Key result
Perioperative chemotherapy with FAC significantly increased the risk of thromboembolic complications compared to surgery alone (2.1% vs 0.8%, P=0.004) in women with early breast cancer.
Why the study?
Does perioperative chemotherapy (fluorouracil, doxorubicin, and cyclophosphamide) increase the risk of thromboembolic complications compared to surgery alone in women with early breast cancer?
Population
2,624 women with early breast cancer undergoing surgery
Comparison
Surgery followed by one short intensive course… vs Surgery alone (observation)
Design
RCT, Randomized phase III trial
Follow-up
6 weeks after surgery
Authors
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May warrant thromboprophylaxis with perioperative FAC in early breast cancer; confirms elevated thromboembolic risk in this RCT.
RCT (n=2,624)
Yes
Does perioperative chemotherapy (fluorouracil, doxorubicin, and cyclophosphamide) increase the risk of thromboembolic complications compared to surgery alone in women with early breast cancer?
Absolute Event Rate: 2.1% vs 0.8%
p-value: p=0.004
Perioperative chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide significantly increases the risk of early postoperative thromboembolic complications in women with early breast cancer.
Clahsen et al. (1994) conducted an RCT in early breast cancer (n=2,624). perioperative fluorouracil, doxorubicin, and cyclophosphamide (FAC) vs. surgery alone (observation) was evaluated on occurrence of thromboembolic complications within 6 weeks after surgery (p=0.004). Perioperative chemotherapy with FAC significantly increased the risk of thromboembolic complications compared to surgery alone (2.1% vs 0.8%, P=0.004) in women with early breast cancer.
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