OBJECTIVES

: Considering the scarcity of data on anaplastic lymphoma kinase (ALK) cancer biomarker, a review of literature was performed to collate information on its prevalence across all common tumor sites, and the estimates of diagnosed incidence of each tumor were used to determine the total number of incident ALK-positive cases for the year 2018 in the United States (US).

METHODS

: A systematic review of literature was performed using the PubMed interface of Medline to identify tumor sites which were ALK-positive. A case was defined ALK-positive if it harbored the echinoderm microtubule-associated protein like-4 (EML4)-ALK mutation determined using either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) techniques. In the absence of country-specific studies, results from studies based in comparable populations were extrapolated. To contextualize and make the review relevant, tumors where licensed precision drug therapies have been launched, are being investigated, or where some other experimental findings suggest that this mutation may be investigated in the future for use in clinical practice were considered. To better estimate the eligibility for ALK-directed treatments – which are typically used in the setting of advanced, unresectable, disease - studies based in early stage or non-metastatic tumors separately from those based in advanced stage or metastatic tumors were included.

RESULTS

: EML4-ALK mutations are present in breast, colorectal, non-small cell lung cancer (NSCLC), renal and thyroid tumors. 57% of all incident cases of ALK-mutated cancers were in NSCLC, followed by breast cancer (23%). Of all the ALK positive incident cases, 36% were diagnosed metastatic. In total, it is estimated that of the 636,800 cases of cancer in 2018, 19,800 have ALK positive mutations.

CONCLUSIONS

: ALK-mutations are found in multiple tumor sites, and collectively represent 19,800 cases of cancer in 2018 in US.