Results of a breast-cancer-surgery trial compared with observational data from routine practice

Autor:	E Marubini, L Mariani, B Salvadori, R Saccozzi, M Merson, R Zucali, F Rilke, U Veronesi
Rok vydání:	1996
Předmět:	Adult medicine.medical_specialty medicine.medical_treatment Population Context (language use) Breast Neoplasms Mastectomy Segmental law.invention Breast cancer Randomized controlled trial law Antineoplastic Combined Chemotherapy Protocols Medicine Humans Prospective Studies Neoplasm Metastasis education Aged Proportional Hazards Models education.field_of_study business.industry Data Collection General Medicine Middle Aged medicine.disease Combined Modality Therapy Surgery Clinical trial Treatment Outcome Italy Axilla Lymph Node Excision Observational study Female Neoplasm Recurrence Local business Mastectomy Radical Quadrantectomy Mastectomy Follow-Up Studies
Zdroj:	Lancet (London, England). 347(9007)
ISSN:	0140-6736
Popis:	Summary Background The strength of randomised controlled trials (RCTs) is that they allow investigators to draw reliable inferences about treatment differences; physicians can then make a choice between different options. Their weakness is that they are conducted on a set of patients who cannot be regarded as a random sample from the population that will be treated outside the trial. Observational data collected in a prospective clinical database may provide more realistic estimates. Methods At the Istituto Nazionale dei Tumori of Milan an RCT was started in 1973 (MI1) in which Halsted mastectomy was compared with quadrantectomy plus axillary dissection and radiotherapy (QUART), a breast conserving treatment, for "early-stage" primary breast cancer. In addition, a prospective clinical database was established to collect, in standard format, information on all women undergoing breast conservation thereafter and followed up at the institute. 1760 women were treated with QUART, 350 of them being accrued in the years 1973-80 in the context of the MI1 trial. The remaining 1408 received QUART after the MI1 trial, up to December, 1984. Results In the years after the trial, the criteria for use of QUART became more liberal. However, after adjustment for baseline characteristics, out-trial patients fared no worse than trial patients in terms of survival or distant metastasis. Out-trial patients did have a slightly higher rate of local recurrence, probably because of subtle and multiple changes in the surgical procedures since the time of the trial. Interpretation The results of QUART in out-trial patients resembled those reported from research settings. In this instance, the results of clinical trials did not exaggerate the benefits obtainable in routine practice.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f7463a05672b35c2b60f9d7252fafd66 https://pubmed.ncbi.nlm.nih.gov/8606606 Zobrazit plný text záznamu Plný text ve formátu HTML
Nepřihlášeným uživatelům se plný text nezobrazuje	K zobrazení výsledku je třeba se přihlásit.