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Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2019 Mar 10; Vol. 37 (8), pp. 658-667. Date of Electronic Publication: 2019 Feb 01. - Publication Year :
- 2019
-
Abstract
- Purpose: No standard adjuvant treatment currently is recommended in localized biliary tract cancer (BTC) after surgical resection. We aimed to assess whether gemcitabine and oxaliplatin chemotherapy (GEMOX) would increase relapse-free survival (RFS) while maintaining health-related quality of life (HRQOL) in patients who undergo resection.<br />Patients and Methods: We performed a multicenter, open-label, randomized phase III trial in 33 centers. Patients were randomly assigned (1:1) within 3 months after R0 or R1 resection of a localized BTC to receive either GEMOX (gemcitabine 1,000 mg/m <superscript>2</superscript> on day 1 and oxaliplatin 85 mg/m <superscript>2</superscript> infused on day 2 of a 2-week cycle) for 12 cycles (experimental arm A) or surveillance (standard arm B). Primary end points were RFS and HRQOL.<br />Results: Between July 2009 and February 2014, 196 patients were included. Baseline characteristics were balanced between the two arms. After a median follow-up of 46.5 months (95% CI, 42.6 to 49.3 months), 126 RFS events and 82 deaths were recorded. There was no significant difference in RFS between the two arms (median, 30.4 months in arm A v 18.5 months in arm B; hazard ratio [HR], 0.88; 95% CI, 0.62 to 1.25; P = .48). There was no difference in time to definitive deterioration of global HRQOL (median, 31.8 months in arm A v 32.1 months in arm B; HR, 1.28; 95% CI, 0.73 to 2.26; log-rank P = .39). Overall survival was not different (median, 75.8 months in arm A v 50.8 months in arm B; HR, 1.08; 95% CI, 0.70 to 1.66; log-rank P = .74). Maximal adverse events were grade 3 in 62% (arm A) versus 18% (arm B) and grade 4 in 11% versus 3% ( P < .001).<br />Conclusion: There was no benefit of adjuvant GEMOX in resected BTC despite adequate tolerance and delivery of the regimen.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols adverse effects
Biliary Tract Neoplasms mortality
Biliary Tract Neoplasms pathology
Chemotherapy, Adjuvant
Deoxycytidine administration & dosage
Deoxycytidine adverse effects
Female
France
Humans
Male
Middle Aged
Oxaliplatin adverse effects
Progression-Free Survival
Quality of Life
Time Factors
Gemcitabine
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Biliary Tract Neoplasms drug therapy
Biliary Tract Neoplasms surgery
Biliary Tract Surgical Procedures adverse effects
Biliary Tract Surgical Procedures mortality
Deoxycytidine analogs & derivatives
Oxaliplatin administration & dosage
Watchful Waiting
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 37
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 30707660
- Full Text :
- https://doi.org/10.1200/JCO.18.00050