293P - Generic dabigatran for cancer-associated venous thromboembolism: Real-world data

Background

Venous thromboembolism (VTE) is common in patients with cancer and is associated with increased mortality. Dabigatran is effective or superior to conventional agents like warfarin or low-mol-wt-heparin (LMWH) for treating cancer-associated thrombosis (CAT). However, there is limited data outside of clinical trials, and concerns exist about the potential side effects in unselected patients.

Methods

The medical records of patients who received generic dabigatran for CAT between July 2019-July 2021 were accessed to get data on: baseline characters, nature and extent of VTE, treatment duration, and outcome.

Results

Thirty pts [median age: 34 years (8-66years), 13 males (43%), ECOG PS 0,1: 28 (93%)] with active cancer [acute lymphoblastic leuk. (N=12), non-Hodgkin's lymphoma (N=2), breast ca (N=5), gastric ca (N=3), colon ca (N=3), ovarian ca (N=2), gestational trophoblastic neoplasia (N=2), Ewing's sarcoma (n=1)] and VTE were included. Only 1/30 had a history of DVT, and 5 pts had central venous catheters (CVC). Drugs associated with thrombosis were used in 16 pts [(Bevacizumab (n=2), L-asparaginase (n=11), cisplatin, bleomycin, and tamoxifen (n=1)]. Sites of VTE: cortical venous thrombosis (CVT, N=12), CVC-associated (N=5), legs (N=8), Others (N=5)]. Dabigatran (150 mg BD) (23 after 2 weeks of LMWH, 7 upfront) was used for a median of 6 mos (3-20mos). At 4 mos, radiological response was available in 19 pts (complete resolution (N=6), partial in 8, stable in 5) and 11 had clinical improvement. Three patients had recurrent VTE after stopping dabigatran (2 pulmonary and 1 CVT). At last follow-up, 21 pts were alive, five died due to cancer, and four were lost from follow-up. Temporary stopping was needed in 3 pts (for low platelets), of which 1 had a bleeding episode.

Conclusions

Generic dabigatran is a safe, inexpensive (INR 800-1000 per month) and effective outpatient option for CAT in developing countries. Owing to its cheaper cost, ease of administration, and likely better patient compliance, dabigatran could become a potential alternative to LMWH.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.