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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

3974 - Quality of Life (QoL) in patients with metastatic pancreatic cancer receiving first-line Nab-paclitaxel/gemcitabine chemotherapy: results of the large QoL study AIO-QoliXane/PARAGON

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy

Tumour Site

Pancreatic Adenocarcinoma

Presenters

Caroline Schönherr

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

C. Schönherr1, T.O. Götze2, G. zur Hausen3, A. Reichart4, C. Pauligk5, R. Schlag6, G.M. Siegler7, S. Dörfel8, A. Aldaoud9, L. Hahn10, J. Schubert11, M. Zahn12, H. Höffkes13, M. Reiser14, M. Koenigsmann15, W. Blau16, O. Waidmann17, N. Homann18, J. Trojan19, S. Al-Batran2

Author affiliations

  • 1 Ikf Klinische Krebsforschung Gmbh, IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest, 60488 - Frankfurt/DE
  • 2 Institute Of Clinical Cancer Research (ikf), Nordwest-Krankenhaus, 60488 - Frankfurt am Main/DE
  • 3 Ikf Klinische Krebsforschung Gmbh, Nordwest-Krankenhaus, 60488 - Frankfurt am Main/DE
  • 4 Institut Für Klinisch-onkologische Forschung, Krankenhaus Nordwest gGmbH, Frankfurt am Main/DE
  • 5 Institut Für Klinisch-onkologische Forschung, Nordwest-Krankenhaus, 60488 - Frankfurt am Main/DE
  • 6 Hämatoonkologische Praxis Dr. R. Schlag, Hämatoonkologische Praxis Dr. R. Schlag, Berlin/DE
  • 7 Medizinische Klinik 5, Klinikum Nuernberg Nord, 90419 - Nürnberg/DE
  • 8 Onkozentrum Dresden, Onkozentrum Dresden, Dresden/DE
  • 9 Pankreaszentrum Leipzig, HELIOS Park-Klinikum, 4289 - Leipzig/DE
  • 10 Dokusan Gesellschaft Für Med. Studien, Dokusan Gesellschaft für med. Studien, Herne/DE
  • 11 Klinik Für Innere Medizin Ii, Elblandklinikum Riesa, 1589 - Riesa/DE
  • 12 Mvz Onkologische Kooperation Harz, MVZ Onkologische Kooperation Harz, 38642 - Goslar/DE
  • 13 Mvz Osthessen, MVZ Osthessen, Fulda/DE
  • 14 Pioh, PIOH (Köln Zentrum) - Praxis Internistischer Onkologie und Hämatologie, 50674 - Köln/DE
  • 15 Gesellschaft Für Medizinstatistik U. Projektentwicklung, MediProjekt Hannover, Hannover/DE
  • 16 Medizinische Klinik Iv/v, Universitätsklinik Giessen, 35385 - Giessen/DE
  • 17 Klinische Studienzentrale, Universitätsklinikum Frankfurt(Johannes-Wolfgang Goethe Institute), 60590 - Frankfurt am Main/DE
  • 18 Med. Klinik Ii, Klinikum Wolfsburg, 38440 - Wolfsburg/DE
  • 19 University Cancer Center, Universitätsklinikum Frankfurt(Johannes-Wolfgang Goethe Institute), 60590 - Frankfurt am Main/DE

Resources

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Abstract 3974

Background

Nab-paclitaxel/gemcitabine (NPG) is standard first-line therapy for metastatic pancreatic cancer (mPC), but the pivotal study did not include QoL analyses.

Methods

QoliXane/PARAGON is a platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer. In this prospective QoL-study, patients (pts) were recruited from 95 German centers. QoL was prospectively measured (prior to and every month thereafter): therapy and efficacy were prospectively collected. QoL and efficacy endpoints were analyzed in the intention-to-treat population (ITT), defined as all pts who were enrolled. The primary endpoint was the rate of pts without deterioration of QoL/Global Health Score (QoL/GHS) at 3 mos.

Results

601 pts were included. Median progression-free survival was 6 mos (95% CI: 5.26, 6.25). Median overall survival (OS) was 10 mos (8.22, 11.74). 1-year OS was 41%. Median survival by ECOG PS of 0, 1, 2, and 3 was 11.1 mos, 8.9 mos, 4.8 mos, and 2.1 mos (p<.0001). The KM-analysis showed that 61% and 41% of pts had maintained QoL/GHS after 3 and 6 mos, respectively. Median time to deterioration of QoL/GHS was 4.7 mos [4.04, 5.59]. Mean QoL/GHS improved from 46.1 at baseline to 52.8 after 6 mos. In the QoL response analysis, 35%, 37% and 28% of evaluable pts had improved, stable and worse QoL/GHS after 3 mos, respectively. In the Cox regression analysis, a 10-point increase in baseline QoL/GHS correlated to 13% decreased risk of death (HR = 0.87; 0.83-0.91; p<.0001).

Conclusions

The QoliXane/PARAGON is among the largest studies on QoL of pancreatic cancer ever conducted. It shows that a relevant group of patients have improved or maintained QoL after 3 and 6 months and that QoL is a predictor of patient’s outcome.

Clinical trial identification

NCT02691052.

Legal entity responsible for the study

IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest.

Funding

Celgene.

Editorial Acknowledgement

Disclosure

C. Schönherr, G. zur Hausen: Celgene. T.O. Götze: COIs: Lilly, MSD, BMS, Celgene, Shire, Bayer. S-E. Al-Batran: Advisory role: Merck, Roche, Celgene, Lilly, Nordic Pharma, Bristol-Myers Squibb, MSD Sharp & Dohme: Speaker: Roche, Celgene, Lilly, Nordic Pharma, AIO gGmbH, MCI, promedicis, Forum für Medizinische Fortbildung; CEO/founder of IKF Klinische Krebsforschung GmbH; Research grants: Sanofi, Merck, Roche, Celgene, Vifor, Medac, Hospira, Lilly, German Cancer Aid (Krebshilfe), German Research Foundation, the Federal Ministry of Education and Research. All other authors have declared no conflicts of interest.

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