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Title: TACTIC: a multicentre, open-label, single-arm phase II trial of panitumumab, cisplatin, and gemcitabine in biliary tract cancer.
Austin Authors: Ferraro, D;Goldstein, D;O'Connell, R L;Zalcberg, J R;Sjoquist, K M;Tebbutt, Niall C ;Grimison, P;McLachlan, S;Lipton, L L;Vasey, P;Gebski, V J;Aiken, C;Cronk, M;Ng, S ;Karapetis, C S;Shannon, J
Affiliation: Department of Medical Oncology, Nepean Cancer Care Centre, Penrith, Sydney, NSW, Australia
Sir Charles Gairdner Hospital, Nedlands, WA, Australia
Flinders University, Adelaide, SA, Australia
National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia
Department of Pathology, University of Melbourne, Parkville, Victoria, Australia
Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia, Australia
Chris O'Brien Lifehouse, Sydney, NSW, Australia
St Vincents Hospital, Melbourne, Victoria, Australia
University of Melbourne, Melbourne, Victoria, Australia
Western Health, Melbourne, Victoria, Australia
Haematology and Oncology Clinics of Australasia, Wesley Medical Centre, Brisbane, QLD, Australia
Nambour General Hospital, Nambour, QLD, Australia
Issue Date: Aug-2016 2016-06-22
Publication information: Cancer chemotherapy and pharmacology 2016; 78(2): 361-7
Abstract: The phase II TACTIC trial prospectively selected patients with KRAS wild-type advanced biliary tract cancer for first-line treatment with panitumumab and combination chemotherapy. Of 78 patients screened, 85 % had KRAS wild-type tumours and 48 were enrolled. Participants received cisplatin 25 mg/m(2) and gemcitabine 1000 mg/m(2) on day 1 and day 8 of each 21-day cycle and panitumumab 9 mg/kg on day 1 of each cycle. Treatment was continued until disease progression, unacceptable toxicity, or request to discontinue. The primary endpoint was the clinical benefit rate (CBR) at 12 weeks (complete response, partial response, or stable disease). CBR of 70 % was considered to be of clinical interest. Secondary outcomes were progression-free survival, time to treatment failure, overall survival, CA19.9 response and safety. Thirty-four patients had a clinical benefit at 12 weeks, an actuarial rate of 80 % (95 % CI 65-89 %). 46 % had a complete or partial response. Median progression-free survival was 8.0 months (95 % CI 5.1-9.9) and median overall survival 11.9 months (95 % CI 7.4-15.8). Infection accounted for 27 % of the grade 3 or 4 toxicity, with rash (13 %), fatigue (13 %), and hypomagnesemia (10 %) among the more common grade 3 or 4 non-haematological toxicities. A marker-driven approach to patient selection was feasible in advanced biliary tract cancer in an Australian population. The combination of panitumumab, gemcitabine, and cisplatin in KRAS wild-type cancers was generally well tolerated and showed promising clinical efficacy. Further exploration of anti-EGFR therapy in a more selected population is warranted.
DOI: 10.1007/s00280-016-3089-4
PubMed URL: 27335026
Type: Journal Article
Subjects: Biliary tract cancer
Cancer antigen 19.9
Phase II trial
Appears in Collections:Journal articles

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