Part A | Age (years) | Burden | ≥ 1 mitosis/mm2 | Chromotype | BRAFV600E status | Percentage of MGMT promoter methylation | Previous therapies | Concomitant diseases -therapies | RECIST 1.1 response | Progression-free survival from 1st melphalan HPP -site of progression | Therapies at progression | Censor -Overall survival from 1st melphalan HPP | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pt 1 | 50 | High | Not | Black | Wild-type | 10 | Surgery Interferon alpha | Hepatitis C -Sofosbuvir and daclatasvir | SD | 3 months -locoregional | 2nd melphalan HPP | Dead -17 months | |||
Pt 2 | 55 | Low | Yes | Black | Wild-type | 14.2 | Surgery Dacarbazine systemic chemotherapy | Inflammatory bowel disease -corticosteroids | SD | 2 months -locoregional | 2nd melphalan HPP; Platinum ECT | Dead -47 months | |||
Pt 3 | 60 | High | Yes | Red | Wild-type | 20.2 | Surgery | Hepatitis C -Sofosbuvir and daclatasvir | PR | 3 months -locoregional and distant | Dacarbazine systemic chemotherapy | Dead -19 months | |||
Pt 4 | 61 | High | Yes | Black | Wild-type | 12.2 | Surgery | Hepatitis C -Sofosbuvir and daclatasvir | SD | 3 months -locoregional and distant | Gemcitabine, paclitaxel systemic chemotherapy | Dead -7 months | |||
Pt 5 | 85 | Low | Not | Black | Wild-type | 21.2 | Surgery Interferon alpha | Inflammatory bowel disease -corticosteroids | SD | 3 months -locoregional | 2nd melphalan HPP; surgery | Dead -21 months | |||
Pt 6 | 38 | Low | Not | Red | Wild-type | 16.2 | Surgery Radiation therapy Dacarbazine systemic chemotherapy | Inflammatory bowel disease -corticosteroids Lymphoma NH B-CLL -corticosteroids | SD | 4 months -locoregional | 2nd melphalan HPP; surgery | Dead -21 months | |||
Pt 7 | 75 | High | Not | Black | Wild-type | 28.5 | Surgery -Bleomycin ECT | Hepatitis C -Sofosbuvir and daclatasvir | SD | 4 months -locoregional and distant | Dacarbazine systemic chemotherapy | Dead -15 months |
Part B | IV-CTCs | 5-FU (%) | Gem (%) | Dacarb (%) | Epi (%) | Alk (%) | Eto (%) | Carbo (%) | Cis (%) | Ox (%) | Paclit (%) | Doce (%) | Vino (%) | Topo (%) | Iri (%) |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pt 1 | 9.6 ml, SD ± 0.3 cells | S = 30 | S = 90 | S = 80 | S = 30 | S = 60 | S = 40 | S = 45 | S = 30 | S = 30 | S = 85 | S = 58 | S = 20 | S = 20 | S = 30 |
Pt 2 | 16.2/ml, SD ± 0.3 cells | S = 30 | S = 85 | S = 80 | S = 25 | S = 50 | S = 50 | S = 75 | S = 90 | S = 40 | S = 50 | S = 50 | S = 50 | S = 30 | S = 30 |
Pt 3 | 6.4/ml, SD ± 0.3 cells | S = 20 | S = 50 | S = 70 | S = 30 | S = 65 | S = 25 | S = 30 | S = 50 | S = 30 | S = 30 | S = 40 | S = 30 | S = 25 | S = 20 |
Pt 4 | 8.4/ml, SD ± 0.3 cells | S = 25 | S = 85 | S = 72 | S = 25 | S = 54 | S = 24 | S = 20 | S = 30 | S = 30 | S = 90 | S = 50 | S = 30 | S = 30 | S = 30 |
Pt 5 | 9.8/ml, SD ± 0.3 cells | S = 35 | S = 65 | S = 30 | S = 31 | S = 72 | S = 23 | S = 30 | S = 30 | S = 30 | S = 95 | S = 60 | S = 30 | S = 30 | S = 30 |
Pt 6 | 9.2/ml, SD ± 0.3 cells | S = 25 | S = 30 | S = 95 | S = 25 | S = 84 | S = 90 | S = 42 | S = 35 | S = 35 | S = 20 | S = 20 | S = 25 | S = 20 | S = 20 |
Pt 7 | 9.8/ml, SD ± 0.3 cells | S = 50 | S = 50 | S = 75 | S = 20 | S = 50 | S = 50 | S = 50 | S = 40 | S = 50 | S = 85 | S = 30 | S = 30 | S = 20 | S = 20 |