1525O - The QOLIXANE trial - Real life QoL and efficacy data in 1st line pancreatic cancer from the prospective platform for outcome, quality of life, and translational research on pancreatic cancer (PARAGON) registry

Background

Gemcitabine and nab-paclitaxel (NPG) is one of the standard 1st therapies for metastatic pancreatic cancer (mPC). Nevertheless, only few data exist on health-related quality of life (QoL) in mPC. receiving first-line systemic chemotherapy.

Methods

The QOLIXANE-PARAGON study is a prospective, non-interventional, multicenter sub-study of the PARAGON- registry, conducted in Germany and transitioned into a permanent registry for pancreatic cancer pts considering all types of treatments.

This report focuses on the pts enrolled into the QOLIXANE portion of the study, treated with NPG in 1^st line. Pts were recruited from 95 German centers. QoL was prospectively measured via EORTC-C30 questionnaires (at baseline and every month thereafter): therapy and efficacy parameters were prospectively collected. QoL and efficacy endpoints were analyzed in the intention-to-treat population (ITT). Main objectives were the rate of patients without deterioration of Global Health Status/QoL (GHS/QoL) at 3 and 6 months.

Results

600 pts were enrolled. MPFS was 5.85 months (95% CI, 5.23 to 6.25). MOS was 8.91 mo (95% CI, 7.89 to 10.19). The mOS in ECOG 0 pts. was significantly better (11.18 mo; p = 0.027) than in ECOG 1 pts. (mOS 8.52 mo) and ECOG 2 (mOS 4.80 mo; p <0.0001). Worst mOS was seen in ECOG 3 (mOS 2.94 mo). The KM-analysis showed that 61% and 41% of pts had maintained QoL/GHS after 3 and 6 months, respectively. Median time to deterioration of QoL/GHS was 4.68 months (95% CI, 4.04 to 5.59). Mean QoL/GHS improved from 46.1 (SD 22.7) at baseline to 52.8 (SD 21.3) after 6 months. In the QoL response analysis, 34.6%, 37.4% and 28% of evaluable pts had improved, stable and worse QoL/GHS after 3 months, respectively. In the Cox regression analysis, GHS/QoL scores strongly predicted survival with a HR of 0.86 (p<0.0001).

Conclusions

QoliXane is the largest study on QoL in mPC and shows that time to deterioration of QoL is short, reflecting the aggressive nature of mPC. Nevertheless, a relevant group of mPC in 1^st line have improved or maintained QoL after 3 and 6 months, indicating that QoL is a predictor of pts outcome.

Clinical trial identification

NCT02691052.

Editorial acknowledgement

Legal entity responsible for the study

Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest.

Funding

Celgene.

Disclosure

T.O. Götze: Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy: MSD Oncology; Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy: Servier; Advisory/Consultancy: Roche; Research grant/Funding (self): Deutsche Forschungsgemeinschaft; Research grant/Funding (self): Gemeinsamer Bundesausschuss. R.D. Hofheinz: Honoraria (self), Advisory/Consultancy: Merck Serono; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Sanofi; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squipp; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Honoraria (self), Speaker Bureau/Expert testimony: Lilly; Speaker Bureau/Expert testimony: Merck; Speaker Bureau/Expert testimony: Servier; Honoraria (self), Honoraria (institution): Medac; Honoraria (institution): Germany Cancer Aid. G.M. Siegler: Honoraria (self): medizinwelten services GmbH; Honoraria (self): Shire; Honoraria (self): Eisai; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy: Janssen-Cilag; Research grant/Funding (institution): Servier; Research grant/Funding (institution): Beigene; Research grant/Funding (institution): Roche-Genentech; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Isofol Medical; Research grant/Funding (institution): Nutricia; Research grant/Funding (institution): Mologen; Research grant/Funding (institution): Sanofi; Travel/Accommodation/Expenses: Lilly. O. Waidmann: Advisory/Consultancy: Amgen; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: Celgene; Advisory/Consultancy: Eisai; Advisory/Consultancy, Investigator: Incyte; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Investigator: Merck kGA; Advisory/Consultancy, Investigator: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Investigator: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Servier; Advisory/Consultancy: Shire; Travel/Accommodation/Expenses: Abbvie; Travel/Accommodation/Expenses: Gilead; Travel/Accommodation/Expenses: Merck Serono; Travel/Accommodation/Expenses: Medac; Advisory/Consultancy, Investigator: Basilea; Advisory/Consultancy, Investigator: Lilly. D. Pink: Full/Part-time employment: Helios Kliniken GmbH; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Research grant/Funding (institution): Clinigen Group; Advisory/Consultancy, Research grant/Funding (institution): Roche; Research grant/Funding (institution): PharmaMar; Research grant/Funding (institution): Novartis pharma SAS. A. Vogel: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Novartis; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Amgen; Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy: Baxalta; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: EISAI; Advisory/Consultancy: BTG; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self): Sanofi; Honoraria (self): Delcath Systems; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): MSD; Honoraria (self): Janssen. T.J. Ettrich: Advisory/Consultancy: Merck Serono; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Bayer; Advisory/Consultancy: Roche; Advisory/Consultancy: Lilly; Advisory/Consultancy: Eisai; Advisory/Consultancy: Safoni/Aventis; Advisory/Consultancy: MSD; Travel/Accommodation/Expenses: Ipsen; Research grant/Funding (self): Baxalta/Shire. C. Schönherr: Honoraria (self): Celgene. G. zur Hausen: Honoraria (self), Travel/Accommodation/Expenses: Celgene. S-E. Al-Batran: Advisory/Consultancy, Research grant/Funding (self): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Lilly; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (self): Merck; Advisory/Consultancy, Speaker Bureau/Expert testimony: Nordic Bioscience; Advisory/Consultancy: Merck Sharp & Dohme; Speaker Bureau/Expert testimony: AIO gGmbH; Speaker Bureau/Expert testimony: Forum für Medizinische Fortbildung; Speaker Bureau/Expert testimony: MCI group; Shareholder/Stockholder/Stock options: Institut für Klinische Krebsforschung IKF GmbH; Research grant/Funding (self): Medac; Research grant/Funding (self): Hospira; Research grant/Funding (self): Sanofi; Research grant/Funding (self): German Cancer Aid; Research grant/Funding (self): German Research Foundation; Research grant/Funding (self): Federal Ministry of Education and Research; Research grant/Funding (self): Vifor Pharma. All other authors have declared no conflicts of interest.