Literature DB >> 24825735

Efficacy and safety of triple therapy with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy for gynecological cancer: KCOG-G1003 phase II trial.

Nobuhiro Takeshima1, Maki Matoda, Masakazu Abe, Yasuyuki Hirashima, Kentaro Kai, Kaei Nasu, Masashi Takano, Kenichi Furuya, Seiya Sato, Hiroaki Itamochi, Hiroshi Tsubamoto, Kosei Hasegawa, Kiminari Terao, Takeo Otsuki, Keiko Kuritani, Kimihiko Ito.   

Abstract

PURPOSE: Prevention of chemotherapy-induced nausea and vomiting (CINV) is crucial for maintaining the quality of life of cancer patients. Female patients have been underrepresented in previous clinical studies of aprepitant or palonosetron. We performed a prospective multicenter study to investigate the efficacy and safety of triple therapy comprising these two agents and dexamethasone in female cancer patients receiving chemotherapy that included cisplatin (≥ 50 mg/m(2)).
METHODS: Aprepitant was administered at a dose of 125 mg before chemotherapy on day 1 and at 80 mg on days 2 and 3. Palonosetron (0.75 mg) was given before chemotherapy on day 1. Dexamethasone was administered at a dose of 9.9 mg before chemotherapy on day 1 and at 6.6 mg on days 2-4. The primary endpoint was the the proportion of patients with a complete response (CR no vomiting and no use of rescue medication) throughout the overall period (0-120 h post-chemotherapy).
RESULTS: Ninety-six women (median age 55 years) were enrolled. The overall CR rate was 54.2 %. CR was obtained during the acute phase (0-24 h post-chemotherapy) and the delayed phase (24-120 h post-chemotherapy) in 87.5 and 56.3 % of the patients, respectively. The most common adverse reactions were constipation and fatigue (reported by three patients each).
CONCLUSIONS: Exhibition of a favorable overall CR rate over existing two-drug combinations suggests that the triple therapy regimen used in the present study is effective and tolerable in patients with gynecological malignancies receiving cisplatin-based chemotherapy. Female patients may have a higher risk of developing CINV.

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Year:  2014        PMID: 24825735     DOI: 10.1007/s00520-014-2280-6

Source DB:  PubMed          Journal:  Support Care Cancer        ISSN: 0941-4355            Impact factor:   3.603


  17 in total

Review 1.  Antiemetics: American Society of Clinical Oncology clinical practice guideline update.

Authors:  Ethan Basch; Ann Alexis Prestrud; Paul J Hesketh; Mark G Kris; Petra C Feyer; Mark R Somerfield; Maurice Chesney; Rebecca Anne Clark-Snow; Anne Marie Flaherty; Barbara Freundlich; Gary Morrow; Kamakshi V Rao; Rowena N Schwartz; Gary H Lyman
Journal:  J Clin Oncol       Date:  2011-09-26       Impact factor: 44.544

2.  Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment.

Authors:  Brigitte Bloechl-Daum; Robert R Deuson; Panagiotis Mavros; Mogens Hansen; Jørn Herrstedt
Journal:  J Clin Oncol       Date:  2006-09-20       Impact factor: 44.544

3.  Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy.

Authors:  Flavia Longo; Giovanni Mansueto; Vittoria Lapadula; Rita De Sanctis; Silvia Quadrini; Roberta Grande; Bruno Gori; Amelia Altavilla; I D'Antoni; Ester Del Signore; Luciano Stumbo; Cristina De Luca; Barbara Cimadon; Enrico Cortesi; Teresa Gamucci; Marisa Di Seri
Journal:  Support Care Cancer       Date:  2010-06-16       Impact factor: 3.603

4.  Establishing the dose of the oral NK1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting.

Authors:  Sant P Chawla; Steven M Grunberg; Richard J Gralla; Paul J Hesketh; Cindy Rittenberg; Mary E Elmer; Carrie Schmidt; Arlene Taylor; Alexandra D Carides; Judith K Evans; Kevin J Horgan
Journal:  Cancer       Date:  2003-05-01       Impact factor: 6.860

5.  The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group.

Authors:  Paul J Hesketh; Steven M Grunberg; Richard J Gralla; David G Warr; Fausto Roila; Ronald de Wit; Sant P Chawla; Alexandra D Carides; Juliana Ianus; Mary E Elmer; Judith K Evans; Klaus Beck; Scott Reines; Kevin J Horgan
Journal:  J Clin Oncol       Date:  2003-10-14       Impact factor: 44.544

6.  Brain penetration of aprepitant, a substance P receptor antagonist, in ferrets.

Authors:  Su-Er W Huskey; Brian J Dean; Ray Bakhtiar; Rosa I Sanchez; F David Tattersall; Wayne Rycroft; Richard Hargreaves; Alan P Watt; Gary G Chicchi; Carolann Keohane; Donald F Hora; Shuet-Hing L Chiu
Journal:  Drug Metab Dispos       Date:  2003-06       Impact factor: 3.922

7.  Evaluation of risk factors predictive of nausea and vomiting with current standard-of-care antiemetic treatment: analysis of two phase III trials of aprepitant in patients receiving cisplatin-based chemotherapy.

Authors:  Paul J Hesketh; Matti Aapro; James C Street; Alexandra D Carides
Journal:  Support Care Cancer       Date:  2009-09-12       Impact factor: 3.603

8.  Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial.

Authors:  Mitsue Saito; Kenjiro Aogi; Ikuo Sekine; Hirohisa Yoshizawa; Yasuhiro Yanagita; Hiroshi Sakai; Kenichi Inoue; Chiyoe Kitagawa; Takashi Ogura; Shoichi Mitsuhashi
Journal:  Lancet Oncol       Date:  2009-01-08       Impact factor: 41.316

9.  Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment.

Authors:  H J Schmoll; M S Aapro; S Poli-Bigelli; H-K Kim; K Park; K Jordan; J von Pawel; H Giezek; T Ahmed; C Y Chan
Journal:  Ann Oncol       Date:  2006-03-08       Impact factor: 32.976

10.  The efficacy of triplet antiemetic therapy with 0.75 mg of palonosetron for chemotherapy-induced nausea and vomiting in lung cancer patients receiving highly emetogenic chemotherapy.

Authors:  Satoru Miura; Satoshi Watanabe; Kazuhiro Sato; Masato Makino; Osamu Kobayashi; Hiromi Miyao; Akira Iwashima; Masaaki Okajima; Junta Tanaka; Hiroshi Tanaka; Hiroshi Kagamu; Akira Yokoyama; Ichiei Narita; Hirohisa Yoshizawa
Journal:  Support Care Cancer       Date:  2013-05-05       Impact factor: 3.603

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  8 in total

1.  Efficacy and safety of olanzapine combined with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy in gynecological cancer: KCOG-G1301 phase II trial.

Authors:  Masakazu Abe; Yasuyuki Hirashima; Yuka Kasamatsu; Nobuhiro Kado; Satomi Komeda; Shiho Kuji; Aki Tanaka; Nobutaka Takahashi; Munetaka Takekuma; Hanako Hihara; Yoshikazu Ichikawa; Yui Itonaga; Tomoko Hirakawa; Kaei Nasu; Kanoko Miyagi; Junko Murakami; Kimihiko Ito
Journal:  Support Care Cancer       Date:  2015-07-01       Impact factor: 3.603

Review 2.  Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis.

Authors:  Vanessa Piechotta; Anne Adams; Madhuri Haque; Benjamin Scheckel; Nina Kreuzberger; Ina Monsef; Karin Jordan; Kathrin Kuhr; Nicole Skoetz
Journal:  Cochrane Database Syst Rev       Date:  2021-11-16

3.  Efficacy of Olanzapine Combined Therapy for Patients Receiving Highly Emetogenic Chemotherapy Resistant to Standard Antiemetic Therapy.

Authors:  Masakazu Abe; Yuka Kasamatsu; Nobuhiro Kado; Shiho Kuji; Aki Tanaka; Nobutaka Takahashi; Munetaka Takekuma; Yasuyuki Hirashima
Journal:  Biomed Res Int       Date:  2015-09-03       Impact factor: 3.411

4.  Comparative evaluation of triplet antiemetic schedule versus doublet antiemetic schedule in chemotherapy-induced emesis in head and neck cancer patients.

Authors:  Pulkit Kaushal; Rajeev Atri; Abhishek Soni; Vivek Kaushal
Journal:  Ecancermedicalscience       Date:  2015-08-25

5.  Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens.

Authors:  Sachin Hingmire; Nirmal Raut
Journal:  South Asian J Cancer       Date:  2015 Jan-Mar

6.  Combination of palonosetron, aprepitant, and dexamethasone as primary antiemetic prophylaxis for cisplatin-based chemotherapy.

Authors:  Chan-Keng Yang; Chiao-En Wu; Chuang-Chi Liaw
Journal:  Biomed J       Date:  2016-03-29       Impact factor: 4.910

7.  Evaluation of the efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with gastric cancer treated with S-1 plus cisplatin.

Authors:  Katsunobu Oyama; Sachio Fushida; Masahide Kaji; Toshiya Takeda; Kazuhisa Yabushita; Hideaki Nezuka; Shinichi Kinami; Naotaka Kadoya; Yuki Takai; Yuji Tsukioka; Shigekazu Ohyama; Kunihiro Tsuji; Tomoya Tsukada; Jun Kinoshita; Takashi Fujimura; Tetsuo Ohta
Journal:  Int J Clin Oncol       Date:  2015-10-27       Impact factor: 3.402

Review 8.  Recent advances in antiemetics: new formulations of 5HT3-receptor antagonists.

Authors:  James Gilmore; Steven D'Amato; Niesha Griffith; Lee Schwartzberg
Journal:  Cancer Manag Res       Date:  2018-07-03       Impact factor: 3.989

  8 in total

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