Background: Amrubicin is one of the most active chemotherapeutic agents for small-cell lung cancer (SCLC). Previous studies reported its effectiveness and severe hematological toxicity. However, the efficacy of amrubicin monotherapy in elderly patients with SCLC has not been described. The objective of this study was to investigate the feasibility of amrubicin monotherapy in elderly patients, and its efficacy for relapsed SCLC. Method: A retrospective cohort study design was used. We retrospectively evaluated the clinical effects and adverse events of amrubicin treatment in elderly (70 years) SCLC patients with relapsed SCLC at one of four Japanese institutions

These data demonstrate that the acarbose/metformin FDC is bioequivalent to the loose combination of these agents. Although acarbose slightly reduced the bioavailability of metformin, the accumulated evidence of the efficacy of this combination implies that this is clinically irrelevant. The observed AE profile was consistent with the established knowledge on the safety of the two drugs.

No abstract

No abstract

EGFR-TKI failure. Patients were randomly assigned to receive either an osimertinib [80 mg/day 1-21; q3w] or a combination of osimertinib [80 mg/day 1-21] with carboplatin/pemetrexed [area under the curve (AUC) ¼ 5 and 500 mg/m 2 day 1; q3w]. The primary endpoint was progression-free survival (PFS). Secondary endpoints included incidence of adverse events, response rate and overall survival. As indication of osimertinib was expanded to a first line during this study, we amended the protocol to discontinue the enrollment and perform final analyses. Results: From October 2016 to January 2019, 62 patients were enrolled [31 patients osimertinib; 31 patients combination] (median age 68 (range 37-80); 53.2% male; 83.3% stage IV; 100% adenocarcinoma; 59.7% exon 19 deletion and 40.3% L858R; 45.2% never smoker). Median PFS was 15.8 months for the osimertinib arm and 14.6 months for the combination arm [hazard ratio (HR) 1.09 (95%CI: 0.51-2.32), P¼0.83]. Median survival times have not been reached in both arms [hazard ratio (HR) 2.42 (95%CI: 0.82-7.15), P¼0.10]. Response rate was 71.4% in the osimertinib and 53.6% in the combination arm. The rate of grade (G) 3 treatment-related adverse events was 45.2% in the osimertinib arm and 83.9% in the combination arm. Neutropenia, anemia and thrombocytopenia were more common in the combination arm and the rates of G 3 were 9.7%, 0% and 6.4% in the osimertinib arm and 51.6%, 25.8% and 29.0% in the combination arm, respectively. One episode (3.2%) of G 3 febrile neutropenia in the combination arm and two episodes (6.5%) of G 3 pneumonitis in the osimertinib arm were observed, however, these were well managed. Any unknown adverse event was not observed in the combination arm, while, more cases of dose reduction or treatment discontinuation were found in the combination arm mainly due to sustained hematological toxicities and intolerable adverse events related with skin-mucosal lesions. Median exposure to osimertinib in the combination arm was thereby shorter (350 days (range 7-938)) than those in the osimertinib arm (442 days (range 35-1050)). Conclusion: This is the first randomized study to investigate the efficacy as well as safety of combination of osimertinib and chemotherapy in NSCLC patients with EGFR sensitizing mutation. Our study did not meet primary endpoint and this could be explained by reduced exposure of osimertinib in patients of the combination arm.