Hypersensitivity Reaction to Paclitaxel: A Retrospective Analysis on the Non-Inferiority of Oral Famotidine to Intravenous Ranitidine in Premedication Regimen
Bibliographic record
Abstract
Abstract Background: Previous studies have only evaluated intravenous histamine H2 receptor antagonists for use as paclitaxel premedication. This study aims to investigate whether oral famotidine is non-inferior to intravenous ranitidine as a premedication to prevent paclitaxel-associated hypersensitivity reactions. It could provide guidance on the use of alternative orally administered agents.Methods: It is a retrospective, multi-center, non-inferiority, historical control cohort study. Paclitaxel-naïve adult patients who began treatment with paclitaxel between August 2018 and December 2020, and received all cycles of paclitaxel in seven tertiary public hospitals in Hong Kong were enrolled. The patients received either intravenous ranitidine (control group) or oral famotidine (study group) as the premedication on the day of paclitaxel infusion. The primary outcome was the occurrence of a paclitaxel-induced hypersensitivity reaction of any severity during any cycle. The proportion of patients with the primary outcome in each group were compared by the two-proportion Z-test. The non-inferiority margin was pre-defined as an absolute hypersensitivity reaction rate difference of 5%.Results: We enrolled 1282 paclitaxel-naïve adult patients. Patients in both control (n = 635) and study (n = 647) groups had a median age of 59 years, and 476 (75%) and 485 (75%) were females, respectively. A median of five cycles of paclitaxel were administered in both groups. Hypersensitivity reactions occurred in 121 (19%) patients in study group, and 105 (17%) patients in control group (difference: +2.2%; 95% confidence interval [CI]: -2.02% to +6.35%; non-inferiority one-sided p = 0.092). A subgroup analysis of patients receiving standard-dose steroid premedication demonstrated a hypersensitivity reaction rate difference of +0.4% (95% CI: -3.97% to +4.83%, non-inferiority one-sided p = 0.021).Conclusions: We found no statistically significant differences in the hypersensitivity reaction rates between intravenous ranitidine and oral famotidine. Oral famotidine was not found to be non-inferior to intravenous ranitidine as a paclitaxel premedication based on the pre-defined non-inferiority margin. The use of oral famotidine with standard-dose steroid as premedication may provide better protection against hypersensitivity reactions.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".