Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial

Ramshorst, Mette S. van; Voort, Anna van der; Werkhoven, Erik van; Mandjes, Ingrid A.M.; Kemper, Inge; Dezentjé, Vincent O.; Oving, Irma M.; Honkoop, Aafke H.; Tick, Lidwine W.; Wouw, Agnès J. van de; Mandigers, Caroline; Warmerdam, Laurence Jc van; Wesseling, Jelle; Peeters, Marie-Jeanne Tfd Vrancken; Linn, Sabine C.; Sonke, Gabe S.

doi:10.1016/s1470-2045(18)30570-9

Cited by 280 publications

(258 citation statements)

References 29 publications

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“…The TRAIN-2 study randomised HER2-positive patients to treatment with 9 cycles of paclitaxel/trastuzumab/carboplatin/pertuzumab (PTCPtz) vs. treatment with 3 cycles of FEC, followed by 6 cycles of PTCPtz. The pCR rates in both randomisation arms were similarly high at 68 vs. 67% 49 . The 3-year survival rates have now been reported, which included 438 patients.…”

Section: Neoadjuvant Therapymentioning

confidence: 89%

“…Die TRAIN-2-Studie randomisierte HER2-positive Patientinnen in eine Behandlung mit 9 Zyklen Paclitaxel/Trastuzumab/Carboplatin/Pertuzumab (PTCPtz) vs. eine Behandlung mit 3 Zyklen FEC, gefolgt von 6 Zyklen PTCPtz. Die pCR-Raten in beiden Randomisationsarmen waren vergleichbar hoch mit 68 vs. 67% 49 . Nun sind die 3-Jahres-Überlebensraten gezeigt worden, in die 438 Patientinnen eingeschlossen waren.…”

Section: Neoadjuvante Platintherapie Anstelle Einer Anthrazyklintheraunclassified

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Update Breast Cancer 2020 Part 3 – Early Breast Cancer

Huober

Schneeweiß

Hartkopf

et al. 2020

Geburtshilfe Frauenheilkd

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The treatment of patients with early breast cancer has always been characterised by escalation by new therapies and de-escalation through identification of better treatment regimens or introduction of better tools to estimate prognosis. Efforts in some of these areas in the last few years have led to solid data. The results of the large studies of de-escalation through use of multi-gene tests are available, as are the results of some studies that investigated the new anti-HER2 substances T-DM1 and pertuzumab in the early treatment situation. Several large-scale studies examining the role of CDK4/6 inhibitors will soon be concluded so innovations can be anticipated in this area also. This review article will summarise and classify the results of the latest publications.

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Section: Neoadjuvant Therapymentioning

confidence: 89%

Section: Neoadjuvante Platintherapie Anstelle Einer Anthrazyklintheraunclassified

Update Breast Cancer 2020 Part 3 – Early Breast Cancer

Huober

Schneeweiß

Hartkopf

et al. 2020

Geburtshilfe Frauenheilkd

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“…Marginal benefits have also been shown with the addition of neratinib following completion of trastuzumab therapy [ 38 , 39 ]. Most patients included in our analysis received anthracyclines as part of their chemotherapy backbone, but excellent survival outcomes and side effect profiles have been demonstrated with anthracycline sparing regimens in low risk patients, with some results confirmed in longer term follow up [ 18 , [40] , [41] , [42] , [43] ]. Anthracycline sparing regimens for low risk patients significantly decrease the risk of cardiotoxicity but no trial has yet to investigate de-escalating both the chemotherapy backbone and trastuzumab duration or to compare these two strategies.…”

Section: Discussionmentioning

confidence: 99%

Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis

et al. 2020

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One year of adjuvant trastuzumab is considered the standard treatment for patients with HER2 positive breast cancer. However, a shorter duration of trastuzumab may be associated with reduced costs and side effects. Results from randomized trials with diverse non-inferiority margins comparing one year to a shorter duration of adjuvant trastuzumab are not consistent and have not been systematically reviewed using a non-inferiority meta-analysis approach. We conducted a systematic review and meta-analysis of randomized trials to assess whether a shorter duration of adjuvant trastuzumab was non-inferior to one year of treatment or not. The non-inferiority margin for the meta-analysis was pre-defined as the median of the margins of all the trials included. Data of 11,376 patients from 5 trials were analyzed. Non-inferiority margins in included studies varied from 1.15 to 1.53 with median of 1.29 for HR of DFS. A shorter duration of trastuzumab was non-inferior to one year of therapy for DFS (HR 1.13, 95%CI 1.03–1.24) but inconclusive for OS (HR 1.14, 95%CI 1.00–1.30). In a subgroup analysis for DFS outcome, shorter therapy was non-inferior in patients with ER positive disease (HR 1.10, 95%CI 0.95–1.28) and those with sequential therapy (HR 0.97, 95%CI 0.75–1.27) and when the duration of treatment was 6 months (HR 1.09, 95%CI 0.98–1.22). Although a shorter duration of adjuvant trastuzumab was non-inferior to one year of therapy for DFS in patients with HER2 positive breast cancer based on our HR margin of 1.29, any benefit of a shorter duration comes at a loss of efficacy with an increase in absolute risk up to 3.9% for 5 year DFS. Whether the potential increased risk is clinically acceptable for the benefits of a shorter duration remains debatable.

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“…4 Observational studies report decreased incidence of ischaemic cardiovascular events in patients with intracerebral haemorrhage who started antiplatelet therapy after the event, with no increased risk of recurrent intracerebral haemorrhage and no worse functional outcomes. [5][6][7][8] These data are compromised from event misclassification, ascertainment bias, and, most substan tially, confounding by indication. Controversy also remains as to whether recurrent intracerebral haemorrhage or ischaemic stroke represents the higher risk for the patient (both estimated at 2-3% per year).…”

Section: Sara a Hurvitzmentioning

confidence: 99%

Is the duration of adjuvant trastuzumab debate still clinically relevant?

Hurvitz

2019

The Lancet

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Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial

Cited by 280 publications

References 29 publications

Update Breast Cancer 2020 Part 3 – Early Breast Cancer

Update Breast Cancer 2020 Part 3 – Early Breast Cancer

Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis

Is the duration of adjuvant trastuzumab debate still clinically relevant?

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