Difference between revisions of "Complex multipart regimens"
Warner-admin (talk | contribs) m (Text replacement - "{| border="1" style="text-align:center;" !align="left"" to "{| class="wikitable" style="width: 100%; text-align:center;"") |
Warner-admin (talk | contribs) m (Text replacement - "|'''Efficacy'''" to "!Efficacy") |
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Without ATO3 | |Without ATO3 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Tamoxifen, then Anastrozole | |Tamoxifen, then Anastrozole | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|FAC, then MV | |FAC, then MV | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Schedule''' | |style="width: 25%"|'''Schedule''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Sequential (AC, then T) | |Sequential (AC, then T) | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Trastuzumab-containing regimens vs. AC, then T''' | |style="width: 25%"|'''Trastuzumab-containing regimens vs. AC, then T''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|AC, then TH | |AC, then TH | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Trastuzumab-containing regimens''' | |style="width: 25%"|'''Trastuzumab-containing regimens''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|AC, then TH | |AC, then TH | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Monotherapy''' | |style="width: 25%"|'''Monotherapy''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Letrozole | |Letrozole | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Sequential therapies''' | |style="width: 25%"|'''Sequential therapies''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Letrozole, then Tamoxifen | |Letrozole, then Tamoxifen | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Letrozole-containing therapies''' | |style="width: 25%"|'''Letrozole-containing therapies''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Letrozole | |Letrozole | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|CMF x 8 | |CMF x 8 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|T, then FEC | |T, then FEC | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|'''Dose density''' | |'''Dose density''' | ||
− | + | ![[Levels_of_Evidence#Efficacy|Efficacy]] | |
|- | |- | ||
|Dose-dense (q2wk) | |Dose-dense (q2wk) | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|'''Schedule''' | |'''Schedule''' | ||
− | + | ![[Levels_of_Evidence#Efficacy|Efficacy]] | |
|- | |- | ||
|Concurrent | |Concurrent | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|DC x 6 | |DC x 6 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|FEC x 6 | |FEC x 6 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|FEC x 6 | |FEC x 6 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Route of administration''' | |style="width: 25%"|'''Route of administration''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|IV trastuzumab | |IV trastuzumab | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|ddFEC → D | |ddFEC → D | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Tamoxifen x 5y | |Tamoxifen x 5y | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Schedule''' | |style="width: 25%"|'''Schedule''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Sequential | |Sequential | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|AC, then T | |AC, then T | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Trastuzumab-containing regimens''' | |style="width: 25%"|'''Trastuzumab-containing regimens''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|AC, then T, then H | |AC, then T, then H | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|CMF x 6 | |CMF x 6 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Schedule''' | |style="width: 25%"|'''Schedule''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Sequential (ddAC, then ddP) | |Sequential (ddAC, then ddP) | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Dose density of epirubicin''' | |style="width: 25%"|'''Dose density of epirubicin''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Dose-dense (q2wk) | |Dose-dense (q2wk) | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Capecitabine vs. CMF''' | |style="width: 25%"|'''Capecitabine vs. CMF''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Capecitabine | |Capecitabine | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Tamoxifen x 5y | |Tamoxifen x 5y | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|BEACOPP<sub>4+4</sub> | |BEACOPP<sub>4+4</sub> | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|MOPP-ABV x 3, then IFRT | |MOPP-ABV x 3, then IFRT | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|MOPP-ABV x 4, then IFRT | |MOPP-ABV x 4, then IFRT | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|ABVD x 4 | |ABVD x 4 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|'''Chemotherapy''' | |'''Chemotherapy''' | ||
− | + | ![[Levels_of_Evidence#Efficacy|Efficacy]] | |
|- | |- | ||
|ABVD | |ABVD | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|'''Radiotherapy''' | |'''Radiotherapy''' | ||
− | + | ![[Levels_of_Evidence#Efficacy|Efficacy]] | |
|- | |- | ||
|IFRT x 20 Gy | |IFRT x 20 Gy | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|'''Chemotherapy''' | |'''Chemotherapy''' | ||
− | + | ![[Levels_of_Evidence#Efficacy|Efficacy]] | |
|- | |- | ||
|BEACOPP<sub>escalated</sub> x 8 | |BEACOPP<sub>escalated</sub> x 8 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|'''Radiotherapy''' | |'''Radiotherapy''' | ||
− | + | ![[Levels_of_Evidence#Efficacy|Efficacy]] | |
|- | |- | ||
|ISRT x 30 Gy | |ISRT x 30 Gy | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|'''Chemotherapy''' | |'''Chemotherapy''' | ||
− | + | ![[Levels_of_Evidence#Efficacy|Efficacy]] | |
|- | |- | ||
|ABVD x 4 | |ABVD x 4 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|BEACOPP<sub>4+4</sub> | |BEACOPP<sub>4+4</sub> | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|ABVD x 4 | |ABVD x 4 | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Regimen''' | |style="width: 25%"|'''Regimen''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|BEACOPP<sub>4+4</sub> | |BEACOPP<sub>4+4</sub> | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Timing''' | |style="width: 25%"|'''Timing''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Maintenance erlotinib | |Maintenance erlotinib | ||
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
|style="width: 25%"|'''Schedule''' | |style="width: 25%"|'''Schedule''' | ||
− | |style="width: 25%" | + | |style="width: 25%"![[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|Concurrent | |Concurrent |
Revision as of 18:51, 26 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".
Acute promyelocytic leukemia
C9710
back to top |
Note: this trial included a second randomization during the maintenance phase, which is not complex and is therefore not reported here.
Arm 1
Arm 2, with ATO3
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
Without ATO3 | Inferior EFS |
With ATO3 | Superior EFS |
References
- Powell BL, Moser B, Stock W, Gallagher RE, Willman CL, Stone RM, Rowe JM, Coutre S, Feusner JH, Gregory J, Couban S, Appelbaum FR, Tallman MS, Larson RA. Arsenic trioxide improves event-free and overall survival for adults with acute promyelocytic leukemia: North American Leukemia Intergroup Study C9710. Blood. 2010 Nov 11;116(19):3751-7. Epub 2010 Aug 12. link to original article contains verified protocol link to PMC article PubMed
Breast cancer
ARNO 95
back to top |
Arm 1, monotherapy
- Tamoxifen x 5y
Arm 2, sequential
- Tamoxifen x 2y, then Anastrozole x 3y
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
Tamoxifen, then Anastrozole | Seems to have superior OS |
Tamoxifen | Seems to have inferior OS |
References
- Kaufmann M, Jonat W, Hilfrich J, Eidtmann H, Gademann G, Zuna I, von Minckwitz G. Improved overall survival in postmenopausal women with early breast cancer after anastrozole initiated after treatment with tamoxifen compared with continued tamoxifen: the ARNO 95 Study. J Clin Oncol. 2007 Jul 1;25(19):2664-70. Epub 2007 Jun 11. link to original article PubMed
Assikis et al. 2003
back to top |
Arm 1
Arm 2
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
FAC, then MV | Seems not superior |
Tamoxifen | Seems not superior |
References
- 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 | style="width: 25%"!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
back to top |
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 | style="width: 25%"!Efficacy |
AC, then TH | Superior OS |
TCH | Seems to have superior OS |
Comparison 2
Trastuzumab-containing regimens | style="width: 25%"!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
BIG 1-98
back to top |
Arm 1, monotherapy
- Letrozole x 5y
Arm 2, sequential
Arm 3, monotherapy
- Tamoxifen x 5y
Arm 4, sequential
Comparative efficacy
- Analyzed by several methods; efficacy here is based on the 2011 update.
Comparison 1
Monotherapy | style="width: 25%"!Efficacy |
Letrozole | Superior OS |
Tamoxifen | Inferior OS |
Comparison 2
Sequential therapies | style="width: 25%"!Efficacy |
Letrozole, then Tamoxifen | Seems not superior |
Tamoxifen, then Letrozole | Seems not superior |
Comparison 3
Letrozole-containing therapies | style="width: 25%"!Efficacy |
Letrozole | Seems not superior |
Letrozole, then Tamoxifen | Seems not superior |
Tamoxifen, then Letrozole | Seems not superior |
References
- Breast International Group (BIG) 1-98 Collaborative Group, Thürlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardley A, Price KN, Goldhirsch A. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005 Dec 29;353(26):2747-57. Erratum in: N Engl J Med. 2006 May 18;354(20):2200. Wardly, Andrew [corrected to Wardley, Andrew ]. link to original article PubMed
- Update: Coates AS, Keshaviah A, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Colleoni M, Láng I, Del Mastro L, Smith I, Chirgwin J, Nogaret JM, Pienkowski T, Wardley A, Jakobsen EH, Price KN, Goldhirsch A. Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98. J Clin Oncol. 2007 Feb 10;25(5):486-92. Epub 2007 Jan 2. link to original article PubMed
- Subgroup analysis: Rasmussen BB, Regan MM, Lykkesfeldt AE, Dell'Orto P, Del Curto B, Henriksen KL, Mastropasqua MG, Price KN, Méry E, Lacroix-Triki M, Braye S, Altermatt HJ, Gelber RD, Castiglione-Gertsch M, Goldhirsch A, Gusterson BA, Thürlimann B, Coates AS, Viale G; BIG 1-98 Collaborative and International Breast Cancer Study Groups. Adjuvant letrozole versus tamoxifen according to centrally-assessed ERBB2 status for postmenopausal women with endocrine-responsive early breast cancer: supplementary results from the BIG 1-98 randomised trial. Lancet Oncol. 2008 Jan;9(1):23-8. Epub 2007 Dec 20. link to original article PubMed
- Subgroup analysis: Crivellari D, Sun Z, Coates AS, Price KN, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens RJ, Castiglione-Gertsch M, Gelber RD, Colleoni M, Láng I, Del Mastro L, Gladieff L, Rabaglio M, Smith IE, Chirgwin JH, Goldhirsch A. Letrozole compared with tamoxifen for elderly patients with endocrine-responsive early breast cancer: the BIG 1-98 trial. J Clin Oncol. 2008 Apr 20;26(12):1972-9. Epub 2008 Mar 10. link to original article PubMed
- Update: Regan MM, Neven P, Giobbie-Hurder A, Goldhirsch A, Ejlertsen B, Mauriac L, Forbes JF, Smith I, Láng I, Wardley A, Rabaglio M, Price KN, Gelber RD, Coates AS, Thürlimann B; BIG 1-98 Collaborative Group.; International Breast Cancer Study Group (IBCSG). Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8·1 years median follow-up. Lancet Oncol. 2011 Nov;12(12):1101-8. link to original article link to PMC article PubMed
BR9601
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Arm 1
- CMF x 8
Arm 2
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
CMF x 8 | Inferior OS |
EC x 4, then CMF x 4 | Superior OS |
References
- 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
Buzdar et al. 2005
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Arm 1
Arm 2
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
T, then FEC | Seems to have inferior pCR rate |
TH, then FEC & H | Seems to have superior pCR rate |
References
- Buzdar AU, Ibrahim NK, Francis D, Booser DJ, Thomas ES, Theriault RL, Pusztai L, Green MC, Arun BK, Giordano SH, Cristofanilli M, Frye DK, Smith TL, Hunt KK, Singletary SE, Sahin AA, Ewer MS, Buchholz TA, Berry D, Hortobagyi GN. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol. 2005 Jun 1;23(16):3676-85. Epub 2005 Feb 28. link to original article 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
- 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
- DC x 6
Arm 2, "EC-D"
Comparative efficacy
Regimen | style="width: 25%"!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
FNCLCC PACS 01
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Arm 1
- FEC x 6
Arm 2
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
FEC x 6 | Seems to have inferior OS |
FEC x 3, then D x 3 | Seems to have superior OS |
References
- Roché H, Fumoleau P, Spielmann M, Canon JL, Delozier T, Serin D, Symann M, Kerbrat P, Soulié P, Eichler F, Viens P, Monnier A, Vindevoghel A, Campone M, Goudier MJ, Bonneterre J, Ferrero JM, Martin AL, Genève J, Asselain B. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol. 2006 Dec 20;24(36):5664-71. Epub 2006 Nov 20. link to original article PubMed
GEICAM 9906
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Arm 1
- FEC x 6
Arm 2
Comparative efficacy
Regimen | style="width: 25%"!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
HannaH
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Arm 1, IV trastuzumab
Arm 2, SC trastuzumab
Comparative efficacy
Route of administration | style="width: 25%"!Efficacy |
IV trastuzumab | Non-inferior pCR rate |
SC trastuzumab | Non-inferior pCR rate |
References
- Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, Pienkowski T, Lichinitser M, Semiglazov V, Melichar B, Jackisch C. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012 Sep;13(9):869-78. Epub 2012 Aug 9. link to original article contains verified protocol PubMed
HORG CT/07.17
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Arm 1
Arm 2
- TC x 6
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
ddFEC → D | Inconclusive whether non-inferior |
TC | Inconclusive whether non-inferior |
References
- Mavroudis D, Matikas A, Malamos N, Papakotoulas P, Kakolyris S, Boukovinas I, Athanasiadis A, Kentepozidis N, Ziras N, Katsaounis P, Saloustros E, Georgoulias V; Breast Cancer Investigators of the Hellenic Oncology Research Group (HORG), Athens, Greece. Dose-dense FEC followed by docetaxel versus docetaxel plus cyclophosphamide as adjuvant chemotherapy in women with HER2-negative, axillary lymph node-positive early breast cancer: a multicenter randomized study by the Hellenic Oncology Research Group (HORG). Ann Oncol. 2016 Oct;27(10):1873-8. Epub 2016 Aug 8. link to original article PubMed
Intergroup Exemestane Study
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Arm 1, monotherapy
- Tamoxifen x 5y
Arm 2, sequential
- Tamoxifen x 2-3y, then Exemestane x 2-3y
Comparative efficacy
Note: reported efficacy is based on the 2007 update.
Regimen | style="width: 25%"!Efficacy |
Tamoxifen x 5y | Might have inferior OS |
Tamoxifen x 2-3y, then Exemestane x 2-3y (5y total) | Might have superior OS |
References
- Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, Jones SE, Alvarez I, Bertelli G, Ortmann O, Coates AS, Bajetta E, Dodwell D, Coleman RE, Fallowfield LJ, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Stewart A, Stuart N, Snowdon CF, Carpentieri M, Massimini G, Bliss JM, van de Velde C; Intergroup Exemestane Study. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004 Mar 11;350(11):1081-92. link to original article PubMed
- Update: Coombes RC, Kilburn LS, Snowdon CF, Paridaens R, Coleman RE, Jones SE, Jassem J, Van de Velde CJ, Delozier T, Alvarez I, Del Mastro L, Ortmann O, Diedrich K, Coates AS, Bajetta E, Holmberg SB, Dodwell D, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Forbes J, Castiglione M, Stuart N, Stewart A, Fallowfield LJ, Bertelli G, Hall E, Bogle RG, Carpentieri M, Colajori E, Subar M, Ireland E, Bliss JM; Intergroup Exemestane Study. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet. 2007 Feb 17;369(9561):559-70. link to original article PubMed
Mavroudis et al. 2017
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Arm 1, sequential
- Epirubicin, then Docetaxel
Arm 2, concurrent
- Docetaxel & Epirubicin
Comparative efficacy
Schedule | style="width: 25%"!Efficacy |
Sequential | Might have superior DFS |
Concurrent | Might have inferior DFS |
References
- 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
NCCTG N9831
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Arm 1, no trastuzumab
Arm 2, sequential trastuzumab
Arm 3, concurrent trastuzumab
Comparative efficacy
Comparison 1
Note: Arm 2 was not included in this joint analysis. Efficacy is based on the 2014 update.
Regimen | style="width: 25%"!Efficacy |
AC, then T | Inferior OS |
AC, then TH | Superior OS |
Comparison 2
Note: efficacy is as reported in the 2011 update.
Trastuzumab-containing regimens | style="width: 25%"!Efficacy |
AC, then T, then H | Might have inferior DFS |
AC, then TH | Might have superior DFS |
References
- Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, Tan-Chiu E, Martino S, Paik S, Kaufman PA, Swain SM, Pisansky TM, Fehrenbacher L, Kutteh LA, Vogel VG, Visscher DW, Yothers G, Jenkins RB, Brown AM, Dakhil SR, Mamounas EP, Lingle WL, Klein PM, Ingle JN, Wolmark N. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1673-84. link to original article PubMed
- Update: Perez EA, Suman VJ, Davidson NE, Gralow JR, Kaufman PA, Visscher DW, Chen B, Ingle JN, Dakhil SR, Zujewski J, Moreno-Aspitia A, Pisansky TM, Jenkins RB. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol. 2011 Dec 1;29(34):4491-7. Epub 2011 Oct 31. link to original article link to PMC article PubMed
- Update: Perez EA, Romond EH, Suman VJ, Jeong JH, Sledge G, Geyer CE Jr, Martino S, Rastogi P, Gralow J, Swain SM, Winer EP, Colon-Otero G, Davidson NE, Mamounas E, Zujewski JA, Wolmark N. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014 Nov 20;32(33):3744-52. link to original article link to PMC article PubMed
NEAT
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Arm 1
- CMF x 6
Arm 2
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
CMF x 6 | Inferior OS |
EC x 4, then CMF x 4 | Superior OS |
References
- 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
- ddAC, then ddPG
Arm 3, concurrent
Comparative efficacy
Schedule | style="width: 25%"!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
TACT2
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Arm 1
- ddE, then capecitabine
Arm 2
- ddE, then CMF
Arm 3
- E, then capecitabine
Arm 4
Comparative efficacy
- Analyzed using a 2 x 2 factorial design
Comparison 1
Dose density of epirubicin | style="width: 25%"!Efficacy |
Dose-dense (q2wk) | Seems not superior |
Standard (q3wk) | Seems not superior |
Comparison 2
Capecitabine vs. CMF | style="width: 25%"!Efficacy |
Capecitabine | Non-inferior TTR |
CMF | Non-inferior TTR |
References
- 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
TEAM
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Arm 1, monotherapy
- Tamoxifen x 5y
Arm 2, sequential
- Tamoxifen x 2.5-3y, then Exemestane x 2-2.5y
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
Tamoxifen x 5y | Seems not superior |
Tamoxifen x 2.5-3y, then Exemestane x 2-2.5y | Seems not superior |
References
- van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31. link to original article contains verified protocol PubMed
- Update: Derks MGM, Blok EJ, Seynaeve C, Nortier JWR, Kranenbarg EM, Liefers GJ, Putter H, Kroep JR, Rea D, Hasenburg A, Markopoulos C, Paridaens R, Smeets JBE, Dirix LY, van de Velde CJH. Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10-year follow-up of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1211-1220. Epub 2017 Jul 18. link to original article PubMed
Hodgkin lymphoma
EORTC 20012
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Arm 1
- BEACOPPescalated x 4, then BEACOPP x 4
Arm 2
- ABVD x 8
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
BEACOPP4+4 | Seems not superior |
ABVD x 8 | Seems not superior |
References
- Carde P, Karrasch M, Fortpied C, Brice P, Khaled H, Casasnovas O, Caillot D, Gaillard I, Bologna S, Ferme C, Lugtenburg PJ, Morschhauser F, Aurer I, Coiffier B, Meyer R, Seftel M, Wolf M, Glimelius B, Sureda A, Mounier N. Eight cycles of ABVD versus four cycles of BEACOPPescalated plus four cycles of BEACOPPbaseline in stage III to IV, International Prognostic Score ≥ 3, high-risk Hodgkin lymphoma: First results of the phase III EORTC 20012 Intergroup trial. J Clin Oncol. 2016 Jun 10;34(17):2028-36. Epub 2016 Apr 25. link to original article contains verified protocol PubMed
EORTC-GELA H8-F
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Arm 1
Arm 2
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
MOPP-ABV x 3, then IFRT | Superior OS |
STNI | Inferior OS |
References
- Fermé C, Eghbali H, Meerwaldt JH, Rieux C, Bosq J, Berger F, Girinsky T, Brice P, van't Veer MB, Walewski JA, Lederlin P, Tirelli U, Carde P, Van den Neste E, Gyan E, Monconduit M, Diviné M, Raemaekers JM, Salles G, Noordijk EM, Creemers GJ, Gabarre J, Hagenbeek A, Reman O, Blanc M, Thomas J, Vié B, Kluin-Nelemans JC, Viseu F, Baars JW, Poortmans P, Lugtenburg PJ, Carrie C, Jaubert J, Henry-Amar M; EORTC-GELA H8 Trial. Chemotherapy plus involved-field radiation in early-stage Hodgkin's disease. N Engl J Med. 2007 Nov 8;357(19):1916-27. link to original article contains verified protocol in supplement PubMed
EORTC-GELA H8-U
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Arm 1
Arm 2
Arm 3
Comparative efficacy
Note: the paper describes this as an equivalence study, although the primary endpoint of EFS had p=0.80.
Regimen | style="width: 25%"!Efficacy |
MOPP-ABV x 4, then IFRT | Inconclusive whether equivalent |
MOPP-ABV x 4, then STNI | Inconclusive whether equivalent |
MOPP-ABV x 6, then IFRT | Inconclusive whether equivalent |
References
- Fermé C, Eghbali H, Meerwaldt JH, Rieux C, Bosq J, Berger F, Girinsky T, Brice P, van't Veer MB, Walewski JA, Lederlin P, Tirelli U, Carde P, Van den Neste E, Gyan E, Monconduit M, Diviné M, Raemaekers JM, Salles G, Noordijk EM, Creemers GJ, Gabarre J, Hagenbeek A, Reman O, Blanc M, Thomas J, Vié B, Kluin-Nelemans JC, Viseu F, Baars JW, Poortmans P, Lugtenburg PJ, Carrie C, Jaubert J, Henry-Amar M; EORTC-GELA H8 Trial. Chemotherapy plus involved-field radiation in early-stage Hodgkin's disease. N Engl J Med. 2007 Nov 8;357(19):1916-27. link to original article contains verified protocol in supplement PubMed
EORTC/LYSA/FIL H10
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Note: randomization in this trial occurred before treatment, but took effect after 2 cycles of ABVD, and only if interim PET-CT was negative.
Arm 1
Arm 2
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
ABVD x 4 | Inconclusive whether non-inferior |
ABVD x 3, then INRT | Inconclusive whether non-inferior |
References
- Raemaekers JM, André MP, Federico M, Girinsky T, Oumedaly R, Brusamolino E, Brice P, Fermé C, van der Maazen R, Gotti M, Bouabdallah R, Sebban CJ, Lievens Y, Re A, Stamatoullas A, Morschhauser F, Lugtenburg PJ, Abruzzese E, Olivier P, Casasnovas RO, van Imhoff G, Raveloarivahy T, Bellei M, van der Borght T, Bardet S, Versari A, Hutchings M, Meignan M, Fortpied C. Omitting radiotherapy in early positron emission tomography-negative stage I/II Hodgkin lymphoma is associated with an increased risk of early relapse: Clinical results of the preplanned interim analysis of the randomized EORTC/LYSA/FIL H10 trial. J Clin Oncol. 2014 Apr 20;32(12):1188-94. Epub 2014 Mar 17. link to original article PubMed
GHSG HD11
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Note: the primary endpoints of this trial, which were to determine the superiority of BEACOPP vs. ABVD and noninferiority of 20 Gy vs. 30 Gy of IFRT, were not reported in the manuscript.
Arm 1
Arm 2
Arm 3
Arm 4
Comparative efficacy
- Designed using a 2 x 2 factorial design
Comparison 1
Chemotherapy | Efficacy |
---|---|
ABVD | Not reported |
BEACOPP | Not reported |
Comparison 2
Radiotherapy | Efficacy |
---|---|
IFRT x 20 Gy | Not reported |
IFRT x 30 Gy | Not reported |
References
- Eich HT, Diehl V, Görgen H, Pabst T, Markova J, Debus J, Ho A, Dörken B, Rank A, Grosu AL, Wiegel T, Karstens JH, Greil R, Willich N, Schmidberger H, Döhner H, Borchmann P, Müller-Hermelink HK, Müller RP, Engert A. Intensified chemotherapy and dose-reduced involved-field radiotherapy in patients with early unfavorable Hodgkin's lymphoma: final analysis of the German Hodgkin Study Group HD11 trial. J Clin Oncol. 2010 Sep 20;28(27):4199-206. Epub 2010 Aug 16. link to original article PubMed
GHSG HD12
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Arm 1
- BEACOPPescalated x 8, then ISRT x 30 Gy for patients with initial bulky disease or residual disease
Arm 2
- BEACOPPescalated x 8, then no further treatment for patients with initial bulky disease or residual disease
Arm 3
- BEACOPPescalated x 4, then BEACOPP x 4, then ISRT x 30 Gy for patients with initial bulky disease or residual disease
Arm 4
- BEACOPPescalated x 4, then BEACOPP x 4, then no further treatment for patients with initial bulky disease or residual disease
Comparative efficacy
- Designed using a 2 x 2 factorial design
Comparison 1
Chemotherapy | Efficacy |
---|---|
BEACOPPescalated x 8 | Non-inferior 5-year FFTF |
BEACOPPescalated x 4, then BEACOPP x 4 | Non-inferior 5-year FFTF |
Comparison 2
Radiotherapy | Efficacy |
---|---|
ISRT x 30 Gy | Might have superior 5-year FFTF |
No radiotherapy | Might have inferior 5-year FFTF |
References
- 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
GHSG HD14
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Arm 1
Arm 2
- Escalated BEACOPP x 2, then ABVD x 2, then IFRT x 30 Gy
Comparative efficacy
Chemotherapy | Efficacy |
---|---|
ABVD x 4 | Inferior FFTF |
eBEACOPP x 2, then ABVD x 2 | Superior FFTF |
References
- von Tresckow B, Plütschow A, Fuchs M, Klimm B, Markova J, Lohri A, Kral Z, Greil R, Topp MS, Meissner J, Zijlstra JM, Soekler M, Stein H, Eich HT, Mueller RP, Diehl V, Borchmann P, Engert A. Dose-intensification in early unfavorable Hodgkin's lymphoma: final analysis of the German Hodgkin Study Group HD14 trial. J Clin Oncol. 2012 Mar 20;30(9):907-13. Epub 2012 Jan 23. link to original article PubMed
LYSA H34
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Arm 1
- BEACOPPescalated x 4, then BEACOPP x 4
Arm 2
- ABVD x 8
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
BEACOPP4+4 | Might have superior EFS |
ABVD x 8 | Might have inferior EFS |
References
- Mounier N, Brice P, Bologna S, Briere J, Gaillard I, Heczko M, Gabarre J, Casasnovas O, Jaubert J, Colin P, Delmer A, Devidas A, Bachy E, Nicolas-Virelizier E, Aoudjhane A, Humbrecht C, Andre M, Carde P; Lymphoma Study Association (LYSA). ABVD (8 cycles) versus BEACOPP (4 escalated cycles ≥4 baseline): final results in stage III-IV low-risk Hodgkin lymphoma (IPS 0-2) of the LYSA H34 randomized trial. Ann Oncol. 2014 Aug;25(8):1622-8. Epub 2014 May 14. link to original article contains verified protocol PubMed
NCIC CTG/ECOG HD.6
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Note: this randomization was for patients with unfavorable risk.
Arm 1
- ABVD x 4
Arm 2
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
ABVD x 4 | Seems to have superior OS |
ABVD x 2, then STNI | Seems to have inferior OS |
References
- Meyer RM, Gospodarowicz MK, Connors JM, Pearcey RG, Wells WA, Winter JN, Horning SJ, Dar AR, Shustik C, Stewart DA, Crump M, Djurfeldt MS, Chen BE, Shepherd LE; NCIC Clinical Trials Group; Eastern Cooperative Oncology Group. ABVD alone versus radiation-based therapy in limited-stage Hodgkin's lymphoma. N Engl J Med. 2012 Feb 2;366(5):399-408. Epub 2011 Dec 11. link to original article link to PMC article PubMed
Viviani et al. 2011 (IIL)
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Arm 1
- BEACOPPescalated x 4, then BEACOPP x 4
Arm 2
- ABVD x 8
Comparative efficacy
Regimen | style="width: 25%"!Efficacy |
BEACOPP4+4 | Seems to have superior FFFP |
ABVD x 8 | Seems to have inferior FFFP |
References
- Viviani S, Zinzani PL, Rambaldi A, Brusamolino E, Levis A, Bonfante V, Vitolo U, Pulsoni A, Liberati AM, Specchia G, Valagussa P, Rossi A, Zaja F, Pogliani EM, Pregno P, Gotti M, Gallamini A, Rota Scalabrini D, Bonadonna G, Gianni AM; Michelangelo Foundation; Gruppo Italiano di Terapie Innovative nei Linfomi; Intergruppo Italiano Linfomi. ABVD versus BEACOPP for Hodgkin's lymphoma when high-dose salvage is planned. N Engl J Med. 2011 Jul 21;365(3):203-12. link to original article PubMed
Non-small cell lung cancer
IUNO
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Arm 1, "early" erlotinib
Arm 2, "late" erlotinib
Comparative efficacy
Timing | style="width: 25%"!Efficacy |
Maintenance erlotinib | Seems not superior |
Second-line erlotinib | Seems not superior |
References
- Cicènas S, Geater SL, Petrov P, Hotko Y, Hooper G, Xia F, Mudie N, Wu YL. Maintenance erlotinib versus erlotinib at disease progression in patients with advanced non-small-cell lung cancer who have not progressed following platinum-based chemotherapy (IUNO study). Lung Cancer. 2016 Dec;102:30-37. Epub 2016 Oct 20. link to original article contains verified protocol PubMed
RTOG 9410
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Arm 1, sequential
- Cisplatin & Vinblastine, then RT
Arm 2, concurrent
Arm 3, concurrent
Comparative efficacy
Schedule | style="width: 25%"!Efficacy |
Concurrent | Seems to have superior OS |
Sequential | Seems to have inferior OS |
References
- Curran WJ Jr, Paulus R, Langer CJ, Komaki R, Lee JS, Hauser S, Movsas B, Wasserman T, Rosenthal SA, Gore E, Machtay M, Sause W, Cox JD. Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410. J Natl Cancer Inst. 2011 Oct 5;103(19):1452-60. Epub 2011 Sep 8. Erratum in: J Natl Cancer Inst. 2012;104(1):79. link to original article link to PMC article PubMed