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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

5325 - A phase II study of nab-paclitaxel and gemcitabine in Korean patients with metastatic pancreatic cancer

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 Cancer

Presenters

Su Jin Lee

Citation

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

Authors

S.J. Lee1, D. Oh2, J. Kang3, H.J. Choi4, M.A. Lee5, S.Y. Oh6, S. Kim7, Y.S. Park8, B. Ryu9, J.O. Park1

Author affiliations

  • 1 Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 2 Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 3 Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Jinju/KR
  • 4 Internal Medicine, Yonsei University College of Medicine Department of Internal Medicine, 120-752 - Seoul/KR
  • 5 Internal Medicine, Seoul St. Mary's Hospital, of the Catholic University, 137-701 - Seoul/KR
  • 6 Internal Medicine, Dong-A University College of Medicine, 602-715 - Busan/KR
  • 7 Medicine, Samsung Medical Center, Seoul/KR
  • 8 Hematology-oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, 06351 - Seoul/KR
  • 9 Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
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Resources

Abstract 5325

Background

Nab-paclitaxel (nab-P) in combination with gemcitabine (G) significantly improved overall survival in patients with pancreatic cancer and is considered as standard first line therapy. However, the efficacy and safety data in Korean patients are lacking as the phase III study was done only in Western countries.

Methods

This open-label, multicenter, phase II, single-arm study was conducted at seven hospitals in South Korea (NCT02426281). Patients with pathologically confirmed metastatic pancreatic cancer were enrolled. Patients received nab-P (125mg/m2) followed by G (1000mg/m2) on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Through a randomized phase III trial, Von Hoff et al. observed a median PFS of 3.7 months from the G alone arm and 5.5 months from the nab-P + G arm. This study is to confirm this outcome from the Korean population. We will not be interested in the combination therapy of nab-P + G if its median PFS is 3.7 months or shorter and will be highly interested in it if its median PFS is 5.5 months or longer. (90% of power and by the one-sample log-rank test with a one-sided alpha=5%).

Results

A total of 65 patients were enrolled between May 2015 and November 2016. The median age of patients was 60 years (range 43-83), 75% of patients were male, and all had an ECOG performance status of 0 or 1. The median PFS was 7.0 months (95% CI; 5.6-8.3), which met primary endpoints. Median overall survival was 12.9 months (95% CI; 10.1-15.6) and the objective response rate was 41.5 % (95% CI; 29.5-53.5) according to RECIST v1.1. The median relative dose intensity was 84% for nab-paclitaxel and 88% for gemcitabine. Grade 3-4 adverse events included neutropenia (62%), anemia (14%), neuropathy (12%) and febrile neutropenia (9%). There was one treatment-related deaths of septic shock.

Conclusions

In Korean patients with metastatic pancreatic cancer, nab-paclitaxel plus gemcitabine regimen showed comparable efficacy and safety profile to previous phase III study of Western countries. Based on this result, we are conducting a phase II trial with the nab-P + G in an expansion cohort of locally advanced pancreatic cancer.

Clinical trial identification

NCT02426281.

Legal entity responsible for the study

Joon Oh Park (PI).

Funding

Nab-paclitaxel was provided by Celgene.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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