Table 1.
Patient and Tumor Characteristics
| Protocol 9603 | Protocol 0004 | |||||
|---|---|---|---|---|---|---|
| Total | Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | P a | |
| Fractions, No. | 12 | 8 | 4 | 4 | ||
| Cases, No. | 126 | 33 | 22 | 27 | 44 | |
| Age, median (range), year | 68 (37‐84) | 67 (45‐80) | 65 (44‐80) | 66 (37‐77) | 69 (46‐84) | .140 |
| Sex, No. (%) | ||||||
| Male | 90 (71) | 22 (67) | 15 (68) | 23 (85) | 30 (68) | .366 |
| Female | 36 (29) | 11 (33) | 7 (32) | 4 (15) | 14 (32) | |
| ECOG performance status, No. (%) | ||||||
| 0‐1 | 109 (87) | 30 (91) | 17 (74) | 23 (85) | 39 (89) | .534 |
| 2 | 17 (13) | 3 (9) | 5 (23) | 4 (15) | 5 (11) | |
| Type of chronic hepatitis, No. (%) | ||||||
| HBV | 17 (13) | 3 (9) | 4 (18) | 6 (22) | 4 (9) | .728 |
| HCV | 93 (74) | 25 (76) | 16 (73) | 18 (67) | 34 (77) | |
| Other | 16 (13) | 5 (15) | 2 (9) | 3 (11) | 6 (14) | |
| Prior treatment, No. (%) | ||||||
| None | 66 (52) | 16 (48) | 10 (45) | 12 (44) | 28 (64) | .316 |
| Recurrence after treatment | 60 (48) | 17 (52) | 12 (55) | 15 (56) | 16 (36) | |
| Child‐Pugh class, No. (%) | ||||||
| A | 97 (77) | 26 (79) | 19 (86) | 17 (63) | 35 (80) | .305 |
| B | 29 (23) | 7 (21) | 3 (14) | 10 (37) | 9 (20) | |
| ICG R15, No. (%)b | ||||||
| ≤20% | 48 (40) | 14 (42) | 9 (43) | 10 (40) | 15 (38) | .969 |
| >20% | 71 (60) | 19 (58) | 12 (57) | 15 (60) | 25 (62) | |
| Clinical stage, No. (%) | ||||||
| I | 10 (8) | 0 (0) | 0 (0) | 0 (0) | 10 (23) | <.001 |
| II | 61 (48) | 12 (36) | 11 (36) | 13 (48) | 25 (57) | |
| IIIA | 43 (34) | 16 (48) | 8 (37) | 11 (41) | 8 (18) | |
| IVA | 12 (10) | 5 (15) | 3 (14) | 3 (11) | 1 (2) | |
| BCLC stage, No. (%) | ||||||
| 0 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | .193 |
| A | 34 (27) | 11 (33) | 9 (41) | 5 (19) | 9 (20) | |
| B | 17 (13) | 7 (21) | 2 (9) | 2 (7) | 6 (14) | |
| C | 75 (60) | 15 (46) | 11 (50) | 20 (74) | 29 (66) | |
| D | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| AFP, No. (%) | ||||||
| <20 ng/mL | 49 (39) | 13 (42) | 9 (42) | 9 (36) | 18 (41) | .926 |
| ≥20 ng/mL | 77 (61) | 20 (58) | 13 (58) | 18 (64) | 26 (59) | |
| PIVKA‐II, No. (%) | ||||||
| <40 ng/mL | 48 (38) | 17 (53) | 8 (33) | 5 (18) | 16 (36) | .073 |
| ≥40 ng/mL | 78 (62) | 16 (47) | 14 (67) | 22 (82) | 28 (64) | |
| Total tumors, No. | 133 | 34 | 24 | 28 | 47 | |
| Maximum tumor size, median (range), mm | 40 (10‐120) | 36 (13‐72) | 26 (10‐120) | 47 (25‐120) | 37 (12‐86) | .002 |
| Maximum tumor size, No. (%) | ||||||
| ≤30 mm | 39 (29) | 7 (21) | 14 (58) | 4 (14) | 14 (30) | .004 |
| >30, ≤50 mm | 56 (42) | 18 (55) | 7 (29) | 10 (36) | 21 (45) | |
| >50 mm | 38 (29) | 9 (26) | 3 (13) | 14 (50) | 12 (25) | |
| Treatment duration (range), day | 8 (4‐22) | 21 (18‐22) | 14 (11‐15) | 4 (4‐8) | 4 (4‐8) | <.001 |
| Tumor thrombus, No. (%) | ||||||
| Present | 23 (17) | 5 (15) | 4 (17) | 11 (39) | 3 (6) | .003 |
| Absent | 110 (83) | 29 (85) | 20 (83) | 17 (61) | 44 (94) | |
| Tumor number, No. (%) | ||||||
| Single | 103 (77) | 23 (64) | 21 (73) | 24 (81) | 35 (74) | .308 |
| Multiple | 30 (23) | 11 (36) | 3 (27) | 4 (19) | 12 (26) | |
| Target volume, No. (%) | ||||||
| <158 mL | 66 (50) | 16 (47) | 15 (63) | 14 (50) | 21 (45) | .543 |
| ≥158 mL | 67 (50) | 18 (53) | 9 (37) | 14 (50) | 26 (55) | |
| Fields, No. (%) | ||||||
| 2 | 109 (82) | 17 (50) | 22 (92) | 27 (96) | 43 (91) | <.001 |
| 3 | 21 (16) | 14 (41) | 2 (8) | 1 (4) | 4 (9) | |
| 4 | 3 (2) | 3 (9) | 0 (0) | 0 (0) | 0 (0) | |
Abbreviations: AFP, α‐fetoprotein; BCLC, Barcelona Clinic Liver Cancer; ECOG, Eastern Cooperative Oncology Group; HBV, hepatitis B virus; HCV, hepatitis C virus; ICG R15, indocyanine green retention rate at 15 minutes; PIVKA‐II, protein induced by vitamin K absence/antagonist II.
a
Age, tumor size, and treatment duration were analyzed with the Kruskal‐Wallis test. Other variables were analyzed with the chi‐square test.
b
Seven cases did not undergo the indocyanine green test because of an allergy.