Objective: to compare the efficacy and toxicity of aflibercept and bevacizumab in combination with fOLfIRI in secondline therapy for patients with metastatic colon cancer.Materials and methods. we performed a retrospective analysis of data on patients with metastatic colon cancer treated in 9 clinics in the Russian federation. The inclusion criteria were as follows: metastatic or locally advanced colon cancer; treatment with bevacizumab or aflibercept plus fOLfIRI in the second-line therapy. The primary outcome measure was progression-free survival (PfS). Secondary outcome measures included objective response rate and incidence of adverse events.Results. A total of 271 patients with metastatic colon cancer who received second-line therapy with bevacizumab (n = 81) or aflibercept (n = 190) between 2014 and 2018 were selected for this study. Study groups were matched for main prognostic signs. The objective response rate was 18.1 % in the bevacizumab group and 20.5 % in the aflibercept group (p = 0.7). The median PfS was 5 months (95 % confidence interval 3.8–6.1) in the aflibercept group and 7 months (95 % confidence interval 0.81–2.1) in the bevacizumab group (hazard ratio 1.4; 95 % confidence interval 0.99–2.1; p = 0.04). multivariate regression analysis demonstrated that the type of the targeted drug independently had no effect on PfS (hazard ratio 1.3; 95 % confidence interval 0.9–1.9; p = 0.2). we observed no statistically significant differences in the incidence of complications of any grades between the groups (58 % vs 72 %, p = 0.1). Patients receiving aflibercept were more likely to develop grade III–Iv arterial hypertension (2 % vs 9.5 %) and diarrhea (0 % vs 5.4 %), whereas thrombotic complications were more common in the bevacizumab group (10 % vs 1.8 %).Conclusion. we observed no significant differences in objective response rate and PfS between patients with metastatic colon cancer receiving bevacizumab or aflibercept in combination with fOLfIRI as second-line therapy. The toxicity profiles were different. Our findings can be used for choosing an optimal targeted drug for second-line treatment.

Introduction. The standard of 1st line treatment of HER2+ metastatic breast cancer (mBC) is double blockade with trastuzumab and pertuzumab + taxane, 2nd line – Trastuzumab-emtazine. There are no standards for further treatment, as well as the optimal drug sequence. Expansion of the arsenal of therapeutic possibilities and the use of new combinations will certainly improve the results of treatment of this category of patients and increase their life expectancy.Aim. We sought to describe treatment patterns of eribulin and clinical outcomes of metastatic HER2-positive breast cancer treated with eribulin plus trastuzumab combination in academic institutions and community oncology practices across the Russian Federation.Materials and methods. Patients treated with eribulin anytime between Jan, 2014 and Sep, 2019 with a diagnosis of MBC were identified by 23 providers from Russia. Providers retrospectively reviewed the health records and abstracted selected data points into an electronic case report form for each eligible patient.Results. 100 HER2-positive pts received eribulin in combination with trastuzumab. Median age was 55 (31–80) yrs and ECOG status 0–3. 67% pts had visceral metastases. Eribulin was administered as 1st and 2nd line to 23 (23%) pts, 3rd line to 31 (31%) pts, 4th line and later to 46 (46%). Median number of cycles was 5 (2–27). ORR was 12%, SD – 72%, SD > 6 months – 23%, PD – 16%. Clinical efficacy rate achieved in 35%. Median PFS was 5.07 months (95% CI 4.021–6.119). According to the ER-status the response to eribulin and trastuzumab was different. ORR was 18.8%, SD 72.9% in pts with ER-positive MBC (n = 48) and 5.8% and 71.2% respectively in ER-negative MBC (n = 52). Median PFS was 6.97 months (95% CI 3.924–10.016) in pts with ER-positive MBC and 4.67 months (95% CI 3.841–5.499) in ER-negative MBC (р = 0.3). The combination was well tolerated: dose reductions were required in 12% pts, withdrawal due to toxicity in 4% pts. The most common type of toxicity was hematological with neutropenia Gr III-IV in 14 (14%) pts. Peripheral neuropathy Gr III was observed in 5 (5%) pts. No cardiotoxicity was detected.Conclusions. This is the real-life data of clinical outcomes for patients receiving eribulin plus trastuzumab for HER2-positive MBC throughout the Russian Federation. Our experience with eribulin plus trastuzumab demonstrates that this combination may be a potential effective treatment option for HER-2 positive MBC patients.

Background: First-line afatinib significantly improved progression-free survival (PFS) in pts with EGFR mutation-positive (EGFRm+) NSCLC (including uncommon mutations) vs chemotherapy (CT) in the LUX-Lung (LL) 3/6 trials (median 11.1 vs 6.9 mos; HR 0.58/11.0 vs 5.6 mos; HR 0.28) and vs gefitinib in LL7 (median 11.0 vs 10.9 mos; HR 0.73). However, in real-world (RW) practice CT remains a first-line choice. Here, we report an interim analysis of a Phase IIIb study of afatinib in treatment-naïve or CT pre-treated pts with EGFRm+ NSCLC, similar to RW practice. Methods: EGFR TKI-naïve pts with locally advanced/metastatic EGFRm+ NSCLC and ECOG PS 0–2 received 40 mg/day afatinib (starting dose). Dose reduction was permitted (to minimum 20 mg/day). Primary endpoint: adverse events (AEs) in a descriptive fashion. Efficacy was also assessed. Results: At data cut-off (30 April 2018), 479 pts were enrolled and treated with afatinib (Caucasian/Asian/other: 97%/2%/<1%; male/female: 34%/66%; 1st/2nd/≥3rd-line therapy: 78%/17%/5%; ECOG PS 0/1/2: 36%/57%/8%; brain metastases: 17%; common/uncommon mutations: 87%/13%). Median time on afatinib was 359 days. The most common grade ≥3 afatinib-related AEs were diarrhoea (16%) and rash (11%). AEs led to dose reduction in 258 (54%) pts (most frequently diarrhoea 25%; rash 11%) and to afatinib discontinuation in 105 (22%) pts (most frequently diarrhoea 3% [rash 0.8%]). Afatinib-related serious AEs occurred in 39 (8%) pts. Time to symptomatic progression (TTSP) and PFS are shown in the table. Objective response rate and disease control rate were 46% and 86%, respectively.Table115OMedian TTSP, months (95% CI)Median PFS, months (95% CI)All pts (n = 479)14.9 (13.8–17.6)13.4 (11.8–14.5)Line of therapy1st (n = 374)15.6 (14.1–18.5)13.8 (12.6–15.1)2nd (n = 81)14.7 (11.3–20.6)13.2 (8.3–17.7)≥3rd (n = 24)8.1 (3.7–14.4)6.6 (3.2–12.6)Baseline ECOG PS*Missing (n = 1);0 (n = 171)17.2 (14.8–19.8)15.4 (13.4–18.8)1 (n = 271)14.7 (13.0–18.7)12.9 (10.3–14.4)2 (n = 36)8.9 (5.7–13.2)6.2 (2.5–11.6)Baseline brain metastasesNo (n = 395)15.8 (14.1–18.8)13.9 (12.7–15.5)Yes (n = 83)13.7 (9.7–17.2)10.1 (8.2–13.9)Baseline mutation type*Missing (n = 1);Common†Del 19 and/or L858R with or without uncommon mutation; (n = 416)15.9 (14.5–19.1)14.1 (13.0–15.7)Uncommon‡Includes ex 20 ins, T790M, S768I, G719S/A/C, L861Q (n = 62)7.4 (5.7–9.0)6.0 (4.2–8.1)* Missing (n = 1);† Del 19 and/or L858R with or without uncommon mutation;‡ Includes ex 20 ins, T790M, S768I, G719S/A/C, L861Q Open table in a new tab Conclusions: Interim analysis of this study, which included pts treated with afatinib in later lines, and pts with ECOG PS 2, brain metastases and/or uncommon mutations, indicates a predictable and manageable safety profile for afatinib, consistent with the pivotal LL trials. Interim efficacy findings are encouraging, with a median TTSP of 14.9 months. Clinical trial identification: NCT01853826. Editorial acknowledgement: Robert Lorence of Boehringer Ingelheim assisted in the study concept, design and data analysis. Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Jessica Sturgess of GeoMed, an Ashfield company, part of UDG Healthcare plc, during the development of this abstract. Legal entity responsible for the study: Boehringer Ingelheim. Funding: Boehringer Ingelheim. Disclosure: M. Hochmair: Honoraria for speakers' bureau, advisory role: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, MSD, Novartis, Pfizer, Roche. M.R. Migliorino: Board of directors, consulting fees: Boehringer Ingelheim, Roche, MSD, Bristol-Myers Squibb, AstraZeneca, Pfizer; Honoraria: Boehringer Ingelheim, Roche, MSD, Bristol-Myers Squibb, AstraZeneca, Pfizer, Gentili. S. Rizzato: Honoraria for Advisory board: AbbVie. G.Z. Mukhametshina: Employment: Republic Clinical Oncology Dispensary. S. Novello: Honoraria for speaker bureau/advisory roles: Eli Lilly, Celgene, AstraZeneca, Boehringer Ingelheim, MSD, Roche, Bristol-Myers Squibb. R. Dziadziuszko: Honoraria: Roche, Pfizer, Boehringer Ingelheim, AstraZeneca, Foundation Medicine, Novartis. W. Tang, L. Clementi, A. Cseh: Employment: Boehringer Ingelheim. F. De Marinis: Advisory council/committee membership: Roche, Pfizer Honoraria: Roche, Bristol-Myers Squibb, AstraZeneca; Grants/funds: Boehringer Ingelheim. All other authors have declared no conflicts of interest.

Objective: to identify factors associated with efficacy of an aflibercept-chemotherapy combination in patients with metastatic colon cancer. Materials and methods. This retrospective multicenter study was conducted in 20 clinics from 15 regions of the Russian Federation. The main efficacy outcome was progression-free survival (PFS). We performed univariate and multivariate analysis to assess the impact of various factors of PFS. Results. Two hundred and fifty-seven patients received aflibercept-containing chemotherapy; of them, 175 participants (68.1 %) received it as a second-line therapy. The objective response rate and median PFS were 18.7% and 5 months (95% confidence interval (CI) 4.2—5.8) respec -tively. The following factors were found to have a positive effect of PFS at multivariate analysis: grade I—II adverse events to aflibercept therapy (hazard ratio (HR) 0.58; 95 % CI 0.38—0.89; p = 0.01), therapy for concomitant diseases (HR 0.47; 95 % CI 0.29—0.76; p = 0.002), and ECOG performance status of 0 (HR 0.53; 95 % CI 0.34—0.81; p = 0.004). Patient with all 3 factors present had median PFS of 9 months, whereas patients without them demonstrated PFS of only 3 months (HR 1.9; 95 % CI 1.5—2.6; p <0.001). Conclusions. Satisfactory performance status, adequate therapy for concomitant diseases, and adverse events to aflibercept therapy were associated with better PFS in patients receiving aflibercept-containing chemotherapy.

Background First-line afatinib significantly improved median progression-free survival (PFS) in pts with EGFRm+ NSCLC vs chemotherapy (CT) in LUX-Lung (LL) 3/6 (HR [95% CI]: 0.58 [0.43, 0.78]/0.28 [0.20, 0.39]), and vs gefitinib in LL7 (0.73 [0.57, 0.95]). We conducted a phase IIIb study of afatinib in a broader patient population, similar to real-world practice, of treatment-naive or CT pre-treated pts with EGFRm+ NSCLC. Here we present an interim analysis. Methods EGFR TKI-naive pts with locally advanced/metastatic EGFRm+ NSCLC and ECOG PS 0–2 received afatinib 40 mg/day; dose reduction was permitted (min. 20 mg/day). Primary endpoint: adverse events (AEs; descriptive fashion). Efficacy was assessed and post-hoc subgroup analysis conducted. Results 479 pts were included (data cut-off: 30/04/18): Caucasian/Asian: 97%/2%; female: 66%; 1st/2nd/≥3rd-line therapy: 78%/17%/5%; ECOG PS 0 or 1/2: 92%/8%; brain metastases: 17%; common/uncommon [C/U] mutations: 87%/13%. Median time on afatinib: 359 days. Objective response rate: 46%. Disease control rate: 86%. Median time to symptomatic progression (TTSP) and PFS were 14.9 (95% CI: 13.8, 17.6) and 13.4 (11.8, 14.5); subgroup analysis is in the table. Most common grade ≥3 afatinib-related AEs were diarrhea (16%) and rash (11%). AEs led to dose reduction in 258 (54%) pts (most frequently diarrhea 25%, rash 11%) and to afatinib discontinuation in 105 (22%) pts (malignant neoplasm progression 3%, diarrhea 3% [rash 0.8%]). Afatinib-related serious AEs occurred in 39 (8%) pts.Table482PTableTTSP, mosPFS, mosBaseline characteristic (n)Median95% CIMedian95% CILine of tx1 (374)15.614.1, 18.513.812.6, 15.22 (81)14.711.3, 20.613.28.3, 17.7≥3 (24)8.13.7, 14.46.63.2, 12.6MutationsaDel 19b (232)19.315.6, 21.815.913.9, 19.1L858Rb (162)14.512.7, 17.913.111.5, 15.2Uc (84)7.45.7, 9.06.04.2, 8.1ECOG PS, inc. mutations0–1 (442)a15.814.4, 18.813.812.8, 15.2Cb (364)18.215.5, 19.815.213.8, 17.7U (77)7.45.7, 9.76.64.6, 8.22 (36)8.95.7, 13.26.22.5, 11.6Cb (30)8.95.7, 13.97.73.9, 13.2U (6)7.00.9, 13.01.40.4, 6.0Brain metsaNo (395)15.814.1, 18.813.912.7, 15.5Yes (83)13.79.7, 17.210.18.2, 13.9aMissing n = 1.bDel 19/L858R only.cIncludes, n (%): ex 20 ins: 37 (44). Conclusions This analysis indicates a predictable and manageable safety profile for afatinib, consistent with the pivotal LL trials, and encouraging efficacy findings in this broad patient population. As expected, TTSP/PFS were longer for pts with ECOG PS 0/1 vs 2, and for pts with Del 19 or L858R mutations, vs those with uncommon mutations, which may be due to the high prevalence (44%) of pts with exon 20 insertions included in this study. Clinical trial identification NCT01853826. Editorial acknowledgement Christina Jennings of GeoMed, an Ashfield company, part of UDG Healthcare plc. Legal entity responsible for the study Boehringer Ingelheim. Funding Boehringer Ingelheim. Disclosure F. De Marinis: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Advisory / Consultancy: Takeda; Research grant / Funding (institution): Boehringer Ingelheim. M. Hochmair: Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck Sharp & Dohme; Advisory / Consultancy: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Speaker Bureau / Expert testimony: Pfizer. M.R. Migliorino: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: B.I.; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: ROCHE; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: PFIZER. G.Z. Mukhametshina: Advisory / Consultancy: Association of oncologists of Russian Federation; Full / Part-time employment: State Autonomous Healthcare Institution «Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan». M. Schumacher: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: AstraZeneca. S. Novello: Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: BI; Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: AbbVie; Advisory / Consultancy, Speaker Bureau / Expert testimony: Celgene; Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Takeda. R. Dziadziuszko: Honoraria (self): Pfizer; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Roche; Honoraria (self): MSD; Honoraria (self): Bristol-Myers Squibb. W. Tang: Full / Part-time employment: Boehringer Ingelheim. L. Clementi: Full / Part-time employment: Boehringer Ingelheim Italia SpA. A. Cseh: Full / Part-time employment: Boehringer Ingelheim. All other authors have declared no conflicts of interest.

Purpose. To assess the incidence and severity of adverse events; to explore clinical factors associated with grade 3–4 non-hematologic toxicity; to assess the immediate efficacy and progression-free survival during treatment with the FOLFIRI regimen in combination with aflibercept in Russia.Materials and Methods. A retrospective multicenter study has been conducted with data collected from 20 clinics in 15 regions of Russia. There was no statistical hypothesis. Progression-free survival was the main efficacy criterion. The statistical analysis was performed using IBM SPPS Statistics v. 20 software.Results. FOLFIRI and Aflibercept combination was administered to 264 patients. The mean number of treatment cycles was 6 (1 to 29). The toxicity of aflibercept was addressed by dose reduction and dosing delay in 10.1 % and 11.4 % of patients, respectively, and dose reductions and dosing delays in any of FOLIFRI components were reported in 20.1 % of participants. The objective response rate was 20.3 %. The median progression-free survival in patients receiving second-line treatment was 6 months (95 % CI: 5.3–6.6 months). Seventy-two percent of patients experienced any grade of adverse events most of which were limited to grade 1–2 (62.1 %). Non-hematologic toxicity was reported in 64 % of patients (grade 3–4 in 17.9 %). Hematologic events were detected in only 17.9 % of patients. Multifactorial analysis has shown that drug therapy for concomitant diseases (OR 1.98, 95 % CI: 1.04–3.78, p = 0.037) and the number of chemotherapy lines prior to aflibercept (ОR 1.5, 95 % CI: 1.06–2.11, p = 0.02) were independent predictors of grade 3–4 non-hematologic toxicity.Conclusions. Objective response rate, progression-free survival, and frequency of toxicity-related aflibercept discontinuations in the Russian study with patients receiving aflibercept in combination with FOLFIRI regimen as a second-line treatment has shown the results that were comparable with VELOUR study. Comorbidities requiring drug treatment and the number of prior chemotherapy lines appear to be risk factors for grade 3–4 nonhematological toxicity events.

First-line afatinib demonstrated significantly improved median PFS in patients with EGFR mutation-positive (EGFRm+) NSCLC versus chemotherapy in LUX-Lung 3/6 (HR [95% CI]: 0.58 [0.43–0.78]/0.28 [0.20–0.39]), and versus gefitinib in LUX-Lung 7 (0.73 [0.57–0.95]). Since these trials had strict inclusion criteria, it is important to support these findings with real-world studies of broader patient populations. We report interim results of a Phase IIIb study of afatinib treatment for EGFRm+ NSCLC in a patient population similar to real-world practice. EGFR TKI-naïve patients with locally advanced/metastatic EGFRm+ NSCLC, and ECOG PS 0–2, received afatinib 40 mg/day. Dose reduction was permitted (minimum 20 mg/day). Primary endpoint: adverse events (AEs; descriptive fashion). Efficacy was also assessed. At data cut-off (30-April-2018), 479 patients were enrolled and treated (Caucasian/Asian/other: 97%/2%/<1%; ECOG PS 0–1/2: 92%/8%; 1st/2nd/≥3rd-line therapy: 78%/17%/5%; common/uncommon mutations: 87%/13%; brain metastases: 17%). Median time on afatinib: 359 days. Objective response and disease control rates were 46% and 86%, respectively. Other efficacy outcomes are in the Table. The most common grade ≥3 afatinib-related AEs were diarrhoea (16%) and rash (11%). 258 (54%) patients had AEs leading to dose reduction (most frequently diarrhoea [25%]/rash [11%]), and 37 (8%) had TRAEs leading to discontinuation (most frequently diarrhoea [3%]; all others [<1%]). Serious afatinib-related AEs occurred in 39 (8%) patients.Tabled 1Median TTSP, months (95% CI)Median PFS, months (95% CI)All pts (n=479)14.9 (13.8–17.6)13.4 (11.8–14.5)Line of therapy1st (n=374)15.6 (14.1–18.5)13.8 (12.6–15.2)2nd (n=81)14.7 (11.3–20.6)13.2 (8.3–17.7)≥3rd (n=24)8.1 (3.7–14.4)6.6 (3.2–12.6)Baseline brain metastases*No (n=395)15.8 (14.1–18.8)13.9 (12.7–15.5)Yes (n=83)13.7 (9.7–17.2)10.1 (8.2–13.9)Baseline mutation type*Common† (n=416)15.9 (14.5–19.1)14.1 (13.0–15.7)Uncommon‡ (n=62)6.7 (5.4–8.3)5.9 (4.0–7.4)Baseline ECOG PS*, including age0–1 (n=442)15.8 (14.4–18.8)13.8 (12.8–15.2)<65 years (n=221)14.7 (12.7–17.6)13.4 (11.6–15.5)≥65 years (n=221)18.9 (14.7–21.7)14.1 (12.6–16.4)2 (n=36)8.9 (5.7–13.2)6.2 (2.5–11.6)<65 years (n=16)6.0 (2.4–13.2)3.2 (1.5–9.1)≥65 years (n=20)9.9 (7.6–13.9)7.7 (5.7–13.9)*Missing (n=1); †Del 19 and/or L858R with or without uncommon mutation; ‡Includes, n (%, of those with uncommon mutations): ex 20 ins: 37 (60), T790M: 12 (19), G719S/A/C: 12 (19), L861Q: 10 (16), S768I: 9 (15). TTSP, time to symptomatic progression; PFS, progression-free survival Open table in a new tab *Missing (n=1); †Del 19 and/or L858R with or without uncommon mutation; ‡Includes, n (%, of those with uncommon mutations): ex 20 ins: 37 (60), T790M: 12 (19), G719S/A/C: 12 (19), L861Q: 10 (16), S768I: 9 (15). TTSP, time to symptomatic progression; PFS, progression-free survival This interim analysis indicated predictable and manageable safety, and encouraging efficacy, with afatinib in a broad patient population. The high proportion of patients with tumours harbouring exon 20 insertions may account for the differences in TTSP/PFS by common/uncommon mutation subgroup. Independent of treatment line, median TTSP/PFS in patients with ECOG PS 0–1 (LUX-Lung trials' inclusion criteria) was 15.8/13.8 months, and, notably, was 18.9/14.1 months in those also aged ≥65 years. These findings by ECOG PS/age are consistent with those of the LUX-Lung trials.

The article presents a pooled experience of the use of eribulin in the real clinical practice of treatment of metastatic breast cancer in Russian oncological institutions. The effectiveness of the drug in monotherapy with HER2‑negative breast cancer was analyzed, groups of patients with most effective use of eribulin were identified depending on the localization of metastases, the most effective lines of therapy. The effectiveness of the drug in combination with trastuzumab in HER2‑positive breast cancer is described, as well as toxic reactions.

The article presents a pooled experience of the use of eribulin in the real clinical practice of treatment of metastatic breast cancer in Russian oncological institutions. The effectiveness of the drug in monotherapy with HER2‑negative breast cancer was analyzed, groups of patients with most effective use of eribulin were identified depending on the localization of metastases, the most effective lines of therapy. The effectiveness of the drug in combination with trastuzumab in HER2‑positive breast cancer is described, as well as toxic reactions.

The article shows the experience of eribulin application in actual clinical practice in Oncology institutions of the Russian Federation concerning metastatic breast cancer. We have analyzed the efficacy of the drug in case of different subtypes of the tumor and have chosen patients, depending on the location of metastases and with proven maximum efficacy of eribulin. We have shown the side reactions and the possibility of application of eribulin in combination with other antineoplastic agents.

The combination of fluoropyrimidines with oxaliplatin is one of the standard first line chemotherapy of metastatic colorectal cancer (mCRC). In Russian cancer research center was performed a full cycle of production the drug Oxaliplatin-RONC®, showed equivalence to Eloxatin® in vitro and in vivo. The main purpose of this study was to evaluate the therapeutic equivalence of Oxaliplatin-RONC ® and Eloxatin® in mFOLFOX6 combination as a first line of chemotherapy in patients with mCRR. The second purpose was to compare the safety of drugs. A total of 59 patients were enrolled in the study. Patients were assigned in a 1:1 ratio to receive up to 9 cycles of mFOLFOX6 with Oxaliplatin-RONC® or Eloxatin®; cycles were repeated every 14 days. 30 patients were randomly assigned to OxaliplatinRCRC® and 29 to Eloxatin®. The objective response rate was 46,67% in the OxaliplatinRONC® group and 37,93% in the Eloxatin® group (р (non inferiority)=0,046); 97,5% CI,–0,16–0,33). The median progression-free survival was 6,9 months in the OxaliplatinRONC® group, as compared with 7 months in the Eloxatin® group (P=0.571). The median of duration response rate was 5,5 months in the Oxaliplatin-RONC® and 6,2 months in the Eloxatin® group (p=0.8). The incidence of adverse events grade 3 or 4 was comparable in groups. Oxaliplatin-RONC® and Eloxatin® in the mFOLFOX6 combination showed comparable efficacy and safety in patients with mCRC.