Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study

被引:76
作者
Houillier, Caroline [1 ]
Dureau, Sylvain [2 ]
Taillandier, Luc [3 ]
Houot, Roch [4 ]
Chinot, Olivier [5 ]
Molucon-Chabrot, Cecile [6 ]
Schmitt, Anna [7 ]
Gressin, Remy [8 ]
Choquet, Sylvain [9 ]
Damaj, Gandhi [10 ,11 ]
Peyrade, Frederic [12 ]
Abraham, Julie [13 ]
Delwail, Vincent [14 ]
Gyan, Emmanuel [15 ]
Sanhes, Laurence [16 ]
Cornillon, Jerome [17 ,18 ]
Garidi, Reda [19 ]
Delmer, Alain [20 ]
Al Jijakli, Ahmad [21 ]
Morel, Pierre [10 ,22 ]
Waultier, Agathe [23 ]
Paillassa, Jerome [24 ]
Chauchet, Adrien [25 ]
Gastinne, Thomas [26 ]
Laadhari, Mouna [27 ]
Plissonnier, Anne-Sophie [28 ]
Feuvret, Loic [29 ]
Cassoux, Nathalie [30 ,31 ,32 ]
Touitou, Valerie [33 ]
Ricard, Damien [34 ]
Hoang-Xuan, Khe [1 ]
Soussain, Carole [35 ,36 ]
机构
[1] Sorbonne Univ, Grp Hosp Pitie Salpetriere, AP HP, IHU,ICM,Serv Neurol Mazarin, Paris, France
[2] Inst Curie, Unite Biometrie, St Cloud, France
[3] Serv Neurol, CHU Nancy, Nancy, France
[4] Univ Rennes 1, Serv Hematol, CHU Rennes, INSERM,U1236, Rennes, France
[5] Aix Marseille Univ, AP HM, CNRS, INP,Serv Neurooncol,CHU Timone, Marseille, France
[6] CHU Clermont Ferrand, Serv Hematol, Clermont Ferrand, France
[7] Inst Bergonie, Serv Hematol, Bordeaux, France
[8] CHU Grenoble, Oncohaematol Dept, Grenoble, France
[9] Grp Hosp Pitie Salpetriere, AP HP, Serv Hematol Clin, Paris, France
[10] CHU Amiens, Serv Hematol, Amiens, France
[11] Univ Hosp, Inst Hematol, Normandy, Caen, France
[12] Ctr Antoine Lacassagne, Serv Hematol, Nice, France
[13] CHU Limoges, Serv Hematol & Therapie Cellulaire, Limoges, France
[14] Univ Poitiers, Ctr Invest Clin, Serv Oncol Hematol & Therapie Cellulaire, CHU Poitiers,INSERM,CIC 1402, Poitiers, France
[15] CHU Tours, Serv Hematol & Therapie Cellulaire, Ctr Invest Clin, INSERM,U1517, Tours, France
[16] Ctr Hosp Perpignan, Serv Hematol, Tours, France
[17] Inst Cancerol Lucien Neuwirth, Serv Hematol, St Priest En Jarez, France
[18] CHU St Etienne, Dept Hematol Clin, St Etienne, France
[19] Ctr Hosp St Quentin, Serv Hematol, St Etienne, France
[20] CHU Reims, Serv Hematol, Reims, France
[21] Ctr Hosp Argenteuil, Serv Hematol, Argenteuil, France
[22] Ctr Hosp Lens, Serv Hematol, Lens, France
[23] CHU Nimes, Serv Hematol, Nimes, France
[24] CHU Angers, Serv Hematol, Angers, France
[25] CHU Besancon, Serv Hematol, Besancon, France
[26] CHU Nantes, Serv Hematol, Nantes, France
[27] Inst Curie, Dept Imagerie Med, Site St Cloud, Paris, France
[28] Inst Curie, DREH Pole Promot, St Cloud, France
[29] Grp Hosp Pitie Salpetriere, AP HP, Serv Radiotherapie, Paris, France
[30] Inst Curie, Serv Ophtalmol, Site Paris, Paris, France
[31] Univ Paris 05, Paris, France
[32] PSL Paris Sci & Lettre, Paris, France
[33] Grp Hosp Pitie Salpetriere, AP HP, Serv Ophtalmol, Paris, France
[34] Hop Instruct Armees Percy, Serv Sante Armees, Ecole Val Grace, Serv Neurol, Clamart, France
[35] PSL Res Univ, Serv Hematol, Inst Curie, Site St Cloud, Paris, France
[36] PSL Res Univ, INSERM, U932, Inst Curie, Paris, France
关键词
NERVOUS-SYSTEM LYMPHOMA; CYCLOPHOSPHAMIDE; BUSULFAN; THIOTEPA;
D O I
10.1200/JCO.22.00491
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported the results of a randomized phase II study in patients with newly diagnosed primary CNS lymphoma (age 18-60 years). Patients were treated with high-dose methotrexate-based induction chemotherapy followed by whole-brain radiotherapy (WBRT) or high-dose chemotherapy (thiotepa-busulfan-cyclophosphamide) with autologous stem-cell transplantation (ASCT). The median follow-up was 33 months. In this report, we provide long-term data (median follow-up, 8 years) regarding the outcomes and toxicities. Fifty-three and 44 patients received induction chemotherapy followed by WBRT or ASCT, respectively. Their 8-year event-free survival from random assignment was 67% and 39% in the ASCT and WBRT arms, respectively (P = .03), with a significantly lower risk of relapse after ASCT (hazard ratio, 0.13; P < .001). One third of patients who relapsed after WBRT were alive after salvage treatment. Five and four patients died of ASCT and WBRT-related toxicities, respectively. The 8-year overall survival was 69% and 65% in the ASCT and WBRT arms, respectively (not significant). Balance (52% v 10%, P <= 0.001) and neurocognition (64% v 13%, P < .001) significantly deteriorated after WBRT compared with ASCT during the follow-up. This study shows that 40 Gy WBRT should be avoided in first-line treatment because of its neurotoxicity and suboptimal efficacy in reducing relapses while ASCT appears to be highly efficient in preventing relapses.
引用
收藏
页码:3692 / +
页数:13
相关论文
共 10 条
[1]   Report of an international workshop to standardize baseline evaluation and response criteria for primary CNS lymphoma [J].
Abrey, LE ;
Batchelor, TT ;
Ferreri, AJM ;
Gospodarowicz, M ;
Pulczynski, EJ ;
Zucca, E ;
Smith, JR ;
Korfel, A ;
Soussain, C ;
DeAngelis, LM ;
Neuwelt, EA ;
O'Neill, BP ;
Thiel, E ;
Shenkier, T ;
Graus, F ;
van den Bent, M ;
Seymour, JF ;
Poortmans, P ;
Armitage, JO ;
Cavalli, F .
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (22) :5034-5043
[2]   Longitudinal cognitive assessment in patients with primary CNS lymphoma treated with induction chemotherapy followed by reduced-dose whole-brain radiotherapy or autologous stem cell transplantation [J].
Correa, Denise D. ;
Braun, Erica ;
Kryza-Lacombe, Maria ;
Ho, Ka-Wai ;
Reiner, Anne S. ;
Panageas, Katherine S. ;
Yahalom, Joachim ;
Sauter, Craig S. ;
Abrey, Lauren E. ;
DeAngelis, Lisa M. ;
Omuro, Antonio .
JOURNAL OF NEURO-ONCOLOGY, 2019, 144 (03) :553-562
[3]   Whole-brain radiotherapy or autologous stem-cell transplantation as consolidation strategies after high-dose methotrexate-based chemoimmunotherapy in patients with primary CNS lymphoma: results of the second randomisation of the International Extranodal Lymphoma Study Group-32 phase 2 trial [J].
Ferreri, Andres J. M. ;
Cwynarski, Kate ;
Pulczynski, Elisa ;
Fox, Christopher P. ;
Schorb, Elisabeth ;
La Rosee, Paul ;
Binder, Mascha ;
Fabbri, Alberto ;
Torri, Valter ;
Minacapelli, Eleonora ;
Falautano, Monica ;
Ilariucci, Fiorella ;
Ambrosetti, Achille ;
Roth, Alexander ;
Hemmaway, Claire ;
Johnson, Peter ;
Linton, Kim M. ;
Pukrop, Tobias ;
Gorlov, Jette Sonderskov ;
Balzarotti, Monica ;
Hess, Georg ;
Keller, Ulrich ;
Stilgenbauer, Stephan ;
Panse, Jens ;
Tucci, Alessandra ;
Orsucci, Lorella ;
Pisani, Francesco ;
Levis, Alessandro ;
Krause, Stefan W. ;
Schmoll, Hans J. ;
Hertenstein, Bernd ;
Rummel, Mathias ;
Smith, Jeffery ;
Pfreundschuh, Michael ;
Cabras, Giuseppina ;
Angrilli, Francesco ;
Ponzoni, Maurilio ;
Deckert, Martina ;
Politi, Letterio S. ;
Finke, Juergen ;
Reni, Michele ;
Cavalli, Franco ;
Zucca, Emanuele ;
Illerhaus, Gerald .
LANCET HAEMATOLOGY, 2017, 4 (11) :E510-E523
[4]   Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results o the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study [J].
Houillier, Caroline ;
Taillandier, Luc ;
Dureau, Sylvain ;
Lamy, Thierry ;
Laadhari, Mouna ;
Chinot, Olivier ;
Molucon-Chabrot, Cecile ;
Soubeyran, Pierre ;
Gressin, Remy ;
Choquet, Sylvain ;
Damaj, Gandhi ;
Thyss, Antoine ;
Abraham, Julie ;
Delwail, Vincent ;
Gyan, Emmanuel ;
Sanhes, Laurence ;
Cornillon, Jerome ;
Garidi, Reda ;
Delmer, Alain ;
Tanguy, Marie-Laure ;
Al Jijakli, Ahmad ;
Morel, Pierre ;
Bourquard, Pascal ;
Moles, Marie-Pierre ;
Chauchet, Adrien ;
Gastinne, Thomas ;
Constans, Jean-Marc ;
Langer, Adriana ;
Martin, Antoine ;
Moisson, Patricia ;
Lacomblez, Lucette ;
Martin-Duverneuil, Nadine ;
Delgadillo, Daniel ;
Turbiez, Isabelle ;
Feuvret, Loic ;
Cassoux, Nathalie ;
Touitou, Valerie ;
Ricard, Damien ;
Hoang-Xuan, Khe ;
Soussain, Carole .
JOURNAL OF CLINICAL ONCOLOGY, 2019, 37 (10) :823-+
[5]  
Mutter JA, 2021, BLOOD, V138, P6, DOI DOI 10.1182/BLOOD-2021-149644
[6]   Outcomes of Consecutively Diagnosed Primary Central Nervous System Lymphoma Patients Using the Alberta Lymphoma Clinical Practice Guideline Incorporating Thiotepa-Busulfan Conditioning for Transplantation-Eligible Patients [J].
Sanders, Sheilagh ;
Chua, Neil ;
Larouche, Jean-Francois ;
Owen, Carolyn ;
Shafey, Mona ;
Stewart, Douglas A. .
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, 2019, 25 (08) :1505-1510
[7]   Intensive chemotherapy followed by autologous stem cell transplantation in primary central nervous system lymphomas (PCNSLs). Therapeutic outcomes in real life-experience of the French Network [J].
Schenone, Laurence ;
Houillier, Caroline ;
Tanguy, Marie Laure ;
Choquet, Sylvain ;
Agbetiafa, Kossi ;
Ghesquieres, Herve ;
Damaj, Gandhi ;
Schmitt, Anna ;
Bouabdallah, Krimo ;
Ahle, Guido ;
Gressin, Remy ;
Cornillon, Jerome ;
Houot, Roch ;
Marolleau, Jean-Pierre ;
Fornecker, Luc-Matthieu ;
Chinot, Olivier ;
Peyrade, Frederic ;
Bouabdallah, Reda ;
Molucon-Chabrot, Cecile ;
Gyan, Emmanuel ;
Chauchet, Adrien ;
Casasnovas, Olivier ;
Oberic, Lucie ;
Delwail, Vincent ;
Abraham, Julie ;
Roland, Virginie ;
Waultier-Rascalou, Agathe ;
Willems, Lise ;
Morschhauser, Franck ;
Fabbro, Michel ;
Ursu, Renata ;
Thieblemont, Catherine ;
Jardin, Fabrice ;
Tempescul, Adrian ;
Malaise, Denis ;
Touitou, Valerie ;
Nichelli, Lucia ;
Le Garff-Tavernier, Magali ;
Plessier, Aurelie ;
Bourget, Philippe ;
Bonmati, Caroline ;
Wantz-Mezieres, Sophie ;
Giordan, Quentin ;
Dorvaux, Veronique ;
Charron, Cyril ;
Jabeur, Waliyde ;
Hoang-Xuan, Khe ;
Taillandier, Luc ;
Soussain, Carole .
BONE MARROW TRANSPLANTATION, 2022, 57 (06) :966-974
[8]   Outcomes Associated With Thiotepa-Based Conditioning in Patients With Primary Central Nervous System Lymphoma After Autologous Hematopoietic Cell Transplant [J].
Scordo, Michael ;
Wang, Trent P. ;
Ahn, Kwang W. ;
Chen, Yue ;
Ahmed, Sairah ;
Awan, Farrukh T. ;
Beitinjaneh, Amer ;
Chen, Andy ;
Chow, Victor A. ;
Dholaria, Bhagirathbhai ;
Epperla, Narendranath ;
Farooq, Umar ;
Ghosh, Nilanjan ;
Grover, Natalie ;
Hamad, Nada ;
Hildebrandt, Gerhard C. ;
Holmberg, Leona ;
Hong, Sanghee ;
Inwards, David J. ;
Jimenez-Jimenez, Antonio ;
Karmali, Reem ;
Kenkre, Vaishalee P. ;
Khimani, Farhad ;
Klyuchnikov, Evgeny ;
Krem, Maxwell M. ;
Munshi, Pashna N. ;
Nieto, Yago ;
Prestidge, Tim ;
Ramakrishnan Geethakumari, Praveen ;
Rezvani, Andrew R. ;
Riedell, Peter A. ;
Seo, Sachiko ;
Shah, Nirav N. ;
Solh, Melhem ;
Yared, Jean A. ;
Kharfan-Dabaja, Mohamed A. ;
Herrera, Alex ;
Hamadani, Mehdi ;
Sauter, Craig S. .
JAMA ONCOLOGY, 2021, 7 (07) :993-1003
[9]   A Comprehensive Assessment of Toxicities in Patients with Central Nervous System Lymphoma Undergoing Autologous Stem Cell Transplantation Using Thiotepa, Busulfan, and Cyclophosphamide Conditioning [J].
Scordo, Michael ;
Bhatt, Valkal ;
Hsu, Meier ;
Omuro, Antonio M. ;
Matasar, Matthew J. ;
DeAngelis, Lisa M. ;
Dahi, Parastoo B. ;
Moskowitz, Craig H. ;
Giralt, Sergio A. ;
Sauter, Craig S. .
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, 2017, 23 (01) :38-43
[10]   Intensive chemotherapy with thiotepa, busulfan and cyclophosphamide and hematopoietic stem cell rescue in relapsed or refractory primary central nervous system lymphoma and intraocular lymphoma: a retrospective study of 79 cases [J].
Soussain, Carole ;
Choquet, Sylvain ;
Fourme, Emmanuelle ;
Delgadillo, Daniel ;
Bouabdallah, Krimo ;
Ghesquieres, Herve ;
Damaj, Gandhi ;
Dupriez, Brigitte ;
Vargaftig, Jacques ;
Gonzalez, Alberto ;
Houillier, Caroline ;
Taillandier, Luc ;
Khe Hoang-Xuan ;
Leblond, Veronique .
HAEMATOLOGICA-THE HEMATOLOGY JOURNAL, 2012, 97 (11) :1751-1756