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5. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: diagnosis, treatment and follow-up

Author

Colombo, N., Creutzberg, C., Amant, F., Bosse, T., González-Martín, A., Ledermann, J., Marth, C., Nout, R., Querleu, D., Mirza, M.R., Sessa, C., Abal, M., Altundag, O., van Leeuwenhoek, Antoni, Banerjee, S., Casado, A., de Agustín, L.C., Cibula, D., del Campo, J.-M., Emons, G., Goffin, F., Greggi, S., Haie-Meder, C., Katsaros, D., Kesic, V., Kurzeder, C., Lax, S., Lécuru, F., Levy, T., Lorusso, D., Mäenpää, J., Matias-Guiu, X., Morice, P., Nijman, H.W., Powell, M., Reed, N., Rodolakis, A., Salvesen, H., Sehouli, J., Taylor, A., Westermann, A., and Zeimet, A.G.

Published
2016
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6. Dilution of molecular-pathologic gene signatures (MPG) by parameter unrelated to tumor biology (UTB) may prevent prediction of the resection status after debulking surgery in patients with advanced ovarian cancer

Author

Heitz, F, Kommoss, S, Tourani, R, Grandelis, A, Uppendahl, L, Aliferis, C, Burges, A, Wang, C, Canzler, U, Wang, J, Belau, A, Prader, S, Hanker, L, Ma, S, Ataseven, B, Hilpert, F, Schneider, S, Sehouli, J, Kimmig, R, Kurzeder, C, Schmalfeldt, B, Braicu, I, Harter, P, Dowdy, S C, Winterhoff, B JN, Pfisterer, J, and du Bois, A

Published
2019
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8. Maintenance Therapy with an Aromatase Inhibitor in epithelial Ovarian Cancer (MATAO/LOGOS): study protocol of a randomized double-blinded placebo-controlled multi-center Phase III Trial

Author

McLaughlin, PMJ, additional, Klar, M, additional, Heitz, F, additional, Zwimpfer, TA, additional, Dutilh, G, additional, Vetter, M, additional, Marth, C, additional, du Bois, A, additional, Schade-Brittinger, C, additional, Reuss, A, additional, Bommer, C, additional, Kurzeder, C, additional, and Heinzelmann, V, additional

Published
2022
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12. LBA18 Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with or without brain metastases (BM): DESTINYBreast-12 primary results

Author

Lin, N., Ciruelos, E.M., Jerusalem, G., Mueller, V., Niikura, N., Viale, G., Bartsch, R., Kurzeder, C., Connolly, R., Baron-Hay, S.E., Gion Cortes, M., Guarneri, V., Bianchini, G., Wildiers, H., Escrivá-de-Romaní, S., Prahladan, M., Bridge, H., Verma, S., and Harbeck, N.

Published
2024
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15. A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy

Author

Baumann, K.H., du Bois, A., Meier, W., Rau, J., Wimberger, P., Sehouli, J., Kurzeder, C., Hilpert, F., Hasenburg, A., Canzler, U., Hanker, L.C., Hillemanns, P., Richter, B., Wollschlaeger, K., Dewitz, T., Bauerschlag, D., and Wagner, U.

Published
2012
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16. Oncoplastic breast consortium recommendations for mastectomy and whole breast reconstruction in the setting of post-mastectomy radiation therapy

Author

Weber, W.P. Shaw, J. Pusic, A. Wyld, L. Morrow, M. King, T. Mátrai, Z. Heil, J. Fitzal, F. Potter, S. Rubio, I.T. Cardoso, M.-J. Gentilini, O.D. Galimberti, V. Sacchini, V. Rutgers, E.J.T. Benson, J. Allweis, T.M. Haug, M. Paulinelli, R.R. Kovacs, T. Harder, Y. Gulluoglu, B.M. Gonzalez, E. Faridi, A. Elder, E. Dubsky, P. Blohmer, J.-U. Bjelic-Radisic, V. Barry, M. Hay, S.D. Bowles, K. French, J. Reitsamer, R. Koller, R. Schrenk, P. Kauer-Dorner, D. Biazus, J. Brenelli, F. Letzkus, J. Saccilotto, R. Joukainen, S. Kauhanen, S. Karhunen-Enckell, U. Hoffmann, J. Kneser, U. Kühn, T. Kontos, M. Tampaki, E.C. Carmon, M. Hadar, T. Catanuto, G. Garcia-Etienne, C.A. Koppert, L. Gouveia, P.F. Lagergren, J. Svensjö, T. Maggi, N. Kappos, E.A. Schwab, F.D. Castrezana, L. Steffens, D. Krol, J. Tausch, C. Günthert, A. Knauer, M. Katapodi, M.C. Bucher, S. Hauser, N. Kurzeder, C. Mucklow, R. Tsoutsou, P.G. Sezer, A. Çakmak, G.K. Karanlik, H. Fairbrother, P. Romics, L. Montagna, G. Urban, C. Walker, M. Formenti, S.C. Gruber, G. Zimmermann, F. Zwahlen, D.R. Kuemmel, S. El-Tamer, M. Vrancken Peeters, M.J. Kaidar-Person, O. Gnant, M. Poortmans, P. de Boniface, J.

Abstract

Aim: Demand for nipple- and skin- sparing mastectomy (NSM/SSM) with immediate breast reconstruction (BR) has increased at the same time as indications for post-mastectomy radiation therapy (PMRT) have broadened. The aim of the Oncoplastic Breast Consortium initiative was to address relevant questions arising with this clinically challenging scenario. Methods: A large global panel of oncologic, oncoplastic and reconstructive breast surgeons, patient advocates and radiation oncologists developed recommendations for clinical practice in an iterative process based on the principles of Delphi methodology. Results: The panel agreed that surgical technique for NSM/SSM should not be formally modified when PMRT is planned with preference for autologous over implant-based BR due to lower risk of long-term complications and support for immediate and delayed-immediate reconstructive approaches. Nevertheless, it was strongly believed that PMRT is not an absolute contraindication for implant-based or other types of BR, but no specific recommendations regarding implant positioning, use of mesh or timing were made due to absence of high-quality evidence. The panel endorsed use of patient-reported outcomes in clinical practice. It was acknowledged that the shape and size of reconstructed breasts can hinder radiotherapy planning and attention to details of PMRT techniques is important in determining aesthetic outcomes after immediate BR. Conclusions: The panel endorsed the need for prospective, ideally randomised phase III studies and for surgical and radiation oncology teams to work together for determination of optimal sequencing and techniques for PMRT for each patient in the context of BR © 2022 The Authors

Published
2022

17. PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel, and CMF versus a standard-dosed epirubicin–cyclophosphamide followed by paclitaxel with or without darbepoetin alfa in primary breast cancer—outcome on prognosis

Author

Untch, M., von Minckwitz, G., Konecny, G.E., Conrad, U., Fett, W., Kurzeder, C., Lück, H.-J., Stickeler, E., Urbaczyk, H., Liedtke, B., Beckmann, M.W., Salat, C., Harbeck, N., Müller, V., Schmidt, M., Hasmüller, S., Lenhard, M., Nekljudova, V., Lebeau, A., Loibl, S., and Fasching, P.A.

Published
2011
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18. PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel and CMF versus a standard-dosed epirubicin/cyclophosphamide followed by paclitaxel ± darbepoetin alfa in primary breast cancer—results at the time of surgery

Author

Untch, M., Fasching, P.A., Konecny, G.E., von Koch, F., Conrad, U., Fett, W., Kurzeder, C., Lück, H.-J., Stickeler, E., Urbaczyk, H., Liedtke, B., Salat, C., Harbeck, N., Müller, V., Schmidt, M., Hasmüller, S., Lenhard, M., Schuster, T., Nekljudova, V., Lebeau, A., Loibl, S., and von Minckwitz, G.

Published
2011
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20. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer

Author

Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Lorusso D., Hilpert F., Gonzalez Martin A., Rau J., Ottevanger P., Greimel E., Luck H. -J., Selle F., Colombo N., Kroep J. R., Mirza M. R., Berger R., Pardo B., Grischke E. -M., Berton-Rigaud D., Martinez-Garcia J., Vergote I., Redondo A., Cardona A., Bastiere-Truchot L., Du Bois A., Kurzeder C., Del Campo J. M., Bover I., Barretina-Ginesta P., Ortega E., Garcia Y., Romero I., Poveda A., Herrero A., Vidal L., Rubio M. J., Romeo M., Mendiola C., Arranz J. A., Santaballa A., Gomez De Liano A., Marme F., Mahner S., Canzler U., Zorr A., Gropp-Meier M., Cayir P., Schmalfeldt B., Rautenberg B., Meier W., Belau A., Gerber B., Rein D., Jackisch C., Janni W., Heubner M., Pautier P., Fabbro M., Floquet A., You B., Favier L., Joly F., Weber B., Hardy-Bessard A. -C., Gadducci A., Tognon G., DeCensi A., Savarese A., PISANO, CARLO MARIA, Sonke G., Reyners A., Kristensen G., Bjurberg M., Rosenberg P., Marth C., Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Lorusso D., Hilpert F., Gonzalez Martin A., Rau J., Ottevanger P., Greimel E., Luck H. -J., Selle F., Colombo N., Kroep J. R., Mirza M. R., Berger R., Pardo B., Grischke E. -M., Berton-Rigaud D., Martinez-Garcia J., Vergote I., Redondo A., Cardona A., Bastiere-Truchot L., Du Bois A., Kurzeder C., Del Campo J. M., Bover I., Barretina-Ginesta P., Ortega E., Garcia Y., Romero I., Poveda A., Herrero A., Vidal L., Rubio M. J., Romeo M., Mendiola C., Arranz J. A., Santaballa A., Gomez De Liano A., Marme F., Mahner S., Canzler U., Zorr A., Gropp-Meier M., Cayir P., Schmalfeldt B., Rautenberg B., Meier W., Belau A., Gerber B., Rein D., Jackisch C., Janni W., Heubner M., Pautier P., Fabbro M., Floquet A., You B., Favier L., Joly F., Weber B., Hardy-Bessard A. -C., Gadducci A., Tognon G., DeCensi A., Savarese A., PISANO, CARLO MARIA, Sonke G., Reyners A., Kristensen G., Bjurberg M., Rosenberg P., and Marth C.

Abstract

Introduction The PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes. Patients and methods Eligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression. Results At database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms. Discussion Consistent with

Published
2019

24. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

Author

Philipp, H, Jalid, S, Ignace, V, Gwenael, F, Alexander, R, Werner, M, Stefano, G, Berit J, M, Frederic, S, Frédéric, G, Christophe, P, Fabrice, L, Rongyu, Z, Elisabeth, A, Jae-Weon, K, Jordi, P, Francesco, R, Gunnar, K, Jean-Marc, C, Peter, H, Pernille, J, Annette, H, Sadaf, G, Mansoor R, M, Bente, L, Ana, S, Adeola, O, Felix, H, Andreas, D, Buchholz, S, Burges, A, Canzler, U, Denschlag, D, El-Balat, A, Emons, G, Felberbaum, R, de Gregorio, N, Gropp-Meier, M, Hanf, V, Hanker, L, Hils, R, Kurzeder, C, Lampe, B, Mustea, A, Schmidt, M, Schutz, R, Weigel, M, Weiser, S, Zorr, A, Marth, C, Petru, E, Scholl, T, Beltran, M, Bover, I, Gomez di Laino, A, Lainez, N, Martinez, S, Poveda Velasco, A, Romeo, M, Crouet, H, de Gournay, E, Deplanque, G, Follana, P, Floquet, A, Lanvin, D, Leveque, J, Pujade-Lauraine, E, Raban, N, Resch, B, M Savoye, A, Aletti, G, Giorda, G, Landoni, F, Scaffa, C, Abu, J, Alexander-Sefre, F, Barton, D, Butler-Manuel, S, Clayton, R, Crawford, R, Duncan, T, El-Ghobashy, A, Fotopoulou, C, Hall, M, Intrivici, C, Lawrence, A, Luesley, D, Naik, R, Nordin, A, Tidy, J, Fokdahl, L, Hofsjö, A, Kjolhede, P, Eyjolfsdottir, B, Y Dai, Z, Zhang, P, Aminossadati, B, Hahmann, M, Nasemann, C, Yahiaoui, S, Wittenberg, M, Schade-Brittinger, C, Elser, G, Reddig, D, Kuncke, M, Polleis, S, Mattukat, Y, Riha, A, Berger, R, de Roover, J, Kaur, B, Crook, J, Nepote, F, Votan, B, Andriamamonjy, M, Bryce, J, Ristinge, S, Harter, Philipp, Sehouli, Jalid, Vergote, Ignace, Ferron, Gwenael, Reuss, Alexander, Meier, Werner, Greggi, Stefano, Mosgard, Berit J, Selle, Frederic, Guyon, Frédéric, Pomel, Christophe, Lécuru, Fabrice, Zang, Rongyu, Avall-Lundqvist, Elisabeth, Kim, Jae-Weon, Ponce, Jordi, Raspagliesi, Francesco, Kristensen, Gunnar, Classe, Jean-Marc, Hillemanns, Peter, Jensen, Pernille, Hasenburg, Annette, Ghaem-Maghami, Sadaf, Mirza, Mansoor R, Lund, Bente, Reinthaller, Alexander, Santaballa, Ana, Olaitan, Adeola, Hilpert, Felix, du Bois, Andreas, S Buchholz, A Burges, U Canzler, D Denschlag, A El-Balat, G Emons, R Felberbaum, N de Gregorio, M Gropp-Meier, V Hanf, L Hanker, R Hils, C Kurzeder, B Lampe, A Mustea, M Schmidt, R Schutz, M Weigel, S Weiser, A Zorr, C Marth, E Petru, T Scholl, M Beltran, I Bover, A Gomez di Laino, N Lainez, S Martinez, A Poveda Velasco, M Romeo, H Crouet, E de Gournay, G Deplanque, P Follana, A Floquet, D Lanvin, J Leveque, E Pujade-Lauraine, N Raban, B Resch, A M Savoye, G Aletti, G Giorda, F Landoni, C Scaffa, J Abu, F Alexander-Sefre, D Barton, S Butler-Manuel, R Clayton, R Crawford, T Duncan, A El-Ghobashy, C Fotopoulou, M Hall, C Intrivici, A Lawrence, D Luesley, R Naik, A Nordin, J Tidy, L Fokdahl, A Hofsjö, P Kjolhede, B Eyjolfsdottir, Z Y Dai, P Zhang, B Aminossadati, M Hahmann, C Nasemann, S Yahiaoui, M Wittenberg, C Schade-Brittinger, G Elser, D Reddig, M Kuncke, S Polleis, Y Mattukat, A Riha, R Berger, J de Roover, B Kaur, J Crook, F Nepote, B Votan, M Andriamamonjy, J Bryce, S Ristinge, Philipp, H, Jalid, S, Ignace, V, Gwenael, F, Alexander, R, Werner, M, Stefano, G, Berit J, M, Frederic, S, Frédéric, G, Christophe, P, Fabrice, L, Rongyu, Z, Elisabeth, A, Jae-Weon, K, Jordi, P, Francesco, R, Gunnar, K, Jean-Marc, C, Peter, H, Pernille, J, Annette, H, Sadaf, G, Mansoor R, M, Bente, L, Ana, S, Adeola, O, Felix, H, Andreas, D, Buchholz, S, Burges, A, Canzler, U, Denschlag, D, El-Balat, A, Emons, G, Felberbaum, R, de Gregorio, N, Gropp-Meier, M, Hanf, V, Hanker, L, Hils, R, Kurzeder, C, Lampe, B, Mustea, A, Schmidt, M, Schutz, R, Weigel, M, Weiser, S, Zorr, A, Marth, C, Petru, E, Scholl, T, Beltran, M, Bover, I, Gomez di Laino, A, Lainez, N, Martinez, S, Poveda Velasco, A, Romeo, M, Crouet, H, de Gournay, E, Deplanque, G, Follana, P, Floquet, A, Lanvin, D, Leveque, J, Pujade-Lauraine, E, Raban, N, Resch, B, M Savoye, A, Aletti, G, Giorda, G, Landoni, F, Scaffa, C, Abu, J, Alexander-Sefre, F, Barton, D, Butler-Manuel, S, Clayton, R, Crawford, R, Duncan, T, El-Ghobashy, A, Fotopoulou, C, Hall, M, Intrivici, C, Lawrence, A, Luesley, D, Naik, R, Nordin, A, Tidy, J, Fokdahl, L, Hofsjö, A, Kjolhede, P, Eyjolfsdottir, B, Y Dai, Z, Zhang, P, Aminossadati, B, Hahmann, M, Nasemann, C, Yahiaoui, S, Wittenberg, M, Schade-Brittinger, C, Elser, G, Reddig, D, Kuncke, M, Polleis, S, Mattukat, Y, Riha, A, Berger, R, de Roover, J, Kaur, B, Crook, J, Nepote, F, Votan, B, Andriamamonjy, M, Bryce, J, Ristinge, S, Harter, Philipp, Sehouli, Jalid, Vergote, Ignace, Ferron, Gwenael, Reuss, Alexander, Meier, Werner, Greggi, Stefano, Mosgard, Berit J, Selle, Frederic, Guyon, Frédéric, Pomel, Christophe, Lécuru, Fabrice, Zang, Rongyu, Avall-Lundqvist, Elisabeth, Kim, Jae-Weon, Ponce, Jordi, Raspagliesi, Francesco, Kristensen, Gunnar, Classe, Jean-Marc, Hillemanns, Peter, Jensen, Pernille, Hasenburg, Annette, Ghaem-Maghami, Sadaf, Mirza, Mansoor R, Lund, Bente, Reinthaller, Alexander, Santaballa, Ana, Olaitan, Adeola, Hilpert, Felix, du Bois, Andreas, S Buchholz, A Burges, U Canzler, D Denschlag, A El-Balat, G Emons, R Felberbaum, N de Gregorio, M Gropp-Meier, V Hanf, L Hanker, R Hils, C Kurzeder, B Lampe, A Mustea, M Schmidt, R Schutz, M Weigel, S Weiser, A Zorr, C Marth, E Petru, T Scholl, M Beltran, I Bover, A Gomez di Laino, N Lainez, S Martinez, A Poveda Velasco, M Romeo, H Crouet, E de Gournay, G Deplanque, P Follana, A Floquet, D Lanvin, J Leveque, E Pujade-Lauraine, N Raban, B Resch, A M Savoye, G Aletti, G Giorda, F Landoni, C Scaffa, J Abu, F Alexander-Sefre, D Barton, S Butler-Manuel, R Clayton, R Crawford, T Duncan, A El-Ghobashy, C Fotopoulou, M Hall, C Intrivici, A Lawrence, D Luesley, R Naik, A Nordin, J Tidy, L Fokdahl, A Hofsjö, P Kjolhede, B Eyjolfsdottir, Z Y Dai, P Zhang, B Aminossadati, M Hahmann, C Nasemann, S Yahiaoui, M Wittenberg, C Schade-Brittinger, G Elser, D Reddig, M Kuncke, S Polleis, Y Mattukat, A Riha, R Berger, J de Roover, B Kaur, J Crook, F Nepote, B Votan, M Andriamamonjy, J Bryce, and S Ristinge

Abstract

BACKGROUND Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear. METHODS We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive platinum-based chemotherapy or to receive platinumbased chemotherapy alone. Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery. A positive AGO score is used to identify patients in whom a complete resection might be achieved. The primary end point was overall survival. We also assessed quality of life and prognostic factors for survival. RESULTS A total of 407 patients underwent randomization: 206 were assigned to cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone. A complete resection was achieved in 75.5% of the patients in the surgery group who underwent the procedure. The median overall survival was 53.7 months in the surgery group and 46.0 months in the no-surgery group (hazard ratio for death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.02). Patients with a complete resection had the most favorable outcome, with a median overall survival of 61.9 months. A benefit from surgery was seen in all analyses in subgroups according to prognostic factors. Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery. CONCLUSIONS In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overa

Published
2021

32. Influence of the postoperative residual tumor on the outcome of therapy with pazopanib in ovarian cancer (OC): A subgroup analysis of an international intergroup trial (AGO-OVAR16): ID 231

Author

Gropp-Meier, M., Schmalfeld, B., Belau, A., Rau, J., Richter, B., Emons, G., Hillemanns, P., Lück, H.-J., Burges, A., Fehm, T., Harter, P., Wimberger, P., Baumann, K., Kurzeder, C., Canzler, U., Meier, W., Hanker, L. C., Mahner, S., Kosse, J., Sehouli, J., Sütterlin, M., Zorr, A., and du Bois, A.

Published
2014

34. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer

Author

Lorusso, D., Hilpert, F., Martin, A.G., Rau, J., Ottevanger, P., Greimel, E., Luck, H.J., Selle, F., Colombo, N., Kroep, J.R., Mirza, M.R., Berger, R., Pardo, B., Grischke, E.M., Berton-Rigaud, D., Martinez-Garcia, J., Vergote, I., Redondo, A., Cardona, A., Bastiere-Truchot, L., Bois, A. du, Kurzeder, C., Campo, J.M. del, Bover, I., Barretina-Ginesta, P., Ortega, E., Garcia, Y., Romero, I., Poveda, A., Herrero, A., Vidal, L., Rubio, M.J., Romeo, M., Mendiola, C., Arranz, J.A., Santaballa, A., Liano, A.G. de, Marme, F., Mahner, S., Canzler, U., Zorr, A., Gropp-Meier, M., Cayir, P., Schmalfeldt, B., Rautenberg, B., Meier, W., Belau, A., Gerber, B., Rein, D., Jackisch, C., Janni, W., Heubner, M., Pautier, P., Fabbro, M., Floquet, A., You, B., Favier, L., Joly, F., Weber, B., Hardy-Bessard, A.C., Gadducci, A., Tognon, G., DeCensi, A., Savarese, A., Pisano, C., Sonke, G., Reyners, A., Kristensen, G., Bjurberg, M., Rosenberg, P., Marth, C., PENELOPE Trial Investigators, Lorusso, D, Hilpert, F, Gonzalez Martin, A, Rau, J, Ottevanger, P, Greimel, E, Luck, H, Selle, F, Colombo, N, Kroep, J, Mirza, M, Berger, R, Pardo, B, Grischke, E, Berton-Rigaud, D, Martinez-Garcia, J, Vergote, I, Redondo, A, Cardona, A, Bastiere-Truchot, L, Du Bois, A, Kurzeder, C, Del Campo, J, Bover, I, Barretina-Ginesta, P, Ortega, E, Garcia, Y, Romero, I, Poveda, A, Herrero, A, Vidal, L, Rubio, M, Romeo, M, Mendiola, C, Arranz, J, Santaballa, A, Gomez De Liano, A, Marme, F, Mahner, S, Canzler, U, Zorr, A, Gropp-Meier, M, Cayir, P, Schmalfeldt, B, Rautenberg, B, Meier, W, Belau, A, Gerber, B, Rein, D, Jackisch, C, Janni, W, Heubner, M, Pautier, P, Fabbro, M, Floquet, A, You, B, Favier, L, Joly, F, Weber, B, Hardy-Bessard, A, Gadducci, A, Tognon, G, Decensi, A, Savarese, A, Pisano, C, Sonke, G, Reyners, A, Kristensen, G, Bjurberg, M, Rosenberg, P, Marth, C, Targeted Gynaecologic Oncology (TARGON), and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
Oncology, Receptor, ErbB-3, medicine.medical_treatment, Carcinoma, Ovarian Epithelial, Deoxycytidine, 0302 clinical medicine, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Aged, 80 and over, Ovarian Neoplasms, 0303 health sciences, education.field_of_study, Obstetrics and Gynecology, Middle Aged, Progression-Free Survival, ovarian cancer, patient-reported outcomes, 030220 oncology & carcinogenesis, Female, Pertuzumab, medicine.drug, Adult, medicine.medical_specialty, Paclitaxel, overall survival, Population, Placebo, patient-reported outcome, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Double-Blind Method, HER3, pertuzumab, Internal medicine, medicine, Humans, Patient Reported Outcome Measures, RNA, Messenger, education, 030304 developmental biology, Aged, Chemotherapy, business.industry, medicine.disease, Gemcitabine, Drug Resistance, Neoplasm, Topotecan, business, Ovarian cancer
Abstract

IntroductionThe PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes.Patients and methodsEligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression.ResultsAt database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms.DiscussionConsistent with the primary results, adding pertuzumab to chemotherapy for low tumor HER3 mRNA-expressing platinum-resistant ovarian cancer did not improve overall survival, but showed trends in some cohorts. Except for increased diarrhea symptoms, pertuzumab had no impact on patient-reported outcomes.ClinicalTrials.gov:ClinicalTrials.gov:NCT01684878.

Published
2019

42. A prognostic nomogram to predict overall survival in patients with platinum-sensitive recurrent ovarian cancer

Author

Lee, C. K., Simes, R. J., Brown, C., Gebski, V., Pfisterer, J., Swart, A.-M., Berton-Rigaud, D., Plante, M., Skeie-Jensen, T., Vergote, I., Schauer, C., Pisano, C., Parma, G., Baumann, K., Ledermann, J. A., Pujade-Lauraine, E., Bentley, J., Kristensen, G., Belau, A., Nankivell, M., Canzler, U., Lord, S. J., Kurzeder, C., and Friedlander, M.

Published
2013
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45. 126TiP Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (SAKK 23/16 / IBCSG 57-18 / ABCSG-53 / GBG 101 - TAXIS): A multicenter randomized phase III trial

Author

Weber, W.P., primary, Henke, G., additional, Ribi, K., additional, Hayoz, S., additional, Seiler, S., additional, Maddox, C., additional, Ruhstaller, T., additional, Zwahlen, D., additional, Muenst, S., additional, Ackerknecht, M., additional, Fitzal, F., additional, Matrai, Z.T., additional, Újhelyi, M., additional, Kurzeder, C., additional, Lelièvre, L., additional, Tausch, C.J., additional, Heil, J., additional, and Knauer, M., additional

Published
2020
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