Antiemetic therapy during GEM/CDDP
Editorial Comment Editorial Comment to Palonosetron with aprepitant plus dexamethasone to prevent chemotherapy-induced nausea and vomiting during gemcitabine/cisplatin in urothelial cancer patients As reported by the principal international guidelines, administration of palonosetron, a second-generation 5-HT3 receptor antagonist (5-HT3RA), aprepitant and dexamethasone represents one of the standard options in preventing nausea and vomiting associated with highly emetogenic chemotherapy (HEC). The study of Kitamura et al. confirmed that this triple therapy might offer a better antiemetic control than the combination of first-generation 5-HT3RA and dexamethasone.1 Although such data arose from a retrospective analysis, the group of patients (cohort 2) treated with triple therapy experienced significantly higher rates of complete response, defined as no emetic episodes and no need for use of rescue medications, than patients included in cohort 1 treated with first-generation 5-HT3RA plus dexamethasone (85.7% vs 65.3% in the first cycle, 78.7% vs 50.7% in all cycles, respectively). It should be underlined that in the group of patients treated with the triple therapy, palonosetron has been used at dose of 0.75 mg i.v.: this dosage was approved in Japan since two Japanese phase II trials showed a substantial dose–response relationship; whereas in the USA and EU, palonosetron is administered for chemotherapy-induced nausea and vomiting (CINV) induced by HEC at a dosage of 0.25 mg i.v.2,3 In a recent article by Miura et al., the combination of aprepitant and dexamethasone plus palonosetron 0.75 mg showed promising emetic control (complete response rates overall, acute, and delayed phases of 81%, 96.8% and 81%, respectively) with a satisfactory profile of tolerability in lung cancer patients receiving HEC.4 Similar efficacy data emerged in the study of Kitamura. As correctly stated by the authors, Kitamura’s study presents some limitations: retrospective data, limited population, lack of patients’ self-assessment of CINV. Nevertheless, Kitamura and colleagues should be congratulated, because they provided interesting data in terms of CINV prevention using the three-drug regimen of palonosetron 0.75 mg plus aprepitant and dexamethasone in a homogeneous group of chemonaive patients with urothelial carcinoma treated with the same chemotherapeutic regimen (cisplatin/gemcitabine): to date, indeed, no data exist about CINV prevention in this specific group of patients treated with HEC. In 2008, an Italian study evaluated the antiemetic efficacy of palonosetron plus dexamethasone in a homogeneous group
© 2015 The Japanese Urological Association
of chemonaive colorectal patients treated with adjuvant folfox-4 regimen: in this specific population, this phase II trial provided useful data that can be easily translated in daily clinical practice.5 Despite some methodological limitations previously cited, results emerging from the present study seem to be interesting in chemonaive patients with urothelial carcinoma treated with cisplatin plus gemcitabine: such promising data in CINV prevention with a three-drug regimen of aprepitant and dexamethasone plus palonosetron 0.75 mg should be confirmed in a prospective study carried out in this specific group of patients. Antonio Rozzi M.D. and Gaetano Lanzetta M.D. Medical Oncology Unit, Istituto Neurotraumatologico Italiano (I.N.I.), Rome, Italy [email protected] DOI: 10.1111/iju.12870
Conflict of interest None declared.
References 1 Kitamura H, Takahashi A, Hotta H et al. Palonosetron with aprepitant plus dexamethasone to prevent chemotherapy-induced nausea and vomiting during gemcitabine/cisplatin in urothelial cancer patients. Int. J. Urol. 2015; 22: 911–4. 2 Segawa Y, Aogi K, Inoue K et al. A phase II dose-ranging study of palonosetron in Japanese patients receiving moderately emetogenic chemotherapy, including anthracycline and cyclophosphamide-based chemotherapy. Ann. Oncol. 2009; 20: 1874–80. 3 Maemondo M, Masuda N, Sekine I et al. A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. Ann. Oncol. 2009; 20: 1860–6. 4 Miura S, Watanabe S, Sato K et al. The efficacy of triplet antiemtic therapy with 0.75 mg of palonosetron for chemotherapy-induced nausea and vomiting in lung cancer patients receiving highly emetogenic chemotherapy. Support. Care Cancer 2013; 21: 2575–81. 5 Giuliani F, Cilenti G, Nugnes I et al. Palonosetron for prevention of acute and delayed nausea and vomiting induced by moderately emetogenic adjuvant folfox-4 regimen in colorectal cancer (CRC) patients: a phase II study of the Gruppo Oncologico dell’Italia Meridionale (GOIM). Eur. J. Cancer Suppl. 2008; 6: 102–6.
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Editorial Comment Editorial Comment to Palonosetron with aprepitant plus dexamethasone to prevent chemotherapy-induced nausea and vomiting during gemcitabine/cisplatin in urothelial cancer patients As reported by the principal international guidelines, administration of palonosetron, a second-generation 5-HT3 receptor antagonist (5-HT3RA), aprepitant and dexamethasone represents one of the standard options in preventing nausea and vomiting associated with highly emetogenic chemotherapy (HEC). The study of Kitamura et al. confirmed that this triple therapy might offer a better antiemetic control than the combination of first-generation 5-HT3RA and dexamethasone.1 Although such data arose from a retrospective analysis, the group of patients (cohort 2) treated with triple therapy experienced significantly higher rates of complete response, defined as no emetic episodes and no need for use of rescue medications, than patients included in cohort 1 treated with first-generation 5-HT3RA plus dexamethasone (85.7% vs 65.3% in the first cycle, 78.7% vs 50.7% in all cycles, respectively). It should be underlined that in the group of patients treated with the triple therapy, palonosetron has been used at dose of 0.75 mg i.v.: this dosage was approved in Japan since two Japanese phase II trials showed a substantial dose–response relationship; whereas in the USA and EU, palonosetron is administered for chemotherapy-induced nausea and vomiting (CINV) induced by HEC at a dosage of 0.25 mg i.v.2,3 In a recent article by Miura et al., the combination of aprepitant and dexamethasone plus palonosetron 0.75 mg showed promising emetic control (complete response rates overall, acute, and delayed phases of 81%, 96.8% and 81%, respectively) with a satisfactory profile of tolerability in lung cancer patients receiving HEC.4 Similar efficacy data emerged in the study of Kitamura. As correctly stated by the authors, Kitamura’s study presents some limitations: retrospective data, limited population, lack of patients’ self-assessment of CINV. Nevertheless, Kitamura and colleagues should be congratulated, because they provided interesting data in terms of CINV prevention using the three-drug regimen of palonosetron 0.75 mg plus aprepitant and dexamethasone in a homogeneous group of chemonaive patients with urothelial carcinoma treated with the same chemotherapeutic regimen (cisplatin/gemcitabine): to date, indeed, no data exist about CINV prevention in this specific group of patients treated with HEC. In 2008, an Italian study evaluated the antiemetic efficacy of palonosetron plus dexamethasone in a homogeneous group
© 2015 The Japanese Urological Association
of chemonaive colorectal patients treated with adjuvant folfox-4 regimen: in this specific population, this phase II trial provided useful data that can be easily translated in daily clinical practice.5 Despite some methodological limitations previously cited, results emerging from the present study seem to be interesting in chemonaive patients with urothelial carcinoma treated with cisplatin plus gemcitabine: such promising data in CINV prevention with a three-drug regimen of aprepitant and dexamethasone plus palonosetron 0.75 mg should be confirmed in a prospective study carried out in this specific group of patients. Antonio Rozzi M.D. and Gaetano Lanzetta M.D. Medical Oncology Unit, Istituto Neurotraumatologico Italiano (I.N.I.), Rome, Italy [email protected] DOI: 10.1111/iju.12870
Conflict of interest None declared.
References 1 Kitamura H, Takahashi A, Hotta H et al. Palonosetron with aprepitant plus dexamethasone to prevent chemotherapy-induced nausea and vomiting during gemcitabine/cisplatin in urothelial cancer patients. Int. J. Urol. 2015; 22: 911–4. 2 Segawa Y, Aogi K, Inoue K et al. A phase II dose-ranging study of palonosetron in Japanese patients receiving moderately emetogenic chemotherapy, including anthracycline and cyclophosphamide-based chemotherapy. Ann. Oncol. 2009; 20: 1874–80. 3 Maemondo M, Masuda N, Sekine I et al. A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. Ann. Oncol. 2009; 20: 1860–6. 4 Miura S, Watanabe S, Sato K et al. The efficacy of triplet antiemtic therapy with 0.75 mg of palonosetron for chemotherapy-induced nausea and vomiting in lung cancer patients receiving highly emetogenic chemotherapy. Support. Care Cancer 2013; 21: 2575–81. 5 Giuliani F, Cilenti G, Nugnes I et al. Palonosetron for prevention of acute and delayed nausea and vomiting induced by moderately emetogenic adjuvant folfox-4 regimen in colorectal cancer (CRC) patients: a phase II study of the Gruppo Oncologico dell’Italia Meridionale (GOIM). Eur. J. Cancer Suppl. 2008; 6: 102–6.
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