BACKGROUND: Carbohydrate antigen 19-9 (CA19-9) is a widely used biomarker in pancreatic cancer. There is no consensus on the interpretation of the change in CA19-9 serum levels and its role in the clinical management of patients with pancreatic cancer. METHODS: Individual patient data from 6 prospective trials evaluating gemcitabine-containing regimens from 3 different institutions were pooled. CA19-9 values were obtained at baseline and after successive cycles of treatment. The objective of this study was to correlate a decline in CA19-9 with outcomes while undergoing treatment. RESULTS: A total of 212 patients with locally advanced (n = 50) or metastatic (n = 162) adenocarcinoma of the pancreas were included. Median baseline CA19-9 level was 1077 ng/mL (range, 15-492,241 ng/mL). Groups were divided into those levels below (low) or above (high) the median. Median overall survival (mOS) was 8.7 versus 5.2 months (P = .0018) and median time to progression (mTTP) was 5.8 versus 3.7 months (P = .082) in the low versus high groups, respectively. After 2 cycles of chemotherapy, up to a 5% increase versus ≥ 5% increase in CA19-9 levels conferred an improved mOS (10.3 vs 5.1 months, P = .0022) and mTTP (7.5 vs 3.5 months, P = 0.0005). CONCLUSIONS: In patients who have advanced pancreatic cancer treated with gemcitabine-containing regimens baseline CA19-9 is prognostic for outcome. A decline in CA19-9 after the second cycle of chemotherapy is not predictive of improved mOS or mTTP; thus, CA19-9 decline is not a useful surrogate endpoint in clinical trials. Clinically, a ≥ 5% rise in CA19-9 after 2 cycles of chemotherapy serves as a negative predictive marker.
BACKGROUND: Carbohydrate antigen 19-9 (CA19-9) is a widely used biomarker in pancreatic cancer. There is no consensus on the interpretation of the change in CA19-9 serum levels and its role in the clinical management of patients with pancreatic cancer. METHODS: Individual patient data from 6 prospective trials evaluating gemcitabine-containing regimens from 3 different institutions were pooled. CA19-9 values were obtained at baseline and after successive cycles of treatment. The objective of this study was to correlate a decline in CA19-9 with outcomes while undergoing treatment. RESULTS: A total of 212 patients with locally advanced (n = 50) or metastatic (n = 162) adenocarcinoma of the pancreas were included. Median baseline CA19-9 level was 1077 ng/mL (range, 15-492,241 ng/mL). Groups were divided into those levels below (low) or above (high) the median. Median overall survival (mOS) was 8.7 versus 5.2 months (P = .0018) and median time to progression (mTTP) was 5.8 versus 3.7 months (P = .082) in the low versus high groups, respectively. After 2 cycles of chemotherapy, up to a 5% increase versus ≥ 5% increase in CA19-9 levels conferred an improved mOS (10.3 vs 5.1 months, P = .0022) and mTTP (7.5 vs 3.5 months, P = 0.0005). CONCLUSIONS: In patients who have advanced pancreatic cancer treated with gemcitabine-containing regimens baseline CA19-9 is prognostic for outcome. A decline in CA19-9 after the second cycle of chemotherapy is not predictive of improved mOS or mTTP; thus, CA19-9 decline is not a useful surrogate endpoint in clinical trials. Clinically, a ≥ 5% rise in CA19-9 after 2 cycles of chemotherapy serves as a negative predictive marker.
Authors: Everardo D Saad; Marcel C Machado; Dalia Wajsbrot; Roberto Abramoff; Paulo M Hoff; Jacques Tabacof; Artur Katz; Sergio D Simon; René C Gansl Journal: Int J Gastrointest Cancer Date: 2002
Authors: Harvey J Mamon; Donna Niedzwiecki; Donna Hollis; Benjamin R Tan; Robert J Mayer; Joel E Tepper; Richard M Goldberg; A William Blackstock; Charles S Fuchs Journal: Cancer Date: 2010-12-23 Impact factor: 6.860
Authors: Daniel D Von Hoff; Ramesh K Ramanathan; Mitesh J Borad; Daniel A Laheru; Lon S Smith; Tina E Wood; Ronald L Korn; Neil Desai; Vuong Trieu; Jose L Iglesias; Hui Zhang; Patrick Soon-Shiong; Tao Shi; N V Rajeshkumar; Anirban Maitra; Manuel Hidalgo Journal: J Clin Oncol Date: 2011-10-03 Impact factor: 44.544
Authors: P A Philip; M M Zalupski; V K Vaitkevicius; P Arlauskas; R Chaplen; L K Heilbrun; V Adsay; D Weaver; A F Shields Journal: Cancer Date: 2001-08-01 Impact factor: 6.860
Authors: Philip A Philip; Jacqueline Benedetti; Christopher L Corless; Ralph Wong; Eileen M O'Reilly; Patrick J Flynn; Kendrith M Rowland; James N Atkins; Barry C Mirtsching; Saul E Rivkin; Alok A Khorana; Bryan Goldman; Cecilia M Fenoglio-Preiser; James L Abbruzzese; Charles D Blanke Journal: J Clin Oncol Date: 2010-07-06 Impact factor: 44.544
Authors: B F El-Rayes; M M Zalupski; A F Shields; U Vaishampayan; L K Heilbrun; V Jain; V Adsay; J Day; P A Philip Journal: J Clin Oncol Date: 2003-08-01 Impact factor: 44.544
Authors: C Ziske; C Schlie; M Gorschlüter; A Glasmacher; U Mey; J Strehl; T Sauerbruch; I G H Schmidt-Wolf Journal: Br J Cancer Date: 2003-10-20 Impact factor: 7.640
Authors: Brian A Boone; Nathan Bahary; Amer H Zureikat; A James Moser; Daniel P Normolle; Wen-Chi Wu; Aatur D Singhi; Phillip Bao; David L Bartlett; Lance A Liotta; Virginia Espina; Patricia Loughran; Michael T Lotze; Herbert J Zeh Journal: Ann Surg Oncol Date: 2015-04-24 Impact factor: 5.344
Authors: Khanh T Nguyen; Aparna Kalyan; H Scott Beasley; Aatur D Singhi; Weijing Sun; Herbert J Zeh; Daniel Normolle; Nathan Bahary Journal: J Gastrointest Oncol Date: 2017-06
Authors: Josep Tabernero; E Gabriela Chiorean; Jeffrey R Infante; Sunil R Hingorani; Vinod Ganju; Colin Weekes; Werner Scheithauer; Ramesh K Ramanathan; David Goldstein; Darryl N Penenberg; Alfredo Romano; Stefano Ferrara; Daniel D Von Hoff Journal: Oncologist Date: 2015-01-12
Authors: E Bonnet; C Mastier; A Lardy-Cléaud; P Rochefort; M Sarabi; P Guibert; A Cattey-Javouhey; F Desseigne; C de La Fouchardière Journal: Curr Oncol Date: 2019-08-01 Impact factor: 3.677