Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial).

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Abstracts

2009 ASCO Annual Meeting

Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial).

Sub-category:

Hepatobiliary Cancer

Category:

Gastrointestinal (Noncolorectal) Cancer

Meeting:

2009 ASCO Annual Meeting

Session Type and Session Title:

Oral Presentation, Gastrointestinal (Noncolorectal) Cancer

Abstract No:

4503

Citation:

J Clin Oncol 27:15s, 2009 (suppl; abstr 4503)

Author(s):

J. W. Valle, H. S. Wasan, D. D. Palmer, D. Cunningham, D. A. Anthoney, A. Maraveyas, S. K. Hughes, M. Roughton, J. A. Bridgewater; Christie Hospital NHS Trust, Manchester, United Kingdom; Imperial College Healthcare Trust, London, United Kingdom; University of Birmingham , Birmingham, United Kingdom; Royal Marsden Hospital, London, United Kingdom; St. James' University Hospital, Leeds, United Kingdom; Castle Hill Hospital, Hull, United Kingdom; University College London, London, United Kingdom

Abstract:

Background: There is no established standard chemotherapy for pts with inoperable ABC. We previously reported an improvement in progression-free survival (PFS) in a randomised phase II trial of 86 pts (ABC-01) using gemcitabine/cisplatin (GemCis) vs. gemcitabine (Gem) (Valle ASCO-GI 2006, abstr. 98). This study was extended into ABC-02, a phase III trial, to recruit a further 314 pts with overall survival (OS) as the primary end-point. Methods: Consenting pts with histologically/cytologically-confirmed ABC, aged ≥18 years, ECOG performance status 0 - 2, and adequate haematological, hepatic and renal function were randomised to receive either Cis (25 mg/m²) followed by Gem (1000 mg/m² D1, 8 q21d) for 8 cycles, or Gem alone (1000 mg/m² on D1, 8, 15 q28d) for 6 cycles, stratified by extent of disease, site of primary tumour, ECOG score and centre. The trial had an 80% power to detect an OS hazard ratio of 0.73. Results: From May 2005 to October 2008, 324 pts were randomised to ABC- 02 from 34 UK centres. We report the pre-planned combined analysis of ABC-01 and ABC-02 based on 410 pts (GemCis=206/Gem=204). Patient characteristics: median age 64 yrs (range 23-85); male (47%); metastatic disease (75%), locally advanced (25%); gallbladder (36%), bile duct (59%), ampulla (5%); and ECOG 0-1 (87%), 2 (12%). With a median follow-up of 6.1 months and 263 deaths, the median OS was greater with GemCis than Gem, 11.7 vs. 8.2 months (log rank p=0.002), with hazard ratio 0.68 (95%-CI 0.53, 0.86). The median PFS was greater with GemCis than Gem, 8.5 vs. 6.5 months (log rank p=0.003), with hazard ratio 0.70 (95%-CI 0.56, 0.88).Toxicity was similar between the arms (by week 12, 57% had a grade 3/4 toxicity in each arm), though there was a slight excess of neutropenia using GemCis. Conclusions: This is the largest ever study in ABC and demonstrates a clear survival advantage for GemCis without added clinically significant toxicity, setting a new international standard of care.

Abstract Disclosures

Faculty and Discussant Disclosures

Annual Meeting Planning Committee Disclosures

2009 Annual Meeting Proceedings Part I Errata

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy and are designated with a caret symbol (^) here and in the print version.

Associated Presentation(s):

1. Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial).

Meeting: 2009 ASCO Annual Meeting
Presenter: Juan W Valle, MD
Session: Gastrointestinal (Noncolorectal) Cancer (Oral Presentation)

Other Abstracts in this Sub-Category:

		1. A multicenter, randomized phase II trial of gemcitabine and oxaliplatin (GEMOX) alone or in combination with biweekly cetuximab in the first-line treatment of advanced biliary cancer: Interim analysis of the BINGO trial. Meeting: 2009 ASCO Annual Meeting Abstract No: 4520 First Author: D. Malka Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer
		2. Biological activity of bevacizumab and erlotinib in patients with advanced hepatocellular carcinoma (HCC). Meeting: 2009 ASCO Annual Meeting Abstract No: 4522 First Author: A. O. Kaseb Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer
		3. A randomized phase II trial of a drug eluting bead in the treatment of hepatocellular carcinoma by transcatheter arterial chemoembolization. Meeting: 2009 ASCO Annual Meeting Abstract No: 4523 First Author: R. Lencioni Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer
		More...

Abstracts by J. W. Valle:

		1. Predictors of survival in patients with advanced biliary tract cancer: Results from the UK ABC-02 randomized phase III trial. Meeting: 2010 Gastrointestinal Cancers Symposium Abstract No: 199 First Author: H. S. Wasan Category: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract - Multidisciplinary Treatment
		2. Updated results of the phase III trial of sunitinib (SU) versus placebo (PBO) for treatment of advanced pancreatic neuroendocrine tumors (NET). Meeting: 2010 Gastrointestinal Cancers Symposium Abstract No: 127 First Author: E. Raymond Category: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract - Multidisciplinary Treatment
		3. Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial). Meeting: 2009 ASCO Annual Meeting Abstract No: 4503 First Author: J. W. Valle Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer
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Presentations by J. W. Valle:

		1. Systemic Chemotherapy for Advanced Biliary Tract Cancer Meeting: 2010 Gastrointestinal Cancers Symposium Speaker: Juan W. Valle, MD Session: General Session VI: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract: Multidisciplinary Treatment (General Sessions)
		2. Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial). Meeting: 2009 ASCO Annual Meeting Presenter: Juan W Valle, MD Session: Gastrointestinal (Noncolorectal) Cancer (Oral Presentation)
		3. Phase II study of volociximab (M200), an α5β1 anti-integrin antibody in metastatic adenocarcinoma of the pancreas (MPC). Meeting: 2006 ASCO Annual Meeting Presenter: Juan W Valle Session: Gastrointestinal (Noncolorectal) Cancer (General Poster Session)
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Educational Book Manuscripts by J. W. Valle:

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