Breast Cancer Female Clinical Trial
Official title:
GENe EXpression in Tissues From Operating Field After Regional or General ANesthesia in Patients Undergoing Breast Cancer Surgery. The GENEXAN Randomized Controlled Genomic Trial
Breast cancer is the most commonly diagnosed cancer in females and the second leading cause
of death from cancer in women. It was estimated that 2 million new cases have occurred in
2018 worldwide 1.
Standard anesthetic procedures for the surgery of breast cancer include general and regional
anesthesia 2. Growing preclinical and clinical data support the hypothesis that anesthetic
choice may affect cancer-related outcomes.
Recurrence in breast cancer was reduced to four-fold in a retrospective study with a 2.5 to 4
year follow up 3. Recurrence and metastasis-free survival, with multivariate analysis, was
94% (95% CI 87,100) versus 82% (74, 91) at 24 months, and 94 (87, 100) versus 77 (68, 87) at
36 months in the paravertebral and general anesthesia patients, respectively, (p=0.013).
Currently large confirmatory randomized trials evaluating breast cancer recurrence in
patients operated with general or regional anesthesia are yet undergoing 4.
Background: Exposure to general or regional anesthesia, can modulate differently breast
cancer biology through a direct activity on cancer cells or indirectly through modifications
in host response (immune system, angiogenesis, nervous system). Alterations occur both
systemically and locally on the surgical site and is supposed that can affect cancer-related
outcomes after months or years.
It is not known whether the action of this short exposure to anesthetics on the host and
cancer biology is driven by epigenetic alterations in gene and protein expression during the
immediate to early post-anesthesia period.
An altered gene and protein expression profile may affect the response of the immune system,
angiogenesis and the nervous system and induce more or less propitious conditions to tumor
progression. Data from studies in animals and humans show that gene expression may change in
the brain and heart after only a short exposure to general anesthesia and that changes may
persist for several weeks.
Methods: The GENEXAN is a randomized, controlled, monocentric, genomic trial aiming to test
the hypothesis that regional (paravertebral) anesthesia, compared to general anesthesia,
would elicit a differential gene and protein expression pattern in cancer tissue and normal
surgical microenvironment after breast cancer surgery in women.
Discussion: This research will serve to map gene and protein expression profile after surgery
with different anesthetics and elucidate which genes specific to biological systems may
affect tumor biology in the immediate operative period.
The findings may also address further research depending on the tissue specificity of the up
or down-regulated genes.
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