Patient
COVERAGE-ANAL-SCC-LA-001 · Algorithm: ALGO-ANAL-SCC-1L
Clinical significance of mutations (ESCAT)
Tumor-board context — the engine does not use these tiers to rank tracks
| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|
| No clinically actionable variants matched in this profile. |
Primary current-line option
- Indication
- IND-ANAL-SCC-LA-1L-NIGRO-CRT
- Regimen
- Nigro protocol (mitomycin-C + 5-FU + RT, anal SCC)
- Drugs + NSZU
- Mitomycin C (DRUG-MITOMYCIN-C) 10–12 mg/m² IV bolus over 30 min (max single dose 20 mg) · Day 1 and Day 29 (two doses total — one per CRT course) · IV ✗ Not registered in UA
- 5-Fluorouracil (DRUG-5-FLUOROURACIL) 1000 mg/m²/day IV continuous infusion (IVCI) · Days 1-4 AND Days 29-32 (two 4-day infusion courses during radiation) · IV ✓ NSZU covered
- Reason
- Provisional current-line default from ALGO-ANAL-SCC-1L: step 1 did not select a treatment branch. Histological confirmation and complete staging workup required before treatment selection. CT CAP mandatory; PET-CT preferred for lymph node staging (inguinal nodes frequently involved; PET detects occult M1). HIV testing required in all anal SCC patients. HPV testing optional (...
Other current-line alternatives (2 tracks)
Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
- Indication
- IND-ANAL-SCC-METASTATIC-1L-RETIFANLIMAB-CARBO-PACLI
- Regimen
- Retifanlimab + carboplatin + paclitaxel (advanced anal SCC 1L, POD1UM-303)
- Drugs + NSZU
- Retifanlimab (DRUG-RETIFANLIMAB) 500 mg flat IV over 30 minutes · Q4 weeks (every 4 weeks) — given on day 1 of every other 21-day chemo cycle to align with Q4W schedule, continued as monotherapy after 6 cycles of chemo until progression / unacceptable toxicity / 24 months total · IV ✗ Not registered in UA
- Carboplatin (DRUG-CARBOPLATIN) AUC 5 IV · Day 1 of each 21-day cycle × 6 cycles · IV ⚠ NSZU — not for this indication
- Paclitaxel (DRUG-PACLITAXEL) 175 mg/m² IV · Day 1 of each 21-day cycle × 6 cycles · IV ⚠ NSZU — not for this indication
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-ANAL-SCC-METASTATIC-1L-CARBO-PACLI
- Regimen
- Carboplatin + paclitaxel (anal carcinoma, metastatic)
- Drugs + NSZU
- Carboplatin (DRUG-CARBOPLATIN) AUC 5 IV over 30 min · Day 1 q21d · IV ⚠ NSZU — not for this indication
- Paclitaxel (DRUG-PACLITAXEL) 175 mg/m² IV over 3h · Day 1 q21d (after carboplatin) · IV ⚠ NSZU — not for this indication
- Reason
- Current-line alternative presented for HCP consideration
Pre-treatment investigations
Investigations before treatment start · critical / standard / desired · merged across tracks
| ID | Name | Priority | Category | Where to order | Needed for |
|---|
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| TEST-CMP | Comprehensive Metabolic Panel | Critical | lab | — | all tracks |
| TEST-CREATININE-CL | Creatinine clearance | Critical | lab | — | standard |
| TEST-LFT | Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin) | Critical | lab | — | all tracks |
| TEST-CT-CAP | CT chest/abdomen/pelvis | Standard | imaging | — | all tracks |
| TEST-MRI-PELVIS | MRI pelvis | Standard | imaging | — | standard |
| TEST-TSH | Thyroid-stimulating hormone | Standard | lab | — | aggressive |
What NOT to do
Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Standard plan (IND-ANAL-SCC-LA-1L-NIGRO-CRT)
- НІКОЛИ не починати з APE (абдомінально-промежинна екстирпація) при плоскоклітинному раку анального каналу — CRT є органозберігаючим стандартом
- Не проводити біопсію залишкового захворювання раnoше 8 тижnoв після CRT — радіаційno зміни дають хибно-позитивний результат
- Не замінювати ММС на цисплатин без кліnoчного обґрунтування — ACT II показав еквівалентnoсть, ММС є стандартом
- Не призначати підтримуючу хіміотерапію після завершення CRT — ACT II не виявив переваг (несприятливий профіль токсичності без підвищення ефективності)
- Не призначати CRT при стадії IV (наявno метастази) — використовувати системну хіміотерапію ± імунотерапію
- Не знижувати дозу опромінення нижче 45 Гр без значного кліnoчного обґрунтування — доза 50.4 Гр пов'язана з оптимальним локальним контролем
Aggressive plan (IND-ANAL-SCC-METASTATIC-1L-RETIFANLIMAB-CARBO-PACLI)
- Не застосовувати без базового ТТГ, кортизолу та повної оцінки аутоімунного анамнезу
- Не застосовувати при активних аутоімунних захворюваннях, що потребують системного лікування (ГКС >10 мг/д)
- Не відкладати ретифанлімаб при irAE ендокринного типу (гіпотиреоз, гіпофізит) — лікувати замісною терапією, продовжувати імунотерапію
Standard plan (IND-ANAL-SCC-METASTATIC-1L-CARBO-PACLI)
- Не ігнорувати POD1UM-303 ретіфанлімаб-схему якщо вона доступна — ICI + хіміотерапія перевершує тільки хіміотерапію (PFS HR 0.63)
- Не забувати преп'едикацію перед пакліyesселем (реакції гіперчутливості 1-3%)
- Не призначати при анальному SCC без підтвердження ВПЛ-позитивного плоскоклітинного раку (виключити аденокарциному прямої кишки або перехідно-клітинний рак)
Timeline
Treatment timeline — derived from regimen + monitoring schedule
Standard plan
Induction · Nigro protocol (mitomycin-C + 5-FU + RT, anal SCC)
57-day cycles × 1 course (2 chemotherapy 'cycles' embedded within one radiation course)
Aggressive plan
Induction · Retifanlimab + carboplatin + paclitaxel (advanced anal SCC 1L, POD1UM-303)
21-day cycles × Chemo × 6 cycles; retifanlimab Q4W up to 24 months total or until progression / unacceptable toxicity
Standard plan
Induction · Carboplatin + paclitaxel (anal carcinoma, metastatic)
21-day cycles × 6 cycles; reassess every 3 cycles
MDT brief
Discussion questions (1, 0 blocking)
MDT talk tree (2 steps)
| # | Owner | Topic | Action |
|---|
| 1 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 2 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
Skills (recommended) — for consideration (1)
Data quality
Complete for MDT review. Required MDT data checks are complete for the current case profile.
- Biomarker coverage: 0/0 known (100%), 0 missing, 0 default-track gaps
Technical MDT skill metadata (1/16 activated in this plan)
All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
Sources cited
- SRC-ACT2-JAMES-2013: Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2×2 factorial trial ()
- SRC-NCCN-ANAL-2025: NCCN Clinical Practice Guidelines in Oncology: Anal Carcinoma ()
Experimental options (clinical trials)
Last synced: 2026-05-13 · 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).
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|
| Standard plan Nigro protocol (mitomycin-C + 5-FU + RT, anal SCC) (REG-NIGRO-MMC-5FU-RT) 1/2 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Aggressive plan Retifanlimab + carboplatin + paclitaxel (advanced anal SCC 1L, POD1UM-303) (REG-RETIFANLIMAB-CARBO-PACLI-ANAL-1L) 1/3 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan Carboplatin + paclitaxel (anal carcinoma, metastatic) (REG-CARBO-PACLI-ANAL-MET) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-13.