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Poster display session

2190 - Risk factors of chemotherapy-induced nausea and vomiting during cisplatin regimen in antiemetic triplet regimen including palonosetron or granisetron: TRIPLE study (Phaselll )

Date

10 Sep 2017

Session

Poster display session

Presenters

KENICHI SUZUKI

Citation

Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388

Authors

K. SUZUKI1, D. Tsuji2, K. Ito2, Y. Kawasaki3, T. Yamanaka4, H. Hashimoto5, K. Goto6, R. Matsui7, N. Seki8, T. Hama1, N. Yamamoto9

Author affiliations

  • 1 Department Of Pharmacy, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 2 Department Of Clinical Pharmacology & Genetics, School of Pharmaceutical Sciences University of Shizuoka, 422-8526 - Shizuoka/JP
  • 3 Department Of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, 606-8501 - Kyoto/JP
  • 4 Department Of Biostatistics, Yokohama City University School of Medicine, 236-0004 - Yokohama/JP
  • 5 Department Of Pharmacy, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 6 Department Of Thoracic Oncolgoy, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 7 Department Of Pharmacy, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 8 Division Of Medical Oncology, Teikyo University School of Medicine, 173-8606 - Tokyo/JP
  • 9 Third Department Of Internal Medhicine, Wakayama Medical University, 641-8509 - Wakayama/JP
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Resources

Abstract 2190

Background

Current antiemetic guidelines recommend antiemetic triplet regimen for cisplatin-based chemotherapy. Although several prior studies have identified risk factors for chemotherapy-induced nausea and vomiting (CINV), only a few have evaluated antiemetic triplet regimen, particularly with palonosetron. Therefore, the purpose of the present study was to confirm and compare the risk factors for CINV when using palonosetron or granisetron.

Methods

A total of 825 patients in the phase III clinical trial on cisplatin regimen were evaluated. The primary endpoint was complete response (CR) rate in the overall period (0–120 h). All patients were evaluated for CINV risk factors. Using a post-hoc analysis, the impact of antiemetic treatment on CR was assessed, and odds ratio (OR) with 95% confidence intervals (CIs) for antiemetic treatment failure were evaluated by using multivariate logistic regression models. CINV risk factors were also evaluated separately in each treatment group.

Results

The multivariate analysis revealed that female (OR: 2.572; 95% CI: 1.855–3.566), less than 60 years old (OR: 1.717; 95% CI: 1.252–2.355), the cisplatin dosage (OR: 1.017; 95% CI: 1.001–1.033), and granisetron use (OR: 1.357; 95% CI: 1.013–1.817) were all significantly associated with antiemetic treatment failure in the entire study group. Similarly, female and age were also identified as the risk factors associated with treatment failure in both groups (P < 0.0001). Kaplan–Meier plots of time to event classified each treatment group and revealed no significant difference between the groups for patients with zero risk factors (P = 0.353). For patients with one or more risk factors, those treated with palonosetron experienced significantly higher CR rates than those treated with granisetron (P = 0.049).

Conclusions

This analysis revealed risk factors of CINV when using triplet antiemetic regimen Including palonosetron or granisetron for cisplatin. Palonosetron might be preferred for patients with one or more risk factors.

Clinical trial identification

Clinical trial information: UMIN 000004863 *UMIN: University Medical Information Network

Legal entity responsible for the study

Pharma Valley Center, Shizuoka Organization for Creation of Industries

Funding

Pharma Valley Center, Shizuoka Organization for Creation of Industries

Disclosure

T. Yamanaka: Reserch Funding: Taiho. K. Goto: Taiho, Chugai, Ono. N. Yamamoto: Consulting or Advisory Role: Chugai Pharmaceutical Co, Ltd, Ono Pharmaceutical Co. Ltd, Research Funding: Ono Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd. All other authors have declared no conflicts of interest.

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