Phase III trial of afatinib vs erlotinib in patients (pts) with squamous cell ca
PUBLISHED: 2015-11-26  594 total views, 1 today

Shun Lu1, Wei Li2,Caicun Zhou3, Shukui Qin4, Chengping Hu5, Kihyeong Lee6Young joo Min7, Jin-hyoung Kang8,Jong-seok Lee9, James Chih-hsin Yang10Chin chou Wang11, Chun-ming Tsai12,Chun-liang Lai13, Bushi Wang14Vikram 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

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