RESUMEN
UNLABELLED: Objective. We conducted this phase II trial to evaluate the efficacy and toxicity of the sequential nonplatinum combination chemotherapy consisting of gemcitabine (GEM) and vinorelbine (VNR) followed by weekly docetaxel (DOC) in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods. ELIGIBILITY CRITERIA: stage IV NSCLC, Performance status =/< 2, adequate renal, hepatic and bone marrow function. Treatment consisted on: VNR 25 mg/m(2) plus gemcitabine 1000 mg/m(2), on days 1 and 8 of each 21-day cycle, followed by docetaxel 36 mg/m(2) weekly until progression or unacceptable toxicity. Results. 21 stage IV patients were enrolled. All patients are evaluable for treatment response and toxicity profile. The mean age of the patients was 63 years (range: 51 to 72) with 18 (86%) males and 3 (14%) females. Histology types were: adenocarcinoma in 8 patients (38%), large cell carcinoma in 1 patients (5%) and squamous cell carcinoma in 12 patients (57%). The majority of the patients had and ECOG PS of 1. Eight patients (38%) did not complete six cycles of gemcitabine-navelbine. The median number of cycles of gemcitabine-navelbine was 4 (range 2-6) Of the 13 patients (61%) who completed six cycles of gemcitabine-navelbine, all of them went on to receive weekly docetaxel and received at least 3 cycles, with a median number of 8 cycles (range 3- 16). The overall response rate was 33%. Respect survival, the minimum follow-up was 6 months (range, 6-25 months). The median survival time (MST) was 7.9 months, and the 1-year survival was 30%, and the median progression-free survival was 4.7 months. Toxicity was mild, well tolerated and mostly hematologic. In the GEM/VNR cycle, grade 3/4 neutropenia occurred in 14%, two patients with febrile neutropenia. Grade 3 anaemia in 1 patients (5%) and grade 3 thrombocytopenia in 1 patient (5%). Nonhematologic toxicity was also mild: 1 patient with Grade 3 skin toxicity with docetaxel, 1 patient with grade 3 infection, 2 patients with grade 3 astenia and 1 patient with a mild allergic reaction postchemotherapy treatment with docetaxel. Conclusion. The sequential triplet nonplatinum chemotherapy consisted of GEM/VNR followed by weekly DOC is active and can be administered safely in advanced NSCLC. Our results are similar with other sequential regimens and did not represent a significant improvement in the treatment of this disease.
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Antimetabolitos Antineoplásicos/administración & dosificación , Antineoplásicos Fitogénicos/administración & dosificación , Antineoplásicos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Desoxicitidina/análogos & derivados , Neoplasias Pulmonares/tratamiento farmacológico , Taxoides/administración & dosificación , Vinblastina/análogos & derivados , Adenocarcinoma/tratamiento farmacológico , Adenocarcinoma/patología , Anciano , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Carcinoma de Pulmón de Células no Pequeñas/patología , Carcinoma de Células Escamosas/tratamiento farmacológico , Carcinoma de Células Escamosas/patología , Desoxicitidina/administración & dosificación , Docetaxel , Femenino , Estudios de Seguimiento , Humanos , Pulmón/patología , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Análisis de Supervivencia , Factores de Tiempo , Vinblastina/administración & dosificación , Vinorelbina , GemcitabinaRESUMEN
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Backbround. In this Phase I/II trial, the maximumtolerateddose (MTD) and activity of cisplatin plusvinorelbine (VRL) administered in continuous infusionas first-line treatment of advanced non smallcell lung cancer (NSCLC) was determined in 12consecutive chemotherapy-naive patients with advancedNSCLC.Patients and methods. The dose of cisplatin was100 mg/m2 in all patients, and vinorelbine was administeredas an initial intravenous (iv) bolus of 8mg/m2 on day 1 followed by a 4-day continuous ivinfusion at 4 different 24 h dose levels (DLs) to berepeated every 21 days. All 12 patients (47 cycles)were evaluable for response and toxicity.Results. The MTD was 8 mg/m2 bolus followed by acontinuous iv infusion of 8 mg/m2 per day over 4days. The dose limiting toxicities (DLT) were febrileneutropenia in 4 patients and grade 3 mucositis in 1patient. There was less neuro-toxicity and comparedto the weekly bolus scheme. There was nosignificant cumulative toxicity after 3 cycles. Partialresponses were observed in 6 patients; an overall responserate of 50% (95% CI: 30-65%). Median time toprogression was 5,5 months (95% CI: 1,5-11 months)and median survival was 11 months (95% CI: 5-20months).Conclusions. The results demonstrate that, in thissetting of first-line treatment of NSCLC, cisplatinplus vinorelbine at 8 mg/m2 bolus followed by acontinuous infusion of 8 mg/m2 per day over 4 daysis the recommended schedule. Further trials wouldbe useful to establish activity of this combination
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Humanos , Cisplatino/farmacocinética , Alcaloides de la Vinca/administración & dosificación , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Neoplasias Pulmonares/tratamiento farmacológico , Infusiones Intravenosas/métodos , Dosis Máxima Tolerada , Protocolos de Quimioterapia Combinada AntineoplásicaRESUMEN
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Bronchiolitis obliterans organizing pneumonia(BOOP) is a clinicopathologic syndrome withcharacteristic features. The diagnosis of BOOPrequires the presence of a combination of pathological,clinical, and radiological features. We reportthe case of a lung cancer patient with bronquiloalveolarcarcinoma (BAC) presenting withBOOP after chemotherapy with docetaxel andgemcitabine producing severe respiratory insufficiency,and simulating a progression of the tumor
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Masculino , Persona de Mediana Edad , Humanos , Neumonía en Organización Criptogénica/diagnóstico , Adenocarcinoma Bronquioloalveolar/complicaciones , Neoplasias Pulmonares/complicaciones , Insuficiencia Respiratoria/etiologíaRESUMEN
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Asunto(s)
Masculino , Anciano , Humanos , Neoplasias Cutáneas/secundario , Neoplasias Pancreáticas/patología , Tejido Subcutáneo/patología , PancreatectomíaRESUMEN
BACKGROUND: In this phase I/II trial, the maximum tolerated dose (MTD) and activity of vinorelbine administered in continuous infusion as first-line treatment for advanced non-small-cell lung cancer (NSCLC) was determined in 25 consecutive chemotherapy-naive patients with advanced NSCLC. PATIENTS AND METHODS: Vinorelbine was administered as an initial intravenous (I.V.) bolus of 8 mg/m(2) on day 1 followed by a 4-day continuous I.V. infusion at 5 different 24-hour dose levels to be repeated every 21 days. All 25 patients (159 cycles) were evaluable for response. The MTD was 8 mg/m(2) bolus followed by a continuous I.V. infusion of 11 mg/m(2) per day over 4 days. RESULTS: The dose-limiting toxicities were febrile neutropenia in 6 patients and grade 3 mucositis in 2 patients. There was less neurotoxicity and constipation and more mucositis compared with the weekly bolus scheme. There was no significant cumulative toxicity after 3 cycles. Treatment responses were observed in 6 patients: 1 complete response and 5 partial responses. The overall response rate was 24% (95% confidence interval [CI], 8%-40%). Median time to progression was 4 months (95% CI, 2-11 months), and median survival was 6 months (95% CI, 2-18 months). CONCLUSION: The results demonstrate that, in this setting of first-line treatment of NSCLC, vinorelbine administered as an 8 mg/m(2) bolus followed by a continuous infusion of 11 mg/m(2) per day over 4 days is the recommended schedule. Further trials are necessary to establish activity and possible benefits of combination with other agents.