386.       King MT, Link ET, Whelan TJ, Olivotto LA, Kunkler I, Westenberg AH, Gruber G, Schofield P, Chua BH, on behalf of BIG 3-07/TROG 07.01 trial investigators. Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial. Lancet Oncol 2020;21(5):685-698. doi: 10.1016/S1470-2045(20)30085-1 Epub 2020 Mar 20. (IBCSG 38-10) (Journal Impact Factor 35.386),

In this health-related quality of life (HRQOL) substudy of the randomized, controlled, phase 3 BIG 3-07/TROG 07.01 trial evaluating tumor bed boost and whole breast RT dose fractionation schedules for women with non-low risk DCIS treated with breast-conserving therapy, Prof. King et al provide patients’ perspectives to complement the primary endpoint, time to local recurrence (to be reported when participants have completed 5 years of follow-up). All patients (n=1208) were followed up at 2 years for the analysis of 8 HRQOL dimensions. Results showed that cosmetic status and arm and shoulder function were worse with tumor bed boost than with no boost across all timepoints. Results have been published in The Lancet Oncology.


385.       Ribi K, Luo W, Walley BA, Burstein HJ, Chirgwin J, Ansari RH, Salim M, van der Westhuizen A, Abdi E, Francis PA, Chia S, Harvey VJ, Giobbie-Hurder A, Fleming GF, Pagani O, Di Leo A, Colleoni M, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J. Treatment-induced symptoms, depression and age as predictors of sexual problems in premenopausal women with early breast cancer receiving adjuvant endocrine therapy. Breast Cancer Res Treat 2020;181(2):347-359. doi: 10.1007/s10549-020-05622-5 Epub 2020 Apr 9. (IBCSG 24-02 and 25-02) (Journal Impact Factor 3.471)

Dr. Ribi et al investigated predictors of sexual problems in premenopausal women with early breast cancer enrolled in IBCSG’s SOFT and TEXT randomized controlled trials. A subset of these women (N=2287) completed global and symptom-specific quality-of-life indicators, CES-Depression and MOS-Sexual Problems scales at baseline, six, 12 and 24 months. Results showed that sexual problems increased by 6 months and persisted at this level during the first two years. Depression scores were significantly associated with sexual problems in the short-term. Results have been published in Breast Cancer Research and Treatment


384.       Fackler MJ, Cho S, Cope L, Gabrielson E, Visvanathan K, Wilsbach K, Meir-Levi D, Lynch CF, Marks J, Geradts J, Regan MM, Viale G, Wolff AC, Sukumar S, Umbricht CB. DNA methylation markers predict recurrence-free interval in triple-negative breast cancer. NPJ Breast Cancer 2020;6(1):1-6. doi: 10.1038/s41523-020-0145-3 Epub 2020 Jan 31. PMCID: PMC6994477 (IBCSG VIII and IX) (Journal Impact Factor 6.230) 

Dr. Fackler et al investigated whether DNA methylation markers have the potential to be used as a prognostic tool to differentiate between breast cancers with a favorable natural history and those with a high risk of recurrence. Data were analyzed from available samples from IBCSG Trials VIII and IX and samples of node-negative triple-negative breast cancer (TNBC) tumors archived at three U.S. academic institutions. Results showed a repeated association between methylation patterns and long-term outcome. Results have been published in NPJ (Nature Partner Journals) Breast Cancer.


383.       Huober J, Holmes E, Baselga J, de Azambuja E, Untch M, Fumagalli D, Sarp S, Lang I, Smith I, Boyle F, Xu B, Lecocq C, Wildiers H, Jouannaud C, Hackman J, Dasappa L, Ciruelos E, Toral Pena JC, Adamchuk H, Hickish T, de la Pena L, Jackisch C, Gelber RD, Piccart-Gebhart M, Di Cosimo M. Survival outcomes of the NeoALTTO study (BIG 1–06): updated results of a randomised multicenter phase III neoadjuvant clinical trial in patients with HER2-positive primary breast cancer Eur J Cancer 2019;118:169-177. doi: 10.1016/j.ejca.2019.04.038. (IBCSG 37-07) (Journal Impact Factor 6.680).


382. 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. Absolute improvements in freedom from distant recurrence to tailor adjuvant endocrine therapies for premenopausal women: Results from TEXT and SOFT. J Clin Oncol. doi: 10.1200/JCO.18.01967. 2019 Oct 16. [Epub ahead of print] (IBCSG 24-02, 25-02) (Journal Impact Factor 26.303).

The manuscript is attached and The Journal of Clinical Oncology link is here: https://ascopubs.org/doi/abs/10.1200/JCO.18.01967


381.  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. Absolute improvements in freedom from distant recurrence to tailor adjuvant endocrine therapies for premenopausal women: Results from TEXT and SOFT. J Clin Oncol 2020 Apr 20;38(12):1293-1303. doi: 10.1200/JCO.18.01967. Epub 2019 Oct 16. (IBCSG 24-02, 25-02) (Journal Impact Factor 26.303).

Dr. Pagani et al investigated absolute improvement in freedom from distance recurrence for premenopausal women with hormone receptor-positive, HER2-negative breast cancer in the TEXT and SOFT trials according to Composite Risk. Results showed that women with low recurrence risk have minimal potential benefit in escalating endocrine therapy, while women with high recurrence risk may experience a 10-15% absolute improvement in 8-year freedom from distant recurrence with exemestane+OFS versus tamoxifen+OFS or tamoxifen alone. 

Along with the 20 April 2020 print version of the manuscript in the Journal of Clinical Oncology, we are pleased to announce the availability of a Composite Risk web application to better illustrate, for an individual set of characteristics, how similar patients in SOFT and TEXT have fared: https://rconnect.dfci.harvard.edu/CompositeRiskSTEPP/.


380. Denkert C, Budczies J, Regan MM, Loibl S, Dell'Orto P, von Minckwitz G, Mastropasqua MG, Solbach C, Thürlimann B, Mehta K, Blohmer JU, Colleoni M, Müller V, Klauschen F, Ataseven B, Engels K, Kammler R, Pfitzner BM, Dietel M, Fasching PA, Viale G. Clinical and analytical validation of Ki-67 in 9069 patients from IBCSG VIII + IX, BIG1-98 and GeparTrio trial: systematic modulation of interobserver variance in a comprehensive in silico ring trial. Breast Cancer Res Treat 2019 Aug;176(3:557-568. doi: 10.1007/s10549-018-05112-9. Epub 2019 May 7. (IBCSG VIII + IX, BIG1-98) (Impact Journal Factor 3.471).

379. Saura C, Hlauschek D, Oliveira M, Zardavas D, Jallitsch-Halper A, de la Peña L, Nuciforo P, Ballestrero A, Dubsky P, Lombard JM, Vuylsteke P, Castaneda CA, Colleoni M, Santos Borges G, Ciruelos E, Fornier M, Boer K, Bardia A, Wilson TP, Stout TJ, Hsu JY, Shi Y, Piccart M, Gnant M, Baselga J, de Azambuja E. Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet 2019 Sep 1;20(9):1226-1238. doi: 10.1016/S1470-2045(19)30334-1. Epub 2019 Aug 8. (IBCSG 46-13) (Journal Impact Factor 59.102).

378. Buechler S, Gray KP, Gökmen-Polar Y, Willis S, Thürlimann B, Kammler R, Viale G, Leyland-Jones B, Badve* SS, Regan* MM. *Co-last authors. Independent validation of EarlyR gene signature in BIG 1-98: A randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer. JNCI Cancer Spectr. doi: 10.1093/jncics/pkz051. Epub 2019 Aug 16. (BIG 1-98).

The manuscript is attached and JNCI Cancer Spectrum link is here: https://academic.oup.com/jncics/advance-article/doi/10.1093/jncics/pkz051/5550648.

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