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1. ESGO–ESMO–ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease

Author

Ledermann, J.A., Matias-Guiu, X., Amant, F., Concin, N., Davidson, B., Fotopoulou, C., González-Martin, A., Gourley, C., Leary, A., Lorusso, D., Banerjee, S., Chiva, L., Cibula, D., Colombo, N., Croce, S., Eriksson, A.G., Falandry, C., Fischerova, D., Harter, P., Joly, F., Lazaro, C., Lok, C., Mahner, S., Marmé, F., Marth, C., McCluggage, W.G., McNeish, I.A., Morice, P., Nicum, S., Oaknin, A., Pérez-Fidalgo, J.A., Pignata, S., Ramirez, P.T., Ray-Coquard, I., Romero, I., Scambia, G., Sehouli, J., Shapira-Frommer, R., Sundar, S., Tan, D.S.P., Taskiran, C., van Driel, W.J., Vergote, I., Planchamp, F., Sessa, C., and Fagotti, A.

Published
2024
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2. ESGO–ESMO–ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease

Author

Ledermann, J, Matias-Guiu, X, Amant, F, Concin, N, Davidson, B, Fotopoulou, C, González-Martin, A, Gourley, C, Leary, A, Lorusso, D, Banerjee, S, Chiva, L, Cibula, D, Colombo, N, Croce, S, Eriksson, A, Falandry, C, Fischerova, D, Harter, P, Joly, F, Lazaro, C, Lok, C, Mahner, S, Marmé, F, Marth, C, Mccluggage, W, Mcneish, I, Morice, P, Nicum, S, Oaknin, A, Pérez-Fidalgo, J, Pignata, S, Ramirez, P, Ray-Coquard, I, Romero, I, Scambia, G, Sehouli, J, Shapira-Frommer, R, Sundar, S, Tan, D, Taskiran, C, van Driel, W, Vergote, I, Planchamp, F, Sessa, C, Fagotti, A, Ledermann J. A., Matias-Guiu X., Amant F., Concin N., Davidson B., Fotopoulou C., González-Martin A., Gourley C., Leary A., Lorusso D., Banerjee S., Chiva L., Cibula D., Colombo N., Croce S., Eriksson A. G., Falandry C., Fischerova D., Harter P., Joly F., Lazaro C., Lok C., Mahner S., Marmé F., Marth C., McCluggage W. G., McNeish I. A., Morice P., Nicum S., Oaknin A., Pérez-Fidalgo J. A., Pignata S., Ramirez P. T., Ray-Coquard I., Romero I., Scambia G., Sehouli J., Shapira-Frommer R., Sundar S., Tan D. S. P., Taskiran C., van Driel W. J., Vergote I., Planchamp F., Sessa C., Fagotti A., Ledermann, J, Matias-Guiu, X, Amant, F, Concin, N, Davidson, B, Fotopoulou, C, González-Martin, A, Gourley, C, Leary, A, Lorusso, D, Banerjee, S, Chiva, L, Cibula, D, Colombo, N, Croce, S, Eriksson, A, Falandry, C, Fischerova, D, Harter, P, Joly, F, Lazaro, C, Lok, C, Mahner, S, Marmé, F, Marth, C, Mccluggage, W, Mcneish, I, Morice, P, Nicum, S, Oaknin, A, Pérez-Fidalgo, J, Pignata, S, Ramirez, P, Ray-Coquard, I, Romero, I, Scambia, G, Sehouli, J, Shapira-Frommer, R, Sundar, S, Tan, D, Taskiran, C, van Driel, W, Vergote, I, Planchamp, F, Sessa, C, Fagotti, A, Ledermann J. A., Matias-Guiu X., Amant F., Concin N., Davidson B., Fotopoulou C., González-Martin A., Gourley C., Leary A., Lorusso D., Banerjee S., Chiva L., Cibula D., Colombo N., Croce S., Eriksson A. G., Falandry C., Fischerova D., Harter P., Joly F., Lazaro C., Lok C., Mahner S., Marmé F., Marth C., McCluggage W. G., McNeish I. A., Morice P., Nicum S., Oaknin A., Pérez-Fidalgo J. A., Pignata S., Ramirez P. T., Ray-Coquard I., Romero I., Scambia G., Sehouli J., Shapira-Frommer R., Sundar S., Tan D. S. P., Taskiran C., van Driel W. J., Vergote I., Planchamp F., Sessa C., and Fagotti A.

Abstract

The European Society of Gynaecological Oncology, the European Society for Medical Oncology (ESMO) and the European Society of Pathology held a consensus conference (CC) on ovarian cancer on 15-16 June 2022 in Valencia, Spain. The CC panel included 44 experts in the management of ovarian cancer and pathology, an ESMO scientific advisor and a methodologist. The aim was to discuss new or contentious topics and develop recommendations to improve and harmonise the management of patients with ovarian cancer. Eighteen questions were identified for discussion under four main topics: (i) pathology and molecular biology, (ii) early-stage disease and pelvic mass in pregnancy, (iii) advanced stage (including older/frail patients) and (iv) recurrent disease. The panel was divided into four working groups (WGs) to each address questions relating to one of the four topics outlined above, based on their expertise. Relevant scientific literature was reviewed in advance. Recommendations were developed by the WGs and then presented to the entire panel for further discussion and amendment before voting. This manuscript focuses on the recommendation statements that reached a consensus, their voting results and a summary of evidence supporting each recommendation.

Published
2024

3. Atezolizumab and chemotherapy for advanced or recurrent endometrial cancer (AtTEnd): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Colombo, N, Biagioli, E, Harano, K, Galli, F, Hudson, E, Antill, Y, Choi, C, Rabaglio, M, Marmé, F, Marth, C, Parma, G, Fariñas-Madrid, L, Nishio, S, Allan, K, Lee, Y, Piovano, E, Pardo, B, Nakagawa, S, Mcqueen, J, Zamagni, C, Manso, L, Takehara, K, Tasca, G, Ferrero, A, Tognon, G, Lissoni, A, Petrella, M, Laudani, M, Rulli, E, Uggeri, S, Barretina Ginesta, M, Zola, P, Casanova, C, Arcangeli, V, Antonuzzo, L, Gadducci, A, Cosio, S, Clamp, A, Persic, M, Mcneish, I, Tookman, L, Redondo Sanchez, A, Baldini, E, Palaia, I, Benedetti Panici, P, Takahashi, N, Lombard, J, Ardizzoia, A, Bologna, A, Herrero Ibáñez, A, Musolino, A, Márquez Vázquez, R, Pietzner, K, Braicu, E, Heinzelmann-Schwarz, V, Powell, M, Yokoyama, Y, Baron-Hay, S, Abeni, C, Martin Lorente, C, Cueva, J, Trillsch, F, Heitz, F, Ataseven, B, Petru, E, Heubner, M, Sadozye, A, Dubey, S, Tazbirkova, A, Tiley, S, Chrystal, K, Kim, S, Fehr, M, Scatchard, K, Anand, A, Taylor, A, Watary, H, Enomoto, T, Yoshihara, K, Selva-Nayagam, S, Karki, B, Harrison, M, Wilkinson, K, Goh, J, Glasgow, A, Chantrill, L, Lee, C, Bertolini, A, Narducci, F, Bellotti, G, Fusco, V, Aebi, S, Del Grande, M, Colombo, I, Tokunaga, H, Shigeta, S, Goss, G, Siow, Z, Steer, C, Lin, H, Colombo N., Biagioli E., Harano K., Galli F., Hudson E., Antill Y., Choi C. H., Rabaglio M., Marmé F., Marth C., Parma G., Fariñas-Madrid L., Nishio S., Allan K., Lee Y. C., Piovano E., Pardo B., Nakagawa S., McQueen J., Zamagni C., Manso L., Takehara K., Tasca G., Ferrero A., Tognon G., Lissoni A. A., Petrella M., Laudani M. E., Rulli E., Uggeri S., Barretina Ginesta M. P., Zola P., Casanova C., Arcangeli V., Antonuzzo L., Gadducci A., Cosio S., Clamp A., Persic M., McNeish I., Tookman L., Redondo Sanchez A., Baldini E., Palaia I., Benedetti Panici P., Takahashi N., Lombard J., Ardizzoia A., Bologna A., Herrero Ibáñez A. M., Musolino A., Márquez Vázquez R., Pietzner K., Braicu E., Heinzelmann-Schwarz V. A., Powell M., Yokoyama Y., Baron-Hay S., Abeni C., Martin Lorente C., Cueva J. F., Trillsch F., Heitz F., Ataseven B., Petru E., Heubner M. L., Sadozye A. H., Dubey S., Tazbirkova A., Tiley S., Chrystal K., Kim S. W., Fehr M., Scatchard K., Anand A., Taylor A., Watary H., Enomoto T., Yoshihara K., Selva-Nayagam S., Karki B., Harrison M., Wilkinson K., Goh J., Glasgow A., Chantrill L., Lee C., Bertolini A., Narducci F., Bellotti G., Fusco V., Aebi S., Del Grande M., Colombo I., Tokunaga H., Shigeta S., Goss G., Siow Z. R., Steer C., Lin H., Colombo, N, Biagioli, E, Harano, K, Galli, F, Hudson, E, Antill, Y, Choi, C, Rabaglio, M, Marmé, F, Marth, C, Parma, G, Fariñas-Madrid, L, Nishio, S, Allan, K, Lee, Y, Piovano, E, Pardo, B, Nakagawa, S, Mcqueen, J, Zamagni, C, Manso, L, Takehara, K, Tasca, G, Ferrero, A, Tognon, G, Lissoni, A, Petrella, M, Laudani, M, Rulli, E, Uggeri, S, Barretina Ginesta, M, Zola, P, Casanova, C, Arcangeli, V, Antonuzzo, L, Gadducci, A, Cosio, S, Clamp, A, Persic, M, Mcneish, I, Tookman, L, Redondo Sanchez, A, Baldini, E, Palaia, I, Benedetti Panici, P, Takahashi, N, Lombard, J, Ardizzoia, A, Bologna, A, Herrero Ibáñez, A, Musolino, A, Márquez Vázquez, R, Pietzner, K, Braicu, E, Heinzelmann-Schwarz, V, Powell, M, Yokoyama, Y, Baron-Hay, S, Abeni, C, Martin Lorente, C, Cueva, J, Trillsch, F, Heitz, F, Ataseven, B, Petru, E, Heubner, M, Sadozye, A, Dubey, S, Tazbirkova, A, Tiley, S, Chrystal, K, Kim, S, Fehr, M, Scatchard, K, Anand, A, Taylor, A, Watary, H, Enomoto, T, Yoshihara, K, Selva-Nayagam, S, Karki, B, Harrison, M, Wilkinson, K, Goh, J, Glasgow, A, Chantrill, L, Lee, C, Bertolini, A, Narducci, F, Bellotti, G, Fusco, V, Aebi, S, Del Grande, M, Colombo, I, Tokunaga, H, Shigeta, S, Goss, G, Siow, Z, Steer, C, Lin, H, Colombo N., Biagioli E., Harano K., Galli F., Hudson E., Antill Y., Choi C. H., Rabaglio M., Marmé F., Marth C., Parma G., Fariñas-Madrid L., Nishio S., Allan K., Lee Y. C., Piovano E., Pardo B., Nakagawa S., McQueen J., Zamagni C., Manso L., Takehara K., Tasca G., Ferrero A., Tognon G., Lissoni A. A., Petrella M., Laudani M. E., Rulli E., Uggeri S., Barretina Ginesta M. P., Zola P., Casanova C., Arcangeli V., Antonuzzo L., Gadducci A., Cosio S., Clamp A., Persic M., McNeish I., Tookman L., Redondo Sanchez A., Baldini E., Palaia I., Benedetti Panici P., Takahashi N., Lombard J., Ardizzoia A., Bologna A., Herrero Ibáñez A. M., Musolino A., Márquez Vázquez R., Pietzner K., Braicu E., Heinzelmann-Schwarz V. A., Powell M., Yokoyama Y., Baron-Hay S., Abeni C., Martin Lorente C., Cueva J. F., Trillsch F., Heitz F., Ataseven B., Petru E., Heubner M. L., Sadozye A. H., Dubey S., Tazbirkova A., Tiley S., Chrystal K., Kim S. W., Fehr M., Scatchard K., Anand A., Taylor A., Watary H., Enomoto T., Yoshihara K., Selva-Nayagam S., Karki B., Harrison M., Wilkinson K., Goh J., Glasgow A., Chantrill L., Lee C., Bertolini A., Narducci F., Bellotti G., Fusco V., Aebi S., Del Grande M., Colombo I., Tokunaga H., Shigeta S., Goss G., Siow Z. R., Steer C., and Lin H.

Abstract

Background: At the time of AtTEnd trial design, standard treatment for advanced or recurrent endometrial cancer included carboplatin and paclitaxel chemotherapy. This trial assessed whether combining atezolizumab with chemotherapy might improve outcomes in this population. Methods: AtTEnd was a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial done in 89 hospitals in 11 countries across Europe, Australia, New Zealand, and Asia. Enrolled patients were aged 18 years or older, and had advanced or recurrent endometrial carcinoma or carcinosarcoma, an Eastern Cooperative Oncology Group performance status of 0–2, and received no previous systemic chemotherapy for recurrence. Patients were randomly assigned (2:1) using an interactive web response system (block size of six) to either atezolizumab 1200 mg or placebo given intravenously with chemotherapy (carboplatin at area under the curve of 5 or 6 and paclitaxel 175 mg/m2 intravenously on day 1 every 21 days) for 6–8 cycles, then continued until progression. Stratification factors were country, histological subtype, advanced or recurrent status, and mismatch repair (MMR) status. Participants and treating clinicians were masked to group allocation. The hierarchically tested co-primary endpoints were progression-free survival (in patients with MMR-deficient [dMMR] tumours, and in the overall population) and overall survival (in the overall population). Primary analyses were done in the intention-to-treat population, defined as all randomly assigned patients who gave their full consent to participation in the study and data processing. Safety was assessed in all patients included in the intention-to-treat population who received at least one dose of study treatment. Here, we report the primary progression-free survival and the interim overall survival results. This study is ongoing and is registered with ClinicalTrials.gov, NCT03603184. Findings: Between Oct 3, 2018, and Jan 7, 2022, 551 patients were r

Published
2024

4. Clinical evaluation of a low-coverage whole-genome test for detecting homologous recombination deficiency in ovarian cancer

Author

Boidot, R, Blum, M, Wissler, M, Gottin, C, Ruzicka, J, Chevrier, S, Delhomme, T, Audoux, J, Jeanniard, A, Just, P, Harter, P, Pignata, S, Gonzalez-Martin, A, Marth, C, Maenpaa, J, Colombo, N, Vergote, I, Fujiwara, K, Duforet-Frebourg, N, Bertrand, D, Philippe, N, Ray-Coquard, I, Pujade-Lauraine, E, Boidot R., Blum M. G. B., Wissler M. -P., Gottin C., Ruzicka J., Chevrier S., Delhomme T. M., Audoux J., Jeanniard A., Just P. -A., Harter P., Pignata S., Gonzalez-Martin A., Marth C., Maenpaa J., Colombo N., Vergote I., Fujiwara K., Duforet-Frebourg N., Bertrand D., Philippe N., Ray-Coquard I., Pujade-Lauraine E., Boidot, R, Blum, M, Wissler, M, Gottin, C, Ruzicka, J, Chevrier, S, Delhomme, T, Audoux, J, Jeanniard, A, Just, P, Harter, P, Pignata, S, Gonzalez-Martin, A, Marth, C, Maenpaa, J, Colombo, N, Vergote, I, Fujiwara, K, Duforet-Frebourg, N, Bertrand, D, Philippe, N, Ray-Coquard, I, Pujade-Lauraine, E, Boidot R., Blum M. G. B., Wissler M. -P., Gottin C., Ruzicka J., Chevrier S., Delhomme T. M., Audoux J., Jeanniard A., Just P. -A., Harter P., Pignata S., Gonzalez-Martin A., Marth C., Maenpaa J., Colombo N., Vergote I., Fujiwara K., Duforet-Frebourg N., Bertrand D., Philippe N., Ray-Coquard I., and Pujade-Lauraine E.

Abstract

Background: The PAOLA-1/ENGOT-ov25 trial showed that maintenance olaparib plus bevacizumab increases survival of advanced ovarian cancer patients with homologous recombination deficiency (HRD). However, decentralized solutions to test for HRD in clinical routine are scarce. The goal of this study was to retrospectively validate on tumor samples from the PAOLA-1 trial, the decentralized SeqOne assay, which relies on shallow Whole Genome Sequencing (sWGS) to capture genomic instability and targeted sequencing to determine BRCA status. Methods: The study comprised 368 patients from the PAOLA-1 trial. The SeqOne assay was compared to the Myriad MyChoice HRD test (Myriad Genetics), and results were analyzed with respect to Progression-Free Survival (PFS). Results: We found a 95% concordance between the HRD status of the two tests (95% Confidence Interval (CI); 92%−97%). The Positive Percentage Agreement (PPA) of the sWGS test was 95% (95% CI; 91%−97%) like its Negative Percentage Agreement (NPA) (95% CI; 89%−98%). In patients with HRD-positive tumors treated with olaparib plus bevacizumab, the PFS Hazard Ratio (HR) was 0.38 (95% CI; 0.26–0.54) with SeqOne assay and 0.32 (95% CI; 0.22–0.45) with the Myriad assay. In patients with HRD-negative tumors, HR was 0.99 (95% CI; 0.68–1.42) and 1.05 (95% CI; 0.70–1.57) with SeqOne and Myriad assays. Among patients with BRCA-wildtype tumors, those with HRD-positive tumors, benefited from olaparib plus bevacizumab maintenance, with HR of 0.48 (95% CI: 0.29–0.79) and of 0.38 (95% CI: 0.23 to 0.63) with the SeqOne and Myriad assay. Conclusion: The SeqOne assay offers a clinically validated approach to detect HRD.

Published
2024

5. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial

Author

Ray-Coquard, I., Leary, A., Pignata, S., Cropet, C., González-Martín, A., Marth, C., Nagao, S., Vergote, I., Colombo, N., Mäenpää, J., Selle, F., Sehouli, J., Lorusso, D., Guerra Alia, E.M., Bogner, G., Yoshida, H., Lefeuvre-Plesse, C., Buderath, P., Mosconi, A.M., Lortholary, A., Burges, A., Medioni, J., El-Balat, A., Rodrigues, M., Park-Simon, T.-W., Dubot, C., Denschlag, D., You, B., Pujade-Lauraine, E., and Harter, P.

Published
2023
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7. European experts consensus: BRCA/homologous recombination deficiency testing in first-line ovarian cancer

Author

Vergote, I., Ausems, M., Brasiuniene, B., Brenton, J., Büttner, R., Colombo, N., González-Martín, A., Harter, P., Lambrechts, D., Lorusso, D., Madry, R., Mirza, M.R., Pujol, P., Ray-Coquard, I., Abreu, M., Balboni, S., Banerjee, S., Barberis, M., Barretina Ginesta, M.P., Baurain, J.-F., Bignami, M., Bjorge, L., Blecharz, P., Bruchim, I., Capilna, M., Cerana, N., Cicchetti, A., Collins, D., Concin, N., D’Incalci, M., Davidson, B., de la Motte Rouge, T., De Iaco, P., Demirkiran, F., Denys, H., Doerk, T., Dorum, A., Ferrero, A., Fidalgo, A.P., Genuardi, M., Gladieff, L., Glasspool, R., Grimm, C., Gultekin, M., Hahnen, E., Hasenburg, A., Hegmane, A., Heinzelmann, V., Hogdall, E., Janavicius, R., Jarmalaite, S., Kalachand, R., Kaneva, R., Kilickap, S., Kocian, R., Kolencik, D., Kristeleit, R., Kryzhanivska, A., Leary, A., Lemley, B., Ligtenberg, M., López-Guerrero, J.A., Lord, C.J., Avall-Lundqvist, E., Maenpaa, J., Mahner, S., Marmé, F., Marth, C., McNeish, I., Merkelbach-Bruse, S., Mourits, M., Normanno, N., Oaknin, A., Ojamaa, K., Papdimitriou, C., Penault-Llorca, F., Perrone, A.M., Pignata, S., Pikarsky, E., Rouleau, E., Rubio, M., Sapino, A., Schmalfeldt, B., Sehouli, J., Shapira, R., Steffensen, K.D., Sukhin, V., Syrios, J., Szallasi, Z., Taskiran, C., Terzic, M., Tischkowitz, M., Toth, I., Van de Vijver, K., Vardar, M.A., Wasag, B., Wimberger, P., Witteveen, E., Brenton, J.D., and Ausems, M.G.E.M.

Published
2022
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8. Continuous versus intermittent extended adjuvant letrozole for breast cancer: final results of randomized phase III SOLE (Study of Letrozole Extension) and SOLE Estrogen Substudy

Author

Jerusalem, G., Farah, S., Courtois, A., Chirgwin, J., Aebi, S., Karlsson, P., Neven, P., Hitre, E., Graas, M.P., Simoncini, E., Abdi, E., Kamby, C., Thompson, A., Loibl, S., Gavilá, J., Kuroi, K., Marth, C., Müller, B., O’Reilly, S., Gombos, A., Ruhstaller, T., Burstein, H.J., Rabaglio, M., Ruepp, B., Ribi, K., Viale, G., Gelber, R.D., Coates, A.S., Loi, S., Goldhirsch, A., Regan, M.M., and Colleoni, M.

Published
2021
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9. ESGO–ESMO–ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease

Author

Ledermann, J. A., Matias-Guiu, X., Amant, F., Concin, N., Davidson, B., Fotopoulou, C., González-Martin, A., Gourley, C., Leary, A., Lorusso, Domenica, Banerjee, S., Chiva, L., Cibula, D., Colombo, N., Croce, S., Eriksson, A. G., Falandry, C., Fischerova, D., Harter, P., Joly, F., Lazaro, C., Lok, C., Mahner, S., Marmé, F., Marth, C., Mccluggage, W. G., Mcneish, I. A., Morice, P., Nicum, S., Oaknin, A., Pérez-Fidalgo, J. A., Pignata, S., Ramirez, P. T., Ray-Coquard, I., Romero, I., Scambia, Giovanni, Sehouli, J., Shapira-Frommer, R., Sundar, S., Tan, D. S. P., Taskiran, C., van Driel, W. J., Vergote, I., Planchamp, F., Sessa, C., Fagotti, Anna, Lorusso, D., Scambia, G. (ORCID:0000-0003-2758-1063), Fagotti, A. (ORCID:0000-0001-5579-335X), Ledermann, J. A., Matias-Guiu, X., Amant, F., Concin, N., Davidson, B., Fotopoulou, C., González-Martin, A., Gourley, C., Leary, A., Lorusso, Domenica, Banerjee, S., Chiva, L., Cibula, D., Colombo, N., Croce, S., Eriksson, A. G., Falandry, C., Fischerova, D., Harter, P., Joly, F., Lazaro, C., Lok, C., Mahner, S., Marmé, F., Marth, C., Mccluggage, W. G., Mcneish, I. A., Morice, P., Nicum, S., Oaknin, A., Pérez-Fidalgo, J. A., Pignata, S., Ramirez, P. T., Ray-Coquard, I., Romero, I., Scambia, Giovanni, Sehouli, J., Shapira-Frommer, R., Sundar, S., Tan, D. S. P., Taskiran, C., van Driel, W. J., Vergote, I., Planchamp, F., Sessa, C., Fagotti, Anna, Lorusso, D., Scambia, G. (ORCID:0000-0003-2758-1063), and Fagotti, A. (ORCID:0000-0001-5579-335X)

Abstract

The European Society of Gynaecological Oncology, the European Society for Medical Oncology (ESMO) and the European Society of Pathology held a consensus conference (CC) on ovarian cancer on 15-16 June 2022 in Valencia, Spain. The CC panel included 44 experts in the management of ovarian cancer and pathology, an ESMO scientific advisor and a methodologist. The aim was to discuss new or contentious topics and develop recommendations to improve and harmonise the management of patients with ovarian cancer. Eighteen questions were identified for discussion under four main topics: (i) pathology and molecular biology, (ii) early-stage disease and pelvic mass in pregnancy, (iii) advanced stage (including older/frail patients) and (iv) recurrent disease. The panel was divided into four working groups (WGs) to each address questions relating to one of the four topics outlined above, based on their expertise. Relevant scientific literature was reviewed in advance. Recommendations were developed by the WGs and then presented to the entire panel for further discussion and amendment before voting. This manuscript focuses on the recommendation statements that reached a consensus, their voting results and a summary of evidence supporting each recommendation.

Published
2024

10. PARP inhibitor predictive value of the Leuven HRD test compared with Myriad MyChoice CDx PLUS HRD on 468 ovarian cancer patients from the PAOLA-1/ENGOT-ov25 trial

Author

Loverix L., Vergote I., Busschaert P., Vanderstichele A., Venken T., Boeckx B., Harter P., Brems H., Van Nieuwenhuysen E., Pignata S., Baert T., Gonzalez-Martin A., Han S., Marth C., Neven P., Colombo N., Berteloot P., Mäenpää J., Olbrecht S., Laga T., Sablon E., Ray-Coquard I., Pujade-Lauraine E., Lambrechts D., Van Gorp T., Loverix, L, Vergote, I, Busschaert, P, Vanderstichele, A, Venken, T, Boeckx, B, Harter, P, Brems, H, Van Nieuwenhuysen, E, Pignata, S, Baert, T, Gonzalez-Martin, A, Han, S, Marth, C, Neven, P, Colombo, N, Berteloot, P, Mäenpää, J, Olbrecht, S, Laga, T, Sablon, E, Ray-Coquard, I, Pujade-Lauraine, E, Lambrechts, D, and Van Gorp, T

Subjects
Targeted therapy, Cancer Research, PARP inhibitor, Oncology, Ovarian cancer, HRD testing, Leuven HRD test
Abstract

Background: The PAOLA-1/ENGOT-ov25 trial showed improved progression-free (PFS) and overall survival (OS) in homologous recombination deficient (HRD) positive patients treated with olaparib, but not when HRD negative (HRD tested with MyChoice CDx PLUS [Myriad test]). Patients and methods: The academic Leuven HRD test consists of capture-based targeted sequencing of genome-wide single-nucleotide polymorphisms and coding exons of eight HR genes including BRCA1, BRCA2, and TP53. We compared the predictive value of the Leuven HRD versus Myriad HRD test for PFS and OS in the randomised PAOLA-1 trial. Results: 468 patients had left-over DNA after Myriad testing for Leuven HRD testing. Positive/negative/overall percent agreement for the Leuven versus Myriad HRD status was 95%/86%/91%, respectively. Tumours were HRD+ in 55% and 52%, respectively. In Leuven HRD+ patients, 5 years PFS (5yPFS) was 48.6% versus 20.3% (HR 0.431; 95% confidence intervals (CI) 0.312–0.595) for olaparib versus placebo, respectively (Myriad test 0.409; 95% CI 0.292–0.572). In Leuven HRD+/BRCAwt patients 5yPFS was 41.3% versus 12.6% (HR 0.497; 95% CI 0.316–0.783), and 43.6% versus 13.3% (HR 0.435; 95% CI 0.261–0.727) for the Myriad test. 5yOS was prolonged in the HRD+ subgroup with both tests 67.2% versus 54.4% (HR 0.663; 95% CI 0.442–0.995) for the Leuven test, and 68.0% versus 51.8% (HR 0.596 95% CI 0.393–0.904) for the Myriad test. HRD status was undetermined in 10.7% and 9.4% of the samples, respectively. Conclusions: A robust correlation between the Leuven HRD and Myriad test was observed. For HRD+ tumours, the academic Leuven HRD showed a similar difference in PFS and OS as the Myriad test.

Published
2023

12. PARP inhibitor predictive value of the Leuven HRD test compared with Myriad MyChoice CDx PLUS HRD on 468 ovarian cancer patients from the PAOLA-1/ENGOT-ov25 trial

Author

Loverix, L, Vergote, I, Busschaert, P, Vanderstichele, A, Venken, T, Boeckx, B, Harter, P, Brems, H, Van Nieuwenhuysen, E, Pignata, S, Baert, T, Gonzalez-Martin, A, Han, S, Marth, C, Neven, P, Colombo, N, Berteloot, P, Mäenpää, J, Olbrecht, S, Laga, T, Sablon, E, Ray-Coquard, I, Pujade-Lauraine, E, Lambrechts, D, Van Gorp, T, Loverix L., Vergote I., Busschaert P., Vanderstichele A., Venken T., Boeckx B., Harter P., Brems H., Van Nieuwenhuysen E., Pignata S., Baert T., Gonzalez-Martin A., Han S., Marth C., Neven P., Colombo N., Berteloot P., Mäenpää J., Olbrecht S., Laga T., Sablon E., Ray-Coquard I., Pujade-Lauraine E., Lambrechts D., Van Gorp T., Loverix, L, Vergote, I, Busschaert, P, Vanderstichele, A, Venken, T, Boeckx, B, Harter, P, Brems, H, Van Nieuwenhuysen, E, Pignata, S, Baert, T, Gonzalez-Martin, A, Han, S, Marth, C, Neven, P, Colombo, N, Berteloot, P, Mäenpää, J, Olbrecht, S, Laga, T, Sablon, E, Ray-Coquard, I, Pujade-Lauraine, E, Lambrechts, D, Van Gorp, T, Loverix L., Vergote I., Busschaert P., Vanderstichele A., Venken T., Boeckx B., Harter P., Brems H., Van Nieuwenhuysen E., Pignata S., Baert T., Gonzalez-Martin A., Han S., Marth C., Neven P., Colombo N., Berteloot P., Mäenpää J., Olbrecht S., Laga T., Sablon E., Ray-Coquard I., Pujade-Lauraine E., Lambrechts D., and Van Gorp T.

Abstract

Background: The PAOLA-1/ENGOT-ov25 trial showed improved progression-free (PFS) and overall survival (OS) in homologous recombination deficient (HRD) positive patients treated with olaparib, but not when HRD negative (HRD tested with MyChoice CDx PLUS [Myriad test]). Patients and methods: The academic Leuven HRD test consists of capture-based targeted sequencing of genome-wide single-nucleotide polymorphisms and coding exons of eight HR genes including BRCA1, BRCA2, and TP53. We compared the predictive value of the Leuven HRD versus Myriad HRD test for PFS and OS in the randomised PAOLA-1 trial. Results: 468 patients had left-over DNA after Myriad testing for Leuven HRD testing. Positive/negative/overall percent agreement for the Leuven versus Myriad HRD status was 95%/86%/91%, respectively. Tumours were HRD+ in 55% and 52%, respectively. In Leuven HRD+ patients, 5 years PFS (5yPFS) was 48.6% versus 20.3% (HR 0.431; 95% confidence intervals (CI) 0.312–0.595) for olaparib versus placebo, respectively (Myriad test 0.409; 95% CI 0.292–0.572). In Leuven HRD+/BRCAwt patients 5yPFS was 41.3% versus 12.6% (HR 0.497; 95% CI 0.316–0.783), and 43.6% versus 13.3% (HR 0.435; 95% CI 0.261–0.727) for the Myriad test. 5yOS was prolonged in the HRD+ subgroup with both tests 67.2% versus 54.4% (HR 0.663; 95% CI 0.442–0.995) for the Leuven test, and 68.0% versus 51.8% (HR 0.596 95% CI 0.393–0.904) for the Myriad test. HRD status was undetermined in 10.7% and 9.4% of the samples, respectively. Conclusions: A robust correlation between the Leuven HRD and Myriad test was observed. For HRD+ tumours, the academic Leuven HRD showed a similar difference in PFS and OS as the Myriad test.

Published
2023

13. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): A randomised, multicentre, double-blind, placebo-controlled phase 3 trial

Author

Monk, BJ, Poveda, A, Vergote, I, Raspagliesi, F, Fujiwara, K, Bae, DS, Oaknin, A, Ray-Coquard, I, Provencher, DM, Karlan, BY, Lhommé, C, Richardson, G, Rincón, DG, Coleman, RL, Herzog, TJ, Marth, C, Brize, A, Fabbro, M, Redondo, A, Bamias, A, Tassoudji, M, Navale, L, Warner, DJ, and Oza, AM

Subjects
Oncology & Carcinogenesis, Oncology and Carcinogenesis
Abstract

Background: Angiogenesis is a valid target in the treatment of epithelial ovarian cancer. Trebananib inhibits the binding of angiopoietins 1 and 2 to the Tie2 receptor, and thereby inhibits angiogenesis. We aimed to assess whether the addition of trebananib to single-agent weekly paclitaxel in patients with recurrent epithelial ovarian cancer improved progression-free survival. Methods: For this randomised, double-blind phase 3 study undertaken between Nov 10, 2010, and Nov 19, 2012, we enrolled women with recurrent epithelial ovarian cancer from 32 countries. Patient eligibility criteria included having been treated with three or fewer previous regimens, and a platinum-free interval of less than 12 months. We enrolled patients with a computerised interactive voice response system, and patients were randomly assigned using a permuted block method (block size of four) in a 1:1 ratio to receive weekly intravenous paclitaxel (80 mg/m2) plus either weekly masked intravenous placebo or trebananib (15 mg/kg). Patients were stratified on the basis of platinum-free interval (≥0 and ≤6 months vs >6 and ≤12 months), presence or absence of measurable disease, and region (North America, western Europe and Australia, or rest of world). The sponsor, investigators, site staff, and patients were masked to the treatment assignment. The primary endpoint was progression-free survival assessed in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT01204749, and is no longer accruing patients. Findings: 919 patients were enrolled, of whom 461 were randomly assigned to the trebananib group and 458 to the placebo group. Median progression-free survival was significantly longer in the trebananib group than in the placebo group (7·2 months [5·8-7·4] vs 5·4 months [95% CI 4·3-5·5], respectively, hazard ratio 0·66, 95% CI 0·57-0·77, p

Published
2014

19. Endometrial cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up ☆

Author

Oaknin, A, Bosse, T, Creutzberg, C, Giornelli, G, Harter, P, Joly, F, Lorusso, D, Marth, C, Makker, V, Mirza, M, Ledermann, J, Colombo, N, Oaknin A., Bosse T. J., Creutzberg C. L., Giornelli G., Harter P., Joly F., Lorusso D., Marth C., Makker V., Mirza M. R., Ledermann J. A., Colombo N., Oaknin, A, Bosse, T, Creutzberg, C, Giornelli, G, Harter, P, Joly, F, Lorusso, D, Marth, C, Makker, V, Mirza, M, Ledermann, J, Colombo, N, Oaknin A., Bosse T. J., Creutzberg C. L., Giornelli G., Harter P., Joly F., Lorusso D., Marth C., Makker V., Mirza M. R., Ledermann J. A., and Colombo N.

Published
2022

20. European experts consensus: BRCA/homologous recombination deficiency testing in first-line ovarian cancer

Author

Vergote, I, Gonzalez-Martin, A, Ray-Coquard, I, Harter, P, Colombo, N, Pujol, P, Lorusso, D, Mirza, M, Brasiuniene, B, Madry, R, Brenton, J, Ausems, M, Buttner, R, Lambrechts, D, Abreu, M, Balboni, S, Banerjee, S, Barberis, M, Barretina Ginesta, M, Baurain, J, Bignami, M, Bjorge, L, Blecharz, P, Bruchim, I, Capilna, M, Cerana, N, Cicchetti, A, Collins, D, Concin, N, D'Incalci, M, Davidson, B, de la Motte Rouge, T, De Iaco, P, Demirkiran, F, Denys, H, Doerk, T, Dorum, A, Ferrero, A, Fidalgo, A, Genuardi, M, Gladieff, L, Glasspool, R, Grimm, C, Gultekin, M, Hahnen, E, Hasenburg, A, Hegmane, A, Heinzelmann, V, Hogdall, E, Janavicius, R, Jarmalaite, S, Kalachand, R, Kaneva, R, Kilickap, S, Kocian, R, Kolencik, D, Kristeleit, R, Kryzhanivska, A, Leary, A, Lemley, B, Ligtenberg, M, Lopez-Guerrero, J, Lord, C, Avall-Lundqvist, E, Maenpaa, J, Mahner, S, Marme, F, Marth, C, Mcneish, I, Merkelbach-Bruse, S, Mourits, M, Normanno, N, Oaknin, A, Ojamaa, K, Papdimitriou, C, Penault-Llorca, F, Perrone, A, Pignata, S, Pikarsky, E, Rouleau, E, Rubio, M, Sapino, A, Schmalfeldt, B, Sehouli, J, Shapira, R, Steffensen, K, Sukhin, V, Syrios, J, Szallasi, Z, Taskiran, C, Terzic, M, Tischkowitz, M, Toth, I, Van de Vijver, K, Vardar, M, Wasag, B, Wimberger, P, Witteveen, E, Vergote I., Gonzalez-Martin A., Ray-Coquard I., Harter P., Colombo N., Pujol P., Lorusso D., Mirza M. R., Brasiuniene B., Madry R., Brenton J. D., Ausems M. G. E. M., Buttner R., Lambrechts D., Ausems M., Brenton J., Abreu M., Balboni S., Banerjee S., Barberis M., Barretina Ginesta M. P., Baurain J. -F., Bignami M., Bjorge L., Blecharz P., Bruchim I., Capilna M., Cerana N., Cicchetti A., Collins D., Concin N., D'Incalci M., Davidson B., de la Motte Rouge T., De Iaco P., Demirkiran F., Denys H., Doerk T., Dorum A., Ferrero A., Fidalgo A. P., Genuardi M., Gladieff L., Glasspool R., Grimm C., Gultekin M., Hahnen E., Hasenburg A., Hegmane A., Heinzelmann V., Hogdall E., Janavicius R., Jarmalaite S., Kalachand R., Kaneva R., Kilickap S., Kocian R., Kolencik D., Kristeleit R., Kryzhanivska A., Leary A., Lemley B., Ligtenberg M., Lopez-Guerrero J. A., Lord C. J., Avall-Lundqvist E., Maenpaa J., Mahner S., Marme F., Marth C., McNeish I., Merkelbach-Bruse S., Mourits M., Normanno N., Oaknin A., Ojamaa K., Papdimitriou C., Penault-Llorca F., Perrone A. M., Pignata S., Pikarsky E., Rouleau E., Rubio M., Sapino A., Schmalfeldt B., Sehouli J., Shapira R., Steffensen K. D., Sukhin V., Syrios J., Szallasi Z., Taskiran C., Terzic M., Tischkowitz M., Toth I., Van de Vijver K., Vardar M. A., Wasag B., Wimberger P., Witteveen E., Vergote, I, Gonzalez-Martin, A, Ray-Coquard, I, Harter, P, Colombo, N, Pujol, P, Lorusso, D, Mirza, M, Brasiuniene, B, Madry, R, Brenton, J, Ausems, M, Buttner, R, Lambrechts, D, Abreu, M, Balboni, S, Banerjee, S, Barberis, M, Barretina Ginesta, M, Baurain, J, Bignami, M, Bjorge, L, Blecharz, P, Bruchim, I, Capilna, M, Cerana, N, Cicchetti, A, Collins, D, Concin, N, D'Incalci, M, Davidson, B, de la Motte Rouge, T, De Iaco, P, Demirkiran, F, Denys, H, Doerk, T, Dorum, A, Ferrero, A, Fidalgo, A, Genuardi, M, Gladieff, L, Glasspool, R, Grimm, C, Gultekin, M, Hahnen, E, Hasenburg, A, Hegmane, A, Heinzelmann, V, Hogdall, E, Janavicius, R, Jarmalaite, S, Kalachand, R, Kaneva, R, Kilickap, S, Kocian, R, Kolencik, D, Kristeleit, R, Kryzhanivska, A, Leary, A, Lemley, B, Ligtenberg, M, Lopez-Guerrero, J, Lord, C, Avall-Lundqvist, E, Maenpaa, J, Mahner, S, Marme, F, Marth, C, Mcneish, I, Merkelbach-Bruse, S, Mourits, M, Normanno, N, Oaknin, A, Ojamaa, K, Papdimitriou, C, Penault-Llorca, F, Perrone, A, Pignata, S, Pikarsky, E, Rouleau, E, Rubio, M, Sapino, A, Schmalfeldt, B, Sehouli, J, Shapira, R, Steffensen, K, Sukhin, V, Syrios, J, Szallasi, Z, Taskiran, C, Terzic, M, Tischkowitz, M, Toth, I, Van de Vijver, K, Vardar, M, Wasag, B, Wimberger, P, Witteveen, E, Vergote I., Gonzalez-Martin A., Ray-Coquard I., Harter P., Colombo N., Pujol P., Lorusso D., Mirza M. R., Brasiuniene B., Madry R., Brenton J. D., Ausems M. G. E. M., Buttner R., Lambrechts D., Ausems M., Brenton J., Abreu M., Balboni S., Banerjee S., Barberis M., Barretina Ginesta M. P., Baurain J. -F., Bignami M., Bjorge L., Blecharz P., Bruchim I., Capilna M., Cerana N., Cicchetti A., Collins D., Concin N., D'Incalci M., Davidson B., de la Motte Rouge T., De Iaco P., Demirkiran F., Denys H., Doerk T., Dorum A., Ferrero A., Fidalgo A. P., Genuardi M., Gladieff L., Glasspool R., Grimm C., Gultekin M., Hahnen E., Hasenburg A., Hegmane A., Heinzelmann V., Hogdall E., Janavicius R., Jarmalaite S., Kalachand R., Kaneva R., Kilickap S., Kocian R., Kolencik D., Kristeleit R., Kryzhanivska A., Leary A., Lemley B., Ligtenberg M., Lopez-Guerrero J. A., Lord C. J., Avall-Lundqvist E., Maenpaa J., Mahner S., Marme F., Marth C., McNeish I., Merkelbach-Bruse S., Mourits M., Normanno N., Oaknin A., Ojamaa K., Papdimitriou C., Penault-Llorca F., Perrone A. M., Pignata S., Pikarsky E., Rouleau E., Rubio M., Sapino A., Schmalfeldt B., Sehouli J., Shapira R., Steffensen K. D., Sukhin V., Syrios J., Szallasi Z., Taskiran C., Terzic M., Tischkowitz M., Toth I., Van de Vijver K., Vardar M. A., Wasag B., Wimberger P., and Witteveen E.

Abstract

Background: Homologous recombination repair (HRR) enables fault-free repair of double-stranded DNA breaks. HRR deficiency is predicted to occur in around half of high-grade serous ovarian carcinomas. Ovarian cancers harbouring HRR deficiency typically exhibit sensitivity to poly-ADP ribose polymerase inhibitors (PARPi). Current guidelines recommend a range of approaches for genetic testing to identify predictors of sensitivity to PARPi in ovarian cancer and to identify genetic predisposition. Design: To establish a European-wide consensus for genetic testing (including the genetic care pathway), decision making and clinical management of patients with recently diagnosed advanced ovarian cancer, and the validity of biomarkers to predict the effectiveness of PARPi in the first-line setting. The collaborative European experts’ consensus group consisted of a steering committee (n = 14) and contributors (n = 84). A (modified) Delphi process was used to establish consensus statements based on a systematic literature search, conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Results: A consensus was reached on 34 statements amongst 98 caregivers (including oncologists, pathologists, clinical geneticists, genetic researchers, and patient advocates). The statements concentrated on (i) the value of testing for BRCA1/2 mutations and HRR deficiency testing, including when and whom to test; (ii) the importance of developing new and better HRR deficiency tests; (iii) the importance of germline non-BRCA HRR and mismatch repair gene mutations for predicting familial risk, but not for predicting sensitivity to PARPi, in the first-line setting; (iv) who should be able to inform patients about genetic testing, and what training and education should these caregivers receive. Conclusion: These consensus recommendations, from a multidisciplinary panel of experts from across Europe, provide clear guidance on the use of BRCA and HRR de

Published
2022

21. The use of PIPAC (pressurized intraperitoneal aerosol chemotherapy) in gynecological oncology: a statement by the German “Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR)”, the Swiss and Austrian AGO, and the North-Eastern German Society of Gynaecologic Oncology

Author

Dueckelmann, A. M., Fink, D., Harter, P., Heinzelmann, V., Marth, C., Mueller, M., Reinthaller, A., Tamussino, K., Wimberger, P., and Sehouli, J.

Published
2018
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22. Multizentrische, retrospektive Kohortenstudie zur Erhebung der Inzidenz der Medikamenten-assoziierten Kiefernekrose bei Patient:innen mit primär oder sekundär ossär metastasiertem Mammakarzinom

Author

Baumgart, F, additional, Egle, D, additional, Ritter, M, additional, Marth, C, additional, Laimer, J, additional, Walch, B, additional, Iannetti, C, additional, Wöll, E, additional, Zabernigg, A, additional, Pinzger, G, additional, Volgger, B, additional, Andraschofsky, T O, additional, Markl, A, additional, Hubalek, M, additional, Siebert, U, additional, Arvandi, M, additional, and Brunner, C, additional

Published
2023
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24. CDK12/13 inhibition in ovarian cancer cell lines

Author

Fiegl, H, additional, Hovdar, L, additional, Handle, F, additional, Santer, F, additional, Tsibulak, I, additional, Wieser, V, additional, Ausserlechner, M J, additional, Schnaiter, S, additional, Zeimet, A G, additional, and Marth, C, additional

Published
2023
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26. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial

Author

Ray-Coquard, I, Leary, A, Pignata, S, Cropet, C, González-Martin, A, Marth, C, Nagao, S, Vergote, I, Colombo, N, Mäenpää, J, Selle, F, Sehouli, J, Lorusso, D, Alia, E, Bogner, G, Yoshida, H, Lefeuvre-Plesse, C, Buderath, P, Mosconi, A, Lortholary, A, Burges, A, Medioni, J, El-Balat, A, Rodrigues, M, Park-Simon, T, Dubot, C, Denschlag, D, You, B, Pujade-Lauraine, E, Harter, P, Alia, E M Guerra, Mosconi, A M, Park-Simon, T-W, Ray-Coquard, I, Leary, A, Pignata, S, Cropet, C, González-Martin, A, Marth, C, Nagao, S, Vergote, I, Colombo, N, Mäenpää, J, Selle, F, Sehouli, J, Lorusso, D, Alia, E, Bogner, G, Yoshida, H, Lefeuvre-Plesse, C, Buderath, P, Mosconi, A, Lortholary, A, Burges, A, Medioni, J, El-Balat, A, Rodrigues, M, Park-Simon, T, Dubot, C, Denschlag, D, You, B, Pujade-Lauraine, E, Harter, P, Alia, E M Guerra, Mosconi, A M, and Park-Simon, T-W

Abstract

Background: In the PAOLA-1/ENGOT-ov25 primary analysis, maintenance olaparib plus bevacizumab demonstrated a significant progression-free survival (PFS) benefit in newly diagnosed advanced ovarian cancer patients in clinical response after first-line platinum-based chemotherapy plus bevacizumab, irrespective of surgical status. Prespecified, exploratory analyses by molecular biomarker status showed substantial benefit in patients with a BRCA1/BRCA2 mutation (BRCAm) or homologous recombination deficiency (HRD; BRCAm and/or genomic instability). We report the prespecified final overall survival (OS) analysis, including analyses by HRD status. Patients and methods: Patients were randomized 2 : 1 to olaparib (300 mg twice daily; up to 24 months) plus bevacizumab (15 mg/kg every 3 weeks; 15 months total) or placebo plus bevacizumab. Analysis of OS, a key secondary endpoint in hierarchical testing, was planned for ∼60% maturity or 3 years after the primary analysis. Results: After median follow-up of 61.7 and 61.9 months in the olaparib and placebo arms, respectively, median OS was 56.5 versus 51.6 months in the intention-to-treat population [hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.76-1.12; P = 0.4118]. Subsequent poly(ADP-ribose) polymerase inhibitor therapy was received by 105 (19.6%) olaparib patients versus 123 (45.7%) placebo patients. In the HRD-positive population, OS was longer with olaparib plus bevacizumab (HR 0.62, 95% CI 0.45-0.85; 5-year OS rate, 65.5% versus 48.4%); at 5 years, updated PFS also showed a higher proportion of olaparib plus bevacizumab patients without relapse (HR 0.41, 95% CI 0.32-0.54; 5-year PFS rate, 46.1% versus 19.2%). Myelodysplastic syndrome, acute myeloid leukemia, aplastic anemia, and new primary malignancy incidence remained low and balanced between arms. Conclusions: Olaparib plus bevacizumab provided clinically meaningful OS improvement for first-line patients with HRD-positive ovarian cancer. These prespecified expl

Published
2023

28. 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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29. Frühes Ovarialkarzinom (FIGO Stadium I–IIA)

Author

Petru, E., Benedicic, C., Kimmig, R., and Marth, C.

Abstract

Zusammenfassung: Etwa 25% der Ovarialkarzinome werden im FIGO-Stadium I, etwa 7% im Stadium IIA diagnostiziert. Die Verdachtsdiagnose eines Ovarialkarzinoms macht immer eine operative Abklärung mit histologischer Diagnosesicherung durch Laparotomie oder evtl. Laparoskopie notwendig, da es präoperativ unmöglich ist, mit halbwegs akzeptabler Sicherheit abzuschätzen, dass es sich um ein Frühstadium eines Ovarialkarzinoms handelt. Der Nachweis eines einzigen positiven Lymphknotens bedeutet, dass die Erkrankung einem FIGO-Stadium IIIc zuzuordnen ist. Im klinischen Stadium I oder II liegt in 31% tatsächlich ein höheres Stadium vor, da sich intraoperativ Metastasen im Omentum majus, Peritoneum oder den Lymphknoten finden. Die Primäroperation umfasst ein operatives Staging per Abdominallängsschnitt und eine Radikaloperation mit dem Ziel der Feststellung des Ausmaßes der Erkrankung sowie einer primären maximalen Tumorreduktion im Becken und Abdomen einschließlich pelviner und paraaortaler Lymphadenektomie. Ungünstige Prognosefaktoren beim FIGO-Stadium I sind v. a. eine intraoperative Kapselruptur und ein Grading G3.

Published
2024
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32. 3P NaPi2b expression in high grade serous ovarian cancer: Results from combined data sets

Author

Banerjee, S., primary, Richardson, D.L., additional, Concin, N., additional, Monk, B.J., additional, Mirza, M.R., additional, Coleman, R.L., additional, Ray-Coquard, I.L., additional, Pothuri, B., additional, Marth, C., additional, Demars, L., additional, Bradshaw, C., additional, Dicristo, C., additional, Mosher, R., additional, and Drapkin, R., additional

Published
2023
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33. 39MO Clinical evaluation of a low-coverage whole-genome test for homologous recombination deficiency detection in ovarian cancer

Author

Boidot, R., primary, Blum, M.G.B., additional, Wissler, M-P., additional, Gottin, C., additional, Ruzicka, J., additional, Duforet-Frebourg, N., additional, Jeanniard, A., additional, Just, P-A., additional, Harter, P., additional, Pignata, S., additional, Gonzalez Martin, A.J., additional, Marth, C., additional, Mäenpää, J., additional, Colombo, N., additional, Vergote, I.B., additional, Fujiwara, K., additional, Bertrand, D., additional, Philippe, N., additional, Ray-Coquard, I.L., additional, and Pujade-Lauraine, E., additional

Published
2023
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35. 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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36. LIO-1: Initiale Phase 2 Erfahrung mit Lucitanib + Nivolumab bei Patientinnen mit persistierendem oder rezidiviertem Zervixkarzinom (NCT04042116; ENGOT-GYN3/AGO/LIO)

Author

Heitz, F, additional, Oaknin, A, additional, Backes, FJ, additional, Van Nieuwenhuysen, E, additional, Eskander, RN, additional, González-Martín, A, additional, Makker, V, additional, Marth, C, additional, Patel, M, additional, Penson, RT, additional, Redondo, A, additional, Pérez, MJR, additional, Hamilton, E, additional, Wimberger, P, additional, Concin, N, additional, Go, J, additional, Wride, K, additional, Lepley, D, additional, Dusek, R, additional, Cameron, T, additional, and Pignata, S, additional

Published
2022
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37. 1524P Epidemiology and demography of gynecological sarcoma: Results of the prospective intergroup registry for gynecological sarcoma REGSA (NOGGO RU1)

Author

Roser, E., primary, Noack, A-S., additional, Zocholl, D., additional, Kommoss, S., additional, Harter, P., additional, Kalder, M., additional, Egger, E.K., additional, Buderath, P., additional, Marth, C., additional, Ulrich, U., additional, Klar, M., additional, Weigel, M., additional, Traub, L., additional, Strauß, H-G., additional, Hanker, L., additional, Pölcher, M., additional, Wimberger, P., additional, Beck, F., additional, Pietzner, K., additional, and Sehouli, J., additional

Published
2022
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40. 764P How long is long enough? An international survey exploring practice variations on the recommended duration of maintenance therapy with PARP inhibitors in platinum sensitive recurrent ovarian cancer and long-term outcomes

Author

Haggstrom, L.R., Lee, Y.C., Scott, C.L., Ledermann, J.A., Gourley, C., McNeish, I., Amant, F., Ray-Coquard, I.L., Leary, A., Oza, A.M., Tinker, A., González-Martín, A., Cecere, S.C., Colombo, N., Yoshida, H., Marth, C., Gomez Garcia, E.M., Tan, D.S., Moore, K.N., and Friedlander, M.L.

Published
2024
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42. Population-adjusted indirect treatment comparison of the SOLO1 and PAOLA-1/ENGOT-ov25 trials evaluating maintenance olaparib or bevacizumab or the combination of both in newly diagnosed, advanced BRCA-mutated ovarian cancer

Author

Vergote, I, Ray-Coquard, I, Anderson, D, Cantuaria, G, Colombo, N, Garnier-Tixidre, C, Gilbert, L, Harter, P, Hettle, R, Lorusso, D, Maenpaa, J, Marth, C, Matsumoto, K, Ouwens, M, Poveda, A, Raspagliesi, F, Rhodes, K, Rubio Perez, M, Shapira-Frommer, R, Shikama, A, Sikorska, M, Moore, K, Disilvestro, P, Vergote I., Ray-Coquard I., Anderson D. M., Cantuaria G., Colombo N., Garnier-Tixidre C., Gilbert L., Harter P., Hettle R., Lorusso D., Maenpaa J., Marth C., Matsumoto K., Ouwens M., Poveda A., Raspagliesi F., Rhodes K., Rubio Perez M. J., Shapira-Frommer R., Shikama A., Sikorska M., Moore K., DiSilvestro P., Vergote, I, Ray-Coquard, I, Anderson, D, Cantuaria, G, Colombo, N, Garnier-Tixidre, C, Gilbert, L, Harter, P, Hettle, R, Lorusso, D, Maenpaa, J, Marth, C, Matsumoto, K, Ouwens, M, Poveda, A, Raspagliesi, F, Rhodes, K, Rubio Perez, M, Shapira-Frommer, R, Shikama, A, Sikorska, M, Moore, K, Disilvestro, P, Vergote I., Ray-Coquard I., Anderson D. M., Cantuaria G., Colombo N., Garnier-Tixidre C., Gilbert L., Harter P., Hettle R., Lorusso D., Maenpaa J., Marth C., Matsumoto K., Ouwens M., Poveda A., Raspagliesi F., Rhodes K., Rubio Perez M. J., Shapira-Frommer R., Shikama A., Sikorska M., Moore K., and DiSilvestro P.

Abstract

Background: In the absence of randomised head-to-head trials, we conducted a population-adjusted indirect treatment comparison (PA-ITC) of phase III trial data to evaluate the relative efficacy and safety of maintenance olaparib and bevacizumab alone and in combination in patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation (BRCAm). Methods: An unanchored PA-ITC was performed on investigator-assessed progression-free survival (PFS) data. Individual patient data from SOLO1 (olaparib versus placebo) and from BRCA-mutated patients in PAOLA-1/ENGOT-ov25 (olaparib plus bevacizumab versus placebo plus bevacizumab) were pooled. Each arm of PAOLA-1 was weighted so that key baseline patient characteristics were similar to the SOLO1 cohort. Analyses were performed in patients with complete baseline data. Weighted Cox regression analysis was used to estimate the comparative efficacy of different maintenance therapy strategies, supplemented by weighted Kaplan–Meier analyses. Results: Data from SOLO1 patients (olaparib, n = 254; placebo, n = 126) were compared with data from BRCA-mutated PAOLA-1 patients (olaparib plus bevacizumab, n = 151; placebo plus bevacizumab, n = 71). Adding bevacizumab to olaparib was associated with a numerical improvement in PFS compared with olaparib alone (hazard ratio [HR] 0.71; 95% confidence interval [CI] 0.45–1.09). Statistically significant improvements in PFS were seen with olaparib alone versus placebo plus bevacizumab (HR 0.48; 95% CI 0.30–0.75), olaparib plus bevacizumab versus placebo (0.23; 0.14–0.34), and placebo plus bevacizumab versus placebo (0.65; 0.43–0.95). Conclusions: Results of this hypothesis-generating PA-ITC analysis support the use of maintenance olaparib alone or with bevacizumab in patients with newly diagnosed, advanced ovarian cancer and a BRCAm.

Published
2021

43. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma

Author

Concin, N, Matias-Guiu, X, Vergote, I, Cibula, D, Mirza, M, Marnitz, S, Ledermann, J, Bosse, T, Chargari, C, Fagotti, A, Fotopoulou, C, Gonzalez Martin, A, Lax, S, Lorusso, D, Marth, C, Morice, P, Nout, R, O'Donnell, D, Querleu, D, Raspollini, M, Sehouli, J, Sturdza, A, Taylor, A, Westermann, A, Wimberger, P, Colombo, N, Planchamp, F, Creutzberg, C, Concin N., Matias-Guiu X., Vergote I., Cibula D., Mirza M. R., Marnitz S., Ledermann J., Bosse T., Chargari C., Fagotti A., Fotopoulou C., Gonzalez Martin A., Lax S., Lorusso D., Marth C., Morice P., Nout R. A., O'Donnell D., Querleu D., Raspollini M. R., Sehouli J., Sturdza A., Taylor A., Westermann A., Wimberger P., Colombo N., Planchamp F., Creutzberg C. L., Concin, N, Matias-Guiu, X, Vergote, I, Cibula, D, Mirza, M, Marnitz, S, Ledermann, J, Bosse, T, Chargari, C, Fagotti, A, Fotopoulou, C, Gonzalez Martin, A, Lax, S, Lorusso, D, Marth, C, Morice, P, Nout, R, O'Donnell, D, Querleu, D, Raspollini, M, Sehouli, J, Sturdza, A, Taylor, A, Westermann, A, Wimberger, P, Colombo, N, Planchamp, F, Creutzberg, C, Concin N., Matias-Guiu X., Vergote I., Cibula D., Mirza M. R., Marnitz S., Ledermann J., Bosse T., Chargari C., Fagotti A., Fotopoulou C., Gonzalez Martin A., Lax S., Lorusso D., Marth C., Morice P., Nout R. A., O'Donnell D., Querleu D., Raspollini M. R., Sehouli J., Sturdza A., Taylor A., Westermann A., Wimberger P., Colombo N., Planchamp F., and Creutzberg C. L.

Abstract

A European consensus conference on endometrial carcinoma was held in 2014 to produce multi-disciplinary evidence-based guidelines on selected questions. Given the large body of literature on the management of endometrial carcinoma published since 2014, the European Society of Gynaecological Oncology (ESGO), the European SocieTy for Radiotherapy and Oncology (ESTRO), and the European Society of Pathology (ESP) jointly decided to update these evidence-based guidelines and to cover new topics in order to improve the quality of care for women with endometrial carcinoma across Europe and worldwide.

Published
2021

46. Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001.

Author

Marth C., Tarnawski R., Tyulyandina A., Pignata S., Gilbert L., Kaen D., Rubio M.J., Frentzas S., Beiner M., Magallanes-Maciel M., Farrelly L., Choi C.H., Berger R., Lee C., Vulsteke C., Hasegawa K., Braicu E.I., Wu X., McKenzie J., Lee J.J., Makker V., Marth C., Tarnawski R., Tyulyandina A., Pignata S., Gilbert L., Kaen D., Rubio M.J., Frentzas S., Beiner M., Magallanes-Maciel M., Farrelly L., Choi C.H., Berger R., Lee C., Vulsteke C., Hasegawa K., Braicu E.I., Wu X., McKenzie J., Lee J.J., and Makker V.

Abstract

BACKGROUND: Pembrolizumab plus lenvatinib is a novel combination with promising efficacy in patients with advanced and recurrent endometrial cancer. This combination demonstrated high objective response rates in a single-arm phase 1b/2 trial of lenvatinib plus pembrolizumab in patients with advanced endometrial cancer (KEYNOTE-146/Study 111) after <=2 previous lines of therapy. In a randomized phase 3 trial of lenvatinib in combination with pembrolizumab versus treatment of physician's choice in patients with advanced endometrial cancer (KEYNOTE-775/Study 309), after 1-2 previous lines of therapy (including neoadjuvant/adjuvant), this combination improved objective response rates, progression-free survival, and overall survival compared with chemotherapy. PRIMARY OBJECTIVE: To compare the efficacy and safety of first-line pembrolizumab plus lenvatinib versus paclitaxel plus carboplatin in patients with newly diagnosed stage III/IV or recurrent endometrial cancer, with measurable or radiographically apparent disease. STUDY HYPOTHESIS: Pembrolizumab plus lenvatinib is superior to chemotherapy with respect to progression-free survival and overall survival in patients with mismatch repair-proficient tumors and all patients (all-comers). TRIAL DESIGN: Phase 3, randomized (1:1), open-label, active-controlled trial. Patients will receive pembrolizumab intravenously every 3 weeks plus lenvatinib orally daily or paclitaxel plus carboplatin intravenously every 3 weeks, stratified by mismatch repair status (proficient vs deficient). Patients with mismatch repair-proficient tumors will be further stratified by Eastern Cooperative Oncology Group performance status (0/1), measurable disease (yes/no), and prior chemotherapy and/or chemoradiation (yes/no). MAJOR INCLUSION/EXCLUSION CRITERIA: Adults with stage III/IV/recurrent histologically confirmed endometrial cancer that is measurable or radiographically apparent per blinded independent central review. Patients may have received

Published
2022

47. Real-life data on treatment and outcomes in advanced ovarian cancer: An observational, multinational cohort study (RESPONSE trial)

Author

Marth, C., Abreu, M.H., Andersen, K.K., Aro, K.M., Batarda, M. de Lurdes, Boll, D., Ekmann-Gade, A.W., Haltia, U.M., Hansen, J., Haug, A.J., Høgdall, C., Korach, J., Lassus, H., Lindemann, K., Nieuwenhuysen, E. Van, Ottevanger, P.B., Polterauer, S., Schnack, T.H., Marth, C., Abreu, M.H., Andersen, K.K., Aro, K.M., Batarda, M. de Lurdes, Boll, D., Ekmann-Gade, A.W., Haltia, U.M., Hansen, J., Haug, A.J., Høgdall, C., Korach, J., Lassus, H., Lindemann, K., Nieuwenhuysen, E. Van, Ottevanger, P.B., Polterauer, S., and Schnack, T.H.

Abstract

Item does not contain fulltext, BACKGROUND: This study aimed to describe the treatment strategies and outcomes for women with newly diagnosed advanced high-grade serous or endometrioid ovarian cancer (OC). METHODS: This observational study collected real-world medical record data from eight Western countries on the diagnostic workup, clinical outcomes, and treatment of adult women with newly diagnosed advanced (Stage III-IV) high-grade serous or endometrioid OC. Patients were selected backward in time from April 1, 2018 (the index date), with a target of 120 patients set per country, followed for ≥20 months. RESULTS: Of the 1119 women included, 66.9% had Stage III disease, 11.7% had a deleterious BRCA mutation, and 26.6% received bevacizumab; 40.8% and 39.3% underwent primary debulking surgery (PDS) and interval debulking surgery (IDS), respectively. Of the patients who underwent PDS, 55.5% had no visible residual disease (VRD); 63.9% of the IDS patients had no VRD. According to physician-assessed responses (at the first assessment after diagnosis and treatment), 53.2% of the total population had a complete response and 25.7% had a partial response to first-line chemotherapy after surgery. After ≥20 months of follow-up, 32.9% of the patients were disease-free, 46.4% had progressive disease, and 20.6% had died. Bevacizumab use had a significant positive effect on overall survival (hazard ratio [HR], 0.62; 95% CI, 0.42-0.91; p = .01). A deleterious BRCA status had a significant positive effect on progression-free survival (HR, 0.60; 95% CI, 0.41-0.84; p < .01). CONCLUSIONS: Women with advanced high-grade serous or endometrioid OC have a poor prognosis. Bevacizumab use and a deleterious BRCA status were found to improve survival in this real-world population. LAY SUMMARY: Patients with advanced (Stage III or IV) ovarian cancer (OC) have a poor prognosis. The standard treatment options of surgery and chemotherapy extend life beyond diagnosis for 5 years or more in only approximately 45% of patients. T

Published
2022

48. Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Author

Vergote, I., Gonzalez-Martin, A., Lorusso, D., Gourley, C., Mirza, M.R., Kurtz, J.E., Okamoto, A., Moore, K., Kridelka, F., McNeish, I., Reuss, A., Votan, B., Bois, A. du, Mahner, S., Ray-Coquard, I., Kohn, E.C., Berek, J.S., Tan, D.S.P., Colombo, N., Zang, R., Concin, N., O'Donnell, D., Rauh-Hain, A., Herrington, C.S., Marth, C., Poveda, A., Fujiwara, K., Stuart, G.C., Ottevanger, N., Oza, A.M., Bookman, M.A., Vergote, I., Gonzalez-Martin, A., Lorusso, D., Gourley, C., Mirza, M.R., Kurtz, J.E., Okamoto, A., Moore, K., Kridelka, F., McNeish, I., Reuss, A., Votan, B., Bois, A. du, Mahner, S., Ray-Coquard, I., Kohn, E.C., Berek, J.S., Tan, D.S.P., Colombo, N., Zang, R., Concin, N., O'Donnell, D., Rauh-Hain, A., Herrington, C.S., Marth, C., Poveda, A., Fujiwara, K., Stuart, G.C., Ottevanger, N., Oza, A.M., and Bookman, M.A.

Abstract

Item does not contain fulltext, 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

49. 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

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