Abstract 1477P
Background
The prognostic and predictive value of CA 19-9 in locally advanced pancreatic cancer (LAPC) has not yet been defined from prospective randomized controlled trials (RCT).
Methods
165 patients LAPC were primarily treated for 4 months with multi-agent induction chemotherapy (either nab-Paclitaxel/Gemcitabine alone or nab-Paclitaxel/Gemcitabine followed by FOLFIRINOX) followed by surgical exploration of all patients without evidence of disease progression. CA 19-9 was evaluated at baseline and during induction chemotherapy (week 8 and 16) and correlated with overall survival (OS) and secondary R0 resection rate.
Results
From the total enrolled and treated NEOLAP study population (n=165) 133 patients (81%) were evaluable for CA 19-9 baseline and 81 patients for week 16 measurement. Median OS in the CA 19-9 cohort (N=133) was 16.2 months (95% CI 13.0-19.4) and R0 resection (31 of 133 patients; 23%) was associated with a significant survival benefit (40.8 [95% CI 21.4-52.7] months vs. 14.2 [95% CI 12.0-17.4] months; p<0.0001). After completion of induction chemotherapy (week 16) the majority of patients showed a CA 19-9 response (median change from baseline: -82%; any decrease: 98%; decrease ≥ 20%: 93%; decrease ≥ 60%: 78%; decrease ≤ 50 U/ml: 43%). Robust CA 19-9 response (decrease ≤ 50 U/ml) was significantly associated with mOS (27.8 [95% CI 18.4-37.2] vs 16.5 [95% CI 11.7-21.2] months; p=0.013), whereas CA 19-9 baseline levels were not prognostic for OS. CA 19-9 non-responders (<20% decrease) had no chance for successful R0 resection (NPV 100%). However, the best cut-off of CA 19-9 decrease (≤ 61 U/ml by ROC-analysis) yielded a sensitivity of 72% and specificity of 62% for successful R0 resection.
Conclusions
In contrast to CA 19-9 baseline levels CA 19-9 response after induction chemotherapy provides prognostic information on overall survival in LAPC. CA 19-9 decrease may serve as a useful predictive biomarker for achieving R0 resection after multi-agent induction chemotherapy.
Clinical trial identification
NCT02125136.
Editorial acknowledgement
Legal entity responsible for the study
AIO-Studien-gGmbH.
Funding
Celgene.
Disclosure
I. Hartlapp: Financial Interests, Personal, Advisory Board: Roche. J. Siveke: Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Research Grant: Celgene; Financial Interests, Personal, Funding: Celgene; Financial Interests, Personal, Research Grant: BMS; Financial Interests, Personal, Funding: BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Other, Honoraria: Morphosys; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Shire; Financial Interests, Personal, Advisory Board: Astrazeneca; Financial Interests, Personal, Advisory Board: Baxalta; Financial Interests, Personal, Advisory Board: Immunocore; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Roche. H. Algül: Financial Interests, Personal, Other, Honoraria: Celgene; Financial Interests, Personal, Other, Honoraria: Servier; Financial Interests, Personal, Research Grant: Chugai; Financial Interests, Personal, Funding: Chugai. E. Goekkurt: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Other, Travel/Accommodation: Servier. G.M. Siegler: Financial Interests, Personal, Funding: Aurikamed; Financial Interests, Personal, Funding: Beigene; Financial Interests, Personal, Funding: Elsai; Financial Interests, Personal, Funding: Celgene; Financial Interests, Personal, Funding: Isofol Medical; Financial Interests, Personal, Funding: Janssen Cilag; Financial Interests, Personal, Funding: Lilly; Financial Interests, Personal, Funding: Medizinwelten Services; Financial Interests, Personal, Funding: Mologen; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Funding: Nutricia; Financial Interests, Personal, Funding: Roche; Financial Interests, Personal, Funding: Sanofi; Financial Interests, Personal, Funding: Servier; Financial Interests, Personal, Funding: Shire. U.M. Martens: Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Other, Travel/Accommodation: Celgene; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Other, Travel/Accommodation: Amgen; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Other, Personal Fees: BMS; Financial Interests, Personal, Other, Personal Fees: Squibb; Financial Interests, Personal, Other, Personal Fees: MSD. D. Waldschmidt: Financial Interests, Personal, Speaker’s Bureau: Celgene; Financial Interests, Personal, Other, Travel/Accommodation: Celgene; Financial Interests, Personal, Speaker’s Bureau: Astrazeneca; Financial Interests, Personal, Speaker’s Bureau: Bayer; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker’s Bureau: EISAI; Financial Interests, Personal, Speaker’s Bureau: Falk; Financial Interests, Personal, Speaker’s Bureau: Incyte; Financial Interests, Personal, Speaker’s Bureau: Ipsen; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Servier; Financial Interests, Personal, Speaker’s Bureau: Shire Baxelta; Financial Interests, Personal, Other, Travel/Accomodation: Sirtex; Financial Interests, Personal, Speaker’s Bureau: Sirtex; Financial Interests, Personal, Other, Travel/Accomodation: Novartis; Financial Interests, Personal, Other, Travel/Accomodation: Ipsen; Financial Interests, Personal, Other, Travel/Accomodation: Bayer; Financial Interests, Institutional, Research Grant: Servier. U. Pelzer: Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Research Grant: Celgene; Financial Interests, Institutional, Funding: Celgene. F. Kullmann: Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Other, Travel/Accommodation: Celgene. S. Boeck: Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Research Grant: Celgene; Financial Interests, Institutional, Funding: Celgene; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Invited Speaker: Servier; Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Personal, Advisory Board: Incyte; Financial Interests, Personal, Advisory Board: Fresenius; Financial Interests, Personal, Advisory Board: AstraZeneca. T.J. Ettrich: Financial Interests, Institutional, Research Grant: Shire; Financial Interests, Institutional, Funding: Shire; Financial Interests, Personal, Speaker’s Bureau: Celgene; Financial Interests, Personal, Expert Testimony: Celgene; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Speaker’s Bureau: Sanofi; Financial Interests, Personal, Expert Testimony: Sanofi; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Expert Testimony: BMS; Financial Interests, Personal, Other, Travel/Accommodation: Ipsen. V. Heinemann: Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Amgen; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: BMS; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Boehringer-Ingelheim; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Celgene; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Halozyme; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Lilly; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Merck; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: MSD; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Roche; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Sanofi; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Servier; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Shire; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Sirtex; Financial Interests, Personal, Other, Grants, Personal Fees, Non-Financial Support: Taiho. V. Kunzmann: Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Institutional, Research Grant: Celgene; Financial Interests, Institutional, Funding: Celgene; Financial Interests, Institutional, Other, Honoraria: Servier; Financial Interests, Personal, Advisory Board: Astrazeneca; Financial Interests, Institutional, Research Grant: Astrazeneca; Financial Interests, Institutional, Funding: Astrazeneca; Financial Interests, Personal, Other, Grants and Personal Fees: Amgen; Financial Interests, Personal, Other, Grants and Personal Fees: BMS; Financial Interests, Personal, Other, Grants and Personal Fees: MSD. All other authors have declared no conflicts of interest.