Table 1.
Characteristics of the studies included in the metanalysis.
| Study | Study Type | Number of PC Patients (Intervention /Control) | Patient Characteristics | Study Treatments | Duration of Thromboprophylaxis | Primary Endpoint | Efficacy Outcome | Major Bleeding | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Intervention | Control | Intervention | Control | |||||||
| Agnelli 2009 PROTECHT [31] | Randomized, double blind, placebo-controlled multicenter phase III study | 36/17 | Ambulatory patients aged 18 years or older on chemotherapy with metastatic or locally advanced PC, ECOG Performance Status ≤ 2 | Nadroparin (3800 IU o.d.) versus placebo | For the duration of chemotherapy up to a maximum of 4 months | Composite of symptomatic VTE or arterial thromboembolism | 3/36 | 1/17 | - | - |
| Agnelli 2012SAVE ONCO [32] | Randomized, double blind, placebo-controlled multicenter phase III study | 126/128 | Ambulatory patients aged 18 years or older with metastatic or locally advanced PC beginning to receive a course of chemotherapy, ECOG PS < 3 | Semuloparin (20 mg o.d.) versus placebo | For the duration of chemotherapy then discontinued when chemotherapy was stopped, or regimen changed | Any symptomatic DVT in lower or upper limbs, any non-fatal PE, or death related to VTE (fatal PE or unexplained death) | 3/126 | 14/128 | - | - |
| Marayevas 2012FRAGEM [25] | Randomized, open label, controlled Phase IIb study | 59/62 | Patients aged 18 years or older with advanced or metastatic PC, Karnofsky performance status 60–100 | Gemcitabine + Dalteparin (200 IU/kg o.d., for 4 weeks, followed by a step-down regimen to 150 IU/kg) versus Gemcitabine alone | For up to 12 weeks | All type DVT/PE, all arterial events and all visceral thromboembolism | 7/59 | 17/62 | 2/59 | 2/62 |
| Pelzer 2015 CONKO [26] | Prospective, open label, randomized, multicenter and group-sequential phase IIb study | 160/152 | Patients aged 18 years or older with advanced PC receiving ambulant first-line chemotherapy | Enoxaparin 1 mg/kg o.d. versus no enoxaparin | Until disease progression | First symptomatic VTE | 2/160 | 15/152 | 7/160 | 5/152 |
| Khorana 2019 CASSINI [29,30] | Double-blind, randomized, placebo-controlled, parallel-group, multicenter phase III study | 135/138 | Adult ambulatory patients with various cancers initiating a new systemic regimen and at increased risk for VTE (defined as Khorana score ≥ 2). | Rivaroxaban 10 mg o.d. versus placebo | 180 (±3) days | Objectively confirmed symptomatic or asymptomatic lower-extremity proximal DVT, symptomatic upper extremity or distal lower-extremity DVT, symptomatic or incidental PE and VTE–related death | 5/135 | 14/138 | 2/135 | 3/138 |
Abbreviations: DVT, deep vein thrombosis; ECOG, Eastern Cooperative Oncology Group; IU, international unit; o.d., once daily; PC, pancreatic cancer; PE, pulmonary embolism; VTE, venous thromboembolism.