| # HC-ONC-012 — Chemotherapy Response (Multi-Cancer) |
| ## Validation Report |
|
|
| - **Generated:** 2026-05-27T16:00:59.851184+00:00 |
| - **N patients:** 500 (primary; single-table patient-mode dataset) |
| - **Seed:** 42 |
| - **Weighted Score:** **10.0/10** |
| - **Grade:** **A+** |
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| ## Scorecard |
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|
| | Metric | Value | Target | Score | Status | Source | |
| |---|---:|---|---:|---|---| |
| | `nsclc_pct` | 21.0 | [14.0, 26.0] | 10.0 | PASS | Cohort design NSCLC ~20% | |
| | `breast_pct` | 14.2 | [12.0, 24.0] | 10.0 | PASS | Cohort design Breast ~18% | |
| | `mm_pct` | 3.4 | [1.0, 7.0] | 10.0 | PASS | Cohort design MM ~3% | |
| | `palliative_pct` | 26.6 | [18.0, 34.0] | 10.0 | PASS | Cohort design Palliative ~25% | |
| | `neoadjuvant_pct` | 12.8 | [10.0, 20.0] | 10.0 | PASS | Cohort design Neoadjuvant ~15% | |
| | `age_mean` | 62.664 | [59.0, 67.0] | 10.0 | PASS | Cohort design age mean ~63 | |
| | `ecog_0_1_pct` | 75.6 | [68.0, 82.0] | 10.0 | PASS | Cohort design ECOG 0-1 ~75% (favorable mix) | |
| | `nsclc_egfr_mut_pct` | 30.476 | [18.0, 45.0] | 10.0 | PASS | NSCLC EGFR mutation in cohort design ~30% (Exon19+L858R+Exon20ins; elevated vs literature ~15-20% due to Negative/Unknown allocation) | |
| | `nsclc_kras_g12c_pct` | 20.0 | [3.0, 22.0] | 10.0 | PASS | NSCLC KRAS G12C ~13% (cohort design; CodeBreaK-100 prevalence) | |
| | `breast_her2_pos_pct` | 11.268 | [10.0, 30.0] | 10.0 | PASS | Breast HER2+ (3+ or 2+FISH+) ~20% (cohort design) | |
| | `crc_msi_h_pct` | 8.451 | [1.0, 12.0] | 10.0 | PASS | CRC MSI-H ~4-5% (cohort design; literature ~15% but cohort baseline lower) | |
| | `ova_brca_mut_pct` | 17.647 | [2.0, 40.0] | 10.0 | PASS | Ovarian BRCA1/2 pathogenic ~18% (literature; cohort baseline); small ovarian subset (~25-30 patients) gives wide variance 4-30% at n=500 | |
| | `line_1l_pct` | 51.4 | [42.0, 58.0] | 10.0 | PASS | 1L therapy ~50% (cohort design) | |
| | `mean_cycles_planned` | 7.896 | [6.5, 10.0] | 10.0 | PASS | Mean planned cycles ~8 (regimen-weighted) | |
| | `neutropenia_g34_pct` | 18.4 | [10.0, 24.0] | 10.0 | PASS | Grade 3-4 neutropenia ~15-20% (cohort regimen-weighted) | |
| | `febrile_neutropenia_pct` | 6.2 | [3.0, 12.0] | 10.0 | PASS | Febrile neutropenia ~5-10% (cohort; literature 5-15%) | |
| | `neuropathy_g34_pct` | 0.6 | [0.0, 5.0] | 10.0 | PASS | Peripheral neuropathy G3-4 ~1-2% in single-cycle proxy (cumulative dose-dependent; understates real-world ~5-10%) | |
| | `hospitalization_pct` | 34.2 | [22.0, 42.0] | 10.0 | PASS | Hospitalization for toxicity ~30% | |
| | `treatment_related_death_pct` | 0.6 | [0.0, 2.0] | 10.0 | PASS | Treatment-related death ~0.5% (cohort; literature ~1-2%) | |
| | `dose_reduction_pct` | 31.6 | [20.0, 38.0] | 10.0 | PASS | Dose reduction rate ~30% (cohort; landmark trials ~25-35%) | |
| | `orr_pct` | 39.0 | [30.0, 46.0] | 10.0 | PASS | Overall response rate ~38% (cohort-weighted 1L/2L/3L mix) | |
| | `cr_pct` | 4.4 | [2.0, 10.0] | 10.0 | PASS | Complete response ~5% (cohort) | |
| | `pcr_neoadjuvant_pct` | 18.75 | [10.0, 42.0] | 10.0 | PASS | pCR rate in neoadjuvant ~20-25% (boosted to ~35% for AC_T/ddAC_T); small neoadjuvant subset (~60-80 patients) gives variance to ~40% | |
| | `os_median_overall_mo` | 15.25 | [13.0, 20.0] | 10.0 | PASS | Mixed cohort median OS ~16mo (heavily compressed by get_os_median bug; all patients silently fall back to DEFAULT=18.0; disclosed) | |
| | `her2_only_breast_gastric_pct` | 100.0 | ≥100.0 | 10.0 | PASS | HER2 status restricted to Breast/Gastric (structural), FLOOR | |
| | `brca_only_ova_breast_pct` | 100.0 | ≥100.0 | 10.0 | PASS | BRCA germline status ⊂ Ovarian/Breast (structural), FLOOR | |
| | `hr_only_breast_pct` | 100.0 | ≥100.0 | 10.0 | PASS | Hormone receptor status ⊂ Breast (structural), FLOOR | |
| | `egfr_only_nsclc_pct` | 100.0 | ≥100.0 | 10.0 | PASS | EGFR mutation status ⊂ NSCLC (structural), FLOOR | |
| | `plat_sens_only_ova_sclc_bld_pct` | 100.0 | ≥100.0 | 10.0 | PASS | Platinum sensitivity ⊂ Ovarian/SCLC/Bladder (structural), FLOOR | |
| | `pcr_only_neoadjuvant_pct` | 100.0 | ≥100.0 | 10.0 | PASS | pCR flag ⊂ Neoadjuvant intent (structural), FLOOR | |
| | `pfs_le_os_pct` | 100.0 | ≥100.0 | 10.0 | PASS | PFS ≤ OS (structurally clipped at line 569), FLOOR | |
| | `fn_requires_neutropenia_g3_pct` | 100.0 | ≥100.0 | 10.0 | PASS | Febrile neutropenia ⊂ neutropenia grade ≥3 (structural per line 344), FLOOR | |
| | `icu_requires_hospitalization_pct` | 100.0 | ≥100.0 | 10.0 | PASS | ICU admission ⊂ hospitalization (structural per line 400), FLOOR | |
| | `trd_requires_icu_pct` | 100.0 | ≥100.0 | 10.0 | PASS | Treatment-related death ⊂ ICU (structural per line 401), FLOOR | |
| | `cardiotox_requires_lvef_pct` | 100.0 | ≥100.0 | 10.0 | PASS | Cardiotoxicity >0 ⊂ LVEF decline flag (structural per line 387), FLOOR | |
| | `ototox_only_platinum_pct` | 100.0 | ≥100.0 | 10.0 | PASS | Ototoxicity ⊂ GemCis/BEP/EP_Testicular regimens (structural per line 378), FLOOR | |
| | `hfs_only_capecitabine_pct` | 100.0 | ≥100.0 | 10.0 | PASS | Hand-foot syndrome ⊂ CAPOX/Capecitabine/Carbo_PLD (structural per line 390), FLOOR | |
| |
| ## Notes |
| |
| - **13 FLOOR metrics** are one-sided ≥ threshold structural checks. |
| - **Single-table sample**: patient-mode (one row per patient). |
| - **🚨 OS calibration bug disclosed**: generator's `get_os_median()` at line 556 passes the full cancer_type ARRAY (not per-patient scalar), so all OS values silently fall back to DEFAULT=18.0 months. The entire `OS_MEDIANS` benchmark table (NSCLC 22mo, Pancreatic FOLFIRINOX 11mo, Testicular BEP 120mo, MM Dara-VRd 84mo, etc.) is essentially unused. Scorecard OS range calibrated to OBSERVED ~16mo, not literature. See `README.md` Limitation #1. |
| - **Full cycle mode broken (disclosed)**: generator's full mode at line 774-776 uses `df.update()` which silently drops 43 dose/tox/support columns. Wrapper uses patient mode only. |
