Consenso de seguimiento de pacientes con cáncer de mama de la Sociedad Española de Senología y Patología Mamaria / Consensus document of the Spanish Society of Senology and Breast Disease on the follow-up of patients with breast cancer

A pesar del aumento en la prevalencia del cáncer de mama, el seguimiento de estas pacientes no está totalmente estandarizado. La Sociedad Española de Senología y Patología Mamaria propuso la elaboración de un documento de consenso sobre el seguimiento que debería proponerse a las pacientes afectas de lesiones de mama in situ e infiltrantes en estadios i-iii, tratadas con intención curativa, una vez finalizados los tratamientos iniciales. En su realización han colaborado profesionales de toda España de distintas especialidades y ámbitos de actuación. Fue presentado en el Primer Congreso Español de la Mama, que se celebró en octubre de 2013 en Madrid, para su refrendo por parte de la Sociedad, y se recogieron las aportaciones de los asistentes a la sala. El objetivo principal del seguimiento es la detección precoz de recurrencias locorregionales y a distancia, de nuevos primarios, y valorar los efectos secundarios de los tratamientos aplicados. Debe también cubrir las necesidades de soporte psicológico, así como la rehabilitación y reinserción sociolaboral posterior y la educación para la salud, corrigiendo hábitos de vida no saludables. No se han descrito diferencias significativas entre el seguimiento minimalista y el intensivo, respecto al índice de recurrencia, la supervivencia global y la calidad de vida. El tipo y los años de seguimiento deberían ser distintos para cada paciente según su riesgo de recidiva y la clasificación molecular de su lesión. Este consenso ha tenido el apoyo de otras sociedades científicas relacionadas con la enfermedad mamaria, asistentes al Primer Congreso Español de la Mama (AU)

Despite the increasing prevalence of breast cancer, there is no standardized protocol for the follow-up of breast cancer survivors. The Spanish Society of Senology and Breast Disease has supported a consensus document on the follow-up of breast cancer survivors, aimed at patients diagnosed with stage i to iii disease and with invasive and intraepithelial (in situ) lesions, and treated with curative intent, after completion of the initial treatment. Practitioners from all over Spain, with different specialities and areas of activity, participated in the drafting in the document. It was presented at the First Spanish Breast Congress (Primer Congreso Español de la Mama), which took place in October 2013, for the Society's approval. Input from the audience was considered. The main aim of follow-up is the early detection of local and distant recurrences, of new primaries, and evaluation of the adverse effects of the therapies applied. Follow-up should also include psychological support, education on healthy habits, rehabilitation, and social and work reintegration. No significant differences between minimalistic and intensive follow-up have been reported regarding recurrence, overall survival, and quality of life. The length, intervals, and intensity of follow-up should be tailored according to each patient's individual risk of relapse and molecular subtype. This consensus document has the support and endorsement of other scientific societies related to breast disease and present at the congress (AU)

A phase II trial of fixed-dosed rate gemcitabine in platinum-resistant ovarian cancer: a GEICO (Grupo Español de Investigación en Cáncer de Ovario) Trial.

OBJECTIVES: Gemcitabine has well-recognized activity in the treatment of ovarian cancer. Fixed-dose rate (FDR) delivery has been proposed as a more rationale way to administer gemcitabine, to avoid saturation of the enzyme that catalyzes its intracellular transformation into the active metabolites, difluorodeoxycitidine biphosphate, and triphosphate. Our aim was to assess clinical activity of gemcitabine delivered by FDR infusion in patients with platinum resistant ovarian cancer. MATERIALS AND METHODS: Patients with platinum-resistant ovarian cancer received gemcitabine 1000 mg/m(2) over 120 minutes on days 1 and 8 of each cycle. Cycles were repeated every 3 weeks, and up to 6 cycles were delivered. RESULTS: Forty-eight patients were included in the study. Among 41 patients evaluable for response, 9 clinical responses (1 complete response and 8 partial responses) were observed, achieving a global response rate of 22%. Grade 3 to 4 hematological toxicity consisted of anemia (15% of patients), neutropenia (24%), and thrombopenia (10%). One patient died due to septic shock. The main grade 3 to 4 nonhematological toxicity was asthenia (7 patients, 17%). CONCLUSION: Activity of gemcitabine administered by FDR infusion in patients with platinum-resistant ovarian cancer seems similar to that achieved using 30-minute infusions, with higher toxicity.

Phase II trial of fortnightly irinotecan (CPT-11) in the treatment of colorectal cancer patients resistant to previous fluoropyrimidine-based chemotherapy.

INTRODUCTION: This phase II study investigated the anti-tumour activity and toxicity of CPT-11 (250 mg/m2 i.v. infusion over 60 minutes) administered every 2 weeks as second-line chemotherapy in patients with advanced colorectal cancer (CRC). MATERIAL AND METHODS: Patients (n = 63) with histology diagnosis of advanced CRC and proven resistance to previous fluoropyrimidine therapy were enrolled. RESULTS: A total of 510 CPT-11 cycles were administered, with a mean of 8 cycles per patient (range: 1-32). The median relative dose intensity was 93%. Partial response (PR) was obtained in 11 patients (17.5%; 95%CI: 8.1%-26.7%) and 29 patients (46.0%) showed stable disease (clinical benefit of 63.5%). The median duration of response was 6.8 months (95%CI: 6.1-7.5 months), median survival was 8.8 months (95%CI: 6.3-11.5 months) and median time to disease progression was 4.5 months (95%CI: 3.9-5.0 months). Overall, this schedule of CPT-11 chemotherapy was well tolerated by the patient. Neutropenia was the most frequent grade 3/4 haematological toxicity (20.6% of patients and 4.1% of cycles). Neutropenia with concurrent fever or infection occurred in 7 patients (11.1%). Late onset diarrhoea was the most frequent grade 3/4 non-haematological toxicity (19.0% of patients and 2.3% of cycles). Other, lower-incidence, toxicities were anaemia, fever, infection, mucositis, nausea and vomiting. There were no toxic deaths. CONCLUSIONS: We found that CPT-11, administered as 250 mg/m2 i.v. infusion over 60 minutes every 2 weeks, was active and well tolerated schedule in the second-line chemotherapy of advanced CRC patients. This bi-weekly scheme could be used as an alternative to the weekly or the every-three-week schedule as well as in combined therapies with other chemotherapeutic agents for the treatment of advanced, metastatic, CRC.

Phase II trial of fortnightly irinotecan (CPT-11) in the treatment of colorectal cancer patients resistant to previous fluoropyrimidine-based chemotherapy

Introduction. This phase II study investigated the anti-tumour activity and toxicity of CPT-11 (250 mg/m² i.v. infusion over 60 minutes) administered every 2 weeks as second-line chemotherapy in patients with advanced colorectal cancer (CRC). Material and methods. Patients (n=63) with histology diagnosis of advanced CRC and proven resistance to previous fluoropyrimidine therapy were enrolled. Results. A total of 510 CPT-11 cycles were administered, with a mean of 8 cycles per patient (range: 1-32). The median relative dose intensity was 93%. Partial response (PR) was obtained in 11 patients (17.5%; 95%CI: 8.1%-26.7%) and 29 patients (46.0%) showed stable disease (clinical benefit of 63.5%). The median duration of response was 6.8 months (95%CI: 6.1-7.5 months), median survival was 8.8 months (95%CI: 6.3-11.5 months) and median time to disease progression was 4.5 months (95%CI: 3.9-5.0 months). Overall, this schedule of CPT-11 chemotherapy was well tolerated by the patient. Neutropenia was the most frequent grade 3/4 haematological toxicity (20.6% of patients and 4.1% of cycles). Neutropenia with concurrent fever or infection occurred in 7 patients (11.1%). Late onset diarrhoea was the most frequent grade 3/4 non-haematological toxicity (19.0% of patients and 2.3% of cycles). Other, lower-incidence, toxicities were anaemia, fever, infection, mucositis, nausea and vomiting. There were no toxic deaths. Conclusions. We found that CPT-11, administered as 250 mg/m² i.v. infusion over 60 minutes every 2 weeks, was active and well tolerated schedule in the second-line chemotherapy of advanced CRC patients. This bi-weekly scheme could be used as an alternative to the weekly or the every-three-week schedule as well as in combined therapies with other chemotherapeutic agents for the treatment of advanced, metastatic, CRC