Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01).

PURPOSE: Operable triple-negative breast cancers (TNBCs) have a higher risk of relapse than non-TNBCs with standard therapy. The GEICAM/2003-11_CIBOMA/2004-01 trial explored extended adjuvant capecitabine after completion of standard chemotherapy in patients with early TNBC. PATIENTS AND METHODS: Eligible patients were those with operable, node-positive-or node negative with tumor 1 cm or greater-TNBC, with prior anthracycline- and/or taxane-containing chemotherapy. After central confirmation of TNBC status by immunohistochemistry, patients were randomly assigned to either capecitabine or observation. Stratification factors included institution, prior taxane-based therapy, involved axillary lymph nodes, and centrally determined phenotype (basal v nonbasal, according to cytokeratins 5/6 and/or epidermal growth factor receptor positivity by immunohistochemistry). The primary objective was to compare disease-free survival (DFS) between both arms. RESULTS: Eight hundred seventy-six patients were randomly assigned to capecitabine (n = 448) or observation (n = 428). Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous anthracyclines plus taxanes. Median length of follow-up was 7.3 years. DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06; P = .136]. In a preplanned subgroup analysis, nonbasal patients seemed to derive benefit from the addition of capecitabine with a DFS HR of 0.53 versus 0.94 in those with basal phenotype (interaction test P = .0694) and an HR for overall survival of 0.42 versus 1.23 in basal phenotype (interaction test P = .0052). Tolerance of capecitabine was as expected, with 75.2% of patients completing the planned 8 cycles. CONCLUSION: This study failed to show a statistically significant increase in DFS by adding extended capecitabine to standard chemotherapy in patients with early TNBC. In a preplanned subset analysis, patients with nonbasal phenotype seemed to obtain benefit with capecitabine, although this will require additional validation.

[Recurrence of breast cancer in women residing in northwestern Mexico]. / Recurrencia de cáncer de mama en mujeres del Noroeste de México.

BACKGROUND: Recurrence of breast cancer has been defined as the presence of a new local or distant tumor after a year of initial treatment. The aim of this study was to assess the prevalence and characteristics of breast cancer recurrence in women diagnosed with breast cancer in northwestern Mexico. METHODS: We designed a cross-sectional study in a cohort of women with breast cancer to determine the prevalence of disease recurrence. We analyzed age, tumor stage, axillary lymph node status, type of tumor, histological grade, estrogen receptor (ER), progesterone receptor (PR) and protein HER2, treatment used and death. RESULTS: We included 397 women with 23% recurrence of the total number who were followed for up to 5 years. There was a higher frequency of recurrence in those cases where diagnosis was stage III of the disease (48%; OR = 3.54; p = 0.0001), axillary lymph node metastases (21%; OR = 1.12; p = 0.05), ER positive (19%; OR = 0.64; p = 0.07) and HER2 protein (28%; OR = 1.53; p = 0.08). Of 121 women who received endocrine therapy, 35 had recurrence (29%; OR = 1.63; p = 0.04) and 15/30 women who received trastuzumab presented recurrence (50%; OR = 3.89; p = 0.01). Death was reported in 77% of cases of disease recurrence (OR = 12.66; p = 0.001). CONCLUSIONS: In the late stage of breast cancer, HER2-positive expression in women with ER positive, axillary node involvement and metastases is associated with a higher frequency of recurrence and death.

Recurrencia de cáncer de mama en mujeres del Noroeste de México / Recurrence of breast cancer in women residing in northwestern Mexico

Introducción: La recurrencia del cáncer de mama se ha definido como la presencia de un nuevo tumor local o distante después de un año del tratamiento inicial. El objetivo de este estudio fue evaluar la prevalencia y características de la recurrencia de cáncer de mama en mujeres con diagnóstico de cáncer de mama en el noroeste de México. Material y métodos: Estudio transversal en una cohorte de seguimiento de mujeres con cáncer de mama, para conocer la prevalencia de la recurrencia de la enfermedad. Se analizó edad, etapa del tumor, estado ganglionar axilar, tipo de tumor, grado histológico, receptores de estrógenos, progesterona y proteína HER2, tratamiento y muerte. Resultados: Se incluyeron 397 mujeres, observándose 23 % de recurrencia en un seguimiento a cinco años, con mayor frecuencia en los casos en que al diagnóstico estaban en etapa III de la enfermedad (48 %; OR = 3.54, p = 0.0001), ante metástasis a ganglios linfáticos axilares (21 %; OR = 1.12, p = 0.05) y positividad a receptores de estrógenos (19 %; OR = 0.64, p = 0.07) y proteína HER2 (28 %; OR = 1.53, p = 0.08). Treinta y cinco de 121 mujeres que recibieron terapia endocrina presentaron recurrencia (29 %; OR = 1.63, p = 0.04) y 15 de 30 que recibieron trastuzumab (50 %; OR = 3.89, p = 0.01). La muerte ocurrió en 77 % de los casos de recurrencia de la enfermedad (OR = 12.66, p = 0.001). Conclusiones: En el cáncer de mama en etapa tardía, la expresión positiva del HER2 en mujeres con receptores de estrógenos positivos y metástasis a ganglios axilares se asocia con mayor frecuencia de recurrencia y muerte.

BACKGROUND: Recurrence of breast cancer has been defined as the presence of a new local or distant tumor after a year of initial treatment. The aim of this study was to assess the prevalence and characteristics of breast cancer recurrence in women diagnosed with breast cancer in northwestern Mexico. METHODS: We designed a cross-sectional study in a cohort of women with breast cancer to determine the prevalence of disease recurrence. We analyzed age, tumor stage, axillary lymph node status, type of tumor, histological grade, estrogen receptor (ER), progesterone receptor (PR) and protein HER2, treatment used and death. RESULTS: We included 397 women with 23% recurrence of the total number who were followed for up to 5 years. There was a higher frequency of recurrence in those cases where diagnosis was stage III of the disease (48%; OR = 3.54; p = 0.0001), axillary lymph node metastases (21%; OR = 1.12; p = 0.05), ER positive (19%; OR = 0.64; p = 0.07) and HER2 protein (28%; OR = 1.53; p = 0.08). Of 121 women who received endocrine therapy, 35 had recurrence (29%; OR = 1.63; p = 0.04) and 15/30 women who received trastuzumab presented recurrence (50%; OR = 3.89; p = 0.01). Death was reported in 77% of cases of disease recurrence (OR = 12.66; p = 0.001). CONCLUSIONS: In the late stage of breast cancer, HER2-positive expression in women with ER positive, axillary node involvement and metastases is associated with a higher frequency of recurrence and death.

Carcinoma cervicouterino localmente avanzado: resultados preliminares con quimioterapia neoadyuvante con fluorouracilo, leucovorin / Locally advanced cervix carcinoma: response at the treatment chemotherapy

Veinte pacientes con carcinoma cervicouterino localmente avanzado fueron tratadas con tres ciclos de quimioterapia neoadyuvante (QT) con fluorouracilo modulado con leucovorin, seguidas de radioterapia convencional (RT). Se evaluó respuesta en 19 de ellas. Hubo buena tolerancia a la QT sola, aunque se observó náuseas y vómitos (47 por ciento), diarrea (21 por ciento) (en todos los casos en grado 1) y toxicidad hematológica en tres pacientes (una con leucopenia y granulocitopenia grado 2, y trombocitopenia grado 1; y las otras dos con leucopenia grado 1). La tolerancia y morbilidad a la RT no se modificaron por el uso previo de la QT. Los resultados a la QT sola fueron: respuestas parcial en cinco casos (26.3 por ciento) y enfermedad estable en ocho (42.1 por ciento). Los resultados a la combinación QT/RT después de 12.5 meses de seguimiento son: respuesta completa (RC) en 14 (73.6 por ciento), otra con RC pero recurrencia pélvica a los nueve meses; lo cual se compara favorablemente con un estudio anterior de pacientes tratados con RT sola con RC de 53 por ciento (p = 0.33, considerada significativa). Estos resultados son alentadores para seguir intentando el uso de la quimioterapia neoadyuvante (o concurrente) en el manejo del cáncer cervicouterino localmenta avanzado en estudios aleatorios, con mayor número de pacientes y más tiempo de seguimiento.