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
| Autor: | Esther Pohl-Rescigno, Peter Klare, Gbg, Kristina Lübbe, Michael Untch, Kerstin Rhiem, Carsten Denkert, Jens Huober, Hans Tesch, Andreas Schneeweiss, Sibylle Loibl, Christian Jackisch, Karin Kast, Rita K. Schmutzler, Christine Solbach, Theresa Link, Valentina Nekljudova, L Michel, Peter A. Fasching, Claus Hanusch, Eric Hahnen, Volker Möbus, Ago-B, Jens-Uwe Blohmer |
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| Rok vydání: | 2021 |
| Předmět: |
Cancer Research
medicine.medical_specialty Paclitaxel medicine.medical_treatment Triple Negative Breast Neoplasms Gastroenterology Loading dose Polyethylene Glycols chemistry.chemical_compound Breast cancer Trastuzumab Risk Factors Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Cyclophosphamide Triple-negative breast cancer Epirubicin Chemotherapy business.industry medicine.disease Survival Analysis Carboplatin Oncology chemistry Doxorubicin Female Pertuzumab business medicine.drug |
| Zdroj: | European journal of cancer (Oxford, England : 1990). 160 |
| ISSN: | 1879-0852 |
| Popis: | Background GeparOcto demonstrated that pathological complete response (pCR) of intense dose-dense epirubicin, paclitaxel and cyclophosphamide (iddEPC) was comparable to weekly paclitaxel/non-pegylated liposomal doxorubicin (plus carboplatin (PM(Cb) in triple-negative breast cancer [TNBC]) in high-risk early breast cancer (BC). Here, we report time-to-event secondary end-points. Patients and methods Patients were randomised to receive 18 weeks of E (150 mg/m2) followed by P (225 mg/m2) followed by C (2000 mg/m2), each q2w or weekly P (80 mg/m2) plus M (20 mg/m2) plus, in TNBC, Cb (AUC 1.5). Patients with human epidermal growth factor receptor 2-positive (HER2+)BC received trastuzumab (6[loading dose 8]mg/kg q3w) and pertuzumab (420[840]mg q3w) with P and C cycles. Results 945 patients started treatment (iddEPC n = 470; PM(Cb) n = 475). After a median follow-up of 47.0 (range 1.6-61.5) months, 162 (75 in iddEPC; 87 in PM(Cb)) invasive disease-free survival (iDFS) events and 79 (41 in iddEPC; 38 in PM(Cb)) deaths were reported. No significant difference was observed in 4-year iDFS (81.9% iddEPC versus 79.7% PM(Cb), HR = 1.16 [95%CI 0.85-1.59], log-rank p = 0.334) or 4-year overall survival (OS) (90.3% iddEPC versus 90.6% PM(Cb), HR = 0.90 [95%CI 0.58-1.40], log-rank p = 0.637) overall and in HER2+ and TNBC subgroups. HR+/HER2- BC patients, however, had significantly better 4-year iDFS (77.9% iddEPC versus 62.5% PM, HR = 2.11 [95%CI 1.08-4.10], log-rank p = 0.025) and 4-year OS with iddEPC (94.7% iddEPC versus 80.1% PM, HR = 3.26 [95%CI 1.06-10.00], log-rank p = 0.029). Conclusion While there was no difference in survival for the entire cohort, the HR+/HER2-subgroup significantly benefits from iddEPC. This supports the concept of an additional effect of NACT beyond pCR in patients with HR+/HER2- BC. CLINICALTRIALS. Gov identifier NCT02125344. |
| Databáze: | OpenAIRE |
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