Investigating Cardiovascular Adverse Events Related to Cancer Treatment

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of these criteria:

• any proven cancer treated with curative intent;
• age ≥ 18 and ≤ 50 years;
• able to comply with the protocol;
• signed written informed consent.

There are specific inclusion criteria for every subject group:

• severe toxicity during 1 to 3 cycles of anthracyclines;
• ≥ 3 months after end of cancer treatment which included the maximum tolerable dose of anthracyclines without (severe) toxicity;
• severe toxicity within 1 to 6 cycles of trastuzumab;
• ≥ 3 months after end of cancer treatment which included a year of trastuzumab without (severe) toxicity.
• severe toxicity during 1 to 3 cycles of cisplatin;
• ≥ 1 year after end of cancer treatment which included high-dose cisplatin without toxicity;
• severe toxicity during 1 to 3 cycles of bleomycin;
• ≥ 1 year after end of cancer treatment which included high-dose bleomycin without toxicity.

Severe toxicity is defined as any of grade 3 - 4 toxicity according to CTCAE 4.03.

A potential subject who meets any of the following exclusion criteria will be excluded from participation in this study:

• history of cardiovascular disease prior to start of cancer treatment, as evidenced by any of the following: symptomatic or treated cardiovascular disease prior to start of cancer treatment; LVEF < 55% at any performed MUGA scan or echocardiography prior to start of cancer treatment;
• any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, or insufficient understanding of the Dutch language;
• any contraindication for skin biopsy, including: extensive skin disorder precluding biopsy of unaffected skin; known allergy to local anaesthetics; use of anticoagulants and INR > 3;
• pregnant or lactating female.

Furthermore, there are specific exclusion criteria for the control groups:

• history of cardiovascular disease during or after cancer treatment, as evidenced by any of the following: any symptomatic or treated cardiovascular disease; LVEF < 55% at any performed MUGA scan or echocardiography.