medwireNews: An Italian study suggests the need to monitor for androgen deficiency in men with ALK-bpositive, advanced non-small-cell lung cancer (NSCLC) receiving alectinib.
As reported in Cancer, testosterone levels were significantly lower among alectinib-treated patients than those with ALK-negative disease receiving other anticancer therapies, and a higher proportion had responses consistent with possible hypogonadism on the Androgen Deficiency in Aging Males (ADAM) questionnaire.
The researchers therefore write: “Symptoms of androgen deficiency should be tracked in male patients with ALK‐positive [advanced] NSCLC who are receiving alectinib, and testosterone replacement should be considered, as appropriate.”
The single-institution study included 95 patients with advanced NSCLC, of whom 54 – 27 men and 27 women – had ALK-positive disease and were receiving the ALK–tyrosine kinase inhibitor (TKI) alectinib in the first line, and 41 were men with ALK-negative disease who were treated with other anticancer therapies.
The median total and free testosterone levels were significantly lower among men who were receiving alectinib than those who were not, at 2.93 versus 4.92 ng/mL, and 0.11 versus 0.17 pg/mL, respectively, report Emanuele Vita and co-authors (all from Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy).
And a higher proportion of alectinib-treated men had positive scores on the ADAM questionnaire, defined as at least one major symptom (eg, loss of libido and/or impotence) or at least three minor symptoms (give eg too), at 62.0% compared with 26.8% among men who did not receive alectinib.
The investigators found no significant differences in the endocrine assessment between men and women who received alectinib, which indicates that “despite a suggested pituitary impairment, alectinib‐related toxicity appears to be limited to testicular function.”
They acknowledge limitations of the study, such as the fact that “symptoms of hypogonadism are likely to overlap with symptoms secondary to advanced cancer, aging, and depression,” and the lack of data on pretreatment androgen levels.
“Despite such limitations, we confirmed that male patients who receive treatment with ALK TKIs could experience a reduced quality of life because of the potential long‐term consequences of undetected and untreated low [testosterone],” write Vita and colleagues.
And they conclude: “Oncologists typically avoid discussions about sexuality with patients and, without a clear awareness of these issues, symptoms of hypogonadism may be overlooked.
“In addition, because ALK TKIs are quickly moving to curative‐intent settings, further research is needed into the long‐term effects on gonadic function, and patients of any age who have a risk of infertility should be given the opportunity to discuss fertility preservation before treatment.”
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