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1. Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II

Author

Oonk, M.H., Slomovitz, B., Baldwin, P.J., Doorn, H.C. van, Velden, J. van der, Hullu, J.A. de, Gaarenstroom, K.N., Slangen, B.F.M., Vergote, I., Brännström, M., Dorst, E.B.L. van, Driel, W.J. van, Hermans, R.H., Nunns, D., Widschwendter, M., Nugent, D., Holland, C.M., Sharma, A., DiSilvestro, P.A., Mannel, R., Boll, D., Cibula, D., Covens, A., Provencher, D., Runnebaum, I.B., Luesley, D., Ellis, P., Duncan, T.J., Tjiong, M.Y., Cruickshank, D.J., Kjølhede, P., Levenback, C.F., Bouda, J., Kieser, K.E., Palle, C., Spirtos, N.M., O'Malley, D.M., Leitao, M.M., Geller, M.A., Dhar, K., Asher, V., Tamussino, K., Tobias, D.H., Borgfeldt, C., Lea, J.S., Bailey, J., Lood, M., Eyjolfsdottir, B., Attard-Montalto, S., Tewari, K.S., Manchanda, R., Jensen, P.T., Persson, P., Le, L, Putter, H., Bock, G.H. de, Monk, B.J., Creutzberg, C.L., Zee, A.G. van der, Oonk, M.H., Slomovitz, B., Baldwin, P.J., Doorn, H.C. van, Velden, J. van der, Hullu, J.A. de, Gaarenstroom, K.N., Slangen, B.F.M., Vergote, I., Brännström, M., Dorst, E.B.L. van, Driel, W.J. van, Hermans, R.H., Nunns, D., Widschwendter, M., Nugent, D., Holland, C.M., Sharma, A., DiSilvestro, P.A., Mannel, R., Boll, D., Cibula, D., Covens, A., Provencher, D., Runnebaum, I.B., Luesley, D., Ellis, P., Duncan, T.J., Tjiong, M.Y., Cruickshank, D.J., Kjølhede, P., Levenback, C.F., Bouda, J., Kieser, K.E., Palle, C., Spirtos, N.M., O'Malley, D.M., Leitao, M.M., Geller, M.A., Dhar, K., Asher, V., Tamussino, K., Tobias, D.H., Borgfeldt, C., Lea, J.S., Bailey, J., Lood, M., Eyjolfsdottir, B., Attard-Montalto, S., Tewari, K.S., Manchanda, R., Jensen, P.T., Persson, P., Le, L, Putter, H., Bock, G.H. de, Monk, B.J., Creutzberg, C.L., and Zee, A.G. van der

Abstract

Item does not contain fulltext, PURPOSE: The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS: GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS: From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION: Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macr

Published
2021

2. Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II

Author

Oonk, M.H., Slomovitz, B., Baldwin, P.J., Doorn, H.C. van, Velden, J. van der, Hullu, J.A. de, Gaarenstroom, K.N., Slangen, B.F.M., Vergote, I., Brännström, M., Dorst, E.B.L. van, Driel, W.J. van, Hermans, R.H., Nunns, D., Widschwendter, M., Nugent, D., Holland, C.M., Sharma, A., DiSilvestro, P.A., Mannel, R., Boll, D., Cibula, D., Covens, A., Provencher, D., Runnebaum, I.B., Luesley, D., Ellis, P., Duncan, T.J., Tjiong, M.Y., Cruickshank, D.J., Kjølhede, P., Levenback, C.F., Bouda, J., Kieser, K.E., Palle, C., Spirtos, N.M., O'Malley, D.M., Leitao, M.M., Geller, M.A., Dhar, K., Asher, V., Tamussino, K., Tobias, D.H., Borgfeldt, C., Lea, J.S., Bailey, J., Lood, M., Eyjolfsdottir, B., Attard-Montalto, S., Tewari, K.S., Manchanda, R., Jensen, P.T., Persson, P., Le, L, Putter, H., Bock, G.H. de, Monk, B.J., Creutzberg, C.L., Zee, A.G. van der, Oonk, M.H., Slomovitz, B., Baldwin, P.J., Doorn, H.C. van, Velden, J. van der, Hullu, J.A. de, Gaarenstroom, K.N., Slangen, B.F.M., Vergote, I., Brännström, M., Dorst, E.B.L. van, Driel, W.J. van, Hermans, R.H., Nunns, D., Widschwendter, M., Nugent, D., Holland, C.M., Sharma, A., DiSilvestro, P.A., Mannel, R., Boll, D., Cibula, D., Covens, A., Provencher, D., Runnebaum, I.B., Luesley, D., Ellis, P., Duncan, T.J., Tjiong, M.Y., Cruickshank, D.J., Kjølhede, P., Levenback, C.F., Bouda, J., Kieser, K.E., Palle, C., Spirtos, N.M., O'Malley, D.M., Leitao, M.M., Geller, M.A., Dhar, K., Asher, V., Tamussino, K., Tobias, D.H., Borgfeldt, C., Lea, J.S., Bailey, J., Lood, M., Eyjolfsdottir, B., Attard-Montalto, S., Tewari, K.S., Manchanda, R., Jensen, P.T., Persson, P., Le, L, Putter, H., Bock, G.H. de, Monk, B.J., Creutzberg, C.L., and Zee, A.G. van der

Abstract

Contains fulltext : 244685.pdf (Publisher’s version ) (Open Access), PURPOSE: The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS: GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS: From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION: Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macr

Published
2021

3. Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II

Author

Oonk, M.H., Slomovitz, B., Baldwin, P.J., Doorn, H.C. van, Velden, J. van der, Hullu, J.A. de, Gaarenstroom, K.N., Slangen, B.F.M., Vergote, I., Brännström, M., Dorst, E.B.L. van, Driel, W.J. van, Hermans, R.H., Nunns, D., Widschwendter, M., Nugent, D., Holland, C.M., Sharma, A., DiSilvestro, P.A., Mannel, R., Boll, D., Cibula, D., Covens, A., Provencher, D., Runnebaum, I.B., Luesley, D., Ellis, P., Duncan, T.J., Tjiong, M.Y., Cruickshank, D.J., Kjølhede, P., Levenback, C.F., Bouda, J., Kieser, K.E., Palle, C., Spirtos, N.M., O'Malley, D.M., Leitao, M.M., Geller, M.A., Dhar, K., Asher, V., Tamussino, K., Tobias, D.H., Borgfeldt, C., Lea, J.S., Bailey, J., Lood, M., Eyjolfsdottir, B., Attard-Montalto, S., Tewari, K.S., Manchanda, R., Jensen, P.T., Persson, P., Le, L, Putter, H., Bock, G.H. de, Monk, B.J., Creutzberg, C.L., Zee, A.G. van der, Oonk, M.H., Slomovitz, B., Baldwin, P.J., Doorn, H.C. van, Velden, J. van der, Hullu, J.A. de, Gaarenstroom, K.N., Slangen, B.F.M., Vergote, I., Brännström, M., Dorst, E.B.L. van, Driel, W.J. van, Hermans, R.H., Nunns, D., Widschwendter, M., Nugent, D., Holland, C.M., Sharma, A., DiSilvestro, P.A., Mannel, R., Boll, D., Cibula, D., Covens, A., Provencher, D., Runnebaum, I.B., Luesley, D., Ellis, P., Duncan, T.J., Tjiong, M.Y., Cruickshank, D.J., Kjølhede, P., Levenback, C.F., Bouda, J., Kieser, K.E., Palle, C., Spirtos, N.M., O'Malley, D.M., Leitao, M.M., Geller, M.A., Dhar, K., Asher, V., Tamussino, K., Tobias, D.H., Borgfeldt, C., Lea, J.S., Bailey, J., Lood, M., Eyjolfsdottir, B., Attard-Montalto, S., Tewari, K.S., Manchanda, R., Jensen, P.T., Persson, P., Le, L, Putter, H., Bock, G.H. de, Monk, B.J., Creutzberg, C.L., and Zee, A.G. van der

Abstract

Contains fulltext : 244685.pdf (Publisher’s version ) (Open Access), PURPOSE: The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS: GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS: From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION: Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macr

Published
2021

4. 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

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