Revision as of 13:30, 25 December 2019

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main HER2+ breast cancer page for current regimens.

11 regimens on this page 13 variants on this page

Adjuvant chemotherapy

Docetaxel monotherapy

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D: Docetaxel
T: Taxotere (Docetaxel)
dT: doceTaxel

Variant #1, 100 mg/m² q3wk x 3

Study	Evidence	Comparator	Comparative Efficacy	Years of study
Joensuu et al. 2006 (FinHer)	Phase III (C)	1. TH (Taxotere) 2. VH	Did not meet primary endpoint of RFS	2000-2003
Joensuu et al. 2006 (FinHer)	Phase III (C)	3. Vinorelbine	Superior DDFS	2000-2003

Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.

Preceding treatment

Surgery with axillary lymph node dissection or sentinel lymph node biopsy, within 12 weeks

Chemotherapy

Docetaxel (Taxotere) 100 mg/m² IV over 60 minutes once on day 1

21-day cycle for 3 cycles

Subsequent treatment

FEC

Variant #2, 100 mg/m² q3wk x 4

Study	Evidence	Comparator	Comparative Efficacy	Years of study
Slamon et al. 2011 (BCIRG 006)	Phase III (C)	See link	See link	2001-2004

Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.

Preceding treatment

Surgery, then AC x 4

Chemotherapy

Docetaxel (Taxotere) 100 mg/m² IV over 60 minutes once on day 1

21-day cycle for 4 cycles

References

FinHer: Joensuu H, Kellokumpu-Lehtinen PL, Bono P, Alanko T, Kataja V, Asola R, Utriainen T, Kokko R, Hemminki A, Tarkkanen M, Turpeenniemi-Hujanen T, Jyrkkiö S, Flander M, Helle L, Ingalsuo S, Johansson K, Jääskeläinen AS, Pajunen M, Rauhala M, Kaleva-Kerola J, Salminen T, Leinonen M, Elomaa I, Isola J; FinHer Study Investigators. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 2006 Feb 23;354(8):809-20. link to original article contains verified protocol PubMed
1. Update: Joensuu H, Bono P, Kataja V, Alanko T, Kokko R, Asola R, Utriainen T, Turpeenniemi-Hujanen T, Jyrkkiö S, Möykkynen K, Helle L, Ingalsuo S, Pajunen M, Huusko M, Salminen T, Auvinen P, Leinonen H, Leinonen M, Isola J, Kellokumpu-Lehtinen PL. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer trial. J Clin Oncol. 2009 Dec 1;27(34):5685-92. link to original article PubMed
BCIRG 006: Slamon D, Eiermann W, Robert N, Pienkowski T, Martín 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

Paclitaxel monotherapy, weekly

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T: Taxol (Paclitaxel)
P: Paclitaxel
pT: pacliTaxel
wP: weekly Paclitaxel
wT: weekly Taxol (Paclitaxel)

Regimen

Study	Evidence	Comparator	Comparative Efficacy	Comparative Toxicity
Romond et al. 2005 (NSABP B-31)	Phase III (C)	TH	Inferior OS	Might have inferior DASI score
Romond et al. 2005 (NCCTG N9831)	Phase III (C)	See link	See link

Note: This paclitaxel dosing schedule was an option after 2003 in NSABP B-31, and was used for all patients in NCCTG N9831. This is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.

Preceding treatment

Surgery, then AC x 4

Chemotherapy

Paclitaxel (Taxol) 80 mg/m² IV over 60 minutes once per day on days 1, 8, 15

21-day cycle for 4 cycles

Subsequent treatment

NCCTG N9831: H x 52 versus no further treatment

References

NSABP B-31/NCCTG N9831: 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
1. Update: Perez EA, Romond EH, Suman VJ, Jeong JH, Davidson NE, Geyer CE Jr, Martino S, Mamounas EP, Kaufman PA, Wolmark N. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011 Sep 1;29(25):3366-73. Epub 2011 Jul 18. link to original article link to PMC article PubMed
2. 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
3. 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
4. Update and HRQoL analysis: Ganz PA, Romond EH, Cecchini RS, Rastogi P, Geyer CE Jr, Swain SM, Jeong JH, Fehrenbacher L, Gross HM, Brufsky AM, Flynn PJ, Wahl TA, Seay TE, Wade JL 3rd, Biggs DD, Atkins JN, Polikoff J, Zapas JL, Mamounas EP, Wolmark N. Long-term follow-up of cardiac function and quality of life for patients in NSABP protocol B-31/NRG Oncology: a randomized trial comparing the safety and efficacy of doxorubicin and cyclophosphamide (AC) followed by paclitaxel with AC followed by paclitaxel and trastuzumab in patients with node-positive breast cancer with tumors overexpressing human epidermal growth factor receptor 2. J Clin Oncol. 2017 Dec 10;35(35):3942-3948. Epub 2017 Oct 26. link to original article link to PMC article PubMed

Vinorelbine monotherapy

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V: Vinorelbine

Regimen

Study	Evidence	Comparator	Comparative Efficacy	Years of study
Joensuu et al. 2006 (FinHer)	Phase III (C)	1. Docetaxel	Inferior DDFS	2000-2003
Joensuu et al. 2006 (FinHer)	Phase III (C)	2. TH (Taxotere) 3. VH	Did not meet primary endpoint of RFS	2000-2003

Preceding treatment

Surgery

Chemotherapy

Vinorelbine (Navelbine) as follows:
- Cycles 1 & 2: 25 mg/m² IV over 5 to 10 minutes once per day on days 1, 8, 15
- Cycle 3: 25 mg/m² IV over 5 to 10 minutes once per day on days 1 & 8

21-day cycle for 3 cycles

Subsequent treatment

FEC

References

FinHer: Joensuu H, Kellokumpu-Lehtinen PL, Bono P, Alanko T, Kataja V, Asola R, Utriainen T, Kokko R, Hemminki A, Tarkkanen M, Turpeenniemi-Hujanen T, Jyrkkiö S, Flander M, Helle L, Ingalsuo S, Johansson K, Jääskeläinen AS, Pajunen M, Rauhala M, Kaleva-Kerola J, Salminen T, Leinonen M, Elomaa I, Isola J; FinHer Study Investigators. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 2006 Feb 23;354(8):809-20. link to original article contains verified protocol PubMed
1. Update: Joensuu H, Bono P, Kataja V, Alanko T, Kokko R, Asola R, Utriainen T, Turpeenniemi-Hujanen T, Jyrkkiö S, Möykkynen K, Helle L, Ingalsuo S, Pajunen M, Huusko M, Salminen T, Auvinen P, Leinonen H, Leinonen M, Isola J, Kellokumpu-Lehtinen PL. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer trial. J Clin Oncol. 2009 Dec 1;27(34):5685-92. link to original article PubMed

Metastatic disease, first-line chemotherapy

Note: in many of these regimens, patients were allowed to have received (neo)adjuvant chemotherapy and hormonal therapy (when applicable). These are first-line regimens in the metastatic setting, with a few being specifically for the locally advanced but unresectable setting.

AC

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AC: Adriamycin (Doxorubicin) & Cyclophosphamide

Regimen

Study	Evidence	Comparator	Comparative Efficacy
Slamon et al. 2001	Phase III (C)	ACH	Seems to have inferior OS

Note: patients in Slamon et al. 2001 had not previously received adjuvant (postoperative) therapy with an anthracycline.

Chemotherapy

Doxorubicin (Adriamycin) 60 mg/m² IV once on day 1
Cyclophosphamide (Cytoxan) 600 mg/m² IV once on day 1

21-day cycles

References

Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. link to original article PubMed

Capecitabine monotherapy

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Regimen

Study	Evidence	Comparator	Comparative Efficacy	Years of study
von Minckwitz et al. 2009 (GBG 26/BIG 3-05)	Phase III (C)	Capecitabine & Trastuzumab	Seems to have inferior TTP	2003-NR
Geyer et al. 2006 (EGF100151)	Phase III (C)	Capecitabine & Lapatinib	Inferior TTP	2004-2005

To our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm in this context.

Chemotherapy

Capecitabine (Xeloda) 1250 mg/m² PO twice per day on days 1 to 14

21-day cycles

References

EGF100151: Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, Jagiello-Gruszfeld A, Crown J, Chan A, Kaufman B, Skarlos D, Campone M, Davidson N, Berger M, Oliva C, Rubin SD, Stein S, Cameron D. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006 Dec 28;355(26):2733-43. link to original article contains verified protocol PubMed
1. Update: Cameron D, Casey M, Press M, Lindquist D, Pienkowski T, Romieu CG, Chan S, Jagiello-Gruszfeld A, Kaufman B, Crown J, Chan A, Campone M, Viens P, Davidson N, Gorbounova V, Raats JI, Skarlos D, Newstat B, Roychowdhury D, Paoletti P, Oliva C, Rubin S, Stein S, Geyer CE. A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat. 2008 Dec;112(3):533-43. link to original article PubMed
2. Update: Cameron D, Casey M, Oliva C, Newstat B, Imwalle B, Geyer CE. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist. 2010;15(9):924-34. link to original article link to PMC article PubMed
GBG 26/BIG 03-05: von Minckwitz G, du Bois A, Schmidt M, Maass N, Cufer T, de Jongh FE, Maartense E, Zielinski C, Kaufmann M, Bauer W, Baumann KH, Clemens MR, Duerr R, Uleer C, Andersson M, Stein RC, Nekljudova V, Loibl S. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a German Breast Group 26/Breast International Group 03-05 study. J Clin Oncol. 2009 Apr 20;27(12):1999-2006. Epub 2009 Mar 16. link to original article contains verified protocol PubMed
1. Update: von Minckwitz G, Schwedler K, Schmidt M, Barinoff J, Mundhenke C, Cufer T, Maartense E, de Jongh FE, Baumann KH, Bischoff J, Harbeck N, Lück HJ, Maass N, Zielinski C, Andersson M, Stein RC, Nekljudova V, Loibl S; GBG 26/BIG 03-05 study group and participating investigators. Trastuzumab beyond progression: overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer. Eur J Cancer. 2011 Oct;47(15):2273-81. Epub 2011 Jul 7. link to original article contains verified protocol PubMed

Docetaxel monotherapy

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D: Docetaxel
T: Taxotere (Docetaxel)

Regimen

Study	Evidence	Comparator	Comparative Efficacy
Marty et al. 2005 (M77001)	Phase III (C)	Docetaxel & Trastuzumab	Seems to have inferior OS

Chemotherapy

Docetaxel (Taxotere) 100 mg/m² IV over 60 minutes once on day 1

21-day cycles

References

M77001: Marty M, Cognetti F, Maraninchi D, Snyder R, Mauriac L, Tubiana-Hulin M, Chan S, Grimes D, Antón A, Lluch A, Kennedy J, O'Byrne K, Conte P, Green M, Ward C, Mayne K, Extra JM. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol. 2005 Jul 1;23(19):4265-74. Epub 2005 May 23. link to original article contains verified protocol PubMed

EC

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EC: Epirubicin & Cyclophosphamide

Regimen

Study	Evidence	Comparator	Comparative Efficacy
Slamon et al. 2001	Phase III (C)	ECH	Seems to have inferior OS

Chemotherapy

Epirubicin (Ellence) 75 mg/m² IV once on day 1
Cyclophosphamide (Cytoxan) 600 mg/m² IV once on day 1

21-day cycle for up to 6 to 8 cycles

References

Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. link to original article PubMed

Paclitaxel monotherapy, weekly

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Regimen

Study	Evidence	Comparator	Comparative Efficacy
Guan et al. 2013 (EGF104535)	Phase III (C)	TL (Taxol)	Seems to have inferior OS

Chemotherapy

Paclitaxel (Taxol) 80 mg/m² IV once per day on days 1, 8, 15

28-day cycles

References

EGF104535: Guan Z, Xu B, DeSilvio ML, Shen Z, Arpornwirat W, Tong Z, Lorvidhaya V, Jiang Z, Yang J, Makhson A, Leung WL, Russo MW, Newstat B, Wang L, Chen G, Oliva C, Gomez H. Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. J Clin Oncol. 2013 Jun 1;31(16):1947-53. Epub 2013 Mar 18. link to original article contains verified protocol PubMed

Paclitaxel monotherapy, q3wk

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Regimen

Study	Evidence	Comparator	Comparative Efficacy
Slamon et al. 2001	Phase III (C)	TH	Seems to have inferior OS

Note: patients in EGF30001 were NOT required to be HER2-positive.

Chemotherapy

Paclitaxel (Taxol) 175 mg/m² IV over 3 hours once on day 1

21-day cycles

References

Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. link to original article PubMed

@@ Line 19: / Line 19: @@
 <br>T: '''<u>T</u>'''axotere (Docetaxel)
 <br>dT: '''<u>d</u>'''oce'''<u>T</u>'''axel
-===Regimen {{#subobject:199d79|Variant=1}}===
+===Variant #1, 100 mg/m<sup>2</sup> q3wk x 3 {{#subobject:bfeef2|Variant=1}}===
+{| class="wikitable" style="width: 100%; text-align:center;"
+!style="width: 20%"|Study
+!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
+!style="width: 20%"|Comparator
+!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+!style="width: 20%"|Years of study
+|-
+| rowspan="2" |[https://www.nejm.org/doi/full/10.1056/NEJMoa053028 Joensuu et al. 2006 (FinHer)]
+| rowspan="2" style="background-color:#1a9851" |Phase III (C)
+|1. [[Breast_cancer,_HER2-positive#TH_.28Taxotere.29_2|TH (Taxotere)]]<br> 2. [[Breast_cancer,_HER2-positive#VH|VH]]
+| style="background-color:#ffffbf" |Did not meet primary endpoint of RFS
+| rowspan="2" |2000-2003
+|-
+|3. [[#Vinorelbine_monotherapy|Vinorelbine]]
+| style="background-color:#1a9850" |Superior DDFS
+|-
+|}
+''Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.''
+====Preceding treatment====
+*[[Surgery#Breast_cancer_surgery|Surgery]] with [[Surgery#Axillary_lymph_node_dissection|axillary lymph node dissection]] or [[Surgery#Sentinel_lymph_node_biopsy|sentinel lymph node biopsy]], within 12 weeks
+====Chemotherapy====
+*[[Docetaxel (Taxotere)]] 100 mg/m<sup>2</sup> IV over 60 minutes once on day 1
+'''21-day cycle for 3 cycles'''
+====Subsequent treatment====
+*[[#FEC_2|FEC]]
+===Variant #2, 100 mg/m<sup>2</sup> q3wk x 4 {{#subobject:199d79|Variant=1}}===
 {| class="wikitable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
@@ Line 42: / Line 71: @@
 '''21-day cycle for 4 cycles'''
 ===References===
+<!-- no pre-pub disclosed -->
+# '''FinHer:''' Joensuu H, Kellokumpu-Lehtinen PL, Bono P, Alanko T, Kataja V, Asola R, Utriainen T, Kokko R, Hemminki A, Tarkkanen M, Turpeenniemi-Hujanen T, Jyrkkiö S, Flander M, Helle L, Ingalsuo S, Johansson K, Jääskeläinen AS, Pajunen M, Rauhala M, Kaleva-Kerola J, Salminen T, Leinonen M, Elomaa I, Isola J; FinHer Study Investigators. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 2006 Feb 23;354(8):809-20. [https://www.nejm.org/doi/full/10.1056/NEJMoa053028 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16495393 PubMed]
+## '''Update:''' Joensuu H, Bono P, Kataja V, Alanko T, Kokko R, Asola R, Utriainen T, Turpeenniemi-Hujanen T, Jyrkkiö S, Möykkynen K, Helle L, Ingalsuo S, Pajunen M, Huusko M, Salminen T, Auvinen P, Leinonen H, Leinonen M, Isola J, Kellokumpu-Lehtinen PL. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer trial. J Clin Oncol. 2009 Dec 1;27(34):5685-92. [https://ascopubs.org/doi/full/10.1200/JCO.2008.21.4577 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/19884557 PubMed]
 <!-- no pre-pub disclosed -->
 # '''BCIRG 006:''' Slamon D, Eiermann W, Robert N, Pienkowski T, Martín 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. [https://www.nejm.org/doi/full/10.1056/NEJMoa0910383 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3268553/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/21991949 PubMed]

Difference between revisions of "Breast cancer, HER2-positive - historical"

Revision as of 13:30, 25 December 2019

Adjuvant chemotherapy

Docetaxel monotherapy

Variant #1, 100 mg/m2 q3wk x 3

Preceding treatment

Chemotherapy

Subsequent treatment

Variant #2, 100 mg/m2 q3wk x 4

Preceding treatment

Chemotherapy

References

Paclitaxel monotherapy, weekly

Regimen

Preceding treatment

Chemotherapy

Subsequent treatment

References

Vinorelbine monotherapy

Regimen

Preceding treatment

Chemotherapy

Subsequent treatment

References

Metastatic disease, first-line chemotherapy

AC

Regimen

Chemotherapy

References

Capecitabine monotherapy

Regimen

Chemotherapy

References

Docetaxel monotherapy

Regimen

Chemotherapy

References

EC

Regimen

Chemotherapy

References

Paclitaxel monotherapy, weekly

Regimen

Chemotherapy

References

Paclitaxel monotherapy, q3wk

Regimen

Chemotherapy

References

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Variant #1, 100 mg/m² q3wk x 3

Variant #2, 100 mg/m² q3wk x 4