ABSTRACT
PURPOSE: The purpose of the present phase 11 trial was to determine the efficacy and toxicity of vinorelbine-gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: From December 1997 to February 1999, 78 chemotherapy-naive patients (median age 60 years, Karnofsky performance status of 100, 90, 80 and 70 present in 5%, 41%, 36% and 18% of the patients, respectively) with stage IIIB (17%) or IV (83%) NSCLC (65% adenocarcinomas, 22% squamous-cell carcinomas, 10% large-cell carcinomas, 3% mixed-cell carcinomas) received 25 mg/m2 vinorelbine and 1200 mg/m2 gemcitabine on days 1, 8 and 15 of a four-week cycle. RESULTS: In an intent-to-treat analysis, partial responses were seen in 19% of the patients. The median duration of response was 4.4 months. The median survival time was seven months and the one-year survival rate was 32%. Myelosuppression was the main side effect with WHO grade 3/4 neutropenia and thrombocytopenia in 35% and 11% of the patients, respectively. Other side effects were usually mild to moderate. CONCLUSIONS: Vinorelbine-gemcitabine is active, well tolerated and easy to administer on an outpatient basis in advanced NSCLC. Thus a randomized comparison of this combination with platinum-based protocols is warranted in patients with advanced NSCLC.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/drug therapy , Vinblastine/analogs & derivatives , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carcinoma, Non-Small-Cell Lung/pathology , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Female , Humans , Lung Neoplasms/pathology , Male , Middle Aged , Neutropenia/chemically induced , Survival Analysis , Treatment Outcome , Vinblastine/administration & dosage , Vinorelbine , GemcitabineABSTRACT
Staging of any tumor, i.e. determination of the extent of the disease, serves to select the patients who might profit from curative surgical intervention or to define those patients with inoperable carcinomas who should be referred for other therapies, such as chemotherapy or irradiation. Furthermore, accurate staging is necessary for assessment of prognosis, for radiation therapy planning, and for differentiation of those with small-cell lung cancer or for follow-up examinations of small-cell lung cancer patients after during and after chemotherapy. The primary radiological staging and diagnostic modalities for assessment of bronchial carcinomas are computed tomography (CT) of the thorax including liver and adrenal glands, abdominal sonography, and bone scintigraphy. Magnetic resonance imaging (MRI) should be reserved for specific indications, e.g. infiltration of the chest wall or staging of patients with intolerance/allergy to intravenous contrast medium. The clinical value of nuclear medicine techniques, such as [18F]2-fluoride-2-desoxy-D-glucose positron emission tomography (FDG-PET) for evaluation of lymph nodes and distant metastases, In-111 octreotide/somatostatin receptor scans for staging of small-cell lung cancer, and thallium-201 SPECT are currently being assessed in numerous studies, although these techniques are already in routine use. In future these or nuclear medicine techniques, as well as techniques using molecular-based contrast material, especially for MR imaging, currently in experimental status, may yield serious potential for staging purposes.
