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1,285 results on '"PIGNATA S."'

1. Unraveling the complexity of HRD assessment in ovarian cancer by combining genomic and functional approaches: translational analyses of MITO16-MaNGO-OV-2 trial

Author

Pellegrino, B., Capoluongo, E.D., Bagnoli, M., Arenare, L., Califano, D., Scambia, G., Cecere, S.C., Silini, E.M., Scaglione, G.L., Spina, A., Tognon, G., Campanini, N., Pisano, C., Russo, D., Pettinato, A., Scollo, P., Iemmolo, R., De Cecco, L., Musolino, A., Marchini, S., Beltrame, L., Paracchini, L., Perrone, F., Mezzanzanica, D., and Pignata, S.

Published
2025
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2. MITO END-3: efficacy of avelumab immunotherapy according to molecular profiling in first-line endometrial cancer therapy

Author

Pignata, S., Califano, D., Lorusso, D., Arenare, L., Bartoletti, M., De Giorgi, U., Andreetta, C., Pisano, C., Scambia, G., Lombardi, D., Farolfi, A., Cinieri, S., Passarelli, A., Salutari, V., De Angelis, C., Mignogna, C., Priolo, D., Capoluongo, E.D., Tamberi, S., Scaglione, G.L., Arcangeli, V., De Cecio, R., Scognamiglio, G., Greco, F., Spina, A., Turinetto, M., Russo, D., Carbone, V., Casartelli, C., Schettino, C., and Perrone, F.

Published
2024
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4. 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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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. Alternative academic approaches for testing homologous recombination deficiency in ovarian cancer in the MITO16A/MaNGO-OV2 trial

Author

Capoluongo, E.D., Pellegrino, B., Arenare, L., Califano, D., Scambia, G., Beltrame, L., Serra, V., Scaglione, G.L., Spina, A., Cecere, S.C., De Cecio, R., Normanno, N., Colombo, N., Lorusso, D., Russo, D., Nardelli, C., D’Incalci, M., Llop-Guevara, A., Pisano, C., Baldassarre, G., Mezzanzanica, D., Artioli, G., Setaro, M., Tasca, G., Roma, C., Campanini, N., Cinieri, S., Sergi, A., Musolino, A., Perrone, F., Chiodini, P., Marchini, S., and Pignata, S.

Published
2022
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8. Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial

Author

Frenel, J.S., Kim, J.W., Aryal, N., Asher, R., Berton, D., Vidal, L., Pautier, P., Ledermann, J.A., Penson, R.T., Oza, A.M., Korach, J., Huzarski, T., Pignata, S., Colombo, N., Park-Simon, T.W., Tamura, K., Sonke, G.S., Freimund, A.E., Lee, C.K., and Pujade-Lauraine, E.

Published
2022
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9. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Lorusso, D, Xiang, Y, Hasegawa, K, Scambia, G, Leiva, M, Ramos-Elias, P, Acevedo, A, Cvek, J, Randall, L, Pereira de Santana Gomes, A, Contreras Mejia, F, Helpman, L, Akilli, H, Lee, J, Saevets, V, Zagouri, F, Gilbert, L, Sehouli, J, Tharavichitkul, E, Lindemann, K, Colombo, N, Chang, C, Bednarikova, M, Zhu, H, Oaknin, A, Christiaens, M, Petru, E, Usami, T, Liu, P, Yamada, K, Toker, S, Keefe, S, Pignata, S, Duska, L, Lorusso D., Xiang Y., Hasegawa K., Scambia G., Leiva M., Ramos-Elias P., Acevedo A., Cvek J., Randall L., Pereira de Santana Gomes A. J., Contreras Mejia F., Helpman L., Akilli H., Lee J. -Y., Saevets V., Zagouri F., Gilbert L., Sehouli J., Tharavichitkul E., Lindemann K., Colombo N., Chang C. -L., Bednarikova M., Zhu H., Oaknin A., Christiaens M., Petru E., Usami T., Liu P., Yamada K., Toker S., Keefe S. M., Pignata S., Duska L. R., Lorusso, D, Xiang, Y, Hasegawa, K, Scambia, G, Leiva, M, Ramos-Elias, P, Acevedo, A, Cvek, J, Randall, L, Pereira de Santana Gomes, A, Contreras Mejia, F, Helpman, L, Akilli, H, Lee, J, Saevets, V, Zagouri, F, Gilbert, L, Sehouli, J, Tharavichitkul, E, Lindemann, K, Colombo, N, Chang, C, Bednarikova, M, Zhu, H, Oaknin, A, Christiaens, M, Petru, E, Usami, T, Liu, P, Yamada, K, Toker, S, Keefe, S, Pignata, S, Duska, L, Lorusso D., Xiang Y., Hasegawa K., Scambia G., Leiva M., Ramos-Elias P., Acevedo A., Cvek J., Randall L., Pereira de Santana Gomes A. J., Contreras Mejia F., Helpman L., Akilli H., Lee J. -Y., Saevets V., Zagouri F., Gilbert L., Sehouli J., Tharavichitkul E., Lindemann K., Colombo N., Chang C. -L., Bednarikova M., Zhu H., Oaknin A., Christiaens M., Petru E., Usami T., Liu P., Yamada K., Toker S., Keefe S. M., Pignata S., and Duska L. R.

Abstract

Background: At the first interim analysis of the phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study, the addition of pembrolizumab to chemoradiotherapy provided a statistically significant and clinically meaningful improvement in progression-free survival in patients with locally advanced cervical cancer. We report the overall survival results from the second interim analysis of this study. Methods: Eligible patients with newly diagnosed, high-risk (FIGO 2014 stage IB2–IIB with node-positive disease or stage III–IVA regardless of nodal status), locally advanced, histologically confirmed, squamous cell carcinoma, adenocarcinoma, or adenosquamous cervical cancer were randomly assigned 1:1 to receive five cycles of pembrolizumab (200 mg) or placebo every 3 weeks with concurrent chemoradiotherapy, followed by 15 cycles of pembrolizumab (400 mg) or placebo every 6 weeks. Pembrolizumab or placebo and cisplatin were administered intravenously. Patients were stratified at randomisation by planned external beam radiotherapy type (intensity-modulated radiotherapy [IMRT] or volumetric-modulated arc therapy [VMAT] vs non-IMRT or non-VMAT), cervical cancer stage at screening (FIGO 2014 stage IB2–IIB node positive vs III–IVA), and planned total radiotherapy (external beam radiotherapy plus brachytherapy) dose (<70 Gy vs ≥70 Gy [equivalent dose of 2 Gy]). Primary endpoints were progression-free survival per RECIST 1.1 by investigator or by histopathological confirmation of suspected disease progression and overall survival defined as the time from randomisation to death due to any cause. Safety was a secondary endpoint. Findings: Between June 9, 2020, and Dec 15, 2022, 1060 patients at 176 sites in 30 countries across Asia, Australia, Europe, North America, and South America were randomly assigned to treatment, with 529 patients in the pembrolizumab–chemoradiotherapy group and 531 patients in the placebo–chemoradiotherapy group. At the protocol-specified second interim analysis (dat

Published
2024

10. Venous Thromboembolism Prophylaxis in Gynecologic Oncology: A MITO-MaNGO Survey

Author

Mongelli, M, Lorusso, D, Zanagnolo, V, Pignata, S, Colombo, N, Cormio, G, Mongelli M., Lorusso D., Zanagnolo V., Pignata S., Colombo N., Cormio G., Mongelli, M, Lorusso, D, Zanagnolo, V, Pignata, S, Colombo, N, Cormio, G, Mongelli M., Lorusso D., Zanagnolo V., Pignata S., Colombo N., and Cormio G.

Abstract

Cancer-associated thrombosis is the second leading cause of death in cancer patients, and its incidence has been increasing in recent years. This survey was aimed at gathering information regarding the management of thromboembolic prophylaxis within the MITO (Multicenter Italian Trials in Ovarian Cancer)-MaNGO (Mario Negri Gynecologic Oncology) groups. We designed a self-administered, multiple-choice online questionnaire available only for MITO-MaNGO members for one month, starting in May 2022 and ending in June 2022. We processed one response form per center, and 50 responses were analyzed, with most of the respondents (78%) over 40 years old. We found that 82% of them consider thromboembolic prophylaxis in gynecologic oncology to be relevant. In 82% of the centers, a standardized protocol on venous thromboembolism (VTE) prophylaxis is used, which is applied to both patients undergoing surgery and those undergoing chemotherapy. In the remaining 18% of centers, prophylaxis is used exclusively for patients undergoing chemotherapy treatment. Prophylaxis of patients undergoing surgery and chemotherapy treatment is managed in most cases by the surgeon (72%) and oncologist (76%), respectively. Only 26% of respondents use a thromboembolic risk assessment scale, and of these, those used are the Caprini Score (6%), Khorana Score (6%), and Wells Score (2%). The respondents have good knowledge of low-molecular-weight heparin (90%) and average knowledge of dicumarolics (40%), direct oral anticoagulants (DOACs) (68%), and antiplatelet agents (40%). The results of our survey indicate that there is a good awareness of thromboembolic prophylaxis in gynecologic oncology. Nevertheless, it is used less in outpatients than in patients undergoing surgery. Moreover, the thromboembolic risk assessment scores are barely used.

Published
2024

11. 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

12. 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

13. 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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14. Management of Metastatic Disease in Campania (MAMETIC): An Observational Multicenter Retrospective and Prospective Trial on Palliative Radiotherapy in an Italian Region. Study Protocol

Author

Di Franco R, Cascella M, Fusco M, Borzillo V, Scipilliti E, Ferraioli P, Iannacone E, De Palma G, Silvestro G, Gherardi F, Buonopane S, Alberti D, Totaro G, Manzo R, Guida G, Cuomo A, Pignata S, Di Napoli M, Rossetti S, Celentano E, Crispo A, Grimaldi M, Ravo V, and Muto P

Subjects
palliative care, metastatic disease, radiotherapy, cancer pain, breakthrough cancer pain, quality of life, Medicine (General), R5-920
Abstract

Rossella Di Franco,1 Marco Cascella,2 Mario Fusco,3 Valentina Borzillo,1 Esmeralda Scipilliti,1 Piera Ferraioli,1 Eva Iannacone,1 Giampaolo De Palma,1 Giustino Silvestro,1 Federica Gherardi,1 Sergio Buonopane,1 Domingo Alberti,1 Giuseppe Totaro,1 Roberto Manzo,1 Giovanna Guida,1 Arturo Cuomo,2 Sandro Pignata,4 Marilena Di Napoli,4 Sabrina Rossetti,4 Egidio Celentano,5 Anna Crispo,5 Maria Grimaldi,5 Vincenzo Ravo,1 Paolo Muto1 1Department of Radiation Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Napoli, Italia; 2Division of Anesthesia and Pain Medicine, Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, Napoli, Italia; 3Cancer Registry Unit, ASL Napoli 3 SUD, Napoli, Italia; 4Department of Uro-Gynecological, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Napoli, Italia; 5Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Napoli, ItaliaCorrespondence: Rossella Di Franco, Department of Radiation Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Napoli, Italia, Email r.difranco@istitutotumori.na.itBackground: In the Italian Campania Region, 30.517 new cases of solid cancer have been diagnosed, in 2019. Of those, patients with metastatic disease are up to 20%. This class of patients is extremely diversified and copious, and the offer of radiotherapy may vary in different geographical areas within the same region. The aim of this observational multicenter retrospective and prospective trial is to evaluate the occurrence of metastatic metastatic cancer patients candidates for palliative radiotherapy in several areas of a great Italian region, the management of the disease through RT approaches, and its impact on cancer-related pain and overall HRQoL.Methods: This is a multicenter, retrospective and prospective observational investigation. The retrospective part of the study concerns all patients enrolled with a diagnosis of metastatic disease and treated in RT centers within the Campania Region between January 2019 and July 2020. The prospective phase is going to involve all the metastatic patients with an indication of palliative RT. Considering regional epidemiological data, we expect an enrollment of 12.500– 21.000 patients in 5 years.Conclusion: The MAMETIC Trial in an observational study designed for investigating on the use of radiotherapy in patients with advanced disease within a regional area, and for evaluating the local response to the patient’s request. It can be a unique opportunity, not only to highlight possible geographic differences but also to regularly collect and share data to standardize the therapeutic offer within the regional area. ClinicalTrials.gov ID NCT04595032, retrospectively registered.Keywords: palliative care, metastatic disease, radiotherapy, cancer pain, breakthrough cancer pain, quality of life

Published
2022

16. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Coleman, Robert L, Oza, Amit M, Lorusso, Domenica, Aghajanian, Carol, Oaknin, Ana, Dean, Andrew, Colombo, Nicoletta, Weberpals, Johanne I, Clamp, Andrew, Scambia, Giovanni, Leary, Alexandra, Holloway, Robert W, Gancedo, Margarita Amenedo, Fong, Peter C, Goh, Jeffrey C, O'Malley, David M, Armstrong, Deborah K, Garcia-Donas, Jesus, Swisher, Elizabeth M, Floquet, Anne, Konecny, Gottfried E, McNeish, Iain A, Scott, Clare L, Cameron, Terri, Maloney, Lara, Isaacson, Jeff, Goble, Sandra, Grace, Caroline, Harding, Thomas C, Raponi, Mitch, Sun, James, Lin, Kevin K, Giordano, Heidi, Ledermann, Jonathan A, investigators, ARIEL3, Buck, M, Dean, A, Friedlander, ML, Goh, JC, Harnett, P, Kichenadasse, G, Scott, CL, Denys, H, Dirix, L, Vergote, I, Elit, L, Ghatage, P, Oza, AM, Plante, M, Provencher, D, Weberpals, JI, Welch, S, Floquet, A, Gladieff, L, Joly, F, Leary, A, Lortholary, A, Lotz, J, Medioni, J, Tredan, O, You, B, El-Balat, A, Hänle, C, Krabisch, P, Neunhöffer, T, Pölcher, M, Wimberger, P, Amit, A, Kovel, S, Leviov, M, Safra, T, Shapira-Frommer, R, Stemmer, S, Bologna, A, Colombo, N, Lorusso, D, Pignata, S, Sabbatini, RF, Scambia, G, Tamberi, S, Zamagni, C, Fong, PC, O'Donnell, A, Gancedo, M Amenedo, Herraez, A Casado, Garcia-Donas, J, Guerra, EM, Oaknin, A, Palacio, I, Romero, I, Sanchez, A, Banerjee, SN, Clamp, A, Drew, Y, Gabra, HG, Jackson, D, Ledermann, JA, McNeish, IA, Parkinson, C, and Powell, M

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Orphan Drug, Clinical Research, Cancer, Genetics, Clinical Trials and Supportive Activities, Ovarian Cancer, Rare Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Aged, Disease-Free Survival, Double-Blind Method, Female, Follow-Up Studies, Humans, Indoles, Internationality, Maintenance Chemotherapy, Middle Aged, Molecular Targeted Therapy, Neoplasm Recurrence, Local, Ovarian Neoplasms, Poly(ADP-ribose) Polymerase Inhibitors, Risk Assessment, Survival Rate, Treatment Outcome, ARIEL3 investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundRucaparib, a poly(ADP-ribose) polymerase inhibitor, has anticancer activity in recurrent ovarian carcinoma harbouring a BRCA mutation or high percentage of genome-wide loss of heterozygosity. In this trial we assessed rucaparib versus placebo after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma.MethodsIn this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients from 87 hospitals and cancer centres across 11 countries. Eligible patients were aged 18 years or older, had a platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma, had received at least two previous platinum-based chemotherapy regimens, had achieved complete or partial response to their last platinum-based regimen, had a cancer antigen 125 concentration of less than the upper limit of normal, had a performance status of 0-1, and had adequate organ function. Patients were ineligible if they had symptomatic or untreated central nervous system metastases, had received anticancer therapy 14 days or fewer before starting the study, or had received previous treatment with a poly(ADP-ribose) polymerase inhibitor. We randomly allocated patients 2:1 to receive oral rucaparib 600 mg twice daily or placebo in 28 day cycles using a computer-generated sequence (block size of six, stratified by homologous recombination repair gene mutation status, progression-free interval after the penultimate platinum-based regimen, and best response to the most recent platinum-based regimen). Patients, investigators, site staff, assessors, and the funder were masked to assignments. The primary outcome was investigator-assessed progression-free survival evaluated with use of an ordered step-down procedure for three nested cohorts: patients with BRCA mutations (carcinoma associated with deleterious germline or somatic BRCA mutations), patients with homologous recombination deficiencies (BRCA mutant or BRCA wild-type and high loss of heterozygosity), and the intention-to-treat population, assessed at screening and every 12 weeks thereafter. This trial is registered with ClinicalTrials.gov, number NCT01968213; enrolment is complete.FindingsBetween April 7, 2014, and July 19, 2016, we randomly allocated 564 patients: 375 (66%) to rucaparib and 189 (34%) to placebo. Median progression-free survival in patients with a BRCA-mutant carcinoma was 16·6 months (95% CI 13·4-22·9; 130 [35%] patients) in the rucaparib group versus 5·4 months (3·4-6·7; 66 [35%] patients) in the placebo group (hazard ratio 0·23 [95% CI 0·16-0·34]; p

Published
2017

17. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial

Author

Pignata, S, Lorusso, D, Joly, F, Gallo, C, Colombo, N, Sessa, C, Bamias, A, Salutari, V, Selle, F, Frezzini, S, De Giorgi, U, Pautier, P, Bologna, A, Orditura, M, Dubot, C, Gadducci, A, Mammoliti, S, Ray-Coquard, I, Zafarana, E, Breda, E, Favier, L, Ardizzoia, A, Cinieri, S, Largillier, R, Sambataro, D, Guardiola, E, Lauria, R, Pisano, C, Raspagliesi, F, Scambia, G, Daniele, G, Perrone, F, Pignata, Sandro, Lorusso, Domenica, Joly, Florence, Gallo, Ciro, Colombo, Nicoletta, Sessa, Cristiana, Bamias, Aristotelis, Salutari, Vanda, Selle, Frédèric, Frezzini, Simona, De Giorgi, Ugo, Pautier, Patricia, Bologna, Alessandra, Orditura, Michele, Dubot, Coraline, Gadducci, Angiolo, Mammoliti, Serafina, Ray-Coquard, Isabelle, Zafarana, Elena, Breda, Enrico, Favier, Laure, Ardizzoia, Antonio, Cinieri, Saverio, Largillier, Rémy, Sambataro, Daniela, Guardiola, Emmanuel, Lauria, Rossella, Pisano, Carmela, Raspagliesi, Francesco, Scambia, Giovanni, Daniele, Gennaro, and Perrone, Francesco

Published
2021
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19. PARP Inhibitors in Endometrial Cancer: Current Status and Perspectives

Author

Musacchio L, Caruso G, Pisano C, Cecere SC, Di Napoli M, Attademo L, Tambaro R, Russo D, Califano D, Palaia I, Muzii L, Benedetti Panici P, and Pignata S

Subjects
endometrial cancer, parp inhibitors, pten mutation, p53 mutation, homologous recombination deficiency, immune checkpoint inhibitors, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Lucia Musacchio,1 Giuseppe Caruso,1 Carmela Pisano,2 Sabrina Chiara Cecere,2 Marilena Di Napoli,2 Laura Attademo,2 Rosa Tambaro,2 Daniela Russo,3 Daniela Califano,3 Innocenza Palaia,1 Ludovico Muzii,1 Pierluigi Benedetti Panici,1 Sandro Pignata2 1Department of Maternal and Child Health and Urological Sciences, University “Sapienza”, Policlinico Umberto I, Rome, Italy; 2Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”, Naples, Italy; 3Functional Genomic Unit, Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”, Naples, ItalyCorrespondence: Sandro PignataDepartment of Urology and Gynecology, Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”, Via Semmola, Naples 80131, ItalyTel +39 0815903409Fax +39 0815903861Email s.pignata@istitutotumori.na.itAbstract: Advanced, recurrent and metastatic endometrial cancer (EC) has a dismal prognosis due to poor response rates to conventional treatments. In the era of precision medicine, the improved understanding of cancer genetics and molecular biology has led to the development of targeted therapies, such as poly (ADP-ribose) polymerase (PARP) inhibitors. This class of drugs that inhibit PARP enzymes has been investigated in many different types of tumors and its use in the treatment of gynecological malignancies has rapidly increased over the past few years. Data from several clinical trials showed that PARP inhibitors have a beneficial role in cancers with a defect in the homologous DNA recombination system, regardless of the BRCA mutational status. Since EC frequently shows mutations in PTEN and TP53 genes, indirectly involved in the homologous DNA recombination pathway, several in vivo and in vitro studies investigated the efficacy of PARP inhibitors in EC, showing promising results. This review will discuss the use of PARP inhibitors in endometrial cancer, summarizing data from preclinical studies and providing an overview of the ongoing trials, with a special focus on the development of combined treatment strategies with PARP inhibitors and immune checkpoint inhibitors.Keywords: endometrial cancer, PARP inhibitors, PTEN mutation, P53 mutation, homologous recombination deficiency, immune checkpoint inhibitors

Published
2020

20. 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
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21. Standardized and simplified reporting of next-generation sequencing results in advanced non-small-cell lung cancer: practical indications from an Italian multidisciplinary group

Author

Malapelle, U, Donne, A, Pagni, F, Fraggetta, F, Rocco, E, Pasello, G, Perrone, G, Pepe, F, Vatrano, S, Pignata, S, Pinto, C, Pruneri, G, Russo, A, Soto Parra, H, Vallone, S, Marchetti, A, Troncone, G, Novello, S, Malapelle, Umberto, Donne, Alessandro Delle, Pagni, Fabio, Fraggetta, Filippo, Rocco, Elena Guerini, Pasello, Giulia, Perrone, Giuseppe, Pepe, Francesco, Vatrano, Simona, Pignata, Sandro, Pinto, Carmine, Pruneri, Giancarlo, Russo, Antonio, Soto Parra, Hector J, Vallone, Stefania, Marchetti, Antonio, Troncone, Giancarlo, Novello, Silvia, Malapelle, U, Donne, A, Pagni, F, Fraggetta, F, Rocco, E, Pasello, G, Perrone, G, Pepe, F, Vatrano, S, Pignata, S, Pinto, C, Pruneri, G, Russo, A, Soto Parra, H, Vallone, S, Marchetti, A, Troncone, G, Novello, S, Malapelle, Umberto, Donne, Alessandro Delle, Pagni, Fabio, Fraggetta, Filippo, Rocco, Elena Guerini, Pasello, Giulia, Perrone, Giuseppe, Pepe, Francesco, Vatrano, Simona, Pignata, Sandro, Pinto, Carmine, Pruneri, Giancarlo, Russo, Antonio, Soto Parra, Hector J, Vallone, Stefania, Marchetti, Antonio, Troncone, Giancarlo, and Novello, Silvia

Abstract

Molecular biomarker testing is increasingly becoming standard of care for advanced non-small cell lung cancer (NSCLC). Tissue and liquid biopsy-based next-generation sequencing (NGS) is now highly recommended and has become an integral part of the routine management of advanced NSCLC patients. This highly sensitive approach can simultaneously and efficiently detect multiple biomarkers even in scant samples. However full optimization of NGS in clinical practice requires accurate reporting and interpretation of NGS findings. Indeed, as the number of NSCLC biomarkers continues to grow, clinical reporting of NGS data is becoming increasingly complex. In this scenario, achieving standardization, simplification, and improved readability of NGS reports is key to ensuring timely and appropriate treatment decisions. In an effort to address the complexity and lengthy reporting of NGS mutation results, an Italian group of 14 healthcare professionals involved in NSCLC management convened in 2023 to address the content, structure, and ease-of-use of NGS reporting practices and proposed a standard report template for clinical use This article presents the key discussion points addressed by the Italian working group and describes the essential elements of the report template.

Published
2024

22. Primary neuroendocrine neoplasms of the vulva: A review of the MITO rare cancer group

Author

Barcellini, A, Golia D'Augè, T, Mandato, V, Cuccu, I, Musella, A, Fruscio, R, Vitale, M, Martinello, R, Mangili, G, Pignata, S, Palaia, I, Barcellini, Amelia, Golia D'Augè, Tullio, Mandato, Vincenzo Dario, Cuccu, Ilaria, Musella, Angela, Fruscio, Robert, Vitale, Maria Giuseppa, Martinello, Ruby, Mangili, Giorgia, Pignata, Sandro, Palaia, Innocenza, Barcellini, A, Golia D'Augè, T, Mandato, V, Cuccu, I, Musella, A, Fruscio, R, Vitale, M, Martinello, R, Mangili, G, Pignata, S, Palaia, I, Barcellini, Amelia, Golia D'Augè, Tullio, Mandato, Vincenzo Dario, Cuccu, Ilaria, Musella, Angela, Fruscio, Robert, Vitale, Maria Giuseppa, Martinello, Ruby, Mangili, Giorgia, Pignata, Sandro, and Palaia, Innocenza

Abstract

Gynecological neuroendocrine neoplasms are rare entities and can be divided into two groups: carcinoids and neuroendocrine carcinomas. Due to their rarity their management is not standardized. The aim of this work is to summarize and discuss the current literature evidence on this pathology. A scoping literature review was performed in multiple databases. Thirty-one studies were included: 30 case reports and one case series. Patients’ age ranged between 28 and 92 years. Surgery was the most used treatment and the surgical approach included local excision (N = 16/31; 51.6%) with (N = 5/16; 31.25%) or without (N = 11/16; 68.75%) inguinal lymphadenectomy. Adjuvant radiotherapy was delivered in 12 (38.7%) cases; instead, platinum-based therapies were frequently used when chemotherapy was chosen for adjuvant treatment. The overall survival ranged between 20 days to 4 years. However, further research is needed; currently, multimodal approach including surgery, chemotherapy and radiotherapy appeared safe and feasible for the treatment of these rare and aggressive diseases.

Published
2024

23. 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

25. Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer

Author

Vergote, I., du Bois, A., Floquet, A., Rau, J., Kim, J.-W., del Campo, J.M., Friedlander, M., Pignata, S., Fujiwara, K., Colombo, N., Mirza, M.R., Monk, B.J., Tsibulak, I., Calvert, P.M., Herzog, T.J., Hanker, L.C., Meunier, J., Lee, J.-Y., Bologna, A., Carrasco-Alfonso, M.J., and Harter, P.

Published
2019
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27. Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study

Author

Matulonis, U.A., Shapira-Frommer, R., Santin, A.D., Lisyanskaya, A.S., Pignata, S., Vergote, I., Raspagliesi, F., Sonke, G.S., Birrer, M., Provencher, D.M., Sehouli, J., Colombo, N., González-Martín, A., Oaknin, A., Ottevanger, P.B., Rudaitis, V., Katchar, K., Wu, H., Keefe, S., Ruman, J., and Ledermann, J.A.

Published
2019
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28. ESMO–ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease

Author

Baert, T., Banerjee, S., Belaroussi, I., Blecharz, P., Bruchim, I., Cibula, D., Colombo, N., Concin, N., Davidson, B., Dashora, A., Devouassoux-Shisheboran, M., du Bois, A., Ferrero, A., Glasspool, R., González-Martin, A., Heinzelmann-Schwarz, V., Joly, F., Kim, J.W., Kridelka, F., Ledermann, J., Lorusso, D., Mahner, S., McCluggage, W.G., McNeish, I., Mikami, M., Mirza, M.R., Morice, P., Nicum, S., Olbrecht, S., O’Donnell, D.M., Pautier, P., Planchamp, F., Pignata, S., Querleu, D., Ray-Coquard, I., Rodolakis, A., Sehouli, J., Selcukbiricik, F., Sessa, C., Singh, N., Tan, D.S.P., Timmerman, D., Tognon, G., van der Velden, J., Vergote, I., Witteveen, P.O., and Zeimet, A.G.

Published
2019
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29. Carboplatin and paclitaxel plus avelumab compared with carboplatin and paclitaxel in advanced or recurrent endometrial cancer (MITO END-3): a multicentre, open-label, randomised, controlled, phase 2 trial

Author

Pignata, S, Scambia, G, Schettino, C, Arenare, L, Pisano, C, Lombardi, D, De Giorgi, U, Andreetta, C, Cinieri, S, De Angelis, C, Priolo, D, Casanova, C, Rosati, M, Greco, F, Zafarana, E, Schiavetto, I, Mammoliti, S, Cecere, S, Salutari, V, Scalone, S, Farolfi, A, Di Napoli, M, Lorusso, D, Gargiulo, P, Califano, D, Russo, D, Spina, A, De Cecio, R, Chiodini, P, Perrone, F, Accinno, V, Altavilla, C, Antonelli, G, Artioli, G, Avola, F, Barbara, B, Barbato, V, Bartoletti, M, Bevilacqua, S, Bordonaro, R, Borghese, O, Buonfanti, G, Camarda, F, Canzanella, G, Carbone, V, Carbone, M, Carlo Stella, G, Cassani, C, Castagna, F, Cattaneo, M, Cinefra, M, Colombo, N, Corsetti, S, Dall'Agata, M, D'Amico, M, Daniele, G, De Marino, E, De Matteis, G, De Placido, S, Del Bene, G, Del Giudice, A, Del Monte, F, Del Sesto, M, Donini, M, Drudi, G, Falcone, G, Favaretto, A, Ferrera, G, Florio, M, Forestieri, V, Gallo, M, Gallo, C, Garibaldi, F, Gerevini, F, Ghizzoni, V, Giganti, M, Gimigliano, A, Giudice, E, Gnocchi, N, Gravina, A, Greggi, S, Iaia, M, Ilardi, A, Iovine, G, Ippoliti, G, Irollo, G, Isidori, I, Lapresa, M, Lavenia, G, Longhitano, L, Lucia, B, Luzi, G, Mariano, S, Marino, V, Marrapese, G, Martino, M, Matocci, R, Mazzoni, E, Mercuri, D, Mirto, M, Pignata S., Scambia G., Schettino C., Arenare L., Pisano C., Lombardi D., De Giorgi U., Andreetta C., Cinieri S., De Angelis C., Priolo D., Casanova C., Rosati M., Greco F., Zafarana E., Schiavetto I., Mammoliti S., Cecere S. C., Salutari V., Scalone S., Farolfi A., Di Napoli M., Lorusso D., Gargiulo P., Califano D., Russo D., Spina A., De Cecio R., Chiodini P., Perrone F., Accinno V., Altavilla C., Antonelli G., Artioli G., Avola F., Barbara B., Barbato V., Bartoletti M., Bevilacqua S., Bordonaro R., Borghese O., Buonfanti G., Camarda F., Canzanella G., Carbone V., Carbone M. R., Carlo Stella G., Cassani C., Castagna F., Cattaneo M., Cinefra M., Colombo N., Corsetti S., Dall'Agata M., D'Amico M., Daniele G., De Marino E., De Matteis G., De Placido S., Del Bene G., Del Giudice A., Del Monte F., Del Sesto M., Donini M., Drudi G., Falcone G., Favaretto A., Ferrera G., Florio M., Forestieri V., Gallo M. S., Gallo C., Garibaldi F., Gerevini F., Ghizzoni V., Giganti M. O., Gimigliano A., Giudice E., Gnocchi N., Gravina A., Greggi S., Iaia M. L., Ilardi A., Iovine G., Ippoliti G., Irollo G., Isidori I., Lapresa M., Lavenia G., Longhitano L., Lucia B., Luzi G., Mariano S., Marino V., Marrapese G., Martino M., Matocci R., Mazzoni E., Mercuri D., Mirto M., Pignata, S, Scambia, G, Schettino, C, Arenare, L, Pisano, C, Lombardi, D, De Giorgi, U, Andreetta, C, Cinieri, S, De Angelis, C, Priolo, D, Casanova, C, Rosati, M, Greco, F, Zafarana, E, Schiavetto, I, Mammoliti, S, Cecere, S, Salutari, V, Scalone, S, Farolfi, A, Di Napoli, M, Lorusso, D, Gargiulo, P, Califano, D, Russo, D, Spina, A, De Cecio, R, Chiodini, P, Perrone, F, Accinno, V, Altavilla, C, Antonelli, G, Artioli, G, Avola, F, Barbara, B, Barbato, V, Bartoletti, M, Bevilacqua, S, Bordonaro, R, Borghese, O, Buonfanti, G, Camarda, F, Canzanella, G, Carbone, V, Carbone, M, Carlo Stella, G, Cassani, C, Castagna, F, Cattaneo, M, Cinefra, M, Colombo, N, Corsetti, S, Dall'Agata, M, D'Amico, M, Daniele, G, De Marino, E, De Matteis, G, De Placido, S, Del Bene, G, Del Giudice, A, Del Monte, F, Del Sesto, M, Donini, M, Drudi, G, Falcone, G, Favaretto, A, Ferrera, G, Florio, M, Forestieri, V, Gallo, M, Gallo, C, Garibaldi, F, Gerevini, F, Ghizzoni, V, Giganti, M, Gimigliano, A, Giudice, E, Gnocchi, N, Gravina, A, Greggi, S, Iaia, M, Ilardi, A, Iovine, G, Ippoliti, G, Irollo, G, Isidori, I, Lapresa, M, Lavenia, G, Longhitano, L, Lucia, B, Luzi, G, Mariano, S, Marino, V, Marrapese, G, Martino, M, Matocci, R, Mazzoni, E, Mercuri, D, Mirto, M, Pignata S., Scambia G., Schettino C., Arenare L., Pisano C., Lombardi D., De Giorgi U., Andreetta C., Cinieri S., De Angelis C., Priolo D., Casanova C., Rosati M., Greco F., Zafarana E., Schiavetto I., Mammoliti S., Cecere S. C., Salutari V., Scalone S., Farolfi A., Di Napoli M., Lorusso D., Gargiulo P., Califano D., Russo D., Spina A., De Cecio R., Chiodini P., Perrone F., Accinno V., Altavilla C., Antonelli G., Artioli G., Avola F., Barbara B., Barbato V., Bartoletti M., Bevilacqua S., Bordonaro R., Borghese O., Buonfanti G., Camarda F., Canzanella G., Carbone V., Carbone M. R., Carlo Stella G., Cassani C., Castagna F., Cattaneo M., Cinefra M., Colombo N., Corsetti S., Dall'Agata M., D'Amico M., Daniele G., De Marino E., De Matteis G., De Placido S., Del Bene G., Del Giudice A., Del Monte F., Del Sesto M., Donini M., Drudi G., Falcone G., Favaretto A., Ferrera G., Florio M., Forestieri V., Gallo M. S., Gallo C., Garibaldi F., Gerevini F., Ghizzoni V., Giganti M. O., Gimigliano A., Giudice E., Gnocchi N., Gravina A., Greggi S., Iaia M. L., Ilardi A., Iovine G., Ippoliti G., Irollo G., Isidori I., Lapresa M., Lavenia G., Longhitano L., Lucia B., Luzi G., Mariano S., Marino V., Marrapese G., Martino M., Matocci R., Mazzoni E., Mercuri D., and Mirto M.

Published
2023

30. Health-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician's Choice

Author

Lorusso, D, Colombo, N, Herraez, A, Santin, A, Colomba, E, Miller, D, Fujiwara, K, Pignata, S, Baron-Hay, S, Ray-Coquard, I, Shapira-Frommer, R, Kim, Y, Mccormack, M, Massaad, R, Nguyen, A, Zhao, Q, Mckenzie, J, Prabhu, V, Makker, V, Lorusso D., Colombo N., Herraez A. C., Santin A. D., Colomba E., Miller D. S., Fujiwara K., Pignata S., Baron-Hay S. E., Ray-Coquard I. L., Shapira-Frommer R., Kim Y. M., McCormack M., Massaad R., Nguyen A. M., Zhao Q., McKenzie J., Prabhu V. S., Makker V., Lorusso, D, Colombo, N, Herraez, A, Santin, A, Colomba, E, Miller, D, Fujiwara, K, Pignata, S, Baron-Hay, S, Ray-Coquard, I, Shapira-Frommer, R, Kim, Y, Mccormack, M, Massaad, R, Nguyen, A, Zhao, Q, Mckenzie, J, Prabhu, V, Makker, V, Lorusso D., Colombo N., Herraez A. C., Santin A. D., Colomba E., Miller D. S., Fujiwara K., Pignata S., Baron-Hay S. E., Ray-Coquard I. L., Shapira-Frommer R., Kim Y. M., McCormack M., Massaad R., Nguyen A. M., Zhao Q., McKenzie J., Prabhu V. S., and Makker V.

Abstract

Purpose: Lenvatinib and pembrolizumab (LEN+PEMBRO) demonstrated clinically meaningful and statistically significant improvements in efficacy versus treatment of physician's choice (TPC) in patients with advanced endometrial cancer (aEC) in the phase 3 Study 309/KEYNOTE-775. Health-related quality-of-life (HRQoL) is reported. Patients and Methods: Patients were randomly assigned to receive LEN+PEMBRO (n = 411; LEN 20 mg/day; PEMBRO 200 mg Q3W) or TPC (n = 416; doxorubicin 60 mg/m2 Q3W or paclitaxel 80 mg/m2 [weekly, 3 weeks on/1 week off]). Impact of treatment on HRQoL assessed by the global health status/quality of life (GHS/QoL) score of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) was a secondary objective; other scales of the Quality-of-Life Questionnaire (QLQ-C30), EORTC QLQ-Endometrial, 24 questions (EORTC QLQ-EN24), and EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) were exploratory objectives. HRQoL was assessed on day 1 of each cycle. Completion/compliance, change from baseline, time to first and definitive deterioration were assessed. No multiplicity adjustments were applied for HRQoL endpoints. Results: The latest timepoint at which the predefined rates of completion (≥60%) and compliance (≥80%) were met was week 12. HRQoL at week 12 between treatment groups was generally similar. Time to first deterioration symptom scales favoured LEN+PEMBRO for QLQ-C30 dyspnoea, and QLQ-EN24 for poor body image, tingling/numbness, and hair loss; and TPC was favoured for QLQ-C30 pain, appetite loss, and diarrhoea, and QLQ-EN24 muscular pain. While the QLQ-C30 physical functional scale favoured TPC, other functional scales were generally similar between arms. Time to definitive deterioration favoured LEN+PEMBRO on most scales. Conclusion: HRQoL data from Study 309/KEYNOTE-775, with previously published efficacy and safety results, indicate that LEN+PEMBRO has an overall favourable benefit/risk profile versus TPC fo

Published
2023

31. Management of primary and recurrent Bartholin’s gland carcinoma: A systematic review on behalf of MITO Rare Cancer Group

Author

Turetta, C, Mazzeo, R, Capalbo, G, Miano, S, Fruscio, R, Di Donato, V, Falcone, F, Mangili, G, Pignata, S, Palaia, I, Turetta C., Mazzeo R., Capalbo G., Miano S., Fruscio R., Di Donato V., Falcone F., Mangili G., Pignata S., Palaia I., Turetta, C, Mazzeo, R, Capalbo, G, Miano, S, Fruscio, R, Di Donato, V, Falcone, F, Mangili, G, Pignata, S, Palaia, I, Turetta C., Mazzeo R., Capalbo G., Miano S., Fruscio R., Di Donato V., Falcone F., Mangili G., Pignata S., and Palaia I.

Abstract

Bartholin gland carcinoma is an extremely rare disease. Information regarding treatment is scarce and there is no strict consensus on best practice. All studies reporting cases of Bartholin’s gland cancer were screened and evaluated for inclusion. Baseline characteristics of studies were extracted. A total number of 290 manuscripts collected were available for the review process. Studies included in a previous systematic review were not duplicated. In total, details of 367 patients were collected, as follows: histological features, clinical presentation, treatment, recurrent rate, treatment of recurrence and outcome. About 35% of Bartholin gland carcinoma were squamous cell carcinoma. Almost 50% of patients presented with advanced stage. The therapeutic approach was mainly surgery, and in 61% of those women lymph node assessment was performed. Recurrence occurred in 21% of cases. Bartholin gland cancer remains a challenge for gynecologic oncologists. Guidelines, centralization to referral centers and standardized therapy are needed.

Published
2023

32. 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

36. Quality-of-life analysis of the MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study comparing platinum-based versus non-platinum-based chemotherapy in patients with partially platinum-sensitive recurrent ovarian cancer

Author

Piccirillo, M.C., Scambia, G., Bologna, A., Signoriello, S., Vergote, I., Baumann, K., Lorusso, D., Murgia, V., Sorio, R., Ferrandina, G., Sacco, C., Cormio, G., Breda, E., Cinieri, S., Natale, D., Mangili, G., Pisano, C., Cecere, S.C., Di Napoli, M., Salutari, V., Raspagliesi, F., Arenare, L., Bergamini, A., Bryce, J., Daniele, G., Gallo, C., Pignata, S., and Perrone, F.

Published
2018
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38. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Buck, M, Dean, A, Friedlander, M L, Goh, J C, Harnett, P, Kichenadasse, G, Scott, C L, Denys, H, Dirix, L, Vergote, I, Elit, L, Ghatage, P, Oza, A M, Plante, M, Provencher, D, Weberpals, J I, Welch, S, Floquet, A, Gladieff, L, Joly, F, Leary, A, Lortholary, A, Lotz, J, Medioni, J, Tredan, O, You, B, El-Balat, A, Hänle, C, Krabisch, P, Neunhöffer, T, Pölcher, M, Wimberger, P, Amit, A, Kovel, S, Leviov, M, Safra, T, Shapira-Frommer, R, Stemmer, S, Bologna, A, Colombo, N, Lorusso, D, Pignata, S, Sabbatini, R F, Scambia, G, Tamberi, S, Zamagni, C, Fong, P C, O'Donnell, A, Gancedo, M Amenedo, Herraez, A Casado, Garcia-Donas, J, Guerra, E M, Oaknin, A, Palacio, I, Romero, I, Sanchez, A, Banerjee, S N, Clamp, A, Drew, Y, Gabra, H G, Jackson, D, Ledermann, J A, McNeish, I A, Parkinson, C, Powell, M, Aghajanian, C, Armstrong, D K, Birrer, M J, Buss, M K, Chambers, S K, Chen, L-m, Coleman, R L, Holloway, R W, Konecny, G E, Ma, L, Morgan, M A, Morris, R T, Mutch, D G, O'Malley, D M, Slomovitz, B M, Swisher, E M, Vanderkwaak, T, Vulfovich, M, Coleman, Robert L, Oza, Amit M, Lorusso, Domenica, Aghajanian, Carol, Oaknin, Ana, Dean, Andrew, Colombo, Nicoletta, Weberpals, Johanne I, Clamp, Andrew, Scambia, Giovanni, Leary, Alexandra, Holloway, Robert W, Gancedo, Margarita Amenedo, Fong, Peter C, Goh, Jeffrey C, O'Malley, David M, Armstrong, Deborah K, Garcia-Donas, Jesus, Swisher, Elizabeth M, Floquet, Anne, Konecny, Gottfried E, McNeish, Iain A, Scott, Clare L, Cameron, Terri, Maloney, Lara, Isaacson, Jeff, Goble, Sandra, Grace, Caroline, Harding, Thomas C, Raponi, Mitch, Sun, James, Lin, Kevin K, Giordano, Heidi, and Ledermann, Jonathan A

Published
2017
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45. Alternative academic approaches for testing homologous recombination deficiency in ovarian cancer in the MITO16A/MaNGO-OV2 trial

Author

Capoluongo, E, Pellegrino, B, Arenare, L, Califano, D, Scambia, G, Beltrame, L, Serra, V, Scaglione, G, Spina, A, Cecere, S, De Cecio, R, Normanno, N, Colombo, N, Lorusso, D, Russo, D, Nardelli, C, D'Incalci, M, Llop-Guevara, A, Pisano, C, Baldassarre, G, Mezzanzanica, D, Artioli, G, Setaro, M, Tasca, G, Roma, C, Campanini, N, Cinieri, S, Sergi, A, Musolino, A, Perrone, F, Chiodini, P, Marchini, S, Pignata, S, Capoluongo E. D., Pellegrino B., Arenare L., Califano D., Scambia G., Beltrame L., Serra V., Scaglione G. L., Spina A., Cecere S. C., De Cecio R., Normanno N., Colombo N., Lorusso D., Russo D., Nardelli C., D'Incalci M., Llop-Guevara A., Pisano C., Baldassarre G., Mezzanzanica D., Artioli G., Setaro M., Tasca G., Roma C., Campanini N., Cinieri S., Sergi A., Musolino A., Perrone F., Chiodini P., Marchini S., Pignata S., Capoluongo, E, Pellegrino, B, Arenare, L, Califano, D, Scambia, G, Beltrame, L, Serra, V, Scaglione, G, Spina, A, Cecere, S, De Cecio, R, Normanno, N, Colombo, N, Lorusso, D, Russo, D, Nardelli, C, D'Incalci, M, Llop-Guevara, A, Pisano, C, Baldassarre, G, Mezzanzanica, D, Artioli, G, Setaro, M, Tasca, G, Roma, C, Campanini, N, Cinieri, S, Sergi, A, Musolino, A, Perrone, F, Chiodini, P, Marchini, S, Pignata, S, Capoluongo E. D., Pellegrino B., Arenare L., Califano D., Scambia G., Beltrame L., Serra V., Scaglione G. L., Spina A., Cecere S. C., De Cecio R., Normanno N., Colombo N., Lorusso D., Russo D., Nardelli C., D'Incalci M., Llop-Guevara A., Pisano C., Baldassarre G., Mezzanzanica D., Artioli G., Setaro M., Tasca G., Roma C., Campanini N., Cinieri S., Sergi A., Musolino A., Perrone F., Chiodini P., Marchini S., and Pignata S.

Published
2022

46. Clear cell carcinoma of the endometrium

Author

Bogani, G, Ray-Coquard, I, Concin, N, Ngoi, N, Morice, P, Enomoto, T, Takehara, K, Denys, H, Lorusso, D, Coleman, R, Vaughan, M, Takano, M, Provencher, D, Sagae, S, Wimberger, P, Poka, R, Segev, Y, Kim, S, Kim, J, Candido dos Reis, F, Mariani, A, Leitao, M, Makker, V, Rustum, N, Vergote, I, Zannoni, G, Tan, D, Mccormack, M, Bini, M, Lopez, S, Raspagliesi, F, Panici, P, di Donato, V, Muzii, L, Colombo, N, Scambia, G, Pignata, S, Monk, B, Bogani G., Ray-Coquard I., Concin N., Ngoi N. Y. L., Morice P., Enomoto T., Takehara K., Denys H., Lorusso D., Coleman R., Vaughan M. M., Takano M., Provencher D., Sagae S., Wimberger P., Poka R., Segev Y., Kim S. I., Kim J. -W., Candido dos Reis F. J., Mariani A., Leitao M. M., Makker V., Rustum N. A., Vergote I., Zannoni G. F., Tan D. S. P., McCormack M., Bini M., Lopez S., Raspagliesi F., Panici P. B., di Donato V., Muzii L., Colombo N., Scambia G., Pignata S., Monk B. J., Bogani, G, Ray-Coquard, I, Concin, N, Ngoi, N, Morice, P, Enomoto, T, Takehara, K, Denys, H, Lorusso, D, Coleman, R, Vaughan, M, Takano, M, Provencher, D, Sagae, S, Wimberger, P, Poka, R, Segev, Y, Kim, S, Kim, J, Candido dos Reis, F, Mariani, A, Leitao, M, Makker, V, Rustum, N, Vergote, I, Zannoni, G, Tan, D, Mccormack, M, Bini, M, Lopez, S, Raspagliesi, F, Panici, P, di Donato, V, Muzii, L, Colombo, N, Scambia, G, Pignata, S, Monk, B, Bogani G., Ray-Coquard I., Concin N., Ngoi N. Y. L., Morice P., Enomoto T., Takehara K., Denys H., Lorusso D., Coleman R., Vaughan M. M., Takano M., Provencher D., Sagae S., Wimberger P., Poka R., Segev Y., Kim S. I., Kim J. -W., Candido dos Reis F. J., Mariani A., Leitao M. M., Makker V., Rustum N. A., Vergote I., Zannoni G. F., Tan D. S. P., McCormack M., Bini M., Lopez S., Raspagliesi F., Panici P. B., di Donato V., Muzii L., Colombo N., Scambia G., Pignata S., and Monk B. J.

Abstract

Clear cell endometrial carcinoma represents an uncommon and poorly understood entity. Data from molecular/genomic profiling highlighted the importance of various signatures in assessing the prognosis of endometrial cancer according to four classes of risk (POLE mutated, MMRd, NSMP, and p53 abnormal). Unfortunately, data specific to clear cell histological subtype endometrial cancer are lacking. More recently, data has emerged to suggest that most of the patients (more than 80%) with clear cell endometrial carcinoma are characterized by p53 abnormality or NSMP type. This classification has important therapeutic implications. Although it is an uncommon entity, clear cell endometrial cancer patients with POLE mutation seem characterized by a good prognosis. Chemotherapy is effective in patients with NSMP (especially in stage III and IV) and patients with p53 abnormal disease (all stages). While, preliminary data suggested that patients with MMRd are less likely to benefit from chemotherapy. The latter group appears to benefit much more from immune checkpoint inhibitors: recent data from clinical trials on pembrolizumab plus lenvatinib and nivolumab plus cabozantinib supported that immunotherapy plus tyrosine kinase inhibitors (TKI) would be the most appropriate treatment for recurrent non-endometrioid endometrial cancer (including clear cell carcinoma) after the failure of platinum-based chemotherapy. Moreover, ongoing clinical trials testing the anti-tumor activity of innovative products will clarify the better strategies for advanced/recurrent clear cell endometrial carcinoma. Further prospective evidence is urgently needed to better characterize clear cell endometrial carcinoma.

Published
2022

47. Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial

Author

Frenel, J, Kim, J, Aryal, N, Asher, R, Berton, D, Vidal, L, Pautier, P, Ledermann, J, Penson, R, Oza, A, Korach, J, Huzarski, T, Pignata, S, Colombo, N, Park-Simon, T, Tamura, K, Sonke, G, Freimund, A, Lee, C, Pujade-Lauraine, E, Frenel J. S., Kim J. W., Aryal N., Asher R., Berton D., Vidal L., Pautier P., Ledermann J. A., Penson R. T., Oza A. M., Korach J., Huzarski T., Pignata S., Colombo N., Park-Simon T. W., Tamura K., Sonke G. S., Freimund A. E., Lee C. K., Pujade-Lauraine E., Frenel, J, Kim, J, Aryal, N, Asher, R, Berton, D, Vidal, L, Pautier, P, Ledermann, J, Penson, R, Oza, A, Korach, J, Huzarski, T, Pignata, S, Colombo, N, Park-Simon, T, Tamura, K, Sonke, G, Freimund, A, Lee, C, Pujade-Lauraine, E, Frenel J. S., Kim J. W., Aryal N., Asher R., Berton D., Vidal L., Pautier P., Ledermann J. A., Penson R. T., Oza A. M., Korach J., Huzarski T., Pignata S., Colombo N., Park-Simon T. W., Tamura K., Sonke G. S., Freimund A. E., Lee C. K., and Pujade-Lauraine E.

Abstract

Background: In the SOLO2 trial (ENGOT Ov-21; NCT01874353), maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer (PSROC) and BRCA mutation significantly improved progression-free survival (PFS) and prolonged overall survival (OS). Following disease progression on olaparib, efficacy of subsequent chemotherapy remains unknown. Patients and methods: We conducted a post-hoc hypothesis-generating analysis of SOLO2 data to determine the efficacy of different chemotherapy regimens following RECIST disease progression in patients who received olaparib or placebo. We evaluated time to second progression (TTSP) calculated from the date of RECIST progression to the next progression/death. Results: The study population comprised 147 patients who received chemotherapy as their first subsequent treatment after RECIST progression. Of these, 69 (47%) and 78 (53%) were originally randomized to placebo and olaparib arms, respectively. In the placebo-treated cohort, 27/69 and 42/69 received non-platinum and platinum-based chemotherapy, respectively, compared with 24/78 and 54/78, respectively, in the olaparib-treated cohort. Among patients treated with chemotherapy (N = 147), TTSP was significantly longer in the placebo than in the olaparib arm: 12.1 versus 6.9 months [hazard ratio (HR) 2.17, 95% confidence interval (CI) 1.47-3.19]. Similar result was obtained on multivariable analysis adjusting for prognostic factors at RECIST progression (HR 2.13, 95% CI 1.41-3.22). Among patients treated with platinum-based chemotherapy (n = 96), TTSP was significantly longer in the placebo arm: 14.3 versus 7.0 months (HR 2.89, 95% CI 1.73-4.82). Conversely, among patients treated with non-platinum-based chemotherapy (n = 51), the TTSP was comparable in the placebo and olaparib arms: 8.3 versus 6.0 months (HR 1.58, 95% CI 0.86-2.90). Conclusions: Following progression from maintenance olaparib in the recurrent setting, the efficacy of platinum-based subsequent chemotherap

Published
2022

48. Biological Role of Tumor/Stromal CXCR4-CXCL12-CXCR7 in MITO16A/MaNGO-OV2 Advanced Ovarian Cancer Patients

Author

D'Alterio, C, Spina, A, Arenare, L, Chiodini, P, Napolitano, M, Galdiero, F, Portella, L, Simeon, V, Signoriello, S, Raspagliesi, F, Lorusso, D, Pisano, C, Colombo, N, Zannoni, G, Losito, N, De Cecio, R, Scognamiglio, G, Califano, D, Russo, D, Tuninetti, V, Piccirillo, M, Gargiulo, P, Perrone, F, Pignata, S, Scala, S, D'alterio C., Spina A., Arenare L., Chiodini P., Napolitano M., Galdiero F., Portella L., Simeon V., Signoriello S., Raspagliesi F., Lorusso D., Pisano C., Colombo N., Zannoni G. F., Losito N. S., De Cecio R., Scognamiglio G., Califano D., Russo D., Tuninetti V., Piccirillo M. C., Gargiulo P., Perrone F., Pignata S., Scala S., D'Alterio, C, Spina, A, Arenare, L, Chiodini, P, Napolitano, M, Galdiero, F, Portella, L, Simeon, V, Signoriello, S, Raspagliesi, F, Lorusso, D, Pisano, C, Colombo, N, Zannoni, G, Losito, N, De Cecio, R, Scognamiglio, G, Califano, D, Russo, D, Tuninetti, V, Piccirillo, M, Gargiulo, P, Perrone, F, Pignata, S, Scala, S, D'alterio C., Spina A., Arenare L., Chiodini P., Napolitano M., Galdiero F., Portella L., Simeon V., Signoriello S., Raspagliesi F., Lorusso D., Pisano C., Colombo N., Zannoni G. F., Losito N. S., De Cecio R., Scognamiglio G., Califano D., Russo D., Tuninetti V., Piccirillo M. C., Gargiulo P., Perrone F., Pignata S., and Scala S.

Abstract

This study investigated the prognostic role of the CXCR4-CXCL12-CXCR7 axis in advanced epithelial ovarian cancer (EOC) patients receiving first-line treatment within the MITO16A/MaNGO-OV2 phase-IV trial. CXCR4-CXCL12-CXCR7 expression was evaluated in the epithelial and stromal component of 308 EOC IHC-stained tumor samples. The statistical analysis focused on biomarkers’ expression, their association with other variables and prognostic value. Zero-inflated tests, shrinkage, bootstrap procedures, and multivariable models were applied. The majority of EOC (75.0%) expressed CXCR4 and CXCR7, 56.5% expressed the entire CXCR4-CXCL12-CXCR7 axis, while only 4.6% were negative for CXCL12 and its cognate receptors, in regard to the epithelial component. Stromal CXCL12 and CXCR7, expressed in 11.2% and 65.5%, respectively, were associated with the FIGO stage. High CXCL12 in epithelial cancer cells was associated with shorter progression-free and overall survival. However, after adjusting for overfitting due to best cut-off multiplicity testing, the significance was lost. This is a wide-ranging, prospective study in which CXCR4-CXCL12-CXCR7 were systematically evaluated in epithelial and stromal components, in selected stage III-IV EOC. Although CXCL12 was not prognostic, epithelial expression identified high-risk FIGO stage III patients for PFS. These data suggest that it might be worth studying the CXCL12 axis as a therapeutic target to improve treatment efficacy in EOC patients.

Published
2022

49. Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma

Author

Lorusso, D, Danesi, R, Locati, L, Masi, G, De Giorgi, U, Gadducci, A, Pignata, S, Roberto, S, Savarese, A, Valabrega, G, Zamagni, C, Colombo, N, Lorusso D., Danesi R., Locati L. D., Masi G., De Giorgi U., Gadducci A., Pignata S., Roberto S., Savarese A., Valabrega G., Zamagni C., Colombo N., Lorusso, D, Danesi, R, Locati, L, Masi, G, De Giorgi, U, Gadducci, A, Pignata, S, Roberto, S, Savarese, A, Valabrega, G, Zamagni, C, Colombo, N, Lorusso D., Danesi R., Locati L. D., Masi G., De Giorgi U., Gadducci A., Pignata S., Roberto S., Savarese A., Valabrega G., Zamagni C., and Colombo N.

Abstract

Introduction: The combination of lenvatinib plus pembrolizumab demonstrated a relevant clinical benefit in patients with endometrial carcinoma. The safety profile was consistent with the established profiles of each drug in monotherapy, with the most frequent adverse events being hypertension, an on-target effect, hypothyroidism, diarrhea, nausea, vomiting, loss of appetite, fatigue, and weight loss. Areas covered: We first review the rationale based on the combination of a VEGFR inhibitor and an immune checkpoint inhibitor, highlighting the main pharmacokinetic and pharmacodynamic features of lenvatinib. Next, we focus on the common adverse events associated with lenvatinib and guide how to optimally prevent, detect, and manage them, while minimizing interruptions during lenvatinib treatment. Discussion: The side effects profile of lenvatinib is very well known, being similar across different tumor types. Most toxicities can be preventable. An appropriate, proactive, and thorough management of lenvatinib toxicities during treatment is required to maximize potential lenvatinib efficacy. Adverse events should be detected as early as possible, by both carefully monitoring the patient from lenvatinib initiation and preventing their occurrence. Patients should be followed also during treatment as some adverse events, e.g., cardiac dysfunction might appear later. Increased awareness on risk to benefit ratio among clinicians would be helpful to avoid dose interruptions or discontinuation of lenvatinib, with preferring other medical interventions and supportive care.

Published
2022

50. Implementation of preventive and predictive BRCA testing in patients with breast, ovarian, pancreatic, and prostate cancer: a position paper of Italian Scientific Societies

Author

Russo, A, Incorvaia, L, Capoluongo, E, Tagliaferri, P, Gori, S, Cortesi, L, Genuardi, M, Turchetti, D, De Giorgi, U, Di Maio, M, Barberis, M, Dessena, M, Del Re, M, Lapini, A, Luchini, C, Jereczek-Fossa, B, Sapino, A, Cinieri, S, Beretta, G, Bella, M, Bracarda, S, Colombo, N, Conteduca, V, Del Mastro, L, Galvano, A, Gristina, V, Guarneri, V, La Verde, N, Lorusso, D, Marchetti, P, Normanno, N, Ottini, L, Pensabene, M, Pignata, S, Procopio, G, Ricevuto, E, Silvestris, N, Tassone, P, Tucci, M, Donato, V, Carrara, S, Paiella, S, Gentilini, O, Gunelli, R, Nicolis, F, Buttitta, F, Colecchia, M, Fassan, M, Malapelle, U, Marchetti, A, Marchio, C, Scarpa, A, Truini, M, Zamboni, G, Gion, M, Trevisiol, C, Gronchi, A, Danesi, R, Di Marco, V, Carrera, P, Ghiorzo, P, Pasini, B, Varesco, L, Artibani, W, Ludovico, G, Campanella, O, Vatrano, S, Tagliafico, E, Russo A., Incorvaia L., Capoluongo E., Tagliaferri P., Gori S., Cortesi L., Genuardi M., Turchetti D., De Giorgi U., Di Maio M., Barberis M., Dessena M., Del Re M., Lapini A., Luchini C., Jereczek-Fossa B. A., Sapino A., Cinieri S., Beretta G., Bella M. A., Bracarda S., Colombo N., Conteduca V., Del Mastro L., Galvano A., Gristina V., Guarneri V., La Verde N., Lorusso D., Marchetti P., Normanno N., Ottini L., Pensabene M., Pignata S., Procopio G., Ricevuto E., Silvestris N., Tassone P., Tucci M., Donato V., Carrara S., Paiella S., Gentilini O., Gunelli R., Nicolis F., Buttitta F., Colecchia M., Fassan M., Malapelle U., Marchetti A., Marchio C., Scarpa A., Truini M., Zamboni G., Gion M., Trevisiol C., Gronchi A., Danesi R., Di Marco V., Carrera P., Ghiorzo P., Pasini B., Varesco L., Artibani W., Ludovico G., Campanella O., Vatrano S., Tagliafico E., Russo, A, Incorvaia, L, Capoluongo, E, Tagliaferri, P, Gori, S, Cortesi, L, Genuardi, M, Turchetti, D, De Giorgi, U, Di Maio, M, Barberis, M, Dessena, M, Del Re, M, Lapini, A, Luchini, C, Jereczek-Fossa, B, Sapino, A, Cinieri, S, Beretta, G, Bella, M, Bracarda, S, Colombo, N, Conteduca, V, Del Mastro, L, Galvano, A, Gristina, V, Guarneri, V, La Verde, N, Lorusso, D, Marchetti, P, Normanno, N, Ottini, L, Pensabene, M, Pignata, S, Procopio, G, Ricevuto, E, Silvestris, N, Tassone, P, Tucci, M, Donato, V, Carrara, S, Paiella, S, Gentilini, O, Gunelli, R, Nicolis, F, Buttitta, F, Colecchia, M, Fassan, M, Malapelle, U, Marchetti, A, Marchio, C, Scarpa, A, Truini, M, Zamboni, G, Gion, M, Trevisiol, C, Gronchi, A, Danesi, R, Di Marco, V, Carrera, P, Ghiorzo, P, Pasini, B, Varesco, L, Artibani, W, Ludovico, G, Campanella, O, Vatrano, S, Tagliafico, E, Russo A., Incorvaia L., Capoluongo E., Tagliaferri P., Gori S., Cortesi L., Genuardi M., Turchetti D., De Giorgi U., Di Maio M., Barberis M., Dessena M., Del Re M., Lapini A., Luchini C., Jereczek-Fossa B. A., Sapino A., Cinieri S., Beretta G., Bella M. A., Bracarda S., Colombo N., Conteduca V., Del Mastro L., Galvano A., Gristina V., Guarneri V., La Verde N., Lorusso D., Marchetti P., Normanno N., Ottini L., Pensabene M., Pignata S., Procopio G., Ricevuto E., Silvestris N., Tassone P., Tucci M., Donato V., Carrara S., Paiella S., Gentilini O., Gunelli R., Nicolis F., Buttitta F., Colecchia M., Fassan M., Malapelle U., Marchetti A., Marchio C., Scarpa A., Truini M., Zamboni G., Gion M., Trevisiol C., Gronchi A., Danesi R., Di Marco V., Carrera P., Ghiorzo P., Pasini B., Varesco L., Artibani W., Ludovico G., Campanella O., Vatrano S., and Tagliafico E.

Abstract

Constitutional BRCA1/BRCA2 pathogenic or likely pathogenic variants (PVs) are associated with an increased risk for developing breast and ovarian cancers. Current evidence indicates that BRCA1/2 PVs are also associated with pancreatic cancer, and that BRCA2 PVs are associated with prostate cancer risk. The identification of carriers of constitutional PVs in the BRCA1/2 genes allows the implementation of individual and family prevention pathways, through validated screening programs and risk-reducing strategies. According to the relevant and increasing therapeutic predictive implications, the inclusion of BRCA testing in the routine management of patients with breast, ovarian, pancreatic and prostate cancers represent a key requirement to optimize medical or surgical therapeutic and prevention decision-making, and access to specific anticancer therapies. Therefore, accurate patient selection, the use of standardized and harmonized procedures, and adherence to homogeneous testing criteria, are essential elements to implement BRCA testing in clinical practice. This consensus position paper has been developed and approved by a multidisciplinary Expert Panel of 64 professionals on behalf of the AIOM–AIRO–AISP–ANISC–AURO–Fondazione AIOM–SIAPEC/IAP–SIBioC–SICO–SIF–SIGE–SIGU–SIU–SIURO–UROP Italian Scientific Societies, and a patient association (aBRCAdaBRA Onlus). The working group included medical, surgical and radiation oncologists, medical and molecular geneticists, clinical molecular biologists, surgical and molecular pathologists, organ specialists such as gynecologists, gastroenterologists and urologists, and pharmacologists. The manuscript is based on the expert consensus and reports the best available evidence, according to the current eligibility criteria for BRCA testing and counseling, it also harmonizes with current Italian National Guidelines and Clinical Recommendations.

Published
2022

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