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1. Supervised, structured and individualized exercise in metastatic breast cancer: a randomized controlled trial

Author

Hiensch, AE, Depenbusch, J, Schmidt, ME, Monninkhof, EM, Pelaez, M, Clauss, D, Gunasekara, N, Zimmer, P, Belloso, J, Trevaskis, M, Rundqvist, H, Wiskemann, J, Mueller, J, Sweegers, MG, Fremd, C, Altena, R, Gorecki, M, Bijlsma, R, van Leeuwen-Snoeks, L, ten Bokkel Huinink, D, Sonke, G, Lahuerta, A, Mann, GB, Francis, PA, Richardson, G, Malter, W, van der Wall, E, Aaronson, NK, Senkus, E, Urruticoechea, A, Zopf, EM, Bloch, W, Stuiver, MM, Wengstrom, Y, Steindorf, K, May, AM, Hiensch, AE, Depenbusch, J, Schmidt, ME, Monninkhof, EM, Pelaez, M, Clauss, D, Gunasekara, N, Zimmer, P, Belloso, J, Trevaskis, M, Rundqvist, H, Wiskemann, J, Mueller, J, Sweegers, MG, Fremd, C, Altena, R, Gorecki, M, Bijlsma, R, van Leeuwen-Snoeks, L, ten Bokkel Huinink, D, Sonke, G, Lahuerta, A, Mann, GB, Francis, PA, Richardson, G, Malter, W, van der Wall, E, Aaronson, NK, Senkus, E, Urruticoechea, A, Zopf, EM, Bloch, W, Stuiver, MM, Wengstrom, Y, Steindorf, K, and May, AM

Abstract

Physical exercise both during and after curative cancer treatment has been shown to reduce side effects. Evidence in the metastatic cancer setting is scarce, and interventions that improve health-related quality of life (HRQOL) are much needed for patients with metastatic breast cancer (MBC). The multinational randomized controlled PREFERABLE-EFFECT trial assessed the effects of exercise on fatigue and HRQOL in patients with MBC. In total, 357 patients with MBC and a life expectancy of ≥6 months but without unstable bone metastases were recruited at eight study centers across five European countries and Australia. Participants were randomly assigned (1:1) to usual care (control group, n = 179) or a 9-month supervised exercise program (exercise group, n = 178). Intervention effects on physical fatigue (European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-FA12 scale) and HRQOL (EORTC QLQ-C30 summary score) were determined by comparing the change from baseline to 3, 6 (primary timepoint) and 9 months between groups using mixed models for repeated measures, adjusted for baseline values of the outcome, line of treatment (first or second versus third or higher) and study center. Exercise resulted in significant positive effects on both primary outcomes. Physical fatigue was significantly lower (-5.3 (95% confidence interval (CI), -10.0 to -0.6), Bonferroni-Holm-adjusted P = 0.027; Cohen's effect size, 0.22) and HRQOL significantly higher (4.8 (95% CI, 2.2-7.4), Bonferroni-Holm-adjusted P = 0.0003; effect size, 0.33) in the exercise group than in the control group at 6 months. Two serious adverse events occurred (that is, fractures), but both were not related to bone metastases. These results demonstrate that supervised exercise has positive effects on physical fatigue and HRQOL in patients with MBC and should be recommended as part of supportive care.ClinicalTrials.gov Identifier: NCT04120298 .

Published
2024

2. 109O Adjuvant endocrine therapy for premenopausal invasive lobular carcinoma (ILC): Results from SOFT and TEXT phase III studies

Author

Metzger, O, Ren, Y, Huober, J, Kammler, R, Dell'Orto, P, Russo, L, Fleming, GF, Francis, PA, Pagani, O, Walley, BA, Loi, S, Colleoni, MA, Thuerlimann, BJK, Viale, G, Regan, MM, Metzger, O, Ren, Y, Huober, J, Kammler, R, Dell'Orto, P, Russo, L, Fleming, GF, Francis, PA, Pagani, O, Walley, BA, Loi, S, Colleoni, MA, Thuerlimann, BJK, Viale, G, and Regan, MM

Published
2024

3. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy

Author

Moore, HCF, Unger, JM, Phillips, KA, Boyle, F, Hitre, E, Porter, D, Francis, PA, Goldstein, LJ, Gomez, HL, Vallejos, CS, Partridge, AH, Dakhil, SR, Garcia, AA, Gralow, J, Lombard, JM, Forbe, JF, Martino, S, Barlow, WE, Fabian, CJ, Minasian, L, Meyskens, FL, Gelber, RD, Hortobagyi, GN, and Albain, KS

Subjects
Rare Diseases, Clinical Trials and Supportive Activities, Contraception/Reproduction, Aging, Estrogen, Breast Cancer, Cancer, Clinical Research, 6.1 Pharmaceuticals, Reproductive Health and Childbirth, Obstetrics & Reproductive Medicine, Paediatrics and Reproductive Medicine
Published
2015

4. Genomic characterisation of hormone receptor-positive breast cancer arising in very young women

Author

Luen, SJ, Viale, G, Nik-Zainal, S, Savas, P, Kammler, R, Dell'Orto, P, Biasi, O, Degasperi, A, Brown, LC, Láng, I, MacGrogan, G, Tondini, C, Bellet, M, Villa, F, Bernardo, A, Ciruelos, E, Karlsson, P, Neven, P, Climent, M, Müller, B, Jochum, W, Bonnefoi, H, Martino, S, Davidson, NE, Geyer, C, Chia, SK, Ingle, JN, Coleman, R, Solbach, C, Thürlimann, B, Colleoni, M, Coates, AS, Goldhirsch, A, Fleming, GF, Francis, PA, Speed, TP, Regan, MM, Loi, S, Nik-Zainal, Serena [0000-0001-5054-1727], and Apollo - University of Cambridge Repository

Subjects
young women, breast cancer, Oncology, Receptor, ErbB-2, Class I Phosphatidylinositol 3-Kinases, genomics, Humans, Female, Breast Neoplasms, hormone receptor positive, prognosis, Hematology, Aged
Abstract

BACKGROUND: Very young premenopausal women diagnosed with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+HER2-) early breast cancer (EBC) have higher rates of recurrence and death for reasons that remain largely unexplained. PATIENTS AND METHODS: Genomic sequencing was applied to HR+HER2- tumours from patients enrolled in the Suppression of Ovarian Function Trial (SOFT) to determine genomic drivers that are enriched in young premenopausal women. Genomic alterations were characterised using next-generation sequencing from a subset of 1276 patients (deep targeted sequencing, n = 1258; whole-exome sequencing in a young-age, case-control subsample, n = 82). We defined copy number (CN) subgroups and assessed for features suggestive of homologous recombination deficiency (HRD). Genomic alteration frequencies were compared between young premenopausal women (

Published
2023
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5. Tumor infiltrating lymphocyte stratification of prognostic staging of early-stage triple negative breast cancer

Author

Loi, S, Salgado, R, Adams, S, Pruneri, G, Francis, PA, Lacroix-Triki, M, Joensuu, H, Dieci, MV, Badve, S, Demaria, S, Gray, R, Munzone, E, Drubay, D, Lemonnier, J, Sotiriou, C, Kellokumpu-Lehtinen, PL, Vingiani, A, Gray, K, Andre, F, Denkert, C, Piccart, M, Roblin, E, Michiels, S, Loi, S, Salgado, R, Adams, S, Pruneri, G, Francis, PA, Lacroix-Triki, M, Joensuu, H, Dieci, MV, Badve, S, Demaria, S, Gray, R, Munzone, E, Drubay, D, Lemonnier, J, Sotiriou, C, Kellokumpu-Lehtinen, PL, Vingiani, A, Gray, K, Andre, F, Denkert, C, Piccart, M, Roblin, E, and Michiels, S

Abstract

The importance of integrating biomarkers into the TNM staging has been emphasized in the 8th Edition of the American Joint Committee on Cancer (AJCC) Staging system. In a pooled analysis of 2148 TNBC-patients in the adjuvant setting, TILs are found to strongly up and downstage traditional pathological-staging in the Pathological and Clinical Prognostic Stage Groups from the AJJC 8th edition Cancer Staging System. This suggest that clinical and research studies on TNBC should take TILs into account in addition to stage, as for example patients with stage II TNBC and high TILs have a better outcome than patients with stage I and low TILs.

Published
2022

6. Aromatase inhibitors versus tamoxifen in premenopausal women with oestrogen receptor-positive early-stage breast cancer treated with ovarian suppression: a patient-level meta-analysis of 7030 women from four randomised trials

Author

Bradley, R, Braybrooke, J, Gray, R, Hills, RK, Liu, Z, Pan, H, Peto, R, Dodwell, D, McGale, P, Taylor, C, Bergh, J, Swain, S, Francis, PA, Gnant, M, Perrone, F, Regan, MM, Bradley, R, Braybrooke, J, Gray, R, Hills, RK, Liu, Z, Pan, H, Peto, R, Dodwell, D, McGale, P, Taylor, C, Bergh, J, Swain, S, Francis, PA, Gnant, M, Perrone, F, and Regan, MM

Abstract

BACKGROUND: For women with early-stage oestrogen receptor (ER)-positive breast cancer, adjuvant tamoxifen reduces 15-year breast cancer mortality by a third. Aromatase inhibitors are more effective than tamoxifen in postmenopausal women but are ineffective in premenopausal women when used without ovarian suppression. We aimed to investigate whether premenopausal women treated with ovarian suppression benefit from aromatase inhibitors. METHODS: We did a meta-analysis of individual patient data from randomised trials comparing aromatase inhibitors (anastrozole, exemestane, or letrozole) versus tamoxifen for 3 or 5 years in premenopausal women with ER-positive breast cancer receiving ovarian suppression (goserelin or triptorelin) or ablation. We collected data on baseline characteristics, dates and sites of any breast cancer recurrence or second primary cancer, and dates and causes of death. Primary outcomes were breast cancer recurrence (distant, locoregional, or contralateral), breast cancer mortality, death without recurrence, and all-cause mortality. As distant recurrence invariably results in death from breast cancer several years after the occurrence, whereas locoregional recurrence and new contralateral breast cancer are not usually fatal, the distant recurrence analysis is shown separately. Standard intention-to-treat log-rank analyses estimated first-event rate ratios (RR) and their confidence intervals (CIs). FINDINGS: We obtained data from all four identified trials (ABCSG XII, SOFT, TEXT, and HOBOE trials), which included 7030 women with ER-positive tumours enrolled between June 17, 1999, and Aug 4, 2015. Median follow-up was 8·0 years (IQR 6·1-9·3). The rate of breast cancer recurrence was lower for women allocated to an aromatase inhibitor than for women assigned to tamoxifen (RR 0·79, 95% CI 0·69-0·90, p=0·0005). The main benefit was seen in years 0-4 (RR 0·68, 99% CI 0·55-0·85; p<0·0001), the period when treatments differed, with a 3·2% (95% CI 1·8-4·5)

Published
2022

7. Understanding the barriers to, and facilitators of, ovarian toxicity assessment in breast cancer clinical trials

Author

Cui, W, Phillips, K-A, Francis, PA, Anderson, RA, Partridge, AH, Loi, S, Loibl, S, Keogh, L, Cui, W, Phillips, K-A, Francis, PA, Anderson, RA, Partridge, AH, Loi, S, Loibl, S, and Keogh, L

Abstract

BACKGROUND: Detailed toxicity data are routinely collected in breast cancer (BC) clinical trials. However, ovarian toxicity is infrequently assessed, despite the adverse impacts on fertility and long-term health from treatment-induced ovarian insufficiency. OBJECTIVES: To determine the barriers to and facilitators of ovarian toxicity assessment in BC trials of anti-cancer drugs. METHODS: Semi-structured interviews were conducted with purposively selected stakeholders from multiple countries involved in BC clinical trials (clinicians, consumers, pharmaceutical company representatives, members of drug-regulatory agencies). Participants were asked to describe the perceived benefits and barriers to evaluating ovarian toxicity. Interviews were transcribed verbatim, coded in NVivo software and analysed using inductive thematic analysis. RESULTS: Saturation of the main themes was reached and the final sample size included 25 participants from 14 countries (9 clinicians, 7 consumers, 5 members of regulatory agencies, 4 pharmaceutical company representatives); half were female. The main reported barrier to ovarian toxicity assessment was that the issue was rarely considered. Reasons included that these data are less important than survival data and are not required for regulatory approval. Overall, most participants believed evaluating the impact of BC treatments on ovarian function is valuable. Suggested strategies to increase ovarian toxicity assessment were to include it in clinical trial design guidelines and stakeholder advocacy. CONCLUSION: Lack of consideration about measuring ovarian toxicity in BC clinical trials that include premenopausal women suggest that guidelines and stronger advocacy from stakeholders, including regulators, would facilitate its more frequent inclusion in future trials, allowing women to make better informed treatment decisions.

Published
2022

9. The tale of TILs in breast cancer: A report from The International Immuno-Oncology Biomarker Working Group

Author

El Bairi, K, Haynes, HR, Blackley, E, Fineberg, S, Shear, J, Turner, S, de Freitas, JR, Sur, D, Amendola, LC, Gharib, M, Kallala, A, Arun, I, Azmoudeh-Ardalan, F, Fujimoto, L, Sua, LF, Liu, S-W, Lien, H-C, Kirtani, P, Balancin, M, El Attar, H, Guleria, P, Yang, W, Shash, E, Chen, I-C, Bautista, V, Do Prado Moura, JF, Rapoport, BL, Castaneda, C, Spengler, E, Acosta-Haab, G, Frahm, I, Sanchez, J, Castillo, M, Bouchmaa, N, Zin, RRM, Shui, R, Onyuma, T, Husain, Z, Willard-Gallo, K, Coosemans, A, Perez, EA, Provenzano, E, Ericsson, PG, Richardet, E, Mehrotra, R, Sarancone, S, Ehinger, A, Rimm, DL, Bartlett, JMS, Viale, G, Denkert, C, Hida, AI, Sotiriou, C, Loibl, S, Hewitt, SM, Badve, S, Symmans, WF, Kim, RS, Pruneri, G, Goel, S, Francis, PA, Inurrigarro, G, Yamaguchi, R, Garcia-Rivello, H, Horlings, H, Afqir, S, Salgado, R, Adams, S, Kok, M, Dieci, MV, Michiels, S, Demaria, S, Loi, S, El Bairi, K, Haynes, HR, Blackley, E, Fineberg, S, Shear, J, Turner, S, de Freitas, JR, Sur, D, Amendola, LC, Gharib, M, Kallala, A, Arun, I, Azmoudeh-Ardalan, F, Fujimoto, L, Sua, LF, Liu, S-W, Lien, H-C, Kirtani, P, Balancin, M, El Attar, H, Guleria, P, Yang, W, Shash, E, Chen, I-C, Bautista, V, Do Prado Moura, JF, Rapoport, BL, Castaneda, C, Spengler, E, Acosta-Haab, G, Frahm, I, Sanchez, J, Castillo, M, Bouchmaa, N, Zin, RRM, Shui, R, Onyuma, T, Husain, Z, Willard-Gallo, K, Coosemans, A, Perez, EA, Provenzano, E, Ericsson, PG, Richardet, E, Mehrotra, R, Sarancone, S, Ehinger, A, Rimm, DL, Bartlett, JMS, Viale, G, Denkert, C, Hida, AI, Sotiriou, C, Loibl, S, Hewitt, SM, Badve, S, Symmans, WF, Kim, RS, Pruneri, G, Goel, S, Francis, PA, Inurrigarro, G, Yamaguchi, R, Garcia-Rivello, H, Horlings, H, Afqir, S, Salgado, R, Adams, S, Kok, M, Dieci, MV, Michiels, S, Demaria, S, and Loi, S

Abstract

The advent of immune-checkpoint inhibitors (ICI) in modern oncology has significantly improved survival in several cancer settings. A subgroup of women with breast cancer (BC) has immunogenic infiltration of lymphocytes with expression of programmed death-ligand 1 (PD-L1). These patients may potentially benefit from ICI targeting the programmed death 1 (PD-1)/PD-L1 signaling axis. The use of tumor-infiltrating lymphocytes (TILs) as predictive and prognostic biomarkers has been under intense examination. Emerging data suggest that TILs are associated with response to both cytotoxic treatments and immunotherapy, particularly for patients with triple-negative BC. In this review from The International Immuno-Oncology Biomarker Working Group, we discuss (a) the biological understanding of TILs, (b) their analytical and clinical validity and efforts toward the clinical utility in BC, and (c) the current status of PD-L1 and TIL testing across different continents, including experiences from low-to-middle-income countries, incorporating also the view of a patient advocate. This information will help set the stage for future approaches to optimize the understanding and clinical utilization of TIL analysis in patients with BC.

Published
2021

10. Heparanase: a potential marker of worse prognosis in estrogen receptor-positive breast cancer

Author

Zahavi, T, Salmon-Divon, M, Salgado, R, Elkin, M, Hermano, E, Rubinstein, AM, Francis, PA, Di Leo, A, Viale, G, de Azambuja, E, Ameye, L, Sotiriou, C, Salmon, A, Kravchenko-Balasha, N, Sonnenblick, A, Zahavi, T, Salmon-Divon, M, Salgado, R, Elkin, M, Hermano, E, Rubinstein, AM, Francis, PA, Di Leo, A, Viale, G, de Azambuja, E, Ameye, L, Sotiriou, C, Salmon, A, Kravchenko-Balasha, N, and Sonnenblick, A

Abstract

Heparanase promotes tumor growth in breast tumors. We now evaluated heparanase protein and gene-expression status and investigated its impact on disease-free survival in order to gain better insight into the role of heparanase in ER-positive (ER+) breast cancer prognosis and to clarify its role in cell survival following chemotherapy. Using pooled analysis of gene-expression data, we found that heparanase was associated with a worse prognosis in estrogen receptor-positive (ER+) tumors (log-rank p < 10-10) and predictive to chemotherapy resistance (interaction p = 0.0001) but not hormonal therapy (Interaction p = 0.62). These results were confirmed by analysis of data from a phase III, prospective randomized trial which showed that heparanase protein expression is associated with increased risk of recurrence in ER+ breast tumors (log-rank p = 0.004). In vitro experiments showed that heparanase promoted tumor progression and increased cell viability via epithelial-mesenchymal transition, stemness, and anti-apoptosis pathways in luminal breast cancer. Taken together, our results demonstrated that heparanase is associated with worse outcomes and increased cell viability in ER+ BC.

Published
2021

11. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)

Author

Cardoso, F, Paluch-Shimon, S, Senkus, E, Curigliano, G, Aapro, MS, Andre, F, Barrios, CH, Bergh, J, Bhattacharyya, GS, Biganzoli, L, Boyle, F, Cardoso, M-J, Carey, LA, Cortes, J, El Saghir, NS, Elzayat, M, Eniu, A, Fallowfield, L, Francis, PA, Gelmon, K, Gligorov, J, Haidinger, R, Harbeck, N, Hu, X, Kaufman, B, Kaur, R, Kiely, BE, Kim, S-B, Lin, NU, Mertz, SA, Neciosup, S, Offersen, B, Ohno, S, Pagani, O, Prat, A, Penault-Llorca, F, Rugo, HS, Sledge, GW, Thomssen, C, Vorobiof, DA, Wiseman, T, Xu, B, Norton, L, Costa, A, Winer, EP, Cardoso, F, Paluch-Shimon, S, Senkus, E, Curigliano, G, Aapro, MS, Andre, F, Barrios, CH, Bergh, J, Bhattacharyya, GS, Biganzoli, L, Boyle, F, Cardoso, M-J, Carey, LA, Cortes, J, El Saghir, NS, Elzayat, M, Eniu, A, Fallowfield, L, Francis, PA, Gelmon, K, Gligorov, J, Haidinger, R, Harbeck, N, Hu, X, Kaufman, B, Kaur, R, Kiely, BE, Kim, S-B, Lin, NU, Mertz, SA, Neciosup, S, Offersen, B, Ohno, S, Pagani, O, Prat, A, Penault-Llorca, F, Rugo, HS, Sledge, GW, Thomssen, C, Vorobiof, DA, Wiseman, T, Xu, B, Norton, L, Costa, A, and Winer, EP

Published
2020

12. Differential Benefit of Adjuvant Docetaxel-Based Chemotherapy in Patients With Early Breast Cancer According to Baseline Body Mass Index

Author

Desmedt, C, Fornili, M, Clatot, F, Demicheli, R, De Bortoli, D, Di Leo, A, Viale, G, de Azambuja, E, Crown, J, Francis, PA, Sotiriou, C, Piccart, M, Biganzoli, E, Desmedt, C, Fornili, M, Clatot, F, Demicheli, R, De Bortoli, D, Di Leo, A, Viale, G, de Azambuja, E, Crown, J, Francis, PA, Sotiriou, C, Piccart, M, and Biganzoli, E

Abstract

PURPOSE: Lipophilic drugs, such as taxanes, have a high affinity for adipose tissue and a resulting higher volume of distribution. Here, we reanalyzed clinical trial data to investigate whether the efficacy of docetaxel-based chemotherapy differs from non-docetaxel-based chemotherapy in patients with breast cancer according to their baseline body mass index (BMI). PATIENTS AND METHODS: We retrospectively analyzed data from all of the patients in the adjuvant BIG 2-98 trial (ClinicalTrials.gov identifier: NCT00174655; N = 2,887) comparing non-docetaxel- to docetaxel-containing chemotherapy. BMI (kg/m2) was categorized as follows: 18.5 to < 25, lean; 25 to < 30, overweight; and ≥ 30, obese. Disease-free survival (DFS) was the primary endpoint, and overall survival (OS) was the secondary endpoint. A second-order interaction was assessed among treatment, BMI, and estrogen receptor (ER) status. RESULTS: There was no difference in DFS or OS according to BMI in the non-docetaxel group, while reduced DFS and OS were observed with increasing BMI category in the docetaxel group. Adjusted hazard ratios for DFS and OS were, respectively, 1.12 (95% CI, 0.98 to 1.50; P = .21) and 1.27 (95% CI, 1.01 to 1.60; P = .04) for overweight versus lean groups and were 1.32 (95% CI, 1.08 to 1.62; P = .007) and 1.63 (95% CI, 1.27 to 2.09; P < .001), respectively, for obese versus lean groups. Similar results were obtained when considering ER-negative and ER-positive tumors separately and when considering only patients who received a relative dose intensity ≥ 85% for docetaxel. A joint modifying role of BMI and ER status on treatment effect was evident for DFS (adjusted P = .06) and OS (adjusted P = .04). CONCLUSION: This retrospective analysis of a large adjuvant trial highlights a differential response to docetaxel according to BMI, which calls for a body composition-based re-evaluation of the risk-benefit ratio of the use of taxanes in breast cancer. These results now must be confirmed in

Published
2020

13. Light-enhanced cognitive behavioural therapy for sleep and fatigue: study protocol for a randomised controlled trial during chemotherapy for breast cancer

Author

Bean, HR, Stafford, L, Little, R, Diggens, J, Ftanou, M, Alexander, M, Francis, PA, Bei, B, Wiley, JF, Bean, HR, Stafford, L, Little, R, Diggens, J, Ftanou, M, Alexander, M, Francis, PA, Bei, B, and Wiley, JF

Abstract

BACKGROUND: Women with breast cancer experience a significantly higher prevalence of sleep disturbance and insomnia than the general population. The experience of persistent sleep disturbance places these women at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment for sleep in this population is not part of routine care and is often managed inadequately. This randomised controlled trial will examine the combined effects of cognitive behavioural therapy (CBT) and bright light therapy (BLT) on the symptoms of insomnia, fatigue and mental health. METHOD/DESIGN: Women diagnosed with breast cancer who receive intravenous chemotherapy treatment at a quaternary referral metropolitan cancer centre in Melbourne, Australia, will be recruited. Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible women will be randomised to the combined CBT and BLT intervention (CBT+) or relaxation audio-enhanced treatment as usual (TAU+). The CBT+ group will receive one face-to-face session on sleep strategies, one subsequent telephone call, and seven email packages containing CBT-based information and strategies. CBT+ participants will also wear Luminette® light glasses for 20 min each morning for the 6-week duration of the intervention. Women in TAU+ will receive two relaxation audio tracks via email. Outcomes will be measured at multiple points throughout the 6 weeks. Primary outcomes will be symptoms of insomnia and sleep efficiency, measured using the Insomnia Severity Index and a self-reported sleep diary. Secondary outcomes include objective measures of sleep assessed using the ActiGraph wGT3X-BT, and sleep-related complaints, fatigue and mental health, all assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). Data will also be collected on potential treatment moderators and mechanisms and adherence to treatment. There will be 3-month follow-up measurements of insomnia symptom

Published
2020

14. Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT

Author

Pagani, O, Francis, PA, Fleming, GF, Walley, BA, Viale, G, Colleoni, M, Lang, I, Gomez, HL, Tondini, C, Pinotti, G, Di Leo, A, Coates, AS, Goldhirsch, A, Gelber, RD, Regan, MM, Pagani, O, Francis, PA, Fleming, GF, Walley, BA, Viale, G, Colleoni, M, Lang, I, Gomez, HL, Tondini, C, Pinotti, G, Di Leo, A, Coates, AS, Goldhirsch, A, Gelber, RD, and Regan, MM

Abstract

PURPOSE: The Tamoxifen and Exemestane Trial (TEXT)/Suppression of Ovarian Function Trial (SOFT) showed superior outcomes for premenopausal women with hormone receptor (HR)-positive breast cancer treated with adjuvant exemestane plus ovarian function suppression (OFS) or tamoxifen plus OFS versus tamoxifen alone. We previously reported the magnitude of absolute improvements in freedom from any recurrence across a continuous, composite measure of recurrence risk to tailor decision making. With longer follow-up, we now focus on distant recurrence. METHODS: The TEXT/SOFT HR-positive/human epidermal growth factor receptor 2 (HER2)-negative analysis population included 4,891 women stratified by predetermined chemotherapy use. Kaplan-Meier estimates of 8-year freedom from distant recurrence were analyzed using subpopulation treatment effect pattern plot (STEPP) methodology across subpopulations defined by the continuous composite measure of recurrence risk. For each patient, the composite risk value was obtained from a Cox model that incorporated age; nodal status; tumor size; grade; and estrogen receptor, progesterone receptor, and Ki-67 labeling index expression levels. RESULTS: The overall rate of 8-year freedom from distant recurrence was 91.1% and ranged from approximately 100% to 63% across lowest to highest composite risks. TEXT patients who received chemotherapy had an average absolute improvement with exemestane plus OFS versus tamoxifen plus OFS of 5.1%, and STEPP analysis showed improvements from less than 1% to more than 15% from lowest to highest composite risks. SOFT patients who remained premenopausal after chemotherapy had an average 5.2% absolute improvement with exemestane plus OFS versus tamoxifen and reached 10% across composite risks; for tamoxifen plus OFS versus tamoxifen, the maximum improvement was approximately 3.5%. Women who did not receive chemotherapy had a more than 97% rate of 8-year freedom from distant recurrence, and improvements with exe

Published
2020

15. Clinical implications of prospective genomic profiling of metastatic breast cancer patients

Author

van Geelen, CT, Savas, P, Teo, ZL, Luen, SJ, Weng, C-F, Ko, Y-A, Kuykhoven, KS, Caramia, F, Salgado, R, Francis, PA, Dawson, S-J, Fox, SB, Fellowes, A, Loi, S, van Geelen, CT, Savas, P, Teo, ZL, Luen, SJ, Weng, C-F, Ko, Y-A, Kuykhoven, KS, Caramia, F, Salgado, R, Francis, PA, Dawson, S-J, Fox, SB, Fellowes, A, and Loi, S

Abstract

BACKGROUND: Metastatic breast cancer remains incurable. Next-generation sequencing (NGS) offers the ability to identify actionable genomic alterations in tumours which may then be matched with targeted therapies, but the implementation and utility of this approach is not well defined for patients with metastatic breast cancer. METHODS: We recruited patients with advanced breast cancer of any subtype for prospective targeted NGS of their most recent tumour samples, using a panel of 108 breast cancer-specific genes. Genes were classified as actionable or non-actionable using the European Society of Medical Oncology Scale for Clinical Actionability of Molecular Targets (ESCAT) guidelines. RESULTS: Between February 2014 and May 2019, 322 patients were enrolled onto the study, with 72% (n = 234) of patients successfully sequenced (n = 357 samples). The majority (74%, n = 171) of sequenced patients were found to carry a potentially actionable alteration, the most common being a PIK3CA mutation. Forty-three percent (n = 74) of patients with actionable alterations were referred for a clinical trial or referred for confirmatory germline testing or had a change in therapy outside of clinical trials. We found alterations in AKT1, BRCA2, CHEK2, ESR1, FGFR1, KMT2C, NCOR1, PIK3CA and TSC2 to be significantly enriched in our metastatic population compared with primary breast cancers. Concordance between primary and metastatic samples for key driver genes (TP53, ERBB2 amplification) was > 75%. Additionally, we found that patients with a higher number of mutations had a significantly worse overall survival. CONCLUSION: Genomic profiling of patients with metastatic breast cancer can have clinical implications and should be considered in all suitable patients.

Published
2020

16. Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial

Author

Ribi, K, Luo, W, Colleoni, M, Karlsson, P, Chirgwin, J, Aebi, S, Jerusalem, G, Neven, P, Di Lauro, V, Gomez, HL, Ruhstaller, T, Abdi, E, Biganzoli, L, Mueller, B, Barbeaux, A, Graas, M-P, Rabaglio, M, Francis, PA, Foukakis, T, Pagani, O, Graff, C, Vorobiof, D, Maibach, R, Di Leo, A, Gelber, RD, Goldhirsch, A, Coates, AS, Regan, MM, Bernhard, J, Ribi, K, Luo, W, Colleoni, M, Karlsson, P, Chirgwin, J, Aebi, S, Jerusalem, G, Neven, P, Di Lauro, V, Gomez, HL, Ruhstaller, T, Abdi, E, Biganzoli, L, Mueller, B, Barbeaux, A, Graas, M-P, Rabaglio, M, Francis, PA, Foukakis, T, Pagani, O, Graff, C, Vorobiof, D, Maibach, R, Di Leo, A, Gelber, RD, Goldhirsch, A, Coates, AS, Regan, MM, and Bernhard, J

Abstract

BACKGROUND: In the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Intermittent therapy with 3-month breaks may be beneficial for patients' quality of life (QoL). METHODS: In the SOLE QoL sub-study, 956 patients completed the Breast Cancer Prevention Trial (BCPT) symptom and further QoL scales up to 24 months after randomisation. Differences in change of QoL from baseline between the two administration schedules were tested at 12 and 24 months using repeated measures mixed-models. The primary outcome was change in hot flushes at 12 months. RESULTS: There was no difference in hot flushes at 12 months between the two schedules, but patients receiving intermittent letrozole reported significantly more improvement at 24 months. They also indicated less worsening in vaginal problems, musculoskeletal pain, sleep disturbance, physical well-being and mood at 12 months. Overall, 25-30% of patients reported a clinically relevant worsening in key symptoms and global QoL. CONCLUSION: Less symptom worsening was observed during the first year of extended treatment with the intermittent administration. For women experiencing an increased symptom burden of extended adjuvant endocrine therapy, an intermittent administration is a safe alternative. CLINICAL TRIAL INFORMATION: Clinical trial information: NCT00651456.

Published
2019

17. Phase 1 trial of olaparib and oral cyclophosphamide in BRCA breast cancer, recurrent BRCA ovarian cancer, non-BRCA triple-negative breast cancer, and non-BRCA ovarian cancer

Author

Lee, CK, Scott, C, Lindeman, GJ, Hamilton, A, Lieschke, E, Gibbs, E, Asher, R, Badger, H, Paterson, R, Macnab, L, Kwan, EM, Francis, PA, Boyle, F, Friedlander, M, Lee, CK, Scott, C, Lindeman, GJ, Hamilton, A, Lieschke, E, Gibbs, E, Asher, R, Badger, H, Paterson, R, Macnab, L, Kwan, EM, Francis, PA, Boyle, F, and Friedlander, M

Abstract

BACKGROUND: We conducted a Phase 1 study to evaluate safety and activity of olaparib tablets and oral cyclophosphamide. METHODS: Patients had metastatic breast cancer (BC) or recurrent high-grade serous ovarian cancer (HGSOC), performance status 0-2, and ≤3 lines of prior therapy. Patients were treated using a dose escalation strategy with cohort expansion once maximal tolerated dose (MTD) was determined. Dose level 1 (DL1): olaparib 300 mg bid, cyclophosphamide 50 mg on days 1, 3, and 5, weekly. DL2: olaparib 300 mg bid, cyclophosphamide 50 mg, days 1-5 weekly. RESULTS: Of 32 patients, 23 had HGSOC (germline BRCA mutation [gBRCAm] 70%) and 9 had BC (gBRCAm 67%). Four were treated at DL1 and 28 at DL2, the MTD. Haematological adverse events (AEs) were most common: grade 3/4 AEs: lymphopenia 75%, anaemia 31%, neutropenia 37%, thrombocytopenia 47%. Two permanently discontinued treatment due to haematological AEs. In BC, no objective response was reported. Unconfirmed objective response was 48% and 64% for all HGSOC and gBRCAm subset, respectively. CA125 responses were 70% (all HGSOC) and 92% (gBRCAm). CONCLUSIONS: In HGSOC and BC, olaparib 300 mg bid and cyclophosphamide 50 mg on days 1-5 weekly were tolerable and active, particularly in gBRCAm, and is worthy of further investigation.

Published
2019

18. 4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)†

Author

Cardoso, F, Senkus, E., Costa, A, Papadopoulos, E, Aapro, M, André, F, Harbeck, N, Aguilar Lopez, B, Barrios, CH, Bergh, J, Prat, A, Boers-Doets, CB, Cardoso, MJ, Carey, LA, Cortés, J, Curigliano, G, Diéras, V, Saghir NS, EL, Eniu, A, Fallowfield, L, Francis, PA, Gelmon, K, Johnston, SRD, Kaufman, B, Koppikar, S, Krop, IE, Mayer, M, Nakigudde, G, Offersen, BV, Ohno, S, Pagani, O, Paluch-Shimon, S, Penault-Llorca, F, Prat, A., Rugo, HS, Sledge, GW, Spence, D, Thomssen, C, Vorobiof, DA, Xu, B., Norton, L, Winer, EP, Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland, Medical University of Gdansk, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])

Subjects
0301 basic medicine, Consensus Development Conferences as Topic, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, Medical Oncology, 03 medical and health sciences, 0302 clinical medicine, Biomarkers, Tumor, Humans, Breast, Mastectomy, Societies, Medical, ComputingMilieux_MISCELLANEOUS, Neoplasm Staging, Clinical Trials as Topic, Integrative Medicine, Evidence-Based Medicine, Hematology, Chemoradiotherapy, Adjuvant, Neoadjuvant Therapy, 3. Good health, Europe, 030104 developmental biology, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Special article, Female, Biopsy, Large-Core Needle
Abstract

International audience

Published
2018
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20. Abstract PD5-09: Immune parameters associated with survival in triple negative and HER2-positive breast cancer patients with 10 years of follow-up

Author

Solinas, C, primary, de Wind, A, additional, Van den Eynden, G, additional, Ameye, L, additional, Garaud, S, additional, De Silva, P, additional, Boisson, A, additional, Noel, G, additional, Langouo Fontsa, M, additional, Buisseret, L, additional, de Azambuja, E, additional, Francis, PA, additional, Di Leo, A, additional, Crown, JP, additional, Sotiriou, C, additional, Larsimont, D, additional, Paesmans, M, additional, Piccart-Gebhart, M, additional, and Willard-Gallo, K, additional

Published
2019
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21. Abstract GS4-03: Randomized comparison of adjuvant tamoxifen (T) plus ovarian function suppression (OFS) versus tamoxifen in premenopausal women with hormone receptor-positive (HR+) early breast cancer (BC): Update of the SOFT trial

Author

Fleming, G, primary, Francis, PA, additional, Láng, I, additional, Ciruelos, EM, additional, Bellet, M, additional, Bonnefoi, HR, additional, Climent, MA, additional, Pavesi, L, additional, Burstein, HJ, additional, Martino, S, additional, Davidson, NE, additional, Geyer, CE, additional, Walley, BA, additional, Coleman, RE, additional, Kerbrat, P, additional, Buchholz, S, additional, Ingle, JN, additional, Rabaglio-Poretti, M, additional, Colleoni, M, additional, and Regan, MM, additional

Published
2018
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23. Abstract P1-15-01: Final analysis of SWOG S0230/Prevention of early menopause study (POEMS)

Author

Moore, HCF, primary, Unger, JM, additional, Phillips, K-A, additional, Boyle, F, additional, Hitre, E, additional, Moseley, A, additional, Porter, D, additional, Francis, PA, additional, Goldstein, LJ, additional, Gomez, HL, additional, Vallejos, CS, additional, Partridge, AH, additional, Dakhil, SR, additional, Garcia, AA, additional, Gralow, J, additional, Lombard, JM, additional, Forbes, JF, additional, Martino, S, additional, Barlow, WE, additional, Fabian, CJ, additional, Minasian, L, additional, Meyskens, FL, additional, Gelber, RD, additional, Hortobagyi, GN, additional, and Albain, KS, additional

Published
2018
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24. Abstract P1-07-15: Withdrawn

Author

Desmedt, C, primary, Fornili, M, additional, Poncet, C, additional, Clatot, F, additional, Orenti, A, additional, Boracchi, P, additional, Di Leo, A, additional, Viale, G, additional, de Azambuja, E, additional, Sotiriou, C, additional, Crown, J, additional, Francis, PA, additional, Bonnefoi, H, additional, Piccart, M, additional, and Biganzoli, E, additional

Published
2018
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25. Abstract GS4-02: Randomized comparison of adjuvant aromatase inhibitor exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor positive (HR+) early breast cancer (BC): Update of the combined TEXT and SOFT trials

Author

Pagani, O, primary, Regan, MM, additional, Fleming, GF, additional, Walley, BA, additional, Colleoni, M, additional, Láng, I, additional, Gomez, HL, additional, Tondini, C, additional, Burstein, HJ, additional, Goetz, MP, additional, Ciruelos, EM, additional, Stearns, V, additional, Debled, M, additional, Martino, S, additional, Geyer, CE, additional, Pinotti, G, additional, Coates, AS, additional, Goldhirsch, A, additional, Gelber, RD, additional, and Francis, PA, additional

Published
2018
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27. Abstract P2-09-09: The effects of treatment-induced symptoms, depression and age on sexuality in premenopausal women with early breast cancer receiving adjuvant endocrine therapy

Author

Ribi, K, primary, Luo, W, additional, Burstein, HJ, additional, Naughton, MJ, additional, Chirgwin, J, additional, Ansari, RH, additional, Walley, BA, additional, Salim, M, additional, van der Westhuizen, A, additional, Abdi, E, additional, Francis, PA, additional, Budman, DR, additional, Kennecke, H, additional, Harvey, VJ, additional, Giobbie-Hurder, A, additional, Fleming, GF, additional, Pagani, O, additional, Regan, MM, additional, and Bernhard, J, additional

Published
2017
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28. The Subclonal Architecture of Metastatic Breast Cancer: Results from a Prospective Community-Based Rapid Autopsy Program “CASCADE”

Author

Savas, P, Teo, ZL, Lefevre, C, Flensburg, C, Caramia, F, Alsop, K, Mansour, M, Francis, PA, Thorne, HA, Silva, MJ, Kanu, N, Dietzen, M, Rowan, A, Kschischo, M, Fox, S, Bowtell, DD, Dawson, SJ, Speed, TP, Swanton, C, Loi, S, Savas, P, Teo, ZL, Lefevre, C, Flensburg, C, Caramia, F, Alsop, K, Mansour, M, Francis, PA, Thorne, HA, Silva, MJ, Kanu, N, Dietzen, M, Rowan, A, Kschischo, M, Fox, S, Bowtell, DD, Dawson, SJ, Speed, TP, Swanton, C, and Loi, S

Abstract

© 2016 Savas et al. Background: Understanding the cancer genome is seen as a key step in improving outcomes for cancer patients. Genomic assays are emerging as a possible avenue to personalised medicine in breast cancer. However, evolution of the cancer genome during the natural history of breast cancer is largely unknown, as is the profile of disease at death. We sought to study in detail these aspects of advanced breast cancers that have resulted in lethal disease. Methods and Findings: Three patients with oestrogen-receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer and one patient with triple negative breast cancer underwent rapid autopsy as part of an institutional prospective community-based rapid autopsy program (CASCADE). Cases represented a range of management problems in breast cancer, including late relapse after early stage disease, de novo metastatic disease, discordant disease response, and disease refractory to treatment. Between 5 and 12 metastatic sites were collected at autopsy together with available primary tumours and longitudinal metastatic biopsies taken during life. Samples underwent paired tumour-normal whole exome sequencing and single nucleotide polymorphism (SNP) arrays. Subclonal architectures were inferred by jointly analysing all samples from each patient. Mutations were validated using high depth amplicon sequencing. Between cases, there were significant differences in mutational burden, driver mutations, mutational processes, and copy number variation. Within each case, we found dramatic heterogeneity in subclonal structure from primary to metastatic disease and between metastatic sites, such that no single lesion captured the breadth of disease. Metastatic cross-seeding was found in each case, and treatment drove subclonal diversification. Subclones displayed parallel evolution of treatment resistance in some cases and apparent augmentation of key oncogenic drivers as an alternative resista

Published
2016

30. The Subclonal Architecture of Metastatic Breast Cancer: Results from a Prospective Community-Based Rapid Autopsy Program 'CASCADE'

Author

Ladanyi, M, Savas, P, Teo, ZL, Lefevre, C, Flensburg, C, Caramia, F, Alsop, K, Mansour, M, Francis, PA, Thorne, HA, Silva, MJ, Kanu, N, Dietzen, M, Rowan, A, Kschischo, M, Fox, S, Bowtell, DD, Dawson, S-J, Speed, TP, Swanton, C, Loi, S, Ladanyi, M, Savas, P, Teo, ZL, Lefevre, C, Flensburg, C, Caramia, F, Alsop, K, Mansour, M, Francis, PA, Thorne, HA, Silva, MJ, Kanu, N, Dietzen, M, Rowan, A, Kschischo, M, Fox, S, Bowtell, DD, Dawson, S-J, Speed, TP, Swanton, C, and Loi, S

Abstract

BACKGROUND: Understanding the cancer genome is seen as a key step in improving outcomes for cancer patients. Genomic assays are emerging as a possible avenue to personalised medicine in breast cancer. However, evolution of the cancer genome during the natural history of breast cancer is largely unknown, as is the profile of disease at death. We sought to study in detail these aspects of advanced breast cancers that have resulted in lethal disease. METHODS AND FINDINGS: Three patients with oestrogen-receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer and one patient with triple negative breast cancer underwent rapid autopsy as part of an institutional prospective community-based rapid autopsy program (CASCADE). Cases represented a range of management problems in breast cancer, including late relapse after early stage disease, de novo metastatic disease, discordant disease response, and disease refractory to treatment. Between 5 and 12 metastatic sites were collected at autopsy together with available primary tumours and longitudinal metastatic biopsies taken during life. Samples underwent paired tumour-normal whole exome sequencing and single nucleotide polymorphism (SNP) arrays. Subclonal architectures were inferred by jointly analysing all samples from each patient. Mutations were validated using high depth amplicon sequencing. Between cases, there were significant differences in mutational burden, driver mutations, mutational processes, and copy number variation. Within each case, we found dramatic heterogeneity in subclonal structure from primary to metastatic disease and between metastatic sites, such that no single lesion captured the breadth of disease. Metastatic cross-seeding was found in each case, and treatment drove subclonal diversification. Subclones displayed parallel evolution of treatment resistance in some cases and apparent augmentation of key oncogenic drivers as an alternative resistance mechanism. We al

Published
2016

31. Adjuvant ovarian function suppression and cognitive function in women with breast cancer

Author

Phillips, K-A, Regan, MM, Ribi, K, Francis, PA, Puglisi, F, Bellet, M, Spazzapan, S, Karlsson, P, Budman, DR, Zaman, K, Abdi, EA, Domchek, SM, Feng, Y, Price, KN, Coates, AS, Gelber, RD, Maruff, P, Boyle, F, Forbes, JF, Ahles, T, Fleming, GF, Bernhard, J, Phillips, K-A, Regan, MM, Ribi, K, Francis, PA, Puglisi, F, Bellet, M, Spazzapan, S, Karlsson, P, Budman, DR, Zaman, K, Abdi, EA, Domchek, SM, Feng, Y, Price, KN, Coates, AS, Gelber, RD, Maruff, P, Boyle, F, Forbes, JF, Ahles, T, Fleming, GF, and Bernhard, J

Abstract

BACKGROUND: To examine the effect on cognitive function of adjuvant ovarian function suppression (OFS) for breast cancer. METHODS: The Suppression of Ovarian Function (SOFT) trial randomised premenopausal women with hormone receptor-positive breast cancer to 5 years adjuvant endocrine therapy with tamoxifen+OFS, exemestane+OFS or tamoxifen alone. The Co-SOFT substudy assessed objective cognitive function and patient reported outcomes at randomisation (T0), and 1 year later (T1); the primary endpoint was change in global cognitive function, measured by the composite objective cognitive function score. Data were compared for the pooled tamoxifen+OFS and exemestane+OFS groups vs the tamoxifen alone group using the Wilcoxon rank-sum test. RESULTS: Of 86 participants, 74 underwent both T0 and T1 cognitive testing; 54 randomised to OFS+ either tamoxifen (28) or exemestane (26) and 20 randomised to tamoxifen alone. There was no significant difference in the changes in the composite cognitive function scores between the OFS+ tamoxifen or exemestane groups and the tamoxifen group (mean±s.d., -0.21±0.92 vs -0.04±0.49, respectively, P=0.71, effect size=-0.20), regardless of prior chemotherapy status, and adjusting for baseline characteristics. CONCLUSIONS: The Co-SOFT study, although limited by small samples size, provides no evidence that adding OFS to adjuvant oral endocrine therapy substantially affects global cognitive function.

Published
2016

32. Supportive care of women with breast cancer: key concerns and practical solutions.

Author

Zdenkowski, N, Tesson, S, Lombard, J, Lovell, M, Hayes, S, Francis, PA, Dhillon, HM, Boyle, FM, Zdenkowski, N, Tesson, S, Lombard, J, Lovell, M, Hayes, S, Francis, PA, Dhillon, HM, and Boyle, FM

Abstract

Patients diagnosed with breast cancer may have supportive care needs for many years after diagnosis. High quality multidisciplinary care can help address these needs and reduce the physical and psychological effects of breast cancer and its treatment. Ovarian suppression and extended endocrine therapy benefits are associated with vasomotor, musculoskeletal, sexual and bone density-related side effects. Aromatase inhibitor musculoskeletal syndrome is a common reason for treatment discontinuation. Treatment strategies include education, exercise, simple analgesia and a change to tamoxifen or another aromatase inhibitor. Chemotherapy-induced alopecia may be a constant reminder of breast cancer to the patient, family, friends, acquaintances and even strangers. Alopecia can be prevented in some patients using scalp-cooling technology applied at the time of chemotherapy infusion. The adverse impact of breast cancer diagnosis and treatment on sexual wellbeing is under-reported. Identification of physical and psychological impacts is needed for implementation of treatment strategies. Fear of cancer recurrence reduces quality of life and increases distress, with subsequent impact on role functioning. Identification and multidisciplinary management are key, with referral to psychosocial services recommended where indicated. The benefits of exercise include reduced fatigue, better mental health and reduced musculoskeletal symptoms, and may also include reduced incidence of breast cancer recurrence. Identification and management of unmet supportive care needs are key aspects of breast cancer care, to maximise quality of life and minimise breast cancer recurrence.

Published
2016

33. Phase III trial (Prevention of Early Menopause Study [POEMS]-SWOG S0230) of LHRH analog during chemotherapy (CT) to reduce ovarian failure in early-stage, hormone receptor-negative breast cancer: An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB (Alliance)

Author

Unger, JM, Phillips, K-A, Boyle, FM, Hitre, E, Porter, DJ, Francis, PA, Minasian, LM, Gelber, RD, Goldstein, LJ, Gomez, HL, Vallejos, C, Partridge, AH, Dakhil, SR, Martino, S, Barlow, WE, Fabian, CJ, Meyskens, FL, Hortobagyi, GN, and Albain, KS

Abstract

LBA505 Background: Premature ovarian failure (POF) is a common toxicity of CT. Risk depends on type and amount of CT, age, and perhaps ovarian cycling at the time of CT. POEMS is a SWOG-coordinated phase III randomized study to evaluate whether LHRH analog administration with CT for early-stage breast cancer (BC) would reduce POF.Premenopausal patients (PT) age .05). POF rates were 22% in the standard arm and 8% in the GN arm (OR=0.30, 95% CI: 0.10-0.87, p=.03 [unadjusted analysis]; OR=0.36, 95%CI: 0.11-1.14, p=0.08 [adjusted logistic regression analysis]). In a sensitivity analysis defining 2-year POF more liberally as either amenorrhea or elevated FSH, 45% in the standard arm and 20% in the GN arm had POF (OR=0.29, 95% CI: 0.12-0.70, p=.006). There were 13 pregnancies in the standard arm and 22 in the GN arm (OR=2.22, 95% CI: 1.00-4.92, p=.05). DFS and OS were better in the GN arm (Cox regression, including stage: HR=0.49, 95% CI: 0.24-0.97, p=.04; HR=0.43, 95% CI: 0.18-1.00, p=.05, respectively).LHRH analog administration with CT was associated with less POF and more pregnancies. In an exploratory analysis, GN use in premenopausal ER-negative BC was associated with improved DFS and OS.NCT00068601.

Published
2014
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34. Abstract S1-03: Pooled individual patient data analysis of stromal tumor infiltrating lymphocytes in primary triple negative breast cancer treated with anthracycline-based chemotherapy

Author

Loi, S, primary, Drubay, D, additional, Adams, S, additional, Francis, PA, additional, Joensuu, H, additional, Dieci, MV, additional, Badve, S, additional, Demaria, S, additional, Gray, R, additional, Piccart, MJ, additional, Kellokumpa-Lehtinen, P-L, additional, Andre, F, additional, Dufaure-Gare, I, additional, Denkert, C, additional, Salgado, R, additional, and Michiels, S, additional

Published
2016
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35. A Prospective Cohort Study of the Effects of Adjuvant Breast Cancer Chemotherapy on Taste Function, Food Liking, Appetite and Associated Nutritional Outcomes

Author

Stemmer, SM, Boltong, A, Aranda, S, Keast, R, Wynne, R, Francis, PA, Chirgwin, J, Gough, K, Stemmer, SM, Boltong, A, Aranda, S, Keast, R, Wynne, R, Francis, PA, Chirgwin, J, and Gough, K

Abstract

BACKGROUND: 'Taste' changes are commonly reported during chemotherapy. It is unclear to what extent this relates to actual changes in taste function or to changes in appetite and food liking and how these changes affect dietary intake and nutritional status. PATIENTS AND METHODS: This prospective, repeated measures cohort study recruited participants from three oncology clinics. Women (n = 52) prescribed adjuvant chemotherapy underwent standardised testing of taste perception, appetite and food liking at six time points to measure change from baseline. Associations between taste and hedonic changes and nutritional outcomes were examined. RESULTS: Taste function was significantly reduced early in chemotherapy cycles (p<0.05) but showed recovery by late in the cycle. Ability to correctly identify salty, sour and umami tastants was reduced. Liking of sweet food decreased early and mid-cycle (p<0.01) but not late cycle. Liking of savory food was not significantly affected. Appetite decreased early in the cycle (p<0.001). Reduced taste function was associated with lowest kilojoule intake (r = 0.31; p = 0.008) as was appetite loss with reduced kilojoule (r = 0.34; p = 0.002) and protein intake (r = 0.36; p = 0.001) early in the third chemotherapy cycle. Decreased appetite early in the third and final chemotherapy cycles was associated with a decline in BMI (p = <0.0005) over the study period. Resolution of taste function, food liking and appetite was observed 8 weeks after chemotherapy completion. There was no association between taste change and dry mouth, oral mucositis or nausea. CONCLUSION: The results reveal, for the first time, the cyclical yet transient effects of adjuvant chemotherapy on taste function and the link between taste and hedonic changes, dietary intake and nutritional outcomes. The results should be used to inform reliable pre-chemotherapy education.

Published
2014

36. Extremes of the Indian summer monsoon rainfall, ENSO and equatorial Indian Ocean oscillation

Author

Gadgil, Sulochana, Vinayachandran, PN, Francis, PA, and Gadgil, Siddhartha

Subjects
Physics::Atmospheric and Oceanic Physics, Centre for Atmospheric & Oceanic Sciences, Physics::Geophysics
Abstract

It is well known that anomalies of the Indian Summer Monsoon Rainfall (ISMR) are linked to El Nino and Southern Oscillation (ENSO). We show that large anomalies of the ISMR are also linked to the Equatorial Indian Ocean Oscillation (EQUINOO) between states with enhancement/ suppression of atmospheric convection over the western part of the equatorial Indian Ocean with suppression/enhancement over the eastern part and associated changes in the anomaly of the zonal wind along the equator. EQUINOO is the atmospheric component of the coupled Indian Ocean Dipole mode. There is a strong relation between the large anomalies of ISMR and a composite index which is a linear combination of the indices for ENSO and EQUINOO with all seasons with large deficits ( excess) characterized by small ( large) values of the index.However, the variation of ISMR within one standard deviation is more complex and does not appear to be related to the composite index.

Published
2004

37. Prognostic and predictive value of TP53 mutations in node-positive breast cancer patients treated with anthracycline- or anthracycline/taxane-based adjuvant therapy: results from the BIG 02-98 phase III trial

Author

Fernandez-Cuesta, L, Oakman, C, Falagan-Lotsch, P, Smoth, K-S, Quinaux, E, Buyse, M, Dolci, MS, De Azambuja, E, Hainaut, P, Dell'Orto, P, Larsimont, D, Francis, PA, Crown, J, Piccart-Gebhart, M, Viale, G, Di Leo, A, Olivier, M, Fernandez-Cuesta, L, Oakman, C, Falagan-Lotsch, P, Smoth, K-S, Quinaux, E, Buyse, M, Dolci, MS, De Azambuja, E, Hainaut, P, Dell'Orto, P, Larsimont, D, Francis, PA, Crown, J, Piccart-Gebhart, M, Viale, G, Di Leo, A, and Olivier, M

Abstract

INTRODUCTION: Pre-clinical data suggest p53-dependent anthracycline-induced apoptosis and p53-independent taxane activity. However, dedicated clinical research has not defined a predictive role for TP53 gene mutations. The aim of the current study was to retrospectively explore the prognosis and predictive values of TP53 somatic mutations in the BIG 02-98 randomized phase III trial in which women with node-positive breast cancer were treated with adjuvant doxorubicin-based chemotherapy with or without docetaxel. METHODS: The prognostic and predictive values of TP53 were analyzed in tumor samples by gene sequencing within exons 5 to 8. Patients were classified according to p53 protein status predicted from TP53 gene sequence, as wild-type (no TP53 variation or TP53 variations which are predicted not to modify p53 protein sequence) or mutant (p53 nonsynonymous mutations). Mutations were subcategorized according to missense or truncating mutations. Survival analyses were performed using the Kaplan-Meier method and log-rank test. Cox-regression analysis was used to identify independent predictors of outcome. RESULTS: TP53 gene status was determined for 18% (520 of 2887) of the women enrolled in BIG 02-98. TP53 gene variations were found in 17% (90 of 520). Nonsynonymous p53 mutations, found in 16.3% (85 of 520), were associated with older age, ductal morphology, higher grade and hormone-receptor negativity. Of the nonsynonymous mutations, 12.3% (64 of 520) were missense and 3.6% were truncating (19 of 520). Only truncating mutations showed significant independent prognostic value, with an increased recurrence risk compared to patients with non-modified p53 protein (hazard ratio = 3.21, 95% confidence interval = 1.740 to 5.935, P = 0.0002). p53 status had no significant predictive value for response to docetaxel. CONCLUSIONS: p53 truncating mutations were uncommon but associated with poor prognosis. No significant predictive role for p53 status was detected. TRIAL REGIST

Published
2012

44. Sustained lymphocyte decreases after treatment for early breast cancer.

Author

Dixon-Douglas J, Virassamy B, Clarke K, Hun M, Luen SJ, Savas P, van Geelen CT, David S, Francis PA, Salgado R, Michiels S, and Loi S

Abstract

The role of adaptive immunity in long-term outcomes in early breast cancer is increasingly recognised. Standard (neo)adjuvant chemotherapy can have adverse effects on immune cells. We conducted a retrospective longitudinal study of full blood counts (FBC) of 200 patients receiving (neo)adjuvant chemotherapy for early breast cancer at a single institution. FBC results at four time points from pre-treatment to 12 months post-chemotherapy were analysed. Flow cytometry was performed for patients with matched pre- and post-chemotherapy peripheral blood mononuclear cell samples. A significant decrease in absolute lymphocyte count at 12 months post-chemotherapy was observed (p < 0.01), most pronounced in pre-menopausal patients (n = 73; p < 0.01), patients receiving dose-dense chemotherapy regimens (n = 60; p < 0.01) and patients receiving adjuvant radiotherapy (n = 147, p < 0.01). In pre-menopausal patients, significant changes in CD4 + T cells subsets post-chemotherapy were observed. Further investigation, including long-term clinical outcomes, is needed to meaningfully improve long-term anti-tumour immunity., (© 2024. The Author(s).)

Published
2024
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45. Breast Cancer Index in Premenopausal Women With Early-Stage Hormone Receptor-Positive Breast Cancer.

Author

O'Regan RM, Zhang Y, Fleming GF, Francis PA, Kammler R, Viale G, Dell'Orto P, Lang I, Bellet M, Bonnefoi HR, Tondini C, Villa F, Bernardo A, Ciruelos EM, Neven P, Karlsson P, Müller B, Jochum W, Zaman K, Martino S, Geyer CE Jr, Jerzak KJ, Davidson NE, Coleman RE, Ingle JN, van Mackelenbergh MT, Loi S, Colleoni M, Schnabel CA, Treuner K, and Regan MM

Subjects
Humans, Female, Adult, Prospective Studies, Middle Aged, Retrospective Studies, Receptors, Interleukin-17, Receptors, Estrogen metabolism, Chemotherapy, Adjuvant, Homeodomain Proteins genetics, Receptors, Progesterone metabolism, Androstadienes therapeutic use, Androstadienes administration & dosage, Neoplasm Staging, Treatment Outcome, Predictive Value of Tests, Aromatase Inhibitors therapeutic use, Breast Neoplasms drug therapy, Breast Neoplasms pathology, Breast Neoplasms genetics, Premenopause, Tamoxifen therapeutic use, Biomarkers, Tumor genetics, Biomarkers, Tumor metabolism, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Agents, Hormonal therapeutic use
Abstract

Importance: Adjuvant ovarian function suppression (OFS) with oral endocrine therapy improves outcomes for premenopausal patients with hormone receptor-positive (HR+) breast cancer but adds adverse effects. A genomic biomarker for selecting patients most likely to benefit from OFS-based treatment is lacking., Objective: To assess the predictive and prognostic performance of the Breast Cancer Index (BCI) for OFS benefit in premenopausal women with HR+ breast cancer., Design, Setting, and Participants: This prospective-retrospective translational study used all available tumor tissue samples from female patients from the Suppression of Ovarian Function Trial (SOFT). These individuals were randomized to receive 5 years of adjuvant tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS. BCI testing was performed blinded to clinical data and outcome. The a priori hypothesis was that BCI HOXB13/IL17BR ratio (BCI[H/I])-high tumors would benefit more from OFS and high BCI portended poorer prognosis in this population. Settings spanned multiple centers internationally. Participants included premenopausal female patients with HR+ early breast cancer with specimens in the International Breast Cancer Study Group tumor repository available for RNA extraction. Data were collected from December 2003 to April 2021 and were analyzed from May 2022 to October 2022., Main Outcomes and Measures: Primary end points were breast cancer-free interval (BCFI) for the predictive analysis and distant recurrence-free interval (DRFI) for the prognostic analyses., Results: Tumor specimens were available for 1718 of the 3047 female patients in the SOFT intention-to-treat population. The 1687 patients (98.2%) who had specimens that yielded sufficient RNA for BCI testing represented the parent trial population. The median (IQR) follow-up time was 12 (10.5-13.4) years, and 512 patients (30.3%) were younger than 40 years. Tumors were BCI(H/I)-low for 972 patients (57.6%) and BCI(H/I)-high for 715 patients (42.4%). Patients with tumors classified as BCI(H/I)-low exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48 [95% CI, 0.33-0.71]) and an absolute benefit of 7.3% from tamoxifen plus OFS (HR, 0.69 [95% CI, 0.48-0.97]) relative to tamoxifen alone. In contrast, patients with BCI(H/I)-high tumors did not benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03 [95% CI, 0.70-1.53]; P for interaction = .006) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05 [95% CI, 0.72-1.54]; P for interaction = .11) compared with tamoxifen alone. BCI continuous index was significantly prognostic in the N0 subgroup for DRFI (n = 1110; P = .004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk N0 cancers, respectively., Conclusions and Relevance: In this prospective-retrospective translational study of patients enrolled in SOFT, BCI was confirmed as prognostic in premenopausal women with HR+ breast cancer. The benefit from OFS-containing adjuvant endocrine therapy was greater for patients with BCI(H/I)-low tumors than BCI(H/I)-high tumors. BCI(H/I)-low status may identify premenopausal patients who are likely to benefit from this more intensive endocrine therapy.

Published
2024
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46. Supervised, structured and individualized exercise in metastatic breast cancer: a randomized controlled trial.

Author

Hiensch AE, Depenbusch J, Schmidt ME, Monninkhof EM, Pelaez M, Clauss D, Gunasekara N, Zimmer P, Belloso J, Trevaskis M, Rundqvist H, Wiskemann J, Müller J, Sweegers MG, Fremd C, Altena R, Gorecki M, Bijlsma R, van Leeuwen-Snoeks L, Ten Bokkel Huinink D, Sonke G, Lahuerta A, Mann GB, Francis PA, Richardson G, Malter W, van der Wall E, Aaronson NK, Senkus E, Urruticoechea A, Zopf EM, Bloch W, Stuiver MM, Wengstrom Y, Steindorf K, and May AM

Subjects
Humans, Female, Middle Aged, Aged, Neoplasm Metastasis, Exercise, Adult, Surveys and Questionnaires, Breast Neoplasms pathology, Breast Neoplasms therapy, Quality of Life, Fatigue etiology, Fatigue therapy, Exercise Therapy methods
Abstract

Physical exercise both during and after curative cancer treatment has been shown to reduce side effects. Evidence in the metastatic cancer setting is scarce, and interventions that improve health-related quality of life (HRQOL) are much needed for patients with metastatic breast cancer (MBC). The multinational randomized controlled PREFERABLE-EFFECT trial assessed the effects of exercise on fatigue and HRQOL in patients with MBC. In total, 357 patients with MBC and a life expectancy of ≥6 months but without unstable bone metastases were recruited at eight study centers across five European countries and Australia. Participants were randomly assigned (1:1) to usual care (control group, n = 179) or a 9-month supervised exercise program (exercise group, n = 178). Intervention effects on physical fatigue (European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-FA12 scale) and HRQOL (EORTC QLQ-C30 summary score) were determined by comparing the change from baseline to 3, 6 (primary timepoint) and 9 months between groups using mixed models for repeated measures, adjusted for baseline values of the outcome, line of treatment (first or second versus third or higher) and study center. Exercise resulted in significant positive effects on both primary outcomes. Physical fatigue was significantly lower (-5.3 (95% confidence interval (CI), -10.0 to -0.6), Bonferroni-Holm-adjusted P = 0.027; Cohen's effect size, 0.22) and HRQOL significantly higher (4.8 (95% CI, 2.2-7.4), Bonferroni-Holm-adjusted P = 0.0003; effect size, 0.33) in the exercise group than in the control group at 6 months. Two serious adverse events occurred (that is, fractures), but both were not related to bone metastases. These results demonstrate that supervised exercise has positive effects on physical fatigue and HRQOL in patients with MBC and should be recommended as part of supportive care.ClinicalTrials.gov Identifier: NCT04120298 ., (© 2024. The Author(s).)

Published
2024
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47. Cardiometabolic Effects of Denosumab in Premenopausal Women With Breast Cancer Receiving Estradiol Suppression: RCT.

Author

Ramchand SK, Hoermann R, White S, Yeo B, Francis PA, Xu CLH, Zajac JD, Seeman E, and Grossmann M

Subjects
Humans, Female, Adult, Double-Blind Method, Middle Aged, Body Mass Index, Aromatase Inhibitors therapeutic use, Aromatase Inhibitors adverse effects, Bone Density Conservation Agents therapeutic use, Denosumab therapeutic use, Breast Neoplasms drug therapy, Breast Neoplasms pathology, Premenopause, Estradiol blood, Body Composition drug effects
Abstract

Context: Menopause is associated with changes in musculoskeletal, body composition, and metabolic parameters that may be amplified in premenopausal women receiving estradiol suppression for breast cancer. Denosumab offsets deleterious skeletal effects of estradiol suppression and has been reported to have effects on body composition and metabolic parameters in preclinical and observational studies, but evidence from double-blind randomized controlled trials is limited., Objective: To assess the effect of denosumab on body composition and metabolic parameters., Methods: In a prespecified secondary analysis of a 12-month randomized, double-blind, placebo-controlled trial, 68 premenopausal women with breast cancer initiating ovarian function suppression and aromatase inhibition were randomized to denosumab 60-mg or placebo administered at baseline and 6 months. Outcome measures were total and regional fat and lean mass (DXA), body mass index (BMI), waist and hip circumference, fasting glucose, HOMA-IR, and lipid profile. Using a mixed model, between-group mean adjusted differences over time are reported., Results: Over 12 months, relative to placebo, android and gynoid fat mass decreased in the denosumab group (-266 g [95% CI -453 to -79], P = .02, and -452 g [-783 to -122], P = .03, respectively). Total fat mass and waist circumference were lower in the denosumab group but not significantly (-1792 g [-3346 to -240], P = .08 and (- 3.77 cm [-6.76 to -0.79], P = .06, respectively). No significant treatment effects were detected in lean mass, BMI, hip circumference, fasting glucose, HOMA-IR, or lipid profile., Conclusion: In premenopausal women receiving estradiol suppression, denosumab decreases some measures of fat mass with no detectable effects on other measures of body composition or metabolic parameters., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.)

Published
2024
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48. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7).

Author

Cardoso F, Paluch-Shimon S, Schumacher-Wulf E, Matos L, Gelmon K, Aapro MS, Bajpai J, Barrios CH, Bergh J, Bergsten-Nordström E, Biganzoli L, Cardoso MJ, Carey LA, Chavez-MacGregor M, Chidebe R, Cortés J, Curigliano G, Dent RA, El Saghir NS, Eniu A, Fallowfield L, Francis PA, Franco Millan SX, Gilchrist J, Gligorov J, Gradishar WJ, Haidinger R, Harbeck N, Hu X, Kaur R, Kiely B, Kim SB, Koppikar S, Kuper-Hommel MJJ, Lecouvet FE, Mason G, Mertz SA, Mueller V, Myerson C, Neciosup S, Offersen BV, Ohno S, Pagani O, Partridge AH, Penault-Llorca F, Prat A, Rugo HS, Senkus E, Sledge GW, Swain SM, Thomssen C, Vorobiof DA, Vuylsteke P, Wiseman T, Xu B, Costa A, Norton L, and Winer EP

Subjects
Humans, Female, Consensus, Practice Guidelines as Topic, Breast Neoplasms therapy, Breast Neoplasms pathology, Palliative Care standards
Abstract

This manuscript describes the Advanced Breast Cancer (ABC) international consensus guidelines updated at the last two ABC international consensus conferences (ABC 6 in 2021, virtual, and ABC 7 in 2023, in Lisbon, Portugal), organized by the ABC Global Alliance. It provides the main recommendations on how to best manage patients with advanced breast cancer (inoperable locally advanced or metastatic), of all breast cancer subtypes, as well as palliative and supportive care. These guidelines are based on available evidence or on expert opinion when a higher level of evidence is lacking. Each guideline is accompanied by the level of evidence (LoE), grade of recommendation (GoR) and percentage of consensus reached at the consensus conferences. Updated diagnostic and treatment algorithms are also provided. The guidelines represent the best management options for patients living with ABC globally, assuming accessibility to all available therapies. Their adaptation (i.e. resource-stratified guidelines) is often needed in settings where access to care is limited., Competing Interests: Declaration of competing interest Matti S. Aapro: Consultant for Accord Pharmaceuticals, Amgen, BMS, Celgene, Clinigen Group, Daiichi Sankyo, Eisai Co.Ltd, Eli Lilly, Genomic Health (Exact Sciences), G1 Therapeutics, Inc., GlaxoSmithKline (GSK), Helsinn Healthcare SA, Hospira (Pfizer), Johnson & Johnson, Merck, Merck Serono (Merck KGaA), Mundipharma International Limited, Novartis, Pfizer, Pierre Fabre, Roche, Sandoz, Tesaro (GSK), Teva Pharmaceuticals Industries Ltd., Vifor Pharma. Received honoraria for lectures at symposia of Accord Pharmaceuticals, Amgen, Astellas, Bayer HealthCare Pharmaceuticals (Schering), Biocon, Boeringer Ingelheim, Cephalon, Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo, Eisai Co., Ltd., Dr Reddy's Laboratories, Genomic Health (Exact Sciences), Glenmark Pharmaceuticals Limited, GSK, Helsinn Healthcare SA, Hospira (Pfizer), Ipsen, Janssen Biotech, Kyowa Kirin Group, Merck, Merck Serono (Merck KGaA), Mundipharma International Limited, Novartis, Pfizer, Pierre Fabre, Roche, Sandoz, Sanofi, Tesaro (GSK), Taiho Pharmaceutical, Teva Pharmaceutical Industries Ltd., Vifor Pharma. Grant/Research supports: Amgen, Eisai, Genomic Health (Exact Sciences), Helsinn, Hospira, Novartis, Merck, Mundipharma, Pfizer, Roche, Sandoz, Tesaro, Teva, Vifor. Jyoti Bajpai: Institutional financial interests for conducting research: Eli Lilly, MSD, Novartis, Roche, Paxman Coolers Ltd, Samsung Bioepis co. Ltd, Sun Pharma. Carlos H. Barrios: Receipt of grants/research supports: (to the institution) Nektar, Pfizer, Polyphor, Amgen, Daiichi Sankyo, Sanofi, Exelixis, Regeneron, Novartis, GSK, Janssen, OBI Pharma, Lilly, Seagen, Roche, BMS, MSD, Merck Serono, AstraZeneca, Novocure, Aveo Oncology, Takeda, TRIO, PharmaMar, Celgene, PPD, Syneos Health, Labcorp, ICON, IQVIA, Parexel, Nuvisan, PSI, Worldwide, Gilead Sciences, Bayer, Servier. Receipt of honoraria or consultation fees: Advisory Boards and Consulting: Boehringer-Ingelheim, GSK, Novartis, Pfizer, Roche/Genentech, Eisai, Bayer, MSD, AstraZeneca, Zodiac, Lilly, Sanofi, Daiichi. Stock shareholder: Ownership or stocks: Tummi, MEDSir. Jonas Bergh: Receipt of grants/research supports: Research grants from Amgen, AstraZeneca, Bayer, Merck, Pfizer, Roche & Sanofi-Aventis to Karolinska Institutet and/or University Hospital. No personal payments. Other support: Payment for a chapter in UpToDate on breast cancer prediction to Asklepios Medicin HB. Laura Biganzoli: Personal financial interests (Honoraria, consultancy or advisory role): Amgen, AstraZeneca, Boehringer-Ingelheim, Daiichi-Sankyo, Eisai, Exact Sciences, Gilead, Lilly, Menarini, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi, SeaGen. Institutional financial interests: Celgene, Genomic Health, Novartis. Travel grants: AstraZeneca, Daiichi-Sankyo. Fatima Cardoso: Receipt of honoraria or consultation fees: Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, Gilead, GlaxoSmithKline, Iqvia, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, prIME Oncology, Roche, Sanofi, Samsung Bioepis, Seagen, Teva, Touchime. Maria-Joao Cardoso: Receipt of honoraria or consultation fees: AstraZeneca, Merck-Sharp, Novartis and Roche. Lisa A. Carey: Other support: Research funding (institution): NanoString Technologies, Seagen, Veracyte, AstraZeneca. Uncompensated relationships: Lilly, Seagen, Novartis, Genentech/Roche, GlaxoSmithKline. Mariana Chavez-MacGregor: Receipt of grants/research supports: BCRF, Susan G Komen. Receipt of honoraria or consultation fees: Astra Zeneca, Pfizer, Lilly, Roche, Merck. Javier Cortés: Receipt of grants/research supports: Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp&Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies. Receipt of honoraria or consultation fees: Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Daiichi Sankyo, Astrazeneca. Stock shareholder: MedSIR, Nektar Pharmaceuticals, Leuko (relative). Other support: Research funding to the Institution: 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. Travel, accommodation, expenses: Roche, Novartis, Eisai, pfizer, Daiichi Sankyo, Astrazeneca, Gilead. Patents: Pharmaceutical Combinations of a Pi3k Inhibitor and A Microtubule Destabilizing Agent. Javier Cortés Castán, Alejandro Piris Giménez, Violeta Serra Elizalde. WO 2014/199294 A. ISSUED. Her2 as a predictor of response to dual HER2 blockade in the absence of cytotoxic therapy. Aleix Prat, Antonio Llombart, Javier Cortés.US 2019/0338368 A1. LICENSED. Giuseppe Curigliano: Receipt of grants/research supports: Merck. Receipt of honoraria or consultation fees: Merck, Lilly, Pfizer, Daichi Sankyo, Seagen, Novartis, Roche, Astra Zeneca, Ellipsis. Participation in a sponsored speakers' bureau: Seagen, Novartis, Lilly, Pfizer, Daichii Sankyo. Rebecca A. Dent: Receipt of grants/research supports: AstraZeneca, Roche. Receipt of honoraria or consultation fees: AstraZeneca, DKSH, Eisai, Merck, Novartis, Pfizer, Roche. Nagi S. El Saghir: Receipt of honoraria or consultation fees: Roche, Novartis, Lilly. Alexandru Eniu: Receipt of honoraria or consultation fees: Astra Zeneca, Daiichi Sankyo, Gilead, Janssen, MSD, Novartis, SeaGen. Receipt of grants/research supports: AstraZeneca. Full or part-time employment: European School of Oncology (ESO). Lesley Fallowfield: Receipt of grants/research supports: Novartis, Bristol-Myers Squibb, Lilly. Receipt of honoraria or consultation fees: Voluntis, Genomic Health, NanoString Technologies, Novartis, Pfizer, MSD, Novartis, Abbvie, Clovis Oncology, Puma Biotechnology, AstraZeneca, Takeda, Genomic Health/Exact Sciences, Lilly, Seagen, Roche. Sandra X. Franco Millan: Receipt of honoraria or consultation fees: Novartis, Pfizer, Eli Lilly. Participation in a sponsored speakers' bureau: Novartis, Pfizer, Eli Lilly. Karen Gelmon: Receipt of grants/research supports: Pfizer, AstraZeneca. Receipt of honoraria or consultation fees: Pfizer, Lilly, Novartis, AstraZeneca, Merck, Gilead, Seagen. Jenny Gilchrist: Receipt of honoraria or consultation fees: Eli-Lilly, AstraZeneca, Novartis, Pfizer, MSD, Gilead, Juniper Biologics. Joseph Gligorov: Receipt of grants/research supports: Eisai, Exact Science, Guardant, Roche Genentech. Receipt of honoraria or consultation fees: Astra Zeneca, Daiichi, Eisai, Evapharma, Exact Science, Gilead, Guardant Lilly, Merck, Novartis, Onxeo, Pfizer, Roche Genentech, Seattle Genetics. Participation in a sponsored speakers' bureau: Eisai, Eva Pharm, Novartis, Roche Genentech, Seattle Genetics. Other support (please specify): Institutional: Institut Universitaire de Cancérologie AP-HP Sorbonne Université; French breast cancer guidelines St Paul. Nadia Harbeck: Receipt of grants/research supports: all to institution. Receipt of honoraria or consultation fees: AstraZeneca, Daiichi-Sankyo, Gilead, Lilly, MSD, Novartis, PierreFabre, Pfizer, Roche, Sandoz, Seagen, Viatris, Zuelligpharma. Participation on a sponsored speakers' bureau: EPG Communication, MEDSCAPE, Springer. Stock shareholder: WSG minority ownership. Spouse/Partner: Consulting for WSG. Ranjit Kaur: Receipt of grants/research supports: Novartis, Roche, Pfizer, Astrazeneca. Receipt of honoraria or consultation fees: Novartis, Roche, Pfizer, Astrazeneca. Participation in a sponsored speakers' bureau: Novartis, Roche, Pfizer, Astrazeneca. Belinda Kiely: Receipt of honoraria or consultation fees: Speakers fees: Novartis, Eisai. Advisory boards: Roche, Gilead, Novartis. Other support (please specify): meeting registrations fees: Novartis, Pfizer, MSD. Sung-Bae Kim: Receipt of grants/research supports: Novartis, Sanofi-Aventis, and DongKook Pharm Co. Receipt of honoraria or consultation fees: Novartis, AstraZeneca, Lilly, Dae Hwa Pharmaceutical Co. Ltd, ISU Abxis, OBI pharma, Beigene and Daiichi-Sankyo. Stock shareholder: Genopeaks. Smruti Koppikar: Receipt of honoraria or consultation fees: Eli Lilly, Novartis, Cipla, Roche. Participation in a sponsored speakers' bureau: Eli Lilly, Novartis, Cipla, Roche. Marion Kuper-Hommel: Receipt of honoraria or consulting fees: Astra Zeneca. Ginny Mason: Participation in a sponsored speakers' bureau: Novartis. Volkmar Mueller: Receipt of grants/research supports: Institutional research support from Novartis, Roche, Seagen, Genentech, Astra Zeneca. Receipt of honoraria or consultation fees: Speaker honoraria: Astra Zeneca, Daiichi-Sankyo, Eisai, GSK, Pfizer, MSD, Medac, Novartis, Roche, Seagen, Onkowissen, high5 Oncology, Medscape, Gilead, Pierre Fabre. Consultancy honoraria from Roche, Pierre Fabre, Amgen, ClinSol, Novartis, MSD, DaiichiSankyo, Eisai, Lilly, Sanofi, Seagen, Gilead, Stemline, ClinSol. Other support (please specify): Travel grants: Roche, Pfizer, Daiichi Sankyo, Gilead. Claire Myerson: Receipt of honoraria or consultation fees: Novartis Pharma. Silvia Neciosup: Receipt of grants/research supports: Roche, Pfizer. Participation in a sponsored speakers' bureau: Tecnofarma, AZ, Roche, Pfizer. Larry Norton: Receipt of honoraria or consultation fees: Blackrock QLS Advisors, Cold Spring Harbor Laboratory, UNC Breast Spore EAB Meeting, Codagenix Scientific Advisory Board Meeting, Martell Diagnostic Laboratories, Inc., Celgene, Agenus, Immix Biopharma, Inc. Shinji Ohno: Participation in a sponsored speakers' bureau: Chugai, Lilly, MSD, Nippon Kayaku. Shani Paluch-Shimon: Receipt of grants/research supports: Pfizer. Receipt of honoraria or consultation fees: Pfizer, Lily, Novartis, Astra Zeneca, Roche, MSD, Gilead, Rhenium/Exact Sciences, Stemline, Daichi Sankyo. Participation in a sponsored speakers' bureau: Pfizer, Lily, Novartis, Astra Zeneca, Roche, MSD, Gilead. Ann H. Partridge: Uptodate Royalties. Aleix Prat: Receipt of grants/research supports: Boehringer, Novartis, Roche, Nanostring, Sysmex Europa GmbH, Medica Scientia inno. Research, SL, Celgene, Astellas and Pzifer. Receipt of honoraria or consultation fees: Roche, Pfizer, Novartis, Amgen, BMS, Puma, Oncolytics Biotech, MSD, Guardan Health, Peptomyc and Lilly, Nanostring Technologies and Daiichi Sankyo. Other support: Clinical trials: Boehringer, Lilly, Roche, Novartis, Amgen and Daiichi Sankyo. Hope S. Rugo: Receipt of grants/research supports: Astellas Pharma Inc.; AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche AG/Genentech, Inc.; Gilead Sciences, Inc.; GlaxoSmithKline; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Pionyr Immunotherapeutics; Sermonix Pharmaceuticals Inc.; Taiho Oncology, Inc. and Veru Inc. Receipt of honoraria or consultation fees: Puma, NAPO, Blueprint, and Scorpion Therapeutics Daichi Sankyo. Elzbieta Senkus: Receipt of honoraria or consultation fees: AstraZeneca, Curio Science, Egis, Eli Lilly, Gilead, high5md, MSD, Novartis, Pfizer, Roche, Swixx. Other support: travel support: AstraZeneca, Egis, Gilead, Novartis, Roche. Contracted research: Amgen, AstraZeneca, Eli Lilly, Gilead, Novartis, OBI Pharma, Roche, Samsung, Seagen. Medical writing: AstraZeneca, Eli Lilly. Royalties: Springer. Sandra M. Swain: Receipt of grants/research supports: Kailos Genetics, Genentech/Roche. Receipt of honoraria or consultation fees: Athenex, AstraZeneca, Biotheranostics, Natera, Exact Sciences, Lilly, Merck, Genentech/Roche, Sanofi, Daiichi Sankyo, Molecular Templates, Napo Pharmaceuticals. Stock shareholder: SEAGEN. Other support: CO- PI of INAVO 122 Genentech/Roche with in-kind travel to investigator meetings, Travel related expenses in kind Sanofi and Daiichi Sankyo. Peter Vuylsteke: Receipt of grants/research supports: UICC grant. Receipt of honoraria or consultation fees: Roche, Novartis and MSD. Theresa Wiseman: Receipt of grants/research supports: Receiver of SPCC Pfizer grant. Binghe Xu: Receipt of grants/research supports: sponsored research to my institution from Roche, AstraZeneca and Pfizer. Receipt of honoraria or consultation fees: advisory or consultancy fees from Novartis and Roche. Participation in a sponsored speakers' bureau: speakers’ bureau fees from AstraZeneca, Pfizer, Roche, Eisai. Elizabeth Bergsten-Nordström, Alberto Costa, Runcie C. W. Chidebe, Prudence A. Francis, Xichun Hu, Renate Haidinger, Leonor Matos, Shirley A. Mertz, Birgitte V. Offersen, Olivia Pagani, Eva Schumacher-Wulf, Daniel A. Vorobiof, Frédéric E. Lecouvet, and Eric P. Winer reported no significant relationships. William J. Gradishar, George W. Sledge and Christoph Thomssen have not submitted a disclosure of interests’ form., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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49. Denosumab Prevents Bone Loss and Microarchitectural Deterioration in Premenopausal Women With Breast Cancer Receiving Estradiol Suppression Therapy: A Randomized Controlled Trial.

Author

Ramchand SK, Ghasem-Zadeh A, Hoermann R, White S, Yeo B, Francis PA, Xu CLH, Coleman O, Shore-Lorenti C, Ebeling PR, Zajac JD, Seeman E, and Grossmann M

Abstract

Purpose: Suppression of ovarian function and aromatase inhibition (AI) increases disease-free survival in premenopausal women with estrogen receptor (ER)-positive early-stage breast cancer but accelerates bone loss. We therefore hypothesized that suppressing bone remodeling using denosumab (DMAB) would prevent bone loss in these women., Methods: In a 12-month double-blind randomized trial, 68 women with ER-positive early-stage breast cancer commencing ovarian function suppression and AI were randomly assigned to 60 mg DMAB (n = 34) or placebo (PBO; n = 34) once every 6 months (at 0 and 6 months). Volumetric bone mineral density (BMD), microarchitecture, and estimated bone strength of the distal tibia and distal radius were measured using high-resolution peripheral quantitative computed tomography, and spine and hip BMD were measured using dual-energy X-ray absorptiometry at 0, 6, and 12 months. The primary end point and treatment effect was the mean adjusted between group difference (MAD; [95% CI]) in distal tibial total volumetric BMD over 12 months, with a single P value tested over all time points. The study is registered with the Australian New Zealand Clinical Trials Registry (anzctr.org.au; identifier: ACTRN12616001051437)., Results: Intention-to-treat analysis included all 68 randomly assigned women. Over 12 months, compared with PBO, DMAB prevented the decrease in distal tibial total BMD (MAD, 20.8 mg HA/cm 3 [95% CI, 17.3 to 24.2]), cortical BMD (42.9 mg HA/cm 3 [95% CI, 32.1 to 53.9]), trabecular BMD (3.32 mg HA/cm 3 [95% CI, 1.45 to 5.20], P = .004), estimated stiffness (11.6 kN/m [95% CI, 7.6 to 15.6]), and failure load (563 N [95% CI, 388 to 736]). Findings were similar at the distal radius. Decreases in BMD at the lumbar spine (MAD, 0.13 g/cm 2 [95% CI, 0.11 to 0.15]), total hip (0.08 g/cm 2 [95% CI, 0.07 to 0.09], and femoral neck (0.06 g/cm 2 [95% CI, 0.05 to 0.07]) were also prevented. All P < .001 unless otherwise noted., Conclusion: Treatment with DMAB at commencement of estradiol suppression therapy preserves BMD, bone microarchitecture, and estimated strength, and is likely to increase fracture-free survival.

Published
2024
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50. The Lancet Breast Cancer Commission.

Author

Coles CE, Earl H, Anderson BO, Barrios CH, Bienz M, Bliss JM, Cameron DA, Cardoso F, Cui W, Francis PA, Jagsi R, Knaul FM, McIntosh SA, Phillips KA, Radbruch L, Thompson MK, André F, Abraham JE, Bhattacharya IS, Franzoi MA, Drewett L, Fulton A, Kazmi F, Inbah Rajah D, Mutebi M, Ng D, Ng S, Olopade OI, Rosa WE, Rubasingham J, Spence D, Stobart H, Vargas Enciso V, Vaz-Luis I, and Villarreal-Garza C

Subjects
Humans, Female, Breast Neoplasms epidemiology
Abstract

Competing Interests: Declaration of interests CEC reports grants from Breast Cancer Now, Cancer Research UK (CRUK), Addenbrooke's Charitable Trust, and the National Institute for Health and Care Research (NIHR); participation in the Independent Data Monitoring Committees for the UK PivotalBoost trial (chair), the PROTIS phase III sinonasal proton versus IMRT trial (member), the TORPEdO Proton Beam Therapy trial (member); and a leadership role for the Lancet Breast Cancer Commission (chair). CHB reports grants and research support from AbbVie, Nektar Therapeutics, Pfizer, Polyphor, Amgen, Daiichi Sankyo, Sanofi, Exelixis, Regeneron, Novartis, Henlius, Shanghai Henlius Biotech, GSK, Janssen, OBI Pharma, Eli Lilly, Seagen, Checkpoint Therapeutics, Roche, Bristol Myers Squibb, MSD, Merck Serono, AstraZeneca, Novocure, Aveo Oncology, Takeda Pharmaceuticals, TRIO Pharmaceuticals, PharmaMar, Celgene, Myovant, PPD, Syneos Health, DOCS, Labcorp, ICON, IQVIA, Parexel, Nuvisan, PSI, and Medpace; ownership or stocks in Tummi and MEDSir; and participation in advisory boards and consulting activities for Boehringer Ingelheim, GSK, Novartis, Pfizer, Genentech, Eisai, Bayer, MSD, AstraZeneca, Zodiac, Eli Lilly, Sanofi, and Daiichi Sankyo. DAC reports research grants and support from Exact Sciences and Novartis; consulting fees from Eli Lilly, Novartis, Seagen, Daiichi Sankyo, Erytech Pharma, Carnall Farrar, Sapience, and Sanofi; payment or honoraria for lectures and presentations from Exact Sciences, Gilead, Eli Lilly, and Pfizer; participation on data safety monitoring or advisory boards for Novartis, AstraZeneca, and Grail; unremunerated leadership roles for Make Seconds Count (chair of charity trustees) and the Breast International Group (chair of board of not-for-profit research organisation); and receipt of funding for analysis and medical writing for Eli Lilly and Novartis. FC reports payment or honoraria for lectures and presentations and support for attending meetings and travel from Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, Gilead, GSK, IQVIA, Macrogenics, Medscape, MSD, Merus, Mylan, Mundipharma, Novartis, Pfizer, Pierre Fabre, prIME Oncology, Roche, Sanofi, Samsung Bioepis, Seagen, Teva Pharmaceuticals, and Touch Independent Medical Education; institutional financial support for clinical trials from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Fresenius, Genentech, Gilead, GSK, Ipsen, Incyte, Nektar Therapeutics, Nerviano, Novartis, Macrogenics, MediGene, MedImmune, MSD, Millenium, Pfizer, Pierre Fabre, Roche, Sanofi, Sonus, Tesaro, Tigris, Wilex, and Wyeth; a leadership role for the ABC Global Alliance and ABC Consensus Conference and Guidelines (president); and membership of ESMO, ESO, EORTC-BCG, IBCSG, SOLTI, ASCO, AACR, EACR, SIS, and ASPIC. WC reports honoraria from AstraZeneca, Pfizer, MSD, and Eisai. PAF reports a former role in the scientific advisory committee of Breast Cancer Trials Australia and New Zealand cooperative group (chair). RJ reports support from the Susan G Komen Foundation; grants from the National Institutes of Health (NIH), the Doris Duke Charitable Foundation, the Greenwall Foundation, and the American Cancer Society; serving as an expert witness for Kleinbard and Hawks Quindel Law; roles in the Board of Directors of ASCO (former member), ASTRO's Ethics Committee (chair), and the Women in Radiation Oncology Affinity Group (chair); membership on the Medical Advisory Board for Blue Cross Blue Shield Association; stock options for their advisory board role in Equity Quotient; and personal fees from the NIH, Doris Duke Charitable Foundation, and the Greenwall Foundation. FMK reports research grants from the ABC Global Alliance, Breast Cancer Now, Merck Serono WHO, MSD, Avon Cosmetics, the US Cancer Pain Relief Committee, and the Medical Research Council; consulting fees from Merck Serono and Instituto Tecnológico y de Estudios Superiores de Monterrey Mexico; and leadership roles for the Board of Directors of Women in Global Health (unpaid member), Tómatelo a Pecho (unpaid president and founder), the Mexican Health Foundation (unpaid Senior Economist), and the Board of Directors of the International Association for Hospice and Palliative Care (unpaid member). SAMcI reports grant funding from the NIHR, CRUK, and Breast Cancer Now; honoraria from Roche, MSD, AstraZeneca, Becton, Dickinson and Company; travel and conference support from Roche, Eli Lilly, and MSD; membership of advisory boards for Eli Lilly, MSD, Roche, and Novartis; and roles for the UK National Cancer Research Institute Breast Research Group (unpaid chair) and the Royal College of Surgeons Breast Surgical Specialty Lead (unpaid). K-AP reports clinical trial funding from AstraZeneca (paid to institution) and unremunerated previous participation in AstraZeneca advisory boards. LR reports grants from the European Commission Horizon 2020 and the German Research Foundation and a role in the International Association for Hospice and Palliative Care (Chair of Board of Directors). MKT reports grants from Addenbrooke's Charitable Trust and CRUK. FA reports grants from Novartis, Pfizer, AstraZeneca, Eli Lilly, Daiichi Sankyo, and Roche and consulting fees from MedImmune, Gilead, Relay Therapeutics, and Guardant Health. JEA reports speaker honoraria from AstraZeneca, Pfizer, Novartis, and Eisai and conference travel support from AstraZeneca. ISB reports participation in the Roche advisory board for ESMO. JMB reports research grants from Breast Cancer Now, AstraZeneca, MSD, Puma Biotechnology, Clovis Oncology, Pfizer, Janssen-Cilag, Novartis, Eli Lilly, Roche, CRUK, and the NIHR. MAF is funded by a Conquer Cancer Breast Cancer Research Foundation Career Development Award for Diversity and Inclusion supported by the Breast Cancer Research Foundation and reports financial support from the WeShare project. AF reports consultancy work for Oxford Immune Algorithmics; grants from Addenbrooke's Charitable Trust and the Ann McLaren Building Preclinical Imaging Suite of the University of Cambridge; and travel support from the University of Cambridge. DIR reports support from the University of Chicago Center for Global Health. DN reports research support from Cepheid; a grant from the US National Cancer Institute; and an unpaid leadership role with the WHO Global Breast Cancer Initiative. WER reports grants from the Cambia Health Foundation, the Robert Wood Johnson Foundation, and the Rita and Alex Hillman Foundation; and book royalties from Springer Publishing and Jones & Bartlett Learning. JR reports funding from the NIHR and support from AstraZeneca for attendance at a teaching event. DS reports a leadership role at the Jamaica Cancer Care and Research Institute (co-director). HS reports membership of the Breast Cancer Now Tissue Bank Advisory Board and voluntary patient membership of the Independent Cancer Patients' Voice charity; an honorarium from the CRUK Precision Grand Challenge; and support for travel expenses from Breast Cancer Now, CRUK, the Association of Breast Surgeons UK, and Breast International Group. IV-L reports grants from Resilience; consulting fees from Novartis, AstraZeneca, and Amgen; payment or honoraria for lectures and presentations from Novartis, Sandoz, Amgen, AstraZeneca, and Pfizer; and support for travel and attending meetings from Novartis. CV-G reports grants from AstraZeneca and Roche; consulting fees from Roche, Novartis, Pfizer, and Eli Lilly; honoraria from Roche, Myriad Genetics, and Novartis; and support for attending meetings and travel from Roche, MSD Oncology, and Pfizer. All other authors declare no competing interests.

Published
2024
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