TABLE 2.
Outcomes of included studies
| First author, year | Study | No. of patients (6 mo.) | Recurrent VTE (6–12mo) | MB (6–12 mo) | CRNMB (6–12 mo) | Mortality (6–12 mo) | AC beyond 6 mo | Age, female (%) | ECOG 0–1 | Cancer types | Advanced cancer stage a |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Marshall et al., 2020 | SELECT‐D: 12m | Index PE / RVT: 2nd randomization: Overall (n = 92) b |
8.7% n = 8 |
2.2% n = 2 |
2.2% n = 2 |
12% n = 15 |
100% | F: 49% | 85% |
GI 39%, Breast 17% Hem 13% GU 12% Lung 8% Prostate 4% |
43% metastatic |
| Index PE / RVT at 6 mo →2nd randomization: Rivaroxaban (n = 46) |
4.3% n = 2 |
4.3% n = 2 |
4.3% n = 2 |
13% n = 6 |
100% | ||||||
| Index PE/RVT at 6 mo →2nd randomization: Placebo (n = 46) |
13% n = 6 |
0% n = 0 |
0% n = 0 |
11% n = 5 |
100% | ||||||
| Index DVT & RVT negative at 6mo (n = 35) c |
0% n = 0 |
n.r. | n.r. |
11% n = 4 |
0% | ||||||
| Di Nisio et al., 2019 | Hokusai VTE Cancer | Overall (n = 567) |
2.1% n = 12 |
1.8% n = 10 |
4.8% n = 27 |
13.8% n = 78 |
100% |
Mean (sd): 64 (11) d F: 47% |
83% |
GI 27% Breast 16% GU 22% Hem 14% Lung 11% |
41% metastatic |
| Edoxaban (n = 294) |
1.4% overall (n = 4) 0.7% on treatment (n = 2) |
2.4% overall (n = 7) 1.7% on treatment (n = 5) |
4.8% overall (n = 14) 3.7% on treatment (n = 11) |
13.3% (n = 39) e | 100% | ||||||
| Dalteparin (n = 273) |
2.9% overall (n = 8) 1.1% on treatment (n = 3) |
1.1% overall (n = 3) 1.1% on treatment (n = 3) |
4.8% overall (n = 13) 3.7% on treatment (n = 10 |
14.3% (n = 39) e | 100% | ||||||
| Napolitano et al., 2014 | Cancer‐DACUS | Overall (n = 347) |
6.9% n = 24 |
1.7% n = 6 |
2.6% n = 9 f |
12% n = 42 g |
34.3% |
Mean (sd): 61 (14) d F: 45% |
/ |
GI 27% Breast 12% GU 11% Hem 23% Lung 5% |
21% metastatic |
| RVT at 6mo →randomization: continue LMWH (n = 119) |
3.4% n = 4 |
3.4% n = 4 |
1.7% n = 2 f |
10% n = 12 g |
100% | ||||||
| RVT at 6mo →randomization: discontinue LMWH (n = 123) |
14.6% n = 18 |
0.8% n = 1 |
3.3% n = 4 f |
15% n = 19 g |
0% | ||||||
| RVT negative at 6mo (n = 105) |
1.9% n = 2 |
1.0% n = 1 |
2.9% n = 3 f |
11% n = 11 g |
0% | ||||||
| Jara‐Palomares et al., 2017 | TiCat | Tinzaparin (n = 184) h |
1.1% n=2 |
2.6% n = 5 i |
n.r. |
23% n = 23 j |
100% | Mean (sd): 62 (13). F: 55% | 83% |
GI 14% Breast 14% GU 21% Hem 8% Lung 16% Prostate 4% |
66% metastatic |
| Francis et al., 2015 | DALTECAN | Dalteparin (n = 185) |
4.1% n = 8 k |
4.3% n = 8 |
n.r. | n.r. | 100% | Mean 65, F: 47% | 84% |
GI 21% Breast 9% Hem 13% Lung 14% |
63% metastatic |
| Poudel et al., 2019 (Meeting Abstract) | Overall (n = 284) |
12.0% n = 34 |
1.8% n = 5 |
3.2% n = 9 |
n.r. | 67.3% | Mean (sd): 61 (13), F: 50% | / |
GI 17% Breast 7% GU 12% Hem 31% Lung 7% Brain 12% |
62% metastatic | |
| AC beyond 6 mo. (n = 191) |
12.0% n = 23 |
2.1% n = 4 |
4.7% n = 9 |
n.r. | 100% | ||||||
| No AC beyond 6 mo. (n = 93) |
11.8% n = 11 |
1.1% n = 1 |
0% n = 0 |
n.r. | 0% | ||||||
| Prandoni et al., 2002 | Overall (n = 92) l |
3.3% n = 3 |
n.r. | n.r. | n.r. | 100% | Mean (sd): 65 (11), F: 54% | / |
GI 20% Breast 19% GU 26% Hem 19% Lung 15% Brain 6% |
37% Stage IV („ex‐tensive“) | |
| Mahé et al., 2020 | USCAT | Overall (n = 432) m |
5.7% n = 24 |
2.7% n = 11 |
2.4% n = 10 |
22.3% n = 96 |
68.9% | Mean (sd): 67 (13), F: 52% | / |
GI 31% Breast 17% GU 26% Hem 7% Lung 20% |
74% metastatic |
| Schmidt et al., 2020 | Overall (n = 322) |
5.3% n = 17 |
4.1% CI 6–18mo CRB n | 26.3% (KM) | 68.9% | Med. (iqr): 63 (55–70), F: 52% | / |
GI 28% Breast 8% GU 18% Hem 20% Lung 13% Prostate 5% |
44% metastatic | ||
| AC beyond 6 months (n = 222) | 9.9% CI 6–18mo n | 5.1% CI 6–18mo CRB n | 25.2% (KM) | 100% | |||||||
| No AC beyond 6 months (n = 100) | 4.4% CI 6–18mo n | 1.8% CI 6–18mo CRB n | 16.2% (KM) | 0% | |||||||
| Sakamoto et al., 2019 |
COMMAND VTE Registry |
Overall (n = 396) o |
2.8% n = 11 |
4.8% n = 19 |
n.r. |
19.2 n = 82 |
79.8% | Mean (sd): 67 (12), F: 60% | / |
GI 31% Breast 4% GU 21% Hem 9% Lung 16% Prostate 5% |
49% metastatic / terminal stage |
| Yhim et al., 2013 | Overall (n = 83) p , q |
3.6% n = 3 |
n.r. | n.r. | n.r. | 100% | Med (range): 65 (27–91), F: 46% | 41% |
GI 57% Breast 5% GU 9% Lung 30% |
72% palliative chemo‐therapy | |
Abbreviations: AC, anticoagulation; CI, cumulative incidence; CRB, clinically relevant bleeding (=MB+CRNMB); CRNMB, clinically relevant non‐major bleeding; DVT, deep vein thrombosis; GI, gastrointestinal cancer; GU, genitourinary cancer; iqr, interquartile range; KM, Kaplan Meier estimate; LMWH, low molecular weight heparin; MB, major bleeding; mo., months; n.r., not reported; PE, pulmonary embolism; RVT, residual vein thrombosis; sd, standard deviation; VTE, venous thromboembolism.
If not otherwise specified, outcomes represent rates between 6 and 12 months after index VTE.
Bold writing has been used to underline overall outcome rates as opposed to subgroups.
Refers to patients with staging information available.
Overall rates for recurrent VTE and mortality comprise patients with index PE/positive RVT at 6 months who underwent second randomization (n = 92) + patients with index DVT/RVT negative at 6 months (n = 35); Overall bleeding rates comprise only patients with index PE/positive RVT at 6 months who underwent second randomization.
Index DVT/RVT negative at 6 months (n = 35): 6 patients with additional anticoagulation treatment beyond 6 months.
Combined mean and SD from subgroups.
VTE related death: 1 patient in the edoxaban group and 1 patient in the dalteparin group. No bleeding‐related death reported.
Rate of minor bleeding.
Mortality in the Cancer‐DACUS study reported for 12 months post randomization (6–18 months post index event).
Number at risk for recurrent VTE at 6 months; patient characteristics from full study cohort (n = 247).
Number at risk for major bleeding at 6 months: 189.
1 fatal recurrent PE, 2 fatal bleeding events; Mortality based on number of patients who completed 6 months follow‐up (n = 198).
Number at risk for recurrent VTE at 6 months: 194.
Patients with cancer at risk 6 months after index DVT according to KM risk table, patient characteristics from full study cohort at month 0 (n = 181).
VTE recurrence, bleeding events, and deaths were documented in 418, 415, and 430 patients, respectively.
Reported rates of recurrent VTE in subgroups and CRB represent Kaplan‐Meier cumulative incidence estimates from month 6 to month 18 after index VTE.
Baseline characteristics at baseline (Month 0) of the total active cancer subgroup (n = 695).
Baseline characteristics at baseline (Month 0) of total cohort (n = 449).
Number at risk at 6 months: 396 for VTE, 398 for MB, 428 for mortality.