tbuckley/cabot-search huggingface dataset:
Efficacy and safety of an interleukin 6 monoclonal antibody for the treatment of systemic lupus erythematosus: a phase II dose-ranging randomised controlled trial
Authors: Daniel J Wallace, Vibeke Strand, Joan T Merrill, Serghei Popa, Alberto J Spindler, Alicia Eimon, Michelle Petri, Josef S Smolen, Joseph Wajdula, Jared Christensen, Cheryl Li, Annette Diehl, Michael S Vincent, Jean Beebe, Paul Healey, Sudhakar Sridharan
Journal: Annals of the Rheumatic Diseases (2016)

Objectives This phase II trial evaluated the efficacy and safety of an interleukin (IL) 6 monoclonal antibody for systemic lupus erythematosus (SLE). Methods Patients with active disease were randomised to placebo or PF-04236921 10 mg, 50 mg or 200 mg, subcutaneously, every 8 weeks with stable background therapy. SLE Responder Index (SRI-4; primary end point) and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) were assessed at week 24. Post hoc analysis identified an enriched population based upon planned univariate analyses. Results 183 patients received treatment (placebo, n=45; 10 mg, n=45; 50 mg, n=47; 200 mg, n=46). The 200 mg dose was discontinued due to safety findings and not included in the primary efficacy analysis. The SRI-4 response rates were not significant for any dose compared with placebo; however, the BICLA response rate was significant for 10 mg (p=0.026). The incidence of severe flares was significantly reduced with 10 mg (n=0) and 50 mg (n=2) combined versus placebo (n=8; p&lt;0.01). In patients with greater baseline disease activity (enriched population), the SRI-4 (p=0.004) and BICLA (p=0.012) response rates were significantly different with 10 mg versus placebo. Four deaths (200 mg, n=3; 10 mg, n=1) occurred. The most frequently reported adverse events included headache, nausea and diarrhoea. Conclusions PF-04236921 was not significantly different from placebo for the primary efficacy end point in patients with SLE. Evidence of an effect with 10 mg was seen in a post hoc analysis. Safety was acceptable for doses up to 50 mg as the 200 mg dose was discontinued due to safety findings. Trial registration number NCT01405196; Pre-results.
Nine in 10 people are exposed to air pollution over WHO limits, warns report
Authors: Susan Mayor
Journal: BMJ (2016)

More than nine in 10 of the world’s population live in places where air pollution exceeds limits set by the World Health Organization, a new modelling study has shown.1

The new WHO air quality model shows that 92% of the population lives in places where levels of air pollution are higher than recommended. Data presented in interactive maps (http://maps.who.int/airpollution) highlight areas that exceed WHO’s upper limit of 10 …
Rebound Syndrome in Multiple Sclerosis After Fingolimod Cessation
Authors: Chittaranjan Andrade
Journal: JAMA Neurology (2016)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Neurology HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Neurology journal
HOVON-65/GMMG-HD4 Randomized Phase III Trial Comparing Bortezomib, Doxorubicin, Dexamethasone (PAD) Vs VAD Followed by High-Dose Melphalan (HDM) and Maintenance with Bortezomib or Thalidomide In Patients with Newly Diagnosed Multiple Myeloma (MM)
Authors: Pieter Sonneveld, Ingo Schmidt-Wolf, Bronno van der Holt, Laila el Jarari, Uta Bertsch, Hans Salwender, Sonja Zweegman, Edo Vellenga, Joerg Schubert, Igor Wolfgang Blau, Asiong Jie, Berna Beverloo, Dirk Hose, Anna Jauch, Helgi van de Velde, Martijn Schaafsma, Walter Lindemann, Marie Jose Kersten, Ulrich Duehrsen, Michel Delforge, Katja Weisel, Sandra Croockewit, Hans Martin, Shulamit Wittebol, Christof Scheid, Gerard Bos, Marinus van Marwijk-Kooy, Pierre Wijermans, Henk Lokhorst, Hartmut Goldschmidt
Journal: Blood (2010)
P1-183: Circulating plasma DNA is not an early marker for HRCT and FDG–PET scan occult intraluminal squamous cell lung cancer lesions
Authors: Hes A. Brokx, Clarissa Kooi, Remco van den Berg, Daniëlle A. Heideman, Peter J. Snijders, Katrien Grünberg, Erik Thunissen, Pieter E. Postmus, Thomas G. Sutedja
Journal: Journal of Thoracic Oncology (2007)
A multi-institutional evaluation of the safety and efficacy of bevacizumab for recurrent, platinum-resistant ovarian cancer
Authors: J. D. Wright, A. Alvarezsecord, T. M. Numnum, R. P. Rocconi, M. A. Powell, A. Berchuck, R. D. Alvarez, K. Trinkaus, J. S. Rader, D. G. Mutch
Journal: Journal of Clinical Oncology (2006)

5019 Background: Bevacizumab has shown activity in recurrent ovarian cancer with an acceptable adverse event profile. However, the incidence of bowel perforation in a recent trial of heavily pretreated ovarian cancer patients was higher than expected from prior experience with bevacizumab. Whether the difference in the rate of bowel perforation was due to refractory disease, treatment history, disease burden, or location of tumor is uncertain. We sought to review our multi-institutional experience with bevacizumab in patients with recurrent ovarian cancer. Methods: A retrospective review of patients with recurrent ovarian cancer treated with single agent or combination bevacizumab therapy was undertaken. Toxicity was assessed using standard criteria. Response was determined radiographically and through serial CA125 measurements. Statistical analysis to determine factors associated with toxicity and response was performed. Results: Sixty-two eligible patients were identified. All had failed prior platinum-based therapy and had received a median of 5 prior chemotherapy regimens and 2 prior platinum-containing regimens. Single agent bevacizumab was administered to 12 (19%) women, while 50 (81%) received the drug in combination with a cytotoxic agent. The most common toxicities were myelosuppression (60%), proteinuria (19%) and hypertension (16%). Grade 3–5 toxicities occurred in 15 (24%) patients, including grade 3–4 hypertension in 4 (7%). Gastrointestinal perforations were identified in 4 (7%) subjects. Nine (15%) patients discontinued therapy due to toxicity. Fifty-eight patients were assessable for response. The overall response rate was 36% (4 CR, 17 PR) with stable disease in 40%. Clinical benefit (CR, PR, stable disease) was seen in 83% of patients treated with single agent therapy and 74% of those treated with bevacizumab-combination regimens. Conclusions: Bevacizumab demonstrates significant activity for recurrent, platinum-resistant ovarian cancer. Life threatening bowel perforations were noted in 7% of our subjects. The frequency of perforations in our cohort suggests that this complication is more likely to occur in heavily pretreated patients. No significant financial relationships to disclose.
Normalisation of ADAMTS 13 Activity and Disappearance of ADAMTS 13 Antibody Following Rituximab in Acute Refractory Thrombotic Thrombocytopenic Purpura.
Authors: Marie Scully, Jamie Cavenagh, Diane Hagger, Sylvia Benjamin, Ian Mackie, Samuel J. Mchin, Hannah Cohen
Journal: Blood (2005)
MYC/BCL2 Double Hit Lymphoma: What Really Matters
Authors: Annapurna Saksena, Parth Desai, Zhuang Zuo, Jie Xu, Pei Lin, Adam C. Seegmiller, C. Cameron Yin, Guilin Tang, Roberto N. Miranda, Jeffrey L. Jorgensen, Nishitha M Reddy, L. Jeffrey Medeiros, Shaoying Li
Journal: Blood (2015)
Identification of Novel Genetic Lesions in Myelodysplastic Syndromes Using High Density SNP-Arrays.
Authors: Saskia Langemeijer, Roland Kuiper, Peter Vandenberghe, Estelle Verburgh, Jan Boezeman, Ad Geurts van Kessel, Bert van der Reijden, Theo de Witte, Joop Jansen
Journal: Blood (2007)
IRST WL: a tool to measure the workload of clinical research coordinators in oncology
Authors: F. Fabbri, B. Vertogen, P. Serra, D. Andreis, M. Dall'Agata, V. Gallà, G. Gentili, I. Massa, E. Montanari, M. Monti, F. Pagan, A. Piancastelli, V. Polli, A. Ragazzini, B. Rudnas, S. Testoni, B. Venturini, F. Zumaglini, O. Nanni
Journal: Annals of Oncology (2015)
Lipid profile and breast cancer characteristics: A retrospective correlational study.
Authors: Debora S. Bruno, Paul S. White, Cheryl L. Thompson, Mobosola Adebisi, Nathan A. Berger
Journal: Journal of Clinical Oncology (2015)

e12659 Background: Obesity is an established risk factor for post-menopausal breast cancer, and is associated with higher mortality. However, it is not clear if dyslipidemia, highly prevalent in obese subjects, is an independent predictor of breast cancer outcome. Methods: A retrospective correlational study analyzed all incident breast cancer cases at our institution from 2009 to 2013. Pre-invasive and metastatic cancers at diagnosis, and individuals lacking lipid profiles were excluded. Primary endpoint was any correlation between serum lipids and predictors of breast cancer outcome. Independent variables included total cholesterol, LDL, HDL and triglyceride levels. The dependent variables were tumor size and grade, nodal involvement, hormone receptor (HR) status, HER2-NEU status and Oncotype DX score. Sample (Pearson) correlation coefficients were determined for numerical variables and a Spearman's rank correlation was used for categorical variables. Multivariate regressions adjusted for age and body mass index (BMI). Further stratification was performed based on HR status. Results: We identified 267 patients that met our inclusion criteria. Mean (SD) age at diagnosis was 59.9 (11.1) years. Races most commonly reported were white (58.2%), black (34.8%) and Hispanic (3.3%). Mean (SD) BMI was 30.2 (7.5) kg/m2. HR positivity was documented in 86.8% of cases. Mean (SD) tumor size was 20.8 (19.1) mm in HR positive and 38.3 (16.5) mm in HR negative patients (p = 0.038). Mean cholesterol, LDL, HDL and triglycerides were not significantly different between HR positive and negative patients. There were no correlations between lipid profiles and tumor characteristics in the overall population. However, in the HR negative sub-cohort, both total cholesterol (r = 0.48, p = 0.01) and LDL correlated (r = 0.48, p = 0.01) with larger tumors at presentation. Correlations remained statistically significant after adjusting for age and BMI (p = 0.026 for total cholesterol and p = 0.022 for LDL). Conclusions: Among breast cancer patients with HR negative tumors, higher serum total cholesterol and LDL was associated with larger tumors at surgical resection/diagnosis. To our knowledge, this is the first description of such correlation.
Treatment with β-Catenin Antagonist BC2059 Exerts Single Agent Efficacy and Exerts Improved Activity with Tyrosine Kinase Inhibitor (TKI) or Pan-Histone Deacetylase (HDAC) Inhibitor Against Human CML and Myeloproliferative Neoplasm (MPN) Progenitor Cells
Authors: Warren Fiskus, Jacqueline Smith, Uma Mudunuru, Stacey Hembruff, Ruben Reyes, Sunil Abhyankar, Joseph McGuirk, Omar S. Aljitawi, Siddhartha Ganguly, Stephen K. Horrigan, Sunil Sharma, Kapil N. Bhalla
Journal: Blood (2011)
Nanoparticle Design For Bone-Specific Chemotherapy and Microenvironmental Targeting In Multiple Myeloma
Authors: Michaela R Reagan, Archana Swami, Pamela A Basto, Yuji Mishima, Jinhe Liu, Siobhan Glavey, Grace B O'Callaghan, Michele Moschetta, Kenichi Nagano, Roland Baron, Aldo M Roccaro, Omid Farokhzad, Irene M. Ghobrial
Journal: Blood (2013)
Comparison of gross tumor volume delineated by anatomic imaging and FDG PET/CT for esophageal carcinoma and validation with pathological specimen
Authors: J. M. Yu, X. J. Zhong, B. J. Zhang, D. B. Mu, A. Q. Han, X. D. Sun, S. H. Yuan, P. P. Song, H. Li, Z. Fu
Journal: Journal of Clinical Oncology (2007)

15090 Background: Although results of clinical studies have demonstrated FDG PET/CT improved target volume delineation in various tumors, only few studies compared delineation based on PET/CT with pathologic examination. Aim of our study was to compare anatomic imaging modalities including computed tomography (CT), esophagram, endoscopy with FDG PET/CT for delineation of gross tumor volume (GTV) in esophageal carcinoma and to validate the results with the pathologic examination. Methods: Thirty patients with stages II-III squamous cell carcinoma underwent transthoracic esophagectomy were enrolled. PET/CT, esophagram and endoscopy were performed with patients before operations. The length of the lesion on the PET/CT scan and on the CT portion of the PET/CT and the PET scan alone was determined independently by 3 separate investigative groups. PET/CT scan was evaluated by visual inspection for abnormality. A standard uptake value (SUV) of 2.5 was used in the PET scan to delineate the tumor extent. The lengths of GTVs determined with the five modalities (PET/CT, PET, CT, esophagram and endoscopy) were compared quantitatively and validated with the pathologic specimen. The sizes of the tumors were measured by pathologic examination which was considered as the gold standard. Results: Of the 30 patients, 9 had T2 tumors, 20 had T3 tumors and 1 had T4 tumor with an involvement of pleura. Three tumors were located at the upper esophagus, 14 at the middle esophagus, 13 at the lower esophagus. The mean length of the carcinoma was 5.85cm(SD 2.50cm) measured by pathologic examination, 5.79cm (SD 2.04cm) as determined by PET scan, 5.14cm (SD 1.65cm) by PET/CT scan, 5.42 cm(SD 2.42cm)by CT scan, 5.50cm(SD 2.79cm) by endoscopy, and 6.07cm(SD 2.75cm) by esophagram respectively. Although the lengths of the tumors as measured by the five imaging modalities were no significant difference, the result of PET was the most accurate. Conclusions: Compared with tumor lengths measured by pathologic examination, PET with a SUV 2.5 was found to be the most accurate modality and can help the radiation oncologist delineate the GTV of esophageal carcinoma precisely. No significant financial relationships to disclose.
A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765 (SAR245409), a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced malignancies.
Authors: I. Brana, P. LoRusso, J. Baselga, E. I. Heath, A. Patnaik, S. Gendreau, A. Laird, K. Papadopoulos
Journal: Journal of Clinical Oncology (2010)

3030 Background: XL765 is a potent and selective inhibitor of class I PI3K isoforms, TORC1, and TORC2. XL765 has shown dose-dependent target modulation and tumor growth inhibition or shrinkage in multiple human xenografts. Methods: Pts receive XL765 twice daily (bid) or daily (qd) for 28-day cycles. Dose escalation follows a standard 3 + 3 design. PK and pharmacodynamic biomarker analyses are performed. Tumor response is assessed by RECIST every 8 weeks. A cohort of lymphoma pts will be enrolled to explore the potential utility of combined inhibition of PI3K and TORC1/2 in this disease setting. Results: 79 pts have been dosed with XL765; 52 pts on a bid regimen (30-240 mg/day) and 27 pts on a qd regimen (70-100 mg/day). On the bid schedule, 25 subjects have been treated at the established maximum tolerated dose (MTD) of 50 mg bid. The maximum administered dose (MAD) is 120 mg bid. On the qd schedule, the MAD is 100 mg and the preliminary MTD is 90 mg. The most common related adverse events (> 10% of pts) were nausea, diarrhea, anorexia, elevated liver enzymes, skin disorders, and vomiting. Drug-related ≥ grade 3 AST/ALT elevation occurred in four pts (three pts initially dosed at 120 mg bid and one pt initially dosed at 50 mg bid). XL765 exposure increased with increasing doses on bid and qd schedules. Median tmax was 1-3 hours post-dose. Mean t1/2,z ranged from 3 to 9 hours at steady-state. Robust pharmacodynamic modulation of PI3K and ERK pathway signaling was evident in tumors and surrogate tissues following repeat-dose administration of XL765. For example, post-dose reductions in pAKT-T308 (57-76%), p4EBP1 (62-80%), and pERK (53-80%) were seen in paired biopsies of diverse solid tumors from five pts administered XL765 at 50 mg bid. Eleven pts have been on study for ≥ 16 weeks and seven pts on treatment for ≥ 24 weeks. Conclusions: In this phase I study, the MTD for single-agent XL765 is 50 mg bid. XL765 exhibited potent pharmacodynamic activity in solid tumors and surrogate tissues at generally well tolerated doses. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Exelixis Exelixis Exelixis Exelixis
Pik3ca, braf, nras and kras mutations and outcome prediction in chemorefractory metastatic colorectal cancer (mcrc) patients treated with egfr-targeting monoclonal antibodies (moabs): results of a european consortium
Authors: Sabine Tejpar, W De Roock, Bart Claes, G Fountzilas, K Kalogeras, Kotoula-Dimitriadou, P Laurent-Puig, F Penault-Llorca, P Rougier, B Vincenzi, D Santini, G Tonini, F Cappuzzo, M Frattini, F Molinari, P Saletti, S De Dosso, A Bardelli, S Siena, A Sartore-Bianchi, F DiNicolantonio, J Tabernero, T Macarulla, F DiFiore, A Oden-Gangloff, F Ciardiello, P Pfeiffer, C Qvortrup, T. Plato Hansen, Eric Van Cutsem, D Lambrechts, M Delorenzi
Journal: Annals of Oncology (2010)
Inferior Vena Cava Filters in Trauma Patients—For Whom the Benefit Tolls?
Authors: Paul Waltz, Brian S. Zuckerbraun
Journal: JAMA Surgery (2016)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Surgery HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Surgery journal
Circular RNA cAGBL3 as an epithelial-mesenchymal transition trigger of liver cancer.
Authors: Hong Zhu, Lu yun He, Kai su Lin, Chong Li
Journal: Journal of Clinical Oncology (2016)

e23245 Background: Circular RNAs (circRNAs) are an important class of non-coding RNAs (ncRNAs) characterized by covalently closed circular structures. It has been revealed that circRNAs may act as cytoplasmic microRNA sponges and be involved in cancer-associated pathways. The up-regulation of cAGBL3 has been observed in liver cancer tissues, however the pathological roles and regulatory mechanism of cAGBL3 remain unclear. Methods: By Quantitative Real-Time PCR and RNAscope and Cell Invasion Assay, we examined expression of cAGBL3 in liver cancer tissues and the relationship between cAGBL3 with tumor metastasis, recurrence and survival of patients. Then,we tested the role of cAGBL3 in tumor invasion and growth with Cell Invasion Assay .By western -blotting, we examined the effect of cAGBL3 in EMT. At last,statistical and bioinformatics analysis results showed that cAGBL3 is associated with AGBL3 expression.Through targeting at miR-128c-3p, we launched RNA immunoprecipitation Assay to determine the mechanism in whtch cAGBL3 works. Results: By the above-mentioned assay, we found the expression of cAGBL3 to be upregulated in liver cancer tissues and significantly correlated with tumor metastasis, recurrence and survival of patients and enhanced tumor invasion and growth. Furthermore, cAGBL3 increased AGBL3 expression level during EMT by weakening miR-128c-3p acting as AGBL3 inhibitor. Conclusions: This model illustrates the relation between cAGBL3 expression and HCC progression and points to a promising direction for the prognosis and therapy of liver cancer.
Efficacy and safety of BCD-017, a novel pegylated filgrastim: Results of open-label controlled phase II study in patients with breast cancer receiving myelosuppressive chemotherapy.
Authors: Olga V. Salafet, Tatiana V. Chernovskaya, Ludmila P. Sheveleva, Andrey V. Khorinko, Tatiana I. Prokopenko, Marina P. Nechaeva, Olga N. Burdaeva, Marina P. Matrosova, Nadezhda V. Kovalenko, Elena G. Ovchinnikova, Irina Koroleva, Roman A. Ivanov
Journal: Journal of Clinical Oncology (2013)

e20593 Background: Pegfilgrastim (conjugate of filgrastim and 20 kDa polyethylene glycol (PEG) is approved for treatment of chemotherapy-associated neutropenia. BCD-017 (empegfilgrastim) is a covalent conjugate of filgrastim with 30 kDa PEG. Increased molecular weight of PEG molecule may provide additional benefits compared to pegfilgrastim. Methods: To compare efficacy and safety of filgrastim and BCD-017 at 3 mg and 6 mg doses an open-label, randomized, active-comparator, non-inferiority trial was conducted. 60 patients with histologically or cytologically confirmed breast cancer were randomly assigned to receive either subcutaneous (s.c.) injection of 3 mg BCD-017 (n=21), 6 mg BCD-017 (n = 20), or 5 mg/kg s.c. injections of filgrastim (n=19) administered daily until ANC ≥ 10x10 9 cells/L (maximum of 14 days) after chemotherapy (doxorubicin 60 mg/m 2 and docetaxel 75 mg/m 2 ) with stratification for weight and prior chemotherapy exposure. The primary efficacy endpoint was the incidence of severe neutropenia (ANC &lt; 1.0x10 9 cells/L) during the first cycle of chemotherapy. Results: Incidence of severe neutropenia during the first chemotherapy cycle was 85,7%, 65,0% and 61,1% in BCD-017 3 mg, BCD-017 6 mg and filgrastim groups, respectively. Differences between BCD-017 groups and filgrastim group were not significant. Mean duration of grade 4 neutropenia in cycle 1 was 0,43, 0,40 and 0,33 days, accordingly (95% CI for difference between BCD-017 3 mg and filgrastim groups -0.22 to 0.41; 95% CI for difference between BCD-017 6 mg and filgrastim groups -0.25 to 0.38). Febrile neutropenia was observed only in BCD-017 3 mg and BCD-017 6 mg groups (one case in each group). A single administration of BCD-017 at the doses of 3 mg and 6 mg was as safe and well tolerated as standard daily filgrastim administration. There were no unexpected adverse events in all groups. Conclusions: The results of this study support comparable efficacy of single s.c. injection of 6 mg BCD-017 versus daily 5 mg/kg s.c. injections of filgrastim. Further phase III study of BCD-017 for treatment and prophylaxis of neutropenia in patients receiving chemotherapy is necessary. Clinical trial information: NCT01569087.