RESUMO
BACKGROUND: Carboplatin-containing regimens are sometimes preferred for patients with advanced non-small cell lung cancer. METHODS: Eighty-three patients with stage III-IV non-small cell lung cancer received 3 to 4 cycles of carboplatin AUC 5 on day 2 and gemcitabine 1250 mg/m2 on days 1 and 8 every 21 days. RESULTS: The overall response rate was 43.4%. Results obtained from elderly and non-elderly groups were compared using the logrank method. Median overall survival and progression-free survival were 11 and 7 months, respectively (12 and 7 months, non-elderly group; 6.5 and 5 months, elderly group, P = 0.28 and 0.25 respectively). Grade 3-4 toxicity included neutropenia, thrombocytopenia, anemia, nausea/vomiting, and diarrhea. Incidences of grade 3-4 toxicity were similar for elderly and non-elderly patients. CONCLUSIONS: Data confirm that carboplatin-gemcitabine is an active and well-tolerated regimen in advanced non-small cell lung cancer and could be investigated in elderly patients.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carboplatina/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Desoxicitidina/análogos & derivados , Intervalo Livre de Doença , Feminino , Humanos , Estimativa de Kaplan-Meier , Neoplasias Pulmonares/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , GencitabinaRESUMO
PURPOSE: Bi-weekly gemcitabine (G) in combination with docetaxel (D) is an effective treatment for metastatic breast cancer (MBC) previously treated with adjuvant/neoadjuvant anthracyclines containing regimens with a good toxicity profile. In the present phase II study, we investigated the activity of the same regimen as first-line treatment. METHODS: Women with breast cancer pretreated in adjuvant/neoadjuvant setting with anthracyclines received bi-weekly G (1,250 mg/m² days 1, 15) and D (50 mg/m² days 1, 15) every 28 days with restaging after 3 and 6 cycles. RESULTS: Overall 42 patients were enrolled. Median age is 48 years (range, 31-71 years). Eight patients (19%) achieved complete responses, 18 (43%) partial responses for an overall response rate (ORR) of 62%; five patients (12%) obtained stable disease (SD), and 8 (19%) patients had progressive disease (PD). After a median 17-month follow-up, the median time to disease progression was 12 months (95% CI, 3-26 months) and the median survival time was 27 months (95% CI, 4-57 months). No grade 4 toxicity was seen except in one patient who developed a grade 4 neutropenia. Grade 3 toxicities were leukopenia (2%), neutropenia (14%), anemia (2%), nausea and vomiting (2%), diarrhea (2%), asthenia (2%), and skin toxicity (12%). CONCLUSION: The GD bi-weekly regimen is well tolerated and active as first line in anthracyclines-pretreated women with MBC. It appears as an interesting alternative compared to a 3-week schedule whenever hematological toxicity is the main clinical concern.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Adulto , Idoso , Antraciclinas/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/patologia , Quimioterapia Adjuvante/métodos , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Progressão da Doença , Docetaxel , Esquema de Medicação , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Terapia Neoadjuvante/métodos , Metástase Neoplásica , Taxa de Sobrevida , Taxoides/administração & dosagem , Resultado do Tratamento , GencitabinaRESUMO
BACKGROUND: To determine whether a dose-dense regimen improves outcome in early breast cancer patients, we compared outcomes with the same fluorouracil, epirubicin, and cyclophosphamide (FEC) chemotherapeutic regimen administered every 3 weeks (FEC21) or administered every 2 weeks (FEC14 including support with filgrastim, a granulocyte colony-stimulating factor) in a multicenter phase III randomized trial. METHODS: A total of 1214 patients with early-stage breast cancer were randomly assigned to receive six cycles of FEC14 (604 patients) or of FEC21 (610 patients). Study endpoints were overall survival and event-free survival. Associations were assessed by multivariable analysis with adjustment for age; tumor size; grade; proliferative rate; and menopausal, lymph node, estrogen receptor, and progesterone receptor status. All statistical tests were two-sided. RESULTS: Patients in the FEC14 arm had fewer dose reductions or treatment delays or discontinuation (26%) than those in the FEC21 arm (33%) (difference = 7%, 95% confidence interval [CI] = 2% to 12%; P = .008). FEC14 therapy, compared with FEC21 therapy, was associated with more asthenia (36% versus 29%, difference = 7%, 95% CI = 2% to 12%; P = .01), bone pain (33% versus 4%, difference = 29%, 95% CI = 25% to 33%; P < .001), anemia (38% versus 19%, difference = 19%, 95% CI = 14% to 24%; P < .001), and thrombocytopenia (8% versus 2%, difference = 6%, 95% CI = 4% to 9%; P < .001), but with less leukopenia (12% versus 45%, difference = 33%, 95% CI = 28% to 37%; P < .001). No acute myelogenous leukemia or myelodysplastic syndrome was observed. At a median follow-up of 10.4 years, no statistically significant difference in the hazard of death (hazard ratio [HR] = 0.87, 95% CI = 0.67 to 1.13) or recurrence (HR = 0.88, 95% CI = 0.71 to 1.08) was found between FEC14 and FEC21 groups after adjustment by multivariable analysis. Although the study was underpowered for subset analysis, we found no evidence that the effect of the treatment type was associated with any of the potential prognostic factors. CONCLUSION: Our results support the long-term safety of FEC14 chemotherapy as an adjuvant treatment of breast cancer. However, this therapy was not associated with improved outcome, but because of the limited statistical power of our study, we cannot rule out a modest improvement in outcome associated with FEC14 therapy.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Adulto , Idoso , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Intervalos de Confiança , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Intervalo Livre de Doença , Relação Dose-Resposta a Droga , Esquema de Medicação , Epirubicina/administração & dosagem , Epirubicina/efeitos adversos , Feminino , Filgrastim , Fluoruracila/administração & dosagem , Fluoruracila/efeitos adversos , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Humanos , Infusões Intravenosas , Itália , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Proteínas Recombinantes , Fatores de Risco , Análise de Sobrevida , Resultado do TratamentoRESUMO
OBJECTIVE: The purpose of the study was to evaluate activity and toxicity of the combination of topotecan and ifosfamide as salvage treatment in patients with advanced ovarian cancer refractory to or relapsing after platinum compound-based chemotherapy. METHODS: Thirty-nine patients entered the trial. Inclusion criteria were: previous platinum compound-based chemotherapy with or without paclitaxel, age =75 years, ECOG PS =2, and measurable or evaluable lesions. Treatment consisted of topotecan 1.3 mg/sqm d. 1-3 in combination with ifosfamide 1500 mg/sqm d. 1 and 2 (plus uroprotector MESNA), q. 21 days. RESULTS: All patients had received previous platinum compound-based chemotherapy (carboplatin + paclitaxel in 72% of patients); 15 patients had received a further second-line therapy. Overall, 179 cycles were administered; median number courses/patient was 5 (range: 1-8). Eighteen patients received at least six courses of therapy. All patients were evaluable for toxicity and 38 patients for response. Main toxicities consisted of gr3-4 neutropenia in 25%, gr3 anaemia in 18%, neutropenic fever in four patients; 7 patients required blood transfusion and 26 patients were treated with G-CSF. Dose reduction of both drugs was performed in five patients, and seven patients required 1-week delay for recovery of toxicity. Objective response was observed in 16/39 patients (41%): complete response in six patients and partial response in 10 patients; in further three patients, >/=50% reduction of baseline CA-125 was recorded. Significant higher response rate was observed in platinum-sensitive population (11/15 patients) compared to resistant disease (8/24 patients). CONCLUSIONS: Chemotherapy with topotecan and ifosfamide (IT) in pretreated advanced ovarian cancer patients is feasible with moderate toxicity. The potential of the regimen for synergistic drug interactions deserves further evaluations.