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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

2398 - A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients With Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01)

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

Gastric Cancer

Presenters

Keun-Wook Lee

Citation

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

Authors

K. Lee1, C.H. Maeng2, T. Kim3, D.Y. Zang4, Y.H. Kim5, I.G. Hwang6, S.C. Oh7, J.S. Chung8, H.S. Song9, J.W. Kim10, S.J. Jeong11, J.Y. Cho12

Author affiliations

  • 1 Department Of Internal Medicine, Seoul National University Bundang Hospital, 13620 - Seoul/KR
  • 2 Medical Oncology, Kyung Hee University Hospital, 130-702 - Seoul/KR
  • 3 Seoul National University Hospital, Department of Internal Medicine, Seoul/KR
  • 4 Division Of Hematology And Oncology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang/KR
  • 5 Division Of Oncology/hematology, Department Of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul/KR
  • 6 Department Of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul/KR
  • 7 Division Of Hematology/oncology, Internal Medicine Department, Korea University Guro Hospital, College of Medicine, Korea University, Seoul/KR
  • 8 Department Of Internal Medicine, Hemato-oncology, Pusan National University Hospital, College of Medicine Pusan National University, Busan/KR
  • 9 Section Of Hemato-oncology, Department Of Internal Medicine, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu/KR
  • 10 Department Of Internal Medicine, Seoul National University Bundang Hospital, Seoul/KR
  • 11 Statistics Support Department, Medical Science Research Institute, Kyung Hee University Hospital, Seoul/KR
  • 12 Department Of Medical Oncology, Division Of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 135-720 - Seoul/KR
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Resources

Abstract 2398

Background

Although emerging treatments have been introduced to patients with metastatic or recurrent gastric cancer (MRGC) as second-line therapy, paclitaxel or irinotecan are still viable options. This phase III study compared the efficacy and safety of paclitaxel versus irinotecan in patients with MRGC who failed to first-line chemotherapy.

Methods

Patients were randomized to receive either paclitaxel (70 mg/m2; days 1, 8, 15, every 4 weeks) or irinotecan (150 mg/m2 biweekly). The primary endpoint was progression-free survival (PFS).

Results

This study was stopped early due to low accrual rate. A total of 112 patients were enrolled, of which 54 were allocated to paclitaxel, and 58 to irinotecan. Median PFS of paclitaxel or irinotecan group were 3.5 and 2.1 months, respectively [hazard ratio (HR) 1.27; 95% confidence interval (CI), 0.86-1.88; p = 0.234]. Non-inferiority of irinotecan to paclitaxel was not proven according to the predefined upper margin of non-inferiority (1.32). Median overall survival (OS) was 8.6 months in the paclitaxel group, and 7.0 months in the irinotecan group (HR, 1.39; 95% CI, 0.91-2.11; p = 0.126). There was no difference in response rate (p = 0.783) between paclitaxel (15.8%) and irinotecan (13.6%). Among toxicities of ≥ grade 3, neutropenia (11.5%) was the most common toxicity, followed by peripheral neuropathy (7.7%) in the paclitaxel group, and neutropenia (34.5%) followed by nausea, vomiting and anemia (8.6%, respectively) in the irinotecan group.

Conclusions

Although paclitaxel showed numerically longer PFS and OS compared with irinotecan, this was statistically insignificant. Both irinotecan and paclitaxel are valid second-line treatment options in MRGC.

Clinical trial identification

Legal entity responsible for the study

Korean Cancer Study Group (KCSG).

Funding

Boryung Pharmaceutical, CJ HealthCare Corp.

Editorial Acknowledgement

This study was partly funded by Boryung Pharmaceutical and CJ HealthCare Corp. The research was supported in part by the Korean Cancer Study Group (KCSG) and KCSG data center (Study Number: KCSG ST10-01).

Disclosure

All authors have declared no conflicts of interest.

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