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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 J+Immunother+Cancer
2017 ; 5
(1
): 72
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Durable response rate as an endpoint in cancer immunotherapy: insights from
oncolytic virus clinical trials
#MMPMID28923101
Kaufman HL
; Andtbacka RHI
; Collichio FA
; Wolf M
; Zhao Z
; Shilkrut M
; Puzanov I
; Ross M
J Immunother Cancer
2017[Sep]; 5
(1
): 72
PMID28923101
show ga
BACKGROUND: Traditional response criteria may be insufficient to characterize
full clinical benefits of anticancer immunotherapies. Consequently, endpoints
such as durable response rate (DRR; a continuous response [complete or partial
objective response] beginning within 12 months of treatment and lasting
?6 months) have been employed. There has not, however, been validation that DRR
correlates with other more traditional endpoints of clinical benefit such as
overall survival. METHODS: We evaluated whether DRR was associated with
clinically meaningful measures of benefit (eg, overall survival [OS], quality of
life [QoL], or treatment-free interval [TFI]) in a phase 3 clinical trial of an
oncolytic virus for melanoma treatment. To evaluate the association between DRR
and OS and to mitigate lead time bias, landmark analyses were used. QoL was
evaluated using the FACT-BRM questionnaire (comprising the FACT-BRM Physical,
Social/Family, Emotional, and Functional well-being domains, the Additional
Concerns, Physical and Mental treatment-specific subscales, and the Trial Outcome
Index [TOI]). TFI was defined as time from the last study therapy dose to first
subsequent therapy dose (including any systemic anticancer therapy for melanoma
after study therapy discontinuation). RESULTS: Four hundred thirty-six patients
were included in the intent-to-treat population. Achieving DR was associated with
a statistically significant improvement in OS in a landmark analysis at 9 months
(HR?=?0.07; P?=?0.0003), 12 months (HR?=?0.05, P < 0.0001), and 18 months
(HR?=?0.11; P?=?0.0002) that persisted after adjusting for disease stage and line
of therapy. Achieving a DR was associated with a longer median TFI (HR?=?0.33;
P?=?0.0007) and a higher TOI improvement rate (58.1% versus 30.0%; P?=?0.025).
CONCLUSIONS: Achieving a DR was associated with clinical benefits such as
improved OS and QoL and prolonged TFI, thus supporting the usefulness of DR as a
meaningful immunotherapy clinical trial endpoint. TRIAL REGISTRATION:
ClinicalTrials.gov identifier, NCT00769704 (
https://clinicaltrials.gov/ct2/show/NCT00769704 ) October 7, 2008.
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