376PD - The multicenter, prospective observational study of the 5-HT3 receptor antagonist and dexamethasone as prophylaxis of chemotherapy- induced nausea...

Date 21 December 2015
Event ESMO Asia 2015 Congress
Session Supportive and palliative care
Topics Anti-Cancer Agents & Biologic Therapy
Complications of Treatment
Supportive Care
Presenter Toshinobu Hayashi
Citation Annals of Oncology (2015) 26 (suppl_9): 111-124. 10.1093/annonc/mdv531
Authors T. Hayashi1, R. Matsui2, T. Seto3, K. Suzuki4, T. Takiguchi4, M. Nishio5, T. Koike2, Y. Kogure6, N. Nogami7, K. Fujiwara8, H. Kaneda9, T. Harada10, S. Shimizu11, M. Kimura12, H. Kenmotsu13, M. Shimokawa14, K. Goto15
  • 1Pharmacy, National Kyushu Cancer Center, 811-1347 - Fukuoka/JP
  • 2Pharmacy, National Cancer Center Hospital East, Kashiwa/JP
  • 3Thoracic Oncology, National Kyushu Cancer Center, Fukuoka/JP
  • 4Pharmacy, Cancer Institute Hospital of JFCR, Tokyo/JP
  • 5Thoracic Oncology, Cancer Institute Hospital of JFCR, Tokyo/JP
  • 6Pharmacy, Shikoku Cancer Center, Matsuyama/JP
  • 7Thoracic Oncology, Shikoku Cancer Center, Matsuyama/JP
  • 8Pharmacy, Kinki University School of Medicine, Osakasayama/JP
  • 9Medical Oncology, Kishiwada City Hospital, osaka-kishiwada city/JP
  • 10Pharmacy, Kanagawa Cancer Center, Yokohama/JP
  • 11Breast Oncology, Kanagawa Cancer Center, Yokohama/JP
  • 12Pharmacy, Shizuoka Cancer Center, Shizuoka/JP
  • 13Thoracic Oncology, Shizuoka Cancer Center, Shizuoka/JP
  • 14Clinical Resaerch Institute, National Kyushu Cancer Center, Fukuoka/JP
  • 15Thoracic Oncology, National Cancer Center Hospital East, Kashiwa/JP

Abstract

Aim/Background

The international antiemetic guidelines are available. However, evidence for antiemetic therapy in MEC is lacking. It is still not clear what regimens provide poor control of CINV. In the present study, we clarified regimens that poorly control CINV due to MEC and the risk factors.

Methods

Patients (pts) received with a 5-HT3 receptor antagonist and dexamethasone during MEC, e.g,, in lung cancer: carboplatin plus etoposide (CBDCA + ETP), carboplatin plus paclitaxel (CBDCA+ PTX) or carboplatin plus pemetrexed (CBDCA + PEM), breast cancer: cyclophosphamide plus docetaxel (TC), colon cancer: oxaliplatin with fluorouracil and folinic acid (FOLFOX) or capecitabine plus oxaliplatin (XELOX), ovarian cancer: carboplatin plus paclitaxel (TC). Efficacy was assessed from the start of MEC administration for up to 7 days. We prospectively evaluated emetic events, administration of rescue therapy and the degree of nausea based on pts diaries.

Results

Between May 2013 and January 2015, a total of 400 pts were registered in the study, and 386 pts were eligible for evaluation. The proportion of pts who achieved a complete response (CR; no emesis and no rescue), during the overall phase (0–168 h) were as follows: CBDCA + ETP-77%, CBDCA + PTX-67%, CBDCA + PEM-54% for lung cancer, TC-70% for breast cancer, FOLFOX-63%, XELOX-64% for colon cancer, and TC-51% for ovarian cancer. The proportion of pts who achieved total control (TC; no emesis, no rescue and nausea) during the overall phase were as follows: CBDCA + ETP-71%, CBDCA + PTX-57%, CBDCA + PEM-33% for lung cancer, TC-48% for breast cancer, FOLFOX-53%, XELOX-54% for colon cancer, and TC-36% for ovarian cancer. CR rates were clinically significantly lower in females (56%) compared with males (70%).

Conclusions

CBDCA + PEM for lung cancer and TC for ovarian cancer resulted in poorly controlled CINV. We also clarified a low emetic control rate in females. Overall, the two antiemetic therapy with poorly controlled CINV and females should be considered for triplet antiemetic regimen including an NK1 receptor antagonist.

Clinical trial identification


Disclosure

T. Hayashi: honoraria or consultation fees, participation in a company sponsored speaker's bureau: Taiho Pharmaceutical Co.,Ltd, Chugai Pharmaceutical Co.,Ltd, Ono Pharmaceutical Co.,Ltd. R. Matsui: honoraria or consultation fees, participation in a company: Chugai Pharmaceutical Co.,Ltd, Taiho Pharmaceutical Co.,Ltd, Yakult Pharmaceutical Industry Co., Ltd., Novartis Pharma K.K. T. Seto: grants/research supports: Yakult, Chugai, Novartis Pharma, Kyowa Hakko Kirin, Taiho, Astellas; participation in a company sponsored speaker's bureau: Yakult, Chugal, Novartis, Kyowa Hakko Kirin, Taiho, Astellas, Ono. K. Suzuki: honoraria or consultation fees, participation in a company: Chugai Pharmaceutical Co.,Ltd, Taiho Pharmaceutical Co, Ono Pharmaceutical Co.,Ltd. M. Nishio: receipt of grants/research supports: Chugai, Taiho, Ono, Astellas, Novartis Pharma, Yakult; receipt of honoraria or consultation fees; participation in a company: Chugal, Taiho, Ono. Y. Kogure: honoraria or consultation fees, participation in a company: Taiho Pharmaceutical Co.,Ltd, Chugai Pharmaceutical Co.,Ltd. N. Nogami: participation in a company sponsored speaker's bureau Eli Lilly Japan K.K., Taiho. K. Fujiwara: honoraria or consultation fees, participation in a company: Taiho Pharmaceutical Co.,Ltd, Ono Pharmaceutical Co., Ltd. H. Kaneda: grants/research supports: Eli Lilly Japan KK; receipt of honoraria or consultation fees: Chugai Pharmaceutical Co., Ltd. H. Kenmotsu: Receipt of grants/research supports: AstraZeneca K.K. K. Goto: Receipt of grants/research supports: Glaxo Smith Kline, Chugai, Kyowa Hakko Kirin, Taiho, Ono, Astellas, Novartis Pharma Receipt of honoraria or consultation fees Participation in a company: Chugal, Kyowa Hakko Kirin, Taiho, Ono, Novartis Pharma. All other authors have declared no conflicts of interest.