Article Document Academic Article Information Content Entity Continuant Continuant Journal Article Entity Entity Generically Dependent Continuant 2025-05-08T00:01:14 RDF description of Phase II study of biweekly carboplatin, gemcitabine, and bevacizumab as first-line treatment in patients with stage IIIB/IV NSCLC - http://repository.healthpartners.com/individual/document-rn6949 public Lung Cancer 10846 document-rn6949 10.1097/COC.0b013e31826b9e12 Chemotherapy Clinical Trials Prospective Studies Adverse Effects 37 2022-02-21T22:48:57.408-06:00 16272 American Journal of Clinical Oncology Drugs and Drug Therapy 2 Phase II study of biweekly carboplatin, gemcitabine, and bevacizumab as first-line treatment in patients with stage IIIB/IV NSCLC <p>BACKGROUND: This study was initiated to assess the safety and efficacy of biweekly carboplatin and gemcitabine with bevacizumab in treatment-naive patients with advanced and metastatic non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: An open-label, nonrandomized phase II clinical trial was conducted. Treatment consisted of a biweekly cycle of gemcitabine, carboplatin, and bevacizumab for a maximum of 6 cycles. If no disease progression or intolerable side effects were observed, maintenance therapy with bevacizumab was continued until disease progressed. Progression-free survival, overall survival (OS), objective response rate, and the safety and tolerability of the therapy were assessed. RESULTS: Treatment was administered to 35 patients with stage IIIB/IV NSCLC. Median age of the patients was 64.5 years, with 58% being male. Median number of cycles of treatment was 6 (range, 4 to 28 cycles); median number of days of treatment was 117 days (range, 43 to 451 d). Sixty-six percent of patients experienced grade >/=3 toxicities. Hypertension (19%) was the most common adverse event. Pulmonary hemorrhage (3%) and pulmonary abscess (3%) were the causes of treatment-related deaths. There were 48% patients with partial response, 23% with stable disease, and 29% with progressive disease. Median progression-free survival was 2.6 months [95% confidence interval (CI), 1.6-3.4], and median OS was 13.4 months (95% CI, 8.4-24). The 2-year OS rate was 30% (95% CI, 12%-51%). CONCLUSIONS: Biweekly therapy with combination of carboplatin, gemcitabine, and bevacizumab in advanced inoperable NSCLC provided limited benefit and was associated with excessive toxicity. Further testing of this regimen is not recommended. CLINICALTRIALSGOV IDENTIFIER: NCT00400803.<p>