Style guide

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The purpose of this page is to document a "manual of style" that should be used for all entries on HemOnc.org. It is important for the overall user experience to adhere to a consistent format for pages and entries because it makes it easier for people to find information. It also contributes to safety by communicating information about chemotherapy regimens in a standard and unambiguous way. It's understood that, due to the ever-evolving nature of this website, some pages will have older formatting, but it is expected that existing pages will gradually be transitioned to the standard format, and all pages moving forward will be created following these guidelines.

This site is collaborative, and suggestions for revisions to the style guide are welcome. The style guide is currently still a work in progress.

Introduction

If you've found this page, chances are you're considering making edits to HemOnc.org. Thank you in advance! The goal of this page is to provide guidance on a uniform style across the site. As with many knowledge base endeavors, HemOnc.org has grown organically and the style has evolved over time. In fact, parts of this style guide are/will be outdated, although we do our best to keep the recommendations here concordant with our current best practice. Future work will include adding more templates here, to make it easier to create your own content on the site.

Units of measurement

We are currently trying to unify our units of measurement, to be concordant with SI units (unless otherwise noted below, e.g., hemoglobin). Further details about conversions between conventional and SI units, here.

Measure Example(s) Wiki code
Separators for large numbers 1000
10,000
10,000,000
BSA-based dosing mg/m2 mg/m<sup>2</sup>
Micrograms mcg
Ranges: don't use dashes 1 to 2
Bounds: don't use symbols greater than
greater than or equal to
less than
less than or equal to
Platelet count 25 x 109/L 25 x 10<sup>9</sup>/L
Hemoglobin (Hb) 12 g/dL
Absolute neutrophil count (ANC) 500/uL
White blood cell (WBC) count 3.5 x 109/L 3.5 x 10<sup>9</sup>/L
Creatinine 0.8 mg/dL
Creatinine clearance (CrCl) 90 mL/min/1.73m2 90 mL/min/1.73m<sup>2</sup>
Bilirubin 1.4 mg/dL
Methotrexate level 100 nmol/L

Drug index

Headings

There is a separate heading for each letter A-Z for which there is at least one medication. Letters for which there are no medications are not made into headings. Letters are level 2 headings, e.g. ==A==.

Medications listed

Examples

Standard wiki format is as follows:

*[[Generic name (Brand name)]] '''FDA approved mm/dd/yyyy''' or '''in clinical trials''' (if applicable)

Medications are listed alphabetically in the drug index by their generic name, with--preferentially--the most common brand name in parentheses, which is usually the predominant United States brand name. Medications which are not yet FDA approved shall have a bold in clinical trials after it. Medications which do not yet have generic or brand names can have placeholder entries based on their pharmaceutical company code name, with updates based on generic names and brand names when they become available. So, for example, a preliminary entry may be:

  • MDV3100 in clinical trials

When a generic name is available, the entry on the drug index and the medication's information page--if it exists--will be updated:

  • Enzalutamide (MDV3100) in clinical trials

The older "MDV3100" page would need to be renamed to "Enzalutamide (MDV3100)" via the move function, which is in the downward pointing triangle menu to the right of "view history" at the top of the page. When the medication gets approved by the FDA, its drug index entry and name of the medication page will again be updated:

  • Enzalutamide (Xtandi) FDA approved 8/31/2012

The FDA approved label remains in place for medications that have been FDA approved since the beginning of last year. Specifically, if the current year is 2013, all medications that have been FDA approved since 1/1/2012 will be included. This choice is made rather than, say, within the last year, to facilitate these updates being made in batches rather than continuously year-round. For example, imatinib, which was FDA approved in 2001, appears as:

  • Imatinib (Gleevec)

Non-FDA approved medications

In order to be comprehensive and in recognition of the worldwide audience that HemOnc.org has, drugs that are approved by agencies other than the FDA in the United States can be included. For example, S-1, comprised of tegafur, gimeracil, oteracil, is currently approved under the brand name Teysuno by the European Medicines Agency, but has not received FDA approval.

Drugs in preclinical or early phase clinical trials

Given that most early phase drugs will not ultimately be approved, one should exercise caution before adding these drugs to the drug index. The only drugs which are in development that should be added are the ones with promising clinical data already presented; for example, drugs featured in plenary sessions at ASCO or ASH and described in phase I or II trials published in high impact journals.

It is also difficult to tell if a drug has officially been dropped from further development, so updating drugs in clinical trials is difficult. However, we have made efforts to include promising drugs even in early stages, e.g. Ibrutinib (PCI-32765).

Drugs that have lost FDA approval

A prime example is Gemtuzumab ozogamicin (Mylotarg), which was withdrawn from the US market on 10/15/2010. These withdrawn drugs may remain on the drug index because the information could still be useful to someone looking at older literature and because they may still be investigated in other studies to evaluate them for new indications. An example of an older medication for which there was renewed interest and eventual FDA approval was Omacetaxine (Synribo) or Homoharringtonine, FDA approved 10/26/2012.

Links on the bottom of the page

Currently, useful links for hematology/oncology medication-related information are listed at the bottom of the Drug index page. Suggestions are welcome for better ways to organize this information--for example, should they remain on this page, or be reorganized into another page of links? How shall things be organized in relation to the references area at the bottom of the page, which contains the full citation for a few papers that are linked?

Medication pages

Template of information contained on medication pages

Sections for which there is no information may be omitted:

==General information==
Class/mechanism: Short description about the medication's class and mechanism of action, written in your own words.  Try to use information contained within the package insert--if available--for this information.<ref name=insert>[http://www.manufacturer.com/link_to_package_insert.pdf Generic_name (Brand_name) package insert]</ref><ref>[[Media:Generic_name.pdf | Generic_name (Brand_name) package insert (locally hosted backup)]]</ref><ref>[http://www.brand_name.com/ Brand_name manufacturer's website]</ref>
<br>Route: IV, PO, SC, IM, IT, intranasal, NG, GT, topical, transdermal, sublingual, intraocular, rectal, intravesicular, intralesional
<br>Extravasation: no information, none, n/a (e.g. for oral medications), [[vesicant]], and/or [[irritant]]

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>

==Diseases for which it is used==
(In general, use the same names for the disease-specific chemotherapy pages)
*[[Bladder cancer]]
*[[Bone sarcoma]]
*[[Breast cancer]]
*[[Cervical cancer]]
*[[Esophageal cancer]]
*[[Gastric cancer]]
*[[Hepatobiliary cancer]]
*[[Hodgkin lymphoma]]
*[[Melanoma]]

==Clinical trials==
*[http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=84883 EMILIA: A phase III, randomized, multicenter study of trastuzumab-DM1 (T-DM1) compared with lapatinib (L) plus capecitabine (X) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) and previously treated with a trastuzumab-based regimen.]<ref>S. Verma, V. Dieras, L. Gianni, D. Miles, M. Welslau, M. D. Pegram, J. Baselga, E. Guardino, L. Fang, C. M. Linehan, K. L. Blackwell. [http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=84883 EMILIA: A phase III, randomized, multicenter study of trastuzumab-DM1 (T-DM1) compared with lapatinib (L) plus capecitabine (X) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) and previously treated with a trastuzumab-based regimen.] 2011 ASCO Annual Meeting abstract TPS116.</ref><ref>[http://clinicaltrials.gov/ct2/show/NCT00829166 EMILIA at ClinicalTrials.gov]</ref>

==Patient drug information==
*[http://www.manufacturer.com/link_to_package_insert.pdf#page=10 Generic_name (Brand_name) package insert PDF pages 10-12]<ref name="insert"></ref>
*Patient counseling information can be found on [http://www.manufacturer.com/link_to_package_insert.pdf#page=8 page 8 of the Generic_name (Brand_name) package insert]<ref name="insert"></ref>
*[http://chemocare.com/chemotherapy/drug-info/generic_name.aspx Generic_name (Brand_name) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/generic_name.aspx Generic_name (Brand_name) patient drug information (Chemocare)]</ref>
*[http://www.uptodate.com/contents/generic_name-patient-drug-information Generic_name (Brand_name) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/generic_name-patient-drug-information Generic_name (Brand_name) patient drug information (UpToDate)]</ref>

==History of changes in FDA indication==
(A useful site to get information about FDA approval histories is http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
*2/22/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340704.htm FDA approved] for "patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination."

==Also known as==
(One source that can be used for this information is: https://www.mediguard.org/medication/facts-figures; sort and reformat the lists by copy and pasting the list to: http://sortmylist.com/)

==References==
<references/>

[[Category:Drug index]]
[[Category:Chemotherapy]]

[[Category:Intramuscular medications]]
[[Category:Intrathecal medications]]
[[Category:Intravenous medications]]
[[Category:Intravesicular chemotherapy]]
[[Category:Oral medications]]
[[Category:Subcutaneous medications]]

[[Category:Neutral chemotherapy]]
[[Category:Irritant chemotherapy]]
[[Category:Vesicant chemotherapy]]

[[Category:Drugs FDA approved in yyyy]]
[[Category:Investigational]]
[[Category:Orphan drug]]
[[Category:Discontinued]]

[[Category:Kinase inhibitors]]
[[Category:Aurora kinase inhibitors]]
[[Category:AKT1 inhibitors]]
[[Category:ALK inhibitors]]
[[Category:Bcr-Abl inhibitors]]
[[Category:BRAF inhibitors]]
[[Category:BTK inhibitors]]
[[Category:CDK9 inhibitors]]
[[Category:EGFR inhibitors]]
[[Category:FGFR inhibitors]]
[[Category:FLT3 inhibitors]]
[[Category:HDAC inhibitors]]
[[Category:IGF inhibitors]]
[[Category:JAK inhibitors]]
[[Category:KIT inhibitors]]
[[Category:LYN inhibitors]]
[[Category:MEK inhibitors]]
[[Category:MET inhibitors]]
[[Category:mTOR inhibitors]]
[[Category:PDGFR inhibitors]]
[[Category:PIK3CA inhibitors]]
[[Category:PLK1 inhibitors]]
[[Category:RET inhibitors]]
[[Category:ROS1 inhibitors]]
[[Category:SRC inhibitors]]
[[Category:SYK inhibitors]]
[[Category:TEK inhibitors]]
[[Category:VEGF inhibitors]]

[[Category:Hedgehog pathway inhibitors]]
[[Category:SMO inhibitors]]

[[Category:Chemotherapy]]
[[Category:Alkylating agents]]
[[Category:Anthracyclines]]
[[Category:DNA synthesis inhibitors]]
[[Category:Enzymes]]
[[Category:Nitrogen mustards]]
[[Category:Nitrosoureas]]
[[Category:Nucleic acid analogs]]
[[Category:Platinum agents]]
[[Category:Proteasome inhibitors]]
[[Category:Taxanes]]
[[Category:Microtubule inhibitors]]
[[Category:Topoisomerase inhibitors]]
[[Category:Vinca alkaloids]]

[[Category:Antimetabolites]]
[[Category:Antifolates]]
[[Category:Purine analogues]]
[[Category:Pyrimidine analogues]]

[[Category:Endocrine therapy]]
[[Category:Antiandrogens]]
[[Category:Androgen receptor inhibitors]]
[[Category:5 alpha-reductase inhibitors]]
[[Category:GnRH agonists]]
[[Category:GnRH antagonists]]
[[Category:Aromatase inhibitors]]
[[Category:Estrogen receptor inhibitors]]
[[Category:Selective estrogen receptor modulators]]
[[Category:Steroid synthesis inhibitors]]

[[Category:Immunotherapy]]
[[Category:Antibody medications]]
[[Category:Antibody-drug conjugates]]
[[Category:Anti-CD20 medications]]
[[Category:Anti-CD38 antibodies]]
[[Category:Anti-CTLA-4 medications]]
[[Category:Anti-HER2 medications]]
[[Category:Anti-PD-1 medications]]
[[Category:Cytokine therapy]]
[[Category:IL-6 inhibitors]]
[[Category:Calcineurin inhibitors]]
[[Category:Immunomodulatory drugs (IMiDs)]]
[[Category:Retinoids]]
[[Category:Steroids]]

[[Category:Bisphosphonates]]
[[Category:RANK ligand inhibitors]]
[[Category:Somatostatin analogs]]

[[Category:Antibacterials]]
[[Category:Antifungals]]
[[Category:Antivirals]]
[[Category:PCP prophylaxis]]

[[Category:Emesis prevention]]
[[Category:Neurokinin 1 (NK1) antagonists]]
[[Category:Serotonin 5-HT3 antagonists]]
[[Category:Chemotherapy protective agents]]

[[Category:Radioactive agents]]
[[Category:Alpha emitters]]

[[Category:Hematology medications]]

[[Category:Anticoagulants]]
[[Category:Antiplatelet agents]]
[[Category:Heparins]]
[[Category:Low molecular weight heparins]]
[[Category:Vitamin K antagonists]]
[[Category:Direct thrombin inhibitors]]
[[Category:Factor Xa inhibitors]]
[[Category:P2Y12 ADP inhibitors]]
[[Category:Vitamins]]
[[Category:Iron]]

[[Category:Hemostasis medications]]
[[Category:Coagulation factors]]
[[Category:Fibrinolysis inhibitors]]

[[Category:Vasopressin analogs]]
[[Category:Phosphodiesterase inhibitors]]
[[Category:Cyclooxygenase inhibitors]]
[[Category:Chelators]]

[[Category:Hematopoietic growth factors]]
[[Category:Erythrocyte growth factors]]
[[Category:Granulocyte growth factors]]
[[Category:Megakaryocyte growth factors]]

[[Category:Solid oncology medications]]
[[Category:Anal cancer medications]]
[[Category:Basal cell and squamous cell skin cancer medications]]
[[Category:Bladder cancer medications]]
[[Category:Bone sarcoma medications]] 
[[Category:Breast cancer medications]]
[[Category:Cancer of unknown primary medications]] 
[[Category:Central nervous system (CNS) cancer medications]]
[[Category:Cervical cancer medications]]
[[Category:Colon cancer medications]]
[[Category:Esophageal cancer medications]]
[[Category:Gastric cancer medications]]
[[Category:Head and neck cancer medications]]
[[Category:Hepatobiliary cancer medications]]
[[Category:Melanoma medications]] 
[[Category:Mesothelioma medications]]
[[Category:Non-small cell lung cancer medications]]
[[Category:Neuroendocrine tumor medications]]
[[Category:Ovarian cancer medications]]
[[Category:Pancreatic cancer medications]] 
[[Category:Penile cancer medications]] 
[[Category:Prostate cancer medications]]
[[Category:Rectal cancer medications]]
[[Category:Renal cancer medications]]
[[Category:Soft tissue sarcoma medications]] 
[[Category:Small cell lung cancer medications]]
[[Category:Testicular cancer medications]]
[[Category:Thymoma medications]]
[[Category:Thyroid cancer medications]]
[[Category:Uterine cancer medications]]

[[Category:Malignant hematology medications]]
[[Category:Acute lymphocytic leukemia medications]]
[[Category:Acute myeloid leukemia medications]]
[[Category:Acute promyelocytic leukemia medications]]
[[Category:Aggressive Non-Hodgkin lymphoma medications]]
[[Category:Castleman’s disease medications]]
[[Category:Chronic lymphocytic leukemia (CLL/SLL) medications]]
[[Category:Chronic myelogenous leukemia medications]]
[[Category:Chronic myelomonocytic leukemia medications]]
[[Category:Central nervous system (CNS) lymphoma medications]]
[[Category:Follicular lymphoma medications]]
[[Category:Hairy cell leukemia medications]]
[[Category:HIV-associated lymphoma medications]]
[[Category:Hodgkin lymphoma medications]]
[[Category:Hodgkin lymphoma, nodular lymphocyte-predominant medications]]
[[Category:Light-chain (AL) amyloidosis medications]]
[[Category:Mantle cell lymphoma medications]]
[[Category:Marginal zone lymphoma medications]]
[[Category:Mast cell diseases]]
[[Category:Multiple myeloma medications]]
[[Category:Myelodysplastic syndrome medications]]
[[Category:Myelofibrosis medications]]
[[Category:T-cell lymphoma medications]]
[[Category:Waldenström macroglobulinemia medications]]

[[Category:Aplastic anemia medications]]
[[Category:Essential thrombocythemia medications]]
[[Category:Immune thrombocytopenic purpura (ITP) medications]]
[[Category:Paroxysmal nocturnal hemoglobinuria (PNH) medications]]
[[Category:Polycythemia vera medications]]

[[Category:Transplant medications]]

Comments

The "Diseases for which it is used" heading should include a list of all diseases for which there are referenced chemotherapy regimens on HemOnc.org that specifically mention the medication being used in primary therapeutic (antineoplastic) roles. If the medication is a required adjunct to an antineoplastic, e.g. Mesna (Mesnex) in regimens that contain Ifosfamide (Ifex), this should also be linked. If the medicine is used in a general supportive role, it should not be linked. For example, dexamethasone is used as a general anti-nausea medication in many regimens, but is also an antineoplastic in *Acute lymphocytic leukemia and some other hematologic malignancies. The links can easily be determined by looking at the left sidebar on each page-->Toolbox-->and clicking on "What links here." This currently should not be used to list other uses of medications for which there are not officially linked references on HemOnc.org, such as listing that Zoledronic acid (Zometa) is used for almost all diseases since it can be used to prevent skeletal-related events from bony metastases. On the other hand, it is acceptable to list it as being used in Multiple myeloma since there are referenced chemotherapy regimens which specifically mention it being used.

Chemotherapy regimen pages

The general format of each chemotherapy regimen page is as follows. See the chemotherapy regimen formatting section for specific information about how to describe chemotherapy regimens in a standard way.

'''Use of this site is subject to you reading and agreeing with the terms set forth in the [[HemOnc.org_-_A_Hematology_Oncology_Wiki:General_disclaimer|disclaimer]]. If this is your first time visiting, we suggest you read the [[tutorial]].'''

Is there a regimen missing from this list?  Would you like to share a different dosage/schedule or an additional reference for a regimen?  Have you noticed an error?  Do you have an idea that will help the site grow to better meet your needs and the needs of many others?  You are [[How_to_contribute|invited to contribute to the site]].

Number of regimens on this page: {{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Regimen |format=sum}}
<br>Number of regimen variants on this page: {{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Variant |format=sum}}

{{TOC limit|limit=3}}

=Disease sub-type and/or clinical scenario=
(see below for examples)

==Regimen name or drugs used in the regimen {{#subobject:1 |Regimen=1}}==
Every regimen needs to have a different subobject number in order to be added up properly, and you should label every additional regimen with as #subobject:2, #subobject:3, etc.  You can refer to the total number of regimens per page to know what number we're up to on that particular page.

===Example orders===
*[[Example orders for Regimen_name in Disease_type]]

===Regimen #1, Author 1 et al. 2010 (Trial 1 name) & Author 2 et al. 2011 (Trial 2 name or other important description) {{#subobject:1 |Variant=1}}===
Similar to what is used for regimens above, every variant of a regimen needs to have a different subobject number in order to be added up properly, and you should label every additional regimen with as #subobject:2, #subobject:3, etc.  You can refer to the total number of variants per page to know what number we're up to on that particular page.
''Comment about trial, if needed."

====Part 1 of the regimen (if needed)====
*[[Generic name (Brand name)]] 10 mg PO once per day on days 1 to 21

'''28-day cycles'''

====Part 2 of the regimen (if needed)====

===Regimen #2, Author 3 et al. 2011 {{#subobject:2 |Variant=1}}===
*[[Generic name (Brand name)]] 10 mg IV over 60 minutes once on day 1

'''21-day cycles'''

====Supportive medications====
*[[Dexamethasone (Decadron)]] 8 mg PO once 30 minutes prior to generic name

===References===
# Authors of reference 1. Title of reference 1. Journal, volume, page of reference 1. [http://journal.com/link_to_article.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/10000000 PubMed]
# Authors of reference 2. Title of reference 2. Journal, volume, page of reference 2. [http://journal.com/link_to_article.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/10000000 PubMed]
# Authors of reference 3. Title of reference 3. Journal, volume, page of reference 3. [http://journal.com/link_to_article.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/10000000 PubMed]

==Second regimen {{#subobject:2 |Regimen=1}}==

===Regimen, Author 1 et al. 2010 {{#subobject:3 |Variant=1}}===
*[[Generic name (Brand name)]] 10 mg PO once per day on days 1 to 21

'''28-day cycles'''

===References===
# Authors of reference 1. Title of reference 1. Journal, volume, page of reference 1. [http://journal.com/link_to_article.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/10000000 PubMed]

=Adjuvant therapy=

==Capecitabine (Xeloda)==

===Regimen===
*[[Capecitabine (Xeloda)]] 1250 mg/m<sup>2</sup> PO BID on days 1 to 14

'''21-day cycles x 8 cycles'''

===References===
# Twelves C, Wong A, Nowacki MP, Abt M, Burris H 3rd, Carrato A, Cassidy J, Cervantes A, Fagerberg J, Georgoulias V, Husseini F, Jodrell D, Koralewski P, Kröning H, Maroun J, Marschner N, McKendrick J, Pawlicki M, Rosso R, Schüller J, Seitz JF, Stabuc B, Tujakowski J, Van Hazel G, Zaluski J, Scheithauer W. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005 Jun 30;352(26):2696-704. [http://www.nejm.org/doi/full/10.1056/NEJMoa043116 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15987918 PubMed]

==CapeOx (XELOX)==
CapeOX: '''<u>Cape</u>'''citabine, '''<u>OX</u>'''aliplatin 
<br>XELOX: '''<u>XEL</u>'''oda, '''<u>OX</u>'''aliplatin

===Example orders===
*[[Example orders for CapeOx (XELOX) in colon cancer]]

===Regimen #1, Schmoll et al. 2007===
''Note: This is the same trial as described by Haller et al. 2011, but the schedule for [[Capecitabine (Xeloda)]] is slightly different.''
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO BID, starting the evening of day 1, to continue through the morning of day 15 (28 total doses)
*[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV over 2 hours once on day 1

'''21-day cycles x 8 cycles'''

===Regimen #2, Haller et al. 2011===
''Note: This is the same trial as described by Schmoll et al. 2007, but the schedule for [[Capecitabine (Xeloda)]] is slightly different.''
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO BID on days 1 to 14
*[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV over 2 hours once on day 1

'''21-day cycles x 8 cycles'''

===References===
# Schmoll HJ, Cartwright T, Tabernero J, Nowacki MP, Figer A, Maroun J, Price T, Lim R, Van Cutsem E, Park YS, McKendrick J, Topham C, Soler-Gonzalez G, de Braud F, Hill M, Sirzén F, Haller DG. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J Clin Oncol. 2007 Jan 1;25(1):102-9. [http://jco.ascopubs.org/content/25/1/102.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17194911 PubMed]
# Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011 Apr 10;29(11):1465-71. Epub 2011 Mar 7. [http://jco.ascopubs.org/content/29/11/1465.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21383294/ PubMed]

==Fluorouracil & Folinic acid==

===Example orders===
*[[Example orders for 5-FU & low-dose Leucovorin (Mayo Clinic regimen/LDLV) in colon cancer]]
*[[Example orders for 5-FU & high-dose Leucovorin (Roswell Park regimen/HDLV) in colon cancer]]

===Regimen #1, O'Connell et al. 1997 & Haller et al. 2005 (5-FU & low-dose Leucovorin, Mayo Clinic regimen/LDLV)===
*[[Folinic acid (Leucovorin)]] 20 mg/m<sup>2</sup> IV push once per day on days 1 to 5, given first before 5-FU 
*[[Fluorouracil (5-FU)]] 425 mg/m<sup>2</sup> IV push once per day on days 1 to 5, given second

'''28-day cycles x 3 cycles, then 35-day cycles x 3 cycles'''

===Regimen #2, Twelves et al. 2005 & Schmoll et al. 2007 (5-FU & low-dose Leucovorin, Mayo Clinic regimen/LDLV)===
*[[Folinic acid (Leucovorin)]] 20 mg/m<sup>2</sup> IV push once per day on days 1 to 5, given first before 5-FU 
*[[Fluorouracil (5-FU)]] 425 mg/m<sup>2</sup> IV push once per day on days 1 to 5, given second

'''28-day cycles x 6 cycles'''

===Regimen #3, Haller et al. 2005; Lembersky et al. 2006; Schmoll et al. 2007; Kuebler et al. 2007 (5-FU & high-dose Leucovorin, Roswell Park regimen/HDLV)===
*[[Folinic acid (Leucovorin)]] 500 mg/m<sup>2</sup> IV over 2 hours once per day on days 1, 8, 15, 22, 29, 36, given first
*[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV push once per day on days 1, 8, 15, 22, 29, 36, given second, 1 hour after start of leucovorin

'''8-week cycles x 3 to 4 cycles'''

===References===
# O'Connell MJ, Mailliard JA, Kahn MJ, Macdonald JS, Haller DG, Mayer RJ, Wieand HS. Controlled trial of fluorouracil and low-dose leucovorin given for 6 months as postoperative adjuvant therapy for colon cancer. J Clin Oncol. 1997 Jan;15(1):246-50. [http://jco.ascopubs.org/content/15/1/246.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8996149 PubMed]
# Twelves C, Wong A, Nowacki MP, Abt M, Burris H 3rd, Carrato A, Cassidy J, Cervantes A, Fagerberg J, Georgoulias V, Husseini F, Jodrell D, Koralewski P, Kröning H, Maroun J, Marschner N, McKendrick J, Pawlicki M, Rosso R, Schüller J, Seitz JF, Stabuc B, Tujakowski J, Van Hazel G, Zaluski J, Scheithauer W. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005 Jun 30;352(26):2696-704. [http://www.nejm.org/doi/full/10.1056/NEJMoa043116 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15987918 PubMed]
# Haller DG, Catalano PJ, Macdonald JS, O'Rourke MA, Frontiera MS, Jackson DV, Mayer RJ. Phase III study of fluorouracil, leucovorin, and levamisole in high-risk stage II and III colon cancer: final report of Intergroup 0089. J Clin Oncol. 2005 Dec 1;23(34):8671-8. [http://jco.ascopubs.org/content/23/34/8671.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16314627 PubMed]
# Lembersky BC, Wieand HS, Petrelli NJ, O'Connell MJ, Colangelo LH, Smith RE, Seay TE, Giguere JK, Marshall ME, Jacobs AD, Colman LK, Soran A, Yothers G, Wolmark N. Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project Protocol C-06. J Clin Oncol. 2006 May 1;24(13):2059-64. [http://jco.ascopubs.org/content/24/13/2059.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16648506 PubMed]
# Schmoll HJ, Cartwright T, Tabernero J, Nowacki MP, Figer A, Maroun J, Price T, Lim R, Van Cutsem E, Park YS, McKendrick J, Topham C, Soler-Gonzalez G, de Braud F, Hill M, Sirzén F, Haller DG. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J Clin Oncol. 2007 Jan 1;25(1):102-9. [http://jco.ascopubs.org/content/25/1/102.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17194911 PubMed]
# Kuebler JP, Wieand HS, O'Connell MJ, Smith RE, Colangelo LH, Yothers G, Petrelli NJ, Findlay MP, Seay TE, Atkins JN, Zapas JL, Goodwin JW, Fehrenbacher L, Ramanathan RK, Conley BA, Flynn PJ, Soori G, Colman LK, Levine EA, Lanier KS, Wolmark N. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007 Jun 1;25(16):2198-204. Epub 2007 Apr 30. [http://jco.ascopubs.org/content/25/16/2198.full link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17470851 PubMed]

==FLOX==
FLOX: '''<u>F</u>'''luorouracil, '''<u>L</u>'''eucovorin, '''<u>OX</u>'''aliplatin

===Example orders===
*[[Example orders for FLOX in colon cancer]]

===Regimen, Kuebler et al. 2007===
*[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV bolus once per day on days 1, 8, 15, 22, 29, 36, given third, to start 1 hour after start of leucovorin
*[[Folinic acid (Leucovorin)]] 500 mg/m<sup>2</sup> IV over 2 hours once per day on days 1, 8, 15, 22, 29, 36, given second, before Fluorouracil (5-FU)
*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once per day on days 1, 15, 29, given first prior to 5-FU and leucovorin

'''8-week cycles x 3 cycles'''

===References===
# Kuebler JP, Wieand HS, O'Connell MJ, Smith RE, Colangelo LH, Yothers G, Petrelli NJ, Findlay MP, Seay TE, Atkins JN, Zapas JL, Goodwin JW, Fehrenbacher L, Ramanathan RK, Conley BA, Flynn PJ, Soori G, Colman LK, Levine EA, Lanier KS, Wolmark N. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007 Jun 1;25(16):2198-204. Epub 2007 Apr 30. [http://jco.ascopubs.org/content/25/16/2198.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17470851 PubMed]

=Mantle cell lymphoma, relapsed/refractory=

==Lenalidomide (Revlimid)==

===Regimen, Goy et al. 2012 (MCL-001, EMERGE)===
''Participants in Goy et al. 2012 "were required to have had prior treatment with rituximab, cyclophosphamide and anthracycline (or mitoxantrone), and to have relapsed or progressed (<12 months) after or were refractory to bortezomib."''
*[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21

'''28-day cycles, given until progression of disease, unacceptable toxicity, or voluntary withdrawal'''

===References===
# Andre Goy, Rajni Sinha, Michael E. Williams, Sevgi Kalayoglu Besisik, Johannes Drach, Radhakrishnan Ramchandren, Michael J. Robertson, Irit Avivi, Jacob M. Rowe, Raoul Herbrecht, Achiel Van Hoof, Miklos Egyed, Lei Zhang, Sherri Cicero, Tommy Fu, and Thomas E. Witzig. Phase II Multicenter Study of Single-Agent Lenalidomide in Subjects with Mantle Cell Lymphoma Who Relapsed or Progressed After or Were Refractory to Bortezomib: The MCL-001 "EMERGE" Study. 2012 ASH Annual Meeting abstract 905.  [https://ash.confex.com/ash/2012/webprogram/Paper48905.html link to abstract]

Regimen names

For regimens with 2 or more drugs that are only identified by the drugs used, e.g. Carboplatin & Docetaxel, only use the generic names. For now, it is acceptable to use the Generic name (Brand name) format for monotherapy regimens. By submitter's discretion, one may 1) include both the generic names and an acronym as the regimen name; for example: Ifosfamide, Carboplatin, Etoposide (ICE) or 2) use the acronym as the regimen name; for example: ICE. There is currently ongoing discussion about whether, if there is no generally accepted acronym for the regimen, we should adhere to the NCI standard of listing the antineoplastic drugs in alphabetical order; for example: Carboplatin, Etoposide, Ifosfamide.

Regimens should be listed in alphabetical order within a disease sub-type and/or clinical scenario. When there is more than one acronym in the literature, please use your judgment to pick the best one to alphabetize by (e.g. ICE-R versus R-ICE).

Variants

A variant is a regimen that is substantively similar to another regimen with minor differences e.g. in dosages, routes, or frequencies of administration. For example, we would consider R-CHOP that uses prednisone and R-CHOP that uses prednisolone as variants, not separate regimens. Conversely, R-CVP is considered a completely different regimen than R-CHOP, due to omission of one of the main chemotherapeutics (doxorubicin). There is no absolute rule for what order different variants of a regimen should be listed in within a regimen. One may choose to put the most commonly used version of the regimen at the top, go chronologically, or just add new ones as successive regimen numbers in the sequence.

References

These should be listed in chronologic order, with the oldest references at the top, and the newest references at the bottom. If a reference says contains verified protocol, that means the original paper has been reviewed by the submitter, with the details of the regimen confirmed with the primary literature. If the reference just says contains protocol, the reference contains details about the regimen, but it was not personally reviewed by the submitted. Exception: numerous regimens on HemOnc.org were manually verified prior to the adoption of the contains verified protocol tag and instead only currently say contains protocol. Those regimens will be changed over time to contains verified protocol as the content is re-reviewed during an update of each page's regimens.

For example, if a submitter is able to see which dosages are described in the abstract, but the submitter lacks a subscription to access the complete paper, the reference would be labelled as contains protocol. A review article which discusses the regimen would not contain one of these labels unless it specifically describes the fine details of the regimen. Review articles are generally discouraged unless they add significant further information to the primary references for chemotherapy regimens. Meta-analyses and comparative effectiveness research articles could be added.

Chemotherapy regimen formatting

Instructions

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The following sections get into the nitty-gritty of regimen formatting. If you would like, you can skip straight to the examples.

Chemotherapy formatting

The standard format for describing chemotherapy administration is:

  • [[Generic name (Brand name)]] (dose) (units) (in what volume and type of fluid) (route) (time of infusion) (frequency and/or number of times given) (schedule) (order of administration) (special comments)
    • This further indented section can be used for special doses, such when patients over a certain age receive a reduced dose, or for other needed comments about the use of this specific medication in this regimen. It is up to the submitter's discretion whether this ** indented area is needed versus just putting the comments in the (special comments) area.

Order of medications within a regimen

List medications within the regimen in the same order as they are found in the title of the regimen. So, for example, if the regimen is an acronym, the medications should be listed in the same order as they are used in the acronym.

Frequency

For now, we have not set strict rules for abbreviated versus written out frequencies. Some acceptable frequencies to use are:

  • once per day
  • once per week
  • once
  • BID
  • TID
  • every 4 hours
  • Q4H
  • 3 times a day

Do not use abbreviations or numbers which are on the Joint Commission (TJC), previously known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)'s "Do not use" list: U, u (unit); IU (international units); Q.D., QD, q.d., qd (daily); Q.O.D., QOD, q.o.d., qod (every other day); MS, MSO4, MgSO4 (morphine sulfate or magnesium sulfate); trailing zeroes (X.0 mg); or omitted leading zeroes (.X mg). Also, based on suggestions in Making Health Care Safer II, please do not use any abbreviations involving frequencies during a week--e.g. use "3 times a week" instead of TIW--and do not use cc as an abbreviation for mL.

Schedule

If a medication is only given once per cycle, then the format "once on day x" is used. On the other hand, if a medication is given two or more times per cycle, then the format once per day on days 1 to 3, etc. is used. Note that an ampersand (&) is used if and only if there are two days involved. If a medication is given continuously and there is no specified cycle length, then it it is not necessary to spell out days on which the medication is taken; one can instead just say "medication 10 mg PO once per day," or "medication 10 mg PO BID." For any ranges, to reduce the chance of error, we use "days x to y" instead of "days x-y." We use "over 30 to 60 minutes" instead of "over 30-60 minutes." This benefit is particularly clear for transplant regimens, when one may need to say something like "once per day on days -6 to -2." Here are some examples of how to properly indicate days of treatment:

  • once on day 1
  • once per day on days 1 to 3
  • once per day on days 1 & 8
  • once per day on days 1, 8, 15
  • BID on days 1 to 14
  • three times per week
  • once per week on weeks 1, 3, 5, 7

In order to further reduce ambiguity, when thought to be beneficial, contributors may optionally add the total number of doses at the end of the instruction, e.g.:

  • once on day 1 (1 dose per cycle)
  • once per day on days 1 to 3 (3 doses per cycle)
  • once per day on days 1 & 8 (2 doses per cycle)
  • once per day on days 1, 8, 15 (3 doses per cycle)
  • BID on days 1 to 14 (28 doses per cycle)
  • three times per week (number of doses varies with length of cycle)
  • once per week on weeks 1, 3, 5, 7 (4 doses per cycle)

Supportive medications

Only list what is specifically described by the cited paper. If the reference only says "5-HT3 antagonists," that is all that can be written; we cannot say, for example, Ondansetron (Zofran). Details about hydration also can go in this section. Both prn and "as needed for" may be used to describe medications taken on an as needed basis. It is encouraged to also list whether the paper specifically mentioned agents which were not used, such as:

  • No routine antibiotic or antiviral prophylaxis was given
  • Growth factor support allowed, such as with Filgrastim (Neupogen)

Duration of cycle

This line should always be bolded. A numeric duration of each cycle should be given in days or weeks. When the reference explicitly identifies a number or range of cycles, this should be reported (spelling out "to" instead of using a dash, so as to avoid confusion). It is acceptable to use "indefinitely" when a regimen gives no finite number of cycles, but to be clear this is generally understood to be equivalent to "until progression, unacceptable side effects, or patient preference to discontinue." If the total duration of a regimen is very long, as with some maintenance regimens, it is acceptable to report the total duration of treatment, as opposed to the actual number of cycles. Although there are various terms used to describe a cycle of chemotherapy (e.g. round or course are often used in the literature) we encourage the consistent use of the word cycle.

Examples:

  • 14-day cycle x 4 cycles
  • 3 to 4-week cycle x 4 to 6 cycles
  • 42-day cycle, continued indefinitely
  • 28-day cycles x 2 years

Linking portions of regimens

Often, a regimen will be divided into portions, e.g. upfront treatment followed by consolidation followed by maintenance. Or, some regimens are response-adopted, e.g. R-MegaCHOP with intensification treatment based on early FDG-PET in patients with high-risk diffuse large B-cell lymphoma. In these cases, even if a regimen is detailed in a single reference, we try to break the regimen up across the appropriate contexts. Links should not be left implicit but rather should be detailed as follows:

First part of regimen

After the bolded "xx-day cycle x y cycles" a new italicized line should be entered:

  • ''Patients meeting so-and-so criteria (e.g. "responders") proceeded to receive [[Wiki_Link|the next thing]].''

Example from R-ICE in DLBCL:

  • ''Patients with complete or partial response then received [[Diffuse_large_B-cell_lymphoma#Autologous_stem_cell_transplant|autologous stem-cell transplant]].''
  • Patients with complete or partial response then received autologous stem-cell transplant.

If there is more than one option for the second part of the regimen but the trial is not randomized, use this format:

  • ''Patients meeting so-and-so criteria (e.g. "responders") proceeded to receive [[thing A]] or [[thing B]].''

If there is more than one option for the second part of the regimen and the trial is randomized, use this format:

  • ''Patients meeting so-and-so criteria (e.g. "responders") proceeded to receive [[thing A]] versus [[thing B]].''
Second part of the regimen

Before the chemotherapy instructions a new italicized line should be entered:

''Treatment preceded by [[Wiki_Link|first part of regimen]].''

Chemotherapy regimen acronyms are encouraged here, for simplicity.

Example from carfilzomib maintenance in multiple myeloma:

''Treatment preceded by [[Multiple_myeloma#CCyd|CCyd x 9]].''

If there is more than one option for the first part of the regimen but the trial is not randomized, use the word or to distinguish the options:

''Treatment preceded by [[regimen A]] or [[regimen B]].''

If there is more than one option for the first part of the regimen and the trial is randomized, use the word versus to distinguish the options:

''Treatment preceded by [[regimen A]] versus [[regimen B]].''

If more than one path leads to the second part of the regimen, this should be clearly noted. These pathways can get fairly complex quickly, so it is important to keep close track of the links! When a trial has a name it is encouraged to use it for simplicity; otherwise the "first author's last name et al. year" format should be used. In both cases use boldface to make it easier for the user to find the trial that they are looking for.

Example from melphalan, then autologous stem cell transplant in multiple myeloma:

''Treatment in '''IFM2007-02''' preceded by [[Multiple_myeloma#VTD|vtD x 4]] versus [[Multiple_myeloma#VD_.28Velcade.29|VD x 4]]. Treatment in '''Palumbo et al. 2014''' preceded by [[Multiple_myeloma#VD_.28Velcade.29|VD x 4]].''
  • Treatment in IFM2007-02 preceded by vtD x 4 versus VD x 4. Treatment in Palumbo et al. 2014 preceded by VD x 4.
Third part of the regimen, etc.

The instructions above can be reused for regimens that have three or more parts. Of course, the "middle" parts of regimens will have both a "preceded by" and "followed by" section.

Examples

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Regimen example #1, Lenalidomide (Revlimid) in Mantle cell lymphoma

28-day cycles, given until progression of disease, unacceptable toxicity, or voluntary withdrawal

Regimen example #2, Mitomycin in Bladder cancer

Induction therapy

6-week course, then proceed to additional therapy

Additional therapy

12-week course; 6 doses given during this course (i.e. once on weeks 1, 3, 5, 7, 9, 11)

Regimen example #3, concurrent cisplatin & radiation therapy in Bladder cancer

Induction therapy
  • Cisplatin (Platinol) 100 mg/m2 IV once per day on days 1 & 22
  • Concurrent radiation therapy, 1.8 Gy fractions x 22 fractions, given 5 times per week (total dose: 39.6 Gy)

21-day cycles x 2 cycles; patient is restaged 4 weeks after completion of radiation with "examination under anesthesia, cystoscopy with tumor-site biopsy, and urinary cytology." Patients not in complete remission usually proceeded to cystectomy. Patients in compete remission usually proceeded to consolidation therapy:

Consolidation therapy
  • Cisplatin (Platinol) 100 mg/m2 IV once on day 1
  • Concurrent radiation therapy, 1.8 Gy fractions x 14 fractions, given 5 times per week (total dose in consolidation phase: 39.6 Gy; total overall dose in induction and consolidation phases: 64.8 Gy)

Regimen example #4, MVAC in Bladder cancer

14-day cycles, given until progression of disease or unacceptable toxicity; in contrast to Sternberg et al. 2001, Sternberg et al. 2006 specified 15-day cycles

Supportive medications

  • G-CSF 240 ug/m2 SC once per day on days 4 to 10 (additional use up to a total of 14 consecutive days if needed), injected at alternating sites, discontinued if ANC >30 x 109/L. In contrast to Sternberg et al. 2001, Sternberg et al. 2006 said G-CSF was given on days 3 to 7.

Regimen example #5, MVAC in Bladder cancer

28-day cycles x 6 cycles (number of cycles and criteria to continue therapy varies depending on reference)

Regimen example #6, mFOLFOX 6 in Colon cancer

14-day cycles x 12 cycles, to start within 10 weeks of surgery

Regimen example #7, Carboplatin & Irinotecan in Small cell lung cancer

Supportive medications

28-day cycle for up to 6 cycles