Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy

Shota Hamada, Shiro Hinotsu, Koji Kawai, Shigeyuki Yamada, Shintaro Narita, Tomomi Kamba, Hiroyuki Nishiyama, Yoichi Arai, Tomonori Habuchi, Osamu Ogawa, Koji Kawakami

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Purpose: This study aimed to determine the antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor (TGCT) receiving 5-day cisplatin-based combination chemotherapy. Methods: An open-label, single-arm, multicenter study was performed in patients with TGCT who were scheduled to receive 5-day cisplatin-based combination chemotherapy. The antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2 to 5, and dexamethasone 9.9 mg on day 1 and 6.6 mg on days 2 to 8. The primary endpoint was complete response (CR) rate, which was defined as no vomiting and no rescue medication, in the overall period (0 to 216 h) in the first chemotherapy course. Incidence and severity of nausea were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) and a subjective rating scale completed by patients. Results: Thirty patients were included in the analysis. CR was achieved in 90.0 % of the patients in the first chemotherapy course, and high CR rates were also observed in the second and third courses (82.1 and 78.3 %, respectively). The incidence of nausea peaked on days 4 to 6 in about 50 % of the patients. The reported adverse drug reactions were hiccups (13.3 %), anorexia (3.3 %), and stomach pain (3.3 %). None of these were unexpected and none were grade 3 or 4. Conclusions: The combination antiemetic therapy examined in this study was highly effective and well-tolerated in patients with TGCT receiving 5-day cisplatin-based combination chemotherapy.

Original languageEnglish
Pages (from-to)2161-2166
Number of pages6
JournalSupportive Care in Cancer
Volume22
Issue number8
DOIs
Publication statusPublished - 2014

Fingerprint

aprepitant
Antiemetics
Combination Drug Therapy
Dexamethasone
Cisplatin
Safety
Nausea
Hiccup
Drug Therapy
Incidence
Anorexia
Testicular Germ Cell Tumor
palonosetron
Drug-Related Side Effects and Adverse Reactions
Terminology
Multicenter Studies
Vomiting
Stomach

Keywords

  • Antiemetic
  • Chemotherapy-induced nausea and vomiting
  • Emesis
  • Multiple cycle
  • Multiple-day chemotherapy

ASJC Scopus subject areas

  • Oncology

Cite this

Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy. / Hamada, Shota; Hinotsu, Shiro; Kawai, Koji; Yamada, Shigeyuki; Narita, Shintaro; Kamba, Tomomi; Nishiyama, Hiroyuki; Arai, Yoichi; Habuchi, Tomonori; Ogawa, Osamu; Kawakami, Koji.

In: Supportive Care in Cancer, Vol. 22, No. 8, 2014, p. 2161-2166.

Research output: Contribution to journalArticle

Hamada, Shota ; Hinotsu, Shiro ; Kawai, Koji ; Yamada, Shigeyuki ; Narita, Shintaro ; Kamba, Tomomi ; Nishiyama, Hiroyuki ; Arai, Yoichi ; Habuchi, Tomonori ; Ogawa, Osamu ; Kawakami, Koji. / Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy. In: Supportive Care in Cancer. 2014 ; Vol. 22, No. 8. pp. 2161-2166.
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abstract = "Purpose: This study aimed to determine the antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor (TGCT) receiving 5-day cisplatin-based combination chemotherapy. Methods: An open-label, single-arm, multicenter study was performed in patients with TGCT who were scheduled to receive 5-day cisplatin-based combination chemotherapy. The antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2 to 5, and dexamethasone 9.9 mg on day 1 and 6.6 mg on days 2 to 8. The primary endpoint was complete response (CR) rate, which was defined as no vomiting and no rescue medication, in the overall period (0 to 216 h) in the first chemotherapy course. Incidence and severity of nausea were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) and a subjective rating scale completed by patients. Results: Thirty patients were included in the analysis. CR was achieved in 90.0 {\%} of the patients in the first chemotherapy course, and high CR rates were also observed in the second and third courses (82.1 and 78.3 {\%}, respectively). The incidence of nausea peaked on days 4 to 6 in about 50 {\%} of the patients. The reported adverse drug reactions were hiccups (13.3 {\%}), anorexia (3.3 {\%}), and stomach pain (3.3 {\%}). None of these were unexpected and none were grade 3 or 4. Conclusions: The combination antiemetic therapy examined in this study was highly effective and well-tolerated in patients with TGCT receiving 5-day cisplatin-based combination chemotherapy.",
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T1 - Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy

AU - Hamada, Shota

AU - Hinotsu, Shiro

AU - Kawai, Koji

AU - Yamada, Shigeyuki

AU - Narita, Shintaro

AU - Kamba, Tomomi

AU - Nishiyama, Hiroyuki

AU - Arai, Yoichi

AU - Habuchi, Tomonori

AU - Ogawa, Osamu

AU - Kawakami, Koji

PY - 2014

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N2 - Purpose: This study aimed to determine the antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor (TGCT) receiving 5-day cisplatin-based combination chemotherapy. Methods: An open-label, single-arm, multicenter study was performed in patients with TGCT who were scheduled to receive 5-day cisplatin-based combination chemotherapy. The antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2 to 5, and dexamethasone 9.9 mg on day 1 and 6.6 mg on days 2 to 8. The primary endpoint was complete response (CR) rate, which was defined as no vomiting and no rescue medication, in the overall period (0 to 216 h) in the first chemotherapy course. Incidence and severity of nausea were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) and a subjective rating scale completed by patients. Results: Thirty patients were included in the analysis. CR was achieved in 90.0 % of the patients in the first chemotherapy course, and high CR rates were also observed in the second and third courses (82.1 and 78.3 %, respectively). The incidence of nausea peaked on days 4 to 6 in about 50 % of the patients. The reported adverse drug reactions were hiccups (13.3 %), anorexia (3.3 %), and stomach pain (3.3 %). None of these were unexpected and none were grade 3 or 4. Conclusions: The combination antiemetic therapy examined in this study was highly effective and well-tolerated in patients with TGCT receiving 5-day cisplatin-based combination chemotherapy.

AB - Purpose: This study aimed to determine the antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor (TGCT) receiving 5-day cisplatin-based combination chemotherapy. Methods: An open-label, single-arm, multicenter study was performed in patients with TGCT who were scheduled to receive 5-day cisplatin-based combination chemotherapy. The antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2 to 5, and dexamethasone 9.9 mg on day 1 and 6.6 mg on days 2 to 8. The primary endpoint was complete response (CR) rate, which was defined as no vomiting and no rescue medication, in the overall period (0 to 216 h) in the first chemotherapy course. Incidence and severity of nausea were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) and a subjective rating scale completed by patients. Results: Thirty patients were included in the analysis. CR was achieved in 90.0 % of the patients in the first chemotherapy course, and high CR rates were also observed in the second and third courses (82.1 and 78.3 %, respectively). The incidence of nausea peaked on days 4 to 6 in about 50 % of the patients. The reported adverse drug reactions were hiccups (13.3 %), anorexia (3.3 %), and stomach pain (3.3 %). None of these were unexpected and none were grade 3 or 4. Conclusions: The combination antiemetic therapy examined in this study was highly effective and well-tolerated in patients with TGCT receiving 5-day cisplatin-based combination chemotherapy.

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