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The multicenter, prospective observational study of the 5-HT3 receptor antagonist and dexamethasone as prophylaxis of chemotherapy- induced nausea and vomiting (CINV) in moderately emetic chemotherapy (MEC) for solid tumors

Date

21 Dec 2015

Session

Supportive and palliative care

Presenters

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

Author affiliations

  • 1 Pharmacy, National Kyushu Cancer Center, 811-1347 - Fukuoka/JP
  • 2 Pharmacy, National Cancer Center Hospital East, Kashiwa/JP
  • 3 Thoracic Oncology, National Kyushu Cancer Center, Fukuoka/JP
  • 4 Pharmacy, Cancer Institute Hospital of JFCR, Tokyo/JP
  • 5 Thoracic Oncology, Cancer Institute Hospital of JFCR, Tokyo/JP
  • 6 Pharmacy, Shikoku Cancer Center, Matsuyama/JP
  • 7 Thoracic Oncology, Shikoku Cancer Center, Matsuyama/JP
  • 8 Pharmacy, Kinki University School of Medicine, Osakasayama/JP
  • 9 Medical Oncology, Kishiwada City Hospital, osaka-kishiwada city/JP
  • 10 Pharmacy, Kanagawa Cancer Center, Yokohama/JP
  • 11 Breast Oncology, Kanagawa Cancer Center, Yokohama/JP
  • 12 Pharmacy, Shizuoka Cancer Center, Shizuoka/JP
  • 13 Thoracic Oncology, Shizuoka Cancer Center, Shizuoka/JP
  • 14 Clinical Resaerch Institute, National Kyushu Cancer Center, Fukuoka/JP
  • 15 Thoracic Oncology, National Cancer Center Hospital East, Kashiwa/JP
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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.

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