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Participants in a randomized controlled trial had longer overall survival than non-participants: a prospective cohort study
- Source :
- Breast Cancer Research and Treatment. 176:631-635
- Publication Year :
- 2019
- Publisher :
- Springer Science and Business Media LLC, 2019.
-
Abstract
- While some studies show improved outcomes in clinical trial participants as compared to non-participants, existence of such a trial effect has not been proved precisely. This was a prospective cohort study to compare the prognoses for participants in the randomized controlled trial (SELECT BC) and non-participants. SELECT BC compared S-1 and taxane as first-line treatment for metastatic breast cancer. Non-participants were all patients who met the eligibility criteria of SELECT BC and who had been requested to participate in that trial by attending doctors and declined. The study aimed to compare the prognoses between participants and non-participants. The primary endpoint was median overall survival. The median OS in participants was significantly superior to that in non-participants with a statistically significant difference (36.8 months vs. 25.2 months. HR 1.48, p = 0.022). A similar result was obtained when only patients who received the same chemotherapy (S-1 or taxane) used in SELECT BC after declining participation were assumed as non-participants (36.8 months vs. 22.0 months. HR 2.03, p = 0.006). This study may suggest the existence of a trial effect, in which, for a given treatment, participation in a clinical trial is associated with a better outcome.
- Subjects :
- Adult
Bridged-Ring Compounds
0301 basic medicine
Cancer Research
medicine.medical_specialty
medicine.medical_treatment
Breast Neoplasms
Kaplan-Meier Estimate
law.invention
03 medical and health sciences
0302 clinical medicine
Breast cancer
Randomized controlled trial
law
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Outcome Assessment, Health Care
Biomarkers, Tumor
medicine
Clinical endpoint
Humans
Neoplasm Metastasis
Prospective cohort study
Aged
Neoplasm Staging
Randomized Controlled Trials as Topic
Tegafur
Chemotherapy
Taxane
business.industry
Middle Aged
medicine.disease
Combined Modality Therapy
Metastatic breast cancer
Survival Rate
Clinical trial
Drug Combinations
Oxonic Acid
Treatment Outcome
030104 developmental biology
Oncology
030220 oncology & carcinogenesis
Female
Taxoids
Patient Participation
business
Subjects
Details
- ISSN :
- 15737217 and 01676806
- Volume :
- 176
- Database :
- OpenAIRE
- Journal :
- Breast Cancer Research and Treatment
- Accession number :
- edsair.doi.dedup.....167c68e1f09c74424430fbf1da102da8