Universität zu Köln

Nitz, Ulrike, Gluz, Oleg, Clemens, Michael, Malter, Wolfram, Reimer, Toralf, Nuding, Benno, Aktas, Bahriye, Stefek, Andrea, Pollmanns, Anke, Lorenz-Salehi, Fatemeh, Uleer, Christoph, Krabisch, Petra, Kuemmel, Sherko, Liedtke, Cornelia, Shak, Steven, Wuerstlein, Rachel, Christgen, Matthias, Kates, Ronald E., Kreipe, Hans H., Harbeck, Nadia, Ackermann, S., Aktas, B., Augustin, D., Baake, G., Baumann, K., Berger, R., Bettscheider, J., Bischoff, J., Clemens, M., Deryal, M., Dubbers, H., Duchting, D., Dunnebacke, J., Fett, W., Fietz, T., Fischer, H., Forner, M., Forstbauer, H., Freese, K., Geberth, M., Glados, M., Gnauert, K., Goette, O., Gohring, U., Goppinger, A., Grafe, A., Hackenberg, R., Hackmann, J., Hellriegel, M., Heyl, V., Hoestermann, C., Hoffmann, G., Hofmann, M., Hucke, J., Jackisch, C., Jungberg, P., Just, M., Kahl, C., Klare, P., Kogel, M., Kohls, A., Amrawy, B. Konigs-El, Konnecke, P., Krabisch, P., Kraudelt, S., Kremers, S., Kummel, S., Kurbacher, C., Kusche, J., Liedtke, B., Liedtke, C., Link, H., Lorenz, R., Salehi, F. Lorenz, Lubbe, K., Malter, W., Melekian, B., Mobus, V., Montenarh, M., Mueller, V., Mundhenke, C., Niederle, N., Nitz, U., Noesselt, T., Oberhoff, C., Paas, L., Paepke, S., Pollmanns, A., Reichert, D., Reimer, T., Romann, D., Ruhland, T., Runde, V., Salem, M., Schlosser, A., Schneider, A., Schrader, I., Schulz, H., Schumacher, C., Schwickerath, J., Soling, U., Stauder, H., Stefek, A., Steinmetz, T., Stickeler, E., Terhaag, J., Thomssen, C., Tome, O., Uleer, C., Warm, M., Wachsmann, G., Wacker, J., Wiebringhaus, H., Wiest, W., Wolfgarten, M., Nitz, U., Christgen, H., Kreipe, H., Buehne, C., Gluz, O., Hansen, K., Hofmann, D., Kates, R., Mangold, M., Mathissen, M., Raeth, P., Renner, I., Reiser, I., Schumacher, J., Staedele, M. and Walter-Kirst, R. (2019). West German Study PlanB Trial: Adjuvant Four Cycles of Epirubicin and Cyclophosphamide Plus Docetaxel Versus Six Cycles of Docetaxel and Cyclophosphamide in HER2-Negative Early Breast Cancer. J. Clin. Oncol., 37 (10). S. 799 - 811. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

PURPOSE The West German Study Group PlanB trial evaluated an anthracycline-free chemotherapy standard (six cycles of docetaxel and cyclophosphamide [TC]) in the routine treatment of human epidermal growth factor receptor 2-negative early breast cancer (EBC). PATIENTS AND METHODS Patients with pT1 to pT4c, all pN+, and pN0/high-risk EBC were eligible. High-risk pN0 was defined by one or more of the following: pT greater than 2, grade 2 to 3, high urokinase-type plasminogen activator/plasminogen activator inhibitor-1, hormone receptor (HR) negativity, and less than 35 years of age. After an early amendment, all HR-positive tumors underwent recurrence score (RS) testing, with chemotherapy omission recommended in RS less than or equal to 11 pN0 to pN1 disease. Patients were randomly assigned to four cycles of epirubicin (E)(90)/cyclophoshamide (C)(600) followed by four cycles of docetaxel (T)(100) or six cycles of T75C600 (administered once every 3 weeks). The primary end point was disease-free survival (DFS); secondary end points were overall survival (OS) and safety. The protocol specified P = .05 for a noninferiority margin of 4.4% for all patients combined. RESULT Of the 3,198 registered patients, 348 (RS <= 11) omitted chemotherapy, and 401 were not randomly assigned. The intention-to-treat population included 2,449 patients (1,227 EC-T v 1,222 TC: postmenopausal, 62.2% v60.8%; pNO, 58.2% v59.5%; pT1, 57.6% v52.3%; HR positive, 81.4% v82.2%; RS greater than 25 [in H.R-positive patients], 26.2% v 27.5%). Within the safety population (1,167 v 1,178 patients), 87.5% v 93.0% completed therapy. After a 60-month median follow-up, 5-year outcomes were similar in the EC-T and TC arms (DFS, 89.6% [95% CI, 87.9% to 91.5%] v89.9% [95% CI, 88.1% to 91.8%]; OS, 94.5% [95% CI, 93.1% to 95.9%] v94.7% [95% CI, 93.3% to 96.1%]). The DFS difference was within the noninferiority margin of the original trial design. Five treatment-related deaths were reported for TC (one for EC-T), despite a trend toward more-severe adverse events in the latter. Interaction analysis revealed no predictive trends with respect to key factors, including triple-negative, luminal A/B-like, pN, age, and RS status. CONCLUSION In the West German Study Group PlanB trial, 5-year outcomes for TC and EC-T were equally excellent. Six cycles of TC is an effective/safe option in human epidermal growth factor receptor 2-negative EBC with pN0 high genomic risk or pN1 EBC with genomically intermediate- to high-risk disease. (C) 2019 by American Society of Clinical Oncology

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Nitz, Ulrike UNSPECIFIED UNSPECIFIED UNSPECIFIED Gluz, Oleg UNSPECIFIED UNSPECIFIED UNSPECIFIED Clemens, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Malter, Wolfram UNSPECIFIED UNSPECIFIED UNSPECIFIED Reimer, Toralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Nuding, Benno UNSPECIFIED UNSPECIFIED UNSPECIFIED Aktas, Bahriye UNSPECIFIED UNSPECIFIED UNSPECIFIED Stefek, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Pollmanns, Anke UNSPECIFIED UNSPECIFIED UNSPECIFIED Lorenz-Salehi, Fatemeh UNSPECIFIED UNSPECIFIED UNSPECIFIED Uleer, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Krabisch, Petra UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuemmel, Sherko UNSPECIFIED UNSPECIFIED UNSPECIFIED Liedtke, Cornelia UNSPECIFIED UNSPECIFIED UNSPECIFIED Shak, Steven UNSPECIFIED UNSPECIFIED UNSPECIFIED Wuerstlein, Rachel UNSPECIFIED UNSPECIFIED UNSPECIFIED Christgen, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Kates, Ronald E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kreipe, Hans H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Harbeck, Nadia UNSPECIFIED UNSPECIFIED UNSPECIFIED Ackermann, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Aktas, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Augustin, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Baake, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Baumann, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Berger, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bettscheider, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bischoff, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Clemens, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Deryal, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dubbers, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Duchting, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dunnebacke, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fett, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fietz, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fischer, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Forner, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Forstbauer, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Freese, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Geberth, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Glados, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gnauert, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Goette, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gohring, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Goppinger, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Grafe, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hackenberg, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hackmann, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hellriegel, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Heyl, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoestermann, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoffmann, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hofmann, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hucke, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jackisch, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jungberg, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Just, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kahl, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Klare, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kogel, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kohls, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Amrawy, B. Konigs-El UNSPECIFIED UNSPECIFIED UNSPECIFIED Konnecke, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Krabisch, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kraudelt, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kremers, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kummel, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kurbacher, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kusche, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Liedtke, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Liedtke, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Link, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lorenz, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Salehi, F. Lorenz UNSPECIFIED UNSPECIFIED UNSPECIFIED Lubbe, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Malter, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Melekian, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mobus, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Montenarh, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mundhenke, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Niederle, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nitz, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Noesselt, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Oberhoff, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Paas, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Paepke, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pollmanns, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Reichert, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Reimer, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Romann, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruhland, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Runde, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Salem, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schlosser, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schneider, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schrader, I. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schulz, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schumacher, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schwickerath, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Soling, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stauder, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stefek, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Steinmetz, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stickeler, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Terhaag, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Thomssen, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Tome, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Uleer, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Warm, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wachsmann, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wacker, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiebringhaus, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiest, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolfgarten, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nitz, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Christgen, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kreipe, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Buehne, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gluz, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hansen, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hofmann, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kates, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mangold, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mathissen, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Raeth, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Renner, I. UNSPECIFIED UNSPECIFIED UNSPECIFIED Reiser, I. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schumacher, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Staedele, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Walter-Kirst, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-152065
DOI:	10.1200/JCO.18.00028
Journal or Publication Title:	J. Clin. Oncol.
Volume:	37
Number:	10
Page Range:	S. 799 - 811
Date:	2019
Publisher:	AMER SOC CLINICAL ONCOLOGY
Place of Publication:	ALEXANDRIA
ISSN:	1527-7755
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PHASE-III TRIAL; FOLLOW-UP; DOXORUBICIN; SURVIVAL; THERAPY; BENEFIT; WOMEN; KI67 Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/15206