PMID- 34788123 OWN - NLM STAT- MEDLINE DCOM- 20220421 LR - 20220531 IS - 2687-8941 (Electronic) IS - 2687-8941 (Linking) VI - 7 DP - 2021 Sep TI - Real-World Data on the Prevalence of Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer in the Middle East and North Africa. PG - 1556-1563 LID - 10.1200/GO.21.00067 [doi] LID - GO.21.00067 AB - PURPOSE: Anaplastic lymphoma kinase (ALK) gene alterations are potent oncogenic drivers in non-small-cell lung cancer (NSCLC). Tyrosine kinase inhibitors targeting the ALK pathway are effective in treating ALK-positive NSCLC. Around 5% of Asian and White patients with NSCLC have ALK-positive tumors, but ALK rearrangement prevalence data in the Middle East and North Africa (MENA) region are limited. METHODS: In this noninterventional epidemiology study, histologically confirmed nonsquamous NSCLC samples retained for < 5 years in tissue banks at six centers in MENA were retrospectively analyzed for ALK rearrangement using the VENTANA immunohistochemistry (IHC) method. Patient characteristics obtained were analyzed for association with ALK rearrangement. Concordance between IHC and Vysis fluorescence in situ hybridization (FISH) ALK detection methods was assessed in a subset of samples. RESULTS: Four hundred forty-eight tissue samples were analyzed using IHC: 137 (30.6%) in Lebanon, 104 (23.2%) in Saudi Arabia, 97 (21.7%) in Egypt, 80 (17.9%) in the United Arab Emirates, and 30 (6.7%) in Morocco. On the basis of IHC, the prevalence was 8.7% (95% CI, 6.3 to 11.7) for ALK-positivity and 91.3% (95% CI, 88.3 to 93.7) for ALK-negativity. On the basis of FISH (n = 148), the prevalence was 5.4% positivity and 81.8% negativity (12.8% nonevaluable). Concordance between IHC and FISH (n = 129) was 98.4% (95% CI, 94.2 to 99.8) for negative agreement and 98.5% (95% CI, 94.5 to 99.8) for overall agreement. Univariate analysis showed that ALK rearrangement was significantly associated with epidermal growth factor receptor wild-type status (P = .03) but was not significantly associated with sex, race, smoking history, or histologic subtype. CONCLUSION: Our findings suggest that ALK rearrangements are more prevalent in MENA than other geographic regions. High concordance was found between FISH and IHC. Except for epidermal growth factor receptor wild-type status, no clinicopathologic characteristics were associated with ALK-positive NSCLC. FAU - Jazieh, Abdul Rahman AU - Jazieh AR AUID- ORCID: 0000-0001-5465-7698 AD - King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Ministry of National Guard Hospital, Riyadh, Saudi Arabia. FAU - Gaafar, Rabab AU - Gaafar R AD - National Cancer Institute, Cairo University, Cairo, Egypt. FAU - Errihani, Hassan AU - Errihani H AD - National Institute of Oncology, Mohammed V University, Rabat, Morocco. FAU - Jaafar, Hassan AU - Jaafar H AD - Sheikh Khalifa Specialty Hospital, Ras Al Khaimah, United Arab Emirates. FAU - Al Dayel, Fouad AU - Al Dayel F AD - King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. FAU - Bahnassy, Abeer A AU - Bahnassy AA AD - National Cancer Institute, Cairo University, Cairo, Egypt. FAU - El Kadi, Hatem AU - El Kadi H AD - Pfizer Inc, Africa and Middle East. FAU - Abdallah, Mohamed Magdy AU - Abdallah MM AUID- ORCID: 0000-0001-8031-6061 AD - Pfizer Inc, Egypt. FAU - Zaatari, Ghazi AU - Zaatari G AD - American University of Beirut Medical Center, Beirut, Lebanon. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - JCO Glob Oncol JT - JCO global oncology JID - 101760170 RN - EC 2.7.10.1 (ALK protein, human) RN - EC 2.7.10.1 (Anaplastic Lymphoma Kinase) RN - EC 2.7.10.1 (ErbB Receptors) RN - EC 2.7.10.1 (Receptor Protein-Tyrosine Kinases) SB - IM MH - Anaplastic Lymphoma Kinase/genetics/*metabolism MH - *Carcinoma, Non-Small-Cell Lung/epidemiology/genetics/metabolism MH - ErbB Receptors/genetics MH - Humans MH - In Situ Hybridization, Fluorescence MH - Lebanon/epidemiology MH - *Lung Neoplasms/epidemiology/genetics/metabolism MH - Prevalence MH - Receptor Protein-Tyrosine Kinases/genetics/metabolism MH - Retrospective Studies PMC - PMC8613346 COIS- Abdul Rahman JaziehStock and Other Ownership Interests: Innovative Healthcare InstituteResearch Funding: MSD Oncology, AstraZeneca, PfizerTravel, Accommodations, Expenses: Bristol Myers SquibbOther Relationship: MSD (Inst) Rabab GaafarConsulting or Advisory Role: Pfizer, AstraZeneca, MSD OncologyResearch Funding: Roche Hassan ErrihaniConsulting or Advisory Role: Pfizer, Roche, MSD, Merck, Janssen Oncology, AstraZenecaSpeakers' Bureau: Novartis, Amgen, Astellas Pharma, ServierResearch Funding: RocheTravel, Accommodations, Expenses: Pierre Fabre (Inst), Merck (Inst) Hatem El KadiEmployment: Pfizer Mohamed Magdy AbdallahEmployment: PfizerStock and Other Ownership Interests: PfizerResearch Funding: PfizerTravel, Accommodations, Expenses: PfizerNo other potential conflicts of interest were reported. EDAT- 2021/11/18 06:00 MHDA- 2022/04/22 06:00 PMCR- 2021/11/17 CRDT- 2021/11/17 17:14 PHST- 2021/11/17 17:14 [entrez] PHST- 2021/11/18 06:00 [pubmed] PHST- 2022/04/22 06:00 [medline] PHST- 2021/11/17 00:00 [pmc-release] AID - GO.21.00067 [pii] AID - 10.1200/GO.21.00067 [doi] PST - ppublish SO - JCO Glob Oncol. 2021 Sep;7:1556-1563. doi: 10.1200/GO.21.00067.