dc.contributor.author | Sternberg, C | |
dc.contributor.author | Armstrong, A | |
dc.contributor.author | Pili, R | |
dc.contributor.author | Ng, S | |
dc.contributor.author | Huddart, R | |
dc.contributor.author | Agarwal, N | |
dc.contributor.author | Khvorostenko, D | |
dc.contributor.author | Lyulko, O | |
dc.contributor.author | Brize, A | |
dc.contributor.author | Vogelzang, N | |
dc.contributor.author | Delva, R | |
dc.contributor.author | Harza, M | |
dc.contributor.author | Thanos, A | |
dc.contributor.author | James, N | |
dc.contributor.author | Werbrouck, P | |
dc.contributor.author | Bögemann, M | |
dc.contributor.author | Hutson, T | |
dc.contributor.author | Milecki, P | |
dc.contributor.author | Chowdhury, S | |
dc.contributor.author | Gallardo, E | |
dc.contributor.author | Schwartsmann, G | |
dc.contributor.author | Pouget, J-C | |
dc.contributor.author | Baton, F | |
dc.contributor.author | Nederman, T | |
dc.contributor.author | Tuvesson, H | |
dc.contributor.author | Carducci, M | |
dc.date.accessioned | 2017-04-21T16:33:49Z | |
dc.date.issued | 2016-08-01 | |
dc.identifier.citation | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016, 34 (22), pp. 2636 - 2643 | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/613 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/jco.2016.66.9697 | |
dc.description.abstract | PURPOSE: Tasquinimod, a novel oral therapy targeting the tumor microenvironment, significantly improved progression-free survival (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). This phase III study was conducted to confirm the phase II results and to detect an overall survival (OS) benefit. PATIENTS AND METHODS: Men with chemotherapy-naïve mCRPC and evidence of bone metastases were assigned (2:1) to receive tasquinimod once per day or placebo until progression or toxicity. The primary end point was radiographic PFS (rPFS; time from random assignment to radiologic progression or death) per Prostate Cancer Working Group 2 criteria and RECIST 1.1. The study had 99.9% power to detect an rPFS hazard ratio (HR) of 0.6 with a two-sided alpha error of .05 and 80% power to detect a target HR of 0.8 for OS, the key secondary end point. RESULTS: In all, 1,245 patients were randomly assigned to either tasquinimod (n = 832) or placebo (n = 413) between March 2011 and December 2012 at 241 sites in 37 countries. Baseline characteristics were balanced between groups: median age, 71 years; Karnofsky performance status ≥ 90%, 77.3%; and visceral metastases, 21.1%. Estimated median rPFS by central review was 7.0 months (95% CI, 5.8 to 8.2 months) with tasquinimod and 4.4 months (95% CI, 3.5 to 5.5 months) with placebo (HR, 0.64; 95% CI, 0.54 to 0.75; P < .001). Median OS was 21.3 months (95% CI, 19.5 to 23.0 months) with tasquinimod and 24.0 months (95% CI, 21.4 to 26.9 months) with placebo (HR, 1.10; 95% CI, 0.94 to 1.28; P = .25). Grade ≥ 3 adverse events were more frequent with tasquinimod (42.8% v 33.6%), the most common being anemia, fatigue, and cancer pain. CONCLUSION: In chemotherapy-naïve men with mCRPC, tasquinimod significantly improved rPFS compared with placebo. However, no OS benefit was observed. | |
dc.format | Print-Electronic | |
dc.format.extent | 2636 - 2643 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | AMER SOC CLINICAL ONCOLOGY | |
dc.rights.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
dc.subject | Humans | |
dc.subject | Neoplasm Metastasis | |
dc.subject | Quinolones | |
dc.subject | Antineoplastic Agents | |
dc.subject | Double-Blind Method | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Middle Aged | |
dc.subject | Male | |
dc.subject | Prostatic Neoplasms, Castration-Resistant | |
dc.title | Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2016-06-13 | |
rioxxterms.versionofrecord | 10.1200/jco.2016.66.9697 | |
rioxxterms.licenseref.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2016-08 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | |
pubs.issue | 22 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research | |
pubs.publication-status | Published | |
pubs.volume | 34 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Academic Radiotherapy (Huddart) | |
icr.researchteam | Prostate and Bladder Cancer Research | |
dc.contributor.icrauthor | Huddart, Robert | |
dc.contributor.icrauthor | James, Nicholas | |