Panitumumab added to docetaxel, cisplatin and fluoropyrimidine in oesophagogastric cancer: ATTAX3 phase II trial.

Autor: Tebbutt NC; Austin Health, PO Box 5555, Heidelberg, VIC 3084, Australia., Price TJ; The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, SA 5011, Australia., Ferraro DA; National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia., Wong N; National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia., Veillard AS; National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia., Hall M; National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia., Sjoquist KM; National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia., Pavlakis N; Royal North Shore Hospital, Pacific Highway, St Leonards, Sydney, NSW 2064, Australia., Strickland A; Monash Medical Centre, 246 Clayton Road, Clayton, Melbourne, VIC 3168, Australia., Varma SC; Townsville Hospital, 100 Angus Smith Drive, Douglas, Townsville, QLD 4814, Australia., Cooray P; Box Hill Hospital, Nelson Road, Box Hill, VIC 3128, Australia., Young R; Royal Hobart Hospital, 48 Liverpool Street, Hobart, TAS 7000, Australia., Underhill C; Border Medical Oncology, 63-69 Nordsvan Drive, Albury, Wodonga, NSW 3690, Australia., Shannon JA; Nepean Cancer Care Centre, Derby Street, Kingswood, Penrith, NSW 2747, Australia., Ganju V; Frankston Hospital, PO Box 52, Frankston, Melbourne, VIC 3199, Australia., Gebski V; National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia.
Jazyk: angličtina
Zdroj: British journal of cancer [Br J Cancer] 2016 Mar 01; Vol. 114 (5), pp. 505-9. Date of Electronic Publication: 2016 Feb 11.
DOI: 10.1038/bjc.2015.440
Abstrakt: Background: This randomised phase II study evaluated the efficacy and safety of panitumumab added to docetaxel-based chemotherapy in advanced oesophagogastric cancer.
Methods: Patients with metastatic or locally recurrent cancer of the oesophagus, oesophagogastric junction or stomach received docetaxel and a fluoropyrimidine with or without panitumumab for 8 cycles or until progression. The primary end point was response rate (RECIST1.1). We planned to enrol 100 patients, with 50% expected response rate for combination therapy.
Results: A total of 77 patients were enrolled. A safety alert from the REAL3 trial prompted a review of data that found no evidence of adverse outcomes associated with panitumumab but questionable efficacy, and new enrolment was ceased. Enrolled patients were treated according to protocol. Response rates were 49% (95% CI 34-64%) in the chemotherapy arm and 58% (95% CI 42-72%) in the combination arm. Common grade 3 and 4 toxicities included infection, anorexia, vomiting, diarrhoea and fatigue. At 23.7 months of median follow-up, median progression-free survival was 6.9 months vs 6.0 months and median overall survival was 11.7 months vs 10.0 months in the chemotherapy arm and the combination arm, respectively.
Conclusions: Adding panitumumab to docetaxel-based chemotherapy for advanced oesophagogastric cancer did not improve efficacy and increased toxicities.
Databáze: MEDLINE
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