BackgroundTrastuzumab emtansine (T-DM1) was studied in the EMILIA trial as a second line of treatment for HER-2 positive metastatic breast cancer (MBC), following the trastuzumab-taxane first-line scheme. However, the demonstration of the superiority of pertuzumab-trastuzumab-taxane as the first line of MBC after the CLEOPATRA trial, means that T-DM1 is currently used in a different scenario from the one studied in the EMILIA.PurposeOur objective is to provide more real-world data of the efficacy of T-DM1 in specific subgroups of patients, in order to know which patients will benefit more from T-DM1 therapy.Material and methodsA retrospective, longitudinal, observational study was conducted between December 2016 and September 2017. Patients who started T-DM1 for MBC between October 2014 and September 2017 were included. Patients who had received T-DM1 in clinical trials were not included.Data collected weredemographic data, previous treatments for MBC, Eastern Cooperative Oncology Group (ECOG) status at baseline, hormone receptor status, dates of therapy start, progression and discontinuation, and adverse events. Subsequently, data were analysed with Stata14®.ResultsThirty-one patients were included. 32.3% of them had a hormone-sensitive tumour. The median of previous treatments for the MBC was 2 (range 0–6). Median progression-free survival (PFS) for all patients was 4.14 months (9.6 months in EMILIA). 38.7% of patients had a serious haematological adverse event.19.3% had previously received trastuzumab-pertuzumab-taxane. They achieved a median PFS of 2.86 months, compared to 4.47 months for non-treated patients.35.5% of patients were previously treated with more than one previous scheme. They had a median PFS of 3.88 months, compared to 6.37 for more pretreated patients.ConclusionThere may be a profile of patients who respond in an excellent manner to T-DM1, as others appear not to have a good response.This could be related to the number of previous regimens received and number of different regimens. It seems not to be related, in our study, with ECOG or age at the beginning of treatment.Characterising patients prior to initiating therapy may be complex but advisable to obtain optimal results with the therapy chosen.No conflict of interest
Four patients presented haematologic toxicity, grade 3 neutropenia, requiring G-CSF, treatment delay was only required in one of them.Other AE: grade 2 anaemia treated with erythropoietin (n=1), grade 2 thrombocytopenia (n=1), respiratory infections (n=2; one patient with hypogammaglobulinaemia previous to treatment required hospital admission and treatment suspension).By the time the study was finished, effectiveness was evaluated in four up to six patients that finished treatment: complete response (n=3) and partial response (n=1). Conclusion In our experience, the obinuzumab-chlorambucil scheme presented a good safety profile in patients with comorbidities. The main AE were IRRs: limited to first administration that did not require treatment suspension; and neutropaenia, which was the most frequent haematologic toxicity.Regarding response, a continuous monitoring is necessary to confirm long-term effectiveness. REFERENCES AND/OR ACKNOWLEDGEMENTSNo conflict of interest.
BackgroundHereditary haemorrhagic telangiectasia (HHT), also known as Osler–Weber–Rendu disease, is a rare, vascular, autosomal dominant disorder. Telangiectasias and arteriovenous malformations (AVMs) of the lung, liver and CNS are vascular lesions present in HHT, most commonly causing epistaxis and gastrointestinal bleeding. The diagnosis is based on the Curaçao criteria. Recently, the epistaxis severity score (ESS) was created as a standardised measure to estimate the degree of epistaxis.PurposeTo describe the effectiveness and safety of treatment with intranasal bevacizumab in HHT.Material and methodsA 42-year-old woman with HHT presented with the chief complaint of frequent episodes of epistaxis. She had undergone gingival mucosa cauterisation 10 years ago and it resolved oral bleeding. Iron studies showed anaemia of iron deficiency from chronic blood loss. Initially her anaemia was treated with oral ferroproteinsuccinylate. This treatment failed; consequently, physicians replaced her treatment with intravenous iron. She received 4 blood transfusions in 2 years. Arterial embolisation was carried out in February 2015; it was unsuccessful.ResultsBecause of the frequent epistaxis (ESS 6.76) and varying haemoglobin (Hb) levels (Hb range 7.7–9.9) her physicians sought treatment with intranasal bevacizumab. This treatment was prepared at the hospital pharmacy department with Avastin 400 mg/16 mL vial in a laminar flow hood. Placed in a nasal spray bottle were 2.5 mL (25 mg). Each bottle was discontinued after 21 days; physicochemical properties were stable during the treatment period (21 days). The dosage was given twice a day for 2 consecutive months. Nasal treatment seemed to control her epistaxis and no adverse effects were reported. She had only a few minor episodes of epistaxis, which were easily controlled. Hb reached normal levels (Hb range 12.8–14.1) and currently iron treatment is not necessary.ConclusionVascular endothelial growth factor is a key pathogenic factor that acts to increase and maintain vascular density. To avoid the systemic adverse effects of bevacizumab, intranasal treatment, by either submucosal injection or topical nasal spray, has recently been reported to be a safe alternative to intravenous injection for nose bleeds.Intranasal bevacizumab is an effective and safe treatment for severe epistaxis in patients with HHT. This therapy reduces epistaxis severity and frequency.No conflict of interest
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