Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44–GeparQuinto)
The GeparQuinto study showed that adding bevacizumab to 24 weeks of anthracycline–taxane–based neoadjuvant chemotherapy increases pathological complete response (pCR) rates overall and specifically in patients with triple-negative breast cancer (TNBC). No difference in pCR rate was observed for addi...
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| Veröffentlicht in: | Annals of oncology 2014-12, Vol.25 (12), p.2363-2372 |
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| creator | von Minckwitz, G. Fasching, P.A. Schrader, I. Kittel, K. Huober, J. Solbach, C. Jackisch, C. Blohmer, J.U. Nekljudova, V. Gerber, B. Groh, U. Villena, C. Liedtke, B. Kittel, K. Mau, C. Potenberg, J. Schilling, J. Just, M. Bückner, U. Doering, G. Feidicker, S. Krabisch, P. Augustin, D. Nestle-Krämling, C. Rezai, M. Höß, C. Terhaag, J. Fasching, P. Staib, P. Aktas, B. Kühn, T. Khandan, F. Möbus, V. Solbach, C. Tesch, H. Stickeler, E. Heinrich, G. Wagner, H. Abdallah, A. Dewitz, T. Emons, G. Belau, A. Rethwisch, V. Lantzsch, T. Müller, V. Holms, F. Müller, T. Deuker, J.-U. Solomayer, E. Runnebaum, I. Link, H. Conrad, B. Feisel-Schwickardi, G. Steinmetz, T. Langanke, D. Ober, A. Fischer, D. Kohls, A. Weikel, W. Bischoff, J. Freese, K. Wiest, W. Sütterlin, M. Dietrich, M. Grießhammer, M. Burgmann, D.-M. Hanusch, C. Rack, B. Salat, C. Sattler, D. Tio, J. Christensen, B. Burkamp, U. Köhne, C.-H. Meinerz, W. Graßhoff, S.-T. Decker, T. Thalmann, I. Sallmann, A. Beck, T. Reimer, T. Bartzke, G. Deryal, M. Weigel, M. Huober, J. Steffens, C.-C. Lemster, S. Stefek, A. Ruhland, F. Hofmann, M. Schuster, J. Clemens, M. Fehm, T. Janni, W. Latos, K. Bauer, W. Roßmann, A. Bauer, L. Hoffmann, G. Schlag, R. |
| description | The GeparQuinto study showed that adding bevacizumab to 24 weeks of anthracycline–taxane–based neoadjuvant chemotherapy increases pathological complete response (pCR) rates overall and specifically in patients with triple-negative breast cancer (TNBC). No difference in pCR rate was observed for adding everolimus to paclitaxel in nonearly responding patients. Here, we present disease-free (DFS) and overall survival (OS) analyses.
Patients (n = 1948) with HER2-negative tumors of a median tumor size of 4 cm were randomly assigned to neoadjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel (EC-T) with or without eight infusions of bevacizumab every 3 weeks before surgery. Patients without clinical response to EC ± Bevacizumab were randomized to 12 weekly cycles paclitaxel with or without everolimus 5 mg/day. To detect a hazard ratio (HR) of 0.75 (α = 0.05, β = 0.8) 379 events had to be observed in the bevacizumab arms.
With a median follow-up of 3.8 years, 3-year DFS was 80.8% and 3-year OS was 89.7%. Outcome was not different for patients receiving bevacizumab (HR 1.03; P = 0.784 for DFS and HR 0.974; P = 0.842 for OS) compared with patients receiving chemotherapy alone. Patients with TNBC similarly showed no improvement in DFS (HR = 0.99; P = 0.941) and OS (HR = 1.02; P = 0.891) when treated with bevacizumab. No other predefined subgroup (HR+/HER2-; locally advanced (cT4 or cN3) or not; cT1–3 or cT4; pCR or not) showed a significant benefit. No difference in DFS (HR 0.997; P = 0.987) and OS (HR 1.11; P = 0.658) was observed for nonearly responding patients receiving paclitaxel with or without everolimus overall as well as in subgroups.
Long-term results, in opposite to the results of pCR, do not support the neoadjuvant use of bevacizumab in addition to an anthracycline–taxane-based chemotherapy or everolimus in addition to paclitaxel for nonearly responding patients.
NCT 00567554, www.clinicaltrials.gov. |
| doi_str_mv | 10.1093/annonc/mdu455 |
| format | Article |
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Patients (n = 1948) with HER2-negative tumors of a median tumor size of 4 cm were randomly assigned to neoadjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel (EC-T) with or without eight infusions of bevacizumab every 3 weeks before surgery. Patients without clinical response to EC ± Bevacizumab were randomized to 12 weekly cycles paclitaxel with or without everolimus 5 mg/day. To detect a hazard ratio (HR) of 0.75 (α = 0.05, β = 0.8) 379 events had to be observed in the bevacizumab arms.
With a median follow-up of 3.8 years, 3-year DFS was 80.8% and 3-year OS was 89.7%. Outcome was not different for patients receiving bevacizumab (HR 1.03; P = 0.784 for DFS and HR 0.974; P = 0.842 for OS) compared with patients receiving chemotherapy alone. Patients with TNBC similarly showed no improvement in DFS (HR = 0.99; P = 0.941) and OS (HR = 1.02; P = 0.891) when treated with bevacizumab. No other predefined subgroup (HR+/HER2-; locally advanced (cT4 or cN3) or not; cT1–3 or cT4; pCR or not) showed a significant benefit. No difference in DFS (HR 0.997; P = 0.987) and OS (HR 1.11; P = 0.658) was observed for nonearly responding patients receiving paclitaxel with or without everolimus overall as well as in subgroups.
Long-term results, in opposite to the results of pCR, do not support the neoadjuvant use of bevacizumab in addition to an anthracycline–taxane-based chemotherapy or everolimus in addition to paclitaxel for nonearly responding patients.
NCT 00567554, www.clinicaltrials.gov.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdu455</identifier><identifier>PMID: 25223482</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adult ; Angiogenesis Inhibitors - administration & dosage ; Angiogenesis Inhibitors - therapeutic use ; Antibodies, Monoclonal, Humanized - administration & dosage ; Antibodies, Monoclonal, Humanized - therapeutic use ; Antineoplastic agents ; Bevacizumab ; Biological and medical sciences ; Breast Neoplasms - drug therapy ; Breast Neoplasms - metabolism ; Chemotherapy, Adjuvant ; disease-free survival ; Drug Therapy, Combination ; Everolimus ; Female ; Gynecology. Andrology. Obstetrics ; Humans ; Mammary gland diseases ; Medical sciences ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; neoadjuvant chemotherapy ; overall survival ; Pharmacology. Drug treatments ; Receptor, ErbB-2 - metabolism ; Sirolimus - administration & dosage ; Sirolimus - analogs & derivatives ; Sirolimus - therapeutic use ; Survival Analysis ; Tumors</subject><ispartof>Annals of oncology, 2014-12, Vol.25 (12), p.2363-2372</ispartof><rights>2014 European Society for Medical Oncology</rights><rights>2015 INIST-CNRS</rights><rights>The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-876d960f04214965d0827083e12a4e2e673f0d2da51cd6ffcea09b769a56f4b63</citedby><cites>FETCH-LOGICAL-c410t-876d960f04214965d0827083e12a4e2e673f0d2da51cd6ffcea09b769a56f4b63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=29004072$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25223482$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>von Minckwitz, G.</creatorcontrib><creatorcontrib>Fasching, P.A.</creatorcontrib><creatorcontrib>Schrader, I.</creatorcontrib><creatorcontrib>Kittel, K.</creatorcontrib><creatorcontrib>Huober, J.</creatorcontrib><creatorcontrib>Solbach, C.</creatorcontrib><creatorcontrib>Jackisch, C.</creatorcontrib><creatorcontrib>Blohmer, J.U.</creatorcontrib><creatorcontrib>Nekljudova, V.</creatorcontrib><creatorcontrib>Gerber, B.</creatorcontrib><creatorcontrib>Groh, U.</creatorcontrib><creatorcontrib>Villena, C.</creatorcontrib><creatorcontrib>Liedtke, B.</creatorcontrib><creatorcontrib>Kittel, K.</creatorcontrib><creatorcontrib>Mau, C.</creatorcontrib><creatorcontrib>Potenberg, J.</creatorcontrib><creatorcontrib>Schilling, J.</creatorcontrib><creatorcontrib>Just, M.</creatorcontrib><creatorcontrib>Bückner, U.</creatorcontrib><creatorcontrib>Doering, G.</creatorcontrib><creatorcontrib>Feidicker, S.</creatorcontrib><creatorcontrib>Krabisch, P.</creatorcontrib><creatorcontrib>Augustin, D.</creatorcontrib><creatorcontrib>Nestle-Krämling, C.</creatorcontrib><creatorcontrib>Rezai, M.</creatorcontrib><creatorcontrib>Höß, C.</creatorcontrib><creatorcontrib>Terhaag, J.</creatorcontrib><creatorcontrib>Fasching, P.</creatorcontrib><creatorcontrib>Staib, P.</creatorcontrib><creatorcontrib>Aktas, B.</creatorcontrib><creatorcontrib>Kühn, T.</creatorcontrib><creatorcontrib>Khandan, F.</creatorcontrib><creatorcontrib>Möbus, V.</creatorcontrib><creatorcontrib>Solbach, C.</creatorcontrib><creatorcontrib>Tesch, H.</creatorcontrib><creatorcontrib>Stickeler, E.</creatorcontrib><creatorcontrib>Heinrich, G.</creatorcontrib><creatorcontrib>Wagner, H.</creatorcontrib><creatorcontrib>Abdallah, A.</creatorcontrib><creatorcontrib>Dewitz, T.</creatorcontrib><creatorcontrib>Emons, G.</creatorcontrib><creatorcontrib>Belau, A.</creatorcontrib><creatorcontrib>Rethwisch, V.</creatorcontrib><creatorcontrib>Lantzsch, T.</creatorcontrib><creatorcontrib>Müller, V.</creatorcontrib><creatorcontrib>Holms, F.</creatorcontrib><creatorcontrib>Müller, T.</creatorcontrib><creatorcontrib>Deuker, J.-U.</creatorcontrib><creatorcontrib>Solomayer, E.</creatorcontrib><creatorcontrib>Runnebaum, I.</creatorcontrib><creatorcontrib>Link, H.</creatorcontrib><creatorcontrib>Conrad, B.</creatorcontrib><creatorcontrib>Feisel-Schwickardi, G.</creatorcontrib><creatorcontrib>Steinmetz, T.</creatorcontrib><creatorcontrib>Langanke, D.</creatorcontrib><creatorcontrib>Ober, A.</creatorcontrib><creatorcontrib>Fischer, D.</creatorcontrib><creatorcontrib>Kohls, A.</creatorcontrib><creatorcontrib>Weikel, W.</creatorcontrib><creatorcontrib>Bischoff, J.</creatorcontrib><creatorcontrib>Freese, K.</creatorcontrib><creatorcontrib>Wiest, W.</creatorcontrib><creatorcontrib>Sütterlin, M.</creatorcontrib><creatorcontrib>Dietrich, M.</creatorcontrib><creatorcontrib>Grießhammer, M.</creatorcontrib><creatorcontrib>Burgmann, D.-M.</creatorcontrib><creatorcontrib>Hanusch, C.</creatorcontrib><creatorcontrib>Rack, B.</creatorcontrib><creatorcontrib>Salat, C.</creatorcontrib><creatorcontrib>Sattler, D.</creatorcontrib><creatorcontrib>Tio, J.</creatorcontrib><creatorcontrib>Christensen, B.</creatorcontrib><creatorcontrib>Burkamp, U.</creatorcontrib><creatorcontrib>Köhne, C.-H.</creatorcontrib><creatorcontrib>Meinerz, W.</creatorcontrib><creatorcontrib>Graßhoff, S.-T.</creatorcontrib><creatorcontrib>Decker, T.</creatorcontrib><creatorcontrib>Thalmann, I.</creatorcontrib><creatorcontrib>Sallmann, A.</creatorcontrib><creatorcontrib>Beck, T.</creatorcontrib><creatorcontrib>Reimer, T.</creatorcontrib><creatorcontrib>Bartzke, G.</creatorcontrib><creatorcontrib>Deryal, M.</creatorcontrib><creatorcontrib>Weigel, M.</creatorcontrib><creatorcontrib>Huober, J.</creatorcontrib><creatorcontrib>Steffens, C.-C.</creatorcontrib><creatorcontrib>Lemster, S.</creatorcontrib><creatorcontrib>Stefek, A.</creatorcontrib><creatorcontrib>Ruhland, F.</creatorcontrib><creatorcontrib>Hofmann, M.</creatorcontrib><creatorcontrib>Schuster, J.</creatorcontrib><creatorcontrib>Clemens, M.</creatorcontrib><creatorcontrib>Fehm, T.</creatorcontrib><creatorcontrib>Janni, W.</creatorcontrib><creatorcontrib>Latos, K.</creatorcontrib><creatorcontrib>Bauer, W.</creatorcontrib><creatorcontrib>Roßmann, A.</creatorcontrib><creatorcontrib>Bauer, L.</creatorcontrib><creatorcontrib>Hoffmann, G.</creatorcontrib><creatorcontrib>Schlag, R.</creatorcontrib><creatorcontrib>for the GBG/AGO-B study groups</creatorcontrib><creatorcontrib>GBG/AGO-B study groups</creatorcontrib><title>Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44–GeparQuinto)</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>The GeparQuinto study showed that adding bevacizumab to 24 weeks of anthracycline–taxane–based neoadjuvant chemotherapy increases pathological complete response (pCR) rates overall and specifically in patients with triple-negative breast cancer (TNBC). No difference in pCR rate was observed for adding everolimus to paclitaxel in nonearly responding patients. Here, we present disease-free (DFS) and overall survival (OS) analyses.
Patients (n = 1948) with HER2-negative tumors of a median tumor size of 4 cm were randomly assigned to neoadjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel (EC-T) with or without eight infusions of bevacizumab every 3 weeks before surgery. Patients without clinical response to EC ± Bevacizumab were randomized to 12 weekly cycles paclitaxel with or without everolimus 5 mg/day. To detect a hazard ratio (HR) of 0.75 (α = 0.05, β = 0.8) 379 events had to be observed in the bevacizumab arms.
With a median follow-up of 3.8 years, 3-year DFS was 80.8% and 3-year OS was 89.7%. Outcome was not different for patients receiving bevacizumab (HR 1.03; P = 0.784 for DFS and HR 0.974; P = 0.842 for OS) compared with patients receiving chemotherapy alone. Patients with TNBC similarly showed no improvement in DFS (HR = 0.99; P = 0.941) and OS (HR = 1.02; P = 0.891) when treated with bevacizumab. No other predefined subgroup (HR+/HER2-; locally advanced (cT4 or cN3) or not; cT1–3 or cT4; pCR or not) showed a significant benefit. No difference in DFS (HR 0.997; P = 0.987) and OS (HR 1.11; P = 0.658) was observed for nonearly responding patients receiving paclitaxel with or without everolimus overall as well as in subgroups.
Long-term results, in opposite to the results of pCR, do not support the neoadjuvant use of bevacizumab in addition to an anthracycline–taxane-based chemotherapy or everolimus in addition to paclitaxel for nonearly responding patients.
NCT 00567554, www.clinicaltrials.gov.</description><subject>Adult</subject><subject>Angiogenesis Inhibitors - administration & dosage</subject><subject>Angiogenesis Inhibitors - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Antineoplastic agents</subject><subject>Bevacizumab</subject><subject>Biological and medical sciences</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - metabolism</subject><subject>Chemotherapy, Adjuvant</subject><subject>disease-free survival</subject><subject>Drug Therapy, Combination</subject><subject>Everolimus</subject><subject>Female</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Mammary gland diseases</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>neoadjuvant chemotherapy</subject><subject>overall survival</subject><subject>Pharmacology. Drug treatments</subject><subject>Receptor, ErbB-2 - metabolism</subject><subject>Sirolimus - administration & dosage</subject><subject>Sirolimus - analogs & derivatives</subject><subject>Sirolimus - therapeutic use</subject><subject>Survival Analysis</subject><subject>Tumors</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kctu1DAUhi0EotOBJVvkDVK7CLUdx0mWUJUpUiXEbR2d2MeMq1wGX4LKikdA4g15EjzMACtWR7Y-_fb5fkKecPacs7a8gGmaJ30xmiSr6h5Z8Uq1RcMkv09WrBVlUVelPCGnIdwyxlQr2ofkRFRClLIRK_L9ffKLW2CgYCN6OuEM5jYtMEWqtzjOcYsednf0i4tbOvvfc06R9riAdl_TCP3-Ghf08-DGFKjNx-urd6KY8BNEtyDdeTeCv6O9Rwg5FyadnzrbvNxQKX9--7HBHfi3yU1xPn9EHlgYAj4-zjX5-Orqw-V1cfNm8_ryxU2hJWexaGplWsUsk4LLVlWGNaJmTYlcgESBqi4tM8JAxbVR1moE1va1aqFSVvaqXJOzQ-7Oz58ThtiNLmgcBsgKUui4ynl11WSFa1IcUO3nEDza7rhQx1m3L6E7lNAdSsj802N06kc0f-k_1jPw7AhA0DBYn4W48I9rGZOs3nP1gcMsYnHou6AdZnnGedSxM7P7zxd-AWi3qFM</recordid><startdate>20141201</startdate><enddate>20141201</enddate><creator>von Minckwitz, G.</creator><creator>Fasching, P.A.</creator><creator>Schrader, I.</creator><creator>Kittel, K.</creator><creator>Huober, J.</creator><creator>Solbach, C.</creator><creator>Jackisch, C.</creator><creator>Blohmer, J.U.</creator><creator>Nekljudova, V.</creator><creator>Gerber, B.</creator><creator>Groh, U.</creator><creator>Villena, C.</creator><creator>Liedtke, B.</creator><creator>Kittel, K.</creator><creator>Mau, C.</creator><creator>Potenberg, J.</creator><creator>Schilling, J.</creator><creator>Just, M.</creator><creator>Bückner, U.</creator><creator>Doering, G.</creator><creator>Feidicker, S.</creator><creator>Krabisch, P.</creator><creator>Augustin, D.</creator><creator>Nestle-Krämling, C.</creator><creator>Rezai, M.</creator><creator>Höß, C.</creator><creator>Terhaag, J.</creator><creator>Fasching, P.</creator><creator>Staib, P.</creator><creator>Aktas, B.</creator><creator>Kühn, T.</creator><creator>Khandan, F.</creator><creator>Möbus, V.</creator><creator>Solbach, C.</creator><creator>Tesch, H.</creator><creator>Stickeler, E.</creator><creator>Heinrich, G.</creator><creator>Wagner, H.</creator><creator>Abdallah, A.</creator><creator>Dewitz, T.</creator><creator>Emons, G.</creator><creator>Belau, A.</creator><creator>Rethwisch, V.</creator><creator>Lantzsch, T.</creator><creator>Müller, V.</creator><creator>Holms, F.</creator><creator>Müller, T.</creator><creator>Deuker, J.-U.</creator><creator>Solomayer, E.</creator><creator>Runnebaum, I.</creator><creator>Link, H.</creator><creator>Conrad, B.</creator><creator>Feisel-Schwickardi, G.</creator><creator>Steinmetz, T.</creator><creator>Langanke, D.</creator><creator>Ober, A.</creator><creator>Fischer, D.</creator><creator>Kohls, A.</creator><creator>Weikel, W.</creator><creator>Bischoff, J.</creator><creator>Freese, K.</creator><creator>Wiest, W.</creator><creator>Sütterlin, M.</creator><creator>Dietrich, M.</creator><creator>Grießhammer, M.</creator><creator>Burgmann, D.-M.</creator><creator>Hanusch, C.</creator><creator>Rack, B.</creator><creator>Salat, C.</creator><creator>Sattler, D.</creator><creator>Tio, J.</creator><creator>Christensen, B.</creator><creator>Burkamp, U.</creator><creator>Köhne, C.-H.</creator><creator>Meinerz, W.</creator><creator>Graßhoff, S.-T.</creator><creator>Decker, T.</creator><creator>Thalmann, I.</creator><creator>Sallmann, A.</creator><creator>Beck, T.</creator><creator>Reimer, T.</creator><creator>Bartzke, G.</creator><creator>Deryal, M.</creator><creator>Weigel, M.</creator><creator>Huober, J.</creator><creator>Steffens, C.-C.</creator><creator>Lemster, S.</creator><creator>Stefek, A.</creator><creator>Ruhland, F.</creator><creator>Hofmann, M.</creator><creator>Schuster, J.</creator><creator>Clemens, M.</creator><creator>Fehm, T.</creator><creator>Janni, W.</creator><creator>Latos, K.</creator><creator>Bauer, W.</creator><creator>Roßmann, A.</creator><creator>Bauer, L.</creator><creator>Hoffmann, G.</creator><creator>Schlag, R.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20141201</creationdate><title>Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44–GeparQuinto)</title><author>von Minckwitz, G. ; Fasching, P.A. ; Schrader, I. ; Kittel, K. ; Huober, J. ; Solbach, C. ; Jackisch, C. ; Blohmer, J.U. ; Nekljudova, V. ; Gerber, B. ; Groh, U. ; Villena, C. ; Liedtke, B. ; Kittel, K. ; Mau, C. ; Potenberg, J. ; Schilling, J. ; Just, M. ; Bückner, U. ; Doering, G. ; Feidicker, S. ; Krabisch, P. ; Augustin, D. ; Nestle-Krämling, C. ; Rezai, M. ; Höß, C. ; Terhaag, J. ; Fasching, P. ; Staib, P. ; Aktas, B. ; Kühn, T. ; Khandan, F. ; Möbus, V. ; Solbach, C. ; Tesch, H. ; Stickeler, E. ; Heinrich, G. ; Wagner, H. ; Abdallah, A. ; Dewitz, T. ; Emons, G. ; Belau, A. ; Rethwisch, V. ; Lantzsch, T. ; Müller, V. ; Holms, F. ; Müller, T. ; Deuker, J.-U. ; Solomayer, E. ; Runnebaum, I. ; Link, H. ; Conrad, B. ; Feisel-Schwickardi, G. ; Steinmetz, T. ; Langanke, D. ; Ober, A. ; Fischer, D. ; Kohls, A. ; Weikel, W. ; Bischoff, J. ; Freese, K. ; Wiest, W. ; Sütterlin, M. ; Dietrich, M. ; Grießhammer, M. ; Burgmann, D.-M. ; Hanusch, C. ; Rack, B. ; Salat, C. ; Sattler, D. ; Tio, J. ; Christensen, B. ; Burkamp, U. ; Köhne, C.-H. ; Meinerz, W. ; Graßhoff, S.-T. ; Decker, T. ; Thalmann, I. ; Sallmann, A. ; Beck, T. ; Reimer, T. ; Bartzke, G. ; Deryal, M. ; Weigel, M. ; Huober, J. ; Steffens, C.-C. ; Lemster, S. ; Stefek, A. ; Ruhland, F. ; Hofmann, M. ; Schuster, J. ; Clemens, M. ; Fehm, T. ; Janni, W. ; Latos, K. ; Bauer, W. ; Roßmann, A. ; Bauer, L. ; Hoffmann, G. ; Schlag, R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-876d960f04214965d0827083e12a4e2e673f0d2da51cd6ffcea09b769a56f4b63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Angiogenesis Inhibitors - administration & dosage</topic><topic>Angiogenesis Inhibitors - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized - administration & dosage</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Antineoplastic agents</topic><topic>Bevacizumab</topic><topic>Biological and medical sciences</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - metabolism</topic><topic>Chemotherapy, Adjuvant</topic><topic>disease-free survival</topic><topic>Drug Therapy, Combination</topic><topic>Everolimus</topic><topic>Female</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Mammary gland diseases</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>neoadjuvant chemotherapy</topic><topic>overall survival</topic><topic>Pharmacology. Drug treatments</topic><topic>Receptor, ErbB-2 - metabolism</topic><topic>Sirolimus - administration & dosage</topic><topic>Sirolimus - analogs & derivatives</topic><topic>Sirolimus - therapeutic use</topic><topic>Survival Analysis</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>von Minckwitz, G.</creatorcontrib><creatorcontrib>Fasching, P.A.</creatorcontrib><creatorcontrib>Schrader, I.</creatorcontrib><creatorcontrib>Kittel, K.</creatorcontrib><creatorcontrib>Huober, J.</creatorcontrib><creatorcontrib>Solbach, C.</creatorcontrib><creatorcontrib>Jackisch, C.</creatorcontrib><creatorcontrib>Blohmer, J.U.</creatorcontrib><creatorcontrib>Nekljudova, V.</creatorcontrib><creatorcontrib>Gerber, B.</creatorcontrib><creatorcontrib>Groh, U.</creatorcontrib><creatorcontrib>Villena, C.</creatorcontrib><creatorcontrib>Liedtke, B.</creatorcontrib><creatorcontrib>Kittel, K.</creatorcontrib><creatorcontrib>Mau, C.</creatorcontrib><creatorcontrib>Potenberg, J.</creatorcontrib><creatorcontrib>Schilling, J.</creatorcontrib><creatorcontrib>Just, M.</creatorcontrib><creatorcontrib>Bückner, U.</creatorcontrib><creatorcontrib>Doering, G.</creatorcontrib><creatorcontrib>Feidicker, S.</creatorcontrib><creatorcontrib>Krabisch, P.</creatorcontrib><creatorcontrib>Augustin, D.</creatorcontrib><creatorcontrib>Nestle-Krämling, C.</creatorcontrib><creatorcontrib>Rezai, M.</creatorcontrib><creatorcontrib>Höß, C.</creatorcontrib><creatorcontrib>Terhaag, J.</creatorcontrib><creatorcontrib>Fasching, P.</creatorcontrib><creatorcontrib>Staib, P.</creatorcontrib><creatorcontrib>Aktas, B.</creatorcontrib><creatorcontrib>Kühn, T.</creatorcontrib><creatorcontrib>Khandan, F.</creatorcontrib><creatorcontrib>Möbus, V.</creatorcontrib><creatorcontrib>Solbach, C.</creatorcontrib><creatorcontrib>Tesch, H.</creatorcontrib><creatorcontrib>Stickeler, E.</creatorcontrib><creatorcontrib>Heinrich, G.</creatorcontrib><creatorcontrib>Wagner, H.</creatorcontrib><creatorcontrib>Abdallah, A.</creatorcontrib><creatorcontrib>Dewitz, T.</creatorcontrib><creatorcontrib>Emons, G.</creatorcontrib><creatorcontrib>Belau, A.</creatorcontrib><creatorcontrib>Rethwisch, V.</creatorcontrib><creatorcontrib>Lantzsch, T.</creatorcontrib><creatorcontrib>Müller, V.</creatorcontrib><creatorcontrib>Holms, F.</creatorcontrib><creatorcontrib>Müller, T.</creatorcontrib><creatorcontrib>Deuker, J.-U.</creatorcontrib><creatorcontrib>Solomayer, E.</creatorcontrib><creatorcontrib>Runnebaum, I.</creatorcontrib><creatorcontrib>Link, H.</creatorcontrib><creatorcontrib>Conrad, B.</creatorcontrib><creatorcontrib>Feisel-Schwickardi, G.</creatorcontrib><creatorcontrib>Steinmetz, T.</creatorcontrib><creatorcontrib>Langanke, D.</creatorcontrib><creatorcontrib>Ober, A.</creatorcontrib><creatorcontrib>Fischer, D.</creatorcontrib><creatorcontrib>Kohls, A.</creatorcontrib><creatorcontrib>Weikel, W.</creatorcontrib><creatorcontrib>Bischoff, J.</creatorcontrib><creatorcontrib>Freese, K.</creatorcontrib><creatorcontrib>Wiest, W.</creatorcontrib><creatorcontrib>Sütterlin, M.</creatorcontrib><creatorcontrib>Dietrich, M.</creatorcontrib><creatorcontrib>Grießhammer, M.</creatorcontrib><creatorcontrib>Burgmann, D.-M.</creatorcontrib><creatorcontrib>Hanusch, C.</creatorcontrib><creatorcontrib>Rack, B.</creatorcontrib><creatorcontrib>Salat, C.</creatorcontrib><creatorcontrib>Sattler, D.</creatorcontrib><creatorcontrib>Tio, J.</creatorcontrib><creatorcontrib>Christensen, B.</creatorcontrib><creatorcontrib>Burkamp, U.</creatorcontrib><creatorcontrib>Köhne, C.-H.</creatorcontrib><creatorcontrib>Meinerz, W.</creatorcontrib><creatorcontrib>Graßhoff, S.-T.</creatorcontrib><creatorcontrib>Decker, T.</creatorcontrib><creatorcontrib>Thalmann, I.</creatorcontrib><creatorcontrib>Sallmann, A.</creatorcontrib><creatorcontrib>Beck, T.</creatorcontrib><creatorcontrib>Reimer, T.</creatorcontrib><creatorcontrib>Bartzke, G.</creatorcontrib><creatorcontrib>Deryal, M.</creatorcontrib><creatorcontrib>Weigel, M.</creatorcontrib><creatorcontrib>Huober, J.</creatorcontrib><creatorcontrib>Steffens, C.-C.</creatorcontrib><creatorcontrib>Lemster, S.</creatorcontrib><creatorcontrib>Stefek, A.</creatorcontrib><creatorcontrib>Ruhland, F.</creatorcontrib><creatorcontrib>Hofmann, M.</creatorcontrib><creatorcontrib>Schuster, J.</creatorcontrib><creatorcontrib>Clemens, M.</creatorcontrib><creatorcontrib>Fehm, T.</creatorcontrib><creatorcontrib>Janni, W.</creatorcontrib><creatorcontrib>Latos, K.</creatorcontrib><creatorcontrib>Bauer, W.</creatorcontrib><creatorcontrib>Roßmann, A.</creatorcontrib><creatorcontrib>Bauer, L.</creatorcontrib><creatorcontrib>Hoffmann, G.</creatorcontrib><creatorcontrib>Schlag, R.</creatorcontrib><creatorcontrib>for the GBG/AGO-B study groups</creatorcontrib><creatorcontrib>GBG/AGO-B study groups</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>von Minckwitz, G.</au><au>Fasching, P.A.</au><au>Schrader, I.</au><au>Kittel, K.</au><au>Huober, J.</au><au>Solbach, C.</au><au>Jackisch, C.</au><au>Blohmer, J.U.</au><au>Nekljudova, V.</au><au>Gerber, B.</au><au>Groh, U.</au><au>Villena, C.</au><au>Liedtke, B.</au><au>Kittel, K.</au><au>Mau, C.</au><au>Potenberg, J.</au><au>Schilling, J.</au><au>Just, M.</au><au>Bückner, U.</au><au>Doering, G.</au><au>Feidicker, S.</au><au>Krabisch, P.</au><au>Augustin, D.</au><au>Nestle-Krämling, C.</au><au>Rezai, M.</au><au>Höß, C.</au><au>Terhaag, J.</au><au>Fasching, P.</au><au>Staib, P.</au><au>Aktas, B.</au><au>Kühn, T.</au><au>Khandan, F.</au><au>Möbus, V.</au><au>Solbach, C.</au><au>Tesch, H.</au><au>Stickeler, E.</au><au>Heinrich, G.</au><au>Wagner, H.</au><au>Abdallah, A.</au><au>Dewitz, T.</au><au>Emons, G.</au><au>Belau, A.</au><au>Rethwisch, V.</au><au>Lantzsch, T.</au><au>Müller, V.</au><au>Holms, F.</au><au>Müller, T.</au><au>Deuker, J.-U.</au><au>Solomayer, E.</au><au>Runnebaum, I.</au><au>Link, H.</au><au>Conrad, B.</au><au>Feisel-Schwickardi, G.</au><au>Steinmetz, T.</au><au>Langanke, D.</au><au>Ober, A.</au><au>Fischer, D.</au><au>Kohls, A.</au><au>Weikel, W.</au><au>Bischoff, J.</au><au>Freese, K.</au><au>Wiest, W.</au><au>Sütterlin, M.</au><au>Dietrich, M.</au><au>Grießhammer, M.</au><au>Burgmann, D.-M.</au><au>Hanusch, C.</au><au>Rack, B.</au><au>Salat, C.</au><au>Sattler, D.</au><au>Tio, J.</au><au>Christensen, B.</au><au>Burkamp, U.</au><au>Köhne, C.-H.</au><au>Meinerz, W.</au><au>Graßhoff, S.-T.</au><au>Decker, T.</au><au>Thalmann, I.</au><au>Sallmann, A.</au><au>Beck, T.</au><au>Reimer, T.</au><au>Bartzke, G.</au><au>Deryal, M.</au><au>Weigel, M.</au><au>Huober, J.</au><au>Steffens, C.-C.</au><au>Lemster, S.</au><au>Stefek, A.</au><au>Ruhland, F.</au><au>Hofmann, M.</au><au>Schuster, J.</au><au>Clemens, M.</au><au>Fehm, T.</au><au>Janni, W.</au><au>Latos, K.</au><au>Bauer, W.</au><au>Roßmann, A.</au><au>Bauer, L.</au><au>Hoffmann, G.</au><au>Schlag, R.</au><aucorp>for the GBG/AGO-B study groups</aucorp><aucorp>GBG/AGO-B study groups</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44–GeparQuinto)</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2014-12-01</date><risdate>2014</risdate><volume>25</volume><issue>12</issue><spage>2363</spage><epage>2372</epage><pages>2363-2372</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>The GeparQuinto study showed that adding bevacizumab to 24 weeks of anthracycline–taxane–based neoadjuvant chemotherapy increases pathological complete response (pCR) rates overall and specifically in patients with triple-negative breast cancer (TNBC). No difference in pCR rate was observed for adding everolimus to paclitaxel in nonearly responding patients. Here, we present disease-free (DFS) and overall survival (OS) analyses.
Patients (n = 1948) with HER2-negative tumors of a median tumor size of 4 cm were randomly assigned to neoadjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel (EC-T) with or without eight infusions of bevacizumab every 3 weeks before surgery. Patients without clinical response to EC ± Bevacizumab were randomized to 12 weekly cycles paclitaxel with or without everolimus 5 mg/day. To detect a hazard ratio (HR) of 0.75 (α = 0.05, β = 0.8) 379 events had to be observed in the bevacizumab arms.
With a median follow-up of 3.8 years, 3-year DFS was 80.8% and 3-year OS was 89.7%. Outcome was not different for patients receiving bevacizumab (HR 1.03; P = 0.784 for DFS and HR 0.974; P = 0.842 for OS) compared with patients receiving chemotherapy alone. Patients with TNBC similarly showed no improvement in DFS (HR = 0.99; P = 0.941) and OS (HR = 1.02; P = 0.891) when treated with bevacizumab. No other predefined subgroup (HR+/HER2-; locally advanced (cT4 or cN3) or not; cT1–3 or cT4; pCR or not) showed a significant benefit. No difference in DFS (HR 0.997; P = 0.987) and OS (HR 1.11; P = 0.658) was observed for nonearly responding patients receiving paclitaxel with or without everolimus overall as well as in subgroups.
Long-term results, in opposite to the results of pCR, do not support the neoadjuvant use of bevacizumab in addition to an anthracycline–taxane-based chemotherapy or everolimus in addition to paclitaxel for nonearly responding patients.
NCT 00567554, www.clinicaltrials.gov.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>25223482</pmid><doi>10.1093/annonc/mdu455</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0923-7534 |
| ispartof | Annals of oncology, 2014-12, Vol.25 (12), p.2363-2372 |
| issn | 0923-7534 1569-8041 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1627075892 |
| source | MEDLINE; Alma/SFX Local Collection; EZB Electronic Journals Library |
| subjects | Adult Angiogenesis Inhibitors - administration & dosage Angiogenesis Inhibitors - therapeutic use Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic agents Bevacizumab Biological and medical sciences Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Chemotherapy, Adjuvant disease-free survival Drug Therapy, Combination Everolimus Female Gynecology. Andrology. Obstetrics Humans Mammary gland diseases Medical sciences Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) neoadjuvant chemotherapy overall survival Pharmacology. Drug treatments Receptor, ErbB-2 - metabolism Sirolimus - administration & dosage Sirolimus - analogs & derivatives Sirolimus - therapeutic use Survival Analysis Tumors |
| title | Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44–GeparQuinto) |
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