Evidence map›Paper›PMID 27557833›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2017

Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy.

Martin Chasen, Laszlo Urban, Ian Schnadig, Bernardo Rapoport, Dan Powers, Sujata Arora, Rudolph Navari, Lee Schwartzberg, Cesare Gridelli

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. 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 · 2018
    Article
  5. Review
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Martin ChasenPalliative Care, William Osler Health Services, 2100 Bovaird Drive East, Brampton, ON, L6R 3J7, Canada. martin.chasen@williamoslerhs.ca.
Laszlo UrbanMatrahaza University Hospital, Mátraháza, Kékestető, 3233, Hungary.
Ian SchnadigCompass Oncology, US Oncology Research, Tualatin Office II, 12960 SW 65th Ave Ste. 435, Tualatin, OR, 97062, USA.
Bernardo RapoportMedical Oncology Center of Rosebank, 129 Oxford Rd, Corner Northwold, Saxonwold, Johannesburg, 2196, South Africa.
Dan PowersTESARO, Inc, 1000 Winter St North, Suite 3300, Waltham, MA, 02451, USA.
Sujata AroraTESARO, Inc, 1000 Winter St North, Suite 3300, Waltham, MA, 02451, USA.
Rudolph NavariIndiana University School of Medicine-South Bend, 202 Lincolnway East, Suite #105, Mishawaka, IN, 46544, USA.
Lee SchwartzbergWest Clinic, Memphis, TN, 38120, USA.
Cesare GridelliDivision of Medical Oncology, San Giuseppe Moscati Hospital, Condtrada Amoretta, 8, Avellino, 83100, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAddition of rolapitant to standard antiemetic therapy improved protection against chemotherapy-induced nausea and vomiting (CINV) in phase 3 trials of patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Here, we assessed the impact of CINV on the daily lives of patients receiving HEC or MEC using the Functional Living Index-Emesis (FLIE).

methodsIn three double-blind phase 3 studies, patients receiving HEC or MEC were randomized 1:1 to receive oral rolapitant 180 mg or placebo prior to chemotherapy plus 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone therapy. Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included FLIE total score, nausea and vomiting domain scores, and the proportion of patients with no impact on daily life (total score >108 [range 18-126]). We performed a prespecified analysis of the MEC/anthracycline-cyclophosphamide (AC) study and a post hoc analysis of two pooled cisplatin-based HEC studies.

resultsIn the pooled HEC studies, rolapitant significantly improved the FLIE total score (114.5 vs 109.3, p < 0.001), nausea score (55.3 vs 53.5, p < 0.05), and vomiting score (59.2 vs 55.8, p < 0.001) versus control; similar results were observed in the MEC/AC study for FLIE total score (112.7 vs 108.6, p < 0.001), nausea score (54.1 vs 52.3, p < 0.05), and vomiting score (58.6 vs 56.3, p < 0.001). A higher proportion of patients reported no impact on daily life with rolapitant than with control in the MEC/AC study (73.2 vs 67.4, p = 0.027).

conclusionsCompared with control, rolapitant improved quality of life in patients receiving HEC or MEC.

Indexed as

AdultAgedAged, 80 and overAnthracyclinesAntiemeticsAntineoplastic Combined Chemotherapy ProtocolsCisplatinCyclophosphamideDexamethasoneDouble-Blind MethodFemaleHumansMaleMiddle AgedNauseaNeoplasmsAnthracyclinesAntiemeticsCisplatinCyclophosphamideDexamethasoneNeurokinin-1 Receptor AntagonistsrolapitantSpiro CompoundsAntiemeticChemotherapy-induced nausea and vomiting (CINV)Functional Living Index-EmesisNeurokinin-1 receptor antagonistQuality of lifeRolapitant

Identifiers

PMID27557833
PMCPMC5127871

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.