A randomized phase 2 study comparing EC or CMF versus nab-paclitaxel plus capecitabine as adjuvant chemotherapy for nonfrail elderly patients with moderate to high-risk early breast cancer (ICE II-GBG 52)
BACKGROUND Although greater than 40% of breast cancers occur in patients aged ≥65 years, these individuals are frequently undertreated. Taxane-based adjuvant chemotherapy is considered the treatment of choice but to the authors' knowledge has only limited evidence in elderly patients. METHODS P...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
June 25, 2015
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| In: |
Cancer
Year: 2015, Jahrgang: 121, Heft: 20, Pages: 3639-3648 |
| ISSN: | 1097-0142 |
| DOI: | 10.1002/cncr.29506 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1002/cncr.29506 Verlag, lizenzpflichtig, Volltext: https://acsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/cncr.29506 
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| Verfasserangaben: | Gunter von Minckwitz, MD; Bettina Conrad, MD; Toralf Reimer, MD; Thomas Decker, MD; Holger Eidtmann, MD; Wolfgang Eiermann, MD; John Hackmann, MD; Volker Möbus, MD; Frederik Marmé, MD; Jochem Potenberg, MD; Elmar Stickeler, MD; Eike Simon, MD; Christoph Thomssen, MD; Jens Huober, MD; Carsten Denkert, MD;Joachim Alfer, MD; Christian Jackisch, MD; Valentina Nekljudova, PhD; Nicole Burchardi, PhD; and Sibylle Loibl, MD; for the German Breast Group Investigators |
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| 245 | 1 | 2 | |a A randomized phase 2 study comparing EC or CMF versus nab-paclitaxel plus capecitabine as adjuvant chemotherapy for nonfrail elderly patients with moderate to high-risk early breast cancer (ICE II-GBG 52) |c Gunter von Minckwitz, MD; Bettina Conrad, MD; Toralf Reimer, MD; Thomas Decker, MD; Holger Eidtmann, MD; Wolfgang Eiermann, MD; John Hackmann, MD; Volker Möbus, MD; Frederik Marmé, MD; Jochem Potenberg, MD; Elmar Stickeler, MD; Eike Simon, MD; Christoph Thomssen, MD; Jens Huober, MD; Carsten Denkert, MD;Joachim Alfer, MD; Christian Jackisch, MD; Valentina Nekljudova, PhD; Nicole Burchardi, PhD; and Sibylle Loibl, MD; for the German Breast Group Investigators |
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| 520 | |a BACKGROUND Although greater than 40% of breast cancers occur in patients aged ≥65 years, these individuals are frequently undertreated. Taxane-based adjuvant chemotherapy is considered the treatment of choice but to the authors' knowledge has only limited evidence in elderly patients. METHODS Patients aged ≥65 years with a Charlson comorbidity index ≤2 and pT1/2 pN0/1 disease and either human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor-negative, grade 3 (according to Common Terminology Criteria for Adverse Events [version 3.0]), high uPA/PAI-1 or any stage pT3/4 pN2/3 breast cancer were randomized to receive 4 cycles of adjuvant epirubicin and cyclophosphamide (EC) (epirubicin at a dose of 90 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 intravenously [iv] on day 1 every 3 22 days) or 6 cycles of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) (cyclophosphamide at a dose of 500 mg/m2, methotrexate at a dose of 40 mg/m2, and 5-fluorouracil at a dose of 600 mg/m2 iv on days 1 plus 8 every 29 days) versus 6 cycles of nab-paclitaxel and capecitabine (nPX) (nab-paclitaxel at a dose of 100 mg/m2 iv on days 1, 8, and 15 every 21 days with 1 week of rest every 6 weeks plus capecitabine at a dose of 2000 mg/m2 orally on days 1-14 every 21 days). Primary endpoints were treatment discontinuations and overall frequency of adverse events. RESULTS Thirteen of 198 patients (6.6%) discontinued EC/CMF and 69 of 193 patients (35.8%) discontinued nPX (P<.001) with 1 and 5 deaths observed during treatment, respectively. Grade 3 to 5 adverse events were more frequent among patients treated with EC/CMF (90.9%) than among those treated with nPX (64.8%) (P<.001), with hematological toxicities being more frequent with EC/CMF (88.4% vs 22.3%; P<.001), but nonhematological toxicities (hand-foot syndrome, diarrhea, mucositis, fatigue, sensory neuropathy, thromboembolisms, and metabolic disorders) being more frequent with nPX (58.5% vs 18.7%; P<.001). None of the geriatric scores (Charlson comorbidity index, Vulnerable Elders Survey [VES-13], Instrumental Activities of Daily Living [IADL], and G8) independently predicted grade 3 to 5 toxic events or treatment discontinuations. No differences in survival between the treatment groups were observed after 22.8 months. CONCLUSIONS Compared with EC/CMF, treatment with nPX led to more treatment discontinuations and nonhematological toxicities in elderly patients with moderate or high-risk breast cancer. Cancer 2015;121:3639-3648. © 2015 American Cancer Society. | ||
| 650 | 4 | |a adjuvant chemotherapy | |
| 650 | 4 | |a capecitabine | |
| 650 | 4 | |a early breast cancer | |
| 650 | 4 | |a elderly patients | |
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| 700 | 1 | |a Decker, Thomas |e VerfasserIn |4 aut | |
| 700 | 1 | |a Eidtmann, Holger |e VerfasserIn |4 aut | |
| 700 | 1 | |a Eiermann, Wolfgang |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hackmann, John |e VerfasserIn |4 aut | |
| 700 | 1 | |a Möbus, Volker |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Potenberg, Jochem |e VerfasserIn |4 aut | |
| 700 | 1 | |a Stickeler, Elmar |e VerfasserIn |4 aut | |
| 700 | 1 | |a Simon, Eike |e VerfasserIn |4 aut | |
| 700 | 1 | |a Thomssen, Christoph |e VerfasserIn |4 aut | |
| 700 | 1 | |a Huober, Jens |e VerfasserIn |4 aut | |
| 700 | 1 | |a Denkert, Carsten |e VerfasserIn |4 aut | |
| 700 | 1 | |a Alfer, Joachim |e VerfasserIn |4 aut | |
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