Randomized controlled trials of treatments for hematologic malignancies: study characteristics and outcomes.

Abstract:

BACKGROUND:Although randomized controlled trials (RCTs) require a great deal of time, money, and effort, the majority of them have resulted in failure to verify a priori hypotheses. Therefore, the intention in the current study was to clarify the differential elements of studies with 'positive' and 'negative' outcomes. METHODS:The authors performed a comprehensive search of RCT reports on treatments for hematologic malignancies published between 1995 and 2004, with 264 reports eventually identified. The expected rate and the observed rate for the primary endpoint were compared for 70 studies with all relevant information available. RESULTS:Of all the superiority trials (n = 256), positive studies accounted for 33%. Most of the major study characteristics were not found to be associated with the study outcome except for the primary endpoint. Studies evaluating event-free survival were more likely to report positive results than were those evaluating overall survival (P = .061). For the experimental treatment arm, the mean difference between the expected and observed rates was -10.1% (standard deviation [SD], 10.1%) in the negative studies, which indicates a rate lower than expected, and was 1.3% (SD, 9.2%) in the positive studies (P < .0001). In contrast, no statistical significance was observed for the standard treatment arm because the mean difference was 6.3% (SD, 10.7%) for the negative studies and 3.0% (SD, 9.0%) for the positive studies (P = .1885). The journal impact factor was statistically significantly higher for the positive than for the negative reports (P < .0001). CONCLUSIONS:Giving adequate consideration to the estimated effect of an experimental therapy may be critical when planning an RCT.

journal_name

Cancer

journal_title

Cancer

authors

Yanada M,Narimatsu H,Suzuki T,Matsuo K,Naoe T

doi

10.1002/cncr.22776

subject

Has Abstract

pub_date

2007-07-15 00:00:00

pages

334-9

issue

2

eissn

0008-543X

issn

1097-0142

journal_volume

110

pub_type

杂志文章

相关文献

CANCER文献大全
  • Preclinical and clinical studies of interferons and interferon inducers in breast cancer.

    abstract::Preclinical and clinical studies suggest interferons and interferon inducers have antitumor activity for breast carcinoma. Observations include inhibition of growth of freshly derived and continuously passaged breast carcinoma cells in vitro, decreased tumor size and increased survival in spontaneous mouse mammary car...

    journal_title:Cancer

    pub_type: 临床试验,杂志文章

    doi:10.1002/1097-0142(19840201)53:3+<783::aid-cncr2820

    authors: Borden EC,Balkwill FR

    更新日期:1984-02-01 00:00:00

  • The added value of geriatric screening and assessment for predicting overall survival in older patients with cancer.

    abstract:BACKGROUND:The aim of this study was to determine and compare the added prognostic value of screening tools, geriatric assessment (GA) components, and GA summaries to clinical information for overall survival (OS) in older patients with cancer. METHODS:A screening and a 10-item GA were systematically performed in pati...

    journal_title:Cancer

    pub_type: 杂志文章,多中心研究

    doi:10.1002/cncr.31581

    authors: Kenis C,Baitar A,Decoster L,De Grève J,Lobelle JP,Flamaing J,Milisen K,Wildiers H

    更新日期:2018-09-15 00:00:00

  • Alterations in plasma sialyltransferase levels in patients with neoplastic disease.

    abstract::Levels of glycoprotein:sialyltransferase activity (EC 2.4.99.1; CMP-acetyl-neuraminate:D-galactosyl-glycoprotein N-acetylneuraminyl-transferase) were measured in plasma of patients with neoplastic disease, and were found elevated above normal control values in 85% of patients examined. There was a correlation between ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197703)39:3<1129::aid-cncr282039

    authors: Henderson M,Kessel D

    更新日期:1977-03-01 00:00:00

  • Favorable prognosis after late relapse of Hodgkin's disease.

    abstract:BACKGROUND:Most relapses of Hodgkin's disease (HD) occur within the first 2 years after diagnosis, but they may develop after a longer observation period. The aim of this study was to define the incidence, clinical course, and prognostic factors for late relapse (LR) of Hodgkin's disease. For this purpose, the authors ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:

    authors: Garcia-Carbonero R,Paz-Ares L,Arcediano A,Lahuerta J,Bartolome A,Cortes-Funes H

    更新日期:1998-08-01 00:00:00

  • Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor.

    abstract:BACKGROUND:Alveolar soft part sarcoma (ASPS), chondrosarcoma (CS), chordoma, epithelioid sarcoma, and solitary fibrous tumor (SFT) are malignant tumors that are relatively resistant to chemotherapy and for which more effective drug therapy is needed. METHODS:The 5 listed subtypes were enrolled into a single indolent s...

    journal_title:Cancer

    pub_type: 杂志文章,多中心研究

    doi:10.1002/cncr.30379

    authors: Schuetze SM,Bolejack V,Choy E,Ganjoo KN,Staddon AP,Chow WA,Tawbi HA,Samuels BL,Patel SR,von Mehren M,D'Amato G,Leu KM,Loeb DM,Forscher CA,Milhem MM,Rushing DA,Lucas DR,Chugh R,Reinke DK,Baker LH

    更新日期:2017-01-01 00:00:00

  • A consensus review on malignancy-associated hemophagocytic lymphohistiocytosis in adults.

    abstract::Hemophagocytic lymphohistiocytosis (HLH) is a syndrome of severe immune activation and dysregulation resulting in extreme and often life-threatening inflammation. HLH has been well recognized in pediatric populations, and most current diagnostic and therapeutic guidelines are based on pediatric HLH. Recently there has...

    journal_title:Cancer

    pub_type: 杂志文章,评审

    doi:10.1002/cncr.30826

    authors: Daver N,McClain K,Allen CE,Parikh SA,Otrock Z,Rojas-Hernandez C,Blechacz B,Wang S,Minkov M,Jordan MB,La Rosée P,Kantarjian HM

    更新日期:2017-09-01 00:00:00

  • Cost-effectiveness of human papillomavirus vaccination for adolescent girls in Punjab state: Implications for India's universal immunization program.

    abstract:BACKGROUND:Introduction of human papillomavirus (HPV) vaccination for adolescent girls is being considered in the Punjab state of India. However, evidence regarding cost-effectiveness is sought by policy makers when making this decision. The current study was undertaken to evaluate the incremental cost per quality-adju...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.30734

    authors: Prinja S,Bahuguna P,Faujdar DS,Jyani G,Srinivasan R,Ghoshal S,Suri V,Singh MP,Kumar R

    更新日期:2017-09-01 00:00:00

  • Notable effects of angiotensin II receptor blocker, valsartan, on acute cardiotoxic changes after standard chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednisolone.

    abstract:BACKGROUND:There are three distinct types of doxorubicin-induced cardiotoxicity (acute, chronic, and late-onset). Although previous studies with animal models suggest that angiotensin II plays a key role in the process of the doxorubicin-induced cardiotoxicity, there has been no such observation in humans. This randomi...

    journal_title:Cancer

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/cncr.21478

    authors: Nakamae H,Tsumura K,Terada Y,Nakane T,Nakamae M,Ohta K,Yamane T,Hino M

    更新日期:2005-12-01 00:00:00

  • Ten-year change in neighborhood socioeconomic status and colorectal cancer.

    abstract:BACKGROUND:A growing body of research has demonstrated that individuals who live in neighborhoods with more severe socioeconomic deprivation may have higher risks for colorectal cancer (CRC). However, previous studies have examined neighborhood socioeconomic status (SES) at only 1 point in time, and it is unclear wheth...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.31832

    authors: Zhang D,Matthews CE,Powell-Wiley TM,Xiao Q

    更新日期:2019-02-15 00:00:00

  • A multicenter study of the prognosis and treatment of adult brain ependymal tumors.

    abstract:BACKGROUND:The current analysis of outcomes in a large series of adult patients with intracranial ependymal tumors contributes to the characterization of the primary prognostic factors and to the therapeutic management of this rare disease, for which limited information is available in the literature. METHODS:The auth...

    journal_title:Cancer

    pub_type: 杂志文章,多中心研究

    doi:10.1002/cncr.20074

    authors: Reni M,Brandes AA,Vavassori V,Cavallo G,Casagrande F,Vastola F,Magli A,Franzin A,Basso U,Villa E

    更新日期:2004-03-15 00:00:00

  • Localization of oncofetal and normal fibronectin in colorectal cancer. Correlation with histologic grade, liver metastasis, and prognosis.

    abstract:BACKGROUND:Expression of oncofetal fibronectin (oncFN) and normal fibronectin (norFN) in colorectal cancer specimens was examined to investigate the correlation between fibronectin localization and histologic grade, liver metastasis, and prognosis. METHODS:Immunohistochemical staining of oncFN and norFN was performed ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19950615)75:12<2802::aid-cncr282

    authors: Inufusa H,Nakamura M,Adachi T,Nakatani Y,Shindo K,Yasutomi M,Matsuura H

    更新日期:1995-06-15 00:00:00

  • Lack of significant differences in the corrected activity of lysophospholipase D, producer of phospholipid mediator lysophosphatidic acid, in incubated serum from women with and without ovarian tumors.

    abstract:BACKGROUND:Several studies have shown that lysophosphatidic acid (LPA), a phospholipidic chemical mediator, is relevant to the pathogenesis of ovarian carcinoma. Higher plasma levels of LPA have been reported in patients with ovarian carcinoma than in healthy patients, and LPA is known to activate ovarian carcinoma cel...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.10146

    authors: Tokumura A,Tominaga K,Yasuda K,Kanzaki H,Kogure K,Fukuzawa K

    更新日期:2002-01-01 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

  • A population-based study evaluating the impact of sunitinib on overall survival in the treatment of patients with metastatic renal cell cancer.

    abstract:BACKGROUND:Sunitinib has replaced interferon (IFN) as a first-line standard of care in the treatment of metastatic renal cell carcinoma (RCC). This study aimed to determine overall survival and to confirm effectiveness in a population that includes poor prognosis patients. METHODS:Data were collected on all patients i...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.24051

    authors: Heng DY,Chi KN,Murray N,Jin T,Garcia JA,Bukowski RM,Rini BI,Kollmannsberger C

    更新日期:2009-02-15 00:00:00

  • Comparison of clinical schemas and morphologic features in predicting Lynch syndrome in mutation-positive patients with endometrial cancer encountered in the context of familial gastrointestinal cancer registries.

    abstract:BACKGROUND:Endometrial cancer (EC) is the most common extraintestinal malignancy in Lynch syndrome (LS) and often is the sentinel malignancy, yet there is no consensus regarding LS-EC detection algorithms. In this study, the authors determined the efficacy of family/personal history and tumor morphology in predicting L...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.26323

    authors: Ryan P,Mulligan AM,Aronson M,Ferguson SE,Bapat B,Semotiuk K,Holter S,Kwon J,Kalloger SE,Gilks CB,Gallinger S,Pollett A,Clarke BA

    更新日期:2012-02-01 00:00:00

  • Tumor downstaging as an intermediate endpoint to assess the activity of neoadjuvant systemic therapy in patients with muscle-invasive bladder cancer.

    abstract:BACKGROUND:Achieving a pathologic complete response (pCR) with neoadjuvant chemotherapy (NAC) in patients with muscle-invasive bladder cancer (MIBC) has been associated with improved overall survival (OS). This study was aimed at evaluating the impact of pathologic downstaging (pDS; ie, a pT stage at least 1 stage lowe...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.32169

    authors: Martini A,Jia R,Ferket BS,Waingankar N,Plimack ER,Crabb SJ,Harshman LC,Yu EY,Powles T,Rosenberg JE,Pal SK,Vaishampayan UN,Necchi A,Wiklund NP,Mehrazin R,Mazumdar M,Sfakianos JP,Galsky MD

    更新日期:2019-09-15 00:00:00

  • Soft tissue sarcoma brain metastases. Prevalence in a cohort of 3829 patients.

    abstract:BACKGROUND:Brain metastases from soft tissue sarcoma (STS) are uncommon. To the authors' knowledge limited information is available regarding the influence of the initial STS site, the significance of parenchymal versus leptomeningeal metastases, and the role of surgical resection. METHODS:STS patients evaluated betwe...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.10554

    authors: Espat NJ,Bilsky M,Lewis JJ,Leung D,Brennan MF

    更新日期:2002-05-15 00:00:00

  • Endocrine therapy for desmoid tumors.

    abstract::Two female patients with desmoid tumors (aggressive fibromatosis) showed tumor regression after endocrine therapy. In one patient, tumor response to tamoxifen has been maintained over several years of treatment. In the second patient, who had inoperable mesenteric fibromatosis, the tumor progressed on tamoxifen but re...

    journal_title:Cancer

    pub_type: 杂志文章,评审

    doi:10.1002/1097-0142(19910915)68:6<1384::aid-cncr2820

    authors: Wilcken N,Tattersall MH

    更新日期:1991-09-15 00:00:00

  • Expression of vascular endothelial growth factor in early cutaneous melanocytic lesion progression.

    abstract:BACKGROUND:A considerable body of evidence supports the concept that a significant number of cutaneous malignant melanomas progress through a precursor lesion or dysplastic melanocytic nevi (DN). Tumor angiogenesis likely plays a critical role in early development of melanoma, and intermediate biomarkers of angiogenesi...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.23076

    authors: Einspahr JG,Thomas TL,Saboda K,Nickolof BJ,Warneke J,Curiel-Lewandrowski C,Ranger-Moore J,Duckett L,Bangert J,Fruehauf JP,Alberts DS

    更新日期:2007-12-01 00:00:00

  • Limb salvage for skeletal and soft tissue sarcomas. Multidisciplinary preoperative therapy.

    abstract::One hundred eighty-three patients with malignant skeletal (83) or soft tissue sarcoma (100) were entered into the multimodality preoperative limb salvage protocol. Local recurrences were observed in 5 of 183 (2.7%). Six patients required amputation because of complications, and 13 patients died within 1 year from meta...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19840615)53:12<2579::aid-cncr282

    authors: Eilber FR,Morton DL,Eckardt J,Grant T,Weisenburger T

    更新日期:1984-06-15 00:00:00

  • The prognostic significance of nuclear DNA content in malignant epithelial tumors of the ovary.

    abstract::Recent studies have indicated that the nuclear DNA content of certain malignant neoplasms can be used as an adjunct in predicting their biologic behavior. The DNA content of 99 ovarian carcinomas was determined by flow cytometric analysis of nuclei obtained from paraffin-embedded tissue. Of the 99 tumors, 51 were dipl...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19900101)65:1<141::aid-cncr28206

    authors: Brescia RJ,Barakat RA,Beller U,Frederickson G,Suhrland MJ,Dubin N,Demopoulos RI

    更新日期:1990-01-01 00:00:00

  • Early lung cancer action project: overall design and findings from baseline screening.

    abstract:BACKGROUND:The Early Lung Cancer Action Project (ELCAP) is designed to evaluate baseline and annual repeat screening by low radiation dose computed tomography (low-dose CT) in persons at high-risk for lung cancer. The authors report on the baseline screening experience. For full evaluation of screening, they await the ...

    journal_title:Cancer

    pub_type: 临床试验,杂志文章

    doi:10.1002/1097-0142(20001201)89:11+<2474::aid-cncr26

    authors: Henschke CI

    更新日期:2000-12-01 00:00:00

  • Standardized activities for lay patient navigators in breast cancer care: Recommendations from a citywide implementation study.

    abstract:BACKGROUND:There is a need for guidelines on patient navigation activities to promote both the quality of patient navigation and the standards of reimbursement for these services because a lack of reimbursement is a major barrier to the implementation, maintenance, and sustainability of these programs. METHODS:A broad...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.32432

    authors: Freund KM,Haas JS,Lemon SC,Burns White K,Casanova N,Dominici LS,Erban JK,Freedman RA,James TA,Ko NY,LeClair AM,Moy B,Parsons SK,Battaglia TA

    更新日期:2019-12-15 00:00:00

  • Malignant rhabdoid tumor of the pelvis.

    abstract::An extrarenal malignant rhabdoid tumor (MRT) of the pelvis in a 14-year-old girl is described. The location of the tumor and age of the patient appear to be unique. The neoplasm is histologically and ultrastructurally identical to malignant rhabdoid tumor of the kidney seen in infants and very young children. The tumo...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19850501)55:9<1963::aid-cncr2820

    authors: Frierson HF Jr,Mills SE,Innes DJ Jr

    更新日期:1985-05-01 00:00:00

  • Squamous cell carcinoma of the buccal mucosa associated with chronic oral polyvinyl chloride exposure: report of a case.

    abstract::The following case report describes a 22-year-old healthy man, non-smoker, non-drinker, who developed a squamous cell carcinoma of the buccal mucosa. The appearance of this unusual tumor in an unexpected clinical setting was unexplained until it was discovered that the patient had a lifetime habit of chewing plastic m...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197704)39:4<1686::aid-cncr282039

    authors: Casterline CL,Casterline PF,Jaques DA

    更新日期:1977-04-01 00:00:00

  • Prognostic factors in elderly women with metastatic breast cancer treated with tamoxifen: an analysis of patients entered on four prospective clinical trials.

    abstract:BACKGROUND:Information regarding prognostic factors and survival in elderly women with metastatic breast cancer treated with tamoxifen is limited. METHODS:The data from 4 prospective clinical trials were analyzed, including information on 396 postmenopausal women with advanced breast cancer who received tamoxifen as i...

    journal_title:Cancer

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1002/(sici)1097-0142(19960215)77:4<683::aid-cnc

    authors: Dhodapkar MV,Ingle JN,Cha SS,Mailliard JA,Wieand HS

    更新日期:1996-02-15 00:00:00

  • Malignant struma ovarii. Light and electron microscopic study.

    abstract::Malignant struma ovarii is a very rare tumor, consisting of a struma ovarii with malignant change. Only 17 examples with metastases have previously been reported. We present a case which involved both ovaries and produced multiple metastases. Microscopy and ultrastructure were identical to a mixed papillary and follic...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19830115)51:2<337::aid-cncr28205

    authors: Pardo-Mindan FJ,Vazquez JJ

    更新日期:1983-01-15 00:00:00

  • Primary carcinoid tumor of testis. Immunohistochemical, ultrastructural, and DNA flow cytometric study of three cases with a review of the literature.

    abstract::The cases of three patients with primary carcinoid tumor of the testis were reported. The patients were 41, 44, and 83 years of age. At initial examination, all three had testicular masses with or without associated pain, and none had the carcinoid syndrome. The tumors measured 4.3 cm, 3.0 cm, and 6.5 cm in dimension....

    journal_title:Cancer

    pub_type: 杂志文章,评审

    doi:10.1002/1097-0142(19930901)72:5<1726::aid-cncr2820

    authors: Zavala-Pompa A,Ro JY,el-Naggar A,Ordóñez NG,Amin MB,Pierce PD,Ayala AG

    更新日期:1993-09-01 00:00:00

  • Intravascular papillary endothelial hyperplasia: light and electron microscopic observations of a case.

    abstract::The ultrastructure of a case of intravascular papillary endothelial hyperplasia is presented. The papillae and septa within the lesion showed a similar organization. The surface was lined by a nonstratified layer of plump endothelial cells. Immediately beneath lay cells and processes of pericytes rich in thin filament...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197811)42:5<2304::aid-cncr282042

    authors: Kreutner A Jr,Smith RM,Trefny FA

    更新日期:1978-11-01 00:00:00

  • Malignant mucosal melanoma of the head and neck: review of the literature and report of 14 patients.

    abstract:BACKGROUND:Fortunately, primary malignant mucosal melanoma of the head and neck is a rare entity. A paucity of data elucidating the predictive factors as well as the unpredictable and aggressive biologic behavior of mucosal melanoma compound the vexing clinical situation. This review summarizes what the literature reve...

    journal_title:Cancer

    pub_type: 杂志文章,评审

    doi:10.1002/(sici)1097-0142(19971015)80:8<1373::aid-cn

    authors: Manolidis S,Donald PJ

    更新日期:1997-10-15 00:00:00