ESMO Congress 2023 | OncologyPRO

Abstract 2101P

Background

Many anticancer drugs' adverse events (AE) are common/known. But, there are little data about the bleeding risk induced by anticancer drugs and some publications recommended to consider bleeding risk when initiating a cancer-associated-thrombosis (CAT) treatment. The aim of this work was to check all the anticancer’s SmPCs (Summary of Product Characteristics) for bleeding AE.

Methods

All SmPCs of anticancer drugs for breast cancer were checked on the EMA website. All bleeding AE from any organ were collected. The frequency (F) of AE experienced were the following: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000).

Results

Of the 36 identified anticancer drugs for breast cancer. Among these, 75.0% had at least one bleeding AE (all F). Gastro-Intestinal (GI) bleeding (36.1%), epistaxis (41.7%) and haematuria (16.7%) were the main bleeding AE (all F). Regarding very common and common AE, 16.7%, 38.9%% and 5.6%% of the anticancer drugs were reported to be potentially induced GI bleeding, epistaxis and haematuria, respectively (Table).

Table: 2101P

Bleeding-AE in the anticancer drug SmPCs used for breast cancer

AE	All Frequencies	Very common	Common	Uncommon	Rare	Very rare	Unknown
GI Bleeding	36.1%	2.8%	13.9%	13.9%	0.0%	2.8%	2.8%
Epistaxis	41.7%	19.4%	19.4%	0.0%	0.0%	0.0%	2.8%
Haematuria	16.7%	5.6%	0.0%	11.1%	0.0%	0.0%	0.0%
Other Bleeding	30.6%	5.6%	16.7%	2.8%	2.8%	0.0%	2.8%

AE: Adverse Events; GI: GastroIntestinal

Conclusions

Bleeding are common AE of many of anticancer drugs. It is important to be aware of this before initiating an anticoagulant in CAT patients. But it seems reasonable to consider a potential bleeding risk caused by anticancer drugs, before/during CAT treatment.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The author.

Funding

Has not received any funding.

Disclosure

N. Janus: Financial Interests, Personal, Invited Speaker: Bayer, Gilead, Leo Pharma A/S, Roche, Vifor Pharma, Amgen, Fresenius, Baxter, BBraun; Financial Interests, Institutional, Other, Grant: Bayer, Gilead, Leo Pharma A/S, Vifor Pharma, Teva; Financial Interests, Institutional, Advisory Board: Daiichi Sankyo, Teva; Financial Interests, Institutional, Invited Speaker: Ipsen, Roche; Financial Interests, Personal, Advisory Board: Leo Pharma A/S, Pfizer, Guerbet; Financial Interests, Personal, Full or part-time Employment, Full time: Leo Pharma A/S; Financial Interests, Institutional, Research Grant: Roche, Amgen, Teva, Vifor Pharma, Guerbet, Pierre Fabre.