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2. Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44–GeparQuinto)

Author

von Minckwitz, G., Loibl, S., Untch, M., Eidtmann, H., Rezai, M., Fasching, P.A., Tesch, H., Eggemann, H., Schrader, I., Kittel, K., Hanusch, C., Huober, J., Solbach, C., Jackisch, C., Kunz, G., Blohmer, J.U., Hauschild, M., Fehm, T., Nekljudova, V., Gerber, B., Gnauert, K., Heinrich, B., Prätz, T., Groh, U., Tanzer, H., Villena, C., Tulusan, A., Liedtke, B., Blohmer, J.-U., Mau, C., Potenberg, J., Schilling, J., Just, M., Weiss, E., Bückner, U., Wolfgarten, M., Lorenz, R., Doering, G., Feidicker, S., Krabisch, P., Deichert, U., Augustin, D., Kast, K., Nestle-Krämling, C., Höß, C., Terhaag, J., Fasching, P., Staib, P., Aktas, B., Kühn, T., Khandan, F., Möbus, V., Stickeler, E., Heinrich, G., Wagner, H., Abdallah, A., Dewitz, T., Emons, G., Belau, A., Rethwisch, V., Lantzsch, T., Thomssen, C., Mattner, U., Nugent, A., Müller, V., Noesselt, T., Holms, F., Müller, T., Deuker, J.-U., Strumberg, D., Uleer, C., Solomayer, E., Runnebaum, I., Link, H., Tomé, O., Ulmer, H.-U., Conrad, B., Feisel-Schwickardi, G., Schumacher, C., Steinmetz, T., Bauerfeind, I., Kremers, S., Langanke, D., Kullmer, U., Ober, A., Fischer, D., Kohls, A., Weikel, W., Bischoff, J., Freese, K., Schmidt, M., Wiest, W., Sütterlin, M., Dietrich, M., Grießhammer, M., Burgmann, D.-M., Rack, B., Salat, C., Sattler, D., Tio, J., von Abel, E., Christensen, B., Burkamp, U., Köhne, C.-H., Meinerz, W., Graßhoff, S.-T., Decker, T., Overkamp, F., Thalmann, I., Sallmann, A., Beck, T., Reimer, T., Bartzke, G., Deryal, M., Weigel, M., Weder, P., Steffens, C.-C., Lemster, S., Stefek, A., Ruhland, F., Hofmann, M., Schuster, J., Simon, W., Kronawitter, U., Clemens, M., Janni, W., Latos, K., Bauer, W., Roßmann, A., Bauer, L., Lampe, D., Heyl, V., Hoffmann, G., Lorenz-Salehi, F., Hackmann, J., and Schlag, R.

Published
2014
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3. 1573P Developing a patient-related predictive model for the occurrence of CINV (NOGGO-EMRISK trial): Prospective, multicentre study in Germany

Author

Sehouli, J., primary, Oskay-Öczelik, G., additional, Zocholl, D., additional, Klemt, A-S., additional, Bangemann, N., additional, Albrecht, O., additional, Strittmatter, H-J., additional, Wimberger, P., additional, Kaczerowsky, A., additional, Lorenz, R., additional, Ruhwedel, W., additional, Fehm, T.N., additional, Zahn, A., additional, Tome, O., additional, Markert, M., additional, Hager, D., additional, Zorr, A., additional, Keller, M., additional, Rittmeister, H., additional, and Grabowski, J.P., additional

Published
2022
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6. 815MO The impact of chemosensitivity assessed by modeled CA-125 KELIM on the likelihood of long progression-free survivorship (PS) after 1st line treatment in ovarian cancer: An analysis of 4,450 patients

Author

You, B., primary, Van Wagensveld, L., additional, Tod, M., additional, Sonke, G.S., additional, Kruitwagen, R., additional, du Bois, A., additional, Selle, F., additional, Perren, T.J., additional, Pfisterer, J., additional, Joly, F., additional, Cook, A., additional, Kaminsky-Forrett, M-C., additional, Wollschlaeger, K., additional, Lortholary, A., additional, Tome, O., additional, Leary, A., additional, Freyer, G., additional, Van Der AA, M., additional, and Colomban, O., additional

Published
2020
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7. 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

Author

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., 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., Walter-Kirst, R., 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., 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.

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), de

Published
2019

9. Abstract P6-09-10: Results of multigene assay (MammaPrint®) and molecular subtyping (BluePrint®) substantially impact treatment decision making in early breast cancer: Final analysis of the WSG PRIME decision impact study

Author

Wuerstlein, R, primary, Gluz, O, additional, Kates, R, additional, Persoon, M, additional, Wasmayr, M, additional, Knauer, M, additional, Koplmüller, R, additional, Grischke, E-M, additional, Schem, C, additional, Thill, M, additional, Hasmueller, S, additional, Griesinger, F, additional, Koehler, A, additional, Otremba, B, additional, Schindlbeck, C, additional, Reimer, T, additional, Krauter, J, additional, Tome, O, additional, Otto, F, additional, Friedrichs, K, additional, Albert, U-S, additional, Gebauer, G, additional, Nitz, U, additional, and Harbeck, N, additional

Published
2017
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10. [Is cardiotoxicity still an issue after breast-conserving surgery and could it be reduced by multifield IMRT?]

Author

Lohr, F, Heggemann, F, Papavassiliu, T, El-Haddad, M, Tome, O, Dinter, D, Dobler, B, Kraus-Tiefenbacher, U, Borggrefe, M, and Wenz, F

Subjects
Treatment Outcome, Heart Diseases, Risk Factors, Incidence, Humans, Breast Neoplasms, Female, Comorbidity, Radiotherapy, Conformal, Risk Assessment, Mastectomy
Abstract

Postoperative radiotherapy after breast cancer surgery effectively reduces local relapses. A survival benefit after breast conservation, however, has only been proven recently which was in part due to excessive cardiac mortality of patients who had been treated with radiotherapy in the past.The literature on postoperative radiotherapy for breast cancer was reviewed with regard to cardiac toxicity as the basis for hypothesis generation.From numerous publications on cardiac toxicity of breast cancer radiotherapy, the following pattern emerges: in series where a high radiation dose was applied to a significant percentage of the heart (postmastectomy and postlumpectomy series) cardiac toxicity/mortality was increased versus a nonexposed cohort or for left over right disease. If, however, a relevant exposure of cardiac muscle could be more or less excluded based on the technique used (mainly more recent postlumpectomy radiotherapy), no cardiac toxicity was observed. Series for which individual dose exposure varied or could not be clarified also came to varying conclusions. Also due to retrospectively unclear dose distributions, an exact quantification of tolerance doses/effects of different geographic dose distribution patterns could not be performed to date. A particularly difficult question to answer is the threshold volume for clinically relevant cardiotoxicity with tangential radiotherapy at prescription doses. As a consequence, this precludes an estimate in which situations multifield intensity-modulated radiotherapy (IMRT) with its characteristic dose distribution pattern of a larger volume exposed to intermediate doses and higher mean/median heart doses (as shown in Figure 1) might be preferable.This review updates the database on cardiac toxicity of breast cancer radiotherapy with special emphasis regarding the issues related to the clinical use of IMRT. Multifield IMRT may reduce the cardiac risk for a small subset of patients at excessive risk with conventional tangential radiotherapy due to unfavorable thoracic geometry, for whom partial-breast radiotherapy is not an option. Due to further concern about the effects of intermediate doses to larger heart volumes, potentially increased contralateral cancer risk and the long latency of clinically apparent toxicity, the introduction of breast IMRT should be closely followed. Accompanying functional studies may have the potential to detect cardiac toxicity at an earlier time.

Published
2008

20. Low probability of disease cure in advanced ovarian carcinomas before the PARP inhibitor era.

Author

You B, Van Wagensveld L, Tod M, Sonke GS, Horlings HM, Kruitwagen RFPM, Du Bois A, Selle F, Perren T, Pfisterer J, Joly F, Cook A, Kaminsky MC, Wollschlaeger K, Lortholary A, Tome O, Leary A, Freyer G, Van Der Aa M, and Colomban O

Subjects
Carcinoma, Ovarian Epithelial pathology, Chemotherapy, Adjuvant, Clinical Trials, Phase III as Topic, Cytoreduction Surgical Procedures methods, Female, Humans, Neoadjuvant Therapy methods, Neoplasm Staging, Poly(ADP-ribose) Polymerase Inhibitors therapeutic use, Probability, Retrospective Studies, Antineoplastic Agents therapeutic use, Ovarian Neoplasms pathology
Abstract

Background: In ovarian carcinomas, the likelihood of disease cure following first-line medical-surgical treatment has been poorly addressed. The objective was to: (a) assess the likelihood of long-term disease-free (LDF) > 5 years; and (b) evaluate the impact of the tumour primary chemosensitivity (assessed with the modelled CA-125 KELIM) with respect to disease stage, and completeness of debulking surgery., Methods: Three Phase III trial datasets (AGO-OVAR 9; AGO-OVAR 7; ICON-7) were retrospectively investigated in an "adjuvant dataset", whilst the Netherlands Cancer Registry was used in a "neoadjuvant dataset". The prognostic values of KELIM, disease stage and surgery outcomes regarding the likelihood of LDF were assessed using univariate/multivariate analyses., Results: Of 2029 patients in the "adjuvant dataset", 82 (4.0%) experienced LDF (Stage I-II: 25.9%; III: 2.1%; IV: 0.5%). Multivariate analyses identified disease stage and KELIM (OR = 4.24) as independent prognostic factors. Among the 1452 patients from the "neoadjuvant dataset", 36 (2.4%) had LDF (Stage II-III: 3.3%; IV: 1.3%). Using multivariate tests, high-risk diseases (OR = 0.18) and KELIM (OR = 2.96) were significant., Conclusion: The probability of LDF > 5 years after first-line treatment in 3486 patients (<4%) was lower than thought. These data could represent a reference for future studies meant to assess progress related to PARP inhibitors., (© 2022. The Author(s).)

Published
2022
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