EUROPA DONNA Session Wednesday, 19 March 2014 S43

Conclusions: Patients with more prominent enhancement in thecontralateral FGT at MRI may have lower DFS and be at larger risk ofDBC than patients with less prominent enhancement.

No conflicts of interest

Wednesday, 19 March 2014 15:45–17:15

EUROPA DONNA SESSION

Survivorship − What Women Need After

Breast Cancer

17 InvitedSurvivorship issues in breast cancer

O. Pagani1. 1Oncology Institute of Southern Switzerland, Bellinzona,Switzerland

Treatment of patients with breast cancer significantly improved over the lastdecades and the development of many new, targeted and multidisciplinarytreatments allows cure in an increasing proportion of patients with earlybreast cancer and long-term, quality of life-oriented survival in women withadvanced disease.Along their journey through breast cancer, patients (and families) face a

number of difficult challenges, which change over time and according todisease status and include, among others; (a) inform family and friends;(b) face the fear of suffering and death; (c) cope with disease symptomsand treatment acute and chronic side effects; (d) address job and socialaspects, such as cost and availability of adequate care in many countries.The context is to some extent different in young as opposed to elderlywomen with specific problems to face according to age, such as forexample young children to take care of, possible job discriminations, fertilityconcerns and premature menopause in younger women, concomitant dis-eases, loneliness, feeling a burden to families and society for older patients.While a lot of research and information is available on patients surviving

after early breast cancer, with specific support programs proven to beeffective, scarce data and tools exist in advanced breast cancer for patients,family members and health-care professionals.The multidisciplinary and quality-controlled setting of breast units should

enable care givers to address survivorship in both early and advancedbreast cancer in a dedicated and focused way; breast nurses, psycho-oncologists, support groups are in fact a constitutional part of the teamand can set the agenda according to the specific needs and resourcesrequired in any local setting.The number of patients surviving breast cancer or living with the disease

is expected to further increase over the next decades and we need to beready to include survivorship in our therapeutic plans not only to improvepatients’ physical wellbeing but also the quality of their daily living andpsychosocial health.

No conflicts of interest

18 InvitedSurvivorship − What women need after breast cancer: Breast care

nurse

M. Eicher1. 1University of Applied Sciences and Arts WesternSwitzerland School of Health Fribourg, Haute Ecole de Sante Fribourg,Freiburg i. UE., Switzerland

Following a breast cancer diagnosis, an ever increasing number of womenlives for a longer period of time. As many of them have to copewith worse health conditions than those without such diagnosis, breastcancer survivors have significant unmet needs, like psychological, physical,informational and health system related needs. Existing cancer follow-upmodels of care were initially developed without associating long term follow-up and chronic disease management directly with cancer. In light of anever increasing number of breast cancer survivors, new models of careare needed that allow us to focus on recovery rather than exclusively ontreatment. Such models should include a personalized needs assessment;a self-management based care approach as well as individualized follow-up and support. As to track the efficacy of such models, evaluation shouldstrive to measure patient reported outcome measures. While Breast CareNurses already comply with many of the aforementioned supportive careapproaches, they have yet to focus specifically on survivorship care. Thus,this presentation will provide an overview of the particular needs of breastcancer survivors and will then demonstrate innovative, promising models

of care (such as survivorship care planning and patient navigation) to moreeffectively respond to these needs of women living with and beyond breastcancer.

No conflicts of interest

19 InvitedRehabilitation and return to work

S. Rozman1. 1Europa Donna Slovensko, Slovenia, Ljubljana, Slovenia

Due to improved treatment results, cancer is increasingly becoming achronic condition. This results in specific care needs and demands oflong term survivors. Compared to prevention and treatment, rehabilitationusually gets less attention (and resources), though it plays a very importantrole in improving the quality of cancer patient’s life. The term “rehabilitation”refers to “a process aimed at enabling persons with disabilities to reachand maintain their optimal physical, sensory, intellectual, psychiatric and/orsocial functional levels, thus providing them with the tools to change theirlives towards a higher level of independence” (WHO definition). It mayinclude measures to provide and/or restore functions, or compensate forthe loss or absence of a function or for a functional limitation. It includesa wide range of measures and activities from more basic and generalrehabilitation to goal-oriented activities, for instance physical, psycho-social and vocational rehabilitation (return to work). The state of the artrehabilitation must consider:• Multidisciplinary team, good communication and coordination• Patient centered approachFor most survivors, work is a financial and emotional necessity, to help

them keep their self-esteem and social support. Permanent consequencesof a disease are very different even in patients with comparable conditions.These differences are hard to account for and stem from the fact that theconsequences of a disease are not present only in impairment of physicalstructures or functions, but also in other fields of human experience, suchas:• physical consequences − loss of function and structure of organs• consequences of aggressive treatments (scars, amputations, contrac-tures, burns, fatigue)

• consequences of stress and the psychological processes of acceptanceof handicap (PTSD, impairment of immune system, depression, anxiety,adjustment disorders)

• changes in values and priorities, expectations and prejudices• social consequences that affect the family (impoverishment, divorce,diseases of other family members)

• social consequences in working environment: loss of employment orcareer opportunities, discrimination, mobbing, conflict with employeesor doctors due to administrative pressures of insurance companies tolower worker’s compensations.The studies on return to work reveal that the severity of the disease

and the impairment of function are usually the most important factorinfluencing the return to work, but other environmental and personal factorsare important too. Factors influencing the return to work are:• demographical factors: age, economic status, education• disease factors: localization, status of disease at diagnosis, functionalstatus after treatment, other diseases and handicaps

• work factors: adaptation of workplace, easier jobs, reduced strain andstress, reduced working hours, suitable transportation to work can bedecisive factors in retaining working ability

• treatment factors: considering quality of life factors at treatment planning,the accessibility of paid sick-leave, vocational and medical rehabilitationin a multidisciplinary teamBecause millions of cancer survivors, more than ever before, are now

working age adults, advocacy efforts should shift from expanding legalprotection from cancer-based discrimination to providing resources to helpsurvivors meet their individual employment related concerns.

No conflicts of interest

20 InvitedThe role of cancer patient support groups

S. Kyriakides1. 1Europa Donna, Nicosia, Cyprus

A diagnosis of cancer finds no individual or family prepared. The initialshock of diagnosis, the confusion and the uncertainty, the anxiety and thefear are emotions that all patients are familiar with, that the professionalsdealing with breast cancer are aware of that families frequently experience.Support groups can help reduce the anxiety, the tension and the depres-

sion, and improve the quality of life of patients by providing information andsupport. Patients who have access to support groups have a greater senseof control, feel less helplessness, and cope better with their therapies.It is important to note that patient support groups provide more than

emotional support. They can actually improve the wellbeing of a patient,physically and psychologically and provide a safety net for the patient.

S44 Wednesday, 19 March 2014 Poster Sessions

There are many types of patient support groups, some run by patients,others by clinicians, support groups can be specific to different ages, whilemany support groups are on line. Internet support groups have openednew pathways allowing patients to meet not in rooms or face to face butacross the globe, sharing information and experiences. This has openednew channels but is also the source of new dangers.Feedback from patients indicates the different value of various types of

support groups.It is unquestionable however that the availability of support, renders the

cancer journey less lonely, and no patient should have to travel this journeyalone.

No conflicts of interest

Wednesday, 19 March 2014

POSTER SESSION

Adjuvant Drug Therapy

22 PosterPopulation pharmacokinetic (PK) analysis of trastuzumab

confirms the appropriateness of a fixed (non-weight-based)

subcutaneous (SC) formulation dose in patients with HER2-positive

early breast cancer (EBC)

A. Quartino1, J. Li1, H. Li2, D.R. Wada2, J. Visich1, C. Li1, J.Y. Jin1,B. Lum1. 1Genentech Inc, Clinical Pharmacology, South San Francisco,USA; 2Quantitative Solutions Inc, Menlo Park, USA

Background: Trastuzumab (Herceptin®) IV and SC formulations havebeen approved to treat patients with HER2-positive breast cancer. Inthe neoadjuvant/adjuvant Phase 3 study HannaH, a 600mg fixed SCdose was compared to the body-weight-adjusted IV regimen (8mg/kgloading followed by 6mg/kg), each 3-weekly (q3w). This analysis evaluatestrastuzumab PK and the appropriateness of a fixed 600mg SC dose in theEBC population.

Methods: Serum trastuzumab concentrations (N = 16,193) from 595EBC patients in the HannaH study were analyzed using the population-modeling approach. The impact of patient factors on PK was evaluated ina step-wise manner at a p < 0.001 level of significance.

Results: Trastuzumab PK is described by a two-compartment modelwith parallel linear and nonlinear elimination and first-order SC absorption.At steady-state, total clearance (CL) is mainly linear and the estimatedvalues for total clearance (0.18 to 0.22 L/day for steady-state trough/peakconcentration of 75 to148 mg/mL) and central volume of distribution (2.9 L)are comparable to reported values for metastatic breast cancer (MBC)patients. The bioavailability for the SC formulation was 77%.Body weight and alanine aminotransferase (ALT), while showing a

significant effect on PK, only explained 8% of the variability in CL.Simulations showed that the exposure distribution in the EBC population issimilar for both formulations. Most patients (98% for SC and 99.5% for IV)achieved or exceeded the target steady-state trough (Cmin,ss) of 20 mg/mL.Thus dose adjustments for body-weight and ALT are not necessary.Comparisons of steady-state simulated PK exposures for the studied IV

and SC regimens in Table 1 show a 17% higher AUC,ss and 32% higherCmin,ss for the SC regimen compared to the IV q3w regimen. Additionally,exposure for the approved weekly IV regimen is shown. Steady-state (90%)was reached by cycle 6 for the SC q3w regimen.

Conclusion: A fixed 600mg SC dose of trastuzumab provides thedesired PK exposure. No dose adjustment per patient factors is requiredin the EBC population.

Table 1. Model-predicted steady-state PK exposures for SC and IVregimens

Regimen Cmin,ss(mg/mL)

Cmax,ss(mg/mL)

AUC,ss(mg·day/mL,per 3 weeks)

SC: fixed 600mg, q3w 75 148 2337IV: 8mg/kg loading, 6mg/kg maintenance, q3w 57 182 1994IV: 4mg/kg loading, 2mg/kg maintenance, weekly 75 116 1951

Conflict of interest: Corporate-sponsored research: I’m a paid employeefor Genentech Inc. All co-authors are paid consultants/employees ofGenentech Inc.

23 PosterPhase 2 trial: Impact of additional 4 cycles of cisplatin (CDDP4)

in patients with triple negative breast cancer (TNBC) who do not

achieve clinical CR after four cycles of neoadjuvant adriamycin plus

cyclophosphamide (AC4) [PACER]

S.B. Kim1, J. Kim1, J.H. Ahn1, K.H. Jung1, N. Je1, G. Gong2, H.J. Lee2,H.H. Kim3, B.H. Son4, S.H. Ahn4. 1Asan Medical Center, Oncology,Seoul, Korea; 2Asan Medical Center, Pathology, Seoul, Korea; 3AsanMedical Center, Radiology, Seoul, Korea; 4Asan Medical Center, Surgery,Seoul, Korea

Background: Triple-negative breast cancers (TNBCs) occur in approxi-mately 15% to 20% of all patients with breast cancer, and are associatedwith unfavorable prognosis. Achievements of pathologic complete response(pCR) are import prognosticator in neoadjuvant therapy for TNBCpatients(pts). Cisplatin has proven to be effective in patients with TNBC.The PACER trial was designed to further evaluate cisplatin activity inpatients with TNBC who do not achieve clinical CR after 4 cycles ofneoadivuant AC and identify potential predictive biomarkers

Methods: The PACER trial is single center phase 2 study for TNBCin neoadjuvant setting. Patients with tumor or lymph node size >1.5 cmare eligible. Primary end points: the pathologic complete response (pCR)in triple-negative breast cancer treated with AC4 with or without CDDP4as neoadjuvant chemotherapy. Key secondary endpoints include metabolicresponse as assed by PET-CT after 2 cycles of AC, rate of overall radiologicresponse using sonography, mammogram and breast MRI. Postoperatively,patients with residual axillary lymph node are allowed to receive 4 cyclesof docetaxel at the discretion of the physician.

Results: At the time of submission, a total of 88 patients were enrolled;Two patients were not evaluable for PET assessment. Seventy-eightpatients achieved metabolic response (8 mCR, 70 mPR). Pathologicalcomplete remission (pCR) occurred in 16 patients (29%) and at least partialremission in 7 (12.5%) among pts who received surgery (N = 56).After 4 cycles of AC, 11 patients had cCR, and among them, 7 patients

achieved pCR.With addition of 4 cycles of cisplatin for those who did not achieve cCR

(N = 71), there was 9 pCR. Treatment with AC followed by cislplatin wasgenerally well tolerated; the most common toxicities included neutropeniaand nausea/vomiting. No serious toxicities were observed.

Conclusions: Intergrating cisplatin in patients with TNBC who do notachieve clinical CR after neoadjuvant AC has modest efficacy in increasingpCR. PET is a useful tool to screen who will be progressive in early diseasesettings. Updated study findings will be provided.

Conflict of interest: Corporate-sponsored research: Samyang, Norvatis

24 PosterPatient attributes considered for decision-making with regard to

adjuvant chemotherapy in early stage HR+, HER2− breast cancer

patients: Results of the Multidisciplinary Application of Genomics in

Clinical Practice (MAGIC) survey

M. Aapro1, M. De Laurentiis2, E. Mamounas3, M. Martin4, D. Rea5,R. Rouzier6, V. Smit7, C. Thomssen8. 1Clinic of Genolier, MultidisciplinaryOncology Institute, Genolier, Switzerland; 2National Cancer InstituteG. Pascale Foundation, Department of Senology, Naples, Italy; 3MDAnderson Cancer Center Orlando, Department of Surgical Oncology,Orlando FL, USA; 4Hospital General Universitario Gregorio Maranon,Medical Oncology Service, Madrid, Spain; 5University of Birmingham,Queen Elizabeth Hospital, Birmingham, United Kingdom; 6Institute Curie,Department of Surgery, Paris, France; 7 Leiden University Medical Center,Department of Pathology, Leiden, Netherlands; 8Martin-Luther-UniversityHalle-Wittenberg, Department of Gynecology, Halle (Saale), Germany

Background: The decision to offer ACT or not to early stage HR+, HER2−BC patients depends on many factors. The MAGIC survey aimed toidentify criteria clinicians use in daily practice regarding ACT need, and tocharacterize patients for whom available data are sufficient to suggest ACTor not and those for whom more data are required for informed decision-making.

Material and Methods: An online survey was made available forphysicians participating in multidisciplinary BC teams with �5 yearsof experience in treating BC. The survey included modules assessingrespondent characteristics and their clinical decisions regarding ACT for896 randomly generated patient profiles. The survey started in Aug 2013;final results will be presented at the meeting. A conjoint analysis wasperformed for patient attributes considered for ACT decision (i.e., age;tumor size/grade; nodal status; ER, PR, and Ki67 status).