Publicação
Intraperitoneal bevacizumab for control of malignant ascites due to advanced-stage gastrointestinal cancers: A multicentre double-blind, placebo-controlled phase II study - AIO SUP-0108
| dc.contributor.author | Jordan, K | |
| dc.contributor.author | Luetkens, T | |
| dc.contributor.author | Gog, C | |
| dc.contributor.author | Killing, B | |
| dc.contributor.author | Arnold, D | |
| dc.contributor.author | Hinke, A | |
| dc.contributor.author | Stahl, M | |
| dc.contributor.author | Freier, W | |
| dc.contributor.author | Rüssel, J | |
| dc.contributor.author | Atanackovic, D | |
| dc.contributor.author | Hegewisch-Becker, S | |
| dc.date.accessioned | 2016-06-21T21:50:32Z | |
| dc.date.available | 2016-06-21T21:50:32Z | |
| dc.date.issued | 2016-06-14 | |
| dc.description.abstract | PURPOSE: Malignant ascites is debilitating for patients with advanced cancer. As shown previously, tumour cell production of vascular endothelial growth factor might be a major cause of the formation of malignant ascites. Intraperitoneal bevacizumab could therefore be an option for symptom control in refractory ascites. PATIENTS AND METHODS: Patients with advanced gastrointestinal cancer and malignant ascites who had undergone paracentesis at least twice within the past 4 weeks were randomly assigned in a 2:1 ratio to intraperitoneal bevacizumab (400 mg absolute) or placebo after paracentesis. During the 8-week treatment period, a minimum interval of 14 d was kept between the applications of the study drug. Primary end-point was paracentesis-free survival (ParFS). RESULTS: Fifty-three patients (median age 63 years) were randomised. Forty-nine patients received at least one study drug application and qualified for the main analysis. The proportion of patients with at least one common toxicity criteria grade III-V event was similar with 20/33 (61%) on bevacizumab and 11/16 (69%) on placebo. Median ParFS was 14 d (95% confidence interval [CI]: 11-17) in the bevacizumab arm and 10.5 d (95% CI: 7-21) on placebo (hazard ratio 0.74, 95% CI: 0.40-1.37; P = 0.16). The longest paracentesis-free period was 19 d on bevacizumab (range 6-66 d) and 17.5 d in the placebo arm (range 4-42) (P = 0.85). Median overall survival was 64 d (95% CI: 45-103) on bevacizumab compared to 31.5 d (95% CI: 20-117) on placebo (P = 0.31). CONCLUSION: Intraperitoneal bevacizumab was well tolerated. Overall, treatment did not result in a significantly better symptom control of malignant ascites. However, patients defined by specific immune characteristics may benefit. | pt_PT |
| dc.identifier.citation | Eur J Cancer. 2016 Jun 14;63:127-134. | pt_PT |
| dc.identifier.doi | 10.1016/j.ejca.2016.05.004 | pt_PT |
| dc.identifier.uri | http://hdl.handle.net/10400.26/14158 | |
| dc.language.iso | eng | pt_PT |
| dc.peerreviewed | yes | pt_PT |
| dc.subject | Ascite | pt_PT |
| dc.subject | Bevacizumab | pt_PT |
| dc.subject | Anticorpos Monoclonais Humanizados | pt_PT |
| dc.subject | Injeçcões Intraperitoneais | pt_PT |
| dc.subject | Neoplasias Gastrointestinais | pt_PT |
| dc.subject | Ascites | pt_PT |
| dc.subject | Injections, Intraperitoneal | pt_PT |
| dc.subject | Gastrointestinal Neoplasms | pt_PT |
| dc.subject | Antibodies, Monoclonal, Humanized | pt_PT |
| dc.title | Intraperitoneal bevacizumab for control of malignant ascites due to advanced-stage gastrointestinal cancers: A multicentre double-blind, placebo-controlled phase II study - AIO SUP-0108 | pt_PT |
| dc.type | journal article | |
| dspace.entity.type | Publication | |
| oaire.citation.endPage | 134 | pt_PT |
| oaire.citation.startPage | 127-134 | pt_PT |
| oaire.citation.title | European journal of cancer (Oxford, England : 1990) | pt_PT |
| oaire.citation.volume | 63 | pt_PT |
| rcaap.rights | openAccess | pt_PT |
| rcaap.type | article | pt_PT |