BACKGROUND
Patients with isolated locoregional recurrences (ILRR) of breast cancer have a high risk of distant metastasis and death from breast cancer. We investigated adjuvant chemotherapy for such patients in a randomised clinical trial.
METHODS
The CALOR trial (clinicaltrials.gov NCT00074152) accrued patients 2003-2010. The 162 patients with resected ILRR were centrally randomised using permuted blocks and stratified by prior chemotherapy, ER/PgR status, and location of ILRR. Eighty-five were allocated to chemotherapy (type selected by the investigator; multidrug for at least four courses recommended) and 77 to no chemotherapy. Patients with oestrogen receptor-positive ILRR received adjuvant endocrine therapy; radiation therapy was mandated for patients with microscopically involved surgical margins, and anti-HER2 therapy was optional. The primary endpoint was disease-free survival (DFS). All analyses were by intention to treat.
FINDINGS
At a median follow up of 4·9 (IQR 3.6,6.0) years we observed 24 DFS events and nine deaths in the chemotherapy group compared with 34 DFS events and 21 deaths in the no chemotherapy group. Five-year DFS was 69% vs. 57%, (hazard ratio for chemotherapy versus no chemotherapy, 0·59; 95% confidence interval 0·35 to 0·99; P=0·046) and five-year overall survival was 88% vs. 76%, (hazard ratio, 0·41; 95% CI, 0·19 to 0·89; P=0·02). Adjuvant chemotherapy was significantly more effective for women with oestrogen receptor-negative disease measured in the recurrence (interaction P=0·04), but analyses of DFS based on the oestrogen receptor status of the primary tumour were not statistically significant (interaction P=0·43). Among the 85 patients who received standard chemotherapy, 12 reported SAEs.
INTERPRETATION
Adjuvant chemotherapy should be recommended for patients with completely resected isolated locoregional recurrences of breast cancer, especially if the recurrence is oestrogen receptor negative.
FUNDING
Public Service Grants U10-CA-37377, -69974, -12027, -69651, and -75362 from the U.S. Department of Health and Human Services.
Propósito: El GIST es un tumor perteneciente a los sarcomas de partes blandas y aunque su localización más frecuente es el tracto gastrointestinal se ha descrito fuera de ésta a pesar de lo cual persiste esa denominación, lo que es, en bastantes casos, motivo de confusión. Material y métodos: Se presenta el caso de un varón de 57 años diagnosticado, en principio, de "tumor de músculo liso de potencial maligno incierto" en base a su localización retroperitoneal. Tras la revisión y determinación de c-kit (CD-117), se hizo el diagnóstico definitivo de "tumor estromal de localización retroperitoneal". Conclusiones: Proponemos el término menos confuso de "tumor estromal con fenotipo de células intersticiales de Cajal". Palabras clave: GIST. c-kit, Tumores estromales extragastrointestinales. Células intersticiales de Cajal.
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