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1. Clinical research in endometrial cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Author

Creutzberg, C, Kim, J, Eminowicz, G, Allanson, E, Eberst, L, Kim, S, Nout, R, Park, J, Lorusso, D, Mileshkin, L, Ottevanger, P, Brand, A, Mezzanzanica, D, Oza, A, Gebski, V, Pothuri, B, Batley, T, Gordon, C, Mitra, T, White, H, Howitt, B, Matias-Guiu, X, Ray-Coquard, I, Gaffney, D, Small, W, Miller, A, Concin, N, Powell, M, Stuart, G, Bookman, M, Barretina-Ginesta, P, Bennett, K, Berek, J, Berger, R, Bjorge, L, Boere, I, Brennan, D, Bruchim, I, Chang, T, Chavez Blanco, A, Chen, X, Colombo, N, Crosbie, E, Denys, H, Duska, L, Fruehauf, F, Gomez Garcia, E, van Gorp, T, Grimm, C, Guitmann, G, Han, K, Hanker, L, Harano, K, Hasegawa, K, Herrington, C, Ip, P, Joly, F, Khaw, P, Kohn, E, Kristeleit, R, Kroep, J, Leary, A, Lee, J, Lheureux, S, Liu, J, Mackay, H, Mahner, S, Mariani, A, Mcalpine, J, Mikami, Y, Mirza, M, Mukhopadhyay, A, Nagao, S, Ng, J, Nogueira-Rodrigues, A, Novak, Z, O'Donnell, J, Osborne, S, Perez-Fidalgo, J, Romeo Marin, M, Roy Chowdhury, R, Sadozye, A, Safra, T, Scott, C, Sehouli, J, Slomovitz, B, Tan, D, Taylor, A, Valabrega, G, Veneziani, A, Verhoeven, K, Vetter, M, Wampfler, J, Westin, S, Wimberger, P, Zola, P, Creutzberg C. L., Kim J. -W., Eminowicz G., Allanson E., Eberst L., Kim S. I., Nout R. A., Park J. -Y., Lorusso D., Mileshkin L., Ottevanger P. B., Brand A., Mezzanzanica D., Oza A., Gebski V., Pothuri B., Batley T., Gordon C., Mitra T., White H., Howitt B., Matias-Guiu X., Ray-Coquard I., Gaffney D., Small W., Miller A., Concin N., Powell M. A., Stuart G., Bookman M. A., Barretina-Ginesta P., Bennett K., Berek J., Berger R., Bjorge L., Boere I., Brennan D., Bruchim I., Chang T. -C., Chavez Blanco A., Chen X., Colombo N., Crosbie E., Denys H., Duska L., Fruehauf F., Gomez Garcia E. M., van Gorp T., Grimm C., Guitmann G., Han K., Hanker L., Harano K., Hasegawa K., Herrington C. S., Ip P., Joly F., Khaw P., Kohn E., Kristeleit R., Kroep J., Leary A., Lee J. -Y., Lheureux S., Liu J., Mackay H., Mahner S., Mariani A., McAlpine J., Mikami Y., Mirza M. R., Mukhopadhyay A., Nagao S., Ng J., Nogueira-Rodrigues A., Novak Z., O'Donnell J., Osborne S., Perez-Fidalgo J. A., Romeo Marin M., Roy Chowdhury R., Sadozye A., Safra T., Scott C., Sehouli J., Slomovitz B., Tan D., Taylor A., Valabrega G., Veneziani A., Verhoeven K., Vetter M., Wampfler J., Westin S., Wimberger P., Zola P., Creutzberg, C, Kim, J, Eminowicz, G, Allanson, E, Eberst, L, Kim, S, Nout, R, Park, J, Lorusso, D, Mileshkin, L, Ottevanger, P, Brand, A, Mezzanzanica, D, Oza, A, Gebski, V, Pothuri, B, Batley, T, Gordon, C, Mitra, T, White, H, Howitt, B, Matias-Guiu, X, Ray-Coquard, I, Gaffney, D, Small, W, Miller, A, Concin, N, Powell, M, Stuart, G, Bookman, M, Barretina-Ginesta, P, Bennett, K, Berek, J, Berger, R, Bjorge, L, Boere, I, Brennan, D, Bruchim, I, Chang, T, Chavez Blanco, A, Chen, X, Colombo, N, Crosbie, E, Denys, H, Duska, L, Fruehauf, F, Gomez Garcia, E, van Gorp, T, Grimm, C, Guitmann, G, Han, K, Hanker, L, Harano, K, Hasegawa, K, Herrington, C, Ip, P, Joly, F, Khaw, P, Kohn, E, Kristeleit, R, Kroep, J, Leary, A, Lee, J, Lheureux, S, Liu, J, Mackay, H, Mahner, S, Mariani, A, Mcalpine, J, Mikami, Y, Mirza, M, Mukhopadhyay, A, Nagao, S, Ng, J, Nogueira-Rodrigues, A, Novak, Z, O'Donnell, J, Osborne, S, Perez-Fidalgo, J, Romeo Marin, M, Roy Chowdhury, R, Sadozye, A, Safra, T, Scott, C, Sehouli, J, Slomovitz, B, Tan, D, Taylor, A, Valabrega, G, Veneziani, A, Verhoeven, K, Vetter, M, Wampfler, J, Westin, S, Wimberger, P, Zola, P, Creutzberg C. L., Kim J. -W., Eminowicz G., Allanson E., Eberst L., Kim S. I., Nout R. A., Park J. -Y., Lorusso D., Mileshkin L., Ottevanger P. B., Brand A., Mezzanzanica D., Oza A., Gebski V., Pothuri B., Batley T., Gordon C., Mitra T., White H., Howitt B., Matias-Guiu X., Ray-Coquard I., Gaffney D., Small W., Miller A., Concin N., Powell M. A., Stuart G., Bookman M. A., Barretina-Ginesta P., Bennett K., Berek J., Berger R., Bjorge L., Boere I., Brennan D., Bruchim I., Chang T. -C., Chavez Blanco A., Chen X., Colombo N., Crosbie E., Denys H., Duska L., Fruehauf F., Gomez Garcia E. M., van Gorp T., Grimm C., Guitmann G., Han K., Hanker L., Harano K., Hasegawa K., Herrington C. S., Ip P., Joly F., Khaw P., Kohn E., Kristeleit R., Kroep J., Leary A., Lee J. -Y., Lheureux S., Liu J., Mackay H., Mahner S., Mariani A., McAlpine J., Mikami Y., Mirza M. R., Mukhopadhyay A., Nagao S., Ng J., Nogueira-Rodrigues A., Novak Z., O'Donnell J., Osborne S., Perez-Fidalgo J. A., Romeo Marin M., Roy Chowdhury R., Sadozye A., Safra T., Scott C., Sehouli J., Slomovitz B., Tan D., Taylor A., Valabrega G., Veneziani A., Verhoeven K., Vetter M., Wampfler J., Westin S., Wimberger P., and Zola P.

Abstract

The Gynecologic Cancer InterGroup (GCIG) Endometrial Cancer Consensus Conference on Clinical Research (ECCC) was held in Incheon, South Korea, Nov 2–3, 2023. The aims were to develop consensus statements for future trials in endometrial cancer to achieve harmonisation on design elements, select important questions, and identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and finalisation of 18 statements within four topic groups, addressing adjuvant treatment in high-risk disease; treatment for metastatic and recurrent disease; trial designs for rare endometrial cancer subgroups and special circumstances; and specific methodology and adaptation for trials in low-resource settings. In addition, eight areas of unmet need were identified. This was the first GCIG Consensus Conference to include patient advocates and an expert on inclusion, diversity, equity, and access to take part in all aspects of the process and output. Four early-career investigators were also selected for participation, ensuring that they represented different GCIG member groups and regions. Unanimous consensus was obtained for 16 of the 18 statements, with 97% concordance for the remaining two. Using the described methodology from previous Ovarian Cancer Consensus Conferences, this conference did not require even one minority statement. The high acceptance rate following active involvement in the preparation, discussion, and refinement of the statements by all representatives confirmed the consensus progress within a global academic setting, and the expectation that the ECCC will lead to greater harmonisation, actualisation, inclusion, and resolution of unmet needs in clinical research for individuals living with and beyond endometrial cancer worldwide.

Published
2024

4. Demonstration of near-ideal Schottky contacts to Si-doped AlN

Author

Quiñones, C. E., primary, Khachariya, D., additional, Bagheri, P., additional, Reddy, P., additional, Mita, S., additional, Kirste, R., additional, Rathkanthiwar, S., additional, Tweedie, J., additional, Pavlidis, S., additional, Kohn, E., additional, Collazo, R., additional, and Sitar, Z., additional

Published
2023
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7. Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Author

Vergote, I, Gonzalez-Martin, A, Lorusso, D, Gourley, C, Mirza, M, Kurtz, J, Okamoto, A, Moore, K, Kridelka, F, Mcneish, I, Reuss, A, Votan, B, du Bois, A, Mahner, S, Ray-Coquard, I, Kohn, E, Berek, J, Tan, D, Colombo, N, Zang, R, Concin, N, O'Donnell, D, Rauh-Hain, A, Herrington, C, Marth, C, Poveda, A, Fujiwara, K, Stuart, G, Oza, A, Bookman, M, Vergote, Ignace, Gonzalez-Martin, Antonio, Lorusso, Domenica, Gourley, Charlie, Mirza, Mansoor Raza, Kurtz, Jean-Emmanuel, Okamoto, Aikou, Moore, Kathleen, Kridelka, Frédéric, McNeish, Iain, Reuss, Alexander, Votan, Bénédicte, du Bois, Andreas, Mahner, Sven, Ray-Coquard, Isabelle, Kohn, Elise C, Berek, Jonathan S, Tan, David S P, Colombo, Nicoletta, Zang, Rongyu, Concin, Nicole, O'Donnell, Dearbhaile, Rauh-Hain, Alejandro, Herrington, C Simon, Marth, Christian, Poveda, Andres, Fujiwara, Keiichi, Stuart, Gavin C E, Oza, Amit M, Bookman, Michael A, Vergote, I, Gonzalez-Martin, A, Lorusso, D, Gourley, C, Mirza, M, Kurtz, J, Okamoto, A, Moore, K, Kridelka, F, Mcneish, I, Reuss, A, Votan, B, du Bois, A, Mahner, S, Ray-Coquard, I, Kohn, E, Berek, J, Tan, D, Colombo, N, Zang, R, Concin, N, O'Donnell, D, Rauh-Hain, A, Herrington, C, Marth, C, Poveda, A, Fujiwara, K, Stuart, G, Oza, A, Bookman, M, Vergote, Ignace, Gonzalez-Martin, Antonio, Lorusso, Domenica, Gourley, Charlie, Mirza, Mansoor Raza, Kurtz, Jean-Emmanuel, Okamoto, Aikou, Moore, Kathleen, Kridelka, Frédéric, McNeish, Iain, Reuss, Alexander, Votan, Bénédicte, du Bois, Andreas, Mahner, Sven, Ray-Coquard, Isabelle, Kohn, Elise C, Berek, Jonathan S, Tan, David S P, Colombo, Nicoletta, Zang, Rongyu, Concin, Nicole, O'Donnell, Dearbhaile, Rauh-Hain, Alejandro, Herrington, C Simon, Marth, Christian, Poveda, Andres, Fujiwara, Keiichi, Stuart, Gavin C E, Oza, Amit M, and Bookman, Michael A

Abstract

The Gynecologic Cancer InterGroup (GCIG) sixth Ovarian Cancer Conference on Clinical Research was held virtually in October, 2021, following published consensus guidelines. The goal of the consensus meeting was to achieve harmonisation on the design elements of upcoming trials in ovarian cancer, to select important questions for future study, and to identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and adoption of 20 statements within four topic groups on clinical research in ovarian cancer including first line treatment, recurrent disease, disease subgroups, and future trials. Unanimous consensus was obtained for 14 of 20 statements, with greater than 90% concordance in the remaining six statements. The high acceptance rate following active deliberation among the GCIG groups confirmed that a consensus process could be applied in a virtual setting. Together with detailed categorisation of unmet needs, these consensus statements will promote the harmonisation of international clinical research in ovarian cancer.

Published
2022

10. LBA34 Association of homologous recombination deficiency (HRD) with clinical outcomes in a phase III study of olaparib or cediranib and olaparib compared to platinum-based chemotherapy in recurrent platinum-sensitive ovarian cancer (PSOC): Biomarker analyses from NRG-GY004

Author

Swisher, E., primary, Miller, A., additional, Kohn, E., additional, Brady, M., additional, Radke, M., additional, Pennil, C., additional, Khasnavis, N., additional, Buscema, J., additional, Tew, W., additional, Muller, C., additional, Hill, E., additional, Moore, R., additional, Michelin, D., additional, Waggoner, S., additional, Geller, M., additional, Fujiwara, K., additional, D'Andre, S., additional, Liu, J., additional, and Birrer, M.J., additional

Published
2021
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11. High-current, high-voltage AlN Schottky barrier diodes

Author

Quiñones, C. E., Khachariya, D., Reddy, P., Mita, S., Almeter, J., Bagheri, P., Rathkanthiwar, S., Kirste, R., Pavlidis, S., Kohn, E., Collazo, R., and Sitar, Z.

Abstract

AlN Schottky barrier diodes with low ideality factor (<1.2), low differential ON-resistance (<0.6 mΩ cm2), high current density (>5 kA cm−2), and high breakdown voltage (680 V) are reported. The device structure consisted of a two-layer, quasi-vertical design with a lightly doped AlN drift layer and a highly doped Al0.75Ga0.25N ohmic contact layer grown on AlN substrates. A combination of simulation, current–voltage measurements, and impedance spectroscopy analysis revealed that the AlN/AlGaN interface introduces a parasitic electron barrier due to the conduction band offset between the two materials. This barrier was found to limit the forward current in fabricated diodes. Further, we show that introducing a compositionally-graded layer between the AlN and the AlGaN reduces the interfacial barrier and increases the forward current density of fabricated diodes by a factor of 104.

Published
2024
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12. Harmonising clinical trials within the Gynecologic Cancer InterGroup: consensus and unmet needs from the Fifth Ovarian Cancer Consensus Conference

Author

Bookman, M. A., Okamoto, A., Stuart, G., Yanaihara, N., Aoki, D., Bacon, M., Fujiwara, K., González-Martín, A., Harter, P., Kim, J. W., Ledermann, J., Pujade-Lauraine, E., Quinn, M., Ochiai, K., Zeimet, A., Marth, C., du Bois, A., Hilpert, F., Pfisterer, J., Reuss, A., Friedlander, M., Wilson, M. K., Kridelka, F., Vergote, I., Berek, J., Dorig, Karam, A., Bekkers, R., Westermann, A., Gatsonis, C., Ng, C., Herráez, A. C., Ottevanger, N., Poveda, A., Redondo, A., Coleman, R., Lu, K., Gallardo-Rincón, D., Gomez-Garcia, E., Joly, F., Leary, A., Ray-Coquard, I., Burger, R., Moore, K. N., Fujiwara, H., Hasegawa, K., Gleeson, N., Levy, T., Rosengarten, O., Katsumata, N., Silverberg, S. G., Sugiyama, T., Chang, S. -J., Kim, B. -G., Nam, B. -H., Colombo, N., Ferrero, A, Lorusso, D., Scambia, G., Edmondson, R., Mcneish, I., Kohn, E., Hirte, H., Mcgee, J., Provencher, D., Sehouli, J., Wimberger, P., Maenpaa, J., Mirza, M. R., Oza, A., Welch, S., Gaffney, D., Small, W., Glasspool, R., Gourley, C., Millan, D., Zang, R., Zhu, J., Bookman, M, Okamoto, A, Stuart, G, Yanaihara, N, Aoki, D, Bacon, M, Fujiwara, K, Gonzalez-Martin, A, Harter, P, Kim, J, Ledermann, J, Pujade-Lauraine, E, Quinn, M, Ochiai, K, Zeimet, A, Marth, C, du Bois, A, Hilpert, F, Pfisterer, J, Reuss, A, Friedlander, M, Wilson, M, Kridelka, F, Vergote, I, Berek, J, Dorigo, O, Karam, A, Bekkers, R, Westermann, A, Gatsonis, C, Ng, C, Herraez, A, Ottevanger, N, Poveda, A, Redondo, A, Coleman, R, Lu, K, Gallardo-Rincon, D, Gomez-Garcia, E, Joly, F, Leary, A, Ray-Coquard, I, Burger, R, Moore, K, Fujiwara, H, Hasegawa, K, Gleeson, N, Levy, T, Rosengarten, O, Katsumata, N, Silverberg, S, Sugiyama, T, Chang, S, Kim, B, Nam, B, Colombo, N, Ferrero, A, Lorusso, D, Scambia, G, Edmondson, R, Mcneish, I, Kohn, E, Hirte, H, Mcgee, J, Provencher, D, Sehouli, J, Wimberger, P, Maenpaa, J, Mirza, M, Oza, A, Welch, S, Gaffney, D, Small, W, Glasspool, R, Gourley, C, Millan, D, Zang, R, and Zhu, J

Subjects
0301 basic medicine, medicine.medical_specialty, media_common.quotation_subject, Unmet needs, 03 medical and health sciences, 0302 clinical medicine, Documentation, Ovarian cancer, Voting, medicine, Humans, Mission statement, media_common, Randomized Controlled Trials as Topic, Ovarian Neoplasms, business.industry, Consensus conference, Hematology, medicine.disease, Clinical trial, Symposium Articles, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Family medicine, Consensus statement, Needs assessment, Female, business, Needs Assessment
Abstract

The Gynecologic Cancer InterGroup (GCIG) Fifth Ovarian Cancer Consensus Conference (OCCC) was held in Tokyo, Japan from 7 to 9 November 2015. It provided international consensus on 15 important questions in 4 topic areas, which were generated in accordance with the mission statement to establish ‘International Consensus for Designing Better Clinical Trials’. The methodology for obtaining consensus was previously established and followed during the Fifth OCCC. All 29 clinical trial groups of GCIG participated in program development and deliberations. Draft consensus statements were discussed in topic groups as well as in a plenary forum. The final statements were then presented to all 29 member groups for voting and documentation of the level of consensus. Full consensus was obtained for 11 of the 15 statements with 28/29 groups agreeing to 3 statements, and 27/29 groups agreeing to 1 statement. The high acceptance rate of the statements among trial groups reflects the fact that we share common questions, and recognise important unmet needs that will guide future research in ovarian cancer.

Published
2017

13. Fifth ovarian cancer consensus conference of the Gynecologic Cancer InterGroup (GCIG): Clinical trial design for rare ovarian tumours

Author

Leary, A, Quinn, M, Fujiwara, K, Coleman, R, Kohn, E, Sugiyama, T, Glasspoo, R, Ray-Coquard, I, Colombo, N, Bacon, M, Zeimet, A, Westermann, A, Gomez-Garcia, E, Provencher, D, Welch, S, Small, W, Millan, D, Okamoto, A, Stuart, G, Ochiai, K, Leary A. F., Quinn M., Fujiwara K., Coleman R. L., Kohn E., Sugiyama T., Glasspoo R., Ray-Coquard I., Colombo N., Bacon M., Zeimet A., Westermann A., Gomez-Garcia E., Provencher D., Welch S., Small W., Millan D., Okamoto A., Stuart G., Ochiai K., Leary, A, Quinn, M, Fujiwara, K, Coleman, R, Kohn, E, Sugiyama, T, Glasspoo, R, Ray-Coquard, I, Colombo, N, Bacon, M, Zeimet, A, Westermann, A, Gomez-Garcia, E, Provencher, D, Welch, S, Small, W, Millan, D, Okamoto, A, Stuart, G, Ochiai, K, Leary A. F., Quinn M., Fujiwara K., Coleman R. L., Kohn E., Sugiyama T., Glasspoo R., Ray-Coquard I., Colombo N., Bacon M., Zeimet A., Westermann A., Gomez-Garcia E., Provencher D., Welch S., Small W., Millan D., Okamoto A., Stuart G., and Ochiai K.

Abstract

This manuscript reports the consensus statements on designing clinical trials in rare ovarian tumours reached at the fifth Ovarian Cancer Consensus Conference (OCCC) held in Tokyo, November 2015. Three important questions were identified concerning rare ovarian tumours (rare epithelial ovarian cancers (eOC), sex-cord stromal tumours (SCST) and germ cell tumours (GCT)): (i) What are the research and trial issues that are unique to rare ovarian tumours? There is a lack of randomised phase III data defining standards of care which makes it difficult to define control arms, but identifies unmet needs that merit investigation. Internationally agreed upon diagnostic criteria, expert pathological review and translational research are crucial. (ii) What should be investigated in rare eOC, GCT and SCST? Trials dedicated to each rare ovarian tumour should be encouraged. Nonetheless, where the question is relevant, rare eOC can be included in eOC trials but with rigorous stratification. Although there is emerging evidence suggesting that rare eOC have different molecular profiles, trials are needed to define new typespecific standards for each rare eOC (clear cell, low grade serous and mucinous). For GCTs, a priority is reducing toxicities from treatment while maintaining cure rates. Both a robust prognostic scoring system and more effective treatments for de novo poor prognosis and relapsed GCTs are needed. For SCSTs, validated prognostic markers as well as alternatives to the current standard of bleomycin/etoposide/cisplatin (BEP) should be identified. (iii) Are randomised trials feasible? Randomised controlled trials (RCT) should be feasible in any of the rare tumours through international collaboration. Ongoing trials have already demonstrated the feasibility of RCT in rare eOC and SCST. Mucinous OC may be considered for inclusion, stratified, into RCTs of nongynaecological mucinous tumours, while RCTs in high risk or relapsed GCT may be carried out as a subset of male and

Published
2017

14. Harmonising clinical trials within the Gynecologic Cancer InterGroup: Consensus and unmet needs from the Fifth Ovarian Cancer Consensus Conference

Author

Bookman, M, Okamoto, A, Stuart, G, Yanaihara, N, Aoki, D, Bacon, M, Fujiwara, K, Gonzalez-Martin, A, Harter, P, Kim, J, Ledermann, J, Pujade-Lauraine, E, Quinn, M, Ochiai, K, Zeimet, A, Marth, C, du Bois, A, Hilpert, F, Pfisterer, J, Reuss, A, Friedlander, M, Wilson, M, Kridelka, F, Vergote, I, Berek, J, Dorigo, O, Karam, A, Bekkers, R, Westermann, A, Gatsonis, C, Ng, C, Herraez, A, Ottevanger, N, Poveda, A, Redondo, A, Coleman, R, Lu, K, Gallardo-Rincon, D, Gomez-Garcia, E, Joly, F, Leary, A, Ray-Coquard, I, Burger, R, Moore, K, Fujiwara, H, Hasegawa, K, Gleeson, N, Levy, T, Rosengarten, O, Katsumata, N, Silverberg, S, Sugiyama, T, Chang, S, Kim, B, Nam, B, Colombo, N, Ferrero, A, Lorusso, D, Scambia, G, Edmondson, R, Mcneish, I, Kohn, E, Hirte, H, Mcgee, J, Provencher, D, Sehouli, J, Wimberger, P, Maenpaa, J, Mirza, M, Oza, A, Welch, S, Gaffney, D, Small, W, Glasspool, R, Gourley, C, Millan, D, Zang, R, Zhu, J, Bookman M. A., Okamoto A., Stuart G., Yanaihara N., Aoki D., Bacon M., Fujiwara K., Gonzalez-Martin A., Harter P., Kim J. W., Ledermann J., Pujade-Lauraine E., Quinn M., Ochiai K., Zeimet A., Marth C., du Bois A., Hilpert F., Pfisterer J., Reuss A., Friedlander M., Wilson M. K., Kridelka F., Vergote I., Berek J., Dorigo O., Karam A., Bekkers R., Westermann A., Gatsonis C., Ng C., Herraez A. C., Ottevanger N., Poveda A., Redondo A., Coleman R., Lu K., Gallardo-Rincon D., Gomez-Garcia E., Joly F., Leary A., Ray-Coquard I., Burger R., Moore K. N., Fujiwara H., Hasegawa K., Gleeson N., Levy T., Rosengarten O., Katsumata N., Silverberg S. G., Sugiyama T., Chang S. -J., Kim B. -G., Nam B. -H., Colombo N., Ferrero A., Lorusso D., Scambia G., Edmondson R., McNeish I., Kohn E., Hirte H., McGee J., Provencher D., Sehouli J., Wimberger P., Maenpaa J., Mirza M. R., Oza A., Welch S., Gaffney D., Small W., Glasspool R., Gourley C., Millan D., Zang R., Zhu J., Bookman, M, Okamoto, A, Stuart, G, Yanaihara, N, Aoki, D, Bacon, M, Fujiwara, K, Gonzalez-Martin, A, Harter, P, Kim, J, Ledermann, J, Pujade-Lauraine, E, Quinn, M, Ochiai, K, Zeimet, A, Marth, C, du Bois, A, Hilpert, F, Pfisterer, J, Reuss, A, Friedlander, M, Wilson, M, Kridelka, F, Vergote, I, Berek, J, Dorigo, O, Karam, A, Bekkers, R, Westermann, A, Gatsonis, C, Ng, C, Herraez, A, Ottevanger, N, Poveda, A, Redondo, A, Coleman, R, Lu, K, Gallardo-Rincon, D, Gomez-Garcia, E, Joly, F, Leary, A, Ray-Coquard, I, Burger, R, Moore, K, Fujiwara, H, Hasegawa, K, Gleeson, N, Levy, T, Rosengarten, O, Katsumata, N, Silverberg, S, Sugiyama, T, Chang, S, Kim, B, Nam, B, Colombo, N, Ferrero, A, Lorusso, D, Scambia, G, Edmondson, R, Mcneish, I, Kohn, E, Hirte, H, Mcgee, J, Provencher, D, Sehouli, J, Wimberger, P, Maenpaa, J, Mirza, M, Oza, A, Welch, S, Gaffney, D, Small, W, Glasspool, R, Gourley, C, Millan, D, Zang, R, Zhu, J, Bookman M. A., Okamoto A., Stuart G., Yanaihara N., Aoki D., Bacon M., Fujiwara K., Gonzalez-Martin A., Harter P., Kim J. W., Ledermann J., Pujade-Lauraine E., Quinn M., Ochiai K., Zeimet A., Marth C., du Bois A., Hilpert F., Pfisterer J., Reuss A., Friedlander M., Wilson M. K., Kridelka F., Vergote I., Berek J., Dorigo O., Karam A., Bekkers R., Westermann A., Gatsonis C., Ng C., Herraez A. C., Ottevanger N., Poveda A., Redondo A., Coleman R., Lu K., Gallardo-Rincon D., Gomez-Garcia E., Joly F., Leary A., Ray-Coquard I., Burger R., Moore K. N., Fujiwara H., Hasegawa K., Gleeson N., Levy T., Rosengarten O., Katsumata N., Silverberg S. G., Sugiyama T., Chang S. -J., Kim B. -G., Nam B. -H., Colombo N., Ferrero A., Lorusso D., Scambia G., Edmondson R., McNeish I., Kohn E., Hirte H., McGee J., Provencher D., Sehouli J., Wimberger P., Maenpaa J., Mirza M. R., Oza A., Welch S., Gaffney D., Small W., Glasspool R., Gourley C., Millan D., Zang R., and Zhu J.

Abstract

The Gynecologic Cancer InterGroup (GCIG) Fifth Ovarian Cancer Consensus Conference (OCCC) was held in Tokyo, Japan from 7 to 9 November 2015. It provided international consensus on 15 important questions in 4 topic areas, which were generated in accordance with the mission statement to establish 'International Consensus for Designing Better Clinical Trials'. The methodology for obtaining consensus was previously established and followed during the Fifth OCCC. All 29 clinical trial groups of GCIG participated in program development and deliberations. Draft consensus statements were discussed in topic groups as well as in a plenary forum. The final statements were then presented to all 29 member groups for voting and documentation of the level of consensus. Full consensus was obtained for 11 of the 15 statements with 28/29 groups agreeing to 3 statements, and 27/29 groups agreeing to 1 statement. The high acceptance rate of the statements among trial groups reflects the fact that we share common questions, and recognise important unmet needs that will guide future research in ovarian cancer.

Published
2017

16. O31 Levetiracetam monitoring in breast-milk: high inter-individual variability

Author

Dinavitser, N, primary, Kohn, E, additional, Berlin, M, additional, Livne, A, additional, Keidar, R, additional, Ben-Nun, L, additional, Agajani, N, additional, Sheinberg, R, additional, Gamsu, S, additional, Flor-Hirsch, H, additional, Brandriss, N, additional, Bar-Chaim, A, additional, Stepenski, D, additional, and Berkovitch, M, additional

Published
2019
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19. Peripheral regional anesthesia for arterial revascularization of lower limbs. Bibliographical review and clinical cases

Author

Moreno, L González, Ramos, G, Prestes, I, Bouchacort, JP, Kohn, E, and Riva, J

Subjects
Anesthesia, Regional, Femoral nerve block, Cirugía vascular periférica, Sciatic nerve block, Nerve block, Peripheral vascular surgery, Regional anesthesia, Bloqueos nerviosos, Anestesia regional, Bloqueo nervio femoral, Bloqueo nervio ciático
Abstract

Resumen: Introducción: La tendencia actual es diferir la cirugía de revascularización de miembros inferiores hasta etapas avanzadas, lo que explica que sean pacientes de mayor complejidad con alta morbimortalidad cardíaca y respiratoria. Los mayores avances para reducirlas, se han desarrollado en la preparación de los pacientes y en las técnicas quirúrgicas. La elección de la técnica anestésica no ha sido considerada un factor determinante. Los bloqueos regionales presentan potenciales ventajas, como mayor estabilidad hemodinámica y respiratoria. Objetivo: Realizar una revisión bibliográfica y presentación de casos clínicos sobre la utilidad de los bloqueos periféricos para anestesia en la cirugía de revascularización de miembros inferiores. Material y métodos: La búsqueda se realizó a través de la base de datos Medline, LILACS y SciELO. Se incluyeron estudios donde los bloqueos periféricos se utilizaron para anestesia. Se describen dos casos clínicos. Resultados: Se seleccionaron 4 artículos originales, 3 de ellos eran estudios descriptivos de la técnica y el cuarto una comparación con anestesia general inhalatoria. 2más correspondieron a casos clínicos. Conclusiones: No existe evidencia suficiente que permita concluir que reducen la mortalidad o la morbilidad cuando se la compara con las demás técnicas anestésicas. Esto puede ser debido al diseño metodológico de los estudios, a la no utilización de la ecografía como guía y la no sistematización de los bloqueos. El análisis de los casos clínicos sugiere que en situaciones específicas como pacientes de alto riesgo cardíaco y respiratorio, bajo tratamiento con anticoagulantes y antiagregantes estos presentan ventajas sobre las otras técnicas. Abstract: Background: The current trend is to defer revascularization surgery from lower limbs to advanced stages, which explains why they are more complex patients with high cardiac and respiratory mortality. The choice of anesthetic technique remains controversial. Regional blockades have potential advantages, such as hemodynamic and respiratory stability. Our primary objective was a bibliographic review to assess the peripheral blockages for anesthesia in lower limb revascularization surgery. Our secondary objective was report two clinical cases. Material and methods: The search was performed through the Medline, LILACS and SciELO database. We included studies where peripheral blocks were used for anesthesia. Two clinical cases are described. Results: Four original articles were selected, 3 of which were descriptive studies of the technique and the fourth a comparison with general inhalation anesthesia. 2 more corresponded to clinical cases. Conclusions: There is insufficient evidence to conclude that peripheral nerve block reduce mortality or morbidity when compared with other anesthetic techniques. This may be due to the methodological design of the studies, to the non-use of echocardiography as a guide and the non-systematization of the blocks. The analysis of the clinical cases suggests that this technique is a good option in specific situations as patients with high cardiac and respiratory risk, under treatment with anticoagulants and antiplatelets drugs.

Published
2016

20. A phase I study of durvalumab (D) in combination with olaparib (O) and cediranib (C) in recurrent women’s cancers

Author

Zimmer, A., primary, Peer, C., additional, Cao, L., additional, Kohn, E., additional, Lipkowitz, S., additional, Annunziata, C., additional, Trepel, J., additional, Lee, M-J., additional, Mikkilineni, L., additional, Gatti-Mays, M., additional, Nunes, A., additional, Soltani, S., additional, Figg, W.D., additional, Houston, N., additional, Nichols, E., additional, and Lee, J-M., additional

Published
2017
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25. Overall survival and updated progression-free survival outcomes in a randomized phase II study of combination cediranib and olaparib versus olaparib in relapsed platinum-sensitive ovarian cancer.

Author

Liu, J F, Barry, W T, Birrer, M, Lee, J -M, Buckanovich, R J, Fleming, G F, Rimel, B J, Buss, M K, Nattam, S R, Hurteau, J, Luo, W, Curtis, J, Whalen, C, Kohn, E C, Ivy, S P, and Matulonis, U A

Subjects
*PROGRESSION-free survival, *OVARIAN cancer, *MATHEMATICAL combinations, *DISEASE progression, *ADVERSE health care events
Abstract

Background Olaparib is a poly(ADP-ribose) polymerase inhibitor and cediranib is an oral anti-angiogenic. In the primary analysis of this phase II study, combination cediranib/olaparib improved progression-free survival (PFS) compared with olaparib alone in relapsed platinum-sensitive ovarian cancer. This updated analysis was conducted to characterize overall survival (OS) and update PFS outcomes. Patients and methods Ninety patients were enrolled to this randomized, open-label, phase II study between October 2011 and June 2013 across nine United States-based academic centers. Data cut-off was 21 December 2016, with a median follow-up of 46 months. Participants had relapsed platinum-sensitive ovarian cancer of high-grade serous or endometrioid histology or had a deleterious germline BRCA1 / 2 mutation (g BRCA m). Participants were randomized to receive olaparib capsules 400 mg twice daily or cediranib 30 mg daily and olaparib capsules 200 mg twice daily until disease progression. Results In this updated analysis, median PFS remained significantly longer with cediranib/olaparib compared with olaparib alone (16.5 versus 8.2 months, hazard ratio 0.50; P  = 0.007). Subset analyses within stratum defined by BRCA status demonstrated statistically significant improvement in PFS (23.7 versus 5.7 months, P  = 0.002) and OS (37.8 versus 23.0 months, P  = 0.047) in g BRCA wild-type/unknown patients, although OS was not statistically different in the overall study population (44.2 versus 33.3 months, hazard ratio 0.64; P  = 0.11). PFS and OS appeared similar between the two arms in g BRCA m patients. The most common CTCAE grade 3/4 adverse events with cediranib/olaparib remained fatigue, diarrhea, and hypertension. Conclusions Combination cediranib/olaparib significantly extends PFS compared with olaparib alone in relapsed platinum-sensitive ovarian cancer. Subset analyses suggest this margin of benefit is driven by PFS prolongation in patients without g BRCA m. OS was also significantly increased by the cediranib/olaparib combination in this subset of patients. Additional studies of this combination are ongoing and should incorporate analyses based upon BRCA status. Trial Registration Clinicaltrials.gov Identifier NCT0111648 [ABSTRACT FROM AUTHOR]

Published
2019
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26. Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Author

Ignace Vergote, Antonio Gonzalez-Martin, Domenica Lorusso, Charlie Gourley, Mansoor Raza Mirza, Jean-Emmanuel Kurtz, Aikou Okamoto, Kathleen Moore, Frédéric Kridelka, Iain McNeish, Alexander Reuss, Bénédicte Votan, Andreas du Bois, Sven Mahner, Isabelle Ray-Coquard, Elise C Kohn, Jonathan S Berek, David S P Tan, Nicoletta Colombo, Rongyu Zang, Nicole Concin, Dearbhaile O'Donnell, Alejandro Rauh-Hain, C Simon Herrington, Christian Marth, Andres Poveda, Keiichi Fujiwara, Gavin C E Stuart, Amit M Oza, Michael A Bookman, Christoph Grimm, Regina Berger, Ting-Chang Chang, Kazunori Ochiai, Val Gebski, Alison Davis, Philip Beale, Hannelore Denys, Vincent Vandecaveye, Francisco Jose Candido dos Reis, Maria Del Pilar Estevez Diz, Gavin Stuart, Helen MacKay, Mark Carey, David Cibula, Pavel Dundr (path), Oliver Dorigo, Jonathan Berek, Abu Saadeh, Ingrid Boere, Christianne Lok, Pluvio Coronado, Nelleke Ottevanger, David SP Tan, Joseph Ng, Antonio Gonzalez Martin, Ana Oaknin, Alejandro Perez Fidalgo, Karen Lu, Carlos López-Zavala, Eva María Gómez-García, Xavier Paoletti, Florence Joly, Michael Bookman, Rebecca Arend, Hiroyuki Fujiwara, Kosei Hasegawa, Ilan Bruchim, Dalia Tsoref, Katsutoshi Oda, Takayuki Enomoto, Dayana Michel, Hee-Seung Kim, Jung-Yun Lee, Asima Mukhopadhyay, Dionyssios Katsaros, Sandro Pignata, Giovanni Scambia, Elise Kohn, Jung-Min Lee, Shibani Nicum, Laura Farrelly, Jalid Sehouli, Maren Keller, Elena Braicu, Line Bjørge, Annika Auranen, Stephen Welch, Viola Heinzelmann, Patricia Roxburgh, Ros Glasspool, Jianqing Zhu, Vergote, I, Gonzalez-Martin, A, Lorusso, D, Gourley, C, Mirza, M, Kurtz, J, Okamoto, A, Moore, K, Kridelka, F, Mcneish, I, Reuss, A, Votan, B, du Bois, A, Mahner, S, Ray-Coquard, I, Kohn, E, Berek, J, Tan, D, Colombo, N, Zang, R, Concin, N, O'Donnell, D, Rauh-Hain, A, Herrington, C, Marth, C, Poveda, A, Fujiwara, K, Stuart, G, Oza, A, and Bookman, M

Subjects
Ovarian Neoplasms, Consensus, Oncology, SDG 3 - Good Health and Well-being, Humans, Consensu, Female, Carcinoma, Ovarian Epithelial, Forecasting, Human, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
Abstract

Contains fulltext : 283536.pdf (Publisher’s version ) (Closed access) The Gynecologic Cancer InterGroup (GCIG) sixth Ovarian Cancer Conference on Clinical Research was held virtually in October, 2021, following published consensus guidelines. The goal of the consensus meeting was to achieve harmonisation on the design elements of upcoming trials in ovarian cancer, to select important questions for future study, and to identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and adoption of 20 statements within four topic groups on clinical research in ovarian cancer including first line treatment, recurrent disease, disease subgroups, and future trials. Unanimous consensus was obtained for 14 of 20 statements, with greater than 90% concordance in the remaining six statements. The high acceptance rate following active deliberation among the GCIG groups confirmed that a consensus process could be applied in a virtual setting. Together with detailed categorisation of unmet needs, these consensus statements will promote the harmonisation of international clinical research in ovarian cancer.

Published
2022
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