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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

2999 - Phase II study of paclitaxel in patients with advanced gastrointestinal stromal tumor (GIST) after failure of at least both imatinib and sunitinib

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Topics

Tumour Site

GIST

Presenters

Hyungwoo Cho

Citation

Annals of Oncology (2018) 29 (suppl_8): viii576-viii595. 10.1093/annonc/mdy299

Authors

H. Cho1, M. Ryu2, B.J. Kim3, Y. Park4, Y. Na5, J. Ma6, M.Y. Beck7, Y. Kang6

Author affiliations

  • 1 Department Of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 2 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 05505 - Seoul/KR
  • 3 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 4 Department Of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 5 Asan Institute For Life Science, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 6 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 7 Department Of Oncology, Asan Medical Center, 05505 - Seoul/KR
More

Resources

Abstract 2999

Background

Most advanced GISTs are known to be resistant to conventional cytotoxic agents but sensitive to tyrosine kinase inhibitors (TKI) such as imatinib and sunitinib. However, majority of patients eventually develop resistance to TKIs and experience disease progression. Recent preclinical studies suggested that a few conventional cytotoxic agents such as paclitaxel might have antitumor effect on GIST. The current study was conducted to evaluate the efficacy and safety of paclitaxel in patients with advanced GIST after failure of at least imatinib and sunitinib.

Methods

Patients received paclitaxel 80 mg/m2 intravenously on days 1, 8, and 15 of a 4-week cycle. The primary endpoint was 16-week disease control rate (complete response [CR] + partial response [PR] + stable disease [SD]). Secondary endpoints were progression-free survival (PFS) and overall survival (OS). Translational correlation of PFS with expression of P-glycoprotein (P-gp) was also evaluated. This trial is registered with ClinicalTrials.gov, no. NCT 02607332.

Results

A total of 25 patients were enrolled. Median age was 61 years (range, 38-71), and 16 patients (64.0%) were male. Small bowel was the most common primary site (n = 17, 68.0%), followed by stomach (n = 7, 28.0%). Median 2 cycles (range, 1-12) of paclitaxel were administered per patient. No CR was observed. PR and SD were observed in one patient (4.0%)and 10 patients (40.0%), respectively. The 16-week disease control rate was 20.1%. With a median follow up duration of 20.8 months (range, 17.9-24.0) in surviving patients, median PFS and OS were 1.7 months (95% CI, 0.23-3.13) and 10.9 months (95% CI, 0.0-23.68), respectively. The most frequent grade 3/4 adverse events were neutropenia (20.0%) and leukopenia (8.0%). P-gp expression was evaluable in 19 patients, and a trend toward poor PFS was documented in patients with high P-gp intensity score (3 vs. 1-2; HR 2.3, P = 0.12).

Conclusions

Paclitaxel was well tolerated with modest antitumor efficacy in heavily pretreated patients with advanced GIST. Additionally, P-gp maybe a potential biomarker for selecting patients for paclitaxel treatment.

Clinical trial identification

NCT 02607332.

Legal entity responsible for the study

Asan Medical Center.

Funding

Hanmi.

Editorial Acknowledgement

Disclosure

Y-K. Kang: Consultant: Ono, BMS, Taiho, Roche, Lilly, Blueprint, Taiho, Daehwa, LSK Biopharma. All other authors have declared no conflicts of interest.

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