Drugs for treating breast cancer in women are effective and well tolerated in men

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Credit: © European Society for Medical Oncology

Munich, Germany, 21 October 2018 – There is growing evidence that drugs approved for the treatment of breast cancer in women are also effective and well tolerated in men, according to the largest real-life study yet to investigate treatment and outcomes in men with breast cancer (1) and two further studies to be reported at ESMO 2018 (2,3).

Approximately one in every 100 cases of breast cancer (1%) occurs in men (4). However, there have been few prospective studies in men, and clinical trials of breast cancer treatments have often excluded men so treatment recommendations are largely extrapolated from the results of clinical trials in women (4).

To learn more about the treatment of breast cancer in men researchers analysed clinical data collected by the Epidemiological Strategy and Medical Economics Metastatic Breast Cancer (ESME MBC) platform (5) between January 2008 and December 2014. This national database collects real-life data from 18 French Comprehensive Cancer Centers for all patients newly diagnosed with metastatic breast cancer starting at least one treatment.

Researchers retrieved the data for men with metastatic breast cancer included in the database and compared their treatment and outcome with those in women. They found 149 men from the total of 16,701 patients (0.89%). The men were slightly older than the women (mean age 68.1 years vs 60.6 years, p

Results showed men received similar treatments to women with metastatic breast cancer. Just under half of those with HR+/HER2-negative breast cancer (45/105, 42.9%) received frontline hormonal therapy: tamoxifen (20/45), aromatase inhibitor + luteinizing hormone releasing hormone (LHRH) analogues (18/45) or others (7/45).

Their median progression-free survival was 9.8 months, which was similar to that seen in a matched group of women (13.0 months, p=0.8) with the same age, breast cancer histology and grade, location of metastasis and adjuvant treatment.

One in four men with HR+/HER2- breast cancer (29/105, 27.6%) were treated with front-line chemotherapy. Their median progression-free survival was also similar to a matched group of women receiving chemotherapy (6.9 months vs 6.3 months, hazard ratio 1.24, 95% confidence interval 0.69-2.23). Overall survival for the whole population of men included in the database was also similar to that for women (41.8 months vs 34.9 months, p=0.745).

"We have reported on one of the biggest series of men with metastatic disease, with comprehensive data on their management and outcome with different types of treatment," said study author Jean-Sebastien Frenel, from the Institut de Cancerologie de l'Ouest, Nantes, France. "We found that most of the men with HR+/HER2- metastatic disease had received frontline chemotherapy and around 40% had received hormonal therapy. Most of the patients receiving hormonal therapy were treated with tamoxifen and the remainder received aromatase inhibitors. But few patients received aromatase inhibitors plus LHRH analogues despite some guidelines recommending that they should be given in combination."

Frénel reported: "The progression-free survival provided by chemotherapy or hormonal therapy was similar in men as in women." In terms of clinical implications, he suggested: "Hormonal therapy should be given to men with HR+/HER2- metastatic breast cancer in the absence of visceral crisis." He added that oncologists should be aware that aromatase inhibitors should not be given without LHRH analogues. The study is continuing and will next assess the prevalence of BRCA mutation in the patient population.

Commenting on the findings for ESMO, Agnes Jager, medical oncologist and associate professor at Erasmus Medical University Cancer Institute, Rotterdam, The Netherlands said: "A recent study looked at tumour characteristics and outcome in a large cohort of men with primary breast cancer but such extensive data on advanced breast cancer in men was missing until now." She added: "This new study shows the prognosis of men and women is similar, which is of great value as this justifies our current clinical practice. We currently treat men with breast cancer in a similar way to women, which is now supported by these data."

Jager noted that although the largest study of its kind, the number of men with breast cancer was still small and data were lacking on the extent of advanced disease, BRAC mutation status and type of chemotherapy. However, she said: "More detailed information and longer-term follow-up will indicate whether there are characteristics or prognostic factors that are specific for men, which will allow us to change practice in the future."

Hormonal treatment

Results from the first prospective randomised trial to assess different hormonal treatments in men with breast cancer (2) showed that levels of estradiol, a form of the hormone estrogen, decreased steeply with a gonadotrophin releasing hormone analogue (GnRHa) plus tamoxifen or the aromatase inhibitor exemestane but increased with tamoxifen alone measured after a 6 months' treatment period.

More than 90% of male breast cancer patients have HR+ disease. Tamoxifen is currently the standard of care hormonal therapy but there is limited data on its efficacy and safety in men and little information on other hormone blocking treatments.

The Male-GBG54 trial randomised 55 men with breast cancer to hormonal therapy with one of three regimens as adjuvant or metastatic therapy for six months: tamoxifen (20mg per day); tamoxifen + gonadotrophin releasing hormone analogue (GnRHa) (subcutaneous every 3 months); exemestane (25mg/day) + GnRHa.

Tamoxifen blocks estrogen from attaching to hormone receptors on cancer cells while exemestane is an aromatase inhibitor that inhibits estrogen synthesis. The use of GnRH analogues in men with breast cancer is controversial but is based on reducing levels of testosterone when used in combination with aromatase inhibitors or antiandrogens (6).

Results reported at ESMO 2018 showed the median level of estradiol increased by 67% at three months and by 41% at six months in men treated with tamoxifen alone. In contrast, estradiol levels decreased by 85% after three months in men treated with a GnRH analogue plus tamoxifen and by 73% in those receiving a GnRH analogue plus exemestane. Estradiol levels continued to be decreased at six months with GnRH analogues plus tamoxifen or exemestane. These therapies were well tolerated with no safety signals.

The researchers also assessed the impact of treatment on quality of life and sexual function in men with breast cancer treated with hormonal therapy for the first time, using a validated questionnaire (Aging Males' Symptoms Scale Questionnaire) and assessment of erectile function (International Index of Erectile Function). Results showed that tamoxifen had little impact on health-related quality of life or erectile function in men with breast cancer while the combination of GnRH analogue plus exemestane had a major adverse effect on both measures.

Lead author Mattea Reinisch, from Klinikum Essen-Mitte, Essen, Germany, said: "We observed a deep and stable decrease of estradiol in patients receiving the combination of tamoxifen or an aromatase inhibitor plus GnRH for six months of therapy within the Male trial. The suppression of peripheral estradiol is a necessary condition for a therapeutic benefit of endocrine therapy in men with breast cancer when receiving an aromatase inhibitor plus GnRH analogue. Within the tamoxifen monotherapy arm, the estradiol values increased. These changes are known from female breast cancer patients and were expected."

Reinisch added: "Tamoxifen monotherapy should be kept as standard hormonal therapy for men with breast cancer. The side-effects are moderate, hardly impairing sexual behavior. The combination with GnRH influenced patients' well-being and erectile function profoundly."

Commenting on the study, associate professor Agnes Jager said: "The authors are to be congratulated with a randomised trial in such a rare study population, which must have been a real effort. However, it is regrettable that the estradiol suppression at 3 months was the primary endpoint. Although it is relevant to know whether and to what extent E2 levels change over time during different endocrine treatment strategies, as far as I know E2 suppression at 3 months is neither a validated nor a clinically useful surrogate endpoint for the efficacy of endocrine treatment."

Jager added: "The finding that tamoxifen without an LHRH agonist led to a pronounced increase of E2 levels after 3 and 6 months of treatment is not new, although the degree of the increase is somewhat unexpected." But she cautioned that the endpoint used in the study did not answer the question of whether an LHRH agonist should be added to tamoxifen in men and further research is needed on this. "Due to the severe side-effects of LHRH agonists in men and the negative impact on quality of life, clarity about this is of great clinical importance."

Prolonging sensitivity to hormonal therapies

The cyclin dependent kinase 4 and 6 inhibitor (CDK4/6 inhibitor) ribociclib plus the aromatase inhibitor letrozole has comparable safety and tolerability as first-line therapy in men with HR+/HER2- advanced breast cancer to that seen in women, according to preliminary results from an international phase 3 trial reported at ESMO 2018 (7).

Most patients with HR+ breast cancer become resistant to hormonal therapies over time so there is a lot of interest in finding treatments to prolong or restore sensitivity. Inhibiting the CDK4/6 has been identified as a potential target for overcoming or delaying resistance to hormonal therapy in advanced HR+/HER2-breast.

The CDK4/6 inhibitor ribociclib is approved for use in combination with an aromatase inhibitor for treating postmenopausal women with HR+/HER2- advanced breast cancer who have received no previous treatment for advanced breast cancer based on results from a trial showing significantly prolonged progression-free survival. However, men were not included in the study.

The international CompLEEment-1 trial included 20 men with HR+, HER2- advanced breast cancer in the first 1008 patients enrolled who completed 56 days of follow-up or discontinued before data cut-off. They were treated on an open-label basis with ribociclib (600mg per day, 3 weeks on/1 week off) plus letrozole (2.5mg/day). Male patients also received concomitant goserelin (3.6mg subcutaneous implant every 28 days). A pre-planned interim analysis was conducted approximately 15 months after the first patient's first visit for the primary outcome of safety and tolerability.

Results reported at ESMO 2018 showed the most frequent adverse events in men were hot flushes (30.0%), neutropenia (20.0%) and constipation (20.0%). Adverse events of grade 3 severity or higher included neutropenia (4 patients, 20.0%), increased alanine aminotransferase (2 patients, 10%) and increased aminotransferase (1 patient, 5.0%). QT prolongation was infrequent, occurring in 3 men (15.0%) and all events were grade 1 or 2.

Just over one-third (35.0%) of men required dose reduction or interruption due to adverse events, while two men discontinued treatment due to adverse events.

"We can conclude in this sub-population of men that the tolerability and the expected toxicity with ribociclib in men is no different to women. And this increases our confidence in data obtained in large trials with women in order to translate the results and the applicability to men," said lead author Claudio Zamagni, Head of Breast and Gynaecological Medical Oncology, Sant'Orsola Malpighi Hospital, Bologna, Italy. The combination of hormonal therapy plus ribociclib should be considered as an option also for male patients with metastatic HR+ HER2- breast cancer," he suggested. He noted that this was the first study to assess the safety of a CDK4/6 inhibitor in men, adding that efficacy data will be reported with longer-term follow-up in the future.

Commenting on the study, associate professor Agnes Jager considered that limitations were the small numbers and the lack of efficacy data at the time of reporting. She said: "As expected, there were no major differences in safety compared to previously published toxicity data for women, with the exception of the prevalence of neutropenia." This was less frequent compared with female breast cancer patients in the MONALEESA 2 study (grade 3/4: 20.0% in men vs 59.3% in women).

Jager suggested that if similar results were shown in other studies, this could be of interest from a mechanistic point of view. "One of the explanations might be that there is a gender-dependent toxic effect on bone marrow. Alternatively, it could be a reflection of different plasma concentrations of ribociclib in men and women," she suggested. If this were the case, efficacy could be lower in man. She continued: "The first step forwards is to compare the outcome between the men and women within the CompLEEment study, as well as cross-comparing with other studies in women."

Summing up the three studies, Dr. Stefan Zimmerman, Centre Hospitalier Universitaire Vaudois, Switzerland, said: "Male breast cancer patients seem to benefit from endocrine therapy to a similar degree as women. Furthermore, these research results add to the current literature suggesting that the addition of GnRH analogues might improve on tamoxifen alone, but studies with clinical endpoints are needed. Lastly, it is urgent that strategies that have proven effective in defering resistance to endocrine therapy in women are explored in men with advanced breast cancer as well, including CDK4/6 inhibitors."

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Notes to Editors

Please make sure to use the official name of the meeting in your reports: ESMO 2018 Congress

Official Congress hashtag: #ESMO18

Disclaimer

This press release contains information provided by the authors of the highlighted abstracts and reflects the content of those abstracts. It does not necessarily reflect the views or opinions of ESMO who cannot be held responsible for the accuracy of the data. Commentators quoted in the press release are required to comply with the ESMO Declaration of Interests policy and the ESMO Code of Conduct.

References

1 Abstract 294PD_PR 'Management and outcome of metastatic breast cancer in men in the national multicenter observational ESME program ' will be presented by Junien Sirieix during the Poster Discussion Session on Monday 22 October, 11:15 to 12:15 (CEST) in Room 14b – ICM. Annals of Oncology, Volume 29 Supplement 8 October 2018

2 Abstract 273PD_PR 'Final analysis of the Male-GBG54 study: a prospective multi-centre phase II study evaluating endocrine treatment with either tamoxifen +/- gonadotropin releasing hormone analogue (GnRHa) or an aromatase inhibitor + GnRHa in male breast cancer patients' will be presented by Mattea Reinisch during the Poster Discussion Session on Monday 22 October, 11:15 to 12:15 (CEST) in Room 14b – ICM. Annals of Oncology, Volume 29 Supplement 8 October 2018

3 Abstract 293PD_PR 'Ribociclib (RIBO) + letrozole (LET) in male patients (pts) with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC) and no prior endocrine therapy (ET) for ABC: preliminary subgroup results from the phase 2 CompLEEment-1 trial' will be presented by Claudio Zamagni during the Poster Discussion Session on Monday 22 October, 11:15 to 12:15 (CEST) in Room 14b – ICM. Annals of Oncology, Volume 29 Supplement 8 October 2018

4 Giordano SH. Breast cancer in men. NEJM 2018; 378: 2311-20

5 Unicancer R&D. ESME Research Program. Epidemiological Strategy and Medical Economic. Academic Real-world Data Platform. http://cddf.org/files/2016/07/10-Coralie-Courtinard-ESME-Data-Platform_CDDF-Wokrshop-RWD-06-Jul-2016.pdf

6 Di Lauro L, Pizzuti L, Barba M et al. Role of gonadotropin-releasing hormone analogues in metastatic male breast cancer: results from a pooled analysis. Journal of Hematology & Oncology 2015: 8: 53

7 Hortobagyi GN, Stemmer SM, Burris HA et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. NEJM 2016; 375: 1738-1748

About the European Society for Medical Oncology (ESMO)

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273PD_PR – Final analysis of the Male-GBG54 study: A prospective, randomised multi-centre phase II study evaluating endocrine treatment with either tamoxifen +/- gonadotropin releasing hormone analogue (GnRHa) or an aromatase inhibitor + GnRHa in male breast cancer patients

M. Reinisch1, S. Seiler2, T. Hauzenberger3, S. Schmatloch4, H-J. Strittmatter5, D-M. Zahm6, C. Thode7, C. Jackisch8, D. Strik9, V. Moebus10, T. Reimer11, B. Sinn12, E. Stickeler13, F. Marme14, W. Janni15, A. Kamischke16, C. Rudlowski17, V. Nekljudova18, G. von Minckwitz19, S. Loibl19

1Senologie/ Interdisziplinares Brustzentrum, Kliniken Essen-Mitte, Essen, Germany, 2Medicine and Research, German Breast Group (GBG) Forschungs GmbH, Neu-Isenburg, Germany, 3Frauenklinik, Klinikum St. Marien, Amberg, Germany, 4Brustzentrum, Elisabeth Krankenhaus, Kassel, Germany, 5Gynecology and Obstetrics, Rems-Murr-Hospital GmbH, Winnenden, Germany, 6Brustzentrum, SRH Wald-Klinikum, Gera, Germany, 7Medizinische Mikrobiologie und Immunologie, Amedes MVZ Wagnerstibbe fuer Laboratoriumsmedizin, Gottingen, Germany, 8Gynekologie und Geburtshilfe, Klinikum Offenbach GmbH, Offenbach, Germany, 9Frauenheilkunde und Geburtshilfe, Endokrinologikum, Berlin, Germany, 10Department of Gynecology and Obstetrics, Klinikum Frankfurt Hoechst, Academic Hospital of the Goethe University Frankfurt, Frankfurt, Germany, 11Klinikum Suedstadt, University of Rostock, Rostock, Germany, 12Pathologie, Charite-Universitaetsmedizin, Berlin, Germany, 13Gynaekologie und Geburtsmedizin, Uniklinik RWTH, Aachen, Germany, 14Gynecologic Oncology, Nationales Zentrum fuer Tumorerkrankungen (NCT), Heidelberg, Germany, 15Frauenheilkunde und Geburtshilfe, Universitaetsklinikum, Ulm, Germany, 16Frauenheilkunde und Geburtshilfe, MVZ Kinderwunsch und Hormonzentrum, Muenster, Germany, 17Gynäkologie, Evangelisches Krankenhaus, Bergisch Gladbach, Germany, 18Statistics, German Breast Group (GBG) Forschungs GmbH, Neu-Isenburg, Germany, 19Department of Medicine and Research, German Breast Group (GBG) Forschungs GmbH, Neu-Isenburg, Germany

Background: Over 90% of mBC pts have hormone receptor positive disease. Until today tam is considered the standard of care. Due to the low incidence of mBC, there is a lack of data regarding its efficacy and safety. No prospectively randomized study in mBC pts has been completed so far. The Male-GBG54 study is the first prospective, randomized, multicenter trial evaluating the efficacy and safety of different endocrine treatment options in male pts with BC.

Methods: In the Male-GBG54 trial (NCT01638247), pts were randomized to receive tam 20mg/day per os (p.o.) in Arm A, tam + GnRHa subcutaneous (s.c.) q3m in Arm B and exemestane 25 mg/day p.o. + GnRHa s.c. in Arm C for 6 months (mo) as (neo)adjuvant or metastatic therapy. Further treatment was conducted as per local guidelines. Primary objective was the estradiol (E2) suppression after 3 mo. Secondary objectives were the E2 suppression after 6 mo and levels of different steroidal hormones after 3 and 6 mo. Quality of life was assessed using validated questionnaires. 14 pts/group were needed for the F-test to have 80% power to detect a difference in estradiol decrease between the groups at the 5% significance level.

Results: Between October 2012 and May 2017, 55 pts were randomized in Germany, of whom 46 pts were fully evaluable and comprised the 6-mo analysis set. The median age was 62 years. Baseline characteristics were well balanced between the 3 arms. The median E2 level with tam increased by 67% after 3 mo and by 41% after 6 mo. In pts receiving tam + GnRH and AI+ GnRH, there was an initial decrease of E2 after 3 mo of 85% and 73% respectively. After 6 mo of therapy the decrease was 59% and 63% respectively. Other hormone parameters will also be presented at the meeting.

Conclusions: This is worldwide the first fully recruited prospective randomized trial, evaluating the impact of 3 different endocrine treatments in male BC. The analysis revealed an increase of E2 levels along the course of therapy after an initial steep decrease when GnRHa was given. The therapy was well tolerated with no safety signals.

Clinical trial identification: Male-GBG54 trial (NCT01638247)

Legal entity responsible for the study: GBG Forschungs GmbH

Funding: Claudia von Schilling Foundation.

Disclosure: C. Jackisch: Travel grants: Celgene, outside the submitted work.

V. Moebus: Personal fees: Amgen, Celgene, Roche, Myelotherapeutics, outside the submitted work.

F. Marme: Personal fees: Roche, AstraZeneca, Pfizer, Tesaro, Novartis, Amgen, PharmaMar, GenomicHealth, CureVac, Eisai, outside the submitted work.

G. von Minckwitz: Research funding for the Institution: Pfizer, Sanofi, Amgen, Roche, Novartis, Celgene, Teva, Astra Zeneca, Myriad Genetics, Abbvie, Vifor Pharma.

S. Loibl: Grants to Institution: AbbVie, Amgen, AstraZeneca, Celgene, Novartis, Pfizer, Roche, Teva, Vifor during the conduct of the study as well as outside the submitted work.

All other authors have declared no conflicts of interest.

293PD_PR – Ribociclib (RIBO) + letrozole (LET) in male patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) and no prior endocrine therapy (ET) for ABC: Preliminary subgroup results from the phase 3b CompLEEment-1 trial

C. Zamagni1, M. Campone2, I. Kudryavcev3, U. Brown-Glaberman4, P.H. Cottu5, A. Ring6, J. Lu7, M. Martin8, M. De Laurentiis9, K. Zhou10, J. Wu10, L. Menon10, H.A. Azim11

1Addarii Medical Oncology Unit, Policlinico S. Orsola-Malpighi-"F.Addarii", Bologna, Italy, 2Medical Oncology, ICO Institut de Cancerologie de l'Ouest Rene Gauducheau, Saint-Herblain, France, 3Department of Medicinal and Antitumor Chemotherapy, Kaluga Regional Clinical Cancer Center, Kaluga, Russian Federation, 4Division of Hematology / Oncology, University of New Mexico Cancer Center, Albuquerque, NM, USA, 5Department of Medical Oncology, Institut Curie, Paris, France, 6Medical Oncology, The Royal Marsden NHS Foundation Trust, Surrey, UK, 7Keck School of Medicine, Division of Medical Oncology, University of Southern California, Los Angeles, CA, USA, 8Instituto de Investigacion Sanitaria Gregorio Maranon, CIBERONC, GEICAM, Universidad Complutense, Madrid, Spain, 9Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori "Fondazione G. Pascale", Naples, Italy, 10Novartis Pharmaceuticals, East Hanover, NJ, USA, 11Department of Clinical Oncology, Cairo Oncology Center Cairo University-CairoCure, Cairo, Egypt

Background: CDK4/6 inhibitor RIBO is approved for use in combination with an aromatase inhibitor for the treatment of HR+, HER2- ABC in postmenopausal women with no prior therapy for ABC, based on the significantly prolonged progression-free survival versus placebo + LET observed in the pivotal phase 3 MONALEESA-2 trial (Hortobagyi et al. NEJM 2016). However, relatively rare pt subsets such as men with HR+, HER2- ABC were not included in that trial. Here, we report early safety results for men enrolled in CompLEEment-1, an open-label, phase 3b trial evaluating RIBO+LET as first-line therapy in an expanded pt population.

Methods: Pts with HR+, HER2- ABC, less or equal 1 line of prior chemotherapy, and no prior ET for ABC received RIBO (600 mg/day, 3 wk on/1 wk off) + LET (2.5 mg/day); men and premenopausal women received concomitant goserelin (3.6-mg subcutaneous implant every 28 days). The primary outcome was safety and tolerability. A pre-planned interim analysis was conducted ~15 months after first pt first visit.

Results: Of the first 1,008 pts enrolled who completed 56 days of follow-up or discontinued before the data cut-off, 20 were men. Median age was 63.5 years and all had an Eastern Cooperative Oncology Group performance status ?1; 45.0% had stage IV disease at diagnosis. The most common sites of metastasis were lung (75.0%), lymph nodes (40.0%), and liver (20.0%). The most frequent adverse events (AEs) were hot flush (30.0%), neutropenia (20.0%), and constipation (20.0%). Grade ?3 AEs included neutropenia (4 pts, 20.0%), increased alanine aminotransferase (2 pts, 10.0%), and increased aspartate aminotransferase (1 pt, 5.0%). QT prolongation was infrequent, occurring in 3 (15.0%) men; all events were grade 1/2. Dose reduction or interruption due to AEs occurred in 35.0% of men; 2 discontinued treatment due to AEs.

Conclusions: Preliminary results from the CompLEEment-1 study demonstrate the safety and tolerability of first-line RIBO+LET+goserelin in male pts, consistent with previous reports in female pts. NCT02941926.

Clinical trial identification: NCT02941926

Editorial Acknowledgement: Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals. We thank Holly C. Cappelli, PhD, ProEd Communications, Inc., for her medical editorial assistance with this abstract

Legal entity responsible for the study: Novartis Pharmaceuticals

Funding: Novartis Pharmaceuticals

Disclosure: C. Zamagni: Consulting or advisory role: AstraZeneca, Eisai, Novartis, Pfizer, PharmaMar, Pierre Fabre, Roche; Travel, accommodations, expenses: Celgene, Novartis, Pierre Fabre, and Roche; Research funding: AbbVie, Array BioPharma, AstraZeneca, Celgene, Medivation, Morphotek, Novartis, Pfizer, Roche, and Roche/Genentech.

M. Campone: Grant and personal fees: Novartis, during the conduct of the study; Personal fees: Pfizer, Astra Zeneca, Lilly, outside the submitted work.

P.H. Cottu: Consulting or advisory role: Novartis and Pfizer; Travel, accommodations, expenses: Novartis, Pfizer, and Roche; Honoraria: AstraZeneca, NanoString Technologies, Novartis, Pfizer, Roche; Research funding: AstraZeneca, Genentech/Roche, Novartis, Pierre Fabre, Pfizer.

A. Ring: Consulting or advisory role: Pfizer, Roche; Honoraria: AstraZeneca, Lilly, Novartis, Pfizer, Roche; Research funding; AstraZeneca.

J. Lu: Travel, accommodations, expenses: Novartis.

M. Martin: Consulting or advisory role: Amgen, Lilly, Novartis, Pfizer, PharmaMar, Roche/Genentech; Research funding: Novartis.

M. De Laurentiis: Consulting or advisory role: AstraZeneca, Celgene, Lilly, Novartis, Pfizer and Roche; Honoraria: AstraZeneca, Celgene, Novartis, Pfizer, Roche.

K. Zhou, L. Menon: Employee of Novartis.

J. Wu: Employee of Novartis; Employment: Janssen (immediate family member); Travel, accommodations, expenses: Janssen (immediate family member).

H.A. Azim: Employment: Innate, France (immediate family member); Consulting or advisory role: ASZ, Bristol-Myers Squibb, Janssen, MSD, Novartis, Pfizer, Roche; Honoraria: Amgen, ASZ, Bristol-Myers Squibb, MSD, Novartis, Pfizer, Roche; Research funding: Pfizer.

All other authors have declared no conflicts of interest.

294PD_PR – Management and outcome of metastatic breast cancer in men in the national multicenter observational ESME program

J. Sirieix1, J. Fraisse2, S. Mathoulin-Pelissier3, M. Leheurteur4, L. Vanlemmens5, C. Jouannaud6, V. Dieras7, C. Levy8, F. Dalenc9, M-A. Mouret-Reynier10, T. Petit11, B. Coudert12, E. Brain13, B. Pistilli14, J-M. Ferrero15, A. Gonçalves16, L. Uwer17, S. Gourgou18, J-S. Frenel19

1Medical Oncology, Centre Hospitalier Regional Universitaire de Tours (Pole Kaplan), Tours, France, 2Biometrics Unit, ICM Regional Cancer Institute of Montpellier, Montpellier, France, 3Bordeaux University, Inserm CIC1401 and Clinical and Epidemiological Research Unit, Institut Bergonie, Bordeaux, France, 4Medical Oncology, Centre Henri Becquerel, Rouen, France, 5Medical Oncology, Centre Oscar Lambret, Lille, France, 6Medical Oncology, Institut Jean Godinot, Reims, France, 7Medical Oncology, Centre Eugene – Marquis, Rennes, France, 8Medical Oncology, Centre Francois Baclesse, Caen, France, 9Medical Oncology, Institut Claudius Regaud – IUCT Oncopôle, Toulouse, France, 10Medical Oncology, Centre Jean Perrin, Clermont-Ferrand, France, 11Medical Oncology, GINECO & Paul Strauss Cancer Center and University of Strasbourg, Strasbourg, France, 12Medical Oncology, Centre Georges-Francois Leclerc, Dijon, France, 13Medical Oncology, Institut Curie, Paris & Saint-Cloud, France, 14Cancer Medecine, Institut Gustave Roussy, Villejuif, France, 15Medical Oncology, Centre Antoine Lacassagne, Nice, France, 16Medical Oncology, Institute Paoli Calmettes, Marseille, France, 17Medical Oncology, Institut de Cancérologie de Lorraine – Alexis Vautrin, Vandoeuvre Les Nancy, France, 18Biometrics Unit, Institut du Cancer de Montpellier, Montpellier, France, 19Medical Oncology, ICO Institut de Cancerologie de l'Ouest – Rene Gauducheau, Saint-Herblain, France

Background: Breast Cancer (BC) in men accounts for 1% of all BC. Management is still based largely on BC management in women. Only small and selected retrospective series on metastatic cases have been reported so far. Based on a national database, we aimed at providing a large comprehensive analysis of metastatic BC (MBC) in men.

Methods: ESME MBC platform is a French multi-center retrospective real life database using a clinical trial-like methodology to collect data from 18 French Comprehensive Cancer Centers. It includes data from each newly diagnosed MBC patients having initiated at least one treatment between 01/2008 and 12/2014. Cases occurring in men were retrieved and compared to the overall female population (characteristics, Student T-test), and to a population of women matched (1/1) on age, histology, grade, adjuvant treatment and metastasis location, regarding treatment effects and survival.

Results: Of 16 701 evaluable patients, 149 (0.89%) men were identified. Main comparative characteristics are listed in the image for this release.

In HR+/HER2- men, 45/105 (42.9%) received frontline hormonal therapy : tamoxifen (20/45), aromatase inhibitor (AI) ± LHRH analogs (18/45), others (7/45). Median PFS was 9.8 months (m) without evidence of statistically difference between HT types. Compared with a matched cohort of women , median PFS was similar : 9.8m versus 13.0m (p=0.8). For HR+/HER2- men receiving front line CT (29/105 (27.6%)), median PFS was 6.9m and was similar to the 6.3m PFS in matched women (HR=1.24, [0.69-2.23]). The overall survival in men was 41.8m versus 34.9m in matched women (p=0.745).

Conclusions: We report on one of the largest series of MBC in men. Compared with women, prognosis and treatment effects look the same. More biological information is needed to improve the customized management of MBC in men.

Legal entity responsible for the study: UNICANCER

Funding: Has not received any funding

Disclosure: All authors have declared no conflicts of interest

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