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DC Field | Value | Language |
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dc.contributor.author | Bridgewater J. | en |
dc.contributor.author | Cunningham D. | en |
dc.contributor.author | Arnold D. | en |
dc.contributor.author | Glynne-Jones R. | en |
dc.contributor.author | Rao S. | en |
dc.contributor.author | Sclafani F. | en |
dc.contributor.author | Eng C. | en |
dc.contributor.author | Adams R.A. | en |
dc.contributor.author | Guren M.G. | en |
dc.contributor.author | Sebag-Montefiore D. | en |
dc.contributor.author | Benson A. | en |
dc.contributor.author | Bryant A. | en |
dc.contributor.author | Peckitt C. | en |
dc.contributor.author | Segelov E. | en |
dc.contributor.author | Bhide S. | en |
dc.contributor.author | Roy A. | en |
dc.contributor.author | Seymour M.T. | en |
dc.contributor.author | Welch J. | en |
dc.contributor.author | Saunders M.P. | en |
dc.contributor.author | Muirhead R. | en |
dc.contributor.author | O'Dwyer P. | en |
dc.date.accessioned | 2021-05-14T09:45:51Z | en |
dc.date.available | 2021-05-14T09:45:51Z | en |
dc.date.copyright | 2020 | en |
dc.date.created | 20201109 | en |
dc.date.issued | 2020-11-09 | en |
dc.identifier.citation | Journal of Clinical Oncology. 38 (22) (pp 2510-2518), 2020. Date of Publication: 12 Jun 2020. | en |
dc.identifier.issn | 0732-183X | en |
dc.identifier.uri | https://repository.monashhealth.org/monashhealthjspui/handle/1/28962 | en |
dc.description.abstract | PURPOSE To compare cisplatin plus fluorouracil (FU) versus carboplatin plus paclitaxel in chemotherapy-naive advanced anal cancer to establish the optimal regimen. PATIENTS AND METHODS Patients who had not received systemic therapy for advanced anal cancer were randomly assigned 1:1 to intravenous cisplatin 60 mg/m2 (day 1) plus FU 1,000 mg/m2 (days 1-4) every 21 days or carboplatin (area under the curve, 5; day 1) plus paclitaxel 80 mg/m2 (days 1, 8, and 15) every 28 days for 24 weeks, until disease progression, intolerable toxicity, or withdrawal of consent. Primary end point was objective response rate (ORR). Primary and secondary end points were assessed in a hierarchic model to compare the regimens and pick the winner. RESULTS We conducted an international multicenter randomized phase II study in 60 centers between December 2013 and November 2017. Median follow-up was 28.6 months. A total of 91 patients were randomly assigned: 46 to cisplatin plus FU and 45 to carboplatin plus paclitaxel. ORR was 57% (95% CI, 39.4% to 73.7%) for cisplatin plus FU versus 59% (95% CI, 42.1% to 74.4%) for carboplatin plus paclitaxel. More serious adverse events were noted in the cisplatin plus FU arm (62%) compared with the carboplatin plus paclitaxel arm (36%; P 5 .016). Median progression-free survival was 5.7 months (95% CI, 3.3 to 9.0 months) for cisplatin plus FU compared with 8.1 months (95% CI, 6.6 to 8.8 months) for carboplatin plus paclitaxel. Median overall survival was 12.3 months for cisplatin plus FU (95% CI, 9.2 to 17.7 months) compared with 20 months (95% CI, 12.7 months to not reached) for carboplatin plus paclitaxel (hazard ratio, 2.00; 95% CI, 1.15 to 3.47; P 5 .014). CONCLUSION This is the first international randomized trial to our knowledge conducted in chemotherapy-naive advanced anal cancer. Although there was no difference in ORR, the association with clinically relevant reduced toxicity and a trend toward longer survival suggest that carboplatin plus paclitaxel should be considered as a new standard of care.Copyright © 2020 American Society of Clinical Oncology. All rights reserved. | en |
dc.language | English | en |
dc.language | en | en |
dc.publisher | American Society of Clinical Oncology (E-mail: jcoservice@asco.org) | en |
dc.relation.ispartof | Journal of Clinical Oncology | en |
dc.title | International rare cancers initiative multicenter randomized phase II trial of cisplatin and fluorouracil versus carboplatin and paclitaxel in advanced anal cancer: InterAAct. | en |
dc.type | Article | en |
dc.identifier.affiliation | Oncology | - |
dc.type.studyortrial | Randomised controlled trial | - |
dc.identifier.doi | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1200/JCO.19.03266 | - |
dc.publisher.place | United States | en |
dc.identifier.pubmedid | 32530769 [http://www.ncbi.nlm.nih.gov/pubmed/?term=32530769] | en |
dc.identifier.source | 2007814053 | en |
dc.identifier.institution | (Rao, Sclafani, Bryant, Peckitt, Cunningham) Royal Marsden Hospital, London, United Kingdom (Eng) MD Anderson Cancer Center, Houston, TX, United States (Adams) Velindre Cancer Centre, Cardiff, United Kingdom (Guren) Oslo University Hospital, Oslo, Norway (Sebag-Montefiore, Seymour) Leeds Cancer Centre, Leeds, United Kingdom (Benson) Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, United States (Segelov) Monash Health and Monash University, Melbourne, VIC, Australia (Roy) Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (Welch) National Cancer Institute, Bethesda, MD, United States (Saunders) Christie Cancer Centre, Manchester, United Kingdom (Muirhead) University of Oxford, Oxford, United Kingdom (O'Dwyer) Eastern Cooperative Oncology Group, American College of Radiology Imaging Network, Philadelphia, PA, United States (Bridgewater) University College Hospital, London, United Kingdom (Bhide) Institute of Cancer Research, London, United Kingdom (Glynne-Jones) Hamburg University Medical Centre, Hamburg, Germany | en |
dc.description.address | S. Rao, GI Unit, Department of Medicine, Royal Marsden Hospital, Downs Rd, Sutton, Surrey SM25PT, United Kingdom. E-mail: sheela.rao@rmh.nhs.uk | en |
dc.description.publicationstatus | Embase | en |
dc.rights.statement | Copyright 2020 Elsevier B.V., All rights reserved. | en |
dc.identifier.authoremail | Rao S.; sheela.rao@rmh.nhs.uk | en |
dc.description.grant | Organization: (CRUK) *Cancer Research UK* Organization No: 501100000289 Country: United Kingdom Organization: (ICR) *Institute of Cancer Research* Organization No: 501100000027 Country: Canada Organization: *NIHR Bristol Biomedical Research Centre* Organization No: 100015250 Country: United Kingdom Organization: *Royal Marsden NHS Foundation Trust* Organization No: 100012139 Country: United Kingdom | en |
item.cerifentitytype | Publications | - |
item.fulltext | No Fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.grantfulltext | none | - |
item.openairetype | Article | - |
crisitem.author.dept | Oncology | - |
Appears in Collections: | Articles |
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