Outcomes of primary and secondary breast diffuse large B-cell lymphoma in rituximab-era

Abstract

Background: We previously reported that low-dose erlotinib has a certain degree of efficacy with lower toxicity in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations (Eur J Cancer 2015). This multicenter phase II study was undertaken to investigate the efficacy and safety of lowdose erlotinib for those patients with frailty. Methods: Chemotherapy-naïve NSCLC patients with EGFR-mt who had frailty were enrolled and received erlotinib 50 mg/d. Dose escalation was allowed to those with stable disease after 4 weeks. Patient's frailty was defined as follows: (Group 1) 20 to 74 years of age with Eastern Cooperative Oncology Group performance status (PS)!2 or Charlson Comorbidity Index (CCI)!6 points; (Group 2) 75 to 80 years of age with PS ! 1 or CCI!6 points; (Group 3)!81 years of age with any PS and CCI. The primary endpoint was independent review committee (IRC)-confirmed objective response rate (ORR) to the low-dose erlotinib, with target ORR of 65% and threshold of 50% (SWOG two-stage design). Results: Eighty patients were enrolled between December 2014 and April 2017: males/ females 26/54; median age 80 (range 49-90); Group 1/2/3 15/28/37; Ad/Sq/Others 76/1/ 3. EGFR-mt types were: exon 19/21 42/38. All 80 patients were included in efficacy and safety analysis. The IRC-confirmed ORR was 60.0% (90%CI: 50.2-69.2%), and the primary endpoint was met. The disease control rate was 86.3% (90%CI: 78.3-92.1%). Median progression-free survival was 9.2 months. Although overall survival data are immature, median survival time and 1-year survival rate were 26.3 months and 68.9%, respectively. Toxicities were generally mild, with a few grade 3 or more toxicities. There was no case of interstitial lung disease or treatment-related death. Conclusion: This is the first prospective study evaluating low-dose erlotinib for frail patients with EGFR-mt NSCLC. Low-dose erlotinib is active and could be a treatment option for those patients. O2 À 11 À 5 Osimertinib for patients with EGFR T790M mutation-positive non-small-cell lung cancer who have poor performance status