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)

F. Giuliani, G. Cilenti, I. Nugnes, E. Maiello, M. Di Bisceglie, V. Lorusso, V. Adamo, G. Colucci

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Introduction. Folfox-4 is the standard adjuvant treatment in stage III colon cancer and is also recommended in high-risk stage II colon cancer. Oxaliplatin-based regimens are considered moderately emetogenic therapies. Palonosetron, a new selective inhibitor of 5-HT3 receptors, in combination with dexhametasone showed a high antiemetic activity in pivotal trials enrolling patients treated with moderately or high emetogenic regimens. Considering these data, the GOIM started a multicentre phase II trial aiming to evaluate the activity and safety of palonosetron plus dexhametasone in patients affected by radically resected colorectal cancer and treated with adjuvant folfox-4. Materials and methods. Patients with stage III or high-risk stage II colorectal cancer and receiving folfox-4 as adjuvant treatment entered into the trial. Informed written consent was required. A single pretreatment dose of palonosetron 0.25 mg (intravenous) i.v. followed by dexamethasone 8 mg i.v. was administered. Nausea and vomiting were evaluated on day 1 and over the following 4 d, with a patient diary including vomiting episodes, daily nausea and use of rescue medications. The main end-point of the study was the absence of vomiting in the entire period (5 d) at the first cycle. The absence of moderately or severe nausea and vomiting on days 1-5 was the secondary end-point. Adverse events were evaluated according to the NCI-CTC criteria. Results. Eighty-five patients entered into the study and were all evaluable for activity and safety. The absence of vomiting on the study period (days 1-5) was observed in 82 (96.5%) patients: one patient on the 1st and two on the 2nd day experienced mild vomiting. With respect to the secondary end-point, the complete control during the acute phase was 96.5% while during the late phase was 92%. The complete responses during the acute and delayed phases were 99% and 89.5%, respectively. The main side-effects (G1 grade) were: constipation 13%, headache 10%, vertigo and insomnia 2%. Conclusions. Palonosetron is a very active antiemetic drug for the prevention of nausea and vomiting induced by folfox-4 regimen.

Original languageEnglish
Pages (from-to)102-106
Number of pages5
JournalEuropean Journal of Cancer, Supplement
Volume6
Issue number14
DOIs
Publication statusPublished - Oct 2008

Fingerprint

Nausea
Vomiting
Colorectal Neoplasms
oxaliplatin
Antiemetics
Colonic Neoplasms
Safety
Receptors, Serotonin, 5-HT3
Vertigo
Sleep Initiation and Maintenance Disorders
Constipation
Folfox protocol
palonosetron
Informed Consent
Dexamethasone
Headache
Therapeutics

Keywords

  • Antiemetic drugs
  • Palonosetron
  • Supportive care

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

@article{4dc48c523a604531b7b4fda64056d815,
title = "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)",
abstract = "Introduction. Folfox-4 is the standard adjuvant treatment in stage III colon cancer and is also recommended in high-risk stage II colon cancer. Oxaliplatin-based regimens are considered moderately emetogenic therapies. Palonosetron, a new selective inhibitor of 5-HT3 receptors, in combination with dexhametasone showed a high antiemetic activity in pivotal trials enrolling patients treated with moderately or high emetogenic regimens. Considering these data, the GOIM started a multicentre phase II trial aiming to evaluate the activity and safety of palonosetron plus dexhametasone in patients affected by radically resected colorectal cancer and treated with adjuvant folfox-4. Materials and methods. Patients with stage III or high-risk stage II colorectal cancer and receiving folfox-4 as adjuvant treatment entered into the trial. Informed written consent was required. A single pretreatment dose of palonosetron 0.25 mg (intravenous) i.v. followed by dexamethasone 8 mg i.v. was administered. Nausea and vomiting were evaluated on day 1 and over the following 4 d, with a patient diary including vomiting episodes, daily nausea and use of rescue medications. The main end-point of the study was the absence of vomiting in the entire period (5 d) at the first cycle. The absence of moderately or severe nausea and vomiting on days 1-5 was the secondary end-point. Adverse events were evaluated according to the NCI-CTC criteria. Results. Eighty-five patients entered into the study and were all evaluable for activity and safety. The absence of vomiting on the study period (days 1-5) was observed in 82 (96.5{\%}) patients: one patient on the 1st and two on the 2nd day experienced mild vomiting. With respect to the secondary end-point, the complete control during the acute phase was 96.5{\%} while during the late phase was 92{\%}. The complete responses during the acute and delayed phases were 99{\%} and 89.5{\%}, respectively. The main side-effects (G1 grade) were: constipation 13{\%}, headache 10{\%}, vertigo and insomnia 2{\%}. Conclusions. Palonosetron is a very active antiemetic drug for the prevention of nausea and vomiting induced by folfox-4 regimen.",
keywords = "Antiemetic drugs, Palonosetron, Supportive care",
author = "F. Giuliani and G. Cilenti and I. Nugnes and E. Maiello and {Di Bisceglie}, M. and V. Lorusso and V. Adamo and G. Colucci",
year = "2008",
month = "10",
doi = "10.1016/j.ejcsup.2008.06.018",
language = "English",
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pages = "102--106",
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TY - JOUR

T1 - Palonosetron for prevention of acute and delayed nausea and vomiting induced by moderately emetogenic adjuvant folfox-4 regimen in colorectal cancer (CRC) patients

T2 - A phase II study of the Gruppo Oncologico dell' Italia Meridionale (GOIM)

AU - Giuliani, F.

AU - Cilenti, G.

AU - Nugnes, I.

AU - Maiello, E.

AU - Di Bisceglie, M.

AU - Lorusso, V.

AU - Adamo, V.

AU - Colucci, G.

PY - 2008/10

Y1 - 2008/10

N2 - Introduction. Folfox-4 is the standard adjuvant treatment in stage III colon cancer and is also recommended in high-risk stage II colon cancer. Oxaliplatin-based regimens are considered moderately emetogenic therapies. Palonosetron, a new selective inhibitor of 5-HT3 receptors, in combination with dexhametasone showed a high antiemetic activity in pivotal trials enrolling patients treated with moderately or high emetogenic regimens. Considering these data, the GOIM started a multicentre phase II trial aiming to evaluate the activity and safety of palonosetron plus dexhametasone in patients affected by radically resected colorectal cancer and treated with adjuvant folfox-4. Materials and methods. Patients with stage III or high-risk stage II colorectal cancer and receiving folfox-4 as adjuvant treatment entered into the trial. Informed written consent was required. A single pretreatment dose of palonosetron 0.25 mg (intravenous) i.v. followed by dexamethasone 8 mg i.v. was administered. Nausea and vomiting were evaluated on day 1 and over the following 4 d, with a patient diary including vomiting episodes, daily nausea and use of rescue medications. The main end-point of the study was the absence of vomiting in the entire period (5 d) at the first cycle. The absence of moderately or severe nausea and vomiting on days 1-5 was the secondary end-point. Adverse events were evaluated according to the NCI-CTC criteria. Results. Eighty-five patients entered into the study and were all evaluable for activity and safety. The absence of vomiting on the study period (days 1-5) was observed in 82 (96.5%) patients: one patient on the 1st and two on the 2nd day experienced mild vomiting. With respect to the secondary end-point, the complete control during the acute phase was 96.5% while during the late phase was 92%. The complete responses during the acute and delayed phases were 99% and 89.5%, respectively. The main side-effects (G1 grade) were: constipation 13%, headache 10%, vertigo and insomnia 2%. Conclusions. Palonosetron is a very active antiemetic drug for the prevention of nausea and vomiting induced by folfox-4 regimen.

AB - Introduction. Folfox-4 is the standard adjuvant treatment in stage III colon cancer and is also recommended in high-risk stage II colon cancer. Oxaliplatin-based regimens are considered moderately emetogenic therapies. Palonosetron, a new selective inhibitor of 5-HT3 receptors, in combination with dexhametasone showed a high antiemetic activity in pivotal trials enrolling patients treated with moderately or high emetogenic regimens. Considering these data, the GOIM started a multicentre phase II trial aiming to evaluate the activity and safety of palonosetron plus dexhametasone in patients affected by radically resected colorectal cancer and treated with adjuvant folfox-4. Materials and methods. Patients with stage III or high-risk stage II colorectal cancer and receiving folfox-4 as adjuvant treatment entered into the trial. Informed written consent was required. A single pretreatment dose of palonosetron 0.25 mg (intravenous) i.v. followed by dexamethasone 8 mg i.v. was administered. Nausea and vomiting were evaluated on day 1 and over the following 4 d, with a patient diary including vomiting episodes, daily nausea and use of rescue medications. The main end-point of the study was the absence of vomiting in the entire period (5 d) at the first cycle. The absence of moderately or severe nausea and vomiting on days 1-5 was the secondary end-point. Adverse events were evaluated according to the NCI-CTC criteria. Results. Eighty-five patients entered into the study and were all evaluable for activity and safety. The absence of vomiting on the study period (days 1-5) was observed in 82 (96.5%) patients: one patient on the 1st and two on the 2nd day experienced mild vomiting. With respect to the secondary end-point, the complete control during the acute phase was 96.5% while during the late phase was 92%. The complete responses during the acute and delayed phases were 99% and 89.5%, respectively. The main side-effects (G1 grade) were: constipation 13%, headache 10%, vertigo and insomnia 2%. Conclusions. Palonosetron is a very active antiemetic drug for the prevention of nausea and vomiting induced by folfox-4 regimen.

KW - Antiemetic drugs

KW - Palonosetron

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