A phase 2 study of fosaprepitant combined with high-dose dexamethasone for Japanese cancer patients receiving highly emetogenic chemotherapy

Hozumi Kumagai, Hitoshi Kusaba, Takeharu Yamanaka, Kenta Nio, Kyoko Inadomi, Kotoe Takayoshi, Mamoru Ito, Shingo Tamura, Akitaka Makiyama, Chinatsu Makiyama, Gen Hirano, Yoshihiro Shibata, Tsuyoshi Shirakawa, Kenji Mitsugi, hiroshi ariyama, Taito Esaki, Koichi Akashi, Eishi Baba

Research output: Contribution to journalArticle

Abstract

Purpose: Combination therapy of fosaprepitant, dexamethasone (DEX) and a serotonin (5-HT 3) receptor antagonist is a standard antiemetic prophylaxis for patients receiving highly emetogenic chemotherapy (HEC). However, the appropriate dose of DEX has not been established in Japan. This study determined the efficacy and safety of triplet antiemetic prophylaxis in Japanese patients receiving HEC when administered the same doses of DEX as those given in a previous international phase 3 study on this drug. Methods: To assess the efficacy and safety of a sufficient dose of DEX (12mg on day 1, 8mg on day 2, 16mg on days 3 and 4) in combination with intravenous fosaprepitant and granisetron, we prospectively examined patients receiving HEC including cisplatin (≥50mg/m 2). The primary endpoint was to determine the percentage of patients who had achieved a complete response (CR), which was defined as no vomiting and no rescue therapy during the entire treatment course. Results: Between February 2013 and January 2015, 44 patients were enrolled with a median age of 65 years (range, 30-75). There were 34 males (77.3%) in the study. Most of the patients had upper gastrointestinal cancers. The CR rate during the treatment course was 70% (95% confidence interval [CI]: 55%-83%) in the overall phase and 91% (95% CI: 78%-97%) in the acute phase and 70% (95% CI: 55%-83%) in the delayed phase. Appreciable severe toxicities related to the antiemetic therapy were not observed. Conclusions: These results suggest that a sufficient dose of DEX in combination with fosaprepitant and granisetron is optimal as an antiemetic prophylaxis for Japanese patients receiving HEC.

Original languageEnglish
Article numbere11042
JournalMedicine (United States)
Volume97
Issue number25
DOIs
Publication statusPublished - Jun 1 2018

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fosaprepitant
Dexamethasone
Antiemetics
Drug Therapy
Neoplasms
Granisetron
Confidence Intervals
Therapeutics
Safety
Gastrointestinal Neoplasms
Serotonin Receptors
Cisplatin
Vomiting

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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A phase 2 study of fosaprepitant combined with high-dose dexamethasone for Japanese cancer patients receiving highly emetogenic chemotherapy. / Kumagai, Hozumi; Kusaba, Hitoshi; Yamanaka, Takeharu; Nio, Kenta; Inadomi, Kyoko; Takayoshi, Kotoe; Ito, Mamoru; Tamura, Shingo; Makiyama, Akitaka; Makiyama, Chinatsu; Hirano, Gen; Shibata, Yoshihiro; Shirakawa, Tsuyoshi; Mitsugi, Kenji; ariyama, hiroshi; Esaki, Taito; Akashi, Koichi; Baba, Eishi.

In: Medicine (United States), Vol. 97, No. 25, e11042, 01.06.2018.

Research output: Contribution to journalArticle

Kumagai, H, Kusaba, H, Yamanaka, T, Nio, K, Inadomi, K, Takayoshi, K, Ito, M, Tamura, S, Makiyama, A, Makiyama, C, Hirano, G, Shibata, Y, Shirakawa, T, Mitsugi, K, ariyama, H, Esaki, T, Akashi, K & Baba, E 2018, 'A phase 2 study of fosaprepitant combined with high-dose dexamethasone for Japanese cancer patients receiving highly emetogenic chemotherapy', Medicine (United States), vol. 97, no. 25, e11042. https://doi.org/10.1097/MD.0000000000011042
Kumagai, Hozumi ; Kusaba, Hitoshi ; Yamanaka, Takeharu ; Nio, Kenta ; Inadomi, Kyoko ; Takayoshi, Kotoe ; Ito, Mamoru ; Tamura, Shingo ; Makiyama, Akitaka ; Makiyama, Chinatsu ; Hirano, Gen ; Shibata, Yoshihiro ; Shirakawa, Tsuyoshi ; Mitsugi, Kenji ; ariyama, hiroshi ; Esaki, Taito ; Akashi, Koichi ; Baba, Eishi. / A phase 2 study of fosaprepitant combined with high-dose dexamethasone for Japanese cancer patients receiving highly emetogenic chemotherapy. In: Medicine (United States). 2018 ; Vol. 97, No. 25.
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abstract = "Purpose: Combination therapy of fosaprepitant, dexamethasone (DEX) and a serotonin (5-HT 3) receptor antagonist is a standard antiemetic prophylaxis for patients receiving highly emetogenic chemotherapy (HEC). However, the appropriate dose of DEX has not been established in Japan. This study determined the efficacy and safety of triplet antiemetic prophylaxis in Japanese patients receiving HEC when administered the same doses of DEX as those given in a previous international phase 3 study on this drug. Methods: To assess the efficacy and safety of a sufficient dose of DEX (12mg on day 1, 8mg on day 2, 16mg on days 3 and 4) in combination with intravenous fosaprepitant and granisetron, we prospectively examined patients receiving HEC including cisplatin (≥50mg/m 2). The primary endpoint was to determine the percentage of patients who had achieved a complete response (CR), which was defined as no vomiting and no rescue therapy during the entire treatment course. Results: Between February 2013 and January 2015, 44 patients were enrolled with a median age of 65 years (range, 30-75). There were 34 males (77.3{\%}) in the study. Most of the patients had upper gastrointestinal cancers. The CR rate during the treatment course was 70{\%} (95{\%} confidence interval [CI]: 55{\%}-83{\%}) in the overall phase and 91{\%} (95{\%} CI: 78{\%}-97{\%}) in the acute phase and 70{\%} (95{\%} CI: 55{\%}-83{\%}) in the delayed phase. Appreciable severe toxicities related to the antiemetic therapy were not observed. Conclusions: These results suggest that a sufficient dose of DEX in combination with fosaprepitant and granisetron is optimal as an antiemetic prophylaxis for Japanese patients receiving HEC.",
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T1 - A phase 2 study of fosaprepitant combined with high-dose dexamethasone for Japanese cancer patients receiving highly emetogenic chemotherapy

AU - Kumagai, Hozumi

AU - Kusaba, Hitoshi

AU - Yamanaka, Takeharu

AU - Nio, Kenta

AU - Inadomi, Kyoko

AU - Takayoshi, Kotoe

AU - Ito, Mamoru

AU - Tamura, Shingo

AU - Makiyama, Akitaka

AU - Makiyama, Chinatsu

AU - Hirano, Gen

AU - Shibata, Yoshihiro

AU - Shirakawa, Tsuyoshi

AU - Mitsugi, Kenji

AU - ariyama, hiroshi

AU - Esaki, Taito

AU - Akashi, Koichi

AU - Baba, Eishi

PY - 2018/6/1

Y1 - 2018/6/1

N2 - Purpose: Combination therapy of fosaprepitant, dexamethasone (DEX) and a serotonin (5-HT 3) receptor antagonist is a standard antiemetic prophylaxis for patients receiving highly emetogenic chemotherapy (HEC). However, the appropriate dose of DEX has not been established in Japan. This study determined the efficacy and safety of triplet antiemetic prophylaxis in Japanese patients receiving HEC when administered the same doses of DEX as those given in a previous international phase 3 study on this drug. Methods: To assess the efficacy and safety of a sufficient dose of DEX (12mg on day 1, 8mg on day 2, 16mg on days 3 and 4) in combination with intravenous fosaprepitant and granisetron, we prospectively examined patients receiving HEC including cisplatin (≥50mg/m 2). The primary endpoint was to determine the percentage of patients who had achieved a complete response (CR), which was defined as no vomiting and no rescue therapy during the entire treatment course. Results: Between February 2013 and January 2015, 44 patients were enrolled with a median age of 65 years (range, 30-75). There were 34 males (77.3%) in the study. Most of the patients had upper gastrointestinal cancers. The CR rate during the treatment course was 70% (95% confidence interval [CI]: 55%-83%) in the overall phase and 91% (95% CI: 78%-97%) in the acute phase and 70% (95% CI: 55%-83%) in the delayed phase. Appreciable severe toxicities related to the antiemetic therapy were not observed. Conclusions: These results suggest that a sufficient dose of DEX in combination with fosaprepitant and granisetron is optimal as an antiemetic prophylaxis for Japanese patients receiving HEC.

AB - Purpose: Combination therapy of fosaprepitant, dexamethasone (DEX) and a serotonin (5-HT 3) receptor antagonist is a standard antiemetic prophylaxis for patients receiving highly emetogenic chemotherapy (HEC). However, the appropriate dose of DEX has not been established in Japan. This study determined the efficacy and safety of triplet antiemetic prophylaxis in Japanese patients receiving HEC when administered the same doses of DEX as those given in a previous international phase 3 study on this drug. Methods: To assess the efficacy and safety of a sufficient dose of DEX (12mg on day 1, 8mg on day 2, 16mg on days 3 and 4) in combination with intravenous fosaprepitant and granisetron, we prospectively examined patients receiving HEC including cisplatin (≥50mg/m 2). The primary endpoint was to determine the percentage of patients who had achieved a complete response (CR), which was defined as no vomiting and no rescue therapy during the entire treatment course. Results: Between February 2013 and January 2015, 44 patients were enrolled with a median age of 65 years (range, 30-75). There were 34 males (77.3%) in the study. Most of the patients had upper gastrointestinal cancers. The CR rate during the treatment course was 70% (95% confidence interval [CI]: 55%-83%) in the overall phase and 91% (95% CI: 78%-97%) in the acute phase and 70% (95% CI: 55%-83%) in the delayed phase. Appreciable severe toxicities related to the antiemetic therapy were not observed. Conclusions: These results suggest that a sufficient dose of DEX in combination with fosaprepitant and granisetron is optimal as an antiemetic prophylaxis for Japanese patients receiving HEC.

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