| Title: |
Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma |
| Authors: |
Wang, Michael; Salek, David; Belada, David; Song, Yuqin; Jurczak, Wojciech; Kahl, Brad S.; Paludo, Jonas; Chu, Michael P.; Kryachok, Iryna; Fogliatto, Laura; Cheah, Chan Y.; Morawska, Marta; Sancho, Juan-Manuel; Li, Yufu; Patti, Caterina; Forsyth, Cecily; Zhang, Jingyang; Lesley, Robin; Ramadan, Safaa; Rule, Simon; Dreyling, Martin; null, null; Cazap, Nicolas; Foncuberta, Maria Cecilia; Garate, Gonzalo; Gustavo, Jarchum; Pavlovsky, Miguel A; Riveros, Dardo; Baker, Ross; Butler, Jason; Cannell, Paul; Cheah, Chan; Cochrane, Tara; Giri, Pratyush; Johnston, Amanda; Lee, Denise; Lee, Hui-Peng; Mapp, Sally; Roncolato, Fernando; Thant, Aung; Walker, Patricia; Doo, Nicole Wong; Demuynck, Hilde; Offner, Fritz; Van Hende, Vanessa; Vergote, Vibeke; Wu, Ka Lung; Chiattone, Carlos; de Azevedo, Sergio; Samuel de Holanda Farias, Joao; Fonseca, Ana; Hamerschlak, Nelson; Lazaretti, Nicolas; Rocha, Vanderson; Rodrigues de Oliveira, Jose Salvador; Salvino, Marco; Santucci, Rodrigo; Schaan, Mariza; Scheinberg, Phillip; Scheliga, Adriana; Vieira, Garles Miller; Berinstein, Neil; Boutin, Melina; Chu, Michael; Keating, Mary-Margaret; Schattner, Ariah; Restrepo, Diego Villa; Cen, Xinan; Du, Xin; Feng, Ru; Gao, Sujun; Huang, Haiwen; Ji, Jie; Jin, Jie; Ke, Xiaoyan; Li, Dengju; Li, Fei; Li, Jianyong; Li, Junmin; Li, Yan; Li, Zhenyu; Lin, Li'e; Liu, Tingbo; LV, Fangfang; Shuang, Yuerong; Sun, Lan; Sun, Xiuhua; Wang, Zhao; Wu, Huijing; Xi, Yaming; Xia, Ruixiang; Xue, Hongwei; Yang, Haiyan; Yi, Shuhua; Zhang, Cheng; Zhang, Huilai; Zhang, Mingzhi; Zhang, Qingyuan; Zhao, Xielan; Zhou, Hui; Hajek, Roman; Jindra, Pavel; Mayer, Jiri; Novak, Jan; Abraham, Julie; Bijou, Fontanet; Bouabdallah, Kamal; Cymbalista, Florence; de Guilbert, Sophie; Delwail, Vincent; Genet, Philippe; Laribi, Kamel; Rodon, Philippe; Decker, Thomas; Dreger, Peter; Hess, Georg; Lenz, Georg; Stilgenbauer, Stephan; Tummes, Dirk; Anargyrou, Konstantinos; Dimopoulos, Meletios-Athanassios; Kapsali, Eleni; Katodritou, Eirini; Kyriakou, Despoina; Panayiotidis, Panayiotis; Pappa, Vasiliki; Stavroyianni, Niki; Symeonidis, Argiris; Cheng, Hoi Ching; Kwong, Yok-Lam; Lee, Harold; Ng, Ting Ying; Wong, Raymond; Borbenyi, Zita; Illés, Árpád; Lazar, Zsolt; Nagy, Ágnes; Nagy, Zsolt; Schneider, Tamas; Avivi, Irit; Gurion, Ronit; Horowitz, Netanel; Ronson, Aaron; Arcaini, Luca; Boccomini, Carola; Ghia, Paolo; Luminari, Stefano; Plenteda, Caterina; Santoro, Armando; Zilioli, Vittorio Ruggero; Zinzani, Pier Luigi; Choi, Ilseung; Ennishi, Daisuke; Fukushima, Kentaro; Ichikawa, Satoshi; Ishikawa, Takayuki; Izutsu, Koji; Kato, Koji; Maruyama, Dai; Nagai, Hirokazu; Ota, Shuichi; Saito, Toko; Sakai, Rika; Suzuki, Ritsuro; Tatetsu, Hiro; Uoshima, Nobuhiko; Yano, Takahiro; Yoshida, Isao; Eom, Ki-Seong; Kim, Jin Seok; Kim, Sang-A; Kim, Seok Jin; Lee, Jung-Hee; Mun, Yeung Chul; Oh, Sung Yong; Yoon, Sung Soo; Avila Arreguin, Elsa Veronica; Andrade, Adriana Dominguez; Almaguer, David Gomez; Rivas Vera, Maria Silvia; Anaya, Luis Solis; Berkahn, Leanne; Issa, Samar; Pemberton, Lucy; Simpson, David; Beltran, Brady; Quintana, Shirely; Revilla, Jose Carlos; Vargas, Ernesto; Grosicki, Sebastian; Halka, Janusz; Jedrzejczak, Wieslaw; Knopinska-Posluszny, Wanda; Krzanowski, Jacek; Lech-Maranda, Ewa; Robak, Tadeusz; Rzepecki, Piotr; Wróbel, Tomasz; Borsaru, Gabriela; Ciuleanu, Tudor Eliade; Danaila, Catalin; Lazaroiu, Mihaela; Alexeeva, Julia; Chistyakov, Valeriy; Manikhas, Georgy; Mikhailova, Natalia; Proydakov, Andrey; Volodicheva, Elena Mikhailovna; Voloshin, Sergey; Bastos, Mariana; Briones, Javier; Cordoba, Raul; Codina, Jose Gómez; Gonzalez, Eva Maria; Marin, Ana; Panizo, Carlos; Rodriguez, Guillermo; Salar, Antonio; Velo, Jose A; Yuste, Victor Jimenez; Chen, Chien-Yuan; Chiu, Chang-Fang; Hsiao, Liang-Tsai; Kuo, Ching-Yuan; Lin, Tung-Liang; Lysa, Tamila; Maslyak, Zvenyslava; Nogaieva, Larysa; Polenkov, Sergey; Usenko, Ganna; Agajanian, Richie; Anz, Bertrand; Chaudhry, Arvind; Chiu, Alden; Cultrera, Jennifer; D'Olimpio, James; Dunleavy, Kieron; Fanning, Suzanne; Flinn, Ian; Gabrail, Nashat; Gallinson, David; Goldenberg, Alec; Goy, Andre; Graf, Solomon; Grover, Natalie; Hess, Brian; Hoffman, Marc; Isufi, Iris; Kahl, Brad; Kambhampati, Suman; Kirkel, Dean; Diaz, Guillermo Lazo; Levy, Moshe; Liu, Delong; Mead, Monica; Patel, Anjan; Peles, Shachar; Persky, Daniel; Portell, Craig; Rosenthal, Allison; Sano, Dahlia; Smith, Sonali; Smith, Stephen; Spurgeon, Stephen; Stevens, Don; Tache, Jason; Tsai, Michaela; Veltri, Lauren; Yimer, Habte; Bach, Quoc Khanh; Do, Huyen Nga; Luu, Hung Vu; Mai, Trong Khoa; Pham, Nhu Hiep; Tran, Thanh Tung |
| Contributors: |
Wang, Michael; Salek, David; Belada, David; Song, Yuqin; Jurczak, Wojciech; Kahl, Brad S.; Paludo, Jona; Chu, Michael P.; Kryachok, Iryna; Fogliatto, Laura; Cheah, Chan Y.; Morawska, Marta; Sancho, Juan-Manuel; Li, Yufu; Patti, Caterina; Forsyth, Cecily; Zhang, Jingyang; Lesley, Robin; Ramadan, Safaa; Rule, Simon; Dreyling, Martin; Null, Null; Cazap, Nicola; Foncuberta, Maria Cecilia; Garate, Gonzalo; Gustavo, Jarchum; Pavlovsky, Miguel A; Riveros, Dardo; Baker, Ro; Butler, Jason; Cannell, Paul; Cheah, Chan; Cochrane, Tara; Giri, Pratyush; Johnston, Amanda; Lee, Denise; Lee, Hui-Peng; Mapp, Sally; Roncolato, Fernando; Thant, Aung; Walker, Patricia; Doo, Nicole Wong; Demuynck, Hilde; Offner, Fritz; Van Hende, Vanessa; Vergote, Vibeke; Wu, Ka Lung; Chiattone, Carlo; De Azevedo, Sergio; Samuel De Holanda Farias, Joao; Fonseca, Ana; Hamerschlak, Nelson; Lazaretti, Nicola; Rocha, Vanderson; Rodrigues De Oliveira, Jose Salvador; Salvino, Marco; Santucci, Rodrigo; Schaan, Mariza; Scheinberg, Phillip; Scheliga, Adriana; Vieira, Garles Miller; Berinstein, Neil; Boutin, Melina; Chu, Michael; Keating, Mary-Margaret; Schattner, Ariah; Restrepo, Diego Villa; Cen, Xinan; Du, Xin; Feng, Ru; Gao, Sujun; Huang, Haiwen; Ji, Jie; Jin, Jie; Ke, Xiaoyan; Li, Dengju; Li, Fei; Li, Jianyong; Li, Junmin; Li, Yan; Li, Zhenyu; Lin, Li'E; Liu, Tingbo; Lv, Fangfang; Shuang, Yuerong; Sun, Lan; Sun, Xiuhua; Wang, Zhao; Wu, Huijing; Xi, Yaming; Xia, Ruixiang; Xue, Hongwei; Yang, Haiyan; Yi, Shuhua; Zhang, Cheng; Zhang, Huilai |
| Publication Year: |
2025 |
| Collection: |
IRIS Università degli Studi di Bologna (CRIS - Current Research Information System) |
| Subject Terms: |
Acalabrutinib Plus Bendamustine-Rituximab; Untreated; Mantle Cell Lymphoma |
| Description: |
PURPOSE The combination of the Bruton tyrosine kinase inhibitor ibrutinib with bendamustine-rituximab for first-line treatment of mantle cell lymphoma (MCL) prolonged progression-free survival (PFS), but without improvement in overall survival (OS), likely because of toxicity. Acalabrutinib was shown to be efficacious and less toxic than ibrutinib in a head-to-head trial in chronic lymphocytic leukemia and therefore might lead to better outcomes in MCL. METHODS Patients 65 years and older with previously untreated MCL received acalabrutinib (100 mg twice daily) or placebo (until disease progression or unacceptable toxicity), plus six cycles of bendamustine (90 mg/m2 once daily; days 1 and 2) and rituximab (375 mg/m2 as a single dose; day 1) followed by rituximab maintenance in responding patients for 2 years. Crossover to acalabrutinib at disease progression was permitted. The primary end point was PFS per the independent review committee; overall response rate and OS were secondary end points. RESULTS In total, 598 patients were randomly assigned, with 299 in each arm. At a median follow-up of 49.8 months using the reverse Kaplan-Meier method, the median PFS was 66.4 months in the acalabrutinib arm and 49.6 months in the placebo arm (hazard ratio [HR], 0.73 [95% CI, 0.57 to 0.94]; P 5 .0160). Benefit was seen across all subgroups, including those with high-risk features. Overall response/complete response rates were 91.0%/66.6% and 88.0%/53.5% in the acalabrutinib and placebo arms, respectively. OS was not significantly different (HR, 0.86 [95% CI, 0.65 to 1.13]; P 5 .27). Grade 3 or greater adverse events were reported in 88.9% and 88.2% in the acalabrutinib and placebo arms, respectively. CONCLUSION The combination of acalabrutinib with bendamustine-rituximab significantly improved PFS. Clinical benefit of acalabrutinib with bendamustine-rituximab was achieved with manageable toxicity. |
| Document Type: |
article in journal/newspaper |
| File Description: |
ELETTRONICO |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/40311141; info:eu-repo/semantics/altIdentifier/wos/WOS:001521354200001; volume:43; issue:20; firstpage:2276; lastpage:2284; numberofpages:9; journal:JOURNAL OF CLINICAL ONCOLOGY; https://hdl.handle.net/11585/1043032 |
| DOI: |
10.1200/jco-25-00690 |
| DOI: |
10.1200/JCO-25-00690 |
| Availability: |
https://hdl.handle.net/11585/1043032; https://doi.org/10.1200/jco-25-00690; https://ascopubs.org/doi/10.1200/JCO-25-00690 |
| Rights: |
info:eu-repo/semantics/openAccess ; license:Licenza per Accesso Aperto. Creative Commons Attribuzione - Non commerciale - Non opere derivate (CCBYNCND) ; license uri:iris.PUB17 |
| Accession Number: |
edsbas.AF67073B |
| Database: |
BASE |