Tutorial
This page is intended for folks using HemOnc.org for the first time, although frequent visitors may also learn about new features here. What follows are descriptions of the main features of the wiki. If you're in a hurry, the FAQ may be sufficient to answer your questions.
Note that the structure and content of HemOnc.org are constantly undergoing evolution, such that information that you read here might be outdated. This page was last reviewed and updated in August 2024.
Introduction
HemOnc.org was created in November 2011 as a freely accessible source of chemotherapy drug and regimen information. The site has grown considerably since then. For example, the number of regimens has increased from 21 to more than 3700! Here is a general FAQ, with much more detailed information below or on other dedicated pages:
FAQ
Q: Why did you create this website?
A: The practice of hematology/oncology involves extensive knowledge about numerous drugs and complex treatment regimens. This information is constantly evolving, and when we conducted a needs assessment in 2011, there was no freely available, comprehensive, centralized repository of such information. HemOnc.org was created to address this unmet need. To learn more, please read our Journal of Oncology Practice article as well as this page describing our core philosophy.
Q: Has all content on the website been reviewed?
A: Yes in the sense that all of the content has been added by manually approved contributors, but the extent of review of content can vary. We emphasize citing references for information added. However, the original reference may or may not have been reviewed in its entirety by the person adding information; for example, sometimes a reference is listed for information, but the reference is not available in its entirety due to subscription or other restrictions. As you peruse the content, please take note of the bolded statement found at the end of each clinical trial reference. This statement will tell you the degree to which the treatment details were reviewed; see specific label explanations below. If there is no statement for a given reference, you should assume the original reference has not yet been reviewed (however, we didn't start using these labels until several years into the project, so absence of a label doesn't mean absence of a review).
Q: Where do you source your information?
A: We look primarily to the published primary literature of prospective clinical trials in hematology/oncology and secondarily to sources such as review articles and guidelines. We are also have an expert Editorial Board that provides ongoing review and feedback. See Sources for more information.
Q: Why don't you have regimen "XYZ"?
A: For systemic anticancer therapy regimens, which make up the bulk of HemOnc.org content, we generally require that a regimen be published in a peer-reviewed manuscript or be well described on a trustworthy resource such as ClinicalTrials.gov before it can be included. We also prefer to only include regimens that have some demonstrated degree of efficacy, ideally through comparative superiority in a randomized clinical trial (RCT). See Eligibility criteria for more information. If you feel that there is a particular regimen that should be added to the website, please use the link at the top of any page to provide us the details. Note: in 2024, we will begin an experiment to include certain regimens that are sourced from real-world data; more details coming soon!
Q: Why don't you have drug "XYZ"?
A: We prioritize including information about approved drugs with approved indications rather than investigative drugs which have greater uncertainty about their utility and relevance to clinical practice. For drugs, we focused first on capturing details on all FDA-approved antineoplastics, and have from there expanded to other regulators (EMA, PMDA, Health Canada, NMPA, etc). We also have tried to include any and all drugs with a supportive role in hematology and/or oncology, in particular those used to address the side effects of antineoplastic agents. We have also tried to include drugs with promising results in clinical trials, preferably those with at least phase 2 results. If you feel that there is a particular drug that should be added to the website, please use the link at the top of any page to provide us the details.
Q: Where can I learn more about your quality control and quality assurance (QC/QA) processes?
A: Information about the processes we use to identify clinical studies and maintain core website functions are described on pages across the site, such as eligibility criteria and sources. In order to centralize this information for quick reference, we have created a Standard Operating Procedure (SOP) describing the QC/QA processes for the website and for the HemOnc Ontology. This document can be downloaded here.
Main page
This is the landing page of HemOnc.org and is primarily a portal to get to the disease-specific regimen pages.
Top section
Here, there are quick links to the disease-specific pages, which are organized into five disciplines: 1) (adult) solid oncology; 2) (adult) malignant hematology; 3) pediatrics; 4) transplant; and 5) classical (a.k.a., benign) hematology. There is also a link to our Editorial Board.
We list statistics about the number of regimens and variants that give you an idea of the scope of the website. The "Regimens" count is a tally of context-specific regimens across all of the pages; "Regimen variants" counts each variant of a context-specific regimen separately, which is why the number is significantly higher. If you are interested in exploring the website through our categories, all pages have at least one categorization and some (such as the medication pages) have many more. The "top-level" categories that you can access directly from the main page are:
- Intervention index, with 5 subcategories
- Regimen index, with 19 subcategories
- General reference pages, with 9 subcategories
Middle section
Each section is further subdivided into disease-focused groups, driven primarily by the subspecialty organization of hematology/oncology. This also parallels the organization of our Editorial Board.
Bottom section
Below the disease-focused groups, we have some additional information, including the core priorities of the HemOnc.org project, which are:
- Creating a database of all approved systemic anticancer therapy agents and supportive medications used in the field of hematology/oncology.
- Creating a database of all standard-of-care systemic anticancer therapy regimens and references to primary literature (PubMed and direct links to the abstracts articles).
- Sample order sets and examples of supportive medications used with treatment regimens
- Aggregating useful links to existing resources by disease, such as guidelines, information about prognosis, clinical calculators, staging, and patient resources.
- Creating, maintaining, and disseminating a formalized ontology of anticancer drugs and regimens.
Left sidebar
No matter what page you're on, you'll always see links on the left part of the page which will take you to some of the most useful pages on the site. Clicking the HemOnc.org logo at the top left will take you back to the main page.
Top pages
This section contains the ten most-visited disease-specific pages, as determined by our internal analytics. Clicking here will take you directly to that page.
References
This menu contains many potentially useful resources, including some our most-visited pages. We have carved out individual pages for some of the most frequently used, such as billing codes, antiemetic support, and performance status. Our vesicant and irritant chemotherapy page is one of our most heavily visited and might very well be the way you found your way to the site.
Beyond these pages, we have an external links page with many, many more links. If you find your organization represented here, please consider linking us back!
Stay in touch
If you enjoy using HemOnc.org, we would really appreciate it if you could spread awareness through social media such as Facebook or following our account on LinkedIn. You are also welcome to join our mailing list.
Contributors
This menu is intended specifically for contributors but given that any visitor is a potential contributor, we encourage you to explore the links. In particular, the editing tutorial and the style guide are very helpful to new and active contributors.
Tools
This information is not really too useful for casual users of the site but can be relevant to contributors or for people with an interest in the software that powers this reference, Mediawiki.
Disease-specific regimen pages
These are probably the pages you are going to visit the most. Treatment regimens are grouped into individual pages by cancer histology, hematologic condition, or sometimes by biomarkers, e.g., HER2-positive breast cancer. Although the inclusion of a regimen on a page is not an endorsement of its efficacy, we generally only include regimens that are either current standard-of-care, recommended by well-known guideline organizations (e.g., NCCN, ASCO, ESMO), or endorsed by our editorial board. See Eligibility criteria for more information. If you do not see the regimen that you are looking for on the page you think it should be on, it is either:
- Present but not on the page you are searching on (this is likely, especially when there are anatomy-specific pages such as bladder cancer and more general histology-specific pages such as urothelial carcinoma);
- Missing and needs to be added to HemOnc.org;
- Intentionally left off the page for not meeting one or more of the criteria just mentioned; or
- Present on an "obsolete" regimens page.
We are still establishing the standards by which a regimen would be considered "obsolete", especially given that novel drug availability can vary widely by country and economic region, and many older regimens are still used quite widely. Proposed definitions of obsolete are:
- No longer recommended by any well-known guideline organization (e.g., NCCN, ASCO, ESMO);
- More than 10 years from initial publication without any additional updates;
- No longer used in practice (difficult to prove, especially when considering international usage patterns).
On a particular regimen page, regimens are listed alphabetically under a given treatment context. Treatment contexts are generally arranged with earlier stage, curable contexts at the top and later stage, palliative contexts towards the bottom.
On some pages, the regimens are further organized by whether or not they are described as part of a randomized trial or as a nonrandomized intervention or retrospective analysis.
Our long-term goal is to organize regimens for advanced or metastatic disease into at least first-line and subsequent lines of therapy, with further subdivisions as driven by the clinical context. For example, the Renal cell carcinoma page has metastatic context regimens divided into first-line, second-line, and third-line therapy.
Table of contents
Almost every page of HemOnc.org has a table of contents, which allows you to jump quickly to the area of the page that you are most interested in. On longer pages (e.g., the regimen pages, and this page) there is also a "back to top" button in the lower right corner that will bring you back to the table of contents.
Guidelines
Most pages contain links to ASCO, ESMO, NCCN, or specialty-specific guidelines. Given the sheer number of societies that might issue guidelines, we have primarily focused on ASCO, ESMO, and NCCN. Guidelines are listed in reverse chronologic order, and a general disclaimer is provided that those that are more than 5 years old should be considered outdated. Providing links to guidelines is not an endorsement of those guidelines; these links are provided as a service to the users of HemOnc.org.
Regimens
Anatomy of a regimen
We have adopted a consistent style across the website with regimens being presented as "cards" following this color scheme:
The contents of a regimen are contained within this box; at the top of the box is a study table with details about the studies that evaluated the regimen; further information about the contents of this table is provided below.
Any eligibility criteria appear here; we are in the process of adding prior treatment criteria; this is where you would also find biomarker eligibility criteria, if applicable.
If there is a linked regimen or procedure that occurs before the regimen, you'll find it here.
This box contains the main treatment information for the regimen, including supportive therapy if applicable. If all you are looking for are the dosing details, this is where you will find them!
If there is a linked regimen or procedure that occurs after the regimen, you'll find it here.
If there are dose modifications, you'll find them here. This box is not that common; we'll work to add more dose modifications in the upcoming years.
Anatomy of a protocol
Certain treatments are given in complex multipart protocols, especially those for pediatric malignancies. For these we use an additional wrapper:
The entire protocol is wrapped in a box. At the top of the box is a study table with details about the studies that evaluated the regimen.
Each phase of the protocol is contained within a box.
Treatment details and the other sections appear the same from here.
Here's an example of another box, say the consolidation phase of a protocol.
Treatment details for this consolidation phase are shown here.
And then you might have a maintenance phase.
Treatment details for this maintenance phase are shown here.
Inclusion criteria
We decide which regimens to include on HemOnc.org based on whether the regimen meets our eligibility criteria. When we use the term "regimen", we are broadly including any prescription with a disease modifying effect, and optionally additional prescriptions to manage the side effects of the disease-modifying agents (i.e., supportive medications). Since we are primarily focused on medical oncology and hematology, the majority of the regimens have one or more antineoplastic or disease-modifying medications; we also have a number of regimens that are radiotherapy-based. When describing a regimen, we try to use a consistent style for each chemotherapy regimen, so that you can find the information that you are looking for quickly and easily. Here are the components you will find:
Preferred name
Each regimen has a main description which we have designated as the preferred name. This is often but may not always be the most common name used in the published literature or clinical documentation. In order to develop a consistent and reproducible approach to the naming of regimens, we have created and published a regimen nomenclature. Follow the link to read about this in much greater detail.
Regimen alias(es)
For regimens that are known by an acronym, the first thing we do is spell out the acronym. Since these acronyms often contain brand names, we include the generic names in parentheses as indicated.
- Example: CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
If there are alternative acronyms in common use, these are also listed.
Example order sets
Many individual practitioners and organizations do not follow published regimens to the letter. This may be because the published regimen is under-specified, especially with respect to supportive medications, sequencing, and infusion times; or, it may be because local patterns influence treatment choices (again, this is probably most applicable to supportive medications such as antiemetics). For this reason, we have created a number of example order sets, which can be accessed directly or searched for. For example, the mFOLFOX6 regimen on the colon cancer page has a link to the example orders for mFOLFOX 6 in colon cancer. There are many fewer example order sets than chemotherapy regimens currently, so this is another area where your contributions would be most appreciated!
Regimen variants
For most regimens, there is only one variant. However, many regimens have a multitude of variants; e.g., BEAM, used as a preparative regimen for autologous hematopoietic stem cell transplantation, has (at least) a dozen variants! Generally we consider a variant to be different dosing, different numbers of cycles, different scheduling, and different routes of administration when the routes are not 100% bio-equivalent.
Another type of variant would be substitution of a similar but not identical medication (e.g., CHOP with prednisolone substituted for prednisone). We don't consider these to be variants in the strict sense but rather we consider them to be therapeutic exchanges; see this page for more information.
We list each variant of a regimen that we have found, numerically and usually with a short description. The short description is usually related to the dosing, and sometimes to eponymous variants (e.g., Roswell Park regimen; modified Magrath). For consistency, we are adopting a uniform ordering of variants by increasing dose of the first drug. If two variants have the same dosing but different cycles, we order them by increasing number of cycles. Here is an example of the regimen FEC, as used in the adjuvant treatment of breast cancer. As of December 2023, this regimen in this context had 17 variants; shown here are the first 5:
Variant | Short description | Number of cycles |
---|---|---|
1 | 500/50/500 x 6 ("FEC 50") | 6 |
2 | 500/50/500 until max anthracycline | Up to 15 |
3 | 500/60/500 x 4 | 4 |
4 | 500/90/500 x 5 | 5 |
5 | 500/100/500 x 4 ("FEC 100") | 4 |
Sometimes, when a range is given for just one drug of a multi-drug regimen, we will split the regimen into two variants, where one represents the lower bound of the range and one represents the upper bound of the range; this is always noted.
Study table elements
The following subsections explain each of the columns found in the table that is present at the top of each regimen/protocol/variant.
Regimen and regimen variant identifiers ("Study")
For each regimen and regimen variant, we reference at least one publication, and more if multiple published protocols have used that variant. In order to frame the appropriate historical context, we try to find the earliest publication of that variant, although this is not always successful. Publications are listed by the last name of the first author "et al." unless in the extremely rare situation that there are only one or two authors. We then list the year of publication as the year that the manuscript was e-published (n.b., this is somewhat different than the standard protocol for bibliographies). If there is a clearly stated protocol acronym or code we list that in parentheses after the year.
Dates of enrollment
When the information is available, all RCTs and many non-randomized studies on the website have the first and last year of the study enrollment period. If more granular dates of enrollment are available, we will provide those. If the information is not available, the abbreviation "NR" - not reported - is used. Note that trials often follow patients for many years after the end of enrollment, which is part of the reason that there may be a large time interval between the end of enrollment and the year of the publication. When there are multiple studies of a particular regimen or regimen variant, they are default ordered by the first year of enrollment. Also note that the dates of enrollment will not always coincide with dates provided in ClinicalTrials.gov, such as the start of the trial, which is a slightly different metric than the start of enrollment.
Trial design ("Evidence")
Next, we label the type of trial or arm of an RCT reporting the regimen with a three color code: 1) dark green for RCTs with at least 20 patients assigned to the regimen; 2) light green for RCTs with fewer than 20 patients assigned to the regimen or non-randomized prospective trials with at least 20 patients; 3) light yellow for non-randomized prospective trials with fewer than 20 patients or retrospective studies (of any size). For RCTs, the letters in the parentheses are a short code which is described on this page and as follows:
Control vs Experimental arms
Code | Definition |
---|---|
(C) | Control arm |
(E) | Experimental arm |
Note: the vast majority of phase 3 RCTs have (at least) one control arm and (at least) one experimental arm. In contrast, a substantial minority of randomized phase 2 RCTs have all experimental arms. Sometimes, it is very difficult to tell from the manuscript which arm is the control and which arm is the experimental - especially with older manuscripts. If we can't determine it from the manuscript, our default is to label all arms as experimental, with two important exceptions:
- Non-active comparators, including placebos, are labeled as the control arm unless explicitly stated to be the experimental arm
- If one (or more) arms includes the drugs in the other arm(s) as well as additional drugs (e.g., R-CHOP versus CHOP), the arm with the least drugs is labeled as the control arm.
Design of the experimental arm
Code | Definition |
---|---|
(E-esc) | Experimental arm with an escalation design - more drugs, higher dose, more cycles, etc. |
(E-de-esc) | Experimental arm with a de-escalation design - fewer drugs, lower dose, fewer cycles, etc. |
(E-switch-ic) | Experimental arm with the same general class of drug as the control arm (e.g., a 2nd-generation EGFR inhibitor compared to a 1st-generation EGFR inhibitor) |
(E-switch-ooc) | Experimental arm with a different class of drug than the control arm (e.g., immunotherapy compared to cytotoxic chemotherapy) |
Experimental arms that led to regulatory approval
Code | Definition |
---|---|
(E-RT-esc) | Experimental arm with an escalation design that led to regulatory approval |
(E-RT-de-esc) | Experimental arm with a de-escalation design that led to regulatory approval |
(E-RT-switch-ic) | Experimental arm with the same class of drug as the control arm that led to regulatory approval |
(E-RT-switch-ooc) | Experimental arm with a different class of drug than the control arm that led to regulatory approval |
(RT) | Non-randomized experimental arm that led to regulatory approval |
Note: Most of these labels are up-to-date for FDA approval, less so for other regulators. We are working to add information from EMA, PMDA, HC, NMPA, and others at this time.
Comparator(s)
For RCTs, we provide a clickable link directly to the comparator arm(s), in most cases. There is an important exception. Some trial designs do not allow for an easy direct link, e.g., arm A patients are treated with "treatment A1", then "treatment A2" and arm B patients are treated with "treatment B". Treatment A1 can't directly be compared to treatment B, in this instance. For such regimens, instead of a direct link to the comparator, you will see a clickable "See link". Clicking on this will take you to the complex multipart regimens page, which have further information about the efficacy of the trial in question. We try our best to avoid this, but sometimes it really is unavoidable.
Efficacy and Comparative Efficacy
For almost all phase 3 trials and most randomized phase 2 trials, we report the comparative efficacy, as reported in the publication. Much more information is available here. If an interim update reports a change in efficacy, we denote this by a footnote. We have also begun to systematically add median time-to-event and hazard ratios with confidence intervals, starting with experimental arms of phase 3 RCTs.
Comparative Toxicity
For some phase 3 trials, we report the comparative toxicity, as reported in the original publication or in subsequent publications focused on HRQoL. Much more information is available here.
Entry and prior treatment criteria
Most regimens currently on HemOnc.org do not specify the entry (eligibility) criteria. Beginning with the randomized controlled trials, we are beginning to add the "top-line" entry criteria, generally of the format:
Note: This regimen was intended for patients with disease X meeting conditions Y, Z.
This information is taken directly from the manuscript and is not yet in a standardized format. At this point reporting the more detailed inclusion and exclusion criteria is out of scope for the HemOnc.org project. See the Multiple myeloma page for an example of what this information looks like.
We are also adding prior treatment criteria in a more structured format, directly above the regimen treatment details.
Disease-modifying drugs
Now, to the actual regimen! We first list the disease-modifying drugs, which for most pages on HemOnc.org, are antineoplastics, alone or in combination. The most common high-level categories that we use for disease-modifying regimens are:
- Chemotherapy
- Endocrine therapy
- Immunotherapy
- Targeted therapy
- Radiotherapy
In the case of a regimen that combines modalities, e.g., Cisplatin & RT, each modality is described under a separate heading.
Prescription details
Next, we list the disease-modifying drugs in the same order as the regimen acronym, or in the order that they are listed in the absence of an acronym. Each drug is described in a particular format:
Generic_name (Brand_name) x units per unit measure (max dose) route frequency on day(s) y to z (notes)
- Example #1: Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Example #2: Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once per day on days 4 & 11
- Example #3: Cyclophosphamide (Cytoxan) 100 mg/m2 PO once per day on days 1 to 14, taken with breakfast
An exception to this rule are continuous infusions, which are described in a slightly different format:
Generic_name (Brand_name) x1 units per unit measure per day IV continuous infusion over y hours, started on day z (total dose per cycle: x2 units per unit measure)
- Example #4: Doxorubicin (Adriamycin) 10 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 40 mg/m2)
- Example #5: Fluorouracil (5-FU) 400 mg/m2 IV bolus once on day 1, then 2400 mg/m2 IV continuous infusion over 46 hours (total dose per cycle: 2800 mg/m2)
- Note that in this example, the continuous infusion is not a multiple of 24 hours, so the "/day" is not used
Generic_name (Brand_name) is always an active link to the drug page. When a primary reference provides details about infusion time, we include them.
- Example #6: Mitoxantrone (Novantrone) 8 mg/m2 IV over 30 minutes once on day 1
When a primary reference provides details about infusion order, we also provide that information.
- Example #7: Mitoxantrone (Novantrone) 8 mg/m2 IV over 30 minutes once on day 1, given second
Supportive medications
Immediately after the disease-modifying drugs, we provide information on supportive medications such as antihistamines, antiemetics, growth factors, etc. as provided in the original reference. On occasion the supportive medication is the regimen, e.g., growth factor regimens for low-risk MDS. Some references provide specific drugs but omit doses or routes and we make note of this. Other references recommend a category of medications and we provide the link to one of our drug category pages, e.g. G-CSF. Supportive medication information is highly variable and sometimes not present in the original reference, in which case it is omitted.
Dose modifications
We occasionally include information on dose modifications, especially if they are integral to the regimen (e.g., DA-R-EPOCH), but this has not been a focus of the HemOnc.org project to date. Please consult the original reference if you suspect that dose modifications might be necessary (e.g., patient age older than 70 years old, reduced cardiac function, etc.).
Treatment duration
As with the drug information, we try to maintain a very consistent style for the length and number of cycles. Here are some common examples:
- 21-day cycle for 6 cycles
- 28-day cycle for 4 to 6 cycles
- 8-week course
- 28-day cycles
- Continued indefinitely
Note that the first three examples are of limited duration, whereas the last two are indefinite. While trials often specify exact stopping rules such as progression of disease, clinical practice is more flexible. Generally, disease progression, intolerance due to side effects, or a patient's request to stop therapy for any reason are the main drivers of therapy discontinuation. So as to more accurately reflect this flexibility in clinical practice, we have moved away from specifying the exact stopping rules that might be specified in a trial.
Cycles versus courses
If a treatment is intended to be given more than once, we use the term cycle. If the treatment is intended to be given once (but could still be repeated, such as with certain AML induction regimens), we use the term course.
Parts and portions
If a reference reports on a multi-part regimen, we take one of two approaches.
Portions
If the regimen is clearly of limited duration and meant to be given as a "package" we include all of the information in one place. Here are two examples:
- AC-T for the adjuvant treatment of breast cancer
- R-Hyper-CVAD alternating with R-MTX-Ara-C in the upfront treatment of mantle cell lymphoma
For these types of regimens, we term the individual sections of the "package" as portions. Note that the first example is a sequential regimen, whereas the second example is an alternating regimen. There are several rare examples of hybrid regimens that are both sequential and alternating, in which case we do our best to explain the pattern in the notes, e.g., "AABAAB" pattern. In order to clearly delineate the portions, we use the following general format:
Chemotherapy, AC portion (cycles 1 to 4)
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
Chemotherapy, T portion (cycles 5 to 16)
- Paclitaxel (Taxol) 80 mg/m2 IV once on day 1
21-day cycle for 4 cycles, then 7-day cycle for 12 cycles (AC x 4; T x 12)
Parts
In other situations, there are clear separations between the phases of treatment. For example, the AIDA 2000 regimen to treat acute promyelocytic leukemia has an induction phase, a three-part consolidation phase, and a maintenance phase. In this example, each part is linked together but are kept separate on the regimen page. There are often criteria to move from one part to another part of a multiphase protocol like AIDA 2000, such as achieving a certain level of disease response.
If the entirety of the protocol is clearly better represented as one unit, which is often the case in many pediatric treatment protocols, we use the additional enclosing box as shown above, and repeated here:
The entire protocol is wrapped in a box. At the top of the box is a study table with details about the studies that evaluated the regimen.
Each phase of the protocol is contained within a box.
Treatment details and the other sections appear the same from here.
Here's an example of another box, say the consolidation phase of a protocol.
Treatment details for this consolidation phase are shown here.
And then you might have a maintenance phase.
Treatment details for this maintenance phase are shown here.
References
Finally, we include all of the original references, in chronological order, that we have used to populate the regimen information. These are listed in PubMed style, and include links to the original article (which is often not free to access), the free PubMed Central article (if available), and the PubMed citation. Many references also include one of the following annotations:
- contains dosing details in manuscript: a contributor has reviewed the original article for accuracy of content
- contains dosing details in abstract: a contributor was able to review the abstract, but not the original article
- does not contain dosing details: a contributor has reviewed the original article and determined that it does NOT contain the protocol
- contains dosing details in supplement: a contributor has reviewed the original article and determined that the protocol is available, but not in the body of the manuscript; when possible, links to the supplement are also provided
If none of these statements are present, please be aware that the information present may not be wholly accurate or complete. Of course, the standard disclaimer always applies!
Updates and subgroup analyses
When a trial has updated results and/or a subsequent subgroup analysis, we nest the reference(s) underneath the original reference. Example:
- BIG 1-98: 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; BIG. 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: Mouridsen H, Giobbie-Hurder A, Goldhirsch A, Thürlimann B, Paridaens R, Smith I, Mauriac L, Forbes J, Price KN, Regan MM, Gelber RD, Coates AS; BIG 1-98 Collaborative Group. Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med. 2009 Aug 20;361(8):766-76. link to original article link to PMC 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
- Update: Ruhstaller T, Giobbie-Hurder A, Colleoni M, Jensen MB, Ejlertsen B, de Azambuja E, Neven P, Láng I, Jakobsen EH, Gladieff L, Bonnefoi H, Harvey VJ, Spazzapan S, Tondini C, Del Mastro L, Veyret C, Simoncini E, Gianni L, Rochlitz C, Kralidis E, Zaman K, Jassem J, Piccart-Gebhart M, Di Leo A, Gelber RD, Coates AS, Goldhirsch A, Thürlimann B, Regan MM; members of the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group. Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial. J Clin Oncol. 2019 Jan 10;37(2):105-114. Epub 2018 Nov 26. link to original article link to PMC article PubMed
Abstracts
We occasionally add regimens based on abstract presentations, before a manuscript has been published. In these cases we clearly label the reference with Abstract:. Additionally, once (if) a manuscript is published we replace the abstract reference with the published reference. If you are curious, we do preserve these abstract references as hidden fields, which can be seen using the view source option at the top of each wiki page.
Response criteria
Many diseases on HemOnc.org have specific response criteria, such as the IMWG international uniform response criteria for multiple myeloma. For these pages, we have a section on response criteria; we also have a dedicated page describing response to treatment in the categories of strong endpoints (e.g., overall survival, intermediate surrogate endpoints (e.g., time-based endpoints such as progression-free survival), and weak surrogate endpoints (e.g., response-based endpoints such as overall response rate).
Prognosis
As with response criteria, many diseases on HemOnc.org have specific prognostic score or calculators, which we have slowly been adding. For example, the multiple myeloma page has five different prognostic scores.
External links
Some of the disease-specific regimen pages have additional links to external sites that we think are useful. You can also find a large number of external links here.
Drug index
Beyond the main page and the disease-specific regimen pages, you may want to visit our drug index page, which is accessible at any time through the top of the left sidebar. This page is pretty self-explanatory but there are a few nuances you may be interested in:
Alphabetical list of drugs
Here, we list drugs alphabetically by their generic name. For all approved drugs, we also include their brand name (if there is more than one brand name we try to choose the most recognizable, with a somewhat US-centric bias). Drugs that are under study are labeled in clinical trials. If a drug has been approved in the current or previous calendar year, we list the details right next to the drug, e.g. FDA approved 2022-12-12. You will probably notice quickly that there are a fair number of red links, which means that the linked page does not yet exist. Help make it happen by contributing!
Drugs by category
Here, we list drugs under a number of different categories. A drug can, of course, be listed under many different categories. For instance, most drugs are categorized by at a minimum their route(s) of delivery, mechanism(s) of action, the diseases for which they are used, and the year in which they were approved. See Individual drug pages for more details.
Interesting and helpful links
As the name says, these links are placed here because they have directly relevance to drugs, e.g. the ASCO-ONS Standards for Safe Chemotherapy Administration
Individual drug pages
As with the chemotherapy regimens, we try to use a predictable style across all individual drug pages. They are sectioned as follows:
General information
Here, we provide a description of the mechanism of action (if known), as well as the route(s) of drug delivery and any other important information, such as links to REMS programs. For conciseness and simplicity, HemOnc.org currently focuses on treatment regimens and not 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 or the prescribing information. For most antineoplastics, we provide links to the package insert provided by the manufacturer, as well as a locally-hosted backup.
Diseases for which it is established (work in progress)
These are the specific conditions for which a fairly high bar of efficacy has been demonstrated, generally through one of the following:
- The drug was a component of a comparator arm of a phase 3 RCT unless it was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.
- The drug was used in a registration study cited in a regular (not accelerated) approval by the FDA or EMA
- The drug was a component of an experimental arm that demonstrated PFS/OS superiority or non-inferiority in a phase 3 RCT
Note: this is a new classification as of 2022 and is a work in progress!
Diseases for which it is used
These are the specific conditions for which some degree of efficacy has been demonstrated. This is NOT the same as saying that the drug is FDA-approved or even on an approved compendium listing; we are merely stating that there is some evidence to support efficacy, as defined by our eligibility criteria. These links will take you to the respective treatment regimen page.
Preliminary results
If a drug is still in clinical trials, instead of the "diseases for which it is used" heading, we list preliminary results, if they merit inclusion as defined by our eligibility criteria. For example, the drug afuresertib (GSK-2110183) has preliminary data for multiple myeloma. If and when these drugs are approved, we replace this heading and move the regimen references to the appropriate page(s).
Patient drug information
As indicated, these links are meant to be useful for patients.
History of changes in [Regulator] indication
Here we try to include, at a minimum, the initial date of regulatory approval for a cancer-related or hematologic indication. When the information is available from the regulator, we also include the specific language regarding the approval; this is quite hard to locate for some of the older drugs and for some regulators such as NMPA. We also do our best to update this list with new indications in near-real-time, for FDA. We are piloting a monthly update for EMA indications, as well.
Also known as
Here we provide synonyms, which can be only a few or sometimes hundreds, as is the case for dexamethasone. We try to include the original coded designators here, since these are often used colloquially for many years after a drug is approved (e.g. "CPT-11" is still in the vernacular). If you notice that a coded name or other synonym seems to be missing, this is an easy and impactful area for you to contribute to.
References
Self-explanatory
Categories
At the bottom of each drug page, there is a list of any number of categories that the drug has been assigned to. By clicking on one of these categories, you can easily move from a drug page to a list of similar drugs in the class, or a list of drugs approved in the same year, etc. These categories also parallel the drugs by category on the main drug index page.
Search box
There is a search box in the upper right hand corner of every page. If you are looking for something on the site, a good way to start is by typing in some search terms and either pressing enter on your keyboard or clicking the magnifying glass. If there is a page which exactly matches what you've typed in, that will automatically show up, and you can go directly to that page by clicking on the name.
Ontology
If you've gotten this far in the tutorial, congratulations! You're almost done. In the summer of 2017, we began the process of converting portions of the HemOnc.org website content into a formal ontology, along with some additional external information such as RxNorm identifiers. You are welcome to learn more and get access to the ontology at this page.