Survival analysis of the randomised phase III GeparOcto trial comparing neoadjuvant chemotherapy of intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for patients with high-risk early breast cancer

2021 ◽  
Author(s):  
Andreas Schneeweiss ◽  
Laura L. Michel ◽  
Volker Möbus ◽  
Hans Tesch ◽  
Peter Klare ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Survival Analysis ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Early Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Liposomal Doxorubicin ◽  
Triple Negative ◽  
Phase Iii ◽  
Dose Dense

scholarly journals Randomized Phase III Postoperative Trial of Platinum-Based Chemotherapy Versus Capecitabine in Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy: ECOG-ACRIN EA1131

2021 ◽  
pp. JCO.21.00976
Author(s):  
Ingrid A. Mayer ◽  
Fengmin Zhao ◽  
Carlos L. Arteaga ◽  
William F. Symmans ◽  
Ben H. Park ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Invasive Disease ◽  
Phase Iii ◽  
Basal Subtype ◽  
Platinum Agents

PURPOSE Patients with triple-negative breast cancer (TNBC) and residual invasive disease (RD) after completion of neoadjuvant chemotherapy (NAC) have a high-risk for recurrence, which is reduced by adjuvant capecitabine. Preclinical models support the use of platinum agents in the TNBC basal subtype. The EA1131 trial hypothesized that invasive disease-free survival (iDFS) would not be inferior but improved in patients with basal subtype TNBC treated with adjuvant platinum compared with capecitabine. PATIENTS AND METHODS Patients with clinical stage II or III TNBC with ≥ 1 cm RD in the breast post-NAC were randomly assigned to receive platinum (carboplatin or cisplatin) once every 3 weeks for four cycles or capecitabine 14 out of 21 days every 3 weeks for six cycles. TNBC subtype (basal v nonbasal) was determined by PAM50 in the residual disease. A noninferiority design with superiority alternative was chosen, assuming a 4-year iDFS of 67% with capecitabine. RESULTS Four hundred ten of planned 775 participants were randomly assigned to platinum or capecitabine between 2015 and 2021. After median follow-up of 20 months and 120 iDFS events (61% of full information) in the 308 (78%) patients with basal subtype TNBC, the 3-year iDFS for platinum was 42% (95% CI, 30 to 53) versus 49% (95% CI, 39 to 59) for capecitabine. Grade 3 and 4 toxicities were more common with platinum agents. The Data and Safety Monitoring Committee recommended stopping the trial as it was unlikely that further follow-up would show noninferiority or superiority of platinum. CONCLUSION Platinum agents do not improve outcomes in patients with basal subtype TNBC RD post-NAC and are associated with more severe toxicity when compared with capecitabine. Participants had a lower than expected 3-year iDFS regardless of study treatment, highlighting the need for better therapies in this high-risk population.

Phase III randomised trial comparing intense dose-dense chemotherapy to tailored dose-dense chemotherapy in high-risk early breast cancer (GAIN-2)

2021 ◽  
Vol 156 ◽  
pp. 138-148
Author(s):  
Volker Möbus ◽  
Hans-Joachim Lück ◽  
Ekkehart Ladda ◽  
Peter Klare ◽  
Marcus Schmidt ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Breast Cancer ◽  
Randomised Trial ◽  
Phase Iii ◽  
Dose Dense

Boosting immune responses against early breast cancer

2020 ◽  
Vol 12 (535) ◽  
pp. eabb2773
Author(s):  
Ecaterina Ileana-Dumbrava
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Immune Responses ◽  
Early Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Therapeutic Responses

Pembrolizumab combined with neoadjuvant chemotherapy improves therapeutic responses in patients with early triple-negative breast cancer.

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