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Multicenter, randomized trial of ramosetron plus dexamethasone versus ramosetron alone in controlling cisplatin-induced emesis

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Abstract

Goals

To establish whether the combination of a corticosteroid (dexamethasone) and the newer serotonin-3 (5-HT3) receptor antagonist ramosetron is superior to ramosetron alone in controlling cisplatin-induced emesis.

Patients and methods

A total of 283 patients aged 18–75 years with confirmed malignant disease who were scheduled to receive cisplatin ≥50 mg/m2 with or without other antineoplastic agents were randomized to intravenous treatment with either ramosetron 300 μg plus dexamethasone 20 mg (n=149) or ramosetron 300 μg alone (n=134) given 30 min prior to cisplatin infusion. If vomiting occurred in the following 24 h, patients in both groups received an intravenous rescue dose of ramosetron 300 μg. Subsequently, on days 2 and 3, treatment was continued orally with either ramosetron 100 μg once daily plus dexamethasone 8 mg twice daily, or ramosetron 100 μg once daily.

Main results

During the first 24 h after cisplatin infusion, significantly more patients receiving combination therapy had a complete response (no nausea or vomiting or requirement for rescue therapy) than those receiving ramosetron alone (68% vs 54%, respectively; P=0.034), and significantly fewer patients needed a rescue dose of ramosetron (22% vs 34%, respectively; P=0.032). In addition, the percentages of patients with no nausea and no vomiting were significantly greater in the ramosetron plus dexamethasone group than in the ramosetron-alone group at both 24 h and 72 h after cisplatin administration.

Conclusions

The antiemetic efficacy of ramosetron in cancer patients receiving highly emetogenic cisplatin chemotherapy is significantly enhanced by its use in combination with dexamethasone.

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Acknowledgement

This study was supported by Yamanouchi Pharmaceutical Co., Ltd.

Author information

Authors and Affiliations

  1. Manila Doctors Hospital, T.M. Kalaw Street, Manila, Philippines

    Antonio Villalon

  2. Veterans Memorial Medical Center, Quezon City, Philippines

    Valorie Chan

Authors
  1. Antonio Villalon
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  2. Valorie Chan
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Corresponding author

Correspondence to Antonio Villalon.

Additional information

This work is presented on behalf of the Philippines Nasea Study Group whose members are listed in the Appendix.

Appendix

Appendix

Members of the Philippine Nasea Study Group

University of the Philippines—Philippine General Hospital: Maria Estrella, S. Puddoc-Santos, Jhade Lotus Peneyra, Maria Karla Malanyaon, Marina Chua, Ellie May Villegas, Joel Tayo, Pauline So-Kaw, Noel Pingoy, Emmanuel Glorioso, Ma. Luisa Tiambeng, Marigold Majarucon, Susie Ponce-Lim, Erly Samson, MD; Jose Reyes Memorial Medical Center: Juanita Lu-Lim, Dennis Dulay, Joselito Maano, Myrna Deresas, Eva Borromeo-Daclan; Manila Doctor’s Hospital: Antonio Villalon; Veterans Memorial Medical Center: Valorie Fullon-Chan; St. Luke’s Medical Center: Gloria Cristal-Luna, Roberto Bolinas Jr, Charity Gorospe, Louella Grace Roces; Bulacan Provincial Hospital: Ferdinand Dacumos; Angeles Medical Center: Apolonio Pasion; Mary Johnson Hospital: Jose Garcia Jr; Rizal Medical Center: Divina Esteban; East Avenue Medical Center: Conrad Lola; AFP Medical Center: Edgardo Castro; New Era General Hospital: Leilani Dantes; Jose Lingad Hospital: Ermelinda Batac; Fatima Medical Center: Leo Marbella; Baguio Provincial Hospital: Jasmin Igama; Region I Medical Center: Luisa Ordono; Pangasinan Medical Center: Rosario Pitarque; Perpetual Help Medical Center: Yolanda Gonzales.

Other institutes involved in this study

Quezon Institute, De los Santos Medical Center, Sta. Teresita General Hospital, Specialist Group Hospital, V. Luna Hospital, Victor Potencio Medical Center, Armando Garcia Hospital, Specialist Group Hospital and Trauma Center, Quezon City Medical Center, Philippine Heart Center, JF Cotton Hospital, St Louie University Hospital, and San Fernando Hospital.

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Villalon, A., Chan, V. Multicenter, randomized trial of ramosetron plus dexamethasone versus ramosetron alone in controlling cisplatin-induced emesis. Support Care Cancer 12, 58–63 (2004). https://doi.org/10.1007/s00520-003-0528-7

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  • DOI: https://doi.org/10.1007/s00520-003-0528-7

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