PURPOSE Approximately 10% of patients with epidermal growth factor receptor (EGFR) mutation–positive non–small-cell lung cancer (NSCLC) harbor uncommon mutations. Here, we report the efficacy and safety of osimertinib in patients with NSCLC harboring uncommon EGFR mutations. PATIENT AND METHODS This was a multicenter, single-arm, open-label, phase II study in Korea. Patients with histologically confirmed metastatic or recurrent NSCLC harboring EGFR mutations other than the exon 19 deletion, L858R and T790M mutations, and exon 20 insertion were eligible for the study. The primary end point of objective response rate was assessed every 6 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary end points were progression-free survival, overall survival, duration of response, and safety. RESULTS Between March 2016 and October 2017, 37 patients were enrolled. All were evaluable except one patient who withdrew consent after starting treatment. Median age was 60 years, and 22 (61%) were male. Among patients, 61% received osimertinib as first-line therapy. The mutations identified were G719X (n = 19; 53%), followed by L861Q (n = 9; 25%), S768I (n = 8; 22%), and others (n = 4; 11%). Objective response rate was 50% (18 of 36 patients; 95% CI, 33% to 67%). Median progression-free survival was 8.2 months (95% CI, 5.9 to 10.5 months), and median overall survival was not reached. Median duration of response was 11.2 months (95% CI, 7.7 to 14.7 months). Adverse events of any grade were rash (n = 11; 31%), pruritus (n = 9; 25%), decreased appetite (n = 9; 25%), diarrhea (n = 8; 22%), and dyspnea (n = 8; 22%), but all adverse events were manageable. CONCLUSION Osimertinib demonstrated favorable activity with manageable toxicity in patients with NSCLC harboring uncommon EGFR mutations.
Toxicities resulting from platinum based chemotherapy in head and neck cancer is a cause for much concern. There is a lack of clinical criteria for defining these patient populations, which has posed serious problems associated with increased morbidity and consequently an adverse effect on patients' quality of life. In addition, there is a lack of consensus on clinical criteria for defining such patient populations, who may be unsuitable for concurrent chemoradiotherapy. A group of experts in the field of head and neck cancer from the Asia Pacific Region convened in August 2014 in Korea to discuss the development of a set of clinical criteria in order to fill the knowledge gap and provide a reference tool for head and neck oncologists. This paper reports the final output from this meeting and the accompanying literature review, with the aim of aiding clinical decision making with the help of some clinical criteria to identify platinum unsuitable patient populations in head and neck cancer management. Some alternative treatment options are also discussed in this paper.
Although enumeration of CD34+ cells in the peripheral blood (PB) on the day of apheresis predicts the quantity of those cells collected, the flow cytometric techniques used are complex and expensive, and several hours are required to obtain the result in the clinical practice setting. The Sysmex SE-9000 automated haematology analyzer provides an estimate of immature cells, called hematopoietic progenitor cells (HPC). The aim of this study was to evaluate the clinical usefulness of HPC in predicting the optimal timing of peripheral blood progenitor cells (PBPC) harvest. Studies were performed on 628 aphereses from 160 patients with hematologic or solid malignancies. Spearman's rank statistics was used to assess correlation between HPC, WBC, mononuclear cells (MNC), and CD34+ cells. A receiver operating characteristic (ROC) curve was drawn for cutoff value of HPC, and predictive values of the chosen cutoff value of HPC for different target CD34+ cell collections were calculated. The PB HPC had a stronger correlation (rho=0.592, p<0.001) with collected CD34+ cells than did PB WBC and PB MNC. The ROC curve showed that the best cutoff value of HPC was 50 x 10(6)/L for the target CD34+ cells > or =1 x 10(6)/kg with sensitivity of 75%. Positive and negative predictive values of HPC > or =50 x 10(6)/L for CD34+ cells > or =1 x 10(6)/kg were 59.7% and 81.1%, respectively. In the clinical practice setting, applying variable cutoff values of HPC would be a useful tool to predict the optimal timing of PBPC collection.
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