Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study

Kovács, Gábor; Wachtel, Antonio; Basharova, E.; Spinelli, Tulla; Pierre, Nicolas; Kabíčková, Edita

doi:10.1016/s1470-2045(15)00520-3

Cited by 42 publications

(69 citation statements)

References 34 publications

(33 reference statements)

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“…The study design has been detailed previously [17]. Briefly, eligible patients were aged from newborn (full term; ≥37 weeks) to <17 years old, naive or non-naive to chemotherapy, scheduled to undergo MEC or HEC on day 1 for histologically/cytologically confirmed malignant disease.…”

Section: • Study Design and Patientsmentioning

confidence: 99%

“…In the diary, every episode of retching and vomiting, as well as any rescue drug given, was to be entered [17]. Nausea was assessed by a yes/no question in the electronic case report form.…”

Section: • Outcomesmentioning

confidence: 99%

“…Safety during cycles 1-4 was assessed on adverse events, physical examinations, vital signs, laboratory assessments and 12-lead electrocardiograms (recorded in triplicate at screening and between days 7 and 10 of each cycle) as detailed previously [17]. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 14.0.…”

Section: • Outcomesmentioning

confidence: 99%

“…Statistical analyses for the primary outcome measure have been described previously in detail (supplementary Methods) [17]. The full analysis set (FAS) included all randomized patients receiving the active study drug and HEC or MEC.…”

Section: • Statistical Analysismentioning

confidence: 99%

“…We have evaluated the efficacy and safety of two palonosetron doses (10 and 20 μg/kg) compared with ondansetron (3 × 150 μg/kg) over four cycles, for the prevention of CINV in 493 pediatric cancer patients scheduled to receive HEC or MEC [17]. The primary end point was complete response (CR) during the acute phase of the first on-study chemotherapy cycle.…”

mentioning

confidence: 99%

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Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study

et al. 2017

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aim:To investigate across multiple cycles the efficacy and safety of palonosetron in the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients receiving highly or moderately emetogenic chemotherapy (HEC/MEC). Patients & methods: Patients were randomly assigned to 10, 20 μg/kg palonosetron or 3 × 150 μg/kg ondansetron for up to four cycles of HEC/MEC. Results: In all on-study chemotherapy cycles, complete response rates were higher in patients in the 20 μg/kg palonosetron group than the ondansetron group. Treatment-emergent adverse events were comparable between the palonosetron 20 μg/kg and ondansetron groups. conclusion: Over four cycles of HEC/ MEC, 20 μg/kg palonosetron was an efficacious and safe treatment for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients. Chemotherapy-induced nausea and vomiting (CINV) are common and distressing side effects in cancer patients receiving highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC) regimens [1,2]. CINV negatively impacts on patient quality of life [3], and can lead to medical complications and to noncompliance or premature discontinuation of anticancer therapy [4]. It is recognized that children receiving chemotherapy are more prone to vomiting than adults, and it is estimated that 70% of pediatric cancer patients receiving chemotherapy will develop CINV [2].Prevention of CINV in adult cancer patients receiving HEC or MEC regimens can be achieved through the use of antiemetic agents, a combination of a 5-hydroxytryptamine-3 (5-HT 3 ) receptor antagonist, a corticosteroid and a neurokinin-1 (NK 1 ) receptor antagonist is recommended [5][6][7]. While fewer studies of these agents have been performed in pediatric cancer patients than in adults, at the time of the study design, the combination of a 5-HT 3 receptor antagonist with a corticosteroid was recommended for pediatric patients receiving HEC or MEC chemotherapy regimens [2,5,6]. In later guidance from the Pediatric Oncology Group of Ontario (POGO), children scheduled to receive HEC are recommended to receive antiemetic prophylactic therapy of ondansetron or granisetron plus dexamethasone and aprepitant (≥12 years of age and receiving antineoplastic drugs not known to interact with aprepitant) or ondansetron or granisetron plus dexamethasone (<12 years of For reprint orders, please contact: reprints@futuremedicine.com

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Section: • Study Design and Patientsmentioning

confidence: 99%

Section: • Outcomesmentioning

confidence: 99%

Section: • Outcomesmentioning

confidence: 99%

Section: • Statistical Analysismentioning

confidence: 99%

mentioning

confidence: 99%

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Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study

et al. 2017

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Site‐Selective C−H Arylation of Diverse Arenes Ortho to Small Alkyl Groups

et al. 2022

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Catalytic systems for direct C−H activation of arenes commonly show preference for electronically activated and sterically exposed C−H sites. Here we show that a range of functionally rich and pharmaceutically relevant arene classes can undergo site‐selective C−H arylation ortho to small alkyl substituents, preferably endocyclic methylene groups. The C−H activation is experimentally supported as being the selectivity‐determining step, while computational studies of the transition state models indicate the relevance of non‐covalent interactions between the catalyst and the methylene group of the substrate. Our results suggest that preference for C(sp2)−H activation next to alkyl groups could be a general selectivity mode, distinct from common steric and electronic factors.

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Site‐Selective C−H Arylation of Diverse Arenes Ortho to Small Alkyl Groups

et al. 2022

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Catalytic systems for direct CÀ H activation of arenes commonly show preference for electronically activated and sterically exposed CÀ H sites. Here we show that a range of functionally rich and pharmaceutically relevant arene classes can undergo site-selective CÀ H arylation ortho to small alkyl substituents, preferably endocyclic methylene groups. The CÀ H activation is experimentally supported as being the selectivitydetermining step, while computational studies of the transition state models indicate the relevance of noncovalent interactions between the catalyst and the methylene group of the substrate. Our results suggest that preference for C(sp 2 )À H activation next to alkyl groups could be a general selectivity mode, distinct from common steric and electronic factors.

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Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study

Abstract: SummaryBackground Palonosetron has demonstrated efficacy in the prevention of chemotherapy-

Cited by 42 publications

References 34 publications

Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study

Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study

Site‐Selective C−H Arylation of Diverse Arenes Ortho to Small Alkyl Groups

Site‐Selective C−H Arylation of Diverse Arenes Ortho to Small Alkyl Groups

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