Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2015
Comparison of an extended-release formulation of granisetron (APF530) versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: results of a prospective, randomized, double-blind, noninferiority phase 3 trial.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis.The Cochrane database of systematic reviews · 2021Pooled it
- Effectiveness of palonosetron versus granisetron in preventing chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis.European journal of clinical pharmacology · 2021Pooled it
- Should palonosetron be a preferred 5-HTSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Pooled it
- 2016 Updated MASCC/ESMO Consensus Recommendations: Prevention of Nausea and Vomiting Following High Emetic Risk Chemotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017Pooled it
- Trial
- Global inequitable distribution of seminal studies of chemotherapy-induced nausea and vomiting.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Review
- A case-control study on the clinical characteristics of granisetron-related arrhythmias and the development of a predictive nomogram.International journal of clinical pharmacy · 2024Article
- Prevention of Chemotherapy-Induced Nausea and Vomiting in the Older Patient: Optimizing Outcomes.Drugs & aging · 2022Review
- Granisetron Extended-Release Subcutaneous Injection versus Palonosetron Infusion for CINV Prevention: Cost Comparison of Unscheduled Hydration.American health & drug benefits · 2021Article
- Granisetron Extended-Release Subcutaneous Injection versus Palonosetron Infusion for CINV Prevention: Cost Comparison of Unscheduled Hydration.American health & drug benefits · 2021Article
- [Chemotherapy-induced nausea and vomiting : Current recommendations for prophylaxis].Der Urologe. Ausg. A · 2018Review
- Getting it right the first time: recent progress in optimizing antiemetic usage.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Article
- Recent advances in antiemetics: new formulations of 5HTCancer management and research · 2018Review
- APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide-based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial.Cancer management and research · 2017Article
- Differential clinical pharmacology of rolapitant in delayed chemotherapy-induced nausea and vomiting (CINV).Drug design, development and therapy · 2017Review
- Granisetron Extended-Release Injection: A Review in Chemotherapy-Induced Nausea and Vomiting.Drugs · 2016Review
- Pharmacokinetics, safety, and efficacy of APF530 (extended-release granisetron) in patients receiving moderately or highly emetogenic chemotherapy: results of two Phase II trials.Cancer management and research · 2015Article
- Biochronomer™ technology and the development of APF530, a sustained release formulation of granisetron.Journal of experimental pharmacology · 2014Article
Corrections and comments
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Authors and funding
6 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeSubcutaneous APF530 provides controlled sustained release of granisetron to prevent acute (0-24 h) and delayed (24-120 h) chemotherapy-induced nausea and vomiting (CINV). This randomized, double-blind phase 3 trial compared APF530 and palonosetron in preventing acute and delayed CINV after moderately (MEC) or highly emetogenic chemotherapy (HEC).
methodsPatients receiving single-day MEC or HEC received single-dose APF530 250 or 500 mg subcutaneously (SC) (granisetron 5 or 10 mg) or intravenous palonosetron 0.25 mg. Primary objectives were to establish APF530 noninferiority to palonosetron for preventing acute CINV following MEC or HEC and delayed CINV following MEC and to determine APF530 superiority to palonosetron for preventing delayed CINV following HEC. The primary efficacy end point was complete response (CR [using CI difference for APF530-palonosetron]). A lower confidence bound greater than -15 % indicated noninferiority.
resultsIn the modified intent-to-treat population (MEC = 634; HEC = 707), both APF530 doses were noninferior to palonosetron in preventing acute CINV after MEC (CRs 74.8 % [-9.8, 9.3] and 76.9 % [-7.5, 11.4], respectively, vs. 75.0 % palonosetron) and after HEC (CRs 77.7 % [-11.5, 5.5] and 81.3 % [-7.7, 8.7], respectively, vs. 80.7 % palonosetron). APF530 500 mg was noninferior to palonosetron in preventing delayed CINV after MEC (CR 58.5 % [-9.5, 12.1] vs. 57.2 % palonosetron) but not superior in preventing delayed CINV after HEC. Adverse events were generally mild and unrelated to treatment, the most common (excluding injection-site reactions) being constipation.
conclusionsA single subcutaneous APF530 injection offers a convenient alternative to palonosetron for preventing acute and delayed CINV after MEC or HEC.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.