Difference between revisions of "Breast cancer - historical"

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## '''Update:''' Fisher B, Glass A, Redmond C, Fisher ER, Barton B, Such E, Carbone P, Economou S, Foster R, Frelick R, Lerner H, Levitt M, Margolese R, MacFarlane J, Plotkin D, Shibata H, Volk H. L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. An update of earlier findings and a comparison with those utilizing L-PAM plus 5-fluorouracil (5-FU). Cancer. 1977 Jun;39(6 Suppl):2883-903. [http://onlinelibrary.wiley.com/doi/10.1002/1097-0142(197706)39:6%3C2883::AID-CNCR2820390676%3E3.0.CO;2-9/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/194679 PubMed]
 
## '''Update:''' Fisher B, Glass A, Redmond C, Fisher ER, Barton B, Such E, Carbone P, Economou S, Foster R, Frelick R, Lerner H, Levitt M, Margolese R, MacFarlane J, Plotkin D, Shibata H, Volk H. L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. An update of earlier findings and a comparison with those utilizing L-PAM plus 5-fluorouracil (5-FU). Cancer. 1977 Jun;39(6 Suppl):2883-903. [http://onlinelibrary.wiley.com/doi/10.1002/1097-0142(197706)39:6%3C2883::AID-CNCR2820390676%3E3.0.CO;2-9/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/194679 PubMed]
 
## '''Update:''' Fisher B, Fisher ER, Redmond C. Ten-year results from the National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trial evaluating the use of L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. J Clin Oncol. 1986 Jun;4(6):929-41. [http://ascopubs.org/doi/full/10.1200/JCO.1986.4.6.929 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/3519883 PubMed]
 
## '''Update:''' Fisher B, Fisher ER, Redmond C. Ten-year results from the National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trial evaluating the use of L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. J Clin Oncol. 1986 Jun;4(6):929-41. [http://ascopubs.org/doi/full/10.1200/JCO.1986.4.6.929 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/3519883 PubMed]
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=Metastatic disease, first-line chemotherapy=
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==Paclitaxel monotherapy {{#subobject:3e5448|Regimen=1}}==
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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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===Regimen #1, 175 mg/m<sup>2</sup> q3wk {{#subobject:72389a|Variant=1}}===
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{| class="wikitable" style="width: 100%; text-align:center;"
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!Study
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![[Levels_of_Evidence#Evidence|Evidence]]
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!Comparator
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![[Levels_of_Evidence#Efficacy|Efficacy]]
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![[Levels_of_Evidence#Toxicity|Toxicity]]
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|-
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|[http://jco.ascopubs.org/content/13/10/2575.long Seidman et al. 1995]
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| style="background-color:#91cf61" |Phase II
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| style="background-color:#d3d3d3" |
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| style="background-color:#d3d3d3" |
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| style="background-color:#d3d3d3" |
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|-
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|[http://www.nejm.org/doi/full/10.1056/NEJM200103153441101 Slamon et al. 2001]
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| style="background-color:#1a9851" |Phase III (C)
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|[[Breast_cancer,_HER2-positive#TH_.28Taxol.29_2|TH]]
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| style="background-color:#fc8d59" |Seems to have inferior OS
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| style="background-color:#d3d3d3" |
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|-
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|[http://jco.ascopubs.org/content/23/31/7794.long Gradishar et al. 2005]
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| style="background-color:#1a9851" |Phase III (C)
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|[[Breast_cancer#Paclitaxel.2C_nanoparticle_albumin-bound_monotherapy_2|Nanoparticle albumin-bound paclitaxel]]
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| style="background-color:#d73027" |Inferior TTP
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| style="background-color:#d3d3d3" |
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|-
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|[http://jco.ascopubs.org/content/26/10/1642.long Seidman et al. 2008 (CALGB 9840)]
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| style="background-color:#1a9851" |Phase III
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|[[Breast_cancer#Paclitaxel_monotherapy_3|Weekly paclitaxel]]
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| style="background-color:#d73027" |Inferior OS
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| style="background-color:#d3d3d3" |
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|-
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|[http://jco.ascopubs.org/content/26/24/3950.long Albain et al. 2008]
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| style="background-color:#1a9851" |Phase III (C)
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|[[Breast_cancer#GT_.28Taxol.29|Gemcitabine & Paclitaxel]]
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| style="background-color:#fc8d59" |Seems to have inferior OS
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| style="background-color:#d3d3d3" |
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|-
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|[http://ascopubs.org/doi/full/10.1200/JCO.2010.34.1255 Brufsky et al. 2011 (RIBBON-2)]
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| style="background-color:#1a9851" |Phase III (C)
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|[[Breast_cancer#Paclitaxel_.26_Bevacizumab|Paclitaxel & Bevacizumab]]
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| style="background-color:#d73027" |Inferior PFS
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| style="background-color:#d3d3d3" |
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|-
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|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00411-8/fulltext Takashima et al. 2015 (SELECT BC)]
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| style="background-color:#1a9851" |Phase III
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|[[Breast_cancer#S-1_monotherapy|S-1]]
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| style="background-color:#eeee01" |Seems to have non-inferior OS
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| style="background-color:#d73027" |Inferior EQ-5D score
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|-
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|}
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====Chemotherapy====
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*[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 3 hours once on day 1
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'''21-day cycles'''
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===Regimen #2, 250 mg/m<sup>2</sup> q3wk {{#subobject:6282a2|Variant=1}}===
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{| class="wikitable" style="width: 100%; text-align:center;"
 +
!Study
 +
![[Levels_of_Evidence#Evidence|Evidence]]
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|-
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|[http://jco.ascopubs.org/content/13/10/2575.long Seidman et al. 1995]
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| style="background-color:#91cf61" |Phase II
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|-
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|}
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''Note: this is the dose used in untreated patients in Seidman et al. 1995. It is not a common dosing.''
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====Chemotherapy====
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*[[Paclitaxel (Taxol)]] 250 mg/m<sup>2</sup> IV over 3 hours once on day 1
 +
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'''21-day cycles'''
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===References===
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# Seidman AD, Tiersten A, Hudis C, Gollub M, Barrett S, Yao TJ, Lepore J, Gilewski T, Currie V, Crown J et al. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol. 1995 Oct;13(10):2575-81. [http://jco.ascopubs.org/content/13/10/2575.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/7595709 PubMed]
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# 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. [http://www.nejm.org/doi/full/10.1056/NEJM200103153441101 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11248153 PubMed]
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<!-- Presented in part at the 26th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 3-6, 2003. -->
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# Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M, O'Shaughnessy J. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005 Nov 1;23(31):7794-803. Epub 2005 Sep 19. [http://jco.ascopubs.org/content/23/31/7794.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16172456 PubMed]
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<!-- Presented at the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA. -->
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# '''CALGB 9840:''' Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, Ungaro P, Norton L, Winer E, Hudis C. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol. 2008 Apr 1;26(10):1642-9. [http://jco.ascopubs.org/content/26/10/1642.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18375893 PubMed]
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<!-- Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003, and the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004. -->
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# Albain KS, Nag SM, Calderillo-Ruiz G, Jordaan JP, Llombart AC, Pluzanska A, Rolski J, Melemed AS, Reyes-Vidal JM, Sekhon JS, Simms L, O'Shaughnessy J. Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol. 2008 Aug 20;26(24):3950-7. [http://jco.ascopubs.org/content/26/24/3950.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18711184 PubMed]
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<!-- Presented at the 32nd Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 9-13, 2009, and at the 46th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 4-8, 2010. -->
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# '''RIBBON-2:''' Brufsky AM, Hurvitz S, Perez E, Swamy R, Valero V, O'Neill V, Rugo HS. RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2011 Nov 10;29(32):4286-93. Epub 2011 Oct 11. [http://ascopubs.org/doi/full/10.1200/JCO.2010.34.1255 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21990397 PubMed]
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# '''SELECT BC:''' Takashima T, Mukai H, Hara F, Matsubara N, Saito T, Takano T, Park Y, Toyama T, Hozumi Y, Tsurutani J, Imoto S, Watanabe T, Sagara Y, Nishimura R, Shimozuma K, Ohashi Y; SELECT BC Study Group. Taxanes versus S-1 as the first-line chemotherapy for metastatic breast cancer (SELECT BC): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2016 Jan;17(1):90-8. Epub 2015 Nov 27. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00411-8/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26617202 PubMed]
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## '''HRQoL analysis:''' Shiroiwa T, Fukuda T, Shimozuma K, Mouri M, Hagiwara Y, Doihara H, Akabane H, Kashiwaba M, Watanabe T, Ohashi Y, Mukai H. Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial. Qual Life Res. 2017 Feb;26(2):445-453. Epub 2016 Aug 12. [https://link.springer.com/article/10.1007%2Fs11136-016-1388-1 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5288429/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/27517267 PubMed]
  
 
=Metastatic disease, combination chemotherapy=
 
=Metastatic disease, combination chemotherapy=

Revision as of 03:05, 5 March 2018

Use of this site is subject to you reading and agreeing with the terms set forth in the disclaimer. If this is your first time visiting, we suggest you read the tutorial.

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 breast cancer page for current regimens.

44 regimens on this page
63 variants on this page


Adjuvant therapy

MV

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MV: Methotrexate & Vinblastine

Regimen

Study Evidence Comparator Efficacy
Assikis et al. 2003 Phase III See link See link

Preceding treatment

Chemotherapy

Supportive medications

21- to 28-day cycle for 4 cycles

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

Observation

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Regimen

Study Evidence Comparator Efficacy
Bonadonna et al. 1976 Phase III CMF Inferior RFS
Henderson et al. 2003 (INT 0148/CALGB 9344) Phase III Paclitaxel Inferior OS
Mamounas et al. 2005 (NSABP B-28) Phase III Paclitaxel Inferior DFS

No further treatment.

Preceding treatment

  • Bonadonna et al. 1976: Mastectomy
  • INT 0148/CALGB 9344: AC x 4 versus high-dose AC x 4 versus very-high-dose AC x 4
  • NSABP B-28: AC x 4

References

  1. Bonadonna G, Brusamolino E, Valagussa P, Rossi A, Brugnatelli L, Brambilla C, De Lena M, Tancini G, Bajetta E, Musumeci R, Veronesi U. Combination chemotherapy as an adjuvant treatment in operable breast cancer. N Engl J Med. 1976 Feb 19;294(8):405-10. link to original article PubMed
    1. Update: Bonadonna G, Rossi A, Valagussa P, Banfi A, Veronesi U. The CMF program for operable breast cancer with positive axillary nodes. Updated analysis on the disease-free interval, site of relapse and drug tolerance. Cancer. 1977 Jun;39(6 Suppl):2904-15. link to original article PubMed
    2. Update: Bonadonna G, Valagussa P, Rossi A, Tancini G, Brambilla C, Zambetti M, Veronesi U. Ten-year experience with CMF-based adjuvant chemotherapy in resectable breast cancer. Breast Cancer Res Treat. 1985;5(2):95-115. PubMed
    3. Update: Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6. link to original article PubMed
  2. Henderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E 3rd, Schilsky RL, Wood WC, Muss HB, Norton L. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003 Mar 15;21(6):976-83. link to original article contains verified protocol PubMed
  3. Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. Epub 2005 May 16. link to original article PubMed

Placebo

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Regimen

Study Evidence Comparator Efficacy
Fisher et al. 1975 (NSABP) Phase III Melphalan Seems to have inferior DFS

No active antineoplastic treatment after mastectomy. Used as a comparator arm, historically; here for reference purposes only.

References

  1. Fisher B, Carbone P, Economou SG, Frelick R, Glass A, Lerner H, Redmond C, Zelen M, Band P, Katrych DL, Wolmark N, Fisher ER. 1-Phenylalanine mustard (L-PAM) in the management of primary breast cancer. A report of early findings. N Engl J Med. 1975 Jan 16;292(3):117-22. link to original article PubMed
    1. Update: Fisher B, Glass A, Redmond C, Fisher ER, Barton B, Such E, Carbone P, Economou S, Foster R, Frelick R, Lerner H, Levitt M, Margolese R, MacFarlane J, Plotkin D, Shibata H, Volk H. L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. An update of earlier findings and a comparison with those utilizing L-PAM plus 5-fluorouracil (5-FU). Cancer. 1977 Jun;39(6 Suppl):2883-903. link to original article PubMed
    2. Update: Fisher B, Fisher ER, Redmond C. Ten-year results from the National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trial evaluating the use of L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. J Clin Oncol. 1986 Jun;4(6):929-41. link to original article PubMed

Metastatic disease, first-line chemotherapy

Paclitaxel monotherapy

back to top

Regimen #1, 175 mg/m2 q3wk

Study Evidence Comparator Efficacy Toxicity
Seidman et al. 1995 Phase II
Slamon et al. 2001 Phase III (C) TH Seems to have inferior OS
Gradishar et al. 2005 Phase III (C) Nanoparticle albumin-bound paclitaxel Inferior TTP
Seidman et al. 2008 (CALGB 9840) Phase III Weekly paclitaxel Inferior OS
Albain et al. 2008 Phase III (C) Gemcitabine & Paclitaxel Seems to have inferior OS
Brufsky et al. 2011 (RIBBON-2) Phase III (C) Paclitaxel & Bevacizumab Inferior PFS
Takashima et al. 2015 (SELECT BC) Phase III S-1 Seems to have non-inferior OS Inferior EQ-5D score

Chemotherapy

21-day cycles

Regimen #2, 250 mg/m2 q3wk

Study Evidence
Seidman et al. 1995 Phase II

Note: this is the dose used in untreated patients in Seidman et al. 1995. It is not a common dosing.

Chemotherapy

21-day cycles

References

  1. Seidman AD, Tiersten A, Hudis C, Gollub M, Barrett S, Yao TJ, Lepore J, Gilewski T, Currie V, Crown J et al. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol. 1995 Oct;13(10):2575-81. link to original article PubMed
  2. 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
  3. Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M, O'Shaughnessy J. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005 Nov 1;23(31):7794-803. Epub 2005 Sep 19. link to original article contains verified protocol PubMed
  4. CALGB 9840: Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, Ungaro P, Norton L, Winer E, Hudis C. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol. 2008 Apr 1;26(10):1642-9. link to original article PubMed
  5. Albain KS, Nag SM, Calderillo-Ruiz G, Jordaan JP, Llombart AC, Pluzanska A, Rolski J, Melemed AS, Reyes-Vidal JM, Sekhon JS, Simms L, O'Shaughnessy J. Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol. 2008 Aug 20;26(24):3950-7. link to original article PubMed
  6. RIBBON-2: Brufsky AM, Hurvitz S, Perez E, Swamy R, Valero V, O'Neill V, Rugo HS. RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2011 Nov 10;29(32):4286-93. Epub 2011 Oct 11. link to original article contains verified protocol PubMed
  7. SELECT BC: Takashima T, Mukai H, Hara F, Matsubara N, Saito T, Takano T, Park Y, Toyama T, Hozumi Y, Tsurutani J, Imoto S, Watanabe T, Sagara Y, Nishimura R, Shimozuma K, Ohashi Y; SELECT BC Study Group. Taxanes versus S-1 as the first-line chemotherapy for metastatic breast cancer (SELECT BC): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2016 Jan;17(1):90-8. Epub 2015 Nov 27. link to original article contains verified protocol PubMed
    1. HRQoL analysis: Shiroiwa T, Fukuda T, Shimozuma K, Mouri M, Hagiwara Y, Doihara H, Akabane H, Kashiwaba M, Watanabe T, Ohashi Y, Mukai H. Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial. Qual Life Res. 2017 Feb;26(2):445-453. Epub 2016 Aug 12. link to original article link to PMC article PubMed

Metastatic disease, combination chemotherapy

VAC

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VAC: Vincristine, Adriamycin (Doxorubicin), Cyclophosphamide

Regimen

Study Evidence Comparator Efficacy
Gundersen et al. 1986 Phase III Doxorubicin Seems not superior

Used as a comparator arm in older trials and found to be more toxic; here for reference purposes only.

Chemotherapy

References

  1. Gundersen S, Kvinnsland S, Klepp O, Kvaløy S, Lund E, Høst H. Weekly adriamycin versus VAC in advanced breast cancer. A randomized trial. Eur J Cancer Clin Oncol. 1986 Dec;22(12):1431-4. link to SD article PubMed
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