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Trial-level analysis of progression-free survival and response rate as end points of trials of first-line chemotherapy in advanced ovarian cancer.

Abstract Progression-free survival (PFS) has been reported as surrogate end point of overall survival (OS) in trials of advanced ovarian cancer (AOC). However, there is not a trial-level evaluation of surrogacy. The aim of this study is to perform an analysis of randomized trials enrolling patients with AOC receiving a first-line systemic chemotherapy, in order to evaluate the results of PFS, the other intermediate end points and their relationship with OS. A literature search of phase 3 randomized trials was performed by a predefined protocol. For each trial, the differences between arms of the results of OS and of other end points were calculated. These differences were compared by Spearman's rho coefficient to find out the potential correlation between every end point and OS. For the end points with the higher relationships with OS, the proportion of variability explained (R (2)) was calculated by regression analysis. Thirty-eight studies have been included. PFS appears to be the end point more closely related to OS (R (2) = 0.506; p < 0.001), and this correlation is higher among studies published before 2003. ORR is correlated with OS only in the trials published after 2003 (R (2) = 0.344; p 0.027; 14 trials). In conclusion, in more recent trials ORR shows a level of correlation with OS similar to that of PFS. Though PFS should no longer be considered a surrogate end points of OS in trials of patients receiving a first-line chemotherapy for AOC, a prospective evaluation of new response-related end points is strongly recommended.
PMID
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Authors

Mayor MeshTerms
Keywords

Chemotherapy

Ovarian cancer

Overall response rate

Overall survival

Progression-free survival

Journal Title medical oncology (northwood, london, england)
Publication Year Start




PMID- 28391579
OWN - NLM
STAT- MEDLINE
DA  - 20170409
DCOM- 20170419
LR  - 20170419
IS  - 1559-131X (Electronic)
IS  - 1357-0560 (Linking)
VI  - 34
IP  - 5
DP  - 2017 May
TI  - Trial-level analysis of progression-free survival and response rate as end points
      of trials of first-line chemotherapy in advanced ovarian cancer.
PG  - 87
LID - 10.1007/s12032-017-0939-9 [doi]
AB  - Progression-free survival (PFS) has been reported as surrogate end point of
      overall survival (OS) in trials of advanced ovarian cancer (AOC). However, there 
      is not a trial-level evaluation of surrogacy. The aim of this study is to perform
      an analysis of randomized trials enrolling patients with AOC receiving a
      first-line systemic chemotherapy, in order to evaluate the results of PFS, the
      other intermediate end points and their relationship with OS. A literature search
      of phase 3 randomized trials was performed by a predefined protocol. For each
      trial, the differences between arms of the results of OS and of other end points 
      were calculated. These differences were compared by Spearman's rho coefficient to
      find out the potential correlation between every end point and OS. For the end
      points with the higher relationships with OS, the proportion of variability
      explained (R 2) was calculated by regression analysis. Thirty-eight studies have 
      been included. PFS appears to be the end point more closely related to OS (R 2 = 
      0.506; p &lt; 0.001), and this correlation is higher among studies published before 
      2003. ORR is correlated with OS only in the trials published after 2003 (R 2 =
      0.344; p 0.027; 14 trials). In conclusion, in more recent trials ORR shows a
      level of correlation with OS similar to that of PFS. Though PFS should no longer 
      be considered a surrogate end points of OS in trials of patients receiving a
      first-line chemotherapy for AOC, a prospective evaluation of new response-related
      end points is strongly recommended.
FAU - Colloca, Giuseppe
AU  - Colloca G
AUID- ORCID: http://orcid.org/0000-0002-0903-6793
AD  - Department of Oncology, "Giovanni Borea" Hospital, Via G. Borea n. 56, 18038,
      Sanremo, Imperia, Italy. [email protected]
FAU - Venturino, Antonella
AU  - Venturino A
AD  - Department of Oncology, "Giovanni Borea" Hospital, Via G. Borea n. 56, 18038,
      Sanremo, Imperia, Italy.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20170408
PL  - United States
TA  - Med Oncol
JT  - Medical oncology (Northwood, London, England)
JID - 9435512
SB  - IM
MH  - Disease-Free Survival
MH  - Endpoint Determination
MH  - Female
MH  - Humans
MH  - Ovarian Neoplasms/*drug therapy
MH  - Randomized Controlled Trials as Topic/methods
OTO - NOTNLM
OT  - Chemotherapy
OT  - Ovarian cancer
OT  - Overall response rate
OT  - Overall survival
OT  - Progression-free survival
EDAT- 2017/04/10 06:00
MHDA- 2017/04/20 06:00
CRDT- 2017/04/10 06:00
PHST- 2017/02/20 [received]
PHST- 2017/03/28 [accepted]
AID - 10.1007/s12032-017-0939-9 [doi]
AID - 10.1007/s12032-017-0939-9 [pii]
PST - ppublish
SO  - Med Oncol. 2017 May;34(5):87. doi: 10.1007/s12032-017-0939-9. Epub 2017 Apr 8.

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