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

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
BIO-SMOSMO activating mutation — activates HH pathway downstream of PTCH1; all BCC harbors HH pathway activation; biomarker testing not required for clinical eligibility; SMO mutation identifies HH pathway driverIA
  • SRC-NCCN-SKIN-2025: Level Category 1 (Supports, Sensitivity/Response)
  • SRC-ESMO-SARCOMA-2024: Level A (Supports, Sensitivity/Response)
Hedgehog (HH) pathway inhibitors — vismodegib (Erivedge, FDA 2012) and sonidegib (Odomzo, FDA 2015) — are approved for locally advanced BCC (laBCC) not amenable to surgery/radiation, and metastatic BCC (mBCC). Both are SMO antagonists; all BCC harbors HH pathway activation (PTCH1 loss ~90%, SMO mutation ~10–20%), so biomarker testing is not required for clinical eligibility. Key efficacy data: Vismodegib (ERIVANCE, Sekulic et al. NEJM 2012): laBCC ORR 43% (CR 13%), mBCC ORR 30%; mDOR ~7.6 months; CR in laBCC can be durable and enable resection. Sonidegib (BOLT, Migden et al. Lancet Oncol 2015): laBCC ORR 58% (200 mg arm); mBCC ORR 17%. Comparable efficacy; different toxicity profile. Cemiplimab (anti-PD-1, FDA 2021) is approved for laBCC/mBCC after HHI failure or in patients where HHI is not appropriate. SMO secondary mutations (D473H most common) drive acquired HHI resistance — clinical crossover between agents has limited efficacy.vismodegib 150 mg PO QD (continuous; break after 24 weeks if CR/near-CR to reduce cumulative toxicity; MIKIE study)
sonidegib 200 mg PO QD with food (preferred over 800 mg arm — similar efficacy, less toxicity)
cemiplimab 350 mg IV q3w — post-HHI progression or HHI-inappropriate patients
  • SRC-NCCN-SKIN-2025
  • SRC-ESMO-SARCOMA-2024

Treatment options (2 tracks)

Standard plan
★ DEFAULT
Indication
IND-BCC-1L-VISMODEGIB
Regimen
Vismodegib monotherapy (locally advanced / metastatic BCC)
Drugs + NSZU
  • Vismodegib (DRUG-VISMODEGIB) 150 mg PO once daily, with or without food · Continuous until progression or unacceptable toxicity · PO ✗ Not registered in UA
Reason
Engine default per algorithm ALGO-BCC-1L: {'step': 2, 'outcome': False, 'branch': {'result': 'IND-BCC-1L-VISMODEGIB'}, 'fired_red_flags': [], 'winner_red_flag': None}
Aggressive plan
Indication
IND-BCC-1L-SONIDEGIB
Regimen
Sonidegib monotherapy (locally advanced BCC)
Drugs + NSZU
  • Sonidegib (DRUG-SONIDEGIB) 200 mg PO once daily on an empty stomach (≥1 h before or ≥2 h after food) · Continuous until progression or unacceptable toxicity · PO ✗ Not registered in UA
Reason
Alternative track presented for HCP consideration

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks
IDNamePriorityCategoryWhere to orderNeeded for
TEST-EXCISIONAL-SKIN-BIOPSYExcisional skin biopsyCriticalhistology—all tracks
TEST-PREGNANCYBeta-HCGCriticallab—all tracks

What NOT to do

Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Standard plan (IND-BCC-1L-VISMODEGIB)
  • Do NOT prescribe during pregnancy — severe embryo-fetal toxicity (teratogenicity, Black Box Warning)
  • Do NOT use for BCC amenable to surgery or radiation — systemic therapy only for laBCC/mBCC
  • Do NOT skip pregnancy prevention — two contraceptive methods required throughout + 24 months post-dose in females
  • Do NOT combine with strong P-gp inhibitors without monitoring
Aggressive plan (IND-BCC-1L-SONIDEGIB)
  • Do NOT prescribe for metastatic BCC — FDA approval is laBCC only
  • Do NOT prescribe during pregnancy — Black Box Warning teratogenicity
  • Do NOT ignore CK — monitor if muscle symptoms (rhabdomyolysis risk)
  • Do NOT prescribe without contraception — 20 months post-dose contraception required for females

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Vismodegib monotherapy (locall
28-day cycles × Continuous until progression

Aggressive plan

Induction · Sonidegib monotherapy (locally
28-day cycles × Continuous until progression

MDT brief

Skills (recommended) — for consideration (2)

  • Clinical pharmacist recommended
    Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
    skill: clinical_pharmacistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD
  • 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

Open questions (1, 0 blocking)

  • OQ-LDH-CURRENT
    What is the current LDH? Marker of tumor burden and transformation.
    LDH is part of the prognostic indices of indolent lymphomas.
    → hematologist

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)

Last synced: 2026-05-04 · ctgov.

No active trials matched this scenario in ctgov.

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
Vismodegib monotherapy (locally advanced / metastatic BCC) (REG-VISMODEGIB-BCC)
1/1 component drug(s) not registered in Ukraine +1
✗ not registered✗ out-of-pocket₴-? — verify pathwaynot recorded
Aggressive plan
Sonidegib monotherapy (locally advanced BCC) (REG-SONIDEGIB-BCC)
1/1 component drug(s) not registered in Ukraine +1
✗ not registered✗ out-of-pocket₴-? — verify pathwaynot recorded

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

plan_id: PLAN-BMA-SMO_BCC-V1 | version: 1 | generated: 2026-05-04T14:13:16.660155+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.