2017 ASCO Annual Meeting!
Session: Head and Neck Cancer
Type: Oral Abstract Session
Time: Monday June 5, 8:00 AM to 11:00 AM
LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts).
Head and Neck Cancer
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr 6001)
Author(s): Barbara Burtness, Robert I. Haddad, José Dinis, Jose Manuel Trigo Perez, Tomoya Yokota, Luciano De Souza Viana, Ilya Romanov, Jan Baptist Vermorken, Jean Bourhis, Makoto Tahara, J.G.M. Segalla, Amanda Psyrri, Irina Vasilevskaya, Chaitali Singh Nangia, Manuel Chaves-Conde, Bushi Wang, Neil Gibson, Eva Ehrnrooth, Kevin Harrington, Ezra E.W. Cohen, On Behalf of the LUX-Head and Neck 2 Investigators; Yale School of Medicine, New Haven, CT; Dana-Farber Cancer Institute, Boston, MA; Instituto Português de Oncologia de Lisboa, Porto, Portugal; Hospital Virgen de la Victoria, Malaga, Spain; Shizuoka Cancer Center, Shizuoka, Japan; Hospital Marcio Cunha, Ipatinga, Brazil; Russian Oncological Research Centre, Moscow, Russia; Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium; Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan; Hospital Amaral Carvalho, Jau, Brazil; University General Hospital Attikon, National and Kapodistrian University of Athens, Athens, Greece; Oncology Center of Moskovskiy, St. Petersburg, Russian Federation; University of California Irvine Comprehensive Cancer Center, Orange, CA; Hospital Virgen del Rocío, Seville, Spain; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT; Boehringer Ingelheim Pharma GmbH and Co. KG, Biberach, Germany; TA Oncology, Boehringer Ingelheim, Denmark A/S, Copenhagen, Denmark; The Institute of Cancer Research, London, United Kingdom; University of California, San Diego, La Jolla, CA
Background: Locally advanced HNSCC is treated curatively, but recurrence is common. In HNSCC, EGFR is richly expressed and EGFR inhibition is validated treatment (tx); the ErbB family blocker afatinib (A) showed efficacy in recurrent/metastatic disease. This Phase III trial assessed if A after definitive CRT improves disease-free survival (DFS). Methods: Eligible pts had complete response after CRT ≥66 Gy (or equivalent) with concurrent cisplatin or carboplatin but not prior EGFR inhibition, for HNSCC of oral cavity, hypopharynx, larynx, or oropharynx with >10 pack years (pk yrs) tobacco use. Pts were stratified by ECOG PS (0/1) and nodal stage (N0–2a/N2b–3), and randomized 2:1 to A 40 mg/d or placebo (P); tx continued for 18 m if tolerated, or until disease recurrence. The primary endpoint was DFS. Results: Of 669 pts planned, 617 were randomized; A 411, P 206. Median age was 58 yrs; 86% were male; 65% ECOG PS 0; most had smoked (A/P ex-smoker: 66/72%; current: 28/22%). Subsites (A/P) were: oropharynx 53/54%; hypopharynx 21/23%; larynx 18/12%; oral cavity 9/10%. The majority had T3 or 4 (A/P 70/68%) and N2 disease (67/63%). Accrual was halted for futility on independent DMC recommendation: at a pre-planned interim analysis (40% of DFS events), median DFS was A 43.4 m vs P not reached (NR; HR 1.13 [95% CI 0.81–1.57], p=0.48); the Table shows key subgroups. Median treatment duration was A 300.0 d, P 455.5 d. Recurrence was A 23%, P 23%. Dose reduction of A was required in 53% (mostly due to diarrhea, stomatitis). Tx was discontinued due to AEs in A 15%, P 4%. Conclusions: A after CRT did not improve DFS vs P. Subgroup analyses were underpowered to provide definitive conclusions. Harrington and Cohen contributed equally. Clinical trial information: NCT01345669
|Subgroup||n||Median DFS, m||HR, A vs P [95% CI]|
|Tobacco, pk yrs|
2. Concurrent chemoradiotherapy with 3-weekly versus weekly cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma: A phase 3 multicentre randomised controlled trial (ChiCTR-TRC-12001979).