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2016 ; 11
(5
): e0154895
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
A Case-Control Study Brings to Light the Causes of Screen Failures in Phase 1
Cancer Clinical Trials
#MMPMID27149667
Kempf E
; Lemoine N
; Tergemina-Clain G
; Turpin A
; Postel-Vinay S
; Lanoy E
; Soria JC
; Massard C
; Hollebecque A
PLoS One
2016[]; 11
(5
): e0154895
PMID27149667
show ga
INTRODUCTION: Enrolling cancer patients in phase I clinical trials (P1s) requires
that they fulfill specific criteria. Between the time they sign the consent form
and the 1st administration of the experimental drug, some patients may be
excluded and considered as screen failures (SFs). Our objective was to assess SF
patients profiles and the reasons and risk factors for SFs. MATERIALS AND
METHODS: All patients included in P1s at Gustave Roussy from 2008 to 2013 were
reviewed retrospectively. SFs were matched with control P1 patients who were
successfully enrolled. Patient and tumor characteristics, P1 types and the
reasons for SF were analyzed. RESULTS: Among 1,293 patients, 192 (15%) were SF
cases; 182 SF cases were matched with 182 controls: median age was 57 (48-64) and
55 (47-63), median home-cancer center distance was 69 vs 55 km, 45% vs 34% had
more than 2 metastatic sites, median screening period was 14 vs 11 days, median
progression-free survival during the previous line was 12 vs 14 weeks, 37% vs 29%
of LDH values were above the upper limit of normal, 42% vs 36% of albumin values
were < 35 g/L, respectively. Reasons for SFs were cancer progression (44%),
sponsor decision unrelated to a clinical reason (25%), patient retrieval (13.5%),
relevant comorbidity (13.5%). Multivariate analysis revealed that a high Royal
Marsden Hospital (RMH) prognostic score was potentially associated with higher
risk of SFs (OR = 2.3; 95% CI [1.0-5.7], p = 0.06). CONCLUSION: Cancer
progression led to half of the SFs in P1s. Physicians should pay attention to the
RMH score at the time of patient inclusion to avoid further SFs.
|Antineoplastic Agents/therapeutic use
[MESH]
|Case-Control Studies
[MESH]
|Clinical Trials, Phase I as Topic/*methods
[MESH]
free
free
free
