Shun Lu¹, Wei Li²,Caicun Zhou³, Shukui Qin⁴, Chengping Hu⁵, Kihyeong Lee⁶, Young joo Min⁷, Jin-hyoung Kang⁸,Jong-seok Lee⁹, James Chih-hsin Yang¹⁰, Chin chou Wang¹¹, Chun-ming Tsai¹²,Chun-liang Lai¹³, Bushi Wang¹⁴, Vikram Chand¹⁴, Glenwood Goss¹⁵,Jean-charles Soria¹⁶

¹Shanghai Lung CancerCenter, Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong UniversitySchool of Medicine, China, ²First Hospital Affiliated to JilinUniversity, ³Shanghai Pulmonary Hospital, Tongji University, ⁴the81th Hospital of PLA, China, ⁵Xiangya Hospital ofCentral South University, ⁶Chungbuk National University Hospital, ⁷UlsanUniversity Hospital, ⁸Seoul st. Mary’s Hospital, ⁹SeoulNational University Budang Hospital, ¹⁰National Taiwan UniversityHospital, ¹¹Kaohsiung Chang Gung Memorial Hospital, ¹2TaipeiVeterans General Hospital, ¹³Buddhist Tzu Chi General Hospital, ¹⁴BoehringerIngelheim Pharmaceuticals, ¹⁵Division of Medical Oncology,Universityof Ottawa, ¹⁶GustaveRoussy Cancer Campus

Objective:Treatment options for pts with advancedSCC of the lung progressing after platinum-based chemotherapy are limited. Overexpression of EGFR, other ErbB receptors and the dysregulation of their down streampathways are implicated in SCC pathobiology. Here we present key efficacy andsafety data at the time of primary OS analysis of the LUX-Lung 8 Phase IIItrial that prospectively compared afatinib (A) and erlotinib (E) in pts withSCC of the lung following failure of first-line chemotherapy. Outcomes ineastern Asian pts are also reported. 

Method: Pts with stage IIIB/IVdisease were randomized 1: 1 (stratified by race: eastern Asian vs non-easternAsian) to receive daily A (40mg, n=398) or E (150mg, n=397) until diseaseprogression. Primary endpoint: PFS. Key secondary endpoint: overall survival(OS). Other endpoints: objective response (ORR), disease control (DCR),patient-reported outcomes and safety. 

Result: OS was significantlyimproved with A vs E; median 7.9 vs 6.8 months (mos), HR 0.81 [95%CI,0.69–0.95], P=0.008. PFS (independent central review [ICR]) median 2.6vs 1.9 mos, HR 0.81 [95%CI, 0.69–0.96], P=0.010, ORR (ICR: 5.5 vs 2.8%; P=0.055)and DCR (ICR: 50.5 vs 39.5%; P=0.002) were all better for A vsE. More pts had significantly improved global health status/quality oflife (35.7 vs 28.3%; P=0.041) with A than E. Adverse event (AE)frequency was similar with A and E (99.5 vs 97.5%; grade ≥3: 57.1 vs 57.5%). Atotal of 172 eastern Asian pts were treated (A: 86; E: 86). Efficacy in theeastern Asian subgroup was also improved with A vs E (OS: median 9.6 vs 7.2mos, HR 0.62 [95% CI, 0.44–0.88], P=0.0065; PFS: median 2.8 vs 1.9 mos,HR 0.54 [95%CI, 0.37–0.79], P=0.0006; ORR: 8.1 vs 7.0%, P=0.7738;DCR: 54.7 vs 37.2%, P=0.0228). In eastern Asian pts the overall AEprofile was similar to the main population, and grade ≥3 AE frequency wassimilar for A (52.3%) and E (54.1%). 

Conclusion: OS was improved with Avs E in pts with SCC of the lung in a second-line treatment setting, both inthe overall treated set and the eastern Asian subgroup. Overall PFS, ORR andDCR were also better with A than E. Based on LUX-Lung 8, afatinib should bepreferred over erlotinib in these pts.

Key Words: afatinib  erlotinib squamous cell carcinoma