Bennouna J.,Institute Of Cancerologie Of Louest |
Havel L.,University Hospital Bulovka |
Krzakowski M.,Center of Oncology of Poland |
Kollmeier J.,Lungenklinik Heckeshorn |
And 16 more authors.
Clinical Lung Cancer | Year: 2014
Background The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer (NSCLC) regardless of histologic subtype. NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous (NS) NSCLC by assessing the feasibility of this doublet (ratio 1:2) in an investigational approach. A reference arm with pemetrexed plus cisplatin was included. Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC. Patients and Methods Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m and cisplatin 75 mg/m on day 1 (arm A) or oral vinorelbine 80 mg/m on days 1 and 8 (first cycle 60 mg/m) and cisplatin 80 mg/m on day 1 (arm B). After 4 cycles, patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine. Results Overall, 153 patients were randomized (arm A/arm B: 51/102). Disease control rate (%) for arm A was 76.5 (95% confidence interval [CI], 62.5-87.2) and for arm B it was 75.0 (95% CI, 65.3-83.1), Response rates for arm A were 31.4% (95% CI, 19.1-45.9) and for arm B were 24.0% (95% CI, 16.0-33.6). Median progression-free survival for arm A was 4.3 months (95% CI, 3.8-5.6) and for arm B it was 4.2 months (95% CI, 3.6-4.7). Median survival for arm A was 10.8 months (95% CI, 7.0-16.4) and for arm B it was 10.2 months (95% CI, 7.8-11.9). Main grade 3/4 hematologic toxicities were neutropenia 18.3% (arm A) and 44.0% (arm B), whereas febrile neutropenia was reported in 2% of patients in each arm. Conclusion Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin, coupled with an acceptable safety profile. © 2014 Elsevier Inc. All rights reserved.
Palini S.,Ospedale Cervesi |
De Stefani S.,Ospedale Cervesi |
Scala V.,Ospedale Cervesi |
Dusi L.,Ospedale Cervesi |
Bulletti C.,Ospedale Cervesi
Annals of the New York Academy of Sciences | Year: 2011
Within the past few years, developmental scientists have switched their attention from the study of DNA sequencing to the epigenetic state of the genome. Studying epigenetics could present the key to understanding gene expression changes without altering the basic structure of DNA. For example, the blastocyst, trophectoderm, and inner cell mass grow within the same environment, having the same genome, but differentiate differently. Each stage of embryo development is characterized by a specific epigenetic pattern. These modifications give the embryos the ability to interact with the uterus. Gene expression profiles change dramatically, and chromatin remodeling allows for core histone elements to undergo significant modifications. In the past, epigenetic mechanisms were studied using less accurate technologies such as PCR techniques and gel electrophoresis. Today microarray, DNA analyzers, and other in silico approaches give us the capability to understand the epigenetic impact on differentiation and cell fate. © 2011 New York Academy of Sciences.