Treatment Patterns Among Patients with Metastatic and/or Unresectable Gastric Cancer in Brazil.

PURPOSE: In Brazil, patients with gastric cancer have not been systematically followed-up and evaluated, thus data regarding patterns of care and outcomes are scarce or missing. The objective of this study was to evaluate patterns of care of advanced gastric cancer in standard practice in Brazil. METHODS: This was an observational, multicenter, retrospective study, which included patients with metastatic and/or unresectable gastric cancer (MGC) who underwent at least one line of treatment. RESULTS: We analyzed data on 155 patients diagnosed with MGC, most are men (57.4%), with mean age of 61.9 years at diagnosis, with 99 (63.9%) from the public healthcare system and 56 (36.1%) from the private setting. Platinum- and/or fluoropyrimidine-containing regimens prevailed as first-line therapy, while irinotecan was the most used regimen in the second and in the third lines. More than 40% of patients underwent only one line of systemic therapy, of which around 40% either died during the treatment or went on to best supportive care (BSC) only. The remaining patients received further treatment lines. A fifth of the patients in the study died within two months after discontinuation of the first-line treatment. Adverse events, use of concomitant medications, support procedures, outpatient visits, and hospitalizations were reported for most patients, especially in the first and second lines of treatment and during exclusive BSC. CONCLUSIONS: Survival during or after the first-line chemotherapy remains poor among patients with MGC. Adverse events and health resource use were common in the first and second lines of treatment and in exclusive BSC. These results suggest that there is space for improvement in the treatment of MGC in Brazil.

Randomized phase III trial of single-agent pemetrexed versus carboplatin and pemetrexed in patients with advanced non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status of 2.

PURPOSE: To compare single-agent pemetrexed (P) versus the combination of carboplatin and pemetrexed (CP) in first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. PATIENTS AND METHODS: In a multicenter phase III randomized trial, patients with advanced NSCLC, ECOG PS of 2, any histology at first and later amended to nonsquamous only, no prior chemotherapy, and adequate organ function were randomly assigned to P alone (500 mg/m(2)) or CP (area under the curve of 5 and 500 mg/m(2), respectively) administered every 3 weeks for a total of four cycles. The primary end point was overall survival (OS). RESULTS: A total of 205 eligible patients were enrolled from eight centers in Brazil and one in the United States from April 2008 to July 2011. The response rates were 10.3% for P and 23.8% for CP (P = .032). In the intent-to-treat population, the median PFS was 2.8 months for P and 5.8 months for CP (hazard ratio [HR], 0.46; 95% CI, 0.35 to 0.63; P < .001), and the median OS was 5.3 months for P and 9.3 months for CP (HR, 0.62; 95% CI, 0.46 to 0.83; P = .001). One-year survival rates were 21.9% and 40.1%, respectively. Similar results were seen when patients with squamous disease were excluded from the analysis. Anemia (grade 3, 3.9%; grade 4, 11.7%) and neutropenia (grade 3, 1%; grade 4, 6.8%) were more frequent with CP. There were four treatment-related deaths in the CP arm. CONCLUSION: Combination chemotherapy with CP significantly improves survival in patients with advanced NSCLC and ECOG PS of 2.