Two-week Rest Research Articles

Efficiency of oocytes retrieval during a repeated series of transvaginal ultrasound-guided puncture of follicles in Simmental heifers

The article presents data on the efficiency of a repeated series of transvaginal ultrasound-guided recovery of oocytes (OPU) in donor heifers of the Simmental breed. Two series were performed — five OPU sessions with an intensity of once a week and a two-week rest period between series. During the repeated series of OPUS, 1.7 fewer follicles were visualized in donor heifers on average per session compared to the value of this indicator established in the first series (7.0 versus 5.3 follicles, p < 0.05). A decrease in the number of ultrasound-visible follicles during repeated series at the trend level was noted in all five OPU sessions. During the repeat series, 0.4 fewer oocyte-cumulus complexes (OCCs) were obtained from one donor on average per session (3.1 versus 2.7 OCCs). There were no differences in the quality of OCCs between the two OPU series: the proportion of OCCs suitable for further use was 67.0% and 63.5%, respectively, while in individual OPU sessions the differences between the series were multidirectional. Fertilization of oocytes and further in vitro cultivation showed a significantly higher degree of the first division — crushing during the 1st series of OPU (p < 0.05), however, these differences were leveled with further cultivation: the yield of blastocysts was, respectively, 23.6% and 21.7%. Considering the absence of significant differences in the quantitative characteristics of the obtained oocytes, as well as their developmental competencies in vitro, conducting a repeat series of OPU after a two-week rest period may be recommended for obtaining oocytes in donor heifers of the Simmental breed.

Effects of short-term whole-body vibration training on muscle strength, balance performance, and body composition.

[Purpose] This study aimed to evaluate the changes in lower-extremity muscle strength, balance performance, and body composition. [Participants and Methods] In this study, 21 healthy university students who underwent short-term whole-body vibration training without previous whole-body vibration training participated. The study design was randomized between-groups design. Participants were randomly assigned to one of the three groups; control, training, and whole-body vibration training. All participants completed a six-week training protocol comprising a first two-week training period, two-week rest period following the first training period, and second two-week training period. Over four periods, the participants' lower-extremity muscle strength, balance performance, and body composition were evaluated. Separate three-by-four repeated-measure analyses of variance, with three exercise mode groups and four periods, were initially used to analyze the primary outcome variables; lower-extremity muscle strength, balance performance, and body composition. [Results] In the three groups, lower-extremity muscle strength, static and dynamic balance performances, and body composition showed no changes during all periods. [Conclusion] This study provides a better insight on the responsiveness of short-term whole-body vibration training and will help determine whole-body vibration programs in revalidation and training.

Prevalence of Sleep Hygiene Awareness, Practices and Quality among Elementary School Students in Canada

Enough sleep is crucial for physical and emotional growth of kids and students. It has been noted that there is a progressive decline in bedtime as kids turn into teens, despite the fact that the need for sleep among students does not decrease. Teenagers need for sleep has been estimated as much as 9.2 h per day. Poor sleep has actually been noted to lead to poor diet regimen, excessive weight, stunted growth, psychological health concerns, as well as chemical abuse. Much as the need for sleep is an individual particular, approximately at least 8.3 hrs. of rest per evening is recommended for teens, to avoid excessive daytime drowsiness. High quality sleep is necessary for young professional athletes for making sure much better performance in psychomotor as well as cognitive activities, and for minimizing the chances of creating challenging factors for musculoskeletal discomfort. Detection of sleep disorders in adolescent complaining of sleeplessness is a day-to-day challenge for doctors and clients alike. The purpose of the research study was to assess the prevalence of sleep hygiene awareness, practices and quality among elementary schools students in Canada. The study was a literature based. The research discovered that a boost in the occurrence of difficulty in getting sleep and in too much screen time exposure and marginal increase in physical activity levels. In addition, teens exceeding 2-h everyday display time had 20% higher probabilities of reporting sleep-onset problems, while no association was discovered for physical activity. The study also discovered that a regular every night routine aids the body recognize that it is going to bed; this could consist of taking warm shower or bathroom, checking out a publication, or light stretches. Whenever feasible it is essential for the students to try to avoid emotionally distressing conversations and activities before attempting to sleep considering that maintaining a routine sleep timetable also on weekends keeps the timing of the body's body clock and also can aid you fall asleep and wake up much more quickly. Based on the finding, the research study concluded that the daily substances that students take, the medicines one takes, how long they sleep in a day and exactly how they choose to invest their nights can considerably influence their quality of sleep. Also a couple of mild adjustments can, in many cases indicate the difference between sound rest as well as a restless evening. Finishing a two-week rest diary can help one understand how their routines impact their sleep. The study suggested that teenagers must reserve no more than eight hrs. For sleep given that the suggested quantity of sleep for a healthy grownup goes to least 7 hrs. Keywords: Sleep Hygiene, Awareness, Sleep Quality, Sleep Disorder, Students

The immediate effect of whole body vibration training on the electromyographic activity of contralateral hand muscles; a randomized controlled trial

Whole Body Vibration (WBV) has been used as a useful adjunct to improve the neuromuscular function of the upper limb. Cross-transfer of strength plays an important role in rehabilitation of unilateral injuries. The present research intended to evaluate the acute effect of low frequency WBV training on cross-transfer of electromyographic activity and hand muscles strength when the measurement was performed on the contralateral limb. This was a randomized crossover trial conducted in a clinical biomechanics laboratory. Twenty-eight healthy participants aging between 20 and 35 years were included who were involved in two sessions with two weeks of rest. The participants were randomly assigned in two groups as follows: 1) active WBV/sham WBV; 2) sham WBV/active WBV. The participants were asked to stand on the vibrating plate and pull its belt in a vibrating mode using their dominant hand. Then, after a two-week rest, they performed the same task in the vibrating mode (35 Hz). Grip strength and electromyography (root mean square) in flexor digitorum profundus (FDP), flexor digitorum superficialis (FDS), extensor carpi radialis (ECR), and extensor carpi ulnaris (ECU) muscles of the contralateral limb were measured before and after exercise in both phases. No significant change was observed in the electrical activity of FDP, FDS, ECR, ECU muscles, and hands' grip strength of the contralateral limb (P > 0.05). WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb. Further studies would help to explore these results for several sessions of WBV on cross-transfer of training.

The Impact of Pre-Slaughter Stress on Beef Eating Quality.

Simple SummaryConsumer satisfaction is essential to the beef industry to ensure return protein purchasing. The Meat Standards Australia grading system has been pivotal in regulating the quality and consistency of meat palatability by creating objective measurements such as carcass characteristics, genetics systems, and production systems to predict consumer eating quality. One of the main objective measurements for carcass compliance is the ultimate pH of the longissimus thoracis et lumborum; however, recent research has demonstrated that pre-slaughter stress is eroding beef eating quality in pH compliant carcasses. Pre-slaughter mixing and transport was associated with lower eating quality in certain cuts. A two-week rest period at the abattoir prior to slaughter was beneficial for improving consumer sensory eating quality scores. Further research is required to determine if the muscle damage enzyme creatine kinase could be used commercially as an objective measurement to identify which cattle could benefit from a pre-slaughter rest period to improve beef quality.The study evaluated the relationship between pre-slaughter stress, plasma biomarkers and consumer-evaluated eating quality of pasture raised beef cattle (n = 488). The design tested steer only, heifer only and mixed sex cattle with a comparison of direct kill versus a 14 day rest period in abattoir holding paddocks prior to slaughter. Experiment One sourced cattle from four farms and tested shipping and road transport. Experiment Two sourced cattle from four farms and tested a commercial saleyard pathway. The impact on treatment on untrained consumer eating quality scores were tested on five muscle groups, m. psoas major, m. longissimus dorsi lumborum, m. biceps femoris, m. semitendinosis, and m. infraspinatus. Across all muscles, a two-week rest period had the biggest improvement in sensory score. Mixed groups scored lower in the outside muscle than non-mixed groups. However, the mixing response was inconsistent in the eye round muscle and not significant in the other muscles. Plasma glucose and L-lactate indicated a marked acute stress response at slaughter with a small detrimental impact on consumer score. The muscle damage enzyme markers creatine kinase (CK) and aspartate aminotransferase (AST) were strongly associated with a lower meat quality score (MQ4). Neither β-hydroxybutyrate (βHB) nor non-esterified fatty acids (NEFA) were associated with MQ4, suggesting that fat mobilisation does not impact consumer sensory score.

The Use of Biochemical Measurements to Identify Pre-Slaughter Stress in Pasture Finished Beef Cattle.

Simple SummaryProducing a product that delivers a consistently high-quality eating experience is paramount to the Australian beef industry to ensure consumer satisfaction and return protein purchasing. The importance of minimising pre-slaughter stress in cattle for animal welfare and meat quality is well understood by the industry, however, there currently exists no objective measurement of detecting which cattle are at greatest risk of producing poor quality meat. A pre-slaughter measurement would enable the beef industry to detect at risk cattle and implement an intervention strategy prior to slaughter. Muscle damage enzyme creatine kinase was the plasma biomarker most correlated with meat quality and a two-week rest period prior to slaughter was beneficial for improving quality. Further research is required to determine the usefulness of creatine kinase as an objective measurement on a commercial scale and the cost benefit of a two-week rest period for the industry. This study considered the relationship between pre-slaughter stressors and plasma biomarkers in 488 pasture-raised cattle across two experiments. The design aimed to test groups consisting of steer only, heifer only, and mixed sex cattle under direct kill versus rested (14 days in abattoir holding paddocks) protocols. In Experiment One, cattle were sourced from four farms, and transported by trucks and ships on the same day. In Experiment Two, cattle were sourced from four farms where a comparison was made between marketing via two commercial saleyards or direct farm gate consignment to abattoir. Blood samples were collected at exsanguination for subsequent analyses and relation to meat quality attributes. Muscle damage, as indicated by creatine kinase, is the biomarker most correlated to ultimate pH and muscle glycogen concentrations. A two-week rest period is effective for lowering this enzyme and improving muscle glycogen concentration. Although the cattle was subjected to a range of stress inducing treatments, we found that plasma biomarkers alone appeared insufficient for use as diagnostic stress indicators.

Impact of endurance exercise and probiotic supplementation on the intestinal microbiota: a cross-over pilot study

BackgroundThe human microbiota has a broad range of functions contributing to metabolic processes and the activities of our immune system. Its influence on health, well-being and chronic diseases are discussed in various studies. The intestinal microbiota and the mucosal integrity are influenced by diet, environment and other lifestyle factors, including physical activity. There are correlations between cardiorespiratory fitness and important markers of intestinal health. However, data linking endurance exercise to microbiota composition are sparse. Many endurance athletes take probiotics to reduce gastrointestinal symptoms linked to exercise or immunosuppression, but the longitudinal data is insufficient.This randomised, controlled cross-over pilot study will examine the impact of specific endurance training and probiotic supplementation on the intestinal microbiota and mucosa in healthy, athletic students.ObjectiveThe aim of this pilot study is to elucidate the impact of physical activity on the intestinal microbiota and mucosa with regard to the effects of a probiotic supplementation.MethodsIn this pilot study, thirty non-specifically trained student athletes will participate in an intervention consisting of a two-week rest (baseline) period, a four-week exercise programme and a four-week probiotic intervention using SymbioLactComp®. The exercise programme consists of three 60-min running workouts per week at 70–85% of the peak heart rate (HRpeak). Primary endpoint of this pilot study is the feasibility and practicality of the intervention as well as a sample size estimation. Furthermore, anthropometric measurements and information on nutrition and lifestyle will be obtained. The peak oxygen uptake (VO2peak) and peak heart rate (HRpeak) (determined during a shuttle run test) as well as selected blood and saliva parameters (haemogram, cytokines) will be evaluated. Changes to the intestinal microbiota will be analysed by stool diagnostics (KyberKompaktPRO®, KyberPlus®). The potential changes may include microbiota composition, bacterial metabolites and mucosa- and immune markers.ConclusionResults will be used for the design of a main randomised controlled trial with a larger collective based on feasibility, validity and sample size estimation as well as the potential effects of endurance exercise on intestinal microbiota and mucosa. Evidence-based information of an exercise-altered microbiota could be of importance for the prevention and therapy of intestinal or immune disorders.Trial registrationGerman Clinical Trials Register: DRKS00011108. Retrospectively registered on 28 November 2016.

Long-term efficacy and toxicity of concurrent chemoradiotherapy with nedaplatin and S-1 for head and neck squamous cell carcinoma

ObjectiveThe present study aimed to retrospectively analyze the long-term efficacy and toxicity of concurrent chemoradiotherapy with nedaplatin and S-1 for head and neck squamous cell carcinoma. MethodsThe study enrolled 53 patients (23 with stage II disease, 13 with stage III disease, and 17 with stage IV disease). S-1 was administered orally twice a day for 14 days, followed by a two-week rest period. Nedaplatin was intravenously administered on day 4. Where possible, two courses of chemotherapy were performed. Radiotherapy was started with the administration of S-1. We analyzed the clinical response, survival rate, acute adverse events, and late swallowing toxicity. ResultsThe complete response rates for the primary tumor and neck lymph node metastases were 94.3% and 79.3%, respectively. The five-year overall survival rate was 79.5%, the five-year disease-specific survival rate was 84.8%, and the five-year relapse-free survival rate was 73.7%. The main acute adverse events were leukopenia, neutropenia, mucositis, and dermatitis. No patient had severe nephrotoxicity. Late swallowing toxicity was observed in 13 patients. ConclusionsThe low toxicity, and low nephrotoxicity of chemoradiotherapy with nedaplatin and S-1 have a positive impact on long-term survival. The combination of nedaplatin and S-1 can be used instead of cisplatin and 5-fluorouracil as a safer regimen, especially in patients with some complications and those requiring treatment in an outpatient setting.

Mouse Model of Colitis-Associated Colorectal Cancer (CAC): Isolation and Characterization of Mucosal-Associated Lymphoid Cells.

Colorectal cancer (CRC) is the third most common malignancy worldwide presenting high mortality due to low treatment efficacy. Existing evidence indicates that inflammatory bowel disease (IBD) is associated with a higher risk of developing CRC. Many murine models of inflammation-related colon carcinogenesis (CAC) have been developed to study colon carcinogenesis and novel treatments. A commonly used model involves the combination of a single dose of azoxymethane (AOM), together with three cycles of the inflammatory agent dextran sodium sulfate (DSS) (5 days in drinking water followed by a two-week rest). Following this protocol, around 50% of the animals develop CRCs after 45days and almost 100% of animals after 60days. During CAC development, immune cells, cytokines, and other immune mediators are involved in both tumorigenesis and the elimination of cancer cells during immunotherapy. Thus, the study of mucosal immune responses (including lamina propria mononuclear cells and intraepithelial lymphocytes) is important to understand the role of the immune system during development and therapy in CRC. Single immune cell suspensions from lamina propria and epithelium can be purified combining selective tissue digestion and Percoll gradient centrifugation. Isolated cells can be characterized using flow cytometry by analyzing surface antigens or intracellular cytokines and cytotoxic mediators or employed for further investigations like comparative studies of mRNA expression, cell-proliferation assay, protein analysis, or even functional cytotoxicity assays. The CAC model is useful to study the involvement of immune cells not only during the carcinogenesis process but, in addition, during the treatment with novel immunotherapy protocols.

INTEGRALLY-TEMPORAL AND SPECTRAL PARAMETERS OF CARDIOVASCULAR SYSTEM OF PRE-ADOLESCENT POPULATION OF KHANTY-MANSI AUTONOMOUS OKRUG - UGRA UNDER THE CONDITIONS OF LATITUDINAL DISPLACEMENTS

The aim of the study is to establish statistical and chaotic regularities in the parameters behavior of the cardiovascular system in schoolchildren of the Khanty-Mansi Autonomous Okrug - Ugra at latitudinal displacements (from the North to the South of the Russian Federation and vice versa) and the effects of various climatic and geographic factors. Methods. Using pulse-intervalography method on the basis of the pulseoxymetry device "EL0KS-01" (instrumental software) information on the state of the cardiovascular system of the children and youth population was received. Results. After a two-week rest, the volume of the students' quasiatractor decreased, which indicated the activation of the regulatory mechanisms of the cardiovascular system and the healthful effect after a two-week stay in the South of Russia. Upon arrival in Surgut, the volume of the quasiatractor in girls decreased, and in boys increased sharply by 6 times. Thus, in girls, the response of the cardiovascular system was more pronounced and persistent than in boys, which showed a partial return to the initial state i.e. an insufficient formation of adaptive mechanisms. Serious gender differences were revealed which derated the cardiovascular system for boys. Conclusions. Within the framework of the new approach from the perspective of the chaos-self-organization theory, the features of the cardiovascular system's parameters of preadolescent population under the influence of various climatic and geographical factors were studied. Be means of new methods gender peculiarities of vegetative regulation of the organism of schoolchildren before and after the recreation activity in the South of Russia were analyzed.

P2-2-56 - Analysis of five days administration of TS-1 followed by a two-day rest in patients with metastatic breast cancer

Background: It is difficult for some patients to keep taking TS-1 at the proposed four weeks administration followed by a two-week rest because of its side effects. When TS-1 is given for five days followed by a two-day rest (five days on/two days off), the drug concentration is almost equal to that of the proposed regimen, but TS-1 can be taken longer without deterioration of its clinical effect. Aim: The purpose of this study was to retrospectively analyze the effect and safety of TS-1 given at a five-day on/two-day off> regimen in metastatic breast cancer. Methods: Twenty-five HER-2 negative patients were recruited between 2006 and 2014 at our hospital. Median age was 68 (44-87), PS 0/1/2 was 8/10/7 cases, ER positive/negative was 15/10 cases, and there was no prior chemotherapy after recurrence in 25 cases. TS-1 was administered at a dose of 80-120mg/day at a five-day on/two-day off> regimen. Results: Median treatment duration was 25 weeks (3-114 weeks), CR/PR/SD/PD clinical response was shown in 0/8/10/7 cases, and response rate was 32%. Five of ten SD patients could maintain the regimen for more than 24 weeks. In terms of hematologic toxicity, anemia was shown in one case, and there were no cases of neutropenia. In terms of non- hematologic toxicity, no severe side effects were shown. Discontinuance was observed in only one case because of diarrhea. Conclusion: A five-day on/two-day off> regimen of TS-1 in metastatic breast cancer is well tolerated, and it can be continually given to elderly patients or those with poor PS without reducing QOL, making TS-1 an effective metronomic treatment.

Reliability and validity of the Daily Cognitive-Communication and Sleep Profile: a new instrument for monitoring sleep, wakefulness and daytime function.

The Daily Cognitive Communicative and Sleep Profile (DCCASP) is a seven-item instrument that captures daily subjective sleep quality, perceived mood, cognitive, and communication functions. The objective of this study was to evaluate the reliability and validity of the DCCASP. The DCCASP was self-administered daily to a convenience sample of young adults (n = 54) for two two-week blocks, interspersed with a two-week rest period. Afterwards, participants completed the Pittsburgh Sleep Quality Index (PSQI). Internal consistency and criterion validity were calculated by Cronbach's α coefficient, Concordance Correlation Coefficient (CCC), and Spearman rank (rs) correlation coefficient, respectively. Results indicated high internal consistency (Cronbach-s α = 0.864-0.938) among mean ratings of sleep quality on the DCCASP. There were significant correlations between mean ratings of sleep quality and all domains (rs=0.38-0.55, p<0.0001). Criterion validity was established between mean sleep quality ratings on the DCCASP and PSQI (rs=0.40, p<0.001). The DCCASP is a reliable and valid self-report instrument to monitor daily sleep quality and perceived mood, cognitive, and communication functions over time, amongst a normative sample of young adults. Further studies on its psychometric properties are necessary to clarify its utility in a clinical population.

ABDOMINAL MUSCLE INJURIES IN SOCCER–SURGICAL CASE SERIES

BackgroundMuscle injuries frequently occur in both competitive and amateur sports. In soccer, muscle injuries are responsible for more than one third of all injuries. The smaller portion are the major...

Phase I dose-escalation study of oral vinflunine administered once daily for 6 weeks every 8 weeks in patients with advanced/metastatic solid tumours

Vinflunine ditartrate is a microtubule inhibitor belonging to the vinca alkaloid family. This phase I study was carried out to evaluate the maximal tolerated dose, the safety profile, the pharmacokinetics and the activity of oral vinflunine (VFL) given daily in patients with advanced/metastatic solid tumours and who have failed standard therapy. Patients were treated with oral VFL administered once daily for 6 weeks followed by a two-week rest. Sequential dose-escalating cohorts of patients were enrolled into 5 dose levels: 20, 40, 60, 75 and 95 mg/day. In total, 27 patients received 53 cycles. Dose-limiting toxicities (DLT) were observed from 60 mg/day. The dose levels 75 and 95 mg/day were both assessed as maximal tolerated dose. The most frequent dose-limiting toxicities were of haematological origin. The recommended dose was defined as 60 mg/day, dose at which 4 patients experienced long stabilizations (≥4 months) and also received longer treatment duration in comparison with the other dose levels. Blood exposure of VFL and its active metabolite 4-O-deacetyl vinflunine (DVFL) increased proportionally to the dose levels. The concentrations of VFL and DVFL reached a steady state at, respectively, 5 and 20 days and remained stable for the rest of the cycle. Increased incidence of DLT/SAE was consistent with the increase of VFL dose and drug exposure. These results showed the feasibility of daily oral vinflunine administration on a 6-week treatment duration. This new schedule of administrations enabled sustained and stable blood concentrations of both VFL and DVFL. The recommended dose was defined at 60 mg/day, dose at which 4 patients experienced clinical benefit.

Advanced medullary thyroid cancer treated with Sorafenib: A case report

Background: Medullary thyroid carcinoma (MTC) accounts for 5% of all thyroid carcinomas. As no effective systemic therapy exists, surgery is the only curative treatment for MTC. In the last few years, several clinical trials have tested the efficacy of new multi-targeted agents such as sorafenib, vandetanib, motesanib, sunitinib and pazopanib in patients with metastatic MTC. Summary: In June 2010, a 38-year-old male patient complained on pain on swallowing and coughs. Physical examination detected a hard nodule of 2 cm on the left side of his neck. A fine-needle aspiration of it yielded evidence of carcinoma. A computed tomography scan showed multiple lyphadenopathies. In August 2010, the patient underwent an incomplete thyroidectomy and received radiotherapy. In spite of that, he was still unable to swallow either solids or liquids, and suffered dyspnoea on moderate exertion. In May 2011, the patient started receiving sorafenib and levothyroxine. After 20 days, his clinical symptoms were less severe and palpable lymphadenopathies shrank by 50%. After 5 months, the patient still had no dysphagia or dyspnoea, but developed fatigue and elevated transaminases. Sorafenib was discontinued and the liver was examined by ultrasonography with no abnormal findings. After a two-week rest period, the patient resumed sorafenib from November 2011 to December 2012, achieving a clinical, biochemical and radiological response. Conclusion: This case provides limited evidence for a potential role for sunitinib in the treatment of patients with metastatic MTC.

Feasibility of adjuvant chemotherapy with S-1 consisting of a 4-week administration and a two-week rest period in patients with completely resected non-small cell lung cancer

The efficacy of adjuvant chemotherapy with S-1 in patients with completely resected non-small cell lung cancer (NSCLC) has yet to be clarified, and the appropriate schedule for the adjuvant chemotherapy with S-1 remains unknown. A phase II study was conducted to evaluate the feasibility and efficacy of adjuvant chemotherapy with S-1. Patients enrolled in this study were 20-75 years old, had pathological stage IB-IIIA NSCLC, and had received complete resection of NSCLC. S-1 (80 mg/m2) was administered orally to the patients for four weeks followed by a two-week rest period (conventional schedule), for a maximum of eight cycles. The primary endpoint was relative dose intensity (RDI), while the secondary endpoints were safety and 1 year of disease-free survival (1y-DFS). Between May 2007 and October 2009, 28 patients were enrolled. The RDI was 63.1% (95% CI, 48.6-77.7). No grade 3 or worse hematological toxicity was observed. Grade 3 non-hematological toxicities were observed in four patients. No grade 4 or worse hematological toxicity was detected. The probability of 1y-DFS was 85.7% (95% CI, 72.8-98.6). In the subgroup analysis, the median RDI of patients over 65 years old was lower compared to the other patients (44.8 vs. 100%; P=0.013; Mann-Whitney U test). Creatinine clearance (CCr) was lower in the older group, with more grade 2 or 3 non-hematological toxicities in the elderly patients. These results suggest that the conventional schedule of adjuvant chemotherapy with S-1 is not likely to be feasible in older patients with completely resected NSCLC.

Safety of sunitinib in renal cell carcinoma

BackgroundRenal cell carcinoma (RCC) represents only 2-3% of all cancers. Sunitinib is a standard initial therapy in advanced and metastatic renal cell carcinoma.PurposeA retrospective review was performed to assess the...

A randomized phase III trial of adjuvant chemotherapy with irinotecan, leucovorin and fluorouracil versus leucovorin and fluorouracil for stage II and III colon cancer: A Hellenic Cooperative Oncology Group study

BackgroundColon cancer is a public health problem worldwide. Adjuvant chemotherapy after surgical resection for stage III colon cancer has been shown to improve both progression-free and overall survival, and is currently recommended as standard therapy. However, its value for patients with stage II disease remains controversial. When this study was designed 5-fluorouracil (5FU) plus leucovorin (LV) was standard adjuvant treatment for colon cancer. Irinotecan (CPT-11) is a topoisomerase I inhibitor with activity in metastatic disease. In this multicenter adjuvant phase III trial, we evaluated the addition of irinotecan to weekly 5FU plus LV in patients with stage II or III colon cancer.MethodsThe study included 873 eligible patients. The treatment consisted of weekly administration of irinotecan 80 mg/m2 intravenously (IV), LV 200 mg/m2 and 5FU 450 mg/m2 bolus (Arm A) versus LV 200 mg/m2 and 5FU 500 mg/m2 IV bolus (Arm B). In Arm A, treatments were administered weekly for four consecutive weeks, followed by a two-week rest, for a total of six cycles, while in Arm B treatments were administered weekly for six consecutive weeks, followed by a two-week rest, for a total of four cycles. The primary end-point was disease-free survival (DFS) at three years.ResultsThe probability of overall survival (OS) at three years was 0.88 for patients in Arm A and 0.86 for those in Arm B, while the five-year OS probability was 0.78 and 0.76 for patients in Arm A and Arm B, respectively (P = 0.436). Furthermore, the probability of DFS at three years was 0.78 and 0.76 for patients in Arm A and Arm B, respectively (P = 0.334). With the exception of leucopenia and neutropenia, which were higher in patients in Arm A, there were no significant differences in Grades 3 and 4 toxicities between the two regimens. The most frequently recorded Grade 3/4 toxicity was diarrhea in both treatment arms.ConclusionsIrinotecan added to weekly bolus 5FU plus LV did not result in improvement in disease-free or overall survival in stage II or III colon cancer, but did increase toxicity.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12610000148077

Experiencia con sunitinib en cáncer de próstata metastásico hormonorresistente sin respuesta a docetaxel

Introduction systemic treatment options for patients with hormone-refractory prostate cancer (HRPC) that progress despite the use of Docetaxel are very limited. One of the options of compassionate use currently available is the use of Sunitinib. We present a joint preliminary experience with the use of Sunitinib in this clinical case. Patients and methods a series of eight cases is presented, which sets forth a prospective multicentre experience with Sunitinib in patients with hormone-refractory metastatic and progressive prostate cancer, previously treated with at least a regime of Docetaxel-based chemotherapy. Other alternative chemotherapy regimes had already been tried in some patients. The primary objective of our study was the PSA response rate and our secondary objective was the progression-free period. We administered a dosage of 50 mg/day for four-week cycles, followed by a two-week rest per cycle, until we reached a total of eight cycles or up to clinical progression or intolerable toxicity. Results in four cases, the PSA dropped to below 50% of the baseline level at the beginning of the treatment, and five patients presented some decrease in PSA. The progression-free time was 16.4 weeks. Toxicity arising from the treatment was moderate and manageable. Conclusions despite the limits of this experience, we can say that Sunitinib appears to be an active and safe option in patients with hormone-refractory prostate cancer that is resistant to chemotherapy with Docetaxel.

Experience with sunitinib in hormone-resistant metastatic prostate cancer that is unresponsive to docetaxel

IntroductionSystemic treatment options for patients with hormone-refractory prostate cancer (HRPC) that progress despite the use of Docetaxel are very limited. One of the options of compassionate use currently available is the use of Sunitinib. We present a joint preliminary experience with the use of Sunitinib in this clinical case. Patients and methodsA series of eight cases is presented, which sets forth a prospective multicentre experience with Sunitinib in patients with hormone-refractory metastatic and progressive prostate cancer, previously treated with at least a regimen of Docetaxelbased chemotherapy. Other alternative chemotherapy regimes had already been tried in some patients. The primary objective of our study was the PSA response rate and our secondary objective was the progression-free period. We administered a dosage of 50 mg/day for four-week cycles, followed by a two-week rest per cycle, until we reached a total of eight cycles or up to clinical progression or intolerable toxicity. ResultsIn four cases, the PSA dropped to below 50% of the baseline level at the beginning of the treatment, and five patients presented some decrease in PSA. The progression-free time was 16.4 weeks. Toxicity arising from the treatment was moderate and manageable. ConclusionsDespite the limits of this experience, we can say that Sunitinib appears to be an active and safe option in patients with hormone-refractory prostate cancer that is resistant to chemotherapy with Docetaxel.