What is the clinical evidence from this study?

Study design: RCT. Population: Breast cancer receiving FAC or FEC chemotherapy (n=75). Intervention: Ondansetron vs. Metoclopramide. Primary outcome: Complete or major control (zero to two emetic episodes) of emesis in the first 24 hours (p=<.001).

What does this research mean for the field?

Ondansetron is significantly more effective than metoclopramide in preventing emesis induced by cyclophosphamide-based chemotherapy, achieving complete or major control in 86% of patients compared to 42% in the first 24 hours. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

June 1, 1990Journal of Clinical Oncology

A randomized double-blind comparison of ondansetron and metoclopramide in the prophylaxis of emesis induced by cyclophosphamide, fluorouracil, and doxorubicin or epirubicin chemotherapy.

Q: What are the key findings of this study?

Ondansetron achieved complete or major control of emesis in 86% of patients compared to 42% with metoclopramide in the first 24 hours (P<.001).

Q: What does this research mean for the field?

Ondansetron is significantly more effective than metoclopramide in preventing emesis induced by cyclophosphamide-based chemotherapy, achieving complete or major control in 86% of patients compared to 42% in the first 24 hours. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

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Key result

Ondansetron achieved complete or major control of emesis in 86% of patients compared to 42% with metoclopramide in the first 24 hours (P<.001).

Why the study?

Does ondansetron improve control of chemotherapy-induced emesis compared to metoclopramide in breast cancer patients?

Study Design

Type

RCT (n=75)

Blinding

Double-blind

Randomization

Randomized

Structured PICO

Does ondansetron improve control of chemotherapy-induced emesis compared to metoclopramide in breast cancer patients?

Population

75 breast cancer patients scheduled to receive a first course (in a new cycle) of cyclophosphamide, fluorouracil, and doxorubicin (FAC) or epirubicin (FEC) chemotherapy.

Intervention

Ondansetron 8 mg loading dose (4 mg IV plus 4 mg orally) before chemotherapy followed by 8 mg every 8 hours orally for 3 to 5 days.

Comparator

Metoclopramide 80 mg loading dose (60 mg IV plus 20 mg orally) before chemotherapy followed by 20 mg every 8 hours orally for 3 to 5 days.

Outcome

Emetic response in the first 24 hours (complete or major control, defined as zero to two emetic episodes).patient reported

Main Result

Absolute Event Rate: 86% vs 42%

p-value: p=<.001

Ondansetron is significantly more effective than metoclopramide in preventing acute emesis and nausea induced by cyclophosphamide-based chemotherapy in breast cancer patients.

Discussion

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Implication

Supports ondansetron preference over metoclopramide for acute CINV in breast cancer; confirms consensus on 5-HT3 antagonists.

Cite This Study

Bonneterre et al. (1990) conducted an RCT in Breast cancer receiving FAC or FEC chemotherapy (n=75). Ondansetron vs. Metoclopramide was evaluated on Complete or major control (zero to two emetic episodes) of emesis in the first 24 hours (p=<.001). Ondansetron achieved complete or major control of emesis in 86% of patients compared to 42% with metoclopramide in the first 24 hours (P<.001).

synapsesocial.com/papers/6a16caa3b13aec50ea6b8350 https://doi.org/10.1200/jco.1990.8.6.1063

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A randomized double-blind comparison of ondansetron and metoclopramide in the prophylaxis of emesis induced by cyclophosphamide, fluorouracil, and doxorubicin or epirubicin chemotherapy.

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

A randomized double-blind comparison of ondansetron and metoclopramide in the prophylaxis of emesis induced by cyclophosphamide, fluorouracil, and doxorubicin or epirubicin chemotherapy.

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Also Consider

Also Consider