Difference between revisions of "Classical Hodgkin lymphoma - null regimens"

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the [[Mantle cell lymphoma|main mantle cell lymphoma page]] for current regimens.
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[[#top|Back to Top]]
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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Classical_Hodgkin_lymphoma|main Hodgkin lymphoma page]] for regimens that include active anticancer treatment.
  
 
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=Adjuvant therapy=
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=Untreated, early-stage favorable (ESF)=
 
==Observation==
 
==Observation==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
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<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1200/jco.2006.07.0482 Engert et al. 2007 (GHSG HD7)]
 +
|1993-1998
 +
| style="background-color:#1a9851" |Phase 3 (C)
 +
|[[Classical_Hodgkin_lymphoma#ABVD|ABVD]] x 2
 +
| style="background-color:#d73027" |Inferior FFTF
 
|-
 
|-
−
|[[#top|back to top]]
 
 
|}
 
|}
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''No anticancer treatment''
 +
<div class="toccolours" style="background-color:#cbd5e7">
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====Subsequent treatment====
 +
*[[#Radiation_therapy_2|EFRT]] consolidation
 +
</div></div>
 +
===References===
 +
# '''GHSG HD7:''' Engert A, Franklin J, Eich HT, Brillant C, Sehlen S, Cartoni C, Herrmann R, Pfreundschuh M, Sieber M, Tesch H, Franke A, Koch P, de Wit M, Paulus U, Hasenclever D, Loeffler M, Müller RP, Müller-Hermelink HK, Dühmke E, Diehl V. Two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine plus extended-field radiotherapy is superior to radiotherapy alone in early favorable Hodgkin's lymphoma: final results of the GHSG HD7 trial. J Clin Oncol. 2007 Aug 10;25(23):3495-502. Epub 2007 Jul 2. [https://doi.org/10.1200/jco.2006.07.0482 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17606976/ PubMed]
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## '''Pooled update:''' Sasse S, Bröckelmann PJ, Goergen H, Plütschow A, Müller H, Kreissl S, Buerkle C, Borchmann S, Fuchs M, Borchmann P, Diehl V, Engert A. Long-term follow-up of contemporary treatment in early-stage Hodgkin lymphoma: updated analyses of the German Hodgkin Study Group HD7, HD8, HD10, and HD11 trials. J Clin Oncol. 2017 Jun 20;35(18):1999-2007. Epub 2017 Apr 18. [https://doi.org/10.1200/JCO.2016.70.9410 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28418763/ PubMed]
 +
 +
=Consolidation after upfront therapy=
 +
 +
==Observation==
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen===
 
===Regimen===
−
{| class="wikitable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(80)90057-4/fulltext Lacour et al. 1980]
+
|rowspan=2|[https://doi.org/10.1016/S0140-6736(73)91672-3 Young et al. 1973]
−
|1972-1979
+
|rowspan=2|1967-1972
−
|style="background-color:#1a9851"|Phase III (C)
+
|rowspan=2 style="background-color:#1a9851" |Phase 3 (C)
−
|Polya.Polyu
+
|1. [[#Carmustine_monotherapy_999|Intermittent BCNU]]
−
| style="background-color:#fee08b" |Might have inferior OS
+
| style="background-color:#ffffbf" |Did not meet efficacy endpoints
 
|-
 
|-
−
|[https://www.nejm.org/doi/full/10.1056/NEJM197602192940801 Bonadonna et al. 1976]
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|2. [[#MOPP_999|Intermittent MOPP]]
−
|1973-1975
+
| style="background-color:#ffffbf" |Did not meet efficacy endpoints
−
|style="background-color:#1a9851"|Phase III (C)
 
−
|[[Breast_cancer#CMF|CMF]]
 
−
|style="background-color:#d73027"|Inferior RFS
 
 
|-
 
|-
−
|[http://www.tandfonline.com/doi/full/10.1080/0284186X.2017.1400179 Jensen et al. 2017 (CBC 02)]
+
|[https://doi.org/10.1056/NEJMoa022628 Aleman et al. 2003 (EORTC 20884)]
−
|1975-1978
+
|1989-2000
−
| style="background-color:#1a9851" |Phase III (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 2 y
+
|[[Classical_Hodgkin_lymphoma#Radiation_therapy_2|IFRT]]
−
| style="background-color:#fc8d59" |Seems to have inferior OS
+
| style="background-color:#ffffbf" |Did not meet primary endpoint of RFS36
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(83)91385-5/fulltext Rubens et al. 1983]
+
|[https://doi.org/10.1182/blood-2004-04-1311 Straus et al. 2004]
−
|1975-1979
+
|1990-2000
−
|style="background-color:#1a9851"|Phase III (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
−
|[[Breast_cancer_-_historical#Melphalan_monotherapy|Melphalan]]
+
|[[Classical_Hodgkin_lymphoma#Radiation_therapy_2|EFRT]]
−
| style="background-color:#fee08b" |Might have inferior RFS
+
| style="background-color:#fee08b" |Might have inferior OS
−
|-
 
−
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(83)91683-5/abstract Baum et al. 1983 (NATO)]
 
−
|1977-1981
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 2 y
 
−
| style="background-color:#d73027" |Inferior OS
 
−
|-
 
−
|rowspan=3|[https://link.springer.com/article/10.1007/BF01806239 Brinker et al. 1983 (DBCG 77B)]
 
−
|rowspan=3|1977-1983
 
−
|rowspan=3 style="background-color:#1a9851" |Phase III (C)
 
−
|1. [[Breast_cancer#CMF|CMF]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior OS (*)
 
−
|-
 
−
|2. [[Breast_cancer_-_historical#Cyclophosphamide_monotherapy|Cyclophosphamide]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior OS (*)
 
−
|-
 
−
|3. [[Breast_cancer_-_historical#Levamisole_monotherapy|Levamisole]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoints of IDFS/OS
 
 
|-
 
|-
−
|rowspan = 2|[https://www.thelancet.com/journals/lancet/article/PIIS0140673684924450/fulltext Goldhirsch et al. 1984 (LBCS III)]
+
|rowspan=2|[https://doi.org/10.1016/j.ijrobp.2017.10.015 Thomas et al. 2017 (EORTC-GELA H9-F)]
−
|rowspan=2|1978-1981
+
|rowspan=2|1998-2004
−
|rowspan = 2 style="background-color:#1a9851" |Phase III (C)
+
|rowspan=2 style="background-color:#1a9851" |Phase 3 (E-de-esc)
−
|1. [[Breast_cancer_-_historical#CMFPT|CMFPT]]
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|1. [[Classical_Hodgkin_lymphoma#Radiation_therapy_2|IFRT]] x 2000 cGy
−
| style="background-color:#d73027" |Inferior DFS
+
| style="background-color:#d3d3d3" |Not reported
 
|-
 
|-
−
|2. [[Breast_cancer_-_historical#PT|PT]]
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|2. [[Classical_Hodgkin_lymphoma#Radiation_therapy_2|IFRT]] x 3600 cGy
−
| style="background-color:#d73027" |Inferior DFS
 
−
|-
 
−
|[https://www.thelancet.com/journals/lancet/article/PIIS0140673684924450/fulltext Goldhirsch et al. 1984 (LBCS IV)]
 
−
|1978-1981
 
−
|style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer_-_historical#PT|PT]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior DFS
 
−
|-
 
−
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(87)90762-8/fulltext Stewart et al. 1987 (Scottish Tamoxifen Trial)]
 
−
|1978-1984
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 5 y
 
−
| style="background-color:#d73027" |Inferior OS (*)
 
−
|-
 
−
|[https://www.nejm.org/doi/full/10.1056/NEJM198902233200801 Fisher et al. 1989 (NSABP B-13)]
 
−
|1981-1988
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer_-_historical#MF|MF]]; sequential
 
−
| style="background-color:#d73027" |Inferior DFS (*)
 
−
|-
 
−
|[https://www.nejm.org/doi/full/10.1056/NEJM198902233200803 Mansour et al. 1989 (INT-0011)]
 
−
|1981-1988
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer_-_historical#CMFP|CMFP]]
 
−
|style="background-color:#d73027"|Inferior DFS
 
−
|-
 
−
|[https://www.ejcancer.com/article/S0959-8049(04)00565-9/fulltext Rydén et al. 2005 (SBII:2pre)]
 
−
|1986-1991
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 2 y
 
 
| style="background-color:#d73027" |Inferior RFS
 
| style="background-color:#d73027" |Inferior RFS
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/23/33/8313.long Hutchins et al. 2005 (INT-0102)]
+
|[https://doi.org/10.1200/jco.2010.33.9549 Borchmann et al. 2011 (GHSG HD12)]
−
|1989-1993
+
|1999-2003
−
| style="background-color:#1a9851" |Phase III (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 5 y
+
|[[Classical_Hodgkin_lymphoma#Radiation_therapy_2|ISRT]] x 3000 cGy
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS
+
|style="background-color:#fee08b"|Might have inferior 5-year FFTF
−
|-
 
−
|[https://ascopubs.org/doi/full/10.1200/JCO.2001.19.19.3929 Paradiso et al. 2001]
 
−
|1989-1994
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer#FEC_2|FEC]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior DFS
 
−
|-
 
−
|[https://ascopubs.org/doi/full/10.1200/JCO.2005.03.0783 Colleoni et al. 2006 (IBCSG 13-93)]
 
−
|1993-1999
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 5 y
 
−
| style="background-color:#1a9850" |Superior DFS
 
−
|-
 
−
|[http://jco.ascopubs.org/content/21/6/976.long Henderson et al. 2003 (INT 0148/CALGB 9344)]
 
−
|1994-1999
 
−
|style="background-color:#1a9851"|Phase III (C)
 
−
|[[Breast_cancer_-_historical#Paclitaxel_monotherapy.2C_q3wk|Paclitaxel]]; q3wk
 
−
|style="background-color:#d73027"|Inferior OS
 
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/23/16/3686.long Mamounas et al. 2005 (NSABP B-28)]
+
|[https://doi.org/10.1056/NEJMoa1408648 Radford et al. 2015 (UK NCRI RAPID)]
−
|1995-1998
+
|2003-2010
−
|style="background-color:#1a9851"|Phase III (C)
+
| style="background-color:#1a9851" |Phase 3 (E-de-esc)
−
|[[Breast_cancer_-_historical#Paclitaxel_monotherapy.2C_q3wk|Paclitaxel]]; q3wk
+
|[[Classical_Hodgkin_lymphoma#Radiation_therapy_2|IFRT]]
−
|style="background-color:#d73027"|Inferior DFS
+
| style="background-color:#ffffbf" |Inconclusive whether non-inferior PFS36
−
|-
 
−
|[https://academic.oup.com/annonc/article/27/5/806/2769820 Zdenkowski et al. 2016 (ANZ0501 LATER)]
 
−
|2007-2012
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer,_ER-positive#Letrozole_monotherapy_2|Letrozole]] x 5 y
 
−
| style="background-color:#fee08b" |Might have inferior DFS
 
 
|-
 
|-
 
|}
 
|}
−
''Note: No further systemic treatment; many of these trials incorporated RT, however (see individual papers for details). Reported efficacy for NSABP B-13 is based on the 1996 update. Reported efficacy for the Scottish Tamoxifen Trial is based on the 2001 update. Reported efficacy for DBCG 77B is based on the 2010 update.''
+
''No further treatment.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
−
*Bonadonna et al. 1976: [[Surgery#Mastectomy|Mastectomy]]
+
*Young et al. 1973: Induction [[Classical_Hodgkin_lymphoma#MOPP|MOPP]]
−
*ECOG E1180: [[Surgery#Modified_radical_mastectomy|Modified radical mastectomy]] or [[Surgery#Mastectomy|total mastectomy]] with [[Surgery#Axillary_lymph_node_dissection|low axillary-node dissection]]
+
*EORTC 20884: Induction [[Classical_Hodgkin_lymphoma#MOPP-ABV_3|MOPP-ABV]] x 6 to 8
−
*INT 0148/CALGB 9344: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#AC_2|AC]] x 4 versus high-dose AC x 4 versus very-high-dose AC x 4
+
*Straus et al. 2004: Induction [[Classical_Hodgkin_lymphoma#ABVD_2|ABVD]] x 6
−
*NSABP B-28: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#AC_2|AC]] x 4
+
*GHSG HD12: Induction [[Classical_Hodgkin_lymphoma#eBEACOPP_2|eBEACOPP]] x 8 versus [[Classical_Hodgkin_lymphoma#eBEACOPP-BEACOPP|BEACOPP<sub>4+4</sub>]]
−
*INT-0102: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#FAC_2|CAF]] x 6 versus [[Breast_cancer#CMF|CMF]] x 6
+
*UK NCRI RAPID: Induction [[Classical_Hodgkin_lymphoma#ABVD|ABVD]] x 3
−
*IBCSG 13-93: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#AC_2|AC]] x 4 or [[Breast_cancer#EC_2|EC]] x 4, then [[Breast_cancer#CMF|CMF]] x 3
+
*EORTC-GELA H9-F: Induction [[Classical_Hodgkin_lymphoma#EBVP|EBVP]] x 6
−
*ANZ0501 LATER: At least 4 years of any endocrine therapy
+
</div></div>
 +
 
 
===References===
 
===References===
−
# Bonadonna G, Brusamolino E, Valagussa P, Rossi A, Brugnatelli L, Brambilla C, De Lena M, Tancini G, Bajetta E, Musumeci R, Veronesi U. Combination chemotherapy as an adjuvant treatment in operable breast cancer. N Engl J Med. 1976 Feb 19;294(8):405-10. [https://www.nejm.org/doi/full/10.1056/NEJM197602192940801 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/1246307 PubMed]
+
# Young RC, Canellos GP, Chabner BA, Schein PS, DeVita VT. Maintenance chemotherapy for advanced Hodgkin's disease in remission. Lancet. 1973 Jun 16;1(7816):1339-43. [https://doi.org/10.1016/S0140-6736(73)91672-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/4122739/ PubMed]
−
## '''Update:''' Bonadonna G, Rossi A, Valagussa P, Banfi A, Veronesi U. The CMF program for operable breast cancer with positive axillary nodes: updated analysis on the disease-free interval, site of relapse and drug tolerance. Cancer. 1977 Jun;39(6 Suppl):2904-15. [https://onlinelibrary.wiley.com/doi/10.1002/1097-0142(197706)39:6%3C2904::AID-CNCR2820390677%3E3.0.CO;2-8/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/326384 PubMed]
+
# '''EORTC 20884:''' Aleman BM, Raemaekers JM, Tirelli U, Bortolus R, van 't Veer MB, Lybeert ML, Keuning JJ, Carde P, Girinsky T, van der Maazen RW, Tomsic R, Vovk M, van Hoof A, Demeestere G, Lugtenburg PJ, Thomas J, Schroyens W, De Boeck K, Baars JW, Kluin-Nelemans JC, Carrie C, Aoudjhane M, Bron D, Eghbali H, Smit WG, Meerwaldt JH, Hagenbeek A, Pinna A, Henry-Amar M; [[Study_Groups#EORTC|EORTC]] Lymphoma Group. Involved-field radiotherapy for advanced Hodgkin's lymphoma. N Engl J Med. 2003 Jun 12;348(24):2396-406. [https://doi.org/10.1056/NEJMoa022628 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12802025/ PubMed]
−
## '''Update:''' Bonadonna G, Valagussa P, Rossi A, Tancini G, Brambilla C, Zambetti M, Veronesi U. Ten-year experience with CMF-based adjuvant chemotherapy in resectable breast cancer. Breast Cancer Res Treat. 1985;5(2):95-115. [https://www.ncbi.nlm.nih.gov/pubmed/3839424 PubMed]
+
# Straus DJ, Portlock CS, Qin J, Myers J, Zelenetz AD, Moskowitz C, Noy A, Goy A, Yahalom J. Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease. Blood. 2004 Dec 1;104(12):3483-9. Epub 2004 Aug 17. [https://doi.org/10.1182/blood-2004-04-1311 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15315964/ PubMed]
−
## '''Update:''' Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6. [https://www.nejm.org/doi/ref/10.1056/NEJM199504063321401 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/7877646 PubMed]
+
# '''GHSG HD12:''' Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dörken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compared with four cycles of escalated-dose BEACOPP followed by four cycles of baseline-dose BEACOPP with or without radiotherapy in patients with advanced-stage Hodgkin's lymphoma: final analysis of the HD12 trial of the German Hodgkin Study Group. J Clin Oncol. 2011 Nov 10;29(32):4234-42. Epub 2011 Oct 11. [https://doi.org/10.1200/jco.2010.33.9549 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21990399/ PubMed] [https://clinicaltrials.gov/study/NCT00265031 NCT00265031]
−
# Lacour J, Lacour F, Spira A, Michelson M, Petit JY, Delage G, Sarrazin D, Contesso G, Viguier J. Adjuvant treatment with polyadenylic-polyuridylic acid (Polya-Polyu) in operable breast cancer. Lancet. 1980 Jul 26;2(8187):161-4. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(80)90057-4/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/6105336 PubMed]
+
## '''Update:''' von Tresckow B, Kreissl S, Dipl-Math HG, Bröckelmann PJ, Pabst T, Fridrik M, Rummel M, Jung W, Thiemer J, Sasse S, Bürkle C, Baues C, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. Intensive treatment strategies in advanced-stage Hodgkin's lymphoma (HD9 and HD12): analysis of long-term survival in two randomised trials. Lancet Haematol. 2018 Oct 01;5(10):e462-73. [https://doi.org/10.1016/S2352-3026(18)30140-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30290903/ PubMed]
−
# '''NATO:''' Baum M, Brinkley DM, Dosset JA, McPherson K, Patterson JS, Rubens RD, Smiddy FG, Stoll BA, Wilson A, Lea JC, Richards D, Ellis SH. Controlled trial of tamoxifen as adjuvant agent in management of early breast cancer: interim analysis at four years by Nolvadex Adjuvant Trial Organisation. Lancet. 1983 Feb 5;1(8319):257-61. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(83)91683-5/abstract link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/6130291 PubMed]
+
<!-- # '''Abstract:''' Radford, John, Barrington, Sally, Counsell, Nicholas, Pettengell, Ruth, Johnson, Peter, Wimperis, Jennie, Coltart, Stewart, Culligan, Dominic, Lister, Andrew, Bessell, Eric, Kruger, Anton, Popova, Bilyana, Hancock, Barry, Hoskin, Peter, Illidge, Timothy, O'Doherty, Michael. Involved Field Radiotherapy Versus No Further Treatment in Patients with Clinical Stages IA and IIA Hodgkin Lymphoma and a 'Negative' PET Scan After 3 cycles ABVD. Results of the UK NCRI RAPID Trial. ASH Annual Meeting Abstracts 2012 120: 547-->
−
## '''Update:''' Baum M, Brinkley DM, Dosset JA, McPherson K, Patterson JS, Rubens RD, Smiddy FG, Stoll BA, Wilson A, Richards D, Ellis SH. Controlled trial of tamoxifen as single adjuvant agent in management of early breast cancer: analysis at six years by Nolvadex Adjuvant Trial Organisation. Lancet. 1985 Apr 13;1(8433):836-40. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(85)92206-8/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/2858709 PubMed]
+
# '''UK NCRI RAPID:''' Radford J, Illidge T, Counsell N, Hancock B, Pettengell R, Johnson P, Wimperis J, Culligan D, Popova B, Smith P, McMillan A, Brownell A, Kruger A, Lister A, Hoskin P, O'Doherty M, Barrington S. Results of a trial of PET-directed therapy for early-stage Hodgkin's lymphoma. N Engl J Med. 2015 Apr 23;372(17):1598-607. [https://doi.org/10.1056/NEJMoa1408648 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25901426/ PubMed] [https://clinicaltrials.gov/study/NCT00943423 NCT00943423]
−
# Rubens RD, Hayward JL, Knight RK, Bulbrook RD, Fentiman IS, Chaudary M, Howell A, Bush H, Crowther D, Sellwood RA, George WD, Howat JM. Controlled trial of adjuvant chemotherapy with melphalan for breast cancer. Lancet. 1983 Apr 16;1(8329):839-43. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(83)91385-5/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/6132179 PubMed]
+
# '''EORTC-GELA H9-F:''' Thomas J, Fermé C, Noordijk EM, Morschhauser F, Girinsky T, Gaillard I, Lugtenburg PJ, André M, Lybeert MLM, Stamatoullas A, Beijert M, Hélias P, Eghbali H, Gabarre J, van der Maazen RWM, Jaubert J, Bouabdallah K, Boulat O, Roesink JM, Christian B, Ong F, Bordessoule D, Tertian G, Gonzalez H, Vranovsky A, Quittet P, Tirelli U, de Jong D, Audouin J, Aleman BMP, Henry-Amar M. Comparison of 36 Gy, 20 Gy, or no radiation therapy after 6 cycles of EBVP chemotherapy and complete remission in early-stage Hodgkin lymphoma without risk factors: results of the EORTC-GELA H9-F intergroup randomized trial. Int J Radiat Oncol Biol Phys. 2018 Apr 1;100(5):1133-1145. Epub 2017 Oct 27. [https://doi.org/10.1016/j.ijrobp.2017.10.015 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29229324/ PubMed] [https://clinicaltrials.gov/study/NCT00005584 NCT00005584]
−
# '''DBCG 77B:''' Brincker H, Mouridsen HT, Andersen KW. Adjuvant chemotherapy with cyclophosphamide or CMF in premenopausal women with stage II breast cancer. Breast Cancer Res Treat. 1983;3(1):91-5. [https://link.springer.com/article/10.1007/BF01806239 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/6347278 PubMed]
 
−
## '''Update:''' Ejlertsen B, Mouridsen HT, Jensen MB, Andersen J, Andersson M, Kamby C, Knoop AS; Danish Breast Cancer Cooperative Group. Cyclophosphamide, methotrexate, and fluorouracil; oral cyclophosphamide; levamisole; or no adjuvant therapy for patients with high-risk, premenopausal breast cancer. Cancer. 2010 May 1;116(9):2081-9. [https://onlinelibrary.wiley.com/doi/10.1002/cncr.24969/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/20186830 PubMed]
 
−
# '''LBCS III/IV:''' Goldhirsch A; Ludwig Breast Cancer Study Group. Randomised trial of chemo-endocrine therapy, endocrine therapy, and mastectomy alone in postmenopausal patients with operable breast cancer and axillary node metastasis. Lancet. 1984 Jun 9;1(8389):1256-60. [https://www.thelancet.com/journals/lancet/article/PIIS0140673684924450/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/6144974 PubMed]
 
−
# '''Scottish Tamoxifen Trial:''' Stewart HJ, Taylor W, Forrest P. Adjuvant tamoxifen in the management of operable breast cancer: the Scottish Trial: report from the Breast Cancer Trials Committee, Scottish Cancer Trials Office (MRC), Edinburgh. Lancet. 1987 Jul 25;2(8552):171-5. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(87)90762-8/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/2885637 PubMed]
 
−
## '''Update:''' Stewart HJ, Forrest AP, Everington D, McDonald CC, Dewar JA, Hawkins RA, Prescott RJ, George WD; The Scottish Cancer Trials Breast Group. Randomised comparison of 5 years of adjuvant tamoxifen with continuous therapy for operable breast cancer. Br J Cancer. 1996 Jul;74(2):297-9. [https://www.nature.com/articles/bjc1996356 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2074573/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/8688340 PubMed]
 
−
## '''Update:''' Stewart HJ, Prescott RJ, Forrest AP. Scottish adjuvant tamoxifen trial: a randomized study updated to 15 years. J Natl Cancer Inst. 2001 Mar 21;93(6):456-62. [https://academic.oup.com/jnci/article/93/6/456/2906503 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11259471 PubMed]
 
−
# '''NSABP B-13:''' Fisher B, Redmond C, Dimitrov NV, Bowman D, Legault-Poisson S, Wickerham DL, Wolmark N, Fisher ER, Margolese R, Sutherland C, Glass A, Foster R, Caplan R. A randomized clinical trial evaluating sequential methotrexate and fluorouracil in the treatment of patients with node-negative breast cancer who have estrogen-receptor-negative tumors. N Engl J Med. 1989 Feb 23;320(8):473-8. [https://www.nejm.org/doi/full/10.1056/NEJM198902233200801 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/2644531 PubMed]
 
−
## '''Update:''' Fisher B, Dignam J, Mamounas EP, Costantino JP, Wickerham DL, Redmond C, Wolmark N, Dimitrov NV, Bowman DM, Glass AG, Atkins JN, Abramson N, Sutherland CM, Aron BS, Margolese RG. Sequential methotrexate and fluorouracil for the treatment of node-negative breast cancer patients with estrogen receptor-negative tumors: eight-year results from National Surgical Adjuvant Breast and Bowel Project (NSABP) B-13 and first report of findings from NSABP B-19 comparing methotrexate and fluorouracil with conventional cyclophosphamide, methotrexate, and fluorouracil. J Clin Oncol. 1996 Jul;14(7):1982-92. [https://ascopubs.org/doi/abs/10.1200/JCO.1996.14.7.1982 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/8683228 PubMed]
 
−
## '''Pooled update:''' Taghian AG, Jeong JH, Mamounas EP, Parda DS, Deutsch M, Costantino JP, Wolmark N. Low locoregional recurrence rate among node-negative breast cancer patients with tumors 5 cm or larger treated by mastectomy, with or without adjuvant systemic therapy and without radiotherapy: results from five national surgical adjuvant breast and bowel project randomized clinical trials. J Clin Oncol. 2006 Aug 20;24(24):3927-32. [https://ascopubs.org/doi/full/10.1200/JCO.2006.06.9054 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/16921044 PubMed]
 
−
# '''INT-0011:''' Mansour EG, Gray R, Shatila AH, Osborne CK, Tormey DC, Gilchrist KW, Cooper MR, Falkson G. Efficacy of adjuvant chemotherapy in high-risk node-negative breast cancer: an intergroup study. N Engl J Med. 1989 Feb 23;320(8):485-90. [https://www.nejm.org/doi/full/10.1056/NEJM198902233200803 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/2915651 PubMed]
 
−
# '''LCBS V:''' Goldhirsch A, Gelber RD; Ludwig Breast Cancer Study Group. Prolonged disease-free survival after one course of perioperative adjuvant chemotherapy for node-negative breast cancer. N Engl J Med. 1989 Feb 23;320(8):491-6. [https://www.nejm.org/doi/full/10.1056/NEJM198902233200804 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/2644533 PubMed]
 
−
# Paradiso A, Schittulli F, Cellamare G, Mangia A, Marzullo F, Lorusso V, De Lena M. Randomized clinical trial of adjuvant fluorouracil, epirubicin, and cyclophosphamide chemotherapy for patients with fast-proliferating, node-negative breast cancer. J Clin Oncol. 2001 Oct 1;19(19):3929-37. [https://ascopubs.org/doi/full/10.1200/JCO.2001.19.19.3929 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11579113 PubMed]
 
−
# '''INT 0148/CALGB 9344:''' Henderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E 3rd, Schilsky RL, Wood WC, Muss HB, Norton L. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003 Mar 15;21(6):976-83. [http://jco.ascopubs.org/content/21/6/976.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/12637460 PubMed]
 
−
# '''SBII:2pre:''' Rydén L, Jönsson PE, Chebil G, Dufmats M, Fernö M, Jirström K, Källström AC, Landberg G, Stål O, Thorstenson S, Nordenskjöld B; South Swedish Breast Cancer Group; South-East Swedish Breast Cancer Group. Two years of adjuvant tamoxifen in premenopausal patients with breast cancer: a randomised, controlled trial with long-term follow-up. Eur J Cancer. 2005 Jan;41(2):256-64. [https://www.ejcancer.com/article/S0959-8049(04)00565-9/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15661551 PubMed]
 
−
## '''Update:''' Ekholm M, Bendahl PO, Fernö M, Nordenskjöld B, Stål O, Rydén L. Two years of adjuvant tamoxifen provides a survival benefit compared with no systemic treatment in premenopausal patients with primary breast cancer: Long-term follow-up (> 25 years) of the phase III SBII:2pre trial. J Clin Oncol. 2016 Jul 1;34(19):2232-8. Epub 2016 May 9. [http://jco.ascopubs.org/content/34/19/2232.full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27161974 PubMed]
 
−
<!-- Presented in abstract form at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003; interim results were presented at the 2000 NIH Consensus Development Conference, Bethesda, MD, November 1-3, 2000. -->
 
−
# '''NSABP B-28:''' Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. Epub 2005 May 16. [http://jco.ascopubs.org/content/23/16/3686.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15897552 PubMed]
 
−
# '''INT-0102:''' Hutchins LF, Green SJ, Ravdin PM, Lew D, Martino S, Abeloff M, Lyss AP, Allred C, Rivkin SE, Osborne CK. Randomized, controlled trial of cyclophosphamide, methotrexate, and fluorouracil versus cyclophosphamide, doxorubicin, and fluorouracil with and without tamoxifen for high-risk, node-negative breast cancer: treatment results of intergroup protocol INT-0102. J Clin Oncol. 2005 Nov 20;23(33):8313-21. [http://jco.ascopubs.org/content/23/33/8313.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/16293862 PubMed]
 
−
# '''IBCSG 13-93:''' Colleoni M, Gelber S, Goldhirsch A, Aebi S, Castiglione-Gertsch M, Price KN, Coates AS, Gelber RD; International Breast Cancer Study Group. Tamoxifen after adjuvant chemotherapy for premenopausal women with lymph node-positive breast cancer: International Breast Cancer Study Group Trial 13-93. J Clin Oncol. 2006 Mar 20;24(9):1332-41. Epub 2006 Feb 27. [https://ascopubs.org/doi/full/10.1200/JCO.2005.03.0783 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16505417 PubMed]
 
−
# '''ANZ0501 LATER:''' Zdenkowski N, Forbes JF, Boyle FM, Kannourakis G, Gill PG, Bayliss E, Saunders C, Della-Fiorentina S, Kling N, Campbell I, Mann GB, Coates AS, Gebski V, Davies L, Thornton R, Reaby L, Cuzick J, Green M; Australia and New Zealand Breast Cancer Trials Group. Observation versus late reintroduction of letrozole as adjuvant endocrine therapy for hormone receptor-positive breast cancer (ANZ0501 LATER): an open-label randomised, controlled trial. Ann Oncol. 2016 May;27(5):806-12. Epub 2016 Feb 9. [https://academic.oup.com/annonc/article/27/5/806/2769820 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26861603 PubMed]
 
−
# '''CBC 02:''' Jensen MB, Krarup JF, Palshof T, Mouridsen HT, Ejlertsen B. Two years of tamoxifen or no adjuvant systemic therapy for patients with high-risk breast cancer: long-term follow-up of the Copenhagen Breast Cancer Trial. Acta Oncol. 2018 Jan;57(1):26-30. Epub 2017 Nov 22. [http://www.tandfonline.com/doi/full/10.1080/0284186X.2017.1400179 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29165021 PubMed]
 
  
−
==Placebo==
+
=Maintenance after upfront therapy=
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
==Observation==
−
|-
+
<div class="toccolours" style="background-color:#eeeeee">
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen===
 
===Regimen===
−
{| class="wikitable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://www.nejm.org/doi/full/10.1056/NEJM197501162920301 Fisher et al. 1975 (NSABP B-05)]
+
|[https://doi.org/10.1056/NEJM197412052912305 Sokal et al. 1974]
−
|1972-1975
+
|1965-1967
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#91cf61"|Randomized, fewer than 20 pts in this subgroup (C)
−
|[[Breast_cancer_-_historical#Melphalan_monotherapy|Melphalan]]
+
|[[Classical_Hodgkin_lymphoma_-_historical#BCG_vaccine_monotherapy|BCG]]
−
|style="background-color:#fee08b" |Might have inferior DFS (*)
+
| style="background-color:#d73027" |Inferior PFS
−
|-
 
−
|[https://www.nejm.org/doi/full/10.1056/NEJM198902233200802 Fisher et al. 1989 (NSABP B-14)]
 
−
|1982-1987
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]]
 
−
| style="background-color:#d73027" |Inferior OS (*)
 
−
|-
 
−
|[http://jco.ascopubs.org/content/19/4/931.full Fisher et al. 2001 (NSABP B-23)]
 
−
|1991-1998
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
−
|-
 
−
|[https://www.nejm.org/doi/full/10.1056/NEJMoa032312 Goss et al. 2003 (NCIC CTG MA.17)]
 
−
|1998-2002
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer,_ER-positive#Letrozole_monotherapy_2|Letrozole]]
 
−
| style="background-color:#d73027" |Inferior DFS
 
−
|-
 
−
|[http://jco.ascopubs.org/content/26/12/1965.long Mamounas et al. 2008 (NSABP B-33)]
 
−
|2001-2003
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer,_ER-positive#Exemestane_monotherapy|Exemestane]]
 
−
| style="background-color:#d73027" |Inferior RFS
 
 
|-
 
|-
 
|}
 
|}
−
''No active antineoplastic treatment. Used as a comparator arm, historically. Reported efficacy for NSABP B-05 is based on the 1986 update. Reported efficacy for NSABP B-14 based on the 2004 update.''
+
''Note: this study was open to patients with "malignant lymphoma" but the majority had Hodgkin disease.''
−
====Preceding treatment====
+
</div>
−
*NSABP B-05: [[Surgery#Mastectomy|Mastectomy]]
+
===References===
−
*NSABP B-14: [[Surgery#Breast_cancer_surgery|Surgery]]
+
# Sokal JE, Aungst CW, Snyderman M. Delay in progression of malignant lymphoma after BCG vaccination. N Engl J Med. 1974 Dec 5;291(23):1226-30. [https://doi.org/10.1056/NEJM197412052912305 link to original article] [https://pubmed.ncbi.nlm.nih.gov/4609380/ PubMed]
−
*NSABP B-23: [[Breast_cancer#CMF|CMF]] x 6 versus [[Breast_cancer#AC_2|AC]] x 4
 
−
*NCIC CTG MA.17: [[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 5y
 
−
*NSABP B-33: [[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 5y
 
  
−
===References===
+
=Maintenance after salvage therapy=
−
# '''NSABP B-05:''' Fisher B, Carbone P, Economou SG, Frelick R, Glass A, Lerner H, Redmond C, Zelen M, Band P, Katrych DL, Wolmark N, Fisher ER. 1-Phenylalanine mustard (L-PAM) in the management of primary breast cancer: a report of early findings. N Engl J Med. 1975 Jan 16;292(3):117-22. [https://www.nejm.org/doi/full/10.1056/NEJM197501162920301 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/1105174 PubMed]
 
−
## '''Update:''' Fisher B, Glass A, Redmond C, Fisher ER, Barton B, Such E, Carbone P, Economou S, Foster R, Frelick R, Lerner H, Levitt M, Margolese R, MacFarlane J, Plotkin D, Shibata H, Volk H. L-phenylalanine mustard (L-PAM) in the management of primary breast cancer: an update of earlier findings and a comparison with those utilizing L-PAM plus 5-fluorouracil (5-FU). Cancer. 1977 Jun;39(6 Suppl):2883-903. [https://onlinelibrary.wiley.com/doi/10.1002/1097-0142(197706)39:6%3C2883::AID-CNCR2820390676%3E3.0.CO;2-9/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/194679 PubMed]
 
−
## '''Update:''' Fisher B, Fisher ER, Redmond C. Ten-year results from the National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trial evaluating the use of L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. J Clin Oncol. 1986 Jun;4(6):929-41. [https://ascopubs.org/doi/full/10.1200/JCO.1986.4.6.929 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/3519883 PubMed]
 
−
# '''NSABP B-14:''' Fisher B, Costantino J, Redmond C, Poisson R, Bowman D, Couture J, Dimitrov NV, Wolmark N, Wickerham DL, Fisher ER, Margolese R, Robidoux A, Shibata H, Terz J, Peterson AHG, Feldman MI, Farrar W, Evans J, Lickley HL, Ketner M. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med. 1989 Feb 23;320(8):479-84. [https://www.nejm.org/doi/full/10.1056/NEJM198902233200802 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/2644532 PubMed]
 
−
## '''Update:''' Fisher B, Dignam J, Bryant J, DeCillis A, Wickerham DL, Wolmark N, Costantino J, Redmond C, Fisher ER, Bowman DM, Deschênes L, Dimitrov NV, Margolese RG, Robidoux A, Shibata H, Terz J, Paterson AH, Feldman MI, Farrar W, Evans J, Lickley HL. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996 Nov 6;88(21):1529-42. [https://academic.oup.com/jnci/article/88/21/1529/922662 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/8901851 PubMed]
 
−
## '''Update:''' Fisher B, Dignam J, Bryant J, Wolmark N. Five versus more than five years of tamoxifen for lymph node-negative breast cancer: updated findings from the National Surgical Adjuvant Breast and Bowel Project B-14 randomized trial. J Natl Cancer Inst. 2001 May 2;93(9):684-90. [https://academic.oup.com/jnci/article/93/9/684/2906559 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11333290 PubMed]
 
−
## '''Update:''' Fisher B, Jeong JH, Bryant J, Anderson S, Dignam J, Fisher ER, Wolmark N; National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Lancet. 2004 Sep 4-10;364(9437):858-68. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)16981-X/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15351193 PubMed]
 
−
## '''Pooled update:''' Taghian AG, Jeong JH, Mamounas EP, Parda DS, Deutsch M, Costantino JP, Wolmark N. Low locoregional recurrence rate among node-negative breast cancer patients with tumors 5 cm or larger treated by mastectomy, with or without adjuvant systemic therapy and without radiotherapy: results from five national surgical adjuvant breast and bowel project randomized clinical trials. J Clin Oncol. 2006 Aug 20;24(24):3927-32. [https://ascopubs.org/doi/full/10.1200/JCO.2006.06.9054 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/16921044 PubMed]
 
−
# '''NSABP B-23:''' Fisher B, Anderson S, Tan-Chiu E, Wolmark N, Wickerham DL, Fisher ER, Dimitrov NV, Atkins JN, Abramson N, Merajver S, Romond EH, Kardinal CG, Shibata HR, Margolese RG, Farrar WB. Tamoxifen and chemotherapy for axillary node-negative, estrogen receptor-negative breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-23. J Clin Oncol. 2001 Feb 15;19(4):931-42. [http://jco.ascopubs.org/content/19/4/931.full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11181655 PubMed]
 
−
## '''Pooled update:''' Taghian AG, Jeong JH, Mamounas EP, Parda DS, Deutsch M, Costantino JP, Wolmark N. Low locoregional recurrence rate among node-negative breast cancer patients with tumors 5 cm or larger treated by mastectomy, with or without adjuvant systemic therapy and without radiotherapy: results from five national surgical adjuvant breast and bowel project randomized clinical trials. J Clin Oncol. 2006 Aug 20;24(24):3927-32. [https://ascopubs.org/doi/full/10.1200/JCO.2006.06.9054 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/16921044 PubMed]
 
−
# '''NCIC CTG MA.17:''' Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. Epub 2003 Oct 9. [https://www.nejm.org/doi/full/10.1056/NEJMoa032312 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/14551341 PubMed]
 
−
## '''Update:''' Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst. 2005 Sep 7;97(17):1262-71. [http://jnci.oxfordjournals.org/content/97/17/1262.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/16145047 PubMed]
 
−
## '''QoL analysis:''' Whelan TJ, Goss PE, Ingle JN, Pater JL, Tu D, Pritchard K, Liu S, Shepherd LE, Palmer M, Robert NJ, Martino S, Muss HB. Assessment of quality of life in MA.17: a randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women. J Clin Oncol. 2005 Oct 1;23(28):6931-40. Epub 2005 Sep 12. [https://ascopubs.org/doi/full/10.1200/JCO.2005.11.181 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/16157934 PubMed]
 
−
## '''Update:''' Muss HB, Tu D, Ingle JN, Martino S, Robert NJ, Pater JL, Whelan TJ, Palmer MJ, Piccart MJ, Shepherd LE, Pritchard KI, He Z, Goss PE. Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG intergroup trial MA.17. J Clin Oncol. 2008 Apr 20;26(12):1956-64. Epub 2008 Mar 10. [http://jco.ascopubs.org/content/26/12/1956.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18332474 PubMed]
 
−
## '''Subgroup analysis:''' Goss PE, Ingle JN, Pater JL, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Tu D. Late extended adjuvant treatment with letrozole improves outcome in women with early-stage breast cancer who complete 5 years of tamoxifen. J Clin Oncol. 2008 Apr 20;26(12):1948-55. Epub 2008 Mar 10. [http://jco.ascopubs.org/content/26/12/1948.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18332475 PubMed]
 
−
## '''Update:''' Jin H, Tu D, Zhao N, Shepherd LE, Goss PE. Longer-term outcomes of letrozole versus placebo after 5 years of tamoxifen in the NCIC CTG MA.17 trial: analyses adjusting for treatment crossover. J Clin Oncol. 2012 Mar 1;30(7):718-21. Epub 2011 Oct 31. [http://jco.ascopubs.org/content/30/7/718.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3295549/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/22042967 PubMed]
 
−
<!-- Presented in part in abstract format in the Breast Cancer Research Treatment 100:S22, 2006 (suppl; abstr A40). -->
 
−
# '''NSABP B-33:''' Mamounas EP, Jeong JH, Wickerham DL, Smith RE, Ganz PA, Land SR, Eisen A, Fehrenbacher L, Farrar WB, Atkins JN, Pajon ER, Vogel VG, Kroener JF, Hutchins LF, Robidoux A, Hoehn JL, Ingle JN, Geyer CE Jr, Costantino JP, Wolmark N. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast And Bowel Project B-33 trial. J Clin Oncol. 2008 Apr 20;26(12):1965-71. Epub 2008 Mar 10. [http://jco.ascopubs.org/content/26/12/1965.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18332472 PubMed]
 
  
−
=Metastatic disease, maintenance after first-line therapy=
+
==Placebo==
−
==Observation==
+
<div class="toccolours" style="background-color:#eeeeee">
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen===
 
===Regimen===
−
{| class="wikitable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 20%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 20%"|Dates of enrollment
−
!style="width: 25%"|Comparator
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
!style="width: 20%"|Comparator
−
|-
+
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
−
|[https://ascopubs.org/doi/abs/10.1200/JCO.1998.16.5.1669 Falkson et al. 1998 (INT-0077)]
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|CMF(P)TH
 
−
| style="background-color:#d73027" |Inferior RFS
 
 
|-
 
|-
−
|[https://ascopubs.org/doi/full/10.1200/JCO.2004.08.054 Sparano et al. 2004 (ECOG E2196)]
+
|[https://doi.org/10.1080/10428194.2016.1182164 von Treskckow et al. 2016 (PATH)]
−
| style="background-color:#1a9851" |Phase III (C)
+
|2010-06 to 2011-05
−
|Marimastat
+
| style="background-color:#1a9851" |Phase 3 (C)
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
+
|[[#Panobinostat_monotherapy_999|Panobinostat]]
 +
| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS<sup>1</sup>
 
|-
 
|-
−
|[https://link.springer.com/article/10.1007%2Fs10549-010-0860-9 Alba et al. 2010 (GEICAM 2001-01)]
+
|[https://doi.org/10.1016/S0140-6736(15)60165-9 Moskowitz et al. 2015 (AETHERA)]
−
| style="background-color:#1a9851" |Phase III (C)
+
|2010-2012
−
|PLD x 6
+
| style="background-color:#1a9851" |Phase 3 (C)
−
| style="background-color:#d73027" |Inferior TTP
+
|[[Classical_Hodgkin_lymphoma#Brentuximab_vedotin_monotherapy_3|Brentuximab vedotin]]
−
|-
+
| style="background-color:#d73027" |Inferior PFS
−
|[https://ascopubs.org/doi/full/10.1200/JCO.2012.45.2490 Park et al. 2013 (KCSG-BR07-02)]
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[Breast_cancer#Gemcitabine_.26_Paclitaxel|PG]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior OS
 
 
|-
 
|-
 
|}
 
|}
−
''No further treatment.''
+
''<sup>1</sup>PATH had a very low accrual and was not powered to investigate the original primary endpoint (DFS).''<br>
 +
''No further active antineoplastic treatment after transplant.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
−
*ECOG E2196: Doxorubicin- and/or taxane-containing chemotherapy x 6-8
+
*[[Regimen_classes#High-dose_chemotherapy_with_auto_HSCT|Autologous HSCT]] consolidation (preparative regimen not specified)
−
*GEICAM 2001-01: A x 3, then D x 3
+
</div></div>
−
*KCSG-BR07-02: [[Breast_cancer#Gemcitabine_.26_Paclitaxel|PG]] x 6
 
  
 
===References===
 
===References===
−
# '''INT-0077:''' Falkson G, Gelman RS, Pandya KJ, Osborne CK, Tormey D, Cummings FJ, Sledge GW, Abeloff MD. Eastern Cooperative Oncology Group randomized trials of observation versus maintenance therapy for patients with metastatic breast cancer in complete remission following induction treatment. J Clin Oncol. 1998 May;16(5):1669-76. [https://ascopubs.org/doi/abs/10.1200/JCO.1998.16.5.1669 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/9586877 PubMed]
+
# '''AETHERA:''' Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. Epub 2015 Mar 18. Erratum in: Lancet. 2015 Aug 8;386(9993):532. [https://doi.org/10.1016/S0140-6736(15)60165-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25796459/ PubMed] [https://clinicaltrials.gov/study/NCT01100502 NCT01100502]
−
# '''ECOG E2196:''' Sparano JA, Bernardo P, Stephenson P, Gradishar WJ, Ingle JN, Zucker S, Davidson NE. Randomized phase III trial of marimastat versus placebo in patients with metastatic breast cancer who have responding or stable disease after first-line chemotherapy: Eastern Cooperative Oncology Group trial E2196. J Clin Oncol. 2004 Dec 1;22(23):4683-90. Erratum in: J Clin Oncol. 2005 Jan 1;23(1):248. [https://ascopubs.org/doi/full/10.1200/JCO.2004.08.054 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15570070 PubMed]
+
## '''HRQoL analysis:''' Ramsey SD, Nademanee A, Masszi T, Holowiecki J, Abidi M, Chen A, Stiff P, Viviani S, Sweetenham JW, Radford J, Zhu Y, Bonthapally V, Thomas E, Richhariya A, Hunder NN, Walewski J, Moskowitz CH. Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma. Br J Haematol. 2016 Dec;175(5):860-867. Epub 2016 Sep 21. [https://doi.org/10.1111/bjh.14316 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5621593/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27649689/ PubMed]
−
# '''GEICAM 2001-01:''' Alba E, Ruiz-Borrego M, Margelí M, Rodríguez-Lescure A, Sánchez-Rovira P, Ruiz A, Mel-Lorenzo JR, Ramos-Vázquez M, Ribelles N, Calvo E, Casado A, Márquez A, Vicente D, García-Sáenz JA, Martín M. Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study. Breast Cancer Res Treat. 2010 Jul;122(1):169-76. Epub 2010 Apr 2. [https://link.springer.com/article/10.1007%2Fs10549-010-0860-9 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/20361253 PubMed]
+
## '''Update:''' Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. Epub 2018 Sep 28. [https://doi.org/10.1182/blood-2018-07-861641 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30266774/ PubMed]
−
# '''KCSG-BR07-02:''' Park YH, Jung KH, Im SA, Sohn JH, Ro J, Ahn JH, Kim SB, Nam BH, Oh DY, Han SW, Lee S, Park IH, Lee KS, Kim JH, Kang SY, Lee MH, Park HS, Ahn JS, Im YH. Phase III, multicenter, randomized trial of maintenance chemotherapy versus observation in patients with metastatic breast cancer after achieving disease control with six cycles of gemcitabine plus paclitaxel as first-line chemotherapy: KCSG-BR07-02. J Clin Oncol. 2013 May 10;31(14):1732-9. Epub 2013 Apr 8. [https://ascopubs.org/doi/full/10.1200/JCO.2012.45.2490 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23569309 PubMed]
+
# '''PATH:''' von Tresckow B, Morschhauser F, Szer J, Eichenauer DA, Abramson JS, Sureda A, Engert A. Panobinostat consolidation in patients with Hodgkin lymphoma at risk for relapse after high dose chemotherapy and autologous stem cell transplant: final results after early trial discontinuation. Leuk Lymphoma. 2017 Jan;58(1):222-225. Epub 2016 May 17. [https://doi.org/10.1080/10428194.2016.1182164 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27184350/ PubMed] [https://clinicaltrials.gov/study/NCT01034163 NCT01034163]
  
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[[Category:Breast cancer regimens]]
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[[Category:Classical Hodgkin lymphoma regimens]]
 
[[Category:Null regimens]]
 
[[Category:Null regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
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[[Category:Malignant breast neoplasm]]
+
[[Category:Aggressive lymphomas]]

Latest revision as of 00:41, 27 June 2024

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main Hodgkin lymphoma page for regimens that include active anticancer treatment.


Untreated, early-stage favorable (ESF)

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Engert et al. 2007 (GHSG HD7) 1993-1998 Phase 3 (C) ABVD x 2 Inferior FFTF

No anticancer treatment

Subsequent treatment

References

  1. GHSG HD7: Engert A, Franklin J, Eich HT, Brillant C, Sehlen S, Cartoni C, Herrmann R, Pfreundschuh M, Sieber M, Tesch H, Franke A, Koch P, de Wit M, Paulus U, Hasenclever D, Loeffler M, Müller RP, Müller-Hermelink HK, Dühmke E, Diehl V. Two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine plus extended-field radiotherapy is superior to radiotherapy alone in early favorable Hodgkin's lymphoma: final results of the GHSG HD7 trial. J Clin Oncol. 2007 Aug 10;25(23):3495-502. Epub 2007 Jul 2. link to original article PubMed
    1. Pooled update: Sasse S, Bröckelmann PJ, Goergen H, Plütschow A, Müller H, Kreissl S, Buerkle C, Borchmann S, Fuchs M, Borchmann P, Diehl V, Engert A. Long-term follow-up of contemporary treatment in early-stage Hodgkin lymphoma: updated analyses of the German Hodgkin Study Group HD7, HD8, HD10, and HD11 trials. J Clin Oncol. 2017 Jun 20;35(18):1999-2007. Epub 2017 Apr 18. link to original article PubMed

Consolidation after upfront therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Young et al. 1973 1967-1972 Phase 3 (C) 1. Intermittent BCNU Did not meet efficacy endpoints
2. Intermittent MOPP Did not meet efficacy endpoints
Aleman et al. 2003 (EORTC 20884) 1989-2000 Phase 3 (C) IFRT Did not meet primary endpoint of RFS36
Straus et al. 2004 1990-2000 Phase 3 (C) EFRT Might have inferior OS
Thomas et al. 2017 (EORTC-GELA H9-F) 1998-2004 Phase 3 (E-de-esc) 1. IFRT x 2000 cGy Not reported
2. IFRT x 3600 cGy Inferior RFS
Borchmann et al. 2011 (GHSG HD12) 1999-2003 Phase 3 (C) ISRT x 3000 cGy Might have inferior 5-year FFTF
Radford et al. 2015 (UK NCRI RAPID) 2003-2010 Phase 3 (E-de-esc) IFRT Inconclusive whether non-inferior PFS36

No further treatment.

Preceding treatment

  • Young et al. 1973: Induction MOPP
  • EORTC 20884: Induction MOPP-ABV x 6 to 8
  • Straus et al. 2004: Induction ABVD x 6
  • GHSG HD12: Induction eBEACOPP x 8 versus BEACOPP4+4
  • UK NCRI RAPID: Induction ABVD x 3
  • EORTC-GELA H9-F: Induction EBVP x 6

References

  1. Young RC, Canellos GP, Chabner BA, Schein PS, DeVita VT. Maintenance chemotherapy for advanced Hodgkin's disease in remission. Lancet. 1973 Jun 16;1(7816):1339-43. link to original article PubMed
  2. EORTC 20884: Aleman BM, Raemaekers JM, Tirelli U, Bortolus R, van 't Veer MB, Lybeert ML, Keuning JJ, Carde P, Girinsky T, van der Maazen RW, Tomsic R, Vovk M, van Hoof A, Demeestere G, Lugtenburg PJ, Thomas J, Schroyens W, De Boeck K, Baars JW, Kluin-Nelemans JC, Carrie C, Aoudjhane M, Bron D, Eghbali H, Smit WG, Meerwaldt JH, Hagenbeek A, Pinna A, Henry-Amar M; EORTC Lymphoma Group. Involved-field radiotherapy for advanced Hodgkin's lymphoma. N Engl J Med. 2003 Jun 12;348(24):2396-406. link to original article PubMed
  3. Straus DJ, Portlock CS, Qin J, Myers J, Zelenetz AD, Moskowitz C, Noy A, Goy A, Yahalom J. Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease. Blood. 2004 Dec 1;104(12):3483-9. Epub 2004 Aug 17. link to original article PubMed
  4. GHSG HD12: Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dörken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compared with four cycles of escalated-dose BEACOPP followed by four cycles of baseline-dose BEACOPP with or without radiotherapy in patients with advanced-stage Hodgkin's lymphoma: final analysis of the HD12 trial of the German Hodgkin Study Group. J Clin Oncol. 2011 Nov 10;29(32):4234-42. Epub 2011 Oct 11. link to original article PubMed NCT00265031
    1. Update: von Tresckow B, Kreissl S, Dipl-Math HG, Bröckelmann PJ, Pabst T, Fridrik M, Rummel M, Jung W, Thiemer J, Sasse S, Bürkle C, Baues C, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. Intensive treatment strategies in advanced-stage Hodgkin's lymphoma (HD9 and HD12): analysis of long-term survival in two randomised trials. Lancet Haematol. 2018 Oct 01;5(10):e462-73. link to original article PubMed
  5. UK NCRI RAPID: Radford J, Illidge T, Counsell N, Hancock B, Pettengell R, Johnson P, Wimperis J, Culligan D, Popova B, Smith P, McMillan A, Brownell A, Kruger A, Lister A, Hoskin P, O'Doherty M, Barrington S. Results of a trial of PET-directed therapy for early-stage Hodgkin's lymphoma. N Engl J Med. 2015 Apr 23;372(17):1598-607. link to original article PubMed NCT00943423
  6. EORTC-GELA H9-F: Thomas J, Fermé C, Noordijk EM, Morschhauser F, Girinsky T, Gaillard I, Lugtenburg PJ, André M, Lybeert MLM, Stamatoullas A, Beijert M, Hélias P, Eghbali H, Gabarre J, van der Maazen RWM, Jaubert J, Bouabdallah K, Boulat O, Roesink JM, Christian B, Ong F, Bordessoule D, Tertian G, Gonzalez H, Vranovsky A, Quittet P, Tirelli U, de Jong D, Audouin J, Aleman BMP, Henry-Amar M. Comparison of 36 Gy, 20 Gy, or no radiation therapy after 6 cycles of EBVP chemotherapy and complete remission in early-stage Hodgkin lymphoma without risk factors: results of the EORTC-GELA H9-F intergroup randomized trial. Int J Radiat Oncol Biol Phys. 2018 Apr 1;100(5):1133-1145. Epub 2017 Oct 27. link to original article PubMed NCT00005584

Maintenance after upfront therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Sokal et al. 1974 1965-1967 Randomized, fewer than 20 pts in this subgroup (C) BCG Inferior PFS

Note: this study was open to patients with "malignant lymphoma" but the majority had Hodgkin disease.

References

  1. Sokal JE, Aungst CW, Snyderman M. Delay in progression of malignant lymphoma after BCG vaccination. N Engl J Med. 1974 Dec 5;291(23):1226-30. link to original article PubMed

Maintenance after salvage therapy

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
von Treskckow et al. 2016 (PATH) 2010-06 to 2011-05 Phase 3 (C) Panobinostat Did not meet primary endpoint of DFS1
Moskowitz et al. 2015 (AETHERA) 2010-2012 Phase 3 (C) Brentuximab vedotin Inferior PFS

1PATH had a very low accrual and was not powered to investigate the original primary endpoint (DFS).
No further active antineoplastic treatment after transplant.

Preceding treatment

References

  1. AETHERA: Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. Epub 2015 Mar 18. Erratum in: Lancet. 2015 Aug 8;386(9993):532. link to original article PubMed NCT01100502
    1. HRQoL analysis: Ramsey SD, Nademanee A, Masszi T, Holowiecki J, Abidi M, Chen A, Stiff P, Viviani S, Sweetenham JW, Radford J, Zhu Y, Bonthapally V, Thomas E, Richhariya A, Hunder NN, Walewski J, Moskowitz CH. Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma. Br J Haematol. 2016 Dec;175(5):860-867. Epub 2016 Sep 21. link to original article link to PMC article PubMed
    2. Update: Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. Epub 2018 Sep 28. link to original article PubMed
  2. PATH: von Tresckow B, Morschhauser F, Szer J, Eichenauer DA, Abramson JS, Sureda A, Engert A. Panobinostat consolidation in patients with Hodgkin lymphoma at risk for relapse after high dose chemotherapy and autologous stem cell transplant: final results after early trial discontinuation. Leuk Lymphoma. 2017 Jan;58(1):222-225. Epub 2016 May 17. link to original article PubMed NCT01034163
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