Weischenfeldt KLH, Kirkegaard T, Rasmussen BB, Giobbie-Hurder A, Jensen M, Ejlertsen B, Lykkesfeldt AE. A high level of estrogen-stimulated proteins selects breast cancer patients treated with adjuvant endocrine therapy with good prognosis. E-published Acta Oncol, 10 May 2017 (BIG-198).
Bartlett JMS, Ahmed I, Regan MM, Sestak I, Mallon EA, Dell'Orto P, Thürlimann B, Seynaeve C, Putter H, Van de Velde CJH, Brookes CL, Forbes JF, Viale G, Cuzick J, Dowsett M, Rea DW; Trans-AIOG. HER2 status predicts for upfront AI benefits: A TRANS-AIOG meta-analysis of 12129 patients from ATAC, BIG 1-98 and TEAM with centrally determined HER2. E-published Eur J Cancer, 9 May 2017 (BIG 1-98).
Morden JP, Alvarez I, Bertelli G, Coates AS, Coleman R, Fallowfield L, Jassem J, Jones S, Kilburn L, Lønning PE, Ortmann O, Snowdon C, van de Velde C, Andersen J, Del Mastro L, Dodwell D, Holmberg S, Nicholas H, Paridaens R, Bliss JM, Coombes RC. Long-Term Follow-Up of the Intergroup Exemestane Study. E-published J Clin Oncol, 3 May 2017 (IBCSG 16-98).
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).
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. 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. Results have been published in The Journal of Clinical Oncology.
The manuscript is attached and The Journal of Clinical Oncology link is here: https://ascopubs.org/doi/abs/10.1200/JCO.18.01967 .
381. Balic M, Thomssen C, Wurstlein R, Gnant M, Harbeck N. St. Gallen/Vienna 2019: A brief summary of the consensus discussion on the optimal primary breast cancer treatment. Breast Care 2019;14:103-110. doi: 10.1159/000499931, Epub 2019 Apr 4. (Commentary) (Journal Impact Factor 2.087).
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).
377. Ruggeri M, Pagan E, Bagnardi V, Bianco N, Gallerani E, Buser K, Giordano M, Gianni L, Rabaglio M, Freschi A, Cretella E, Clerico M, Farolfi A, Simoncini E, Ciccarese M, Rauch D, Ramello M, Glaus A, Berardi R, Franzetti Pellanda A, Ribi K, Gelber S, Partridge AH, Goldhirsch A, Pagani O. Fertility concerns, preservation strategies and quality of life in young women with breast cancer: Baseline results from an ongoing prospective cohort study in selected European Centers. Breast 2019 July 10;47:85-92. doi: 10.1016/j.breast.2019.07.001. (IBCSG 43-09) (Journal Impact Factor 3.494).
Monica Ruggeri et al published the first manuscript based on the IBCSG’s 43-09 HOHO study. HOHO (Helping Ourselves, Helping Others) is a prospective study conducted at 18 centers in Italy and Switzerland that focuses on young women ≤40 years newly diagnosed with breast cancer regarding fertility, psychosocial, and quality of life concerns. Surveys and medical records were collected from 297 eligible respondents; subscales from the CAncer Rehabilitation Evaluation System-Short Form (CARESSF) were administered. The baseline result, published in The Breast, found fertility to be the main concern of young women with newly diagnosed breast cancer.
The manuscript is attached and The Breast link is here: https://www.nature.com/articles/s41416-019-0435-4
376. Holmes EM, Bradbury I, Williams LS, Korde L, de Azambuja E, Fumagalli D, Moreno-Aspitia A, Baselga J, Piccart-Gebhart M, Dueck AC, Gelber RD. Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. doi: 10.1093/annonc/mdz195. 2019 June 26. [Epub ahead of print] (IBCSG 36-07) (Journal Impact Factor 13.926).
375. 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, Müller B, Barbeaux A, Graas MP, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J, SOLE Investigators. Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. doi: 10.1038/s41416-019-0435-4. 2019 Apr 10. [Epub ahead of print] (IBCSG 35-07) (Journal Impact Factor 5.922).
Dr. Ribi et al published the quality of life (QoL) assessment from the IBCSG 35-07 / BIG 3-07 SOLE clinical trial in The British Journal of Cancer. In the SOLE QoL substudy, 956 patients completed the Breast Cancer Prevention Trial symptom and further QoL scales up to 24 months after randomization. During the first year, patients showed less symptom worsening, in terms of vaginal problems, musculoskeletal pain, sleep disturbance, physical well-being and mood, with intermittent therapy than with continuous therapy. For women experiencing an increased symptom burden of extended adjuvant endocrine therapy, an intermittent administration is a safe alternative.
The manuscript is attached and The British Journal of Cancer link is here: https://www.nature.com/articles/s41416-019-0435-4.
374. Regan MM, Fleming GF, Walley B, Francis PA, Pagani O. Adjuvant systemic treatment of premenopausal women with hormone receptor–positive early breast cancer: Lights and shadows. J Clin Oncol 2019 April 10;37(11)862-866. doi: 10.1200/JCO.18.02433. Epub 2019 Feb 27. (IBCSG 24-02, 25-02) (Journal Impact Factor 26.303).
373. Kensler KH, Regan MM, Heng YJ, Baker GM, Pyle ME, Schnitt SJ, Hazra A, Kammler R, Thürlimann B, Colleoni M, Viale G, Brown M, Tamimi RM. Prognostic and predictive value of androgen receptor expression in postmenopausal women with estrogen receptor-positive breast cancer: results from the Breast International Group Trial 1-98. Breast Cancer Res 2019 Feb 22;21(1)30. doi: 10.1186/s13058-019-1118-z. (BIG 1-98) (Journal Impact Factor 6.142)
Dr. Kensler et al reported the prognostic and predictive value of androgen receptor expression in 3021 postmenopausal women, with estrogen receptor-positive breast cancer, enrolled in the BIG 1-98 study. The BIG 1-98 study was a four-armed, double-blind, phase III randomized clinical trial that compared 5 years of tamoxifen or letrozole monotherapy, or sequences of 2 years and 3 years treatment with one drug and then the other.
This study found no association between androgen receptor expression and prognosis, nor was there heterogeneity based on treatment arm. These findings suggest that androgen receptor expression may not be an informative biomarker for the selection of adjuvant endocrine therapy for postmenopausal women with estrogen receptor-positive breast cancers.
Results were published in Breast Cancer Research.
The manuscript and data supplement are attached and Breast Cancer Research link is here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6387478/
372. Loi S, Drubay D, Adams S, Pruneri G, Francis PA, Lacroix-Triki M, Joensuu H, Dieci MV, Badve S, Demaria S, Gray R, Munzone E, Lemonnier J, Sotiriou C, Piccart MJ, Kellokumpu-Lehtinen PL, Vingiani A, Gray K, Andre F, Denkert C, Salgado R, Michiels S. Tumor-Infiltrating Lymphocytes and Prognosis: A Pooled Individual Patient Analysis of Early-Stage Triple-Negative Breast Cancers. J Clin Oncol 2019 Mar 1;37(7)559-569. doi: 10.1200/JCO.18.01010. Epub 2019 Jan 16. (IBCSG 22-00) (Journal Impact Factor 26.303).
371. Loi S, Giobbie-Hurder A, Gombos A, Bachelot T, Hui R, Curigliano G, Campone M, Biganzoli L, Bonnefoi H, Jerusalem G, Bartsch R, Rabaglio-Poretti M, Kammler R, Maibach R, Smyth MJ, Di Leo A, Colleoni M, Viale G, Regan MM, André F. Pembrolizumab plus trastuzumab in trastuzumab-resistant, advanced, HER2-positive breast cancer (PANACEA): a single-arm, multi-centre, phase 1b-2 trial. Lancet Oncol. doi: 10.1016/S1470-2045(18)30812-X. 2019 February 11. [Epub ahead of print] (IBCSG 45-13) (Journal Impact Factor 36.418).
The manuscript is attached and The Lancet Oncology link is here: https://doi.org/10.1016/S1470-2045(18)30812-X
Prof. Loi et al reported the results of the single-arm, multicentre, phase 1b–2 trial, IBCSG 45-13/BIG 04-13 PANACEA, evaluating pembrolizumab plus trastuzumab in trastuzumab-resistant, advanced, histologically confirmed, HER2-positive breast cancer. The trial was conducted in collaboration with BIG and the BIG Immunotherapy Working Group. From February 2015 to April 2017, 58 women were enrolled (6 patients were enrolled in phase Ib, 52 in phase II). In the phase Ib portion, there were no dose-limiting toxicities. In the PD-L1-positive cohort, the trial met its primary objective, observing an objective response rate of 15%. In a subgroup of the PD-L1 positive cohort having 5% or more TILs present in the metastatic tumor, the objective response rate was 39%, suggesting that quantification of TILs may help identify patients who will most benefit from this treatment. No objective responses were observed in the PD-L1 negative cohort. Results were e-published in The Lancet Oncology this month.
370. Dellapasqua S, Gray KP, Munzone E, Rubino D, Gianni L, Johansson H, Viale G, Ribi K, Bernhard J, Kammler R, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Regan MM, Goldhirsch A, Colleoni M; International Breast Cancer Study Group. Neoadjuvant degarelix versus triptorelin in premenopausal patients who receive letrozole for locally advanced endocrine-responsive breast cancer: A randomized phase II trial. J Clin Oncol. doi: 10.1200/JCO.18.00296. 2018 Dec 27. [Epub ahead of print] (IBCSG 41-13) (Journal Impact Factor 26.303).
Dr. Dellapasqua et al reported the results of the randomized phase II trial, IBCSG 41-13 TREND, evaluating the endocrine activity, in terms of optimal ovarian function suppression, of a GnRH antagonist versus a GnRH agonist in premenopausal patients receiving neoadjuvant letrozole for locally advanced endocrine-responsive breast cancer. In a three-year span from 2014 to 2017, 51 women received either degarelix and letrozole or triptorelin and letrozole for six 28-day cycles. The primary endpoint was time to optimal ovarian function suppression (as measured by centrally-assessed estradiol levels), which was achieved faster and maintained longer in patients who received degarelix and letrozole than those who received triptorelin and degarelix. Secondary objectives explored response, tolerability, and patient-reported endocrine symptoms.
The manuscript is attached and the JCO link is here:
369. Ruhstaller T, Giobbie-Hurder A, Colleoni M, Jensen MB, Ejlertsen B, de Azambuja E, Neven P, Láng I, Jakobsen EH, Gladieff L, Bonnefoi H, Harvey VJ, Spazzapan S, Tondini C, Del Mastro L, Veyret C, Simoncini E, Gianni L, Rochlitz C, Kralidis E, Zaman K, Jassem J, Piccart-Gebhart M, Di Leo A, Gelber RD, Coates AS, Goldhirsch A, Thürlimann B, Regan MM; members of the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group. Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial. J Clin Oncol. doi: 10.1200/JCO.18.0044. 2018 Nov 26. [Epub ahead of print] (BIG 1-98) (Journal Impact Factor 26.303).
Dr. Ruhstaller et al reported the long-term follow-up results of the four-arm, phase III, double-blind, randomized trial, IBCSG 18-98/BIG 1-98 study, comparing adjuvant letrozole versus tamoxifen. The 8,010 women enrolled received either treatment continuously for five years or received a sequence or two years of a treatment plus three years of the other. The 12.6 median follow-up continued to show trend favoring letrozole, reducing contralateral breast cancer frequency in the first 10 years, but reversed beyond 10 years. As stated in the conclusion, this study illustrates the value of extended follow-up in trials with luminal breast cancer.
The manuscript and data supplement are attached and the JCO link is here:
368. Moore HCF, Unger JM, Phillips KA, Boyle F, Hitre E, Moseley A, Porter D, Francis PA, Goldstein LJ, Gomez HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL, Gelber RD, Hortobagyi GN, Albain KS. Final Analysis of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230. J Natl Cancer Inst. doi: 10.1093/jnci/djy185. 2018 Oct 27. [Epub ahead of print] (IBCSG 34-05) (Journal Impact Factor 12.589).
Dr. Moore et al reported the final analysis of the Prevention of Early Menopause Study, (POEMS; IBCSG 34-05)/SWOG Intergroup S0230. 257 women with stage I-IIIA ER/PgR-negative breast cancer were randomly assigned standard chemotherapy with or without goserelin, a GnRH agonist. This long-term analysis found continued evidence that patients randomly assigned to receive chemotherapy + goserelin were not only more likely to avoid premature menopause, but were also more likely to become pregnant without adverse effect on disease-related outcomes.
The manuscript and editorial are attached and the J Natl Cancer Inst links are:
367. Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. doi: 10.1016/S1470-2045(18)30380-2. 2018 September 5. [Epub ahead of print] (23-01) (Journal Impact Factor 36.418).
366. Van Asten K, Slembrouck L, Olbrecht S, Jongen L, Bouckaert O, Wildiers H, Floris G, van Limbergen E, Weltens C, Smeets A, Paridaens R, Giobbie-Hurder A, Regan MM, Viale G, Thürlimann B, Vergote I, Christodoulou E, van Calster B, Neven P. Prognostic value of progresterone receptor by subtype in patients with estrogen receptor-positive, HER-2 negative breast cancer. Oncologist. doi: 10.1634/theoncologist.2018-0176. 2018 August 31. [Epub ahead of print] (BIG 1-98) (Journal Impact Factor 5.306).
365. Procter M, Robertson C. Performance of standard imputation methods for missing quality of life data as covariate in survival analysis based on simulations from the International Breast Cancer Study Group Trials VI and VII*. Communications in Statistics – Simulation and Computation. doi: 10.1080/03610918.2018.1473587. 2018 August 12. [Epub ahead of print] (IBCSG VI, VII) (Journal Impact Factor 0.457).
364. Luen SJ, Asher R, Lee CK, Savas P, Kammler R, Dell'Orto P, Biasi OM, Demanse D, JeBailey L, Dolan S, Hackl W, Thürlimann B, Viale G, Colleoni M, Regan MM, Loi S. Association of somatic driver alterations with prognosis in postmenopausal, hormone receptor-positive, HER2-negative early breast cancer: A secondary analysis of the BIG 1-98 randomized clinical trial. JAMA Oncol. doi: 10.1001/jamaoncol.2018.1778. 2018 Jun 14. [Epub ahead of print] (BIG 1-98) (Journal Impact Factor 16.559).
363. Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, Gómez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer Jr. CE, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio‑Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM, the SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med. doi: 10.1056/NEJMoa1803164. 2018 June 4. [Epub ahead of print] (IBCSG 24-02, 25-02) (Journal Impact Factor 72.406).
Drs. Francis and Pagani, et al reported the updated results of IBCSG-led Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT). Premenopausal women were randomly assigned to receive 5 years of adjuvant tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression in SOFT; or to receive 5 years of adjuvant tamoxifen plus ovarian suppression or exemestane plus ovarian suppression in TEXT. Among premenopausal women with early breast cancer, the addition of ovarian suppression to tamoxifen resulted in significantly improved disease-free and overall survival compared with tamoxifen alone. The use of exemestane plus ovarian suppression further reduced recurrence as compared with both tamoxifen alone and tamoxifen plus ovarian suppression.
The paper is attached and linked here: https://www.nejm.org/doi/full/10.1056/NEJMoa1803164.
Dr. Marc Lippman’s editorial is attached and linked here: https://www.nejm.org/doi/full/10.1056/NEJMe1806130?query=recirc_curatedRelated_article.
The paper is attached and linked here: