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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e21023-e21023
    Abstract: e21023 Background: Ipilimumab (Ipi) is the first agent in metastatic melanoma treatment that achieved long-term efficacy in selected patients. Nivolumab (Nivo) is one of agents, PD-1 inhibitors, that change treatment paradigm of advanced melanoma due to improving OS for lots of patients. There is still needed to evaluate efficacy of this drugs in regular medical settings. Methods: 43 patients with advanced melanoma were treated in SPb Clinical Oncology Dispensary from 2014 till now: 16 male and 27 female, median age is 58y.o. (from 39 to 84). 31 patients received Ipi, 12 patients received Nivo. Almost of patients are progressed after 1-4 lines of previous systemic therapy before starting treatment with Ipi or Nivo. Initial performance status (PS) assessed by ECOG scale was following; 1 patient had PS = 0 by ECOG, 37 patients – PS = 1 by ECOG and 5 patients had PS = 2 status by ECOG. Adverse events (AEs) are collected according to CTC AE v4.03. Results: At the time of analysis median FU is 25.75 month (95% CI: 6,6-35.9). The most frequently reported AEs are: pruritis 20%, fatigue 10%, diarrhea 7%, hepatitis 4%. 6% of AEs are grade 3/4. There are no any infusion reactions to Ipi and Nivo. Ipilimumab: median PFS is 6.0 month (95% CI: 4.9;7.1), 19% of patients (n = 6) have no PD at the moment. Median OS is 12.0 months (95% CI: 9.7;14.3), 29% of patients are still alive (n = 9). 6-months OS is 81%, 1-year OS is 35%. Nivolumab: Only 3 from 12 patients have PD after Nivo on the time of analysis. Median PFS and OS is not reached: 10 patients are still alive. 1-year OS is 83,33%. 52% of patients have reported AEs. Conclusions: Efficacy and tolerability of Ipi and Nivo in our clinical practice is similar to data from international clinical studies. The treatment with Ipi and Nivo is not associated with drug related infusion reactions and immediate AEs and doesn’t require supervision of patients at in-patient departments.Ipi and Nivo treatment is safe, could be used on out patients’ basis in regular medical settings.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e15570-e15570
    Abstract: e15570 Background: Ramucirumab is the first anti-angiogenic targeted agent to demonstrate improved survival as monotherapy or in combination with CT among patients with disseminated stomach cancer. Methods: Under our supervision there were 24 patients: 12 men (50%) and 12 women (50%), from 29 to 72 years old, the median age was 52 years (95% CI 43.56-60.32). The median time to diagnosis of the 4th stage of the disease was 2 months (95% CI 0-11.44). All patients received 1 line of treatment; the median duration of 1-line therapy was 5 months (95% CI 4.00-6.83). Results: The duration of therapy with ramucirumab ranged from 2 to 16 months; median duration was 5.0 months (95% CI 3.00-7.44). The therapy with ramucirumab in 11 patients (45.83%) was followed by SD, in 3 patients (12.50%) - PR, in 4 patients (16.67%) - PD, and in 6 patients (25 , 00%) assessment of the effectiveness of therapy was not conducted due to the deterioration of the general condition during treatment. Thus, the ORR was 58.33%. The median overall survival was 18 months (95% CI 14–23). In order to identify adverse factors affecting overall survival, we constructed a Cox's regression model showing the dependence of overall survival on unfavourable prognosis factors. In general, the constructed model was reliable - p = 0.0013. The gender of the patients (p = 0.0642), the time before staging the 4th stage of the disease (p = 0.4312) and the duration of the 1st line therapy (p = 0.8675) did not have a significant effect on the survival of patients. Such factors as the patients' age (p = 0.0121), the localisation of the primary tumor (p = 0.0441), the differentiation of the tumor (p = 0.0095), the fact of removal of the primary tumor (p = 0.0133) had a significant impact, general status on the ECOG scale (p = 0.0250), the presence of anemia (p = 0.0192), damage to the peritoneum (p = 0.0022) and damage to metastases of more than 3 organs (p = 0.0062). Conclusions: An increase in OS in patients who received a combination of ramucirumab and paclitaxel can be considered clinically significant for this patient population and will allow considering this therapeutic regimen as a new standard of second line treatment of patients with poor prognosis of gastric cancer.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 3
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e16529-e16529
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e16529-e16529
    Abstract: e16529 Background: Aproximetly 16 % of patients with metastatic gastric cancer (GC) have HER2+ tumors. With localized stages, the detection rate of HER2+ is known to be lower. Addition of trastuzumab (T) to chemotherapy (CT) improved survival in metastatic, HER2+ GC. Unlike the metastatic disease, Her-2 did not represent an independent prognostic biomarker for early stages during exploratory analysis of MAGIC trial. The aim of the study was to compare human epidermal growth factor receptor 2 (HER2) expression before and after trastuzumab-based chemotherapy in patients with locally advanced HER2-positive gastric cancer, to evaluate the contribution of trastuzumab to the effectiveness of neoadjuvant treatment in this rare patient population. Methods: We assessed HER2 expression using immunohistochemistry in pre-treatment biopsied specimens and post-treatment resected specimens obtained from 10 patients with locally advanced HER2-positive (3+) gastric cancer receiving trastuzumab-based neoadjuvant chemotherapy: 8 men (80%) and 2 women (20%), from 30 to 80 years old, the median age was 63,5 years. Included 7 patients with resectable adenocarcinoma of the stomach and 3 patients with adenocarcinoma of the esophageal-gastric junction. All patients received neoadjuvant therapy with trastuzumab (100%) + chemotherapy: FLOT (2 patients), FOLFOX (7 patients), XELOX (1 patient). All patients underwent R0 gastrectomy. Tumor regression grading (TRG) after treatment were determined according to Mandard system. Results: Two patients showed a complete pathomorphological response of the tumor (20%,TRG1), therefore, the determination of postoperative HER2 status was not possible. Two patients (20%) maintained the HER2-positive status and six patients (60%) had a change in HER2 expression from positive to negative. Three patients had a (y)pT3 and 5 had a (y)pN+ tumor. Basing on histological changes the tumor regression TRG3 ( 〈 10% residual tumor cells) was observed in 5 patients (50%). TRG 4-5(preponderance of tumor cells/tumors without changes of regression) observed in 3 patients (30%). The follow-up period is too short for disease-free survival or overall survival to be assessed. Conclusions: HER2 expression can change after trastuzumab-based chemotherapy in patients with locally advanced HER2-positive gastric cancer. Continuous monitoring of HER2 expression after neoadjuvant treatments may be utilized to determine whether the continued use of trastuzumab is advisable.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e22009-e22009
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e22009-e22009
    Abstract: e22009 Background: According to the clinical studies, the frequency of melanoma brains metastasis reaches 43%, and according to autopsy data, this percentage is even higher - up to 75%. New drugs in clinical practice has significantly improved the prognosis of the metastatic melanoma, however, patients with metastases in the brain are often excluded from large clinical studies, which limits the evidence base of the effectiveness of new therapy methods in this category of patients. Methods: 44 patients with advanced melanoma were treated in SPb Clinical Oncology Dispensary from 2012 till now: 19 male and 25 female, median age is 54y.o. (from 26 to 81). 31 (70%) patients received combination of BRAF and MEK inhibitors, 13 (30%) patients received only BRAF inhibitors. 26 (59%) of patients received target therapy (TT) as 1st line of therapy. Initial performance status (PS) assessed by ECOG scale was following; 8 patient had PS = 0 by ECOG, 29 patients – PS = 1 by ECOG and 6 patients had PS = 2/3 status by ECOG. 8 (18%) patients with brain metastasis has radiation before the TT: 6 patients received at least 1 session of stereotactic radiotherapy and 2 patients underwent radiation of the entire brain. Results: Group of patients without brain metastases: median PFS is 10.0 month (95% CI: 6.0;15.0). The average PFS is 16,90 ± 3,19 month (95% CI:10,64;23,16). Median OS is 15.0 months (95% CI: 11.0;64.0). The average OS is 33,16 ± 5,89 month (95% CI: 21,62 – 44,70). Group of patients with brain metastases: median PFS and OS is not reached. The average PFS is 17,86 +/- 3,3 month (95% CI: 11,42-24,33). The average OS is 20,31 ±2,86 month (95% CI: 14,71 - 25,92). Only 3 from 8 patients have PD after TT on the time of analysis. 5 patients are still alive. Conclusions: Our clinical experience demonstrates comparable efficacy of TT (PFS and OS) in patients with melanoma, regardless of the presence of metastatic brain disease. In the treatment of this category of patients, an integrated approach is very important, including both the use of targeted drugs and the conduct of surgical and radiotherapy. An equally important factor is the rapid onset of treatment.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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