THE EXPERIENCE WITH ERIBULIN IN REAL CLINICAL PRACTICE FROM MOSCOW AND MOSCOW REGION

Introduction.Eribulin, an non-taxane microtubule inhibitor, has been registered in Russia for patients with locally advanced or metastatic breast cancer (mBC) who received at least one chemotherapy regimen for a advanced disease, previous therapy should include anthracyclines and taxanes in adjuvant or metastatic setting, except the patients who could not be prescribed these drugs. We present our experience with eribulin in real clinical practice in Moscow and the Moscow Region.Patients and methods. We conducted a retrospective analysis of the experience with the use of eribulin in Moscow and the Moscow Region in 202 patients with mBC from January 2016 to February 2017 to assess the effectiveness and safety of the drug. All patients received previous therapy with anthracyclines and taxanes for locally advanced and / or metastatic cancer. The average age of patients at the time of inclusion in the analysis was 5 years (28–81). The status of the general condition on the ECOG 0-1 scale was registered in 81.3 % (100 / 123) of patients, the status of ECOG 2-3 in 18.7 % (23 / 123) of patients. The median of the number of courses of chemotherapy with eribulin is 4 (2–17). Patients received eribulin in 1-7 chemotherapy lines for metastatic disease. The average number of affected organs is 2 (1–5).Results.Complete response (CR) was in 3 (2 %) patients. Partial response (PR) was in 24 (15.7 %) patients, stabilization of the disease – in 89 (58. 2 %). Progression of the disease was recorded in 37 (24.1 %) patients. The median of progression-free survival (PFS) on the therapy was 4.64 (95 % CI 2.97-6.87) months. Stabilization of the disease for more than 6 months was registered in 28 (18.3 %) patients. The most significant toxicity was neutropenia and polyneuropathy (21 patients (10.4 %) and 7 patients (3.5 %), respectively).Dose reduction due to neutropenia was required by 26 patients (12.9 %). The objective response rate (ORR) depended on the chemotherapy line: in 1-3 lines the efficacy of the treatment was higher: the ORR was 21.6 %, compared to the 4th and subsequent lines – 12.3 %, respectively. With HER2-positive mBC, eribulin showed clinically significant results in combination with trastuzumab.Conclusions.Our analysis confirms that eribulin has a predictable and manageable safety profile, is an effective drug for the treatment of patients with different subtypes of mBC in a real clinical setting.

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A phase Ib study of abemaciclib in combination with pembrolizumab for patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer (MBC) (NCT02779751): Interim results.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.1051 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 1051-1051 ◽

Cited By ~ 1

Author(s):

Hope S. Rugo ◽

Peter Kabos ◽

Joseph Thaddeus Beck ◽

Michael Jon Chisamore ◽

Anwar Hossain ◽

...

Keyword(s):

Partial Response ◽

Objective Response ◽

Locally Advanced ◽

Metastatic Breast ◽

Progression Free Survival ◽

Complete Response ◽

Primary Objective ◽

Open Label ◽

Phase Ib ◽

Metastatic Setting

1051 Background: Abemaciclib is an orally administered, selective small molecule cyclin-dependent kinase (CDK)4 and 6 inhibitor, approved to treat HR+, HER2- MBC patients (pts) on a continuous twice daily dosing schedule as monotherapy or in combination with an aromatase inhibitor as initial endocrine based therapy or in combination with fulvestrant. Abemaciclib monotherapy increased tumor immunogenicity and synergized with anti-PD-1 to boost antitumor efficacy in murine models. Here we report safety and antitumor activity of abemaciclib plus pembrolizumab in HR+, HER2- MBC pts. Methods: This multicenter, nonrandomized, open-label, multi-cohort phase Ib study of abemaciclib plus pembrolizumab enrolled a cohort of endocrine resistant HR+, HER2- MBC pts who had received 1 or 2 prior chemotherapy regimens for MBC. No prior CDK4/6 inhibitor was allowed. Patients received 150mg abemaciclib orally every 12 hours plus pembrolizumab 200mg IV on day 1 every 21 days. Primary objective was to characterize safety of the abemaciclib plus pembrolizumab combination. Secondary objectives included objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: Of 28 pts enrolled, 15 (54%) received 1 line and 10 (36%) 2 lines of prior systemic chemotherapy in the locally advanced/metastatic setting. Safety of the combination was generally consistent with known side effects of abemaciclib and pembrolizumab and was generally manageable. Grade 3/4 adverse events in >2 pts included neutropenia (8 pts/29%), AST increase (5 pts/18%), diarrhea, and ALT increase (3 pts/11% each). Eight pts had confirmed partial response (29% ORR), and disease control rate (complete response [CR]+partial response [PR]+stable disease [SD]) was 82%. Clinical benefit rate (CR+PR+SD persisting for ≥6 months) was 46%. Median PFS and OS were 8.9 months (95% CI 3.9, 11.1) and 26.3 months (95% CI 20.0, 31.0), respectively. Conclusions: Combination of abemaciclib plus pembrolizumab demonstrated a generally tolerable safety profile with numerically higher rate of transaminase elevations than reported for the individual treatments. Compared to historical data for abemaciclib monotherapy in a similar pt population, a numerically higher but not obviously different ORR, PFS, and OS was observed. Clinical trial information: NCT02779751 .

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HORMONE-POSITIVE HER2-NEGATIVE METASTATIC BREAST CANCER: DECISION MAKING IN REAL CLINICAL PRACTICE

South Russian Journal of Cancer ◽

10.37748/2687-0533-2020-1-2-6 ◽

2020 ◽

Vol 1 (2) ◽

pp. 46-51

Author(s):

L. Yu. Vladimirova ◽

A. E. Storozhakova ◽

T. A. Snezhko ◽

L. K. Strakhova ◽

N. A. Abramova ◽

...

Keyword(s):

Breast Cancer ◽

Decision Making ◽

Metastatic Breast Cancer ◽

Clinical Practice ◽

Metastatic Breast ◽

Real Clinical Practice

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Long-term follow-up of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in advanced squamous cell carcinoma of the head and neck (SCCHN).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.6020 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 6020-6020

Author(s):

Byoung Chul Cho ◽

Amaury Daste ◽

Alain Ravaud ◽

Sébastien Salas ◽

Nicolas Isambert ◽

...

Keyword(s):

Fusion Protein ◽

Safety Profile ◽

Objective Response ◽

Locally Advanced ◽

Clinical Activity ◽

Metastatic Setting ◽

Heavily Pretreated ◽

Bifunctional Fusion Protein

6020 Background: Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor (a TGF-β “trap”) fused to a human IgG1 mAb blocking PD-L1. A previous report of an expansion cohort from a phase 1 study (NCT02517398) suggested that bintrafusp alfa had a manageable safety profile and early signs of clinical activity in patients with heavily pretreated, advanced SCCHN after a median follow-up of 86.4 weeks. Here we report long-term efficacy and safety for this cohort. Methods: Patients with advanced SCCHN that progressed/recurred after platinum therapy in the recurrent/metastatic setting, or < 6 months after platinum therapy in the locally advanced setting, received bintrafusp alfa 1200 mg every 2 weeks until confirmed progressive disease, unacceptable toxicity, or trial withdrawal. The primary endpoint was confirmed best overall response assessed per RECIST 1.1 assessed by independent review committee (IRC); safety was a secondary endpoint. Results: As of May 15, 2020, 32 patients had received bintrafusp alfa for a median of 2.8 months (range, 0.5-29.9 months), no patient remained on treatment, and median follow-up to data cutoff was 41.7 months (range, 39.8-43.5 months). The objective response rate (ORR; 13%) was unchanged since the previous report; median duration of response (DOR) was increased at 21.4 months (95% CI, 5.5 months to not reached [NR]). While the clinical activity of bintrafusp alfa may be improved in patients with HPV-positive tumors (Table), outcomes were generally similar between PD-L1 subgroups (≥1% vs < 1% tumor cells). The overall safety profile was consistent with the previous report for this cohort, without grade 4 nor 5 treatment-related adverse events (TRAEs); no new TRAEs of grade 3 or that led to discontinuation of bintrafusp alfa were reported. Conclusions: With a median follow-up of over 3 years in patients with heavily pretreated advanced SCCHN, bintrafusp alfa showed sustained clinical activity and 3-year OS of 24.0%, which compares favorably to historical data. Clinical activity appeared to be greater in patients with HPV-positive tumors than those with HPV-negative tumors. The safety profile was manageable and consistent with earlier analysis. Further investigation of bintrafusp alfa in SCCHN and other HPV-associated cancers is ongoing. Clinical trial information: NCT02517398. [Table: see text]

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TRLS-06. PHASE 1 EXPANSION STUDY OF IRINOTECAN LIPOSOME INJECTION (nal-IRI) IN PATIENTS WITH METASTATIC BREAST CANCER (mBC): FINDINGS FROM THE COHORT WITH ACTIVE BRAIN METASTASIS (BM)

Neuro-Oncology Advances ◽

10.1093/noajnl/vdz014.039 ◽

2019 ◽

Vol 1 (Supplement_1) ◽

pp. i9-i9 ◽

Cited By ~ 1

Author(s):

Carey Anders ◽

Pamela Munster ◽

Donald Northfelt ◽

Hyo Sook Han ◽

Cynthia Ma ◽

...

Keyword(s):

Disease Control ◽

Phase 1 ◽

Objective Response ◽

Metastatic Breast ◽

Median Number ◽

Cns Metastases ◽

Cns Disease ◽

Topoisomerase 1 ◽

Metastatic Setting ◽

Heavily Pretreated

Abstract BACKGROUND: nal-IRI is a liposomal formulation of irinotecan (topoisomerase-1 inhibitor). Preclinical data show that nal-IRI accumulates in BMs and prolongs survival in animal models of BM. Findings from a phase 1 expansion study (NCT01770353), evaluating patients with mBC and active BM, are reported. METHODS: This phase 1 expansion study enrolled patients with mBC who received multiple prior lines of cytotoxic therapy in the metastatic setting, including one cohort with mBC and active BM, defined as radiographic evidence of new or progressive central nervous system (CNS) metastases after radiation therapy with ≥1 lesion of ≥1 cm in the longest dimension on gadolinium-enhanced magnetic resonance imaging. Patients received nal-IRI 50 mg/m2 (free-base equivalent; FBE) every two weeks (q2w) as an intravenous infusion over 90 minutes, escalating to 70 mg/m2 FBE q2w, if tolerated. RECIST v1.1 and modified RECIST criteria were used to assses non-CNS and CNS disease, respectively. RESULTS: In total, 30 patients were enrolled (10 with active BM). Median age was 53 years (range 29–70 years) and median number of prior cytotoxic anti-cancer regimens was 3 (range 0–6); 29 patients received ≥1 dose of nal-IRI 50 mg/m2 FBE. Overall, nal-IRI monotherapy appeared to be well tolerated, and achieved ≥30% objective response rates for both CNS and non-CNS disease. Among the 10 patients with active BM, 6 achieved CNS disease control (3 partial responses [PRs] and 3 stable disease [SD]), including one patient with durable CNS SD and non-CNS PR for 2 years. Among 7 patients with serial evaluation of CNS metastases posttreatment, 6 patients achieved a reduction in target CNS lesions compared with baseline. CONCLUSION: Treatment with nal-IRI resulted in CNS disease control among 6 of 10 heavily pretreated patients with mBC and active BM. Further exploration of nal-IRI in patients with mBC and active BM is warranted.

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Evaluation of the effectiveness of adjuvant chemotherapy for locally advanced gastric cancer in real clinical practice

Pharmateca ◽

10.18565/pharmateca.2020.7.41-45 ◽

2020 ◽

Vol 7_2020 ◽

pp. 41-45

Author(s):

N.P. Belyak Belyak ◽

R.V. Orlova Orlova ◽

S.I. Kutukova Kutukova ◽

N.V. Zhukova Zhukova ◽

S.A. Borozdina Borozdina ◽

...

Keyword(s):

Gastric Cancer ◽

Clinical Practice ◽

Adjuvant Chemotherapy ◽

Advanced Gastric Cancer ◽

Locally Advanced ◽

Locally Advanced Gastric Cancer ◽

Real Clinical Practice

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Trastuzumab emtansine (T-DM1) in previously treated HER2-positive metastatic breast cancer (MBC): Results from an expanded access study.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.26_suppl.166 ◽

2013 ◽

Vol 31 (26_suppl) ◽

pp. 166-166 ◽

Cited By ~ 1

Author(s):

Denise Aysel Yardley ◽

Ian E. Krop ◽

Patricia LoRusso ◽

Nicholas J. Robert ◽

Musa Mayer ◽

...

Keyword(s):

Objective Response ◽

Locally Advanced ◽

Metastatic Breast ◽

Significant Activity ◽

Bleeding Events ◽

Antibody Drug Conjugate ◽

Her2 Positive ◽

Expanded Access ◽

Previously Treated ◽

Grade 3

166 Background: T-DM1 is an antibody-drug conjugate composed of trastuzumab, a stable linker, and the cytotoxic agent DM1. Few T-DM1 data are available in settings approximating clinical practice. We present safety and efficacy data from T-PAS, an expanded access study of T-DM1 in patients (pts) with previously treated HER2-positive MBC. Methods: T-PAS is a US multicenter study of T-DM1 (3.6 mg/kg q3w) in HER2-positive (IHC 3+ or FISH/CISH+) locally advanced or MBC. Key eligibility criteria: prior anthracycline and taxane; prior capecitabine or 5-FU and ≥2 HER2-directed agents (including trastuzumab and lapatinib) for MBC; LVEF ≥50%. Primary endpoint: safety; secondary endpoint: investigator-assessed objective response rate (ORR) in pts with measurable disease. Safety was assessed on day 1 of each cycle; ECHO/MUGA scans were every 12 weeks. Results: This analysis includes 215 pts enrolled in May 2010–Sep 2011 (data cutoff 7/31/2012). Pts received a median of 7 prior systemic MBC therapies (range 1–23) with a median cumulative anthracycline dose of 240 mg/m2(range 6–2645). At baseline, median LVEF was 60% and 50% of pts had investigator-reported cardiovascular disease. Median follow-up was 5.9 months (range 0.1–25.3); median T-DM1 duration was 5.0 months (range 0–23) with 15.8% receiving >18 cycles. ORR was 25.6% (42/164). Rate of grade ≥3 AEs was 43.7% and of SAEs of any grade was 18.1%. Most common all-grade AEs were fatigue (50.7%), nausea (36.3%), and headache (24.2%). Most common grade ≥3 AEs were thrombocytopenia (7.9%), fatigue (4.7%), and increased aspartate aminotransferase and anemia (each 3.7%). There were no grade ≥3 bleeding events. Cardiac dysfunction (primarily asymptomatic decreases in LVEF) was reported in 8 pts (3.7%); 4 were grade ≥3, 3 resulting in T-DM1 discontinuation. Conclusions: In this study that more closely reflects the real-world setting, the safety profile of T-DM1 was similar to that previously reported in conventional clinical trials, with no new safety signals. In this pretreated population (median of 7 prior therapies for HER2-positive MBC), significant activity was observed. Clinical trial information: NCT01120561.

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The role of taxanes in HR+ve/HER2-ve metastatic breast cancer (MBC) patients (pts) from adjuvant to metastatic setting in the clinical practice: Results from GIM13-AMBRA study.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.1055 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 1055-1055

Author(s):

Giorgio Mustacchi ◽

Marina Elena Cazzaniga ◽

Emanuela Romagnoli ◽

Filippo Montemurro ◽

Michele De Laurentiis ◽

...

Keyword(s):

Breast Cancer ◽

Cohort Study ◽

Metastatic Breast Cancer ◽

Clinical Practice ◽

Molecular Subtypes ◽

Metastatic Breast ◽

Metastatic Setting ◽

Patterns Of Behavior ◽

Treatment Table

1055 Background: The molecular subtypes of BC have individual patterns of behavior, prognosis and sensitivity to treatment, with subsequent implications for the choice of, or indeed role, for adjuvant (Adj) and metastatic chemotherapy (CHT). Taxanes (T) play a central role in chemotherapy for BC. However, previous studies have reported that T are relatively ineffective in patients with Luminal (HR+ve) BC compared with other subtypes. Aim of the present analysis is to describe the use of T in the clinical practice in Italy in HR+ve pts. Methods: AMBRA is a longitudinal cohort study, aiming to describe the choice of first and subsequent lines of treatment in HER2-ve MBC pts receiving at least one CHT (SABCS 2016, P5-15-07 & P5-14-09) in the years 2012-2015. For the present analysis, we focused on the use of T from the AdJ to the metastatic setting. Results: So far, 791/1500 pts have been registered into the study, 651 of them (82,3%) evaluable with HR+ MBC. Main characteristics are: Mean age 52 years; pN: UK 64 (9.8%) N+=405 (62.2%); Adj CHT=397 (61 %), mean DFI=96,99 months. T were used in 60.3% of the cases in the Adj setting, alone or in combination with other drugs, mainly anthracyclines (82.6%), with a mean DFI of 56.9 months. In the metastatic setting, across 1st to 3rd line, 460 pts (70.6%) received T, alone (49.7%) or in combination with Bevacizumab (38.2%), or other CHT drugs (11.9%). Details of the use of T in MBC are described in the table below. Conclusions: T have been used in more than 60% of cases of Luminal tumours in the Adj setting. In this population DFS is significantly shorter as compared with the non-T treated luminal population, as previously suggested by different Authors. Re-challenge with T is very frequent across different lines for MBC. Paclitaxel is the most used T, Docetaxel the less used and Nab-paclitaxel, labelled for MBC only, shows an increasing use from 1st-to 3rd line of treatment. [Table: see text]

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Updated results of a phase 1 study combining the matrix metalloproteinase 9 inhibitor GS-5745 with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.4_suppl.363 ◽

2017 ◽

Vol 35 (4_suppl) ◽

pp. 363-363 ◽

Cited By ~ 1

Author(s):

Johanna C. Bendell ◽

Manish R. Patel ◽

Carrie Baker Brachmann ◽

Xi Huang ◽

Julia D. Maltzman ◽

...

Keyword(s):

Pancreatic Cancer ◽

Matrix Metalloproteinase ◽

Pancreatic Adenocarcinoma ◽

Phase 1 ◽

Objective Response ◽

Locally Advanced ◽

Matrix Metalloproteinase 9 ◽

Phase 1 Study ◽

Metastatic Setting ◽

Metalloproteinase 9

363 Background: GS-5745 is a monoclonal antibody inhibitor of matrix metalloproteinase 9 (MMP9), an extracellular enzyme involved in matrix remodeling, tumor growth, and metastasis. We present data from patients (pts) with advanced pancreatic adenocarcinoma enrolled in an ongoing multi-indication phase 1 study (NCT01803282) evaluating GS-5745. Methods: Following a monotherapy dose finding stage, pts with locally advanced or metastatic pancreatic cancer received gemcitabine (G) + nab-paclitaxel (Abraxane, A) and GS-5745 800 mg IV every 2 weeks. Treatment continued until disease progression, unacceptable toxicity or withdrawal of consent. Response was assessed every 8 weeks per RECIST version 1.1 criteria. Results: As of April 2016, 36 pts were enrolled (1 continues to receive GS-5745). The most frequently observed adverse events (AEs) of any grade include fatigue (75%), alopecia (55.6%), peripheral edema (55.6%) and nausea (50%). Grade ≥ 3 AEs observed in ≥ 10% of pts included neutropenia (25%), anemia (19.4%) and fatigue (13.9%). The median progression free survival (PFS) for all pts is 7.8 (90% confidence interval (CI) = [6.1, 11]) months (mos), median duration of response (DOR) is 5.8 mos and the objective response rate (ORR) is 44.4%. Of the 31 pts who were treatment naïve in the metastatic setting, median PFS is 9.2 (90% CI = [6.1, 11]) mos, median DOR 5.8 mos and the ORR 51.6%. Median baseline circulating MMP9 was 44.3 (range 12.4-549.6) ng/mL and 31 of 32 patients with post-baseline samples had undetectable MMP9 levels within 8 weeks. Conclusions: GS-5745+GA demonstrated numerically higher ORR and PFS compared to historical data without additional toxicity. Additionally, reductions in circulating MMP9 levels post treatment suggest target engagement by GS-5745 . These results suggest this combination may warrant additional study in first line metastatic pancreatic adenocarcinoma. Clinical trial information: NCT01803282.

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A lower apatinib dose provides equivalent efficacy and reduced toxicity: A phase II, single-arm study of apatinib and oral etoposide in metastatic breast cancer

10.21203/rs.3.rs-25022/v1 ◽

2020 ◽

Author(s):

Nanlin Hu ◽

Anjie Zhu ◽

Yiran Si ◽

Jian Yue ◽

Xue Wang ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Kinase Inhibitor ◽

Objective Response ◽

Locally Advanced ◽

Eastern Cooperative Oncology Group ◽

Metastatic Breast ◽

Oral Etoposide ◽

Equivalent Efficacy ◽

Reduced Toxicity

Abstract Background:The effectiveness of antiangiogenic drugs in metastatic breast cancer(MBC) is still unclear. Apatinib is a small tyrosine kinase inhibitor that inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). We performed this clinical trial to evaluate the efficacy and safety of apatinib and oral etoposide in patients with HER2-negative locally advanced or MBC.Methods:Patients with HER2-negative MBC previously treated with anthracycline and taxanes and failed ≥ 1 prior chemotherapy regimens were recruited. The starting dose of apatinib was 500 mg and 425 mg in patients with Eastern Cooperative Oncology Group (ECOG) scores of 0–1 and 2, respectively. The etoposide capsules were given at 50 mg/m2 on days 1 to 10 for 21 days. The primary end point was progression-free survival (PFS) which is assessed every 6 weeks (RECIST v1.1). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.Results:Thirty-one eligible patients were enrolled. The median follow-up time was 11 months. The median PFS for all patients was 6.93 months (95% confidence interval (CI), 5.97–7.90), and 6.93 months(95% CI 5.27–8.60) and 6.56 months (95% CI 1.41–11.73) for patients with apatinib 425 mg and 500 mg once daily, respectively. The ORR was 35.5% (11/31). The DCR was 87.1% (27/31). The median OS was 20.37 months (95% CI, 11.39–29.34). The median PFS of patients who had hypertension and proteinuria was longer than that for those without hypertension and proteinuria. The most common grade 3/4 treatment-related adverse events(AE) were hypertension (12/31, 38.71%), fatigue (3/31, 9.68%), thrombocytopenia (3/31, 9.68%).Conclusion:Apatinib combined with etoposide capsules is effective and tolerable in heavily pretreated, metastatic HER2-negative breast cancer patients. A lower apatinib dose provide equivalent efficacy and reduced toxicity.

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Efficacy and Safety of the use of Pertuzumab in Metastatic Breast Cancer Patients in a Real-World Setting: Results from the SUPER-GONO (Gruppo Oncologico del Nord Ovest) Study

10.21203/rs.3.rs-409228/v1 ◽

2021 ◽

Author(s):

Ornella Garrone ◽

Tommaso Giarratano ◽

Eva Blondeaux ◽

Loretta D'Onofrio ◽

Andrea Michelotti ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Clinical Practice ◽

Real World ◽

Objective Response ◽

Metastatic Breast ◽

Breast Cancer Patients ◽

Her2 Positive ◽

Real World Data ◽

Adjuvant Trastuzumab

Abstract Background: Real world data have the potential to demonstrate the applicability of the results of randomized studies in the general population. SUPER trial was conducted in order to assess the activity, the efficacy and the safety of the combination of pertuzumab, trastuzumab and chemotherapy in clinical practice.Material and methods: Patients diagnosed with HER2 positive metastatic breast cancer (mBC) and treated with pertuzumab, trastuzumab and chemotherapy were accrued at 18 italian hospitals. Data were retrospectively collected in the time frame between pertuzumab availability in clinical practice and study approval in 2016, and prospectively collected thereafter. Results: Overall 342 HER2 positive mBC were accrued. 172 patients had relapsed disease and 56.4% of them received neo/adjuvant trastuzumab. 205 patients received docetaxel. Objective response rate was 76.3% (95%CI: 71.4–80.7). Median progression free survival (PFS) and overall survival (OS) were 24.3 months (95% CI: 20.0–28.9) and 70.2 months (95% CI: 61.4–79.0) respectively. Triple positive patients treated with endocrine therapy in addition to pertuzumab and trastuzumab maintenance had a significant longer PFS and OS than patients who did not. mPFS was 31.2 months and 13 months respectively (HR=0.47; 95% CI: 0.33–0.66; p<0.001) and mOS was 72.3 months and 56.8 months respectively (HR=0.58; 95% CI: 0.36–0.92; p=0.02). Pretreatment with trastuzumab did not hamper the outcome. In addition, maintaining the dual blockade inhibition at disease progression with the same CT partner or alternative endocrine agent leading to further benefit.Conclusions: SUPER suggests that results of first-line treatment with pertuzumab, trastuzumab and chemotherapy in unselected patients are consistent with findings from CLEOPATRA trial.Moreover, as expected from real world evidence, new insights have emerged.

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