Difference between revisions of "Complex multipart regimens"
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===References=== | ===References=== | ||
# 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. [http://jco.ascopubs.org/content/21/8/1431.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/12668651 PubMed] | # 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. [http://jco.ascopubs.org/content/21/8/1431.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/12668651 PubMed] | ||
+ | |||
+ | ==DBCG 07-READ== | ||
+ | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
+ | |- | ||
+ | |[[#top|back to top]] | ||
+ | |} | ||
+ | ===Arm 1=== | ||
+ | *[[Breast_cancer#DC|DC]] x 6 | ||
+ | ===Arm 2, "EC-D"=== | ||
+ | *[[Breast_cancer#EC_2|EC]] x 3, then [[Breast_cancer#Docetaxel_monotherapy_2|D]] x 3 | ||
+ | ===Comparative efficacy=== | ||
+ | {| border="1" style="text-align:center;" !align="left" | ||
+ | |style="width: 25%"|'''Regimen''' | ||
+ | |style="width: 25%"|[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
+ | |- | ||
+ | |DC x 6 | ||
+ | |style="background-color:#ffffbf"|Seems not superior | ||
+ | |- | ||
+ | |EC x 3, then D x 3 | ||
+ | |style="background-color:#ffffbf"|Seems not superior | ||
+ | |- | ||
+ | |} | ||
+ | ===References=== | ||
+ | # 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. [http://ascopubs.org/doi/abs/10.1200/JCO.2017.72.3494 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/28661759 PubMed] | ||
==GEICAM 9906== | ==GEICAM 9906== | ||
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===Comparative efficacy=== | ===Comparative efficacy=== | ||
{| border="1" style="text-align:center;" !align="left" | {| border="1" style="text-align:center;" !align="left" | ||
− | |'''Regimen''' | + | |style="width: 25%"|'''Regimen''' |
− | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | + | |style="width: 25%"|[[Levels_of_Evidence#Efficacy|'''Efficacy''']] |
|- | |- | ||
|FEC x 6 | |FEC x 6 |
Revision as of 22:39, 9 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
BCIRG-005
back to top |
Arm 1, sequential
Arm 2, concurrent
Comparative efficacy
Schedule | Efficacy |
Sequential (AC, then T) | Seems not superior |
Concurrent (TAC) | Seems not superior |
References
- 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
- 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
CALGB 9741
back to top |
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
- 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
back to top |
Arm 1
- DC x 6
Arm 2, "EC-D"
Comparative efficacy
Regimen | Efficacy |
DC x 6 | Seems not superior |
EC x 3, then D x 3 | Seems not superior |
References
- 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
back to top |
Arm 1
- FEC x 6
Arm 2
Comparative efficacy
Regimen | Efficacy |
FEC x 6 | Inferior DFS |
FEC x 4, then T | Superior DFS |
References
- 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
NSABP B-38
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Arm 1, sequential without gemcitabine
Arm 1, sequential with gemcitabine
- ddAC, then ddPG
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
- 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