Table 1.
Patients | Biomarkers | Treatment on Study | Post-Study Treatment | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Patient ID | Age at Study Entry | Ethnicity | Sites of Metastatic Disease | Prior Therapies (neo/adjuvant) |
Prior Therapies (metastatic) |
Pre-PIKTOR Biopsy Site |
Post-PIKTOR Biopsy Site |
Standard of Care Germline Tumor/Blood NGS and IHC Results | Total weeks on PIKTOR | Total Weeks on Cis/Nab Pac | Response to Cis/Nab Pac | Treatment | Duration (weeks) |
001 | 40 | White | Internal mammary LN, abdominal LN, bone, brain |
Cisplatin Docetaxel + Cyclophosphamide |
Gemcitabine + Carploplatin Xeloda |
Inguinal LN |
Same as pre-PIKTOR site |
G: BRCA1 +; BRCA2 - | 7 | 16 | SD | Pembrolizumab | 106 |
S: NOTCH1; TP53; MYC; FGFR2; CIC Amplification of PDGFRA | |||||||||||||
IHC: PD-L1 Negative; 22C3: PD-L1 Negative | |||||||||||||
002 | 57 | White | Chest wall, mediastinal LN, lung |
Doxorubicin + Cyclophosphamide + Paclitaxel Carboplatin + Capecitabine |
N/A | Lung | Axillary LN | G: BRCA1/2 - | 9 | 3 | PD | Entrectinib | 5 |
S: TP53; MYO5A NTRK3; PAK1; CDKN2A; CDKN2B Amplification of C11ORF30 (EMSY); PIK3CA | |||||||||||||
004 | 38 | White | Mediastinum LN, lung |
Doxorubicin + Cyclophosphamide + Paclitaxel Carboplatin Capecitabine |
N/A | Cervical LN | Supraclavicular LN | G: Panel Germline Testing Negative | 10 | 17 | PR | Paclitaxel + Bevacizumab + Pembrolizumab | 18 |
S: PTEN; LZTR1; NOTCH2; TP53; AR; FGFR1; PIK3CA; MET MTAP; ARID2 Amplification of ZNF217; PIK3CA; RAF1; KRAS; CCND2; CCND1; MET; BRAF; FGFR2; PDGFRA; KIT; CDK6; CCNE1 | |||||||||||||
IHC: PD-L1 Negative | |||||||||||||
005 | 58 | White | Axilla LN, lung | Doxorubicin + Cyclophosphamide + Paclitaxel | N/A | Lung |
Same as pre-PIKTOR site |
G: BRCA1 +; other Panel Germline Testing Negative | 5 | 9 | PD | Eribulin + Pembrolizumab | 11 |
S: TP53 | |||||||||||||
PD-L1 Negative | |||||||||||||
006 | 68 | White | Internal mammary LN, supraclavicular LN |
Doxorubicin + Cyclophosphamide + Paclitaxel Carboplatin + Capecitabine |
Letrozole + Xeloda Faslodex + Palbociclib |
Supraclavicular LN |
Same as pre-PIKTOR site |
G: BRCA1/2 -; MUTYH | 11 | 6 | PD | Pembrolizumab | 190 |
S: TP53; INPP4B; MLL3; MEF2B; Amplification of CDK4 | |||||||||||||
IHC: PD-L1 Positive | |||||||||||||
008 | 39 | African American | Axillary LN, supraclavicular LN, thoracic LN, internal mammary LN |
Doxorubicin + Cyclophosphamide Carboplatin + Paclitaxel |
Gemcitabine + Carboplatin | Axillary LN |
Same as pre-PIKTOR site |
G: Panel Germline Testing Negative | 14 | 18 | SD | Pembrolizumab | 65 |
S: PIK3CA; TP53; RB1; | |||||||||||||
IHC: P-L1 Negative, CPS 10, 22C3; PD-L1 Positive, CPS 11, 22C3 | |||||||||||||
009 | 48 | White, Hispanic/ Latino | Lung, mediastinal LN | Docetaxel + Cyclophosphamide | N/A | Lung |
Same as pre-PIKTOR site |
G: Panel Germline Testing Negative | 4 | 7 | PD | Pembrolizumab | 12 |
S: PTEN; TP53; RB1; MLL2; CREBBP; MLL3 Amplification of FGFR1; PIK3CA; CCNE1; MYC | |||||||||||||
IHC: PD-L1 Negative | |||||||||||||
010 | 63 | White, | Supraclavicular LN, mediastinal LN, hilar LN | Doxorubicin + Cyclophosphamide + Paclitaxel | Taxol | Supraclavicular LN |
Same as pre-PIKTOR site |
G: Unknown | 14 | 17 | SD | N/A | N/A |
S: TP53; BAP1; PTEN; ETV6; | |||||||||||||
IHC: PD-L1 Negative | |||||||||||||
011 | 42 | Asian | Supraclavicular LN | Epirubicin + Docetaxel |
Niraparib PARP inhibitor clinical trial Carboplatin + Gemzar Eribulin |
Supraclavicular LN |
Same as pre-PIKTOR site |
G: BRCA1 +; other Panel Germline Testing Negative | 7 | 3 | PD | Paclitaxel + Bevacizumab + Capecitabine | 5 |
S: TP53; TCF7L2; INPP4B; BAP1 Amplification of FGFR2; MYC | |||||||||||||
IHC: PD-L1 Negative | |||||||||||||
012 | 51 | White | Paratracheal LN, lung | Doxorubicin + Cyclophosphamide + Paclitaxel |
Carboplatin, Gemcitabine Abraxane + Tecentriq Pembrolizumab |
Lung |
Same as pre-PIKTOR site |
G: Panel Germline Testing Negative | 3 | 6 | PD | Erubilin | 7 |
S: TP53 |
Abbreviations: LN = lymph node; N/A = not applicable; PD = progression of disease; PR = partial response; SD = stable disease; Cis = Cisplatin; Nab Pac = Nab-Paclitaxel; G = Germline Mutations; S: Somatic Mutations; VUS: Variance of Unknown Significance; IHC = Immunohistochemistry; NGS = Next-generation sequencing;
Footnote: Patients 003 and 007 were screen fails and did not receive treatment; Patients 001 and 006 are still alive, Patient 001 is on currently on bevacizumab and Patient 006 is currently on pembrolizumab