Thromboembolic events and antithrombotic prophylaxis in advanced ovarian cancer patients treated with bevacizumab: secondary analysis of the phase IV MITO--16A/MaNGO-OV2A trial

被引:4
作者
Di Liello, Raimondo [1 ]
Arenare, Laura [1 ]
Raspagliesi, Francesco [2 ]
Scambia, Giovanni [3 ]
Pisano, Carmela [4 ]
Colombo, Nicoletta [5 ,6 ]
Frezzini, Simona [7 ,8 ]
Tognon, Germana [9 ]
Artioli, Grazia [10 ]
Gadducci, Angiolo [11 ]
Lauria, Rossella [12 ]
Ferrero, Annamaria [13 ]
Cinieri, Saverio [14 ]
De Censi, Andrea [15 ]
Breda, Enrico [16 ]
Scollo, Paolo [17 ]
De Giorgi, Ugo [18 ]
Lissoni, Andrea Alberto [19 ]
Katsaros, Dionyssios [20 ]
Lorusso, Domenica [21 ]
Salutari, Vanda [3 ]
Cecere, Sabrina Chiara [4 ]
Lapresa, Mariateresa [21 ]
Nardin, Margherita [7 ,8 ]
Bogani, Giorgio [2 ]
Distefano, Mariagrazia [21 ]
Greggi, Stefano [22 ]
Gargiulo, Piera [1 ]
Schettino, Clorinda [1 ]
Gallo, Ciro [23 ]
Daniele, Gennaro [24 ]
Califano, Daniela [25 ]
Perrone, Francesco [1 ]
Pignata, Sandro [4 ]
Piccirillo, Maria Carmela [1 ]
机构
[1] Ist Nazl Tumori IRCCS Fdn G Pascale, Unita Sperimentaz Clin, Naples, Italy
[2] Fdn IRCCS Ist Nazl Tumori, SC Chirurg Ginecol, Dipartimento Chirurg, Milan, Italy
[3] Univ Cattolica Sacro Cuore, Fdn Policlin Univ Gemelli IRCCS, Dipartimento Sci Salute Donna Bambino & Sanita Pu, Ginecol Oncol, Rome, Italy
[4] Ist Nazl Tumori IRCCS Fdn G Pascale, Oncol Clin Sperimentale Uroginecol, Naples, Italy
[5] Univ Milano Bicocca, Ist Europeo Oncol IRCCS, Milan, Italy
[6] Univ Milano Bicocca, Dipartimento Med & Chirurg, Milan, Italy
[7] Ist Oncol Veneto IRCCS, Oncol Med & Radiol 2, Padua, Italy
[8] Univ Padua, Padua, Italy
[9] Univ Brescia, Div Ostetricia & Ginecol, ASST Spedali Civili Brescia, Brescia, Italy
[10] ULSS2 Mama Trevigiana, Oncol Med, Treviso, Italy
[11] Univ Pisa, UO Ginecol & Ostetricia, Dipartimento Med Clin & Sperimentale, Pisa, Italy
[12] Univ Napoli Federico II, Dipartimento Med Clin & Chirurg, Oncol Med, Naples, Italy
[13] AO Ordine Mauriziano, Div Univ Ginecol & Ostetricia, Turin, Italy
[14] Osped Senatore Antonio Perrino, Oncol Med, Brindisi, Italy
[15] Osped Galliera, Oncol Med, Genoa, Italy
[16] Osped S Giovanni Calibita Fatebenefratelli, Dipartimento Oncol, Rome, Italy
[17] Osped Cannizzaro, Dipartimento Maternoinfantile, UO Ostetricia & Ginecol, Catania, Italy
[18] IRCCS Ist Romagnolo Studio Tumori IRST Dino Amado, Meldola, Italy
[19] Osped San Gerardo, Ginecol Chirurg, Monza, Italy
[20] Osped Ostetr Ginecol S Anna, Dipartimento Sci Chirurg, AOU Citta Salute, Ginecol Oncol, Turin, Italy
[21] Ist Europeo Oncol IRCCS, Div Ginecol Med, Milan, Italy
[22] Ist Nazl Tumori IRCCS Fdn G Pascale, SC Ginecol Oncol, Naples, Campania, Italy
[23] Univ Campania Luigi Vanvitelli, Dipartimento Salute Mentale & Fis & Med Prevent, Naples, Italy
[24] Fdn Policlin Univ A Gemelli IRCCS, Direz Sci, Rome, Italy
[25] Ist Nazl Tumori IRCCS Fdn Pascale, Bersagli Mol Microambiente, Naples, Italy
关键词
ovarian cancer; venous thromboembolism; MOLECULAR-WEIGHT HEPARIN; VENOUS THROMBOEMBOLISM; RECEIVING CHEMOTHERAPY; DOUBLE-BLIND; PLACEBO; LUNG; THROMBOPROPHYLAXIS; METAANALYSIS; PREVENTION; THROMBOSIS;
D O I
10.1136/ijgc-2021-002786
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Introduction The use of routine antithrombotic prophylaxis is not recommended for advanced cancer patients receiving chemotherapy. The effect of bevacizumab-containing therapy on the risk of thromboembolic events remains controversial in ovarian cancer patients. We report on the incidence of thromboembolic events and the prevalence of antithrombotic therapy in patients enrolled in the single arm, phase IV, MITO-16A/MaNGO-OV2A trial. Methods In this trial, potential prognostic factors for patients with previously untreated ovarian cancer receiving a combination of platinum-based chemotherapy and bevacizumab were explored and the final analysis has already been reported. In this secondary analysis, the occurrence of thromboembolic events and the use of antithrombotic therapy were described according to the clinical characteristics of the patients. The prognostic role of thromboembolic events for progression-free and overall survival were also evaluated. Results From October 2012 to November 2014, 398 eligible patients were enrolled. 76 patients (19.1%) were receiving some type of anticoagulant or anti-aggregant treatment at baseline. Overall, 24 thromboembolic events were reported (cumulative incidence of 6.0%). The occurrence of thromboembolic events was not associated with baseline patient characteristics and was not modified by the use of antithrombotic prophylaxis (HR 0.60, 95% CI 0.18 to 2.0). Occurrence of thromboembolic events was not associated with progression-free survival (HR 1.34, 95% CI 0.83 to 2.15) or overall survival (HR 0.78, 95% CI 0.37 to 1.61). Conclusions In our study, a 6.0% rate of thromboembolic events was reported during treatment with bevacizumab plus chemotherapy. Thromboembolic events were not associated with the clinical characteristics of the patients or with the use of antithrombotic prophylaxis, nor did they significantly affect the long-term prognosis.
引用
收藏
页码:1348 / 1355
页数:8
相关论文
共 31 条
[1]   Prediction of venous thromboembolism in cancer patients [J].
Ay, Cihan ;
Dunkler, Daniela ;
Marosi, Christine ;
Chiriac, Alexandru-Laurentiu ;
Vormittag, Rainer ;
Simanek, Ralph ;
Quehenberger, Peter ;
Zielinski, Christoph ;
Pabinger, Ingrid .
BLOOD, 2010, 116 (24) :5377-5382
[2]   Updated meta-analysis on prevention of venous thromboembolism in ambulatory cancer patients [J].
Becattini, Cecilia ;
Verso, Melina ;
Munoz, Andres ;
Agnelli, Giancarlo .
HAEMATOLOGICA, 2020, 105 (03) :838-848
[3]   Low molecular weight heparin (LMWH) for primary thrombo-prophylaxis in patients with solid malignancies - systematic review and meta-analysis [J].
Ben-Aharon, Irit ;
Stemmer, Salomon M. ;
Leibovici, Leonard ;
Shpilberg, Ofer ;
Sulkes, Aaron ;
Gafter-Gvili, Anat .
ACTA ONCOLOGICA, 2014, 53 (09) :1230-1237
[4]   Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer [J].
Burger, Robert A. ;
Brady, Mark F. ;
Bookman, Michael A. ;
Fleming, Gini F. ;
Monk, Bradley J. ;
Huang, Helen ;
Mannel, Robert S. ;
Homesley, Howard D. ;
Fowler, Jeffrey ;
Greer, Benjamin E. ;
Boente, Matthew ;
Birrer, Michael J. ;
Liang, Sharon X. .
NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (26) :2473-2483
[5]   Final overall survival (OS) analysis of an international randomized trial evaluating bevacizumab (BEV) in the primary treatment of advanced ovarian cancer: A NRG oncology/Gynecologic Oncology Group (GOG) study [J].
Burger, Robert Allen ;
Enserro, Danielle ;
Tewari, Krishnansu Sujata ;
Brady, Mark F. ;
Bookman, Michael A. ;
Fleming, Gini F. ;
Huang, Helen Q. ;
Homesley, Howard D. ;
Fowler, Jeffrey ;
Boente, Matthew ;
Randall, Leslie M. ;
Chan, John K. ;
Ferris, James Stuart ;
DiSaia, Philip J. ;
Copeland, Larry J. ;
Mannel, Robert S. ;
Birrer, Michael J. ;
Monk, Bradley J. .
JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (15)
[6]   Preventing Venous Thromboembolism in Ambulatory Cancer Patients: The ONKOTEV Study [J].
Cella, Chiara Alessandra ;
Di Minno, Giovanni ;
Carlomagno, Chiara ;
Arcopinto, Michele ;
Cerbone, Anna Maria ;
Matano, Elide ;
Tufano, Antonella ;
Lordick, Florian ;
De Simone, Biagio ;
Muehlberg, Katja Sibylle ;
Bruzzese, Dario ;
Attademo, Laura ;
Arturo, Claudia ;
Sodano, Marta ;
Moretto, Roberto ;
La Fata, Ersilia ;
De Placido, Sabino .
ONCOLOGIST, 2017, 22 (05) :601-608
[7]   Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial [J].
Coleman, Robert L. ;
Oza, Amit M. ;
Lorusso, Domenico ;
Aghajanian, Carol ;
Oaknin, Ana ;
Dean, Andrew ;
Colombo, Nicoletta ;
Weberpals, Johanne, I ;
Clamp, Andrew ;
Scambia, Giovanni ;
Leary, Alexandra ;
Holloway, Robert W. ;
Amenedo Gancedo, Margarita ;
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, lain 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. .
LANCET, 2017, 390 (10106) :1949-1961
[8]   ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease [J].
Colombo, N. ;
Sessa, C. ;
du Bois, A. ;
Ledermann, J. ;
McCluggage, W. G. ;
McNeish, I. ;
Morice, P. ;
Pignata, S. ;
Ray-Coquard, I. ;
Vergote, I. ;
Baert, T. ;
Belaroussi, I. ;
Dashora, A. ;
Olbrecht, S. ;
Planchamp, F. ;
Querleu, D. ;
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. ;
Gonzalez-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. .
ANNALS OF ONCOLOGY, 2019, 30 (05) :672-705
[9]   Bevacizumab, carboplatin, and paclitaxel in the first line treatment of advanced ovarian cancer patients: the phase IV MITO-16A/MaNGO-OV2A study [J].
Daniele, Gennaro ;
Raspagliesi, Francesco ;
Scambia, Giovanni ;
Pisano, Carmela ;
Colombo, Nicoletta ;
Frezzini, Simona ;
Tognon, Germana ;
Artioli, Grazia ;
Gadducci, Angiolo ;
Lauria, Rossella ;
Ferrero, Annamaria ;
Cinieri, Saverio ;
De Censi, Andrea ;
Breda, Enrico ;
Scollo, Paolo ;
De Giorgi, Ugo ;
Lissoni, Andrea Alberto ;
Katsaros, Dionyssios ;
Lorusso, Domenica ;
Salutari, Vanda ;
Cecere, Sabrina Chiara ;
Zaccarelli, Eleonora ;
Nardin, Margherita ;
Bogani, Giorgio ;
Distefano, Mariagrazia ;
Greggi, Stefano ;
Piccirillo, Maria Carmela ;
Fossati, Roldano ;
Giannone, Gaia ;
Arenare, Laura ;
Gallo, Ciro ;
Perrone, Francesco ;
Pignata, Sandro .
INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 2021, 31 (06) :875-882
[10]   Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy [J].
Di Nisio, Marcello ;
Porreca, Ettore ;
Candeloro, Matteo ;
De Tursi, Michele ;
Russi, Ilaria ;
Rutjes, Anne W. S. .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2016, (12)