Randomized, placebo-controlled trial of Saforis for prevention and treatment of oral mucositis in breast cancer patients receiving anthracycline-based chemotherapy.

Abstract:

BACKGROUND:Oral mucositis (OM) is a frequent complication of mucotoxic cancer therapy, causing significant oral pain, increased infection risk, and impaired functioning. The efficacy and safety of Saforis (glutamine) powder in UpTec for oral suspension was evaluated for the prevention and treatment of OM. METHODS:Three hundred twenty-six patients developing World Health Organization (WHO) grade >or=2 OM during a chemotherapy screening cycle were randomized to Saforis (n = 163) or placebo (n = 163) 3 times/day during their next chemotherapy cycle (Treatment Cycle 1). Patients were crossed over to the alternate treatment during Treatment Cycle 2. As prespecified in the statistical plan, because of a carryover effect in Treatment Cycle 2 the primary efficacy analysis was based on Treatment Cycle 1 only. RESULTS:Compared with placebo, Saforis significantly reduced the incidence of clinically significant WHO grade >or=2 OM (38.7% vs. 49.7%; P = .026) and severe WHO grade >or=3 OM (1.2% vs. 6.7%; P = .005) in Treatment Cycle 1. Saforis also significantly reduced the worst Oral Mucositis Assessment Scale ulceration score in Treatment Cycle 1 compared with placebo (mean, 0.23 +/- 0.39 vs. 0.32 +/- 0.45; P = .013). Patients receiving Saforis in Treatment Cycle 1 had a lower-than-expected OM incidence when crossed over to placebo in Treatment Cycle 2, indicating a significant carryover effect (P = .027). The incidence of treatment-emergent adverse events was similar between groups. CONCLUSIONS:Saforis is safe and effective for preventing and treating OM in patients receiving mucotoxic cancer chemotherapy.

journal_name

Cancer

journal_title

Cancer

authors

Peterson DE,Jones JB,Petit RG 2nd

doi

10.1002/cncr.22384

subject

Has Abstract

pub_date

2007-01-15 00:00:00

pages

322-31

issue

2

eissn

0008-543X

issn

1097-0142

journal_volume

109

pub_type

杂志文章,多中心研究,随机对照试验

相关文献

CANCER文献大全
  • Imaging characteristics of large lipoma and angiomyolipoma of the liver. Case reports.

    abstract::A large lipoma and a large angiomyolipoma of the liver, one case each, are described. In the first case, a 24 X 14-cm homogeneous mass demonstrated a fatty density (-96H) on computed tomography (CT), echogenicity on sonography, and fine neovascular vessels on angiography in the right lobe of the liver. Histopathologic...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19870301)59:5<916::aid-cncr28205

    authors: Takayasu K,Shima Y,Muramatsu Y,Moriyama N,Yamada T,Makuuchi M,Hirohashi S

    更新日期:1987-03-01 00:00:00

  • BRCA1, TP53, and CHEK2 germline mutations in uterine serous carcinoma.

    abstract:BACKGROUND:Uterine serous carcinoma (USC) is not recognized as part of any defined hereditary cancer syndrome, and its association with hereditary breast and ovarian carcinoma and Lynch syndrome are uncertain. METHODS:Using targeted capture and massively parallel genomic sequencing, 151 subjects with USC were assessed...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.27720

    authors: Pennington KP,Walsh T,Lee M,Pennil C,Novetsky AP,Agnew KJ,Thornton A,Garcia R,Mutch D,King MC,Goodfellow P,Swisher EM

    更新日期:2013-01-15 00:00:00

  • Significance of blasts in low-cell-count cerebrospinal fluid specimens from children with acute lymphoblastic leukemia.

    abstract::The purpose of this study was to determine whether the presence of more than 5% blasts in a differential count of cytocentrifuged cerebrospinal fluid (CSF) with less than 6 leukocytes/microliter was predictive of central nervous system (CNS) relapse in children with acute lymphoblastic leukemia (ALL). A double concent...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19901015)66:8<1748::aid-cncr2820

    authors: Odom LF,Wilson H,Cullen J,Bank J,Blake M,Jamieson B

    更新日期:1990-10-15 00:00:00

  • DNA content measurement can be obtained using archival material for DNA flow cytometry. A comparison with cytogenetic analysis in 56 pediatric solid tumors.

    abstract:BACKGROUND:Although flow cytometry (FCM) has become a widely used technique for the measurement of DNA content in solid tumors, the correlation of ploidy analysis by FCM with cytogenetic analysis (CGA) is not well described. The sensitivities of G-banded CGA and FCM were compared to determine the accuracy of the DNA in...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19930915)72:6<2033::aid-cncr2820

    authors: Dressler LG,Duncan MH,Varsa EE,McConnell TS

    更新日期:1993-09-15 00:00:00

  • Economic independence in survivors of cancer diagnosed at a young age: A Norwegian national cohort study.

    abstract:BACKGROUND:The impact of cancer on socioeconomic outcomes is attracting attention as the number of survivors of cancer in young age continues to rise. This study examines economic independence in a national cohort of survivors of cancer at a young age in Norway. METHODS:Through the linkage of several national registri...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.30253

    authors: Gunnes MW,Lie RT,Bjørge T,Syse A,Ruud E,Wesenberg F,Moster D

    更新日期:2016-12-15 00:00:00

  • Cancer incidence in the rural community of Tecumseh, Michigan: a pattern of increased lymphopoietic neoplasms.

    abstract:BACKGROUND:The Tecumseh Community Health Study (TCHS), initiated in 1959 at the University of Michigan School of Public Health, has provided a resource for long term prospective studies of the incidence of cancer in the setting of a midwestern rural farming community. METHODS:A survey of total and site specific cancer...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.1996.2820770402

    authors: Waterhouse D,Carman WJ,Schottenfeld D,Gridley G,McLean S

    更新日期:1996-02-15 00:00:00

  • Early detection of malignancy in ulcerative colitis. A flow-cytometric DNA study.

    abstract::The cellular DNA content in colorectal biopsies from 51 patients with chronic ulcerative colitis has been studied with flow-cytometric technique. The DNA pattern has been related to the duration of the disease, and to histopathology. Aneuploid cell lines were found in eight patients, two of which had histopathological...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19840115)53:2<291::aid-cncr28205

    authors: Hammarberg C,Slezak P,Tribukait B

    更新日期:1984-01-15 00:00:00

  • Clinical and economic burden associated with stage III to IV triple-negative breast cancer: A SEER-Medicare historical cohort study in elderly women in the United States.

    abstract:BACKGROUND:The current study was performed to describe patient characteristics, treatment patterns, survival, health care resource use (HRU), and costs among older women in the United States with advanced (American Joint Committee on Cancer stage III/IV) triple-negative breast cancer (TNBC) in the Surveillance, Epidemi...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.31299

    authors: Schwartz KL,Simon MS,Bylsma LC,Ruterbusch JJ,Beebe-Dimmer JL,Schultz NM,Flanders SC,Barlev A,Fryzek JP,Quek RGW

    更新日期:2018-05-15 00:00:00

  • Genetic and pathologic findings in a kindred with hereditary sarcoma, breast cancer, brain tumors, leukemia, lung, laryngeal, and adrenal cortical carcinoma.

    abstract::A familial cancer aggregation comprising sarcomas, brain tumors, leukemias, and carcinomas of breast, larynx, lung, adrenal, cortex, and other sites has been studied from a pathologic--genetic standpoint. Based upon sibships segregating for cancer, the genetic segregation parameter is estimated to be 45.6 +/- 11% whi...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197805)41:5<2055::aid-cncr282041

    authors: Lynch HT,Mulcahy GM,Harris RE,Guirgis HA,Lynch JF

    更新日期:1978-05-01 00:00:00

  • Oesophageal cancer in South Africa. A review of 1926 cases.

    abstract::From November 1985 to August 1988, the National Study Group for Oesophageal Cancer collected and centralized data on 1926 new cases of oesophageal cancer in South Africa. A standard data sheet was used to record the age, sex, and condition of the patients, the site, length, and circumferential extent of the tumor, the...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19891215)64:12<2604::aid-cncr282

    authors: Mannell A,Murray W

    更新日期:1989-12-15 00:00:00

  • Influence of p53 status on prognosis in preoperatively irradiated rectal carcinoma.

    abstract:BACKGROUND:Even when they are analogous in microscopic and macroscopic appearance, tumors vary in their response rates to radiotherapy. Cell culture and xenograft experiments with colorectal cell lines have demonstrated that wild-type p53 increases radiosensitivity. Hence, the authors investigated, in a well-defined po...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:

    authors: Nehls O,Klump B,Holzmann K,Lammering G,Borchard F,Gruenagel HH,Gaco V,Gregor M,Porschen R

    更新日期:1999-06-15 00:00:00

  • Osteosarcoma of the soft tissue of the larynx: report of a case with light and electron microscopic studies.

    abstract::A case of osteosarcoma arising in the soft tissue of the larynx in an elderly man is presented with light and electron microscopic documentation. The patient developed chronic hoarseness and a recurring polypoid laryngeal tumor, causing acute airway obstruction. He was treated by total laryngectomy, but he died with m...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197811)42:5<2343::aid-cncr282042

    authors: Dahm LJ,Schaefer SD,Carder HM,Vellios F

    更新日期:1978-11-01 00:00:00

  • Esophagitis in a population at risk for esophageal carcinoma.

    abstract::A previously unreported high incidence of endoscopically identifiable, diffuse, largely nonulcerative esophagitis, is described in a selected population of Southern African blacks at risk of cancer of the esophagus. This is comparable with findings in similar groups in Iran and China. The incidence of dysplasia and "e...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19860601)57:11<2222::aid-cncr282

    authors: Oettlé GJ,Paterson AC,Leiman G,Segal I

    更新日期:1986-06-01 00:00:00

  • What is the best treatment for patients with human papillomavirus-positive and -negative oropharyngeal cancer?

    abstract::The discovery that the human papilloma virus (HPV) is associated with a high and increasing percentage of oropharyngeal squamous cell carcinomas (SCCs) is among the most significant advances in the field of head and neck oncology. HPV-positive oropharyngeal cancer (HPVOPC) has clinical, etiologic, pathologic, and mole...

    journal_title:Cancer

    pub_type: 杂志文章,评审

    doi:10.1002/cncr.28595

    authors: Urban D,Corry J,Rischin D

    更新日期:2014-05-15 00:00:00

  • Oncology clinic attendance at an inner city hospital.

    abstract::Compliance in oncology clinic attendance was prospectively evaluated over a 12-month period at Harlem Hospital Center, an inner city municipal facility serving a predominantly black population. One hundred patients were followed (97 blacks, 2 Hispanics, 1 white) with an average age of 60 years. There were 41 men and 5...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19860801)58:3<793::aid-cncr28205

    authors: Garrett TJ,Ashford A,Savage DG

    更新日期:1986-08-01 00:00:00

  • Annual number of lung cancer deaths potentially avertable by screening in the United States.

    abstract:BACKGROUND:The National Lung Screening Trial (NLST), which was conducted between 2002 and 2009, demonstrated that screening with low-dose computed tomography (LDCT) reduced lung cancer mortality by 20% among screening-eligible populations compared with chest x-ray. In this article, the authors provide an estimate of th...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.27813

    authors: Ma J,Ward EM,Smith R,Jemal A

    更新日期:2013-04-01 00:00:00

  • Papanicolaou smear sensitivity for the detection of adenocarcinoma of the cervix: a study of 49 cases.

    abstract:BACKGROUND:Papanicolaou smear sensitivity for cervical adenocarcinoma (CVCA) is not well established. Also uncertain are the relative contributions to falsely negative diagnoses of sampling, screening, and interpretive errors. METHODS:Papanicolaou smears were identified from all patients at our institutions with biops...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:

    authors: Krane JF,Granter SR,Trask CE,Hogan CL,Lee KR

    更新日期:2001-02-25 00:00:00

  • Small carcinoma of the pancreas. Clinical and pathologic evaluation of 17 patients.

    abstract::The clinical and pathologic characteristics of 17 small carcinomas (less than 2 cm in diameter) of the pancreas are reviewed in this article. All the tumors were located in the head of the pancreas, and the clue to the diagnosis was jaundice in ten patients and abdominal pain in seven. Carcinoembryonic antigen (CEA) a...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19880701)62:1<135::aid-cncr28206

    authors: Manabe T,Miyashita T,Ohshio G,Nonaka A,Suzuki T,Endo K,Takahashi M,Tobe T

    更新日期:1988-07-01 00:00:00

  • Flow cytometric analysis of deparaffinized nuclei in urinary bladder carcinoma. Comparison with cytogenetic analysis.

    abstract::Both cytogenetic analysis and flow cytometry (FCM) have prognostic efficacy in the analysis of transitional cell carcinoma (TCC) of urinary bladder. To correlate results of the two methods, we studied a unique group of patients whose tumors had undergone prospective conventional cytogenetic analysis. Paraffin blocks o...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19860415)57:8<1594::aid-cncr2820

    authors: Coon JS,Schwartz D,Summers JL,Miller AW 3rd,Weinstein RS

    更新日期:1986-04-15 00:00:00

  • Angioinvasive plasma cell granulomas of the lung.

    abstract::A series of eight plasma cell granulomas of the lung were examined. Their clinical, pathologic, and immunohistochemical characteristics as well as the ultrastructural features of one case are in agreement with those found in the literature. One patient died after a surgical intervention complicated by invasion of pulm...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19870201)59:3<435::aid-cncr28205

    authors: Warter A,Satge D,Roeslin N

    更新日期:1987-02-01 00:00:00

  • Suppression of proline-directed protein kinase F(A) expression potentiates erythroid differentiation of human myeloid leukemia cells.

    abstract:BACKGROUND:Initial clinic studies revealed that the overexpression of proline-directed protein kinase F(A) (PDPK F(A)) is associated conversely with various stages of tumor tissue differentiation. However, the role of overexpressed PDPK F(A) in tumor cell differentiation remains unknown and needs to be established. In ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:

    authors: Hsu CP,Yang CC,Yang SD

    更新日期:2000-09-01 00:00:00

  • The pathophysiology of undernutrition in the child with cancer.

    abstract::The physiologic consequences of malnutrition in children with cancer are reviewed. It is stressed that the child with cancer has a nutritional state that is no different from the average population from which the child comes. What little malnutrition is seen is calorie malnutrition. The physiologic consequences are th...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19861015)58:8+<1874::aid-cncr282

    authors: van Eys J

    更新日期:1986-10-15 00:00:00

  • The current state of brachytherapy nomograms for patients with clinically localized prostate cancer.

    abstract::For men diagnosed with clinically localized prostate cancer, definitive therapy with radical prostatectomy, external beam radiation therapy, or brachytherapy offers a high chance of cure. Currently, there are insufficient data to recommend 1 treatment approach over another, leaving physicians and patients to decide ba...

    journal_title:Cancer

    pub_type: 杂志文章,评审

    doi:10.1002/cncr.24344

    authors: Nguyen CT,Zelefsky MJ,Kattan MW

    更新日期:2009-07-01 00:00:00

  • Complications of radiotherapy in laryngopharyngeal cancer: effects of a prospective smoking cessation program.

    abstract:BACKGROUND:Radiotherapy (XRT) is effective as the primary treatment modality for laryngopharyngeal cancer; however, complications of XRT can result in significant morbidity. Few previous studies have examined the effect of continued smoking on complications of XRT. The authors of this report hypothesized that patients ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.24499

    authors: Zevallos JP,Mallen MJ,Lam CY,Karam-Hage M,Blalock J,Wetter DW,Garden AS,Sturgis EM,Cinciripini PM

    更新日期:2009-10-01 00:00:00

  • Virtual microscopy for cytology proficiency testing: are we there yet?

    abstract:BACKGROUND:The objective of this study was to investigate the potential of virtual microscopy (VM) as an avenue for the delivery of mandatory cytology proficiency tests). METHODS:Three senior cytotechnologists and 2 board-certified cytopathologists participated in 3 virtual proficiency tests. Each set consisted of 10 ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.22766

    authors: Stewart J 3rd,Miyazaki K,Bevans-Wilkins K,Ye C,Kurtycz DF,Selvaggi SM

    更新日期:2007-08-25 00:00:00

  • Hereditary diffuse gastric cancer: diagnosis, genetic counseling, and prophylactic total gastrectomy.

    abstract:BACKGROUND:A subset of patients with diffuse gastric cancer harbor deleterious cancer-causing germline mutations in the type 1 E-cadherin (epithelial) gene (CDH1), which predisposes to the autosomal dominantly inherited hereditary diffuse gastric cancer (HDGC) syndrome. These mutations are associated with a 70% life-ti...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.23501

    authors: Lynch HT,Kaurah P,Wirtzfeld D,Rubinstein WS,Weissman S,Lynch JF,Grady W,Wiyrick S,Senz J,Huntsman DG

    更新日期:2008-06-15 00:00:00

  • Multiple myeloma associated with immune thrombocytopenic purpura.

    abstract::Thrombocytopenia in patients with multiple myeloma is usually due to chemotherapy or marrow replacement with myeloma cells. Two patients with multiple myeloma who fulfilled criteria for the diagnosis of immune thrombocytopenic purpura are presented. The etiologic and therapeutic implications of this unusual associatio...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19850901)56:5<1199::aid-cncr2820

    authors: Verdirame JD,Feagler JR,Commers JR

    更新日期:1985-09-01 00:00:00

  • Prostaglandin-E-producing hepatocellular carcinoma with hypercalcemia.

    abstract::An autopsy case of prostaglandin E-producing hepatocellular carcinoma with hypercalcemia is presented in this article. A 72-year-old man showed high serum calcium levels (14.2 to 17.3 mg/100 ml) and hypophosphatemia. The plasma level of immunoreactive parathyroid hormone was below the normal range. Administration of o...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19880501)61:9<1813::aid-cncr2820

    authors: Ikeda T,Tozuka S,Hasumura Y,Takeuchi J

    更新日期:1988-05-01 00:00:00

  • Prognostic value of the proliferation-related antigen Ki-67 in oligodendrogliomas.

    abstract:BACKGROUND:In various neoplasms expression of the proliferation-related Ki-67 antigen has successfully been linked with parameters of progression of disease. While a definite grading scheme for oligodendrogliomas has still not been agreed upon, any parameter of tumor proliferation that might be helpful in predicting cl...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/(SICI)1097-0142(19960901)78:5<1107::AID-CN

    authors: Kros JM,Hop WC,Godschalk JJ,Krishnadath KK

    更新日期:1996-09-01 00:00:00

  • Mucin 1 antigens in the serum and bronchial lavage fluid of patients with lung cancer.

    abstract:BACKGROUND:Lung cancer (LC) is the most common fatal malignancy, but there are no useful tumor markers for diagnosis or monitoring. Mucin 1 has an established role as a marker in other malignancies, but has undergone limited assessment in LC. METHODS:Serum from 86 patients with LC and 24 with benign pulmonary disease ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19931115)72:10<2936::aid-cncr282

    authors: Willsher PC,Xing PX,Clarke CP,Ho DW,McKenzie IF

    更新日期:1993-11-15 00:00:00