Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer.

Abstract:

BACKGROUND:Sipuleucel-T is an investigational active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. The safety and efficacy of sipuleucel-T was evaluated in 2 identically designed, randomized, double-blind, placebo-controlled trials (D9901 and D9902A) conducted in men with advanced prostate cancer. METHODS:A total of 225 patients were randomized in D9901 or D9902A to sipuleucel-T (n = 147) or placebo (n = 78), given as 3 intravenous infusions approximately 2 weeks apart. Patients were followed for survival until death or a prespecified cutoff of 36 months after randomization. RESULTS:In the integrated analysis of D9901 and D9902A, patients randomized to sipuleucel-T demonstrated a 33% reduction in the risk of death (hazard ratio, 1.50; 95% confidence interval, 1.10-2.05; P = .011; log-rank). The treatment effect remained strong after performing adjustments for imbalances in baseline prognostic factors, poststudy treatment chemotherapy use, and non-prostate cancer-related deaths. Additional support for the activity of sipuleucel-T is provided by the correlation between a measure of the product's potency, CD54 up-regulation, and overall survival. The most common adverse events associated with treatment were chills, pyrexia, headache, asthenia, dyspnea, vomiting, and tremor. These events were primarily grade 1 and 2, with durations of 1 to 2 days. CONCLUSIONS:The integrated results of D9901 and D9902A demonstrate a survival benefit for patients treated with sipuleucel-T compared with those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk-benefit ratio for sipuleucel-T in patients with advanced prostate cancer.

journal_name

Cancer

journal_title

Cancer

authors

Higano CS,Schellhammer PF,Small EJ,Burch PA,Nemunaitis J,Yuh L,Provost N,Frohlich MW

doi

10.1002/cncr.24429

subject

Has Abstract

pub_date

2009-08-15 00:00:00

pages

3670-9

issue

16

eissn

0008-543X

issn

1097-0142

journal_volume

115

pub_type

杂志文章,随机对照试验

相关文献

CANCER文献大全
  • Total body irradiation with 8 MeV X-rays in generalized malignant disease.

    abstract::The authors describe their experience with total body irradiation (TBI) with 8 MeV-x rays in the treatment of disseminated tumors. With a dose of 125 rad, given three times with 2-week intervals, some objective remissions (6/26) were obtained, especially in patients with lymphomas. For solid tumors only subjective imp...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197704)39:4<1435::aid-cncr282039

    authors: Huys JV,Simons MJ,Dewulf LM,Schelstraete KH

    更新日期:1977-04-01 00:00:00

  • The value of current staging systems for melanoma of the extremities.

    abstract::The validity of current staging systems for malignant melanoma was analyzed in a prospective study on 220 patients with extremity melanoma. Patients were followed 2 to 9 years after a wide excision of the primary, regional cytostatic perfusion and dissection of regional lymph nodes. The "original three-stage" system y...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19900715)66:2<396::aid-cncr28206

    authors: Ghussen F,Krüger I,Groth W

    更新日期:1990-07-15 00:00:00

  • Value of integrated positron emission tomography revised using a phantom study to evaluate malignancy grade of lung adenocarcinoma: a multicenter study.

    abstract:BACKGROUND:The malignant biological behavior of small-sized lung adenocarcinomas remains obscure, although understanding this feature is important for selecting appropriate treatment. In the current study, the authors evaluated malignancy grades of small adenocarcinomas using fluorodeoxyglucose-positron emission tomogr...

    journal_title:Cancer

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1002/cncr.25244

    authors: Nakayama H,Okumura S,Daisaki H,Kato Y,Uehara H,Adachi S,Yoshimura M,Okada M

    更新日期:2010-07-01 00:00:00

  • A morphometric study of neovascularization in colorectal carcinoma.

    abstract:BACKGROUND:Neovascularization reportedly is correlated with metastasis, recurrence, and prognosis in some types of tumors. Microvessel quantification in so-called "hot spots" has been studied extensively as the only factor reflecting angiogenesis in various malignant tumors. The objective of this report was to evaluate...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:

    authors: Pavlopoulos PM,Konstantinidou AE,Agapitos E,Kavantzas N,Nikolopoulou P,Davaris P

    更新日期:1998-11-15 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

  • Positive impact of the Patient Protection and Affordable Care Act Medicaid expansion on Louisiana women with breast cancer.

    abstract:BACKGROUND:Louisiana is one of the few Southern states that enacted the Medicaid expansion of the Patient Protection and Affordable Care Act (ACA). To the authors' knowledge, the issue of how this has affected the breast cancer landscape in Louisiana is unknown. The authors have postulated that ACA expansion had a posi...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.33265

    authors: Chu QD,Li T,Hsieh MC,Yi Y,Gibbs JF,Lyons JM 3rd,Wu XC

    更新日期:2020-11-03 00:00:00

  • Insular carcinoid primary in the ovary. A clinicopathologic analysis of 48 cases.

    abstract::Forty-eight cases of primary insular carcinoid of the ovary were analyzed from a clinicopathologic viewpoint. Sixteen (33%) were associated with preoperative clinical evidence of the carcinoid syndrome. At operation only one ovary was usually enlarged, but in 16% the contralateral ovary was also enlarged by either a d...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197508)36:2<404::aid-cncr2820360

    authors: Robboy SJ,Norris HJ,Scully RE

    更新日期:1975-08-01 00:00:00

  • Leukocyte function in children with malignancies.

    abstract::Blood was obtained on 414 occasions from 106 children with acute lymphocytic leukemia (ALL) or solid tumors. Resting and stimulated hexose monophosphate shunt (HMPS) activity and unstimulated and stimulated nitroblue tetrazolium (NBT) dye reduction were assessed on each sample. The values obtained were compared to sim...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197505)35:5<1365::aid-cncr282035

    authors: Pickering LK,Anderson DC,Choi S,Feigin RD

    更新日期:1975-05-01 00:00:00

  • Concurrent vinblastine and radiation therapy in bladder cancer.

    abstract:BACKGROUND:Since mid-1987, 29 patients with invasive transitional cell carcinoma of the urinary bladder (T1-3 N0-X M0) were treated with concurrent radiation therapy (RT) (target dose [TD], 62-66 Gy) 1.8-2.0 Gy/day for 5 days a week with a break in the middle of treatment of 2-3 weeks and vinblastine weekly 2 mg/5-12 h...

    journal_title:Cancer

    pub_type: 临床试验,杂志文章

    doi:10.1002/1097-0142(19921215)70:12<2885::aid-cncr282

    authors: Kragelj B,Jereb B,Kragelj L,Stanonik M

    更新日期:1992-12-15 00:00:00

  • The prognostic significance of vascular invasion by endometrial carcinoma.

    abstract:BACKGROUND:Recently, invasion of vascular spaces by endometrial carcinoma has received particular attention as a prognostic factor. The goal of the current investigation was to re-examine the effect of vascular invasion on tumor recurrence and survival in patients with endometrial carcinoma. METHODS:Surgical specimens...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/(SICI)1097-0142(19961001)78:7<1447::AID-CN

    authors: Inoue Y,Obata K,Abe K,Ohmura G,Doh K,Yoshioka T,Hoshiai H,Noda K

    更新日期:1996-10-01 00:00:00

  • An immunohistochemical analysis for cancer of the esophagus using monoclonal antibodies specific for modified nucleosides.

    abstract:BACKGROUND:Modified nucleosides such as 1-methyl-adenosine and pseudouridine exist as minute components of transfer ribonucleic acid (tRNA) and are excreted in the urine in large amounts in the presence of malignancy. Although use of these modified nucleosides as tumor markers has long been studied and many reports hav...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19931215)72:12<3571::aid-cncr282

    authors: Masuda M,Nishihira T,Itoh K,Mizugaki M,Ishida N,Mori S

    更新日期:1993-12-15 00:00:00

  • Neutropenic enterocolitis. Clinical diagnosis and treatment.

    abstract::Review of the consultation records of the Gastrointestinal Surgical Oncology service at Roswell Park Memorial Institute from 1982 to 1987 revealed 22 patients with a clinical diagnosis of neutropenic enterocolitis. Ninety-one percent of the patients had hematologic malignancies, and 95% were receiving cytotoxic chemot...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19920101)69:1<17::aid-cncr282069

    authors: Wade DS,Nava HR,Douglass HO Jr

    更新日期:1992-01-01 00:00:00

  • Image-directed percutaneous biopsy. A comparison of cytologic and histologic findings.

    abstract:BACKGROUND:Image-directed biopsies may be collected as histologic or cytologic specimens. METHODS:In 34 patients, the results of aspiration cytologic examination were compared prospectively with core tissue biopsy findings obtained and diagnosed independently using the same image-guided procedure. RESULTS:Cytologic e...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19921015)70:8<2187::aid-cncr2820

    authors: Jonasson JG,Wang HH,Porter DH,Tyagi G,Ducatman BS

    更新日期:1992-10-15 00:00:00

  • Metastasizing basal cell carcinoma of the skin with myelophthisic anemia.

    abstract::A case report of a metastasizing basal cell carcinoma is presented, primary in the leg with regional inguinal lymph node metastasis, followed by extensive metastasis to skin and bone marrow with myelophthisic anemia and terminal splenohepatic and unilateral adrenal metastasis. ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(196810)22:4<879::aid-cncr2820220

    authors: Coletta DF,Haentze FE,Thomas CC

    更新日期:1968-10-01 00:00:00

  • Radiation-induced long thoracic nerve palsy.

    abstract::The incidence of long thoracic nerve palsy after radical mastectomy has been documented to be approximately 10%. No cases have been reported after the more recent treatment for breast cancer, lumpectomy with axillary dissection. This more recent surgical procedure is customarily followed by aggressive radiation therap...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19870915)60:6<1247::aid-cncr2820

    authors: Pugliese GN,Green RF,Antonacci A

    更新日期:1987-09-15 00:00:00

  • Prostatic cancer after prostatectomy for benign disease.

    abstract::Twenty of 391 newly diagnosed cases of prostatic cancer (5%) had a prior prostatectomy for benign disease. Digital rectal examination in 16 of 19 patients (84%) revealed a significant prostatic abnormality. Continued serial digital rectal examination should be performed routinely after prostatectomy for benign disease...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19860815)58:4<994::aid-cncr28205

    authors: Schwartz I,Wein AJ,Malloy TR,Glick JH

    更新日期:1986-08-15 00:00:00

  • Comparative genomic hybridization in patients with supratentorial and infratentorial primitive neuroectodermal tumors.

    abstract:BACKGROUND:Intracranial primitive neuroectodermal tumors (PNETs) occur in the supratentorial and infratentorial regions of the brain. Although histologically similar, the natural history of the tumor at each site differs. The study goal was to determine whether there was evidence of a genetic difference between suprate...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/(sici)1097-0142(19990715)86:2<331::aid-cnc

    authors: Russo C,Pellarin M,Tingby O,Bollen AW,Lamborn KR,Mohapatra G,Collins VP,Feuerstein BG

    更新日期:1999-07-15 00:00:00

  • Primary yolk-sac (endodermal sinus) tumor of the prostate.

    abstract::A primary yolk-sac (endodermal sinus) tumor of the prostate occurring in a 51-year-old man is described, and the difficulties associated with classification of this tumor are discussed. Yolk-sac tumors have been reported to arise in several extragonadal sites, but to our knowledge this is the first documented case of ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197804)41:4<1395::aid-cncr282041

    authors: Benson RC Jr,Segura JW,Carney JA

    更新日期:1978-04-01 00:00:00

  • Outcome of advanced, unresectable conventional central chondrosarcoma.

    abstract:BACKGROUND:For patients who have chondrosarcoma with unresectable disease, because of tumor location, tumor size, or extensive metastatic disease, treatment options are very limited because of their relative resistance to radiotherapy and chemotherapy. The overall survival of this patient population is poor; however, s...

    journal_title:Cancer

    pub_type: 杂志文章,多中心研究

    doi:10.1002/cncr.28845

    authors: van Maldegem AM,Gelderblom H,Palmerini E,Dijkstra SD,Gambarotti M,Ruggieri P,Nout RA,van de Sande MA,Ferrari C,Ferrari S,Bovée JV,Picci P

    更新日期:2014-10-15 00:00:00

  • The multidiscipline team in a cancer center.

    abstract::To surgery, radiation, and chemotherapy for cancer has been added a fourth modality: multidisciplinary therapy, which is improving the survival and cure rate among children. Specialists working together in a coordinated effort suspect, confirm, then treat cancer; follow and rehabilitate the patient; analyze and report...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197503)35:3+<876::aid-cncr282035

    authors: Murphy ML

    更新日期:1975-03-01 00:00:00

  • Analysis of the impact of imatinib mesylate therapy on the prognosis of patients with Philadelphia chromosome-positive chronic myelogenous leukemia treated with interferon-alpha regimens for early chronic phase.

    abstract:BACKGROUND:The effect on prognosis of adding imatinib mesylate to the treatment of patients with Philadelphia chromosome (Ph)-positive chronic myelogenous leukemia (CML) has not been explored fully. The objective of the current study was to evaluate the benefit of adding imatinib to the treatment sequence of patients w...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/cncr.11665

    authors: Kantarjian H,O'Brien S,Cortes J,Shan J,Giles F,Garcia-Manero G,Verstovsek S,Faderl S,Rios MB,Talpaz M

    更新日期:2003-10-01 00:00:00

  • Thymoma in a 12-year-old boy.

    abstract::A case of thymoma in a 12-year-old boy is presented. The patient had a history of thymic irradiation in infancy, and a family history of leukemia. The mass was readily resected and the patient is well 10 years later. The tumor contained an unusual admixture of normal thymic tissue with the neoplastic epithelial elemen...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197602)37:2<953::aid-cncr2820370

    authors: Chatten J,Katz SM

    更新日期:1976-02-01 00:00:00

  • Preoperative or postoperative irradiation as adjunctive treatment with radical mastectomy in breast cancer.

    abstract::Results from the standpoint of survival rates and locoregional failures are compared in three series of patients having had a radical mastectomy for breast cancer: (1) radical mastectomy alone for the patients who had essentially outer quadrant lesions and a negative axilla; (2) postoperative irradiation when the axil...

    journal_title:Cancer

    pub_type: 临床试验,杂志文章

    doi:10.1002/1097-0142(19830415)51:8<1388::aid-cncr2820

    authors: Rodger A,Montague ED,Fletcher G

    更新日期:1983-04-15 00:00:00

  • Prognostic factors after hepatectomy for hepatocellular carcinomas. A univariate and multivariate analysis.

    abstract::The current study determines the prognostic factors after hepatectomy for hepatocellular carcinomas. The 295 patients who underwent hepatectomy from 1973 through 1987 were included for a univariate and a Cox multivariate analysis. The favoring conditions were determined as follows. The essential requirements are (1) t...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19900301)65:5<1104::aid-cncr2820

    authors: Yamanaka N,Okamoto E,Toyosaka A,Mitunobu M,Fujihara S,Kato T,Fujimoto J,Oriyama T,Furukawa K,Kawamura E

    更新日期:1990-03-01 00:00:00

  • Symptoms and rehabilitation needs of patients with early stage breast cancer during primary therapy.

    abstract::The treatment for women diagnosed with early breast cancer is complex, dynamic, and controversial. More choices are available for local control and indications for systemic adjuvant therapy have changed dramatically. Knowledge of predictable physical and psychological responses through the various phases of primary tr...

    journal_title:Cancer

    pub_type: 杂志文章,评审

    doi:10.1002/1097-0142(19900915)66:14+<1392::aid-cncr28

    authors: Knobf MT

    更新日期:1990-09-15 00:00:00

  • Distinctive flow histogram pattern in molar pregnancies with elevated maternal serum human chorionic gonadotropin levels.

    abstract:BACKGROUND:Flow cytometric analysis of trophoblastic tissue has shown that most partial hydatidiform moles (PMs) are triploid, whereas most complete moles (CMs) are diploid or tetraploid. Ploidy analysis can support a diagnosis of CM or PM. However, in some cases, a precise diagnosis cannot be rendered. METHODS:This s...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19940601)73:11<2782::aid-cncr282

    authors: Bocklage TJ,Smith HO,Bartow SA

    更新日期:1994-06-01 00:00:00

  • Chemotherapy for adenocystic carcinoma.

    abstract::Seventeen patients with adenocystic carcinoma have received 34 adequate trials of chemotherapy at Princess Margaret Hospital since 1969. There have been five objective responses to chemotherapy in 4 cases, lasting from five to 24 months, and 3 other patients have had stabilized disease for a period of five to seven mo...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19800801)46:3<452::aid-cncr28204

    authors: Tannock IF,Sutherland DJ

    更新日期:1980-08-01 00:00:00

  • Breast adenomas.

    abstract::True adenomas of the breast are cellular epithelial lesions, which may be confused with carcinoma and are difficult to classify. We have reviewed 28 adenomas of the breast and have developed specific diagnostic criteria, as well as a classification of breast adenomas based on histologic features. Electron microscopic ...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(197606)37:6<2891::aid-cncr282037

    authors: Hertel BF,Zaloudek C,Kempson RL

    更新日期:1976-06-01 00:00:00

  • Serum ferritin in patients undergoing bone marrow transplantation.

    abstract::Serum ferritin levels were monitored in nine patients with acute lymphoblastic leukemia (ALL), nine patients with acute nonlymphoblastic leukemia (ANLL), four patients with chronic myelogenous leukemia (CML), three patients with non-Hodgkin's lymphoma (NHL), and three patients with severe aplastic anemia (SAA) undergo...

    journal_title:Cancer

    pub_type: 杂志文章

    doi:10.1002/1097-0142(19870901)60:5<1127::aid-cncr2820

    authors: Or R,Matzner Y,Konijn AM

    更新日期:1987-09-01 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