Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: 15015
© 2007 American Society of Clinical Oncology

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Abstract

ABC; An AGITG trial of fixed dose rate (FDR) gemcitabine (gem) and cisplatin for patients (pts) with advanced biliary tract cancer (ABC)

Prince of Wales Hospital, Randwick, Australia; Nepean Hospital, Nepean, Australia; NHMRC Clinical Trials Centre, University of Sydney, Australia; Austin Health, Melbourne, Australia; Mater Misericordiae Hospital, Newcastle, Australia; Sir Charles Gairdner Hospital, Perth, Australia; Tweed Hospital, Tweed Heads, Australia; Peter MacCallum Cancer Centre, Melbourne, Australia

15015

Background: No standard regimen exists for pts with ABC. Previous studies suggest that FDR optimises gem activity. This study evaluated the activity of FDR gem with low dose cisplatin using a previously identified schedule. Methods: Single arm, multi- centre phase II trial, planned to enrol 45 pts > 18 years, ECOG PS = 2, with previously untreated histologically / cytologically confirmed, inoperable locally advanced or metastatic ABC. Treatment consisted of FDR gem 1000 mg/m2 (10 mg/m2/min) and cisplatin 20 mg/m2 days 1& 8 q21 days until progression or intolerable toxicity. The primary end point was response rate (RR) by RECIST. Secondary end points included tolerability and safety, progression free and overall survival (PFS, OS) and response duration (RD). Results: 50 pts were enrolled from Feb 05 to Oct 06. Mean age was 60y (39–78); 88% had ECOG PS 0–1; 54% were female. Primary sites were gall bladder 45%, biliary tree 51%, ampulla 4%. Distant metastases were present in 63%. Past treatments included biliary stent in 29%, bypass in 6%, and an external drain in 4%. With a minimum follow-up of 12 weeks, best response was a confirmed PR in 11 pts (RR 22%, 95% CI 11 - 36) and SD (after 4 cycles) in 11 pts (22%), 1 (2%) unevaluable. CA19–9 responses occurred in 6 of 33 pts (18%). Median OS was 7 mo (0.3–13), PFS 4.4 mo (0.3–13), and RD 8 mo (5–12). One year survival rate was 30%. The median number of cycles was 4 (1–16). Treatment was delayed at least once in 45% of pts; mean delay 9d. Grade 3/4 (NCI/CTC) toxicities included infection 9%, fatigue 9%, anorexia/nausea 11%, vomiting 9%, anaemia 9%, neutropenia 28%, thrombocytopenia 15%, abnormal ALP 25%, GGT 47%, AST 6%. There was 1 treatment related death (hematemesis with grade 4 thrombocytopenia). Exploratory analysis of CA 19–9 and its association with response assessment and overall survival will be presented in June. Conclusions: This combination was well tolerated. The observed response rate is consistent with the expected 35% rate and may be superior to that expected with gem monotherapy. Further testing of this dose and scheduling is warranted. The authors thank Lilly for an unrestricted grant to conduct this study.

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly, Merck, Novartis, Pfizer Oncology, Roche, sanofi-aventis Merck, Novartis, Pfizer Oncology, Roche, sanofi-aventis Eli Lilly