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OpenOnco · DIS-LAM · BIO-TSC1 (ESCAT IA)
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OpenOnco · Treatment Plan
Treatment plan — DIS-LAM
PLAN-BMA-TSC1_LAM-V1 · v1 · 2026-05-04
Patient
BMA-TSC1_LAM · Algorithm: ALGO-LAM-1L

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
BIO-TSC1TSC1 or TSC2 loss-of-function (LAM context — somatic in sporadic LAM, germline in TSC-associated LAM); mTORC1 hyperactivation is the therapeutic target regardless of TSC1 vs TSC2 specificityIA
  • SRC-MILES-MCCORMACK-2011: Level A (Supports, Sensitivity/Response)
Sirolimus (rapamycin), an mTORC1 inhibitor, is FDA-approved (May 2015) and EMA-approved (2017) for treatment of LAM in adults. MILES phase III RCT (McCormack et al., NEJM 2011): N=89 (46 sirolimus, 43 placebo); 12-month treatment + 12-month observation. Primary endpoint: FEV1 change from baseline to 12 months (mL/month rate). FEV1 slope: +1 mL/month (sirolimus) vs -12 mL/month (placebo); difference 11 mL/month (p<0.001). Secondary: FVC improvement, VEGF-D reduction, 6-min walk improvement, QoL. After 12-month observation: benefits partially lost (FEV1 decline resumes), suggesting need for continuous therapy. mTOR inhibition does not eliminate LAM cells but controls their mTORC1-driven proliferation. Everolimus is used for TSC-associated LAM and for renal angiomyolipoma (EXIST-2). VEGF-D ≥800 pg/mL is a diagnostic biomarker (non-invasive diagnosis of LAM possible in right clinical context without biopsy).sirolimus (target trough 5–15 ng/mL; start 2 mg/day PO, adjust to trough; continuous indefinitely for progressive LAM)
everolimus 10 mg PO QD (TSC-associated LAM and renal AML; EXIST-2 dosing)
  • SRC-MILES-MCCORMACK-2011

Treatment options (1 tracks)

Standard plan
★ DEFAULT
Indication
IND-LAM-1L-SIROLIMUS
Regimen
Sirolimus monotherapy (progressive LAM)
Drugs + NSZU
  • Sirolimus (DRUG-SIROLIMUS) 2 mg PO once daily initially; titrate to target trough 5–15 ng/mL · Continuous; long-term treatment; monitor trough levels · PO ⚠ Out-of-pocket
Reason
Engine default per algorithm ALGO-LAM-1L: {'step': 2, 'outcome': False, 'branch': {'result': 'IND-LAM-1L-SIROLIMUS'}, 'fired_red_flags': [], 'winner_red_flag': None}

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks
IDNamePriorityCategoryWhere to orderNeeded for
TEST-CBCComplete Blood Count with DifferentialCriticallab—all tracks
TEST-CMPComprehensive Metabolic PanelCriticallab—all tracks

What NOT to do

Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Standard plan (IND-LAM-1L-SIROLIMUS)
  • Do NOT ignore sirolimus trough level monitoring — check 1–2 weeks post dose change; target 5–15 ng/mL
  • Do NOT initiate during active infections — mTOR inhibition impairs immune defense
  • Do NOT ignore new respiratory symptoms — non-infectious pneumonitis is a class effect
  • Do NOT co-administer with grapefruit juice or strong CYP3A4 inhibitors/inducers — markedly alters drug levels
  • Do NOT use during pregnancy — teratogenicity

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Sirolimus monotherapy (progres
28-day cycles × Long-term continuous

MDT brief

Skills (recommended) — for consideration (2)

  • Molecular geneticist / molecular oncologist recommended
    Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.
    skill: molecular_geneticistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD
  • Social worker / case manager recommended
    Plan includes drugs without NSZU reimbursement — patient access pathway must be assessed.
    skill: social_worker_case_managerv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD

Skill catalog (2/16 activated in this plan)

All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).
Specialistskill_idVersionLast reviewedSign-offsDomain
Cellular therapy specialist (CAR-T)cellular_therapy_specialistv0.1.02026-04-250cellular_therapy
Clinical pharmacistclinical_pharmacistv0.1.02026-04-250clinical_pharmacy
Hematologist / oncohematologisthematologistv0.1.02026-04-250hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)hematopathologistv0.1.02026-04-250hematopathology
Infectious disease / hepatologyinfectious_disease_hepatologyv0.1.02026-04-250infectious_diseases
Medical oncologist (solid-tumor chemotherapist)medical_oncologistv0.1.02026-04-250solid_oncology
Molecular geneticist / molecular oncologistmolecular_geneticistv0.1.02026-04-250molecular_oncology
Palliative carepalliative_carev0.1.02026-04-250palliative_care
Pathologist (general)pathologistv0.1.02026-04-250pathology
Primary care / family physicianprimary_carev0.1.02026-04-250primary_care
Psycho-oncologistpsychologistv0.1.02026-04-250psychosocial
Radiation oncologistradiation_oncologistv0.1.02026-04-250radiation_oncology
Radiologistradiologistv0.1.02026-04-250diagnostic_imaging
Social worker / case managersocial_worker_case_managerv0.1.02026-04-250psychosocial
Surgical oncologistsurgical_oncologistv0.1.02026-04-250surgical_oncology
Transplant specialist (BMT)transplant_specialistv0.1.02026-04-250cellular_therapy

Sources cited

Experimental options (clinical trials)

Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-05-04.
NCTTitlePhaseStatusSponsorUAEligibility (excerpt)
NCT05676099TSC Biosample Repository and Natural History DatabaseN/ARECRUITINGNational Tuberous Sclerosis Association—

Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.

Option availability in Ukraine

Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).
OptionUA registrationNSZUCost orientationAccess pathway
Standard plan
Sirolimus monotherapy (progressive LAM) (REG-SIROLIMUS-LAM)
1/1 component drug(s) not on NSZU formulary
✓ registered✗ out-of-pocket₴-? — verify pathwaynot recorded
Trial · NCT05676099
TSC Biosample Repository and Natural History Database
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-04.

plan_id: PLAN-BMA-TSC1_LAM-V1 | version: 1 | generated: 2026-05-04T14:13:16.669956+00:00
Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.
Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.
This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.