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).
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.
362. Zeidan YH, Habib JG, Ameye L, Paesmans M, de Azambuja E, Gelber RD, Campbell I, Nordenskjöld B, Gutiérez J, Anderson M, Lluch A, Gnant M, Goldhirsch A, Di Leo A, Joseph DJ, Crown J, Piccart-Gebhart M, Francis PA. Postmastectomy radiation therapy in women with T1-T2 tumors and 1 to 3 positive lymph nodes: Analysis of the Breast International Group 02-98 Trial. Int J Radiat Oncol Biol Phys 2018 Jun 1:101(2):316-324. doi: 10.1016/j.ijrobp.2018.01.105. Epub 2018 February 6. (IBCSG 20-98) (Journal Impact Factor 5.133).
361. Dowsett M, Sestak I, Regan MM, Dodson A, Viale G, Thürlmann B, Colleoni M, Cuzick J. Integration of clinical variables for the prediction of late distant recurrence in patients with oestrogen receptor positive breast cancer treated with 5 years of endocrine therapy: CTS5. J Clin Oncol. doi: 10.1200/JCO.2017.76.4258. 2018 April 20. [Epub ahead of print] (BIG 1-98) (Journal Impact Factor 24.08).
Professor Dowsett et al developed and validated a simple clinicopathologic tool (Clinical Treatment Score post–5 years [CTS5]) to estimate residual risk of distant recurrence after 5 years of endocrine treatment. The ATAC data set (N = 4,735) was used to create a prognostic score for post–5-year risk of late distant recurrence, and validity of CTS5 (ATAC) was validated in the BIG 1-98 data set (N = 6,711). Results were published in the Journal of Clinical Oncology.
The paper and data supplement are attached and linked here: http://ascopubs.org/doi/full/10.1200/JCO.2017.76.4258
360. Munzone E, Gray KP, Fumagalli C, Guerini-Rocco E, Láng I, Ruhstaller T, Gianni L, Kammler R, Viale G, Di Leo A, Coates AS, Gelber RD, Regan MM, Goldhirsch A, Barberis M, Colleoni M. Mutational analysis of triple-negative breast cancers within the International Breast Cancer Study Group (IBCSG) Trial 22-00. Breast Cancer Res Treat. doi: 10.1007/s10549-018-4767-1. Epud 2018 March 27. [Epub ahead of print] (IBCSG 22-00).
Dr. Munzone et al investigated the occurrence and the prognostic and predictive relationship of a selected number of somatic mutations in triple-negative breast cancer (TNBC) patients having known clinical outcomes treated within the IBCSG Trial 22-00. Mutational analysis was performed with OncoCarta panel v1.0 using Mass Array System. The panel includes 19 genes belonging to different functional pathways as PI3K pathway, receptor tyrosine kinase and cell cycle-metabolic group. Mutation assessment was successful for 135 patients (49 cases, 86 controls). A manuscript was published in Breast Cancer Research Treatment.
The paper and is attached and linked here:
359. Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martin M, Nortier JWR, Paterson AHG, Rimawi MF, Lang I, Baena-Cañada JM, Thürlimann B, Mamounas EP, Geyer Jr CE, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S, International Breast Cancer Study Group, NRG Oncology, GEICAM Spanish Breast Cancer Group, BOOG Dutch Breast Cancer Trialists’ Group, Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. doi: 10.1200/JCO.2017.76.5719. Epub 2018 February 14. [Epub ahead of print] (IBCSG 27-02).
The CALOR trial investigates the effectiveness of chemotherapy (CT) following local therapy for isolated locoregional recurrence (ILRR), which is associated with a high risk of developing breast cancer distant metastases and death. From August 2003 to January 2010, 162 patients were enrolled. Eligible patients were randomized to CT or No-CT, and stratified by prior CT, hormone-receptor (ER, PR) status, and location of ILRR. A report after 5 years median follow-up showed significant benefit of CT for ER-negative ILRR, but further follow-up was required in ER-positive ILRR.
The final analysis of CALOR after 9 years median follow-up confirms that CT benefits patients with resected ER-negative ILRR. Long-term CALOR trial results do not support the use of CT for ER+ ILRR. The final analysis of the trial was displayed during a poster session at ASCO 2017 and a manuscript has now been published in the Journal of Clinical Oncology.
The paper is attached and linked here:
The editorial is attached and linked here:
358. Lee CK, Hudson M, Simes J, Ribi K, Bernhard J, Coates AS. When do patient reported quality of life indicators become prognostic in breast cancer? Health Qual Life Outcomes. 2-18(16)13. doi: 10.1186/s12955-017-0834-2. Epub 2018 January 12. (IBCSG VI–IX and 13–15) (Impact Factor 2.143).
Dr. Lee’s manuscript investigates individual patient data meta-analysis of seven IBCSG Trials (VI–IX and 13–15) investigated the prognostic value of QL scores at several times before and after disease relapse on overall survival. Among 8024 patients enrolled in one of seven randomized controlled trials in early-stage breast cancer, 3247 had a breast cancer relapse after a median follow-up of 12.1 years. Of these, 677 had completed QL indicator assessments within defined windows 1, 2 or 3 months prior to relapse. Cox regression analyses were performed using these assessments and using identical instruments after relapse. Results have been published in Health and Quality of Life Outcomes.
The paper is attached and linked here:
357. Pan H, Gray R, Braybrooke J, Davies C, Taylor C, McGale P, Peto R, Pritchard KI, Bergh J, Dowsett M, Hayes DF; EBCTCG. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med 2017 Nov 9;377(19):1836-1846. doi: 10.1056/NEJMoa1701830. (Journal Impact Factor 72.406).
356. Wang XV, Cole B, Bonetti M, Gelber RD. Meta-STEPP with Random Effects. Res Synth Methods. doi: 10.1002/jrsm.1288. Epub 2017 December 27. [Epub ahead of print] (Journal Impact Factor 3.018).
355. Alkner S, Jensen MB, Rasmussen BB, Bendahl PO, Fernö M, Rydén L, Mouridsen H, and Danish Breast Cancer Cooperative Group. Prognostic and predictive importance of the estrogen receptor coactivator AIB1 in a randomized trial comparing adjuvant letrozole and tamoxifen therapy in postmenopausal breast cancer: the Danish cohort of BIG 1-98. Breast Cancer Res Treat 2017;166(2):481-490. doi: 10.1007/s10549-017-4416-0. Epub 2017 August 1.
Alkner’s paper and is attached and linked here:
354. Lykkesfeldt AE, Iversen BR, Jensen MB, Ejlertsen B, Giobbie-Hurder A, Reiter BE, Kirkegaard T, Rasmussen BB. Aurora kinase A as a possible marker for endocrine resistance in early estrogen receptor positive breast cancer. Acta Oncol 2018;57(1):67-73. doi: 10.1080/0284186X.2017.1404126. Epub 2017 December 4.
Lykkesfeldt’s paper and is attached and linked here: http://www.tandfonline.com/doi/abs/10.1080/0284186X.2017.1404126?journalCode=ionc20.
353. Procter M, Robertson C. Imputing missing quality of life data as covariate in survival analysis of the International Breast Cancer Study Group Trials VI and VII. Communications in Statistics – Simulation and Computation. doi: 10.1080/03610918.2017.1390123. Epub 2017 December 15. [Epub ahead of print] (IBCSG VI, VII) (Journal Impact Factor 0.457).
352. Gennari A, Sun Z, Hasler-Strub U, Colleoni M, Kennedy MJ, Von Moos R, Cortés J, Vidal MJ, Hennessy B, Walshe J, Amillano Parraga K, Ribi K, Bernhard J, Morales SM, Pagani O, Barbeaux A, Borstnar S, Rabaglio-Poretti M, Maibach R, Regan MM, Jerusalem G. A randomized phase II study evaluating different maintenance schedules of nab-Paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial. Ann Oncol. doi: 10.1093/annonc/mdx772. Epub 2017 December 8. [Epub ahead of print] (IBCSG 42-12) (Journal Impact Factor 11.855).
351. Colleoni M, Luo W, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Hitre E, Graas MP, Simoncini E, Kamby C, Thompson A, Loibl S, Gavilá J, Kuroi K, Marth C, Müller B, O’Reilly S, Di Lauro V, Gombos A, Ruhstaller T, Burstein H, Ribi K, Bernhard J, Viale G, Maibach R, Rabaglio-Poretti M, Gelber RD, Coates AS, Di Leo A, Regan MM, Goldhirsch A; SOLE Investigators. Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. doi: 10.1016/S1470-2045(17)30715-5. 2017 Nov 17. [Epub ahead of print] (IBCSG 35-07).
The SOLE trial is a randomized phase III clinical trial that enrolled almost 4,900 postmenopausal women, in 22 countries, with hormone-sensitive, lymph node-positive breast cancer who were breast cancer-free following 4 to 6 years of prior adjuvant endocrine therapy. Patients were randomly assigned to extend endocrine therapy by either taking an additional 5 years of continuous letrozole or 5 years of intermittent letrozole; taken for the first 9 months during years 1 to 4, and then continuously for 12 months in year 5). This is the first trial that evaluates a de-escalation of extended adjuvant endocrine therapy. 5 years of intermittent letrozole did not reduce the risk of recurrence of breast cancer compared with taking the aromatase inhibitor treatment continuously for 5 years. The results were presented at the 2017 ASCO Annual Meeting and published online in The Lancet Oncology.
The paper and supplement are attached and linked here: http://dx.doi.org/10.1016/S1470-2045(17)30715-5 .
The editorial is attached and linked here:
The commentary is attached and linked here: https://jamanetwork.com/journals/jamaoncology/article-abstract/2663286.