Trial reportThe oncologist2011
Tumor status at 12 weeks predicts survival in advanced colorectal cancer: findings from NCCTG N9741.
Trial report in The oncologist, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00003594 (A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum), which is not on this map. Cited by 7 papers.
What it found
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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.
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.
A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum
Who cites it
7 citing papers in PubMed.
- Trial
- Impact of the first tumor response at eight weeks on overall survival in metastatic breast cancer patients treated with first-line combination chemotherapy.Medical oncology (Northwood, London, England) · 2013Trial
- Article
- The power of phase II end-points for different possible mechanisms of action of an experimental treatment.European journal of cancer (Oxford, England : 1990) · 2015Article
- Resampling the N9741 trial to compare tumor dynamic versus conventional end points in randomized phase II trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015Article
- Evaluation of RECIST in chemotherapy-treated lung cancer: the Pharmacogenoscan Study.BMC cancer · 2014Article
- Evaluation of alternate categorical tumor metrics and cut points for response categorization using the RECIST 1.1 data warehouse.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWe explored the prognostic value of actual tumor measurements (TM) versus World Health Organization (WHO) criteria as three-level (responder, stable, and progression) and two-level (responder and non-responder) variables at 12 and 24 weeks as predictors of survival in Intergroup Trial N9741, a phase III trial in metastatic colorectal cancer (CRC).
methodsAll patients with measurable disease (N = 1,188) were included. The percentage changes in TM from baseline to 12 and 24 weeks were calculated. The prognostic values of TM versus WHO criteria (as three- and two-level variables) at 12 and 24 weeks were compared, using Cox models for overall survival (OS) in a landmark analysis, adjusting for baseline tumor size, performance status, and treatment arm.
resultsTumor status at 12 weeks by WHO criteria (three or two levels) or actual TM were all strongly associated with OS. Actual TM provided no meaningful additional benefit compared with the three-level WHO criteria. Tumor status at 24 weeks was also strongly associated with survival, but added no additional prognostic value compared with the 12-week assessment. At 12 weeks, actual TM improved prognostic characterization of patients with WHO status of response, but provided no additional value in patients with stable disease or progression.
conclusionsIn N9741, the use of actual TM, or following tumor status beyond 12 weeks, did not improve survival prediction compared with a single three-level response assessment at 12 weeks, suggesting that 12-week tumor status could be an appropriate phase II trial endpoint in metastatic CRC.
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