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Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial
| Content Provider | Scilit |
|---|---|
| Author | O'Connor, Owen A. D'Amore, Francesco Horwitz, Steven Pro, Barbara Illidge, Tim Fanale, Michelle Advani, Ranjana Bartlett, Nancy L. Christensen, Jacob Haaber Morschhauser, Franck Domingo-Domenech, Eva Rossi, Giuseppe Kim, Won Seog Feldman, Tatyana Lennard, Anne Belada, David Illés, Árpád Tobinai, Kensei Tsukasaki, Kunihiro Yeh, Su-Peng Shustov, Andrei Hüttmann, Andreas Savage, Kerry J. Yuen, Sam Iyer, Swaminathan Zinzani, Pier Luigi Hua, Zhaowei Little, Meredith Rao, Shangbang Woolery, Joseph Manley, Thomas Trümper, Lorenz Aboulafia, David Alpdogan, Onder Ando, Kiyoshi Arcaini, Luca Baldini, Luca Bellam, Naresh Yehuda, Dina Ben Benedetti, Fabio Borchman, Peter Bordessoule, Dominique Brice, Pauline Briones, Javier Caballero, Dolores Carella, Angelo Michele Chang, Hung Cheong, June Weon Cho, Seok-Goo Choi, Ilseung Choquet, Sylvain Colita, Andrei Congui, Angela Giovanna Dang, Nam Davison, Kelly de Guibert, Sophie Brown, Peter De Nully Delwail, Vincent Demeter, Judit Raimondo, Francesco di Do, Young Rok Domingo, Eva Douvas, Michael Dreyling, Martin Ernst, Thomas Fay, Keith Ferrero, Silvia Fernandez Flinn, Ian Winchester Forero-Torres, Andres Fox, Christopher Friedberg, Jonathan Fukuhara, Noriko Garcia-Marco, Jose Cruz, Jorge Gayoso Codina, Jose Gomez Gressin, Remy Grigg, Andrew Gurion, Ronit Haioun, Corinne Hajek, Roman Hanel, Mathias Hatake, Kiyohiko Hensen, Robert Horowitz, Netanel Ishizawa, Kenichi Islas-Ohlmayer, Miguel Jacobsen, Eric Janakiram, Murali Jurczak, Wojciech Kaminski, Mark Kato, Koji Kirgner, Ilya Kuo, Ching-Yuan Lazaroiu, Mihaela Cornelia Du, Katell Le Lee, Jong-Seok LeGouill, Steven LaRosee, Paul Levi, Itai Link, Brian Maisonneuve, Herve Maruyama, Dai Mayer, Jiri McCarty, John McKay, Pam Minami, Yosuke Mocikova, Heidi Morra, Enrica Munoz, Javier Nagai, Hirokazu Opat, Stephen Pettengell, Ruth Pezzutto, Antonio Pfreundschuh, Michael Pluta, Andrzej Porcu, Pierluigi Quach, Hang Rambaldi, Alessandro Renwick, William Reyes, Ruben Izquierdo, Antonia Rodriguez Ruan, Jia Rusconi, Chiara Salles, Gilles Santoro, Armando Sarriera, Jose Shibayama, Hirohiko Suh, Cheolwon Sureda, Anna Tanimoto, Mitsune Taniwaki, Masafumi Tilly, Herve Trneny, Marek Tsukamoto, Norifumi Vitolo, Umberto Walewski, Jan Weidmann, Eckhart Wilhelm, Martin Witzens-Harig, Mathias Yacoub, Abdulraheem Yamamoto, Kazuhito Yoon, Sung-Soo Yun, Hwan Jung Zain, Jasmine |
| Copyright Year | 2018 |
| Description | Journal: The Lancet |
| Abstract | Summary Background Based on the encouraging activity and manageable safety profile observed in a phase 1 study, the ECHELON-2 trial was initiated to compare the efficacy and safety of brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone (A+CHP) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) for the treatment of CD30-positive peripheral T-cell lymphomas. Methods ECHELON-2 is a double-blind, double-dummy, randomised, placebo-controlled, active-comparator phase 3 study. Eligible adults from 132 sites in 17 countries with previously untreated CD30-positive peripheral T-cell lymphomas (targeting 75% with systemic anaplastic large cell lymphoma) were randomly assigned 1:1 to receive either A+CHP or CHOP for six or eight 21-day cycles. Randomisation was stratified by histological subtype according to local pathology assessment and by international prognostic index score. All patients received cyclophosphamide 750 $mg/m^{2}$ and doxorubicin 50 $mg/m^{2}$ on day 1 of each cycle intravenously and prednisone 100 mg once daily on days 1 to 5 of each cycle orally, followed by either brentuximab vedotin 1·8 mg/kg and a placebo form of vincristine intravenously (A+CHP group) or vincristine 1·4 $mg/m^{2}$ and a placebo form of brentuximab vedotin intravenously (CHOP group) on day 1 of each cycle. The primary endpoint, progression-free survival according to blinded independent central review, was analysed by intent-to-treat. This trial is registered with ClinicalTrials.gov, number NCT01777152. Findings Between Jan 24, 2013, and Nov 7, 2016, 601 patients assessed for eligibility, of whom 452 patients were enrolled and 226 were randomly assigned to both the A+CHP group and the CHOP group. Median progression-free survival was 48·2 months (95% CI 35·2–not evaluable) in the A+CHP group and 20·8 months (12·7–47·6) in the CHOP group (hazard ratio 0·71 [95% CI 0·54–0·93], p=0·0110). Adverse events, including incidence and severity of febrile neutropenia (41 [18%] patients in the A+CHP group and 33 [15%] in the CHOP group) and peripheral neuropathy (117 [52%] in the A+CHP group and 124 [55%] in the CHOP group), were similar between groups. Fatal adverse events occurred in seven (3%) patients in the A+CHP group and nine (4%) in the CHOP group. Interpretation Front-line treatment with A+CHP is superior to CHOP for patients with CD30-positive peripheral T-cell lymphomas as shown by a significant improvement in progression-free survival and overall survival with a manageable safety profile. Funding Seattle Genetics Inc, Millennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmacuetical Company Limited, and National Institutes of Health National Cancer Institute Cancer Center. |
| Related Links | http://europepmc.org/articles/pmc6436818?pdf=render https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/pdf http://www.thelancet.com/article/S0140673618329842/pdf |
| Ending Page | 240 |
| Page Count | 12 |
| Starting Page | 229 |
| ISSN | 01406736 |
| DOI | 10.1016/s0140-6736%2818%2932984-2 |
| Journal | The Lancet |
| Issue Number | 10168 |
| Volume Number | 393 |
| Language | English |
| Publisher | Elsevier BV |
| Publisher Date | 2018-12-03 |
| Access Restriction | Open |
| Subject Keyword | Journal: The Lancet General Medicine Chp Group Randomly Assigned |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
