Difference between revisions of "Complex multipart regimens"

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=Breast cancer=
 
=Breast cancer=
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==Assikis et al. 2003==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[#top|back to top]]
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|}
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===Arm 1===
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*[[Breast_cancer#FAC|FAC]], then [[Breast_cancer_-_obsolete#MV|MV]]
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===Arm 2===
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*[[Breast_cancer#Tamoxifen_monotherapy|Tamoxifen]]
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===Comparative efficacy===
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{| border="1" style="text-align:center;" !align="left"
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|style="width: 25%"|'''Regimen'''
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|style="width: 25%"|[[Levels_of_Evidence#Efficacy|'''Efficacy''']]
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|-
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|FAC, then MV
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|style="background-color:#ffffbf"|Seems not superior
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|-
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|Tamoxifen
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|style="background-color:#ffffbf"|Seems not superior
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|-
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|}
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===References===
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# Assikis V, Buzdar A, Yang Y, Smith T, Theriault R, Booser D, Valero V, Walters R, Singletary E, Ames F, Hortobagyi G. A phase III trial of sequential adjuvant chemotherapy for operable breast carcinoma: final analysis with 10-year follow-up. Cancer. 2003 Jun 1;97(11):2716-23. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.11396/full link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/12767083 PubMed]
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==BCIRG-005==
 
==BCIRG-005==
 
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{| class="wikitable" style="float:right; margin-left: 5px;"
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===Comparative efficacy===
 
===Comparative efficacy===
 
{| border="1" style="text-align:center;" !align="left"  
 
{| border="1" style="text-align:center;" !align="left"  
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|'''Schedule'''
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|style="width: 25%"|'''Schedule'''
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|[[Levels_of_Evidence#Efficacy|'''Efficacy''']]
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|style="width: 25%"|[[Levels_of_Evidence#Efficacy|'''Efficacy''']]
 
|-
 
|-
 
|Sequential (AC, then T)
 
|Sequential (AC, then T)

Revision as of 02:52, 10 December 2017

The purpose of this page is to capture information about complex comparisons that is not easily conveyed on the treatment regimen pages. Many complex multipart RCTs are of the "Y-shaped" format "A followed by B1 versus B2" or "A1 versus A2 followed by B" and this can be captured on the treatment regimen pages. This page will convey information on more complicated designs, such as "A followed by B versus B followed by A" or "A followed by B versus C followed by D".


Breast cancer

Assikis et al. 2003

back to top

Arm 1

Arm 2

Comparative efficacy

Regimen Efficacy
FAC, then MV Seems not superior
Tamoxifen Seems not superior

References

  1. Assikis V, Buzdar A, Yang Y, Smith T, Theriault R, Booser D, Valero V, Walters R, Singletary E, Ames F, Hortobagyi G. A phase III trial of sequential adjuvant chemotherapy for operable breast carcinoma: final analysis with 10-year follow-up. Cancer. 2003 Jun 1;97(11):2716-23. link to original article contains protocol PubMed

BCIRG-005

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Arm 1, sequential

Arm 2, concurrent

Comparative efficacy

Schedule Efficacy
Sequential (AC, then T) Seems not superior
Concurrent (TAC) Seems not superior

References

  1. Eiermann W, Pienkowski T, Crown J, Sadeghi S, Martin M, Chan A, Saleh M, Sehdev S, Provencher L, Semiglazov V, Press M, Sauter G, Lindsay MA, Riva A, Buyse M, Drevot P, Taupin H, Mackey JR. Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol. 2011 Oct 10;29(29):3877-84. Epub 2011 Sep 12. link to original article contains verified protocol PubMed

BCIRG 006

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Arm 1, sequential without trastuzumab

Arm 2, sequential with trastuzumab

Arm 3, concurrent with trastuzumab

Comparative efficacy

  • Analyzed using a step-down design

Comparison 1

Trastuzumab-containing regimens vs. AC, then T Efficacy
AC, then TH Superior OS
TCH Seems to have superior OS

Comparison 2

Trastuzumab-containing regimens Efficacy
AC, then TH Seems not superior
TCH Seems not superior

References

  1. Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. link to original article link to PMC article PubMed

BR9601

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Arm 1

Arm 2

Comparative efficacy

Regimen Efficacy
CMF x 8 Inferior OS
EC x 4, then CMF x 4 Superior OS

References

  1. Poole CJ, Earl HM, Hiller L, Dunn JA, Bathers S, Grieve RJ, Spooner DA, Agrawal RK, Fernando IN, Brunt AM, O'Reilly SM, Crawford SM, Rea DW, Simmonds P, Mansi JL, Stanley A, Harvey P, McAdam K, Foster L, Leonard RC, Twelves CJ; NEAT Investigators and the SCTBG. Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer. N Engl J Med. 2006 Nov 2;355(18):1851-62. link to original article contains verified protocol PubMed

CALGB 9741

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Note: what is referred to in this study as concurrent is in fact the same regimen that is referred to as sequential in other studies.

Arm 1, sequential

  • A, then T, then C

Arm 2, dose-dense sequential

Arm 3, "concurrent"

Arm 4, dose-dense "concurrent"

Comparative efficacy

  • Analyzed using a 2 x 2 factorial design

Comparison 1

Dose density Efficacy
Dose-dense (q2wk) Seems to have superior OS
Standard (q3wk) Seems to have inferior OS

Comparison 2

Schedule Efficacy
Concurrent Seems not superior
Sequential Seems not superior

References

  1. Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, Davidson NE, Martino S, Livingston R, Ingle JN, Perez EA, Carpenter J, Hurd D, Holland JF, Smith BL, Sartor CI, Leung EH, Abrams J, Schilsky RL, Muss HB, Norton L. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003 Apr 15;21(8):1431-9. Epub 2003 Feb 13. link to original article contains verified protocol PubMed

DBCG 07-READ

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Arm 1

Arm 2, "EC-D"

  • EC x 3, then D x 3

Comparative efficacy

Regimen Efficacy
DC x 6 Seems not superior
EC x 3, then D x 3 Seems not superior

References

  1. Ejlertsen B, Tuxen MK, Jakobsen EH, Jensen MB, Knoop AS, Højris I, Ewertz M, Balslev E, Danø H, Vestlev PM, Kenholm J, Nielsen DL, Bechmann T, Andersson M, Cold S, Nielsen HM, Maae E, Carlsen D, Mouridsen HT. Adjuvant cyclophosphamide and docetaxel with or without epirubicin for early TOP2A-normal breast cancer: DBCG 07-READ, an open-label, phase III, randomized trial. J Clin Oncol. 2017 Aug 10;35(23):2639-2646. Epub 2017 Jun 29. link to original article contains verified protocol PubMed

GEICAM 9906

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Arm 1

Arm 2

Comparative efficacy

Regimen Efficacy
FEC x 6 Inferior DFS
FEC x 4, then T Superior DFS

References

  1. Martín M, Rodríguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Munárriz B, Rodríguez CA, Crespo C, de Alava E, López García-Asenjo JA, Guitián MD, Almenar S, González-Palacios JF, Vera F, Palacios J, Ramos M, Gracia Marco JM, Lluch A, Alvarez I, Seguí MA, Mayordomo JI, Antón A, Baena JM, Plazaola A, Modolell A, Pelegrí A, Mel JR, Aranda E, Adrover E, Alvarez JV, García Puche JL, Sánchez-Rovira P, Gonzalez S, López-Vega JM; GEICAM 9906 Study Investigators. Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by paclitaxel for early breast cancer. J Natl Cancer Inst. 2008 Jun 4;100(11):805-14. Epub 2008 May 27. link to original article contains verified protocol PubMed

Mavroudis et al. 2017

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Arm 1, sequential

Arm 2, concurrent

  • Docetaxel & Epirubicin

Comparative efficacy

Schedule Efficacy
Sequential Might have superior DFS
Concurrent Might have inferior DFS

References

  1. Mavroudis D, Saloustros E, Boukovinas I, Papakotoulas P, Kakolyris S, Ziras N, Christophylakis C, Kentepozidis N, Fountzilas G, Rigas G, Varthalitis I, Kalbakis K, Agelaki S, Hatzidaki D, Georgoulias V. Sequential vs concurrent epirubicin and docetaxel as adjuvant chemotherapy for high-risk, node-negative, early breast cancer: an interim analysis of a randomised phase III study from the Hellenic Oncology Research Group. Br J Cancer. 2017 Jul 11;117(2):164-170. Epub 2017 Jun 22. link to original articlecontains verified protocol PubMed

NEAT

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Arm 1

Arm 2

Comparative efficacy

Regimen Efficacy
CMF x 6 Inferior OS
EC x 4, then CMF x 4 Superior OS

References

  1. Poole CJ, Earl HM, Hiller L, Dunn JA, Bathers S, Grieve RJ, Spooner DA, Agrawal RK, Fernando IN, Brunt AM, O'Reilly SM, Crawford SM, Rea DW, Simmonds P, Mansi JL, Stanley A, Harvey P, McAdam K, Foster L, Leonard RC, Twelves CJ; NEAT Investigators and the SCTBG. Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer. N Engl J Med. 2006 Nov 2;355(18):1851-62. link to original article contains verified protocol PubMed

NSABP B-38

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Arm 1, sequential without gemcitabine

Arm 1, sequential with gemcitabine

Arm 3, concurrent

Comparative efficacy

Schedule Efficacy
Sequential (ddAC, then ddP) Seems not superior
Sequential (ddAC, then ddPG) Seems not superior
Concurrent (TAC) Seems not superior

References

  1. Swain SM, Tang G, Geyer CE Jr, Rastogi P, Atkins JN, Donnellan PP, Fehrenbacher L, Azar CA, Robidoux A, Polikoff JA, Brufsky AM, Biggs DD, Levine EA, Zapas JL, Provencher L, Northfelt DW, Paik S, Costantino JP, Mamounas EP, Wolmark N. Definitive results of a phase III adjuvant trial comparing three chemotherapy regimens in women with operable, node-positive breast cancer: the NSABP B-38 trial. J Clin Oncol. 2013 Sep 10;31(26):3197-204. Epub 2013 Aug 12. link to original article link to PMC article contains verified protocol PubMed

TACT2

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Arm 1

Arm 2

Arm 3

Arm 4

Comparative efficacy

  • Analyzed using a 2 x 2 factorial design

Comparison 1

Dose density of epirubicin Efficacy
Dose-dense (q2wk) Seems not superior
Standard (q3wk) Seems not superior

Comparison 2

Capecitabine vs. CMF Efficacy
Capecitabine Non-inferior TTR
CMF Non-inferior TTR

References

  1. Cameron D, Morden JP, Canney P, Velikova G, Coleman R, Bartlett J, Agrawal R, Banerji J, Bertelli G, Bloomfield D, Brunt AM, Earl H, Ellis P, Gaunt C, Gillman A, Hearfield N, Laing R, Murray N, Couper N, Stein RC, Verrill M, Wardley A, Barrett-Lee P, Bliss JM; TACT2 Investigators. Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2017 Jul;18(7):929-945. Epub 2017 Jun 7. link to original article link to PMC article contains verified protocol PubMed
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