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3. 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

4. Impact of sentinel node biopsy on long-term quality of life in breast cancer patients

Author

De Gournay, E, primary, Guyomard, A, additional, Coutant, C, additional, Boulet, S, additional, Arveux, P, additional, Causeret, S, additional, Gouy, S, additional, Padeano, M-M, additional, Loustalot, C, additional, Sauzedde, J-M, additional, Smail, M, additional, Combier, J-P, additional, Chevillote, P, additional, Rosburger, C, additional, Bonnetain, F, additional, Fraisse, J, additional, and S Dabakuyo-Yonli, T, additional

Published
2013
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6. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

Author

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, and Ristinge, S

Subjects
EPITHELIAL OVARIAN, Oncology, medicine.medical_specialty, BEVACIZUMAB, MULTICENTER, Antineoplastic Agents, PACLITAXEL, Systemic therapy, law.invention, Antineoplastic Agent, Randomized controlled trial, law, Internal medicine, Humans, Medicine, RECURRENT, Proportional Hazards Models, Aged, Ovarian Neoplasms, SECONDARY CYTOREDUCTION, business.industry, Ovarian Neoplasm, Antineoplastic Agents/therapeutic use, Obstetrics and Gynecology, Ovarian Neoplasms/drug therapy, Cytoreduction Surgical Procedures, General Medicine, CHEMOTHERAPY, Middle Aged, OPEN-LABEL, medicine.disease, Survival Analysis, Combined Modality Therapy, Neoplasm Recurrence, Local/drug therapy, Recurrent Ovarian Cancer, Proportional Hazards Model, Quality of Life, Female, Survival Analysi, Neoplasm Recurrence, Local, business, Cytoreductive surgery, Ovarian cancer, Human
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 platinum-based 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 overall survival than chemotherapy alone. (Funded by the AGO Study Group and others; DESKTOP III ClinicalTrials.gov number, NCT01166737.).

Published
2021
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7. [Psychological impact of the announcement of an abnormal cervical smear: How to improve patient experience and information? COLANX: a multicenter study in Seine-Maritime].

Author

Jorda P, Hullot J, Crouzet A, Poteau A, Carrilho J, De Gournay E, and Georgescu D

Subjects
Humans, Female, Vaginal Smears, Quality of Life, Cervix Uteri pathology, Patient Outcome Assessment, Uterine Cervical Neoplasms pathology
Abstract

Introduction: When an anomaly in the screening by cervical smear or by the HPV-HR test is detected, the women are called for a colposcopy. Waiting for colposcopy is often an anxiety-provoking situation for women, probably linked to a widespread ignorance of the value of screening and the pathophysiology of HPV infection., Methods: The COLANX was a multicentric study, in Seine-Maritime, conducted with 8 colposcopist practitioners. Self-questionnaires were distributed to volunteer women, summoned for a first abnormal smear result, at the exit of colposcopy and filled out immediately on site. This questionnaire evaluated: the psychological impact of the announcement of the abnormal cervico-uterine smear, its impact on the sexual quality of life, the epidemiological characteristics of the population studied, the modalities of the announcement made of the abnormal result, the satisfaction of the women and their desire for additional information. 131 questionnaires were included, from June 1, 2020 to January 18, 2021., Results: 61.5% of responding women presented proven psychological distress, as evidenced by a GHQ-12 score ≥ 2. The state of psychological distress was significantly different depending on the time left by the practitioner between the announcement of the abnormal cytology result and the colposcopy appointment. The GHQ-12 score was significantly different according to the initial classification of the cervico-uterine smear, high in case of suspicion of high-grade lesions in particular. 36.3% of patients had a significant deterioration in their sexual quality of life, demonstrated by an ASEX score ≥ 18. The women were statistically more satisfied when the announcement of their abnormal screening result had been made by telephone or during a consultation, rather than by mail, but no significant difference was found on the presence or absence of distress psychological according to this mode of announcement. 52.3% of the women in this study expressed a request for additional information support, preferably written support (for 89.4% of these women), to be delivered when the abnormal screening was announced (for 76, 5% of these women)., Discussion: The main results of the COLANX study are consistent with those of the literature, in particular concerning the negative psychological impact in the announcement of an abnormal smear result., Conclusion: The new methods of organized screening will increase the use of colposcopy for many women. There is a significant impact on their psyche and their intimate life. The issuance of additional information during this announcement would probably reduce this anxiety., (Copyright © 2023. Published by Elsevier Masson SAS.)

Published
2023
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8. Non-sentinel lymph node metastasis prediction in breast cancer with metastatic sentinel lymph node: impact of molecular subtypes classification.

Author

Reyal F, Belichard C, Rouzier R, de Gournay E, Senechal C, Bidard FC, Pierga JY, Cottu P, Lerebours F, Kirova Y, Feron JG, Fourchotte V, Vincent-Salomon A, Guinebretiere JM, Sigal-Zafrani B, Sastre-Garau X, De Rycke Y, and Coutant C

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Middle Aged, Receptor, ErbB-2 genetics, Breast Neoplasms metabolism, Lymphatic Metastasis, Receptor, ErbB-2 metabolism, Sentinel Lymph Node Biopsy
Abstract

Introduction: To decipher the interaction between the molecular subtype classification and the probability of a non-sentinel node metastasis in breast cancer patients with a metastatic sentinel lymph-node, we applied two validated predictors (Tenon Score and MSKCC Nomogram) on two large independent datasets., Materials and Methods: Our datasets consisted of 656 and 574 early-stage breast cancer patients with a metastatic sentinel lymph-node biopsy treated at first by surgery. We applied both predictors on the whole dataset and on each molecular immune-phenotype subgroups. The performances of the two predictors were analyzed in terms of discrimination and calibration. Probability of non-sentinel lymph node metastasis was detailed for each molecular subtype., Results: Similar results were obtained with both predictors. We showed that the performance in terms of discrimination was as expected in ER Positive HER2 negative subgroup in both datasets (MSKCC AUC Dataset 1 = 0.73 [0.69-0.78], MSKCC AUC Dataset 2 = 0.71 (0.65-0.76), Tenon Score AUC Dataset 1 = 0.7 (0.65-0.75), Tenon Score AUC Dataset 2 = 0.72 (0.66-0.76)). Probability of non-sentinel node metastatic involvement was slightly under-estimated. Contradictory results were obtained in other subgroups (ER negative HER2 negative, HER2 positive subgroups) in both datasets probably due to a small sample size issue. We showed that merging the two datasets shifted the performance close to the ER positive HER2 negative subgroup., Discussion: We showed that validated predictors like the Tenon Score or the MSKCC nomogram built on heterogeneous population of breast cancer performed equally on the different subgroups analyzed. Our present study re-enforce the idea that performing subgroup analysis of such predictors within less than 200 samples subgroup is at major risk of misleading conclusions.

Published
2012
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