This was a single-arm surveillance study with no control group, no strictly defined period of observation, and no patient selection criteria. The duration of tumor response assessment was
not defined because the primary endpoint of POLARSTAR was to identify the onset of interstitial lung disease and to examine the factors that seem to affect PF-01367338 occurrence in Japan. In the POLARSTAR study population, 20.8% of the patients were ≥75 years old; given the high proportion of elderly lung cancer patients in the general population in Japan and worldwide, this number was lower than might be expected, which suggested that some potential selection bias for age existed. However, as the study includes all patients who received erlotinib over a 23-month period, including patients with poor ECOG PS and comorbidities who
would usually be excluded from clinical trials, it can be considered to reflect real-world clinical practice in Japan during the study period. The efficacy of erlotinib treatment for elderly patients (≥75 years) with previously treated NSCLC was click here not numerically inferior to that seen in younger patients, and the tolerability was similar between age groups. Erlotinib could be considered as a treatment option for elderly patients with NSCLC, as for younger patients. This trial was designed, funded, and monitored by Chugai Pharmaceutical Co., Ltd. Data were gathered, analyzed, and
interpreted by Chugai with input from all authors. The corresponding author had full access to the relevant data and took full responsibility for the final decision to submit the report for publication. Dr Yoshioka, Komuta, and Imamura received honoraria outside of this study from Chugai Pharmaceuticals Co. Ltd. Dr Fukuoka and Dr Kudoh received personal fees from Chugai Pharmaceuticals Co. Ltd. as members of an independent advisory board for erlotinib. Mr Seki is an employee Montelukast Sodium of Chugai Pharmaceuticals Co. Ltd. Medical writing assistance was provided by Emma McConnell of Gardiner-Caldwell Communications, and was funded by Chugai Pharmaceutical Co. Ltd. The authors would like to thank all patients who participated in the study and clinical personnel involved in data collection. “
“Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related deaths in the United States with brain metastasis as one of the most dreaded complications [1]. Historically, the prognosis of NSCLC with brain metastasis has been poor, with a median overall survival of 4.5 months for patients treated with standard whole brain radiation therapy (WBRT) and 4–11 weeks in untreated patients [2] and [3]. The prevalence of brain metastasis in NSCLC is reported to be increasing, possibly due to improved diagnosis in brain imaging and prolonged survival with new systemic treatment options [4].