Evidence map›Paper›PMID 20354522›Full record

Trial reportBritish journal of cancer2010

Megestrol acetate versus metronomic cyclophosphamide in patients having exhausted all effective therapies under standard care.

N Penel, S Clisant, E Dansin, C Desauw, M Dégardin, L Mortier, M Vanhuyse, F Bonodeau, C Fournier, J-L Cazin and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
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

13 citing papers in PubMed, 24 citations in OpenAlex.

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  13. Immunological effects of low-dose cyclophosphamide in cancer patients treated with oncolytic adenovirus.Molecular therapy : the journal of the American Society of Gene Therapy · 2011
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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

11 authors at 2 institutions in 1 country.

N PenelCentre Oscar Lambret, Lille, France. n-penel@o-lambret.fr
S Clisant
E Dansin
C Desauw
M Dégardin
L Mortier
M Vanhuyse
F Bonodeau
C Fournier
J-L Cazin
A Adenis
Centre Oscar Lambret · FRHôpital Saint-Vincent-de-Paul · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the antitumour activity and safety of metronomic cyclophosphamide vs megestrol acetate in progressive and advanced cancer patients having exhausted all effective therapies under standard care.

methodsPatients were randomly assigned to receive orally metronomic cyclophosphamide (50 mg b.i.d) or megestrol acetate (160 mg only daily) until intolerance or progression (RECIST 1.0). The primary efficacy end point was a 2-month progression-free rate (PFR(2m)). According to Optimal Simon's design and the following assumptions, namely, P0=5%, P1=20%, alpha=beta=10%, the treatment is considered as effective if atleast 5 out of 44 patients achieved PFR(2m).

resultsBetween September 2006 and January 2009, 88 patients were enrolled. Two patients experienced grade 3-4 toxicities in each arm (4%). One toxic death occurred in the megestrol acetate arm as a consequence of thrombosis. The metronomic cyclophosphamide arm reached the predefined level of efficacy with a PFR(2m) rate of 9 out of 44 and a PFR(4m) rate of 5 out of 44. The MA arm failed to achieve the level of efficacy with a PFR(2m) of 4 out of 44 and a PFR(4m) of 1 out of 44. The median overall survival was 195 and 144 days in the metronomic cyclophosphamide arm and megestrol acetate arm, respectively.

conclusionMetronomic cyclophosphamide is well tolerated and provides stable disease in such vulnerable and poor-prognosis cancer patients. This regimen warrants further evaluations.

Indexed as

AgedAntineoplastic Agents, AlkylatingAntineoplastic Agents, HormonalCyclophosphamideDisease-Free SurvivalDisease ProgressionDrug Administration ScheduleDrug EvaluationFemaleHumansMaleMegestrol AcetateMiddle AgedNeoplasmsPalliative CareAntineoplastic Agents, AlkylatingAntineoplastic Agents, HormonalCyclophosphamideMegestrol Acetate

Identifiers

PMID20354522
PMCPMC2856003
OpenAlexW2038544543

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.