausea and vomiting in patients with ovarian cancer.
You, Q, Yu, H, Wu, D, Zhang, Y, Zheng, J, Peng, C
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. 2009;(4):567-71
Abstract
The impact of chemotherapy-induced nausea and vomiting on the quality of life of ovarian cancer patients is well known. The purpose of this study was to compare the effectiveness of acupuncture plus vitamin B6 PC6 points injection with acupuncture or vitamin B6 alone in controlling emesis of 142 patients undergoing a highly emetogenic chemotherapy regimen between March 1, 2006, and June 30, 2008. The patients were divided into 3 groups randomly and were given different antiemesis treatments accordingly. All patients received the same concurrent antiemetic pharmacotherapy and high-dose chemotherapy. We compared the total number of emesis episodes and the proportion of emesis-free days among the 3 groups during the study period. The acupuncture plus vitamin B6 PC6 points injection group had significantly fewer emesis episodes and a greater proportion of emesis-free days than the acupuncture group or the vitamin B6 alone group. We conclude that acupuncture plus vitamin B6 PC6 point injection is a quite useful method against emesis in cancer patients undergoing chemotherapy.
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Renal protection with magnesium subcarbonate and magnesium sulphate in patients with epithelial ovarian cancer after cisplatin and paclitaxel chemotherapy: a randomised phase II study.
Bodnar, L, Wcislo, G, Gasowska-Bodnar, A, Synowiec, A, Szarlej-Wcisło, K, Szczylik, C
European journal of cancer (Oxford, England : 1990). 2008;(17):2608-14
Abstract
BACKGROUND The aim of this study was to examine the effect of magnesium supplementation on nephrotoxicity accompanying standard cisplatin-based chemotherapy in patients with epithelial ovarian cancer (EOC). PATIENTS AND METHODS A double-blind, placebo-controlled, randomised study was conducted in which study arm magnesium sulphate (5 g) was administered before each course of standard chemotherapy with paclitaxel (135 mg/m(2)/24 h) plus cisplatin (75 mg/m(2)) every 3 weeks in patients with EOC. Magnesium subcarbonate (500 mg), three times per day orally, was administered during the treatment intervals. The control arm was administered a placebo instead of both magnesium salts. Magnesium serum levels (sMg) and GFR markers: serum levels of creatinine (sCr), Cockroft-Gault (ClCG) and Modification Diet of Renal Disease (MDRD) formulae were recorded before each cycle, and 3 weeks after the sixth course. RESULTS 41 EOC patients were randomised and 40 were eligible. sMg varied significantly between the supplemented and placebo groups (p<0.0001). The control group showed a significantly greater decrease of GFR assessed by: sCr (p=0.0069), ClCG (p=0.0077) and MDRD (p=0.032) formulae compared with the magnesium supplemented group. CONCLUSIONS These results demonstrate the nephroprotective effect of magnesium supplementation during chemotherapy with cisplatin.