Efficacy and safety results from GEICO 1205, a randomized phase II trial of neoadjuvant chemotherapy with or without bevacizumab for advanced epithelial ovarian cancer.

BACKGROUND: Bevacizumab is an approved treatment after primary debulking surgery for ovarian cancer. However, there is limited information on bevacizumab added to neoadjuvant chemotherapy before interval debulking surgery. OBJECTIVE: To evaluate neoadjuvant bevacizumab in a randomized phase II trial. METHODS: Patients with newly diagnosed stage III/IV high-grade serous/endometrioid ovarian cancer were randomized to receive four cycles of neoadjuvant chemotherapy with or without ≥3 cycles of bevacizumab 15 mg/kg every 3 weeks. After interval debulking surgery, all patients received post-operative chemotherapy (three cycles) and bevacizumab for 15 months. The primary end point was complete macroscopic response rate at interval debulking surgery. RESULTS: Of 68 patients randomized, 64 completed four neoadjuvant cycles; 22 of 33 (67%) in the chemotherapy-alone arm and 31 of 35 (89%) in the bevacizumab arm (p=0.029) underwent surgery. The complete macroscopic response rate did not differ between treatment arms in either the intention-to-treat population of 68 patients (6.1% vs 5.7%, respectively; p=0.25) or the 55 patients who underwent surgery (8.3% vs 6.5%; p=1.00). There was no difference in complete cytoreduction rate or progression-free survival between the treatment arms. During neoadjuvant therapy, grade ≥3 adverse events were more common with chemotherapy alone than with bevacizumab (61% vs 29%, respectively; p=0.008). Intestinal (sub)occlusion, fatigue/asthenia, abdominal infection, and thrombocytopenia were less frequent with bevacizumab. The incidence of grade ≥3 adverse events was 9% in the control arm versus 16% in the experimental arm in the month after surgery. CONCLUSIONS: Adding three to four pre-operative cycles of bevacizumab to neoadjuvant chemotherapy for unresectable disease did not improve the complete macroscopic response rate or surgical outcome, but improved surgical operability without increasing toxicity. These results support the early integration of bevacizumab in carefully selected high-risk patients requiring neoadjuvant chemotherapy for initially unresectable ovarian cancer.

Infección de catéter central tipo reservorio por Leclercia adecarboxylata en paciente con sarcoma de Ewing sarcoma / Infection of reservoir-central venous catheter by Leclercia adecarboxylata in a patient with Ewing sarcoma

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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.

Histerectomía radical laparoscópica total en el cáncer de cérvix. Factibilidad, morbilidad y supervivencia / Total laparoscopic radical hysterectomy in cervical cancer. Feasibility, morbidity and survival

Objetivo: Evaluación retrospectiva de la factibilidad, la morbilidad perioperatoria y supervivencia a medio plazo de la histerectomía radical laparoscópica total en el cáncer de cérvix. Material y métodos: El estudio incluye 31 casos consecutivos de cáncer de cérvix en estadio clínico IA2 (n = 4), IB1 (n = 21), IIA (n = 2) y IB2 (n = 3) programados para histerectomía radical laparoscópica total. Se analizan las características histológicas de los tumores, la evolución de la técnica quirúrgica, las variables perioperatorias, las complicaciones postoperatorias y los resultados de supervivencia a medio plazo. Resultados: La tasa de factibilidad fue del 96%. La complicación operatoria más frecuente fue la cistotomía accidental (3 casos). La tasa de complicaciones postoperatorias fue del 20% (6 casos), incluido 1 caso de reintervención quirúrgica. El tiempo operatorio medio fue de 258 min (rango: 180-360). La tasa de transfusión sanguínea fue del 17% (5 casos) y la estancia hospitalaria fue de 7,8 días (rango: 2-29). Al mes de la intervención el 72% de las pacientes habían normalizado la función miccional. El tamaño tumoral medio fue de 26,5 mm y la tasa de ganglios pélvicos positivos fue del 17% (n = 5). El tiempo medio de seguimiento fue de 26 meses. La tasa de recidivas fue del 17% (n = 5) y la supervivencia libre de enfermedad fue del 100% para los estadios IB2, el 82,6% para los estadios IB1/IIA y 66,7% para los estadios IB2. Conclusiones: La histerectomía radical laparoscópica total es una técnica factible en la mayoría de los pacientes con cáncer de cérvix, requiere más tiempo operatorio que la vía abdominal, pero presenta menor morbilidad perioperatoria, menor necesidad de transfusiones y menor estancia hospitalaria. La supervivencia a medio plazo es equiparable a la vía abdominal convencional

Objective: To assess feasibility, perioperative morbidity and medium term survival of total laparoscopic radical hysterectomy in cervical cancer. Material and methods: A total of 31 consecutive patients diagnosed FIGO clinical stage IA2 (n = 4), IB1 (n = 22), IIA (n = 2) and IB2 (n = 3) in Son Llàtzer hospital (Palma de Mallorca) that were programmed for a total laparoscopic radical hysterectomy were studied. We analyzed tumor histological characteristics, surgical technique, perioperative variables, postoperative complications and mid-term survival results. Results: Feasibility rate was 96%. The most frequently operative complication was accidental bladder incision (3 cases). Postoperative complications rate was 20% (6 cases) which includes one surgical reintervention. Average operative time was 258 minutes (range: 180-360). Blood transfusion rate was 17% (n = 5) and mean hospital stay was 7.8 days (range: 2-29). After one month after surgery 72% of patients had a normal miccional function. Mean tumoral size was 26.5 mm and lymphatic positive nodes rate was 17% (n = 5). Mean follow-up time was 26 months. Tumor relapse rate was 17% (n = 5) and survival-free disease of 100% for IA2 stage, 82.6% of IB1/IIA stages and 66.7% for IB2 stage. Conclusions: Total laparoscopic radical hysterectomy is a feasible technique in most of the patients with cervical cancer. It needs more operative time than abdominal route but it presents less perioperative morbidity, less blood transfusion and less hospitalization days. The medium term survival is comparable with conventional abdominal route