Kaposi Sarcoma

Archetype F 28 regimens (Main Regimens) kaposi

HHV-8 associated, classic, endemic, and iatrogenic KS

Clinical FeaturesClick to collapse

Typical Presentation

Kaposi sarcoma (KS) is a multifocal malignancy of endothelial cells that presents with characteristic purpuric, red, or brown macules, papules, and plaques. Four types are described: HIV-associated (epidemic), classic, iatrogenic (transplant-associated), and endemic [1]. Classic KS generally involves indolent cutaneous lesions, often of the lower extremities, which may wax and wane or slowly progress over years to decades; it is most common in people of Mediterranean, Eastern European, Middle Eastern, and/or Jewish origins, with a mean age of 74 years at diagnosis and a male-to-female ratio of 7–15:1 [1,3]. HIV-associated KS, when immunosuppression is advanced, is more aggressive and more likely to involve viscera, mucosa, and lymph nodes and to cause lymphedema; however, it can also occur in PWH with normal CD4+ counts and undetectable HIV viral load, typically with more limited disease [MS-3]. Endemic KS occurs in children and younger adults (<40 years) of equatorial Africa, is more aggressive than classic KS, and may involve viscera, bone, and/or lymph nodes, with a male predominance of 10–17:1 [1]. Iatrogenic KS appears 2–8 months after initiation of immunosuppressive therapy (e.g., for organ transplant or other reasons), is 2–3 times more common in males, and can be aggressive but often responds to cessation or reduction of immunosuppression [1]. Lymphedema is a common complication and may also be a predisposing factor; it can be caused by nodal involvement or involvement of lymphatic vessels [MS-6]. Hyperkeratotic variants with verrucous changes are notably associated with chronic and severe KS-associated lymphedema [MS-6].

Symptoms

Universal in cutaneous presentations; variable distribution.
Cutaneous lesions

Painless or sometimes pruritic purpuric, red, or brown macules, papules, plaques, nodules (sometimes pedunculated), and bullae. Large plaques may form from coalescence of smaller plaques or nodules and may ulcerate or develop bullae.

Common in advanced disease; may be presenting symptom.
Lymphedema

Swelling of extremities, often lower limbs, due to lymphatic involvement. Associated with increased risk of cellulitis and deep tissue infections.

Common in HIV-associated KS; minimal oral disease (non-nodular confined to palate) is T0, extensive oral is T1.
Oral lesions

Purple or red macules, plaques, or nodules on the palate, gingiva, or tongue. May cause pain, bleeding, or difficulty eating.

More common in advanced immunosuppression; GI and pulmonary are T1 criteria.
Visceral involvement

Gastrointestinal (GI) KS may cause nausea, vomiting, abdominal pain, melena, or blood in stool. Pulmonary KS may cause dyspnea, cough, hemoptysis. Nodal KS may cause lymphadenopathy.

Variable; when present, should prompt workup for KICS/MCD.
Constitutional symptoms

Fever, night sweats, weight loss, fatigue – may indicate KSHV-associated inflammatory cytokine syndrome (KICS) or multicentric Castleman disease (MCD).

Signs

Present in the vast majority of cases.
Skin lesions

Purpuric, red, or brown macules, papules, plaques, nodules. Hyperpigmented macules (lacking palpable change) are common after regression due to residual hemosiderin pigmentation (not active disease). Histologic subtypes include anaplastic, telangiectatic, lymphedematous, hyperkeratotic, keloidal, micronodular, pyogenic granuloma-like, ecchymotic, and intravascular variants [MS-6].

Common in HIV-associated KS.
Oral lesions

Located on palate, gingiva, buccal mucosa, tongue. May be nodular or plaque-like.

Frequent in advanced disease.
Lymphedema

Pitting or non-pitting edema of extremities, often unilateral or asymmetric. Hyperkeratotic changes may accompany chronic lymphedema.

Present in nodal disease; may also occur with MCD/KICS.
Lymphadenopathy

Palpable lymph nodes, often in cervical, axillary, or inguinal regions. May be bulky.

Less common but important in advanced disease.
Visceral signs

Hepatosplenomegaly, ascites, pleural effusion, pulmonary rales, or signs of GI bleeding.

Red FlagsClick to collapse

InvestigationsClick to collapse

Diagnostic

Biopsy (skin punch, incisional, or excisional) with histopathology review by pathologist with expertise in KS

Gold standard for diagnosis. Adequate tissue and immunophenotyping required.

Immunohistochemistry panel: KSHV (HHV-8) LANA-1

Essential to confirm diagnosis; KSHV infection present in 95–98% of KS [2,3].

IHC: CD31 and CD34 (if unclear vascular origin)

Useful in certain circumstances to confirm vascular origin when morphology is ambiguous.

Biopsy of nodal or visceral sites (if coexisting disorder suspected)

Encouraged if infection, lymphoma, or MCD is suspected.

Cytology and flow cytometry of effusion fluid (if present)

To evaluate for coexisting primary effusion lymphoma (PEL).

Staging

History and physical examination (complete skin, oral, lymph node exams; evaluation of edema)

Essential for staging and assessment of disease extent.

Photography of oral, conjunctival, and cutaneous lesions (with reference unit of measure)

For evaluation and monitoring of extent of disease over time.

Complete blood count (CBC) with differential and comprehensive metabolic panel (CMP)

Baseline assessment for cytopenias, organ function, and monitoring during therapy.

HIV screening and diagnostic testing (if not known HIV-positive)

Essential to identify HIV-associated KS; all KS patients should be tested.

CD4+ T-cell count and HIV viral load (if HIV-positive)

Assess immune function and HIV control; staging I0/I1 based on CD4 count.

Pregnancy testing (if chemotherapy or RT planned and patient of childbearing potential)

To avoid harm to fetus from anticancer therapy.

Stool hemoccult and/or chest x-ray (as clinically indicated, e.g., advanced disease)

Screen for occult GI bleeding or pulmonary involvement.

Chest CT with contrast and bronchoscopy (if unexplained pulmonary symptoms or abnormal chest x-ray)

Evaluate for pulmonary KS or opportunistic infections.

Abdomen/pelvis CT with contrast or MRI with and without contrast and EGD/colonoscopy (if GI symptoms or positive hemoccult)

Evaluate for GI KS or other pathology.

CT scan or FDG-PET/CT scan and/or lab workup (if concerns for coexisting KICS, MCD, or KSHV+ lymphoma)

Detect hypermetabolic lymphadenopathy or visceral involvement; FDG-PET/CT can assess whole-body disease.

Transthoracic echocardiogram (if anthracycline planned or suspected pericardial effusion)

Assess baseline cardiac function; monitor for cardiotoxicity.

Biopsy of lymphadenopathy (excisional preferred)

To differentiate MCD (requires histology) from KS nodal involvement or other diagnoses.

Biomarkers

C-reactive protein (CRP)

Marker of inflammation; useful when KICS or MCD suspected.

KSHV serum viral load

Elevated during flares of MCD (≥4 log) and KICS; undetectable/low during remissions.

Serum protein electrophoresis (SPEP)

Evaluate for paraproteinemia associated with MCD.

Interleukin-6 (IL-6) and/or IL-10

Cytokines driving inflammation in KICS/MCD.

StagingClick to collapse

AIDS Clinical Trials Group (ACTG) TIS staging system adapted from Krown SE, Metroka C, Wernz JC. J Clin Oncol 1989;7:1201-1207 [KS-A 1 of 2].

T Categories

StageDescription
T0 (Good risk)Tumor confined to skin and/or lymph nodes and/or minimal oral disease (non-nodular KS confined to palate).
T1 (Poor risk)Tumor-associated edema or ulceration; extensive oral KS; gastrointestinal KS; KS in organs other than lymph nodes.

Stage Groupings

GroupCriteriaClinical MeaningFive Yr SurvivalTreatment Intent
T0I0S0T0 + CD4 ≥150/μL + no history of OI/thrush, no B symptoms, KPS ≥70.Good risk in all three categories. Best prognosis.Approximately 88% 3-year survival (Nasti et al., 2003) [MS-7].Limited cutaneous disease: observation with ART for PWH; local therapy if symptomatic.
T1I0S0T1 (any poor risk tumor factor) but good immune and systemic status.Advanced disease by tumor criteria but preserved immune function and no systemic illness. 3-year survival 80% [MS-7].80% 3-year survival.Systemic therapy with ART for PWH.
T0I1S0Good tumor but CD4 <150/μL.Poor immune status may increase risk of progression and IRIS.81% 3-year survival [MS-7].ART optimization; may need systemic therapy if progressive or symptomatic.
T1S1 (any I)T1 + S1 (history of OI/thrush, B symptoms, KPS <70, or other HIV-related illness). Often also I1.Worst prognosis group; combined poor tumor and systemic status. Median survival significantly reduced.53% 3-year survival [MS-7].Immediate systemic therapy with ART for PWH; supportive care for medical optimization.
T0S0 (any I)Good tumor and systemic status regardless of CD4 (I stage less prognostic on ART).Limited disease; good prognosis.88% 3-year survival [MS-7].Observation or local therapy; ART for PWH.

Staging Pearls

  • I stage (CD4 count) has less prognostic value than T or S stages in patients on ART [KS-A 1 of 2, MS-7].
  • T1S1 confers the worst prognosis: 3-year survival 53% vs. 88% for T0S0 [MS-7].
  • Management is primarily stratified by limited cutaneous vs. advanced disease (T1, extensive T0 cutaneous, or nodal disease) [KS-1 footnote e].
  • B symptoms defined as unexplained fever, night sweats, >10% involuntary weight loss, or diarrhea persisting >2 weeks [KS-A 1 of 2].
  • Response criteria (ACTG) define CR as absence of detectable disease including tumor-associated edema for ≥4 weeks; PR requires ≥50% decrease in lesions or flattening of ≥50% raised lesions [KS-A 2 of 2].
  • Residual hyperpigmented macules after treatment represent hemosiderin 'tattoo' effect, not active disease; biopsy may show siderophages without tumor cells [MS-8].

Management PrinciplesClick to collapse

Kaposi sarcoma (KS) is a multifocal malignancy of endothelial cells universally associated with KSHV infection. Four types exist: HIV-associated, classic, iatrogenic/transplant-associated, and endemic. Immunosuppression is a key pathogenic factor. Treatment philosophy focuses on disease control rather than cure, as KSHV persists lifelong and individual lesions may represent distinct clones. Management emphasizes optimization of immune function, avoidance of additional immunosuppression (especially glucocorticoids in any formulation), and use of the least toxic therapy appropriate to disease extent. Complete remissions are rare in advanced disease; goals are symptom reduction, reversal of lymphedema, and preservation of organ function.

Observation and immune optimization

PWH with asymptomatic limited cutaneous disease cosmetically acceptable; patients without HIV with asymptomatic limited disease

For PWH: start/continue ART, reassess within 4 weeks for IRIS. For non-HIV: observation until symptomatic or progressive. Remissions or stable disease may occur with ART and immune function optimization alone [KS-B; MS-10].

Minimally invasive symptom control

Patients with symptomatic or cosmetically bothersome limited cutaneous disease

Use least toxic therapy: local therapy (topical alitretinoin, intralesional vinblastine/bleomycin, cryotherapy, marginal excision, electrodessication and curettage), RT, or limited cycles (3-6) of systemic therapy. For PWH, concurrent ART is critical. A limited number of systemic therapy cycles may be sufficient for those initiating or re-initiating ART [KS-2; KS-B].

Systemic disease control

Patients with advanced symptomatic disease (T1, extensive T0, nodal, visceral)

Systemic therapy is first-line (preferred: liposomal doxorubicin for non-transplant KS; paclitaxel as other recommended; sirolimus for transplant KS). RT reserved when systemic therapy not feasible. For PWH, ART must be continued/initiated. Goals: reduce/reverse symptoms, lymphedema, organ threat. Treatment continues until unacceptable toxicity or plateau; no maintenance beyond 2 cycles after plateau [KS-3; KS-B].

KICS management

Patients with KSHV-associated inflammatory cytokine syndrome (KICS)

First-line: liposomal doxorubicin + rituximab (preferred) or alternative KS-directed therapy + rituximab. In mild cases, KS-directed therapy alone may suffice. For transplant recipients, maximize sirolimus and minimize other immunosuppression. Refractory: add anti-IL-6 therapy (tocilizumab or siltuximab). Continue KS-directed therapy for ≥3 months after stopping rituximab [KICS-1].

Co-management by oncology and HIV specialists is recommended for the duration of therapy. Oncology and HIV pharmacists should review proposed cancer therapy, supportive care, and ART for DDIs and overlapping toxicities. Involvement of dermatology, medical oncology, hematology, and primary HIV care is appropriate during surveillance. Lymphedema specialist referral is recommended for patients with lymphedema. Collaboration with a pharmacist regarding immunosuppression options is advised for patients requiring immunosuppression [KS-B; KS-4; KS-1].

Performance status (Karnofsky) is part of the TIS staging system (S0 ≥70, S1 <70). For advanced disease, if poor performance status is due to KS itself, systemic therapy should be considered as it may improve performance status. If performance status precludes upfront chemotherapy, reversible medical issues (active infection, high HIV viremia) should be addressed to enable systemic therapy. RT or best supportive care may be used if performance status remains poor [KS-3; KS-A 1 of 2].

Management PathwaysClick to collapse

Limited Cutaneous KS – Asymptomatic and Cosmetically Acceptable

Branching: HIV status, Symptom status, Cosmetic acceptability

PWH: Asymptomatic, cosmetically acceptable limited cutaneous disease
Observe and start or continue ART (recommended)
Non-HIV: Asymptomatic, cosmetically acceptable limited cutaneous disease
Observe (recommended)
Limited Cutaneous KS – Symptomatic and/or Cosmetically Bothersome

Branching: HIV status, Previous therapy response

Symptomatic and/or cosmetically bothersome limited cutaneous disease (any HIV status)
Local therapy (topical alitretinoin, imiquimod, cryotherapy, marginal excision, electrodessication and curettage, intralesional vinblastine/bleomycin) (appropriate); RT (appropriate); Systemic therapy (limited cycles, 3-6) (appropriate); Clinical trial (appropriate)
For PWH: ART must be started/continued. Initiation of ART may cause IRIS; systemic KS therapy should be started as soon as possible in symptomatic patients. ART should not be delayed. Avoid glucocorticoids [KS-2; KS-C].
After first-line therapy: stable disease or response
Observe and continue ART for PWH (recommended)
After first-line therapy: progressive, relapsed, or refractory disease (limited cutaneous or advanced)
Consider biopsy to confirm KS vs post-inflammatory pigment (recommended); Relapsed/refractory therapy (see systemic therapy pathway) (appropriate)
Advanced Cutaneous, Oral, Visceral, or Nodal KS

Branching: Eligibility for systemic therapy, HIV status, Response to therapy

Eligible for systemic therapy
Systemic therapy (first-line) (preferred); Clinical trial (appropriate)
For PWH: initiate or continue ART. Avoid glucocorticoids. Co-management with HIV specialist. Reassess within 4 weeks if on ART alone (but systemic therapy should be started as soon as possible for symptomatic advanced disease) [KS-3; KS-B].
Not immediately eligible for systemic therapy
Medical optimization (recommended); RT (appropriate)
For PWH: continue or initiate ART. Reassess eligibility for systemic therapy after medical optimization.
After first-line systemic therapy: response or stable disease
Observe and continue ART for PWH (recommended)
After first-line systemic therapy: progressive disease or relapsed after response
Relapsed/refractory systemic therapy (recommended); RT (appropriate); Clinical trial (appropriate)
For PWH: continue ART. Evaluate for inadequate HIV control. Consider biopsy to rule out mimickers. Ipilimumab+nivolumab should not be used in patients with MCD or KICS; use ICIs with caution if history of KSHV-associated diseases [KS-F 3 of 4].
KSHV-Associated Inflammatory Cytokine Syndrome (KICS)

Branching: Severity, Transplant status, Response to initial therapy

All patients with KICS (diagnosis requires exclusion of MCD and lymphoma by excisional lymph node biopsy if feasible)
Preferred: Liposomal Doxorubicin + Rituximab (preferred); Other recommended: Alternative KS-directed systemic therapy + Rituximab (other_recommended)
Refractory/progressive disease after initial therapy
Add anti-IL-6 directed therapy (Tocilizumab or Siltuximab) (recommended)
After response: inflammatory symptoms/lab markers improve
Withhold rituximab while continuing KS-directed therapy for ≥3 months or until adequate KS response (recommended)

Pretreatment EvaluationClick to collapse

Essential
History and physical examination
Include complete skin, oral, lymph node examinations; evaluation of edema; history of additional immunosuppressive disease or immunomodulatory therapy (e.g., transplant, local or systemic corticosteroids).
CBC with differential and comprehensive metabolic panel
Obtain baseline blood work.
HIV screening and/or diagnostic testing
For all patients to confirm HIV status.
Photography of oral, conjunctival, and cutaneous lesions (with reference unit of measure)
For evaluation and monitoring of extent of disease.
Pathology review
Review of adequate slides from paraffin block representative of tumor by pathologist with expertise in KS. Immunohistochemistry panel: KSHV (HHV-8) LANA-1. Rebiopsy if non-diagnostic.
For PWH: T-cell subsets and HIV viral load
All HIV-seropositive patients should have recent CD4+ count and HIV viral load. Involvement of HIV specialist for OI evaluation appropriate, especially with advanced immunosuppression.
Discuss ART for PWH
Begin discussions regarding possible need to modify ART due to DDIs; involve HIV specialist. Co-management by oncologist and HIV clinician recommended for duration of therapy.
Distress screening
Refer to NCCN Distress Thermometer and Problem List, including social determinants of health (see NCCN Guidelines for Distress Management).
Useful in Selected Cases
Pregnancy testing
In patients of childbearing potential if chemotherapy or RT planned.
Evaluation for suspected OIs
Involve HIV specialist as needed.
Stool hemoccult and/or chest x-ray as clinically indicated
For advanced disease (e.g., advanced cutaneous, oral, visceral, or nodal involvement).
Chest CT with contrast and bronchoscopy
If unexplained pulmonary symptoms or abnormalities on chest x-ray.
Abdomen/pelvis CT with contrast or MRI with and without contrast and EGD/colonoscopy
If GI symptoms or positive hemoccult.
Imaging and lab workup for coexisting KICS, MCD, or KSHV+ lymphoma
CT scan or FDG-PET/CT scan and/or lab workup (C-reactive protein, KSHV serum viral load, SPEP, IL-6, IL-10) if clinical features (fever, dyspnea, effusions) suggesting KICS or KSHV-associated MCD.
Transthoracic echocardiogram
If anthracycline planned or suspected pericardial effusion.
Additional biopsy of nodal or visceral sites
If coexisting disorder suspected (infection, lymphoma, MCD).
Cytology and flow cytometry of effusion fluid
Encourage if present to evaluate for coexisting PEL.

SurgeryClick to collapse

Limited role; used for local control of small, symptomatic lesions in patients with limited cutaneous disease. Wide excision with negative margins is not indicated as it does not prevent new lesions. For larger lesions, radiotherapy is preferred over excision when systemic therapy is not feasible.

Marginal excision is appropriate for small lesions; wide excision is not indicated.

Surgery does not prevent occurrence of future lesions because individual KS lesions are distinct clones arising from immunosuppression and KSHV persistence.

Electrodesiccation and curettage may be considered for small lesions.

For plantar and palmar surfaces, excision or intralesional chemotherapy should be approached with caution due to toxicity and functional concerns.

Procedures

Marginal excision

Local control of small, symptomatic lesions in limited cutaneous disease.

Electrodesiccation and curettage

Small, symptomatic lesions.

Radiation TherapyClick to collapse

Used for limited cutaneous disease that is symptomatic/cosmetically bothersome, and for palliation in advanced disease when systemic therapy is not feasible. Also for relapsed/refractory disease. RT is radioresponsive with CR rates 60-93%. Systemic therapy is preferred over RT for first-line and relapsed/refractory disseminated disease whenever feasible.

Principles

  • For most skin lesions, electrons or superficial x-rays achieve optimal dosimetry. For deeper/larger lesions, IMRT with or without image guidance may be useful.
  • Bolus may be necessary for adequate skin dose.
  • Caution with plantar/palmar surfaces; high doses may impair wound healing, especially with lymphedema.
  • Risk of secondary cancer, severe/worsening lymphedema, and long-term wound healing complications; mitigate with lower-dose regimens.
  • For advanced cutaneous disease, RT reserved for when systemic therapy not feasible, goal palliation or short-term disease management until systemic therapy can be delivered.
  • Treatment responses may be delayed in significant lymphedema.

Dose Frameworks

NameTotal DoseDose Per FractionFractionsScheduleIndication
Single fraction6-8 Gy6-8 Gy1Single fractionSmall, superficial lesions; palliative situations.
Hypofractionated20 Gy4 Gy5Daily fractionsEffective for KS; equivalent to 24 Gy/12 fractions.
Standard fractionation (1)24 Gy2 Gy12Daily fractionsStandard regimen.
Standard fractionation (2)30 Gy2-3 Gy10-15Daily fractionsMore extensive or deeply invasive lesions; durable local response desired.
Extended fractionation40 Gy2 Gy20Daily fractionsWhen more durable response needed; may be used for oral cavity with adjacent radiosensitive structures.

Approaches

NameDose FractionationConcurrent ChemotherapyIndicationKey TrialToxicities
Electron or superficial x-ray therapyAny of the above regimens depending on indicationNot typically given concurrently; sequential if needed.Most skin lesions; minimize dose to underlying structures.Singh NB et al. Radiother Oncol 2008;88:211-216 [KS-E reference 1]Dermatitis, oral mucositis, lymphedema exacerbation, long-term wound healing issues, secondary cancer risk. Risk increased with pre-existing lymphedema.
IMRT with or without image guidanceFractionated regimens preferred for large/deep lesions or near critical structuresNone specifiedLarger, deeper disease, or disease adjacent to critical structures.No specific trial cited; expert consensus.Same as above; potential for higher conformality reducing toxicity.

Systemic TherapyClick to collapse

Systemic therapy is the mainstay for advanced symptomatic KS and an option for limited cutaneous disease. First-line options differ by transplant status. For non-transplant KS, liposomal doxorubicin is preferred; paclitaxel is other recommended. For transplant KS, sirolimus alone may be sufficient; liposomal doxorubicin and paclitaxel are other recommended. After first-line failure, subsequent options include nivolumab, pembrolizumab, pomalidomide (preferred); and in certain circumstances: albumin-bound paclitaxel, bortezomib, etoposide, gemcitabine, imatinib, ipilimumab+nivolumab, lenalidomide, sirolimus (transplant), thalidomide (IRIS), vinorelbine. Corticosteroid pre-medication should generally be avoided except for prior reaction. An FDA-approved biosimilar is appropriate substitute for any recommended biologic. ICIs should not be used in MCD or KICS; use with caution if history of KSHV-associated diseases.

First-line – non-transplant KS (limited or advanced)
Superior response rates over combination chemotherapy in randomized trials (46% vs 25%; 59% vs 23%) [KS-F references; MS-13]. Lower toxicity compared to ABV or BV.
Preferred: Liposomal Doxorubicin
First-line – transplant KS
Switching immunosuppression to sirolimus can lead to complete remission of KS lesions; avoids systemic chemotherapy in many cases. Systemic therapy can be added for aggressive disease.
Preferred: Sirolimus
Relapsed/refractory after first-line – if durable response (≥3 months) to first-line
If tolerated and response was durable, retreatment is reasonable.
Preferred: Repeat first-line regimen
Relapsed/refractory after first-line – if no response or progression on first-line
If both first-line options exhausted, proceed to subsequent therapy.
Preferred: Alternate first-line regimen
KICS – initial therapy
Standard for KICS based on expert consensus and parallels MCD management.
Preferred: Liposomal Doxorubicin + Rituximab
KICS – refractory
Anti-IL-6 agents are effective for KSHV-associated MCD and may benefit KICS.
Preferred: Add anti-IL-6 therapy (Tocilizumab or Siltuximab) to KS-directed therapy

Key Regimens

Liposomal Doxorubicin
Liposomal Doxorubicin 20 mg/m2 IV Every 2 to 3 weeks
Paclitaxel (weekly)
Paclitaxel 60 mg/m2 IV Weekly
Paclitaxel (every 2 weeks)
Paclitaxel 100 mg/m2 IV Every 2 weeks
Paclitaxel (every 3 weeks)
Paclitaxel 135 mg/m2 IV Every 3 weeks
Sirolimus (for transplant KS)
Sirolimus Loading dose 0.15 mg/kg PO followed by 0.04-0.06 mg/kg/day to maintain trough 6-10 ng/mL, or 2 mg PO daily adjusted to trough 6-10 ng/mL PO Daily
Nivolumab
Nivolumab 480 mg IV every 4 weeks Every 4 weeks
Pembrolizumab
Pembrolizumab 200 mg IV every 3 weeks for up to 6 months Every 3 weeks
Pomalidomide
Pomalidomide 4 or 5 mg/day (NCCN panel believes 4 mg is sufficient; trial used 5 mg) PO Days 1-21 of 28-day cycle
Albumin-bound Paclitaxel (if Paclitaxel intolerant)
Albumin-bound Paclitaxel 100 mg IV Days 1, 8, 15 of 28-day cycle
Bortezomib
Bortezomib 1.6 mg/m2 IV or SC Days 1, 8, 15 of 28-day cycle
Etoposide
Etoposide 50 mg/day PO for 7 days of 14-day cycle; after 2 cycles escalate to 100 mg/day if no PR/CR and no >Grade 2 toxicity; further escalate to 150 mg/day based on tolerance PO Days 1-7 of 14-day cycle
Gemcitabine
Gemcitabine 1000 mg/m2 IV Every 2 weeks or days 1 and 8 every 21 days
Imatinib
Imatinib 400 mg PO Daily
Ipilimumab + Nivolumab
Nivolumab 240 mg IV every 2 weeks IV Every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks IV Every 6 weeks
Lenalidomide
Lenalidomide 25 mg/day PO Days 1-21 of 28-day cycle
Sirolimus (for transplant KS, in relapsed/refractory setting)
Sirolimus Loading dose 0.15 mg/kg PO followed by 0.04-0.06 mg/kg/day to maintain trough 6-10 ng/mL, or 2 mg PO daily adjusted to trough 6-10 ng/mL PO Daily
Thalidomide (for patients with IRIS)
Thalidomide 200 mg/day orally (starting dose, titrated to effect and tolerability) PO Daily
Vinorelbine
Vinorelbine 30 mg/m2 IV Every 2 weeks

Treatment Response AssessmentClick to collapse

Title

Response Definitions for Kaposi Sarcoma (adapted from ACTG Oncology Committee criteria, 1989)

Timing

Response assessments should be performed after each treatment cycle or as clinically indicated. For patients on observation, reassess at intervals based on disease stability. For PWH on ART alone, reassess within 4 weeks to monitor for IRIS. Long-term surveillance is life-long.

Response Logic
  • Complete response (CR): Absence of any detectable residual disease, including tumor-associated (local) edema, persisting for at least 4 weeks. Patients with prior visceral disease should have restaging with appropriate endoscopic or radiographic procedures relevant to sites involved at baseline. Residual non-palpable macular pigmentation (hemosiderin tattooing) is not active disease.

  • Partial response (PR): No new mucocutaneous lesions, visceral sites of involvement, or appearance/worsening of tumor-associated edema or effusions; AND one of: (1) ≥50% decrease in number of all pre-existing lesions lasting ≥4 weeks; OR (2) complete flattening of ≥50% of all previously raised lesions; OR (3) ≥50% decrease in sum of products of largest perpendicular diameters of at least 5 measurable lesions. Note: If residual tumor-associated edema or effusion but otherwise meets CR criteria, classify as PR.

  • Stable disease (SD): Any response not meeting criteria for PD or PR.

  • Progressive disease (PD): >25% increase in size of pre-existing lesions and/or appearance of new lesions/sites, and/or change in character from macular to plaque-like or nodular of >25%. New or increasing tumor-associated edema or effusion constitutes PD.

Imaging Recommendations
  • Imaging should be directed by symptoms or findings concerning for visceral or bone involvement, or for coexisting KICS, MCD, or KSHV+ lymphoma. Can include whole-body FDG-PET/CT.

  • For patients with known visceral disease at baseline, appropriate endoscopic or radiographic procedures (CT, MRI, bronchoscopy, EGD, colonoscopy) should be repeated to confirm CR.

  • In patients with effusions, encourage cytology and flow cytometry to evaluate for PEL.

  • For surveillance: if signs and symptoms concerning for visceral involvement or prior to new therapy for progression/refractory disease, perform imaging as clinically indicated (chest CT with contrast, abdomen/pelvis CT or MRI, FDG-PET/CT as needed).

Biopsy Or Salvage Logic
  • If progressive, relapsed, or refractory disease suspected, consider biopsy of lesions to distinguish active KS from post-inflammatory pigment or mimickers (e.g., bacillary angiomatosis, cryptococcosis).

  • If KS confirmed, evaluate for inadequate HIV control as contributing factor; address possible change in ART with HIV specialist.

  • If after initial response, KS relapses or progresses, repeat use of previously effective therapy may be considered, particularly if response was durable (≥3 months) and well tolerated.

  • For patients on observation with rapid progression, initiate therapy as indicated per disease state.

  • In transplant KS, if sirolimus alone insufficient, add systemic therapy.

  • For KICS, if inflammatory markers flare after rituximab cessation, resume rituximab; consider repeating cytology of effusions and biopsy of lymphadenopathy if lymphoma suspected.