PMID- 28784862
OWN - NLM
STAT- MEDLINE
DCOM- 20180423
LR  - 20190423
IS  - 1540-1413 (Electronic)
IS  - 1540-1405 (Linking)
VI  - 15
IP  - 8
DP  - 2017 Aug
TI  - The Evolution of Metastatic Colorectal Cancer Clinical Trials: Application of the 
      ASCO Framework for Assessing Value.
PG  - 1005-1013
LID - jnccn_15_8_009 [pii]
LID - 10.6004/jnccn.2017.0137 [doi]
AB  - Background: Phase III trials in metastatic colorectal cancer (mCRC) have 
      collectively led to progressive advancements in patient outcomes over the past 
      decades. This study characterizes the evolution of mCRC phase III trials through 
      assessing the value of cancer therapy, as measured by the ASCO Value Framework. 
      Methods: Phase III trial results of systemic therapy for mCRC published between 
      1980 and 2015 were identified, and their outcome, statistical significance, 
      journal impact factor, and citation by the 2016 NCCN Clinical Practice Guidelines 
      in Oncology (NCCN Guidelines) for CRC were recorded. For each trial, the net 
      health benefit (NHB) score was calculated using the June 2015 (original) and May 
      2016 (revised) ASCO Value Framework: Advanced Disease. Results: There were 114 
      mCRC phase III trials eligible for calculation of the NHB score. Using the 
      revised framework, the median NHB score was 4.6 (range, -30 to 43.5); 12% of 
      trials received bonus points. Trials with statistically significant results had 
      higher NHB scores compared with nonsignificant trials (median NHB score, 21.6 vs 
      2.9; P<.0001). Clinical trials cited in the NCCN Guidelines had higher NHB scores 
      than those not cited (median score, 8.0 vs 0.3; P=.02). In multivariate linear 
      regression analysis, the only significant predictor of high NHB score was 
      statistically significant studies. Conclusions: The median NHB score for mCRC 
      phase III trials was 4.6. Higher NHB scores are associated with statistically 
      significant studies and are cited in the NCCN Guidelines, a surrogate for 
      practice-changing trials. The 2016 ASCO Value Framework may not fully capture the 
      benefits on an individual patient level.
CI  - Copyright (c) 2017 by the National Comprehensive Cancer Network.
FAU - Ezeife, Doreen A
AU  - Ezeife DA
FAU - Parimi, Sunil
AU  - Parimi S
FAU - Cusano, Ellen R
AU  - Cusano ER
FAU - Smith, Matthew K
AU  - Smith MK
FAU - Truong, Tony H
AU  - Truong TH
FAU - Raissouni, Soundouss
AU  - Raissouni S
FAU - Lin, Yongtao
AU  - Lin Y
FAU - Monzon, Jose G
AU  - Monzon JG
FAU - Li, Haocheng
AU  - Li H
FAU - Tam, Vincent C
AU  - Tam VC
FAU - Tang, Patricia A
AU  - Tang PA
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PL  - United States
TA  - J Natl Compr Canc Netw
JT  - Journal of the National Comprehensive Cancer Network : JNCCN
JID - 101162515
SB  - IM
MH  - *Clinical Trials as Topic
MH  - Clinical Trials, Phase III as Topic
MH  - Colonic Neoplasms/diagnosis/*epidemiology/mortality/therapy
MH  - Cost-Benefit Analysis
MH  - Humans
MH  - Neoplasm Metastasis
MH  - ROC Curve
MH  - Treatment Outcome
EDAT- 2017/08/09 06:00
MHDA- 2018/04/24 06:00
CRDT- 2017/08/09 06:00
PHST- 2016/12/21 00:00 [received]
PHST- 2017/04/12 00:00 [accepted]
PHST- 2017/08/09 06:00 [entrez]
PHST- 2017/08/09 06:00 [pubmed]
PHST- 2018/04/24 06:00 [medline]
AID - jnccn_15_8_009 [pii]
AID - 10.6004/jnccn.2017.0137 [doi]
PST - ppublish
SO  - J Natl Compr Canc Netw. 2017 Aug;15(8):1005-1013. doi: 10.6004/jnccn.2017.0137.