RESUMEN
UNLABELLED: We assessed the efficacy and safety of a liposomal cisplatin (lipoplatin) and vinorelbine combination in metastatic breast cancer (MBC). Thirty-five patients were treated. The objective response rate was 53.1% and the median survival time was 22 months. Grade 3/4 neutropenia was observed in 44% of cycles, and febrile neutropenia was seen in 4 patients (11.4%). No grade 3/4 nephrotoxicity or neuropathy was noted. This combination is effective and well tolerated in patients with MBC and it warrants investigation as first-line treatment. BACKGROUND: Liposomal cisplatin (lipoplatin) has a mechanism of action similar to that of cisplatin, with reduced toxicities and enhanced or similar efficacy. We wanted to assess the efficacy and safety of a lipoplatin/vinorelbine combination in a phase II clinical trial in metastatic breast cancer (MBC). METHODS: Thirty-five patients with HER-2/neu-negative (HER-2/neu(-)) MBC were enrolled. Lipoplatin 120 mg/m(2) (days 1, 8, and 15) and vinorelbine 30 mg/m(2) (days 1 and 8) were administered in a 21-day cycle. RESULTS: Thirty-five patients were included in the intent-to-treat (ITT) analysis; 32 patients were evaluable for response. The objective response rate was 53.1%. Complete response (CR) was achieved in 3 patients (9.4%), partial response (PR) was seen in 14 patients (43.8%), stable disease (SD) was obtained in 12 patients (37.5%), and progressive disease (PD) was seen in 3 patients (9.4%). Median time to disease progression was 8 months (range 6-10 months). After a median follow-up of 15.5 months, 18 patients were still alive; the median survival time was 22 months (95% confidence interval [CI], 14-30). A total of 174 cycles were administered. Neutropenia was the most frequent hematologic toxicity, with grade 3/4 neutropenia observed in 44% of cycles. Febrile neutropenia was observed in 4 patients (11.4%). No grade 3/4 nephrotoxicity or neuropathy was noted. Grade 1/2 nephrotoxicity occurred in 8 patients (22.9%) and grade 3 vomiting was seen in 3 patients (8.6%). CONCLUSIONS: The results of this trial reveal that vinorelbine/lipoplatin is effective in treating patients with MBC. This regimen is well tolerated with no grade 3/4 nephrotoxicity or neuropathy. The investigation of this regimen as first-line treatment in MBC is warranted.
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Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Adolescente , Adulto , Anciano , Neoplasias de la Mama/metabolismo , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Cisplatino/administración & dosificación , Cisplatino/efectos adversos , Supervivencia sin Enfermedad , Femenino , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia , Receptor ErbB-2/metabolismo , Células Receptoras Sensoriales/metabolismo , Resultado del Tratamiento , Vinblastina/administración & dosificación , Vinblastina/efectos adversos , Vinblastina/análogos & derivados , Vinorelbina , Adulto JovenRESUMEN
AIMS: The aim of this study is to evaluate the activity and toxicity of the combination docetaxel and irinotecan as first-line therapy for advanced non-small-cell lung cancer (NSCLC). MATERIALS & METHODS: Twenty-two chemotherapy-naive patients with stage IIIB with pleural effusion or stage IV NSCLC received irinotecan 50 mg/m2 on days 1, 8, and 15, and docetaxel 50 mg/m2 on day 2, every 28 days until disease progression. RESULTS: Median follow-up was 10 months (range: 2-28 months). The overall response rate was 36.4% (8/22 patients; 95% confidence interval: 16.8-56.0), with no complete responses. Median time to disease progression was 5 months (range: 1-24 months) and median overall survival was 10 months (range: 2-28). Grade 3-4 diarrhea was observed in 2 patients (9.1%). Grade 3-4 neutropenia occurred in 2 patients (9.1%): 1 episode of febrile neutropenia in one patient, and 1 death due to neutropenic sepsis in another patient. One patient received transfusion for grade 4 anemia. CONCLUSIONS: Irinotecan showed a moderate response rate and overall survival of clinical interest. Diarrhea was the main toxicity. This regimen may be suitable for patients unable to tolerate cisplatin-based therapy, for elderly and/or for patients with poor performance status, and should be investigated in a larger trial.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Neoplasias Pulmonares/tratamiento farmacológico , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/toxicidad , Camptotecina/administración & dosificación , Camptotecina/análogos & derivados , Camptotecina/toxicidad , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Carcinoma de Pulmón de Células no Pequeñas/patología , Docetaxel , Esquema de Medicación , Femenino , Humanos , Irinotecán , Estimación de Kaplan-Meier , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Neutropenia/inducido químicamente , Neutropenia/mortalidad , Derrame Pleural Maligno/tratamiento farmacológico , Derrame Pleural Maligno/mortalidad , Derrame Pleural Maligno/patología , Análisis de Supervivencia , Taxoides/administración & dosificación , Taxoides/toxicidadRESUMEN
Primary bladder tumor is a frequent urological malignancy, whereas the incidence of secondary bladder tumor from a distant organ is quite rare. Secondary bladder neoplasms represent no more than 3% of all malignant bladder tumors in surgical specimens, of which distant metastases from stomach account for about 4%. The signs of bladder neoplasm in a patient with malignancy elsewhere should alarm the clinician for a possible metastatic origin. We present a patient with primary adenocarcinoma of the stomach, who underwent total gastrectomy and received adjuvant chemotherapy, and was diagnosed with metastasis to the urinary bladder 15 months later. We review the epidemiology of secondary adenocarcinoma of the bladder, mechanisms of metastasis, associated common primaries with focus on gastric malignancies, radiological findings, and role of immunohistochemical staining.
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Adenocarcinoma/secundario , Neoplasias Gástricas/patología , Neoplasias de la Vejiga Urinaria/secundario , Quimioterapia Adyuvante , Estudios de Seguimiento , Gastrectomía , Humanos , Masculino , Persona de Mediana Edad , Neoplasias Gástricas/cirugíaRESUMEN
BACKGROUND: We tested a sequential combination regimen using cisplatin and vinorelbine (PVn) followed by docetaxel as first-line chemotherapy in a phase II clinical trial in metastatic breast cancer (MBC). PATIENTS AND METHODS: Thirty-five patients were enrolled. Cisplatin 80 mg/m(2) was given on day 1 and vinorelbine 30 mg/m(2) on days 1 and 8 every 3 weeks for 4 cycles. Responding patients received docetaxel 75 mg/m(2) every 21 days for a maximum of 4 cycles. Three patients were excluded from analysis because of death unrelated to treatment. RESULTS: After a median follow-up of 14 months, 32 patients completed the study. The overall response rate was 53.1%. Complete remission was seen in 5 patients (15.6%), partial response in 12 (37.5%), stable disease in 6 (18.75%), and progressive disease in 9 patients (28.1%). Median time to disease progression was 8 months (range 1-24). At 24 months, 12 (37.5%) patients were alive. A total of 183 cycles were administered. Febrile neutropenia was observed in 4 patients (2.2%). Grade II nephrotoxicity occurred in 12 cycles (6.5%) and grade III vomiting in 31/183 cycles (16.9%). DISCUSSION: PVn is a feasible non-anthracycline option as first-line chemotherapy in patients with metastatic breast cancer and has acceptable toxicity. The sequential addition of 4 cycles of docetaxel following 4 cycles of PVn did not improve the overall response rate and results.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/patología , Cisplatino/administración & dosificación , Progresión de la Enfermedad , Supervivencia sin Enfermedad , Docetaxel , Esquema de Medicación , Femenino , Fiebre/inducido químicamente , Estudios de Seguimiento , Humanos , Riñón/efectos de los fármacos , Persona de Mediana Edad , Estadificación de Neoplasias , Neutropenia/inducido químicamente , Análisis de Supervivencia , Taxoides/administración & dosificación , Resultado del Tratamiento , Vinblastina/administración & dosificación , Vinblastina/análogos & derivados , Vinorelbina , Vómitos/inducido químicamenteRESUMEN
OBJECTIVES: The effectiveness of cisplatinum and vinorelbine (PVn) as a salvage regimen in patients with metastatic breast cancer was reported in previous studies. This report is a pilot study assessing the antitumor efficacy and safety of this regimen as first line therapy for advanced breast cancer patients. METHODS: Thirty-five patients were enrolled: 22 with metastatic breast carcinoma and 13 with locally advanced breast carcinoma (stage III). A total of 4 cycles of PVn were planned. After the 4th cycle, patients with metastatic breast cancer received vinorelbine biweekly until disease progression or for a total of 12 cycles, whereas those with locally advanced breast cancer who showed complete or partial response underwent curative surgery. RESULTS: The overall response rate of our whole population was 74.29%. For the metastatic breast cancer group, the overall response rate was 64%, with a median survival of 19 months (range 2-36). For the locally advanced breast cancer group, the overall response rate was 92.3% with a median time to disease progression of 26 months (range 25-27). Toxicity was acceptable, and no treatment-related mortality was encountered. CONCLUSIONS: PVn is effective as first line treatment of advanced breast cancer with overall response rate of 64% in metastatic breast cancer and 92.3% in locally advanced breast cancer, and acceptable toxicity.