Background

CRA is common among premenopausal women with early BC and may determine substantial impact on post-CT QOL. We examined factors associated with CRA in a modern cohort of patients receiving current standard (neo)adjuvant CT regimens (anthracycline [A]- and taxane [T]-based) and the relationship between CRA and long-term QOL.

Methods

We used CANTO, a multicenter, prospective cohort of stage I–III BC (NCT01993498) to include premenopausal women aged ≤50 years at BC diagnosis, treated with CT, and not receiving adjuvant ovarian-function suppression. In the main analysis, our outcome of interest was CRA at year-1 (Y1), year-2 (Y2), and year-4 (Y4) after diagnosis. Multivariable logistic regression models assessed associations between CRA at each time-point and covariates. Among women with follow-up (FU) ≥4 years and menses status available at all time-points, multivariable linear regression models assessed the relationship between persistent CRA (defined as never resumption of menses) and QOL at Y4 (EORTC QLQ-C30/BR23), adjusting for QOL at diagnosis and all covariates.

Results

Among 1676 women, mean age at diagnosis was 42.2 years (SD 5.6). 83.1% reported CRA at Y1, 72.8% at Y2 and 66.7% at Y4, with expected variability across age groups and other patient characteristics (Table). Among 745 women with FU ≥ 4 years, 57.7% had persistent CRA, which was associated with worse sexual function (estimate vs resumption at any time -7,0 [95% CI -12,1 to -1,9]) and more long-term CT-related side effects (i.e. dry mouth, dysgeusia, hot flushes, headaches, alopecia; +3,0 [95% CI +0,1 to +6,0]). Table: 1551O

Factors associated with CRA

Conclusions

Most women reported CRA, including more than half with persistent CRA. Older age, receipt of hormonotherapy, combination of AT and a lower BMI were associated with higher rates of CRA. Persistent CRA was associated with worse sexual function and long-term CT-related side effects.

Clinical trial identification

NCT01993498.

Legal entity responsible for the study

Unicancer.

Funding

Conquer Cancer, the ASCO Foundation and Rising Tide Foundation for Clinical Cancer Research.

Disclosure

B. Pistilli: Financial Interests, , Invited Speaker: AstraZeneca, Pierre Fabre, Myriad; Financial Interests, Advisory Board: AstraZeneca, Pierre Fabre, Daiichi-Sankyo; Non-Financial Interests, Principal Investigator: Daiichi-Sankyo, AstraZeneca, Pierre Fabre, Merus, Puma; Financial Interests: Pfizer, Gilead. M. Lambertini: Financial Interests, Advisory Board: Roche, Novartis, Lilly, AstraZeneca, Exact Sciences, MSD, Pfizer, Seagen, Gilead; Financial Interests, Invited Speaker: Roche, Novartis, Lilly, Pfizer, Takeda, Ipsen, Knight, Libbs, Sandoz. I.V. Luis: Financial Interests, Institutional, Invited Speaker: Amgen, Pfizer/Edimark, Pfizer/Edimark, AstraZeneca. All other authors have declared no conflicts of interest.

Background

Cancer cachexia is a multifactorial syndrome characterized by anorexia and unintentional weight loss associated with poor clinical outcomes. Conversely, weight gain during cancer treatment may improve survival. The objective of this post-hoc analysis was to examine the relationship between sex, weight gain, and overall survival (OS) in patients with advanced lung cancer receiving standard-of-care (SOC) chemotherapy.

Methods

Data were pooled from three phase III clinical trials (NCT00254891, NCT00254904, NCT00596830) conducted between Nov 2005 and Mar 2011 in patients with advanced (stage IIIB/IV) NSCLC treated with first-line SOC chemotherapy (control arm). Weight was recorded at baseline, day 1 of each 3-week treatment cycle (up to 6 cycles), and after treatment per each study’s schedule. Weight gain was categorized as >0%, >2.5%, and >5% increase from baseline up to 4.5 months after chemotherapy initiation. The Kaplan-Meier method was used to estimate each subgroup's survival and median survival.

Results

The total 1,030 patients were predominantly male (70.5%) with stage IV NSCLC (88.4% male and 88.8% female). The median age (range) of male and female patients was 62 (34-87) and 60 (34-83) years, while the mean BMI (SD) was 24.5 (4.2) and 24.8 (4.8) kg/m², respectively. Most patients were current/previous smokers (94.2% male and 67.4% female). Overall, 486 (46.1% male vs. 49.7% female), 299 (29.6% vs. 27.6%), and 164 (17.2% vs. 12.8%) patients experienced weight gain from baseline of >0%, >2.5%, and >5%, respectively. Weight gain was associated with a significant decrease in the risk of death in both sexes (Table). The interaction test showed no significant difference in the association between weight gain and increased survival in males vs. females. Table: 1263O

OS hazard ratios (95% CI) associated with weight gain in male and female patients

Conclusions

The beneficial effect of weight gain on OS was observed regardless of sex in advanced NSCLC patients.

Clinical trial identification

NCT00254891, NCT00254904, NCT00596830.

Editorial acknowledgement

Medical writing support was provided by Diane Hoffman, PhD, of Engage Scientific Solutions and was funded by Pfizer.

Legal entity responsible for the study

Pfizer Inc.

Funding

Pfizer Inc.

Disclosure

E.J. Roeland: Financial Interests, Personal, Advisory Board: Care4ward, Actimed Therapeutics, Meter Health, Napo Pharmaceuticals, Alerion, Takeda; Financial Interests, Personal, Advisory Role: Veloxis Therapeutics, BOYMass; Financial Interests, Personal, Data Monitoring Committee: Enzychem Lifesciences Pharmaceutical Company. R. Yang: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. L.C. Tarasenko: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. T.D. McRae: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. J.H. Revkin: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. P.D. Bonomi: Financial Interests, Personal, Advisory Role: Merck, Pfizer, Roche Genentech. All other authors have declared no conflicts of interest.

Background

CIPN is a common, dose-limiting side effect of taxane-based chemotherapy. Currently there is no established strategy for prevention or treatment. Smaller studies suggest that cooling or compression could have a preventive effect. In this randomized trial we investigated the effectiveness of one-sided hand-cooling or compression for the prevention of CIPN.

Methods

122 breast cancer patients who received weekly (nab-)paclitaxel-based (neo-)adjuvant chemotherapy were 1:1 randomized to either cooling or compression of the dominant hand. No intervention was performed on the other hand. Cooling was performed with a frozen glove (Elasto-Gel; 84400APT Cedex, Akromed), compression was applied by two surgical gloves (one size smaller than tight-fitting size) 30 minutes before, during and 30 minutes after taxane therapy. The primary endpoint was efficacy to prevent grade ≥2 sensory polyneuropathy evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE). In a second hierarchical test, CIPN rates between both intervention groups were compared. CIPN was further assessed by the Total Neuropathy Score (TNSc), patient self-report questionnaires (EORTC-QLQ-CIPN20), MR-neurography (n=21) and nerve conduction studies. Additionally, we evaluated onycholysis, skin toxicity, quality of life, CIPN-associated dose-reductions, treatment discontinuations and potential risk factors.

Results

Cooling and compression were highly effective in preventing grade ≥2 CIPN (cooling: 25 vs. 46%; p-value=0.0008; compression: 23 vs. 39%; p-value=0.0016) with similar efficacy (no significant difference was found: p-value=0.7303). MR-neurography was highly sensitive for detecting CIPN showing increased T2 nerve-to-muscle signal ratio indicating edematous nerve changes. Updated results will be presented.

Conclusions

POLAR is the first trial to compare cooling and compression for preventing CIPN. Both interventions were highly effective and almost halved the risk of grade ≥2 CIPN. These findings could play an important role beyond gynecological oncology.

Legal entity responsible for the study

The authors.

Funding

Intramural funding as part of the elevator pitch of the National Center for Tumor Diseases (NCT) Heidelberg.

Disclosure

L. Michel: Non-Financial Interests, Personal and Institutional, Advisory Board: German Breast Group (GBG); Financial Interests, Personal, Invited Speaker: Pfizer, Roche, Eisai, AstraZeneca, Lilly, MSD; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Funding: Pfizer. K. Smetanay: Financial Interests, Personal, Invited Speaker: Celgene, Roche, AstraZeneca, MSD, Novartis, Lilly; Financial Interests, Personal, Advisory Board: MSD. C. Fremd: Financial Interests, Personal, Invited Speaker: Celgene, Pfizer, Novartis, Amgen, AstraZeneca, EISAI, Lilly; Financial Interests, Personal, Funding: Pfizer. D. Jäger: Financial Interests, Personal, Advisory Role: CureVac AG, Definiens, F. Hoffmann-La Roche Ltd, Genmab A-S, Life Science Inkubator GmbH, VAXIMM AG, OncoOne Research & Development Research GmbH, Oncolytics Biotech Inc, BMS Stiftung Immunonkologie; Financial Interests, Personal, Writing Engagements: Terrapinn, Touch Medical Media, BMS GmbH & Co KGaA; Financial Interests, Personal, Sponsor/Funding: Amgen Inc, Oryx GmbH, Roche Glycart AG, Parcel.com, BMS, IKTZ HD GmbH; Financial Interests, Personal, Advisory Board: CureVac, Definiens, Hoffmann-La Roche, Genmab A-S, Life Science Inkubator GmbH, Vaximm AG, Oncolytics Biotech Inc. F. Marmé: Financial Interests, Personal, Invited Speaker: AstraZeneca, Tesaro, Pfizer, PharmaMar, Eisai, MSD, celgene , Lilly, Pierre-Fabre, Vaccibody, Seagen, Immunomedics, Janssen-Cilag, Myriad, Curevac; Financial Interests, Personal, Sponsor/Funding: Clovis, GenomicHealth. A. Schneeweiss: Financial Interests, Personal, Invited Speaker: Celgene, Roche, Abbvie, Pfizer, AstraZeneca, Novartis, MSD, Tesaro, Lilly, GSK, Seagen, Gilead, Pierre Fabre, onkowissen.de; Financial Interests, Personal, Funding: Molecular Partner, Roche, Pfizer; Financial Interests, , Invited Speaker: Metaplan. All other authors have declared no conflicts of interest.

Background

The antibody-drug conjugate SG comprises an anti-Trop-2 antibody coupled to SN-38 via a hydrolyzable linker. In the ongoing randomized TROPiCS-02 trial, SG is being evaluated vs single-agent chemotherapy treatment of physician’s choice (TPC) after CDK 4/6 inhibitor, endocrine therapy, and at least 2 chemotherapies in HR+/HER2- MBC setting. Here we assess the impact of SG on HRQoL in TROPiCS-02.

Methods

Patients (pts) with locally determined HR+/HER2- MBC following (2-4 prior chemotherapies) for metastatic disease, were randomized to receive SG (10 mg/kg IV on days 1 and 8 of a 21-day treatment [Tx] cycle) or TPC (capecitabine, eribulin, gemcitabine, or vinorelbine). HRQoL was assessed at baseline (BL), day 1 of each Tx cycle (CxDx) and at end of treatment visit using the EORTC QLQ-C30. The analysis included all pts with valid HRQoL assessments at BL and ≥1 post-BL visit. Linear mixed-effect models for repeated measures were used to estimate differences in overall least-square mean changes from BL between Tx arms, using on-Tx data up to C11D1 (n ≥25 in both arms).

Results

The analysis included 446 pts (236 SG, 210 TPC; median age 56 y). The EORTC QLQ-C30 completion rate was ≥85% up to C13D1 in both Tx arms. Mean HRQoL scores at BL were generally similar for SG and TPC. The SG arm showed a trend of improvement in most HRQoL domains. A significantly greater improvement in physical functioning and dyspnea was observed for SG vs TPC and greater worsening in diarrhea (table). Table: 1553O

EORTC QLQ-C30 least-square mean change from baseline

Conclusions

Despite the association with worsening diarrhea, SG demonstrated an overall HRQoL benefit in heavily-pretreated patients with HR+/HER2- MBC.

Clinical trial identification

NCT03901339.

Legal entity responsible for the study

Gilead Sciences, Inc.

Funding

Gilead Sciences, Inc.

Disclosure

H.S. Rugo: Financial Interests, Personal, Invited Speaker: Puma Biotechnology, Mylan, Samsung Bioepis; Financial Interests, Institutional, Funding: Macrogenics, OBI Pharma, Pfizer, Novartis, Lilly, Genetech, Merck, Odonate Therapeutics, Daiichi Sankyo, Seattle Genetics, Sermonix Pharmaceuticals, Astra Zeneca, Gilead Sciences, Ayala Pharmaceuticals. P. Schmid: Financial Interests, Institutional, Research Grant, Grant/Funding to Institution: Astellas, AstraZeneca, Genentech, Novartis, Oncogenex, Roche, Medivation; Financial Interests, Personal, Advisory Role, Consulting fees: AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, Puma, Roche, Eisai, Celgene; Financial Interests, Personal, Writing Engagements, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, Puma, Roche, Eisai, Celgene; Financial Interests, Personal, Full or part-time Employment, Employee – Roche (spouse): Roche (spouse). S.M. Tolaney: Financial Interests, Institutional, Funding, Funding to institute for duration of study: Gilead; Financial Interests, Institutional, Funding, All funding to institute: AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Gilead, Exelixis, BMS, Eisai, Nanostring, Cyclacel, Sanofi, Odonate, SeaGen; Financial Interests, Personal, Invited Speaker, Honorarium payments to self for participation in advisory boards/consulting from all companies listed: AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Gilead, BMS, Eisai, Nanostring, Sanofi, Odonate, SeaGen, Daiichi-Sankyo, Athenex, CytomX, Blueprint Medicines, Zentalis, Zymeworks, Ellipses Pharma, 4D Pharma, OncoSec, Infinity Therapeutics, BeyondSpring Pharma, OncXerna, Reveal Genomics, ARC Therapeutics; Financial Interests, Personal, Invited Speaker, Honorarium payments to self for participation in advisory boards/consulting from all companies listed – 1 time event: Kyowa Kirin Pharma, G1 Therapeutics, Silverback Therapeutics, Certara, Mersana Therapeutics, OncoPep; Financial Interests, Personal, Invited Speaker, To self – lecture/educational series: Chugai, Genentech/Roche, Eisai, Gilead, AstraZeneca, BMS. F. Marmé: Financial Interests, Institutional, Funding: Pfizer; Financial Interests, Personal and Institutional, Research Grant: Roche, Novartis, Astra Zeneca, GSK/Tesaro, MED, Clovis, Vaccibody, Gilead Sciences, Eisai; Financial Interests, Personal, Advisory Role, Consulting Fees: Astra Zeneca, Tesaro/GSK, Pfizer, EISAI, Gilead, Genomic Health; Financial Interests, Institutional, Advisory Role, Consulting Fees: VACIIBODY; Financial Interests, Personal, Invited Speaker, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Astra Zeneca, Clovis, GSK/Tesaro, Eli Lilly, Novartis, Pfizer, Roche, Myriad Genetics, PharmaMar, Eisai, MSD, Immunomedis/Gilead, Pierre-Fabre, Agendia, Genomic Health, Seattle Genetics; Financial Interests, Personal and Institutional, Sponsor/Funding, Support for attending meetings and/or travel: Pfizer, Roche, Astra Zeneca ; Financial Interests, Personal and Institutional, Advisory Role, Participation on a Data Safety Monitoring Board or Advisory Board: Palleos, Amgen. L. Shi: Financial Interests, Personal and Institutional, Funding, Evidera received payment for statistical analysis for this project: Gilead. W. Verret: Financial Interests, Personal, Full or part-time Employment: Genentech, Gilead; Financial Interests, Personal, Stocks/Shares: Genentech. M. Gharaibeh: Financial Interests, Personal, Full or part-time Employment, Gilead employee – therefore, granted with Gilead stocks and stocks options: Gilead. A. Bardia: Financial Interests, Personal and Institutional, Research Grant, Grants or contracts from any entity: Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health/Menarini, Immunomedics/Gilead, Daiichi Pharma/Astra Zeneca, Eli Lilly; Financial Interests, Personal, Advisory Role, Consulting fees: Pfizer, Novartis, Genentech, Merck, Radius Health/Menarini, Immunomedics/Gilead, Sanofi, Daiichi Pharma/Astra Zeneca, Phillips, Eli Lilly, Foundation Medicine. J. Cortés: Financial Interests, Personal, Advisory Role: Roche +, Celgene -, Celestial, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, Merck Sharp&Dohme +, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Kyowa Kirin; Financial Interests, Personal, Invited Speaker: Roche +, Novartis +, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Daiichi Sankyo; Financial Interests, Institutional, Funding: Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London; Financial Interests, Personal, Stocks/Shares, Stock, patents and intellectual property: MedSIR; Financial Interests, Personal, Travel, accommodation, expenses: Roche, Novartis, Eisai, pfizer, Daiichi Sankyo. All other authors have declared no conflicts of interest.

Background

DESTINY-Breast04 (NCT03734029) showed improvement in progression-free and overall survival of T-DXd vs TPC in pts with HER2-low MBC regardless of hormone receptor status, with no new safety signals. Here we report PROs on the effect of treatment on health-related quality of life (QOL) of T-DXd vs TPC in the hormone receptor–positive cohort.

Methods

Pts with centrally confirmed HER2-low (IHC1+ or IHC2+/ISH-) MBC with 1-2 prior lines of chemotherapy in the metastatic setting were assigned 2:1 to T-DXd (Q3W) or TPC (Q3W or Q4W). PROs were measured using the European Organization for Research and Treatment of Cancer QOL questionnaires (EORTC QLQ-C30, primary variable: global health status [GHS]/QOL scale score, and EORTC QLQ-BR23) and the EuroQol 5-dimension, 5-level (EQ-5D-5L) visual analog scale (VAS). PROs were assessed at prespecified timepoints per the protocol. Change from baseline (CFB) and time to definitive deterioration (TDD) were assessed. Deterioration was defined as an increase of ≥10 points.

Results

In both arms, compliance for questionnaires was >92% at baseline and >80% for cycles 2-27. Baseline GHS score was 36.3 for T-DXd and 37.8 for TPC. Mean CFB for GHS/QOL of the QLQ-C30 remained stable (within ± 10 points) over time for pts in the T-DXd arm (n=331) up to 27 cycles and TPC arm (n=163) up to 13 cycles; beyond these cycles, the number of pts on treatment (n<10%) was too low to be informative. Median TDD of QLQ-C30 GHS/QOL was 7.6 mo for T-DXd vs 5.1 mo for TPC (hazard ratio [HR], 0.71 [95% CI, 0.56-0.92]), and all prespecified QLQ-C30 subscales had longer TDD with T-DXd, including pain (HR, 0.51 [95% CI, 0.39-0.65]) and physical functioning (HR, 0.54 [95% CI, 0.42-0.70]). For breast-specific arm symptoms of the QLQ-BR23, median TDD was 9.8 mo for T-DXd vs 5.4 mo for TPC (HR, 0.67 [95% CI, 0.50-0.88]). Median TDD of EQ-5D-5L VAS was 8.8 mo for T-DXd vs 4.7 mo for TPC (HR, 0.70 [0.54-0.91]).

Conclusions

Pts who received T-DXd maintained GHS/QOL longer than TPC in all prespecified QLQ-C30 subscales while on therapy. These results are consistent with the primary results and confirm the QOL benefit of T-DXd vs TPC for pts with HER2-low MBC.

Clinical trial identification

NCT03734029.

Editorial acknowledgement

Under the guidance of authors, medical writing and editorial support was provided by Marianna B. Johnson, PhD, and Soniya Patel, PhD, of ApotheCom, and was funded by Daiichi Sankyo.

Legal entity responsible for the study

Daiichi Sankyo and AstraZeneca.

Funding

Daiichi Sankyo and AstraZeneca.

Disclosure

N.T. Ueno: Financial Interests, Personal, Advisory Role: DSI; Financial Interests, Personal, Other, Honoraria: DSI; Financial Interests, Personal, Research Grant: DSI. W. Jacot: Financial Interests, Personal, Other, Honoraria: AstraZeneca, BMS, Daiichi Sankyo, Eisai, Lilly France, MSD, Novartis, Pfizer, Roche, Seagen; Financial Interests, Personal, Other, Travel Expenses: AstraZeneca, Chugai Pharma, Eisai, Glaxo Smithkline, Lilly France, Novartis, Pfizer, Roche, Pierre Fabre, Sanofi Aventis; Financial Interests, Institutional, Research Grant: AstraZeneca, Daiichi Sankyo. T. Yamashita: Financial Interests, Personal, Other, Honoraria: Chugai, Eisai, Daiichi Sankyo, Novartis Pharma, Taiho, Nippon Kayaku, AstraZeneca, Kyowa kirin, Pfizer; Financial Interests, Institutional, Research Grant: Chugai, Taiho, Nippon Kayaku, Kyowa kirin. J. Sohn: Financial Interests, Institutional, Research Grant: MSD, Roche, Novartis, AstraZeneca, Lilly, Pfizer, GSK, Daiichi Sankyo, Sanofi, Boehringer Ingelheim. E. Tokunaga: Financial Interests, Personal, Speaker’s Bureau: Daiichi Sankyo, Eli Lilly, AstraZeneca. A. Prat: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker, Lecture fees: Novartis, Daiichi Sankyo; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Novartis, Pfizer, BMS, Puma, Oncolytics Biotech, MSD, Guardant Health, Peptomyc; Financial Interests, Institutional, Invited Speaker, Clinical trials: Daiichi Sankyo; Financial Interests, Institutional, Other, Contracted research: Boehringer, Medica Scientia inno. Research; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker, Leadership role: Reveal Genomics, SL.; Financial Interests, Personal, Stocks/Shares: Reveal Genomics, Oncolytics Biotech; Financial Interests, Personal, Royalties: Reveal Genomics; Financial Interests, Institutional, Invited Speaker: Roche, AstraZeneca, Novartis; Financial Interests, Personal and Institutional, Invited Speaker: Daiichi Sankyo; Non-Financial Interests, Institutional, Other, Leadership roles: Patronage committee: SOLTI Foundation, Actitud Frente al Cáncer Foundation. J. Tsurutani: Financial Interests, Personal, Advisory Board: Daiichi Sankyo, AstraZeneca, Eisai Inc.; Financial Interests, Personal, Expert Testimony: Daiichi Sankyo, Taiho Inc.; Financial Interests, Personal, Invited Speaker: West Japan Oncology Group; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Funding: Daiichi Sankyo, West Japan Oncology Group; Financial Interests, Institutional, Invited Speaker: FSJD. Y.H. Park: Financial Interests, Personal, Advisory Board: AstraZeneca, Pfizer, Roche, Novartis, MSD, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca, Pfizer, Roche, Novartis, MSD; Financial Interests, Institutional, Other, Research Grant: AstraZeneca, Pfizer, Roche, MSD; Non-Financial Interests, Principal Investigator: AstraZeneca, Pfizer, Novartis, MSD, Lilly, Roche, Daiichi Sankyo. H.S. Rugo: Financial Interests, Personal, Other, Honoraria: Puma, Samsung, NAPO; Financial Interests, Institutional, Research Grant: Pfizer, Merck, Novartis, Lilly, Roche, Daiichi, Seattle Genetics, Macrogenics, Sermonix, Boehringer Ingelheim, Polyphor, AstraZeneca, Ayala, Astellas, Gilead. B. Xu: Financial Interests, Personal, Advisory Board: Novartis, AstraZeneca; Financial Interests, Personal, Invited Speaker: Pfizer, Roche, Eisai; Financial Interests, Institutional, Research Grant: Henrui. F. Cardoso: Financial Interests, Personal, Other, Consultancy: Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, Prime Oncology, Roche, Sanofi, Samsung Bioepis, Seagen, Teva; Financial Interests, Institutional, Invited Speaker: Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers-Squibb, Bayer, Daiichi, Eisai, Fresenius GmbH, Genentech, GlaxoSmithKline, Ipsen, Incyte, Nektar Therapeutics, Nerviano, Novartis, Macrogenics, Medigene, MedImmune, Merck, Millenium, Pfizer, Pierre-Fabre, Roche, Sanofi-Aventis, Sonus, Taiho Oncology, Tesaro, Tigris, Wilex, Wyeth; Non-Financial Interests, Leadership Role, President: ABC Global Alliance and ABC Consensus Conference and Guidelines; Non-Financial Interests, Member: ESMO, ESO, EORTC, BCG, IBCSG, SOLTI, ASCO, AACR, EACR, SIS, ASPIC. Z. Mitri: Financial Interests, Personal, Advisory Board: Lilly, AstraZenica, Gilead; Financial Interests, Personal, Research Grant: Lilly, GSK, AstraZenica. R. Mahtani: Financial Interests, Personal, Advisory Board: Amgen, Agendia, AstraZeneca, Biotheranostics, Daiichi, Eisai, Genentech, Immunomedics, Lilly, Merck, Novartis, Pfizer, Puma, Sanofi, Seagen. K. Dunton: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo. Y. Wang: Financial Interests, Personal, Stocks/Shares: Daiichi Sankyo. D. Gambhire: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo. F. Cottone: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo. N. Harbeck: Financial Interests, Personal, Invited Speaker: AstraZeneca, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Seagen, Medscape, Art Tempi, Onkowissen, Gilead, Sanofi, Exact Sciences; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo, Novartis, Pfizer, Roche, Sandoz-Hexal, Seagen, Aptitude Health, Gilead, Sanofi; Financial Interests, Personal, Other, Husband: WSG (Husband); Financial Interests, Personal, Ownership Interest: West German Study Group; Financial Interests, Institutional, Funding: AstraZeneca, BMS, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Palleos, Seagen, TRIO, WSG; Non-Financial Interests, Member, Member German AGO Breast Guideline Committee: AGO Breast Committee; Non-Financial Interests, Member, Breast Cancer Educational Programs: ESO/ESCO; Other, Other, Founding Editor: BreastCare Journal. D.A. Cameron: Financial Interests, Institutional, Other, Consulting: Lilly, Novartis, Sanofi; Financial Interests, Institutional, Advisory Board: Roche, Grail, AstraZenica, Syntheon. S. Modi: Financial Interests, Personal, Other, Honoraria: Genentech, Daiichi Sankyo, AstraZeneca, Seattle Genetics, Novartis; Financial Interests, Personal, Advisory Board: Genentech, Daiichi Sankyo, AstraZeneca, Seattle Genetics, Macrogenics; Financial Interests, Personal, Speaker’s Bureau: Genentech, Seattle Genetics, Daiichi Sankyo; Financial Interests, Personal, Research Grant: Genentech, AstraZeneca, Seattle Genetics, Daiichi Sankyo.