Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): Analysis of overall survival data from two randomised, phase 3 trials

The Lancet Oncology

Volumn 16, Issue 2, 2015, Pages 141-151

  Yang, James Chih Hsin ^a   Wu, Yi Long ^b   Schuler, Martin ^c   Sebastian, Martin ^d   Popat, Sanjay ^e   Yamamoto, Nobuyuki ^f   Zhou, Caicun ^g   Hu, Cheng Ping ^h   O'Byrne, Kenneth ⁱ   Feng, Jifeng ^j   Lu, Shun ^k   Huang, Yunchao ^l   Geater, Sarayut L ^m   Lee, Kye Young ⁿ   Tsai, Chun Ming ^o   Gorbunova, Vera ^p   Hirsh, Vera ^q   Bennouna, Jaafar ^r   Orlov, Sergey ^s   Mok, Tony ^t   Boyer, Michael ^u   Su, Wu Chou ^v   Lee, Ki Hyeong ^w   Kato, Terufumi ^x   Massey, Dan ^y   Shahidi, Mehdi ^y   Zazulina, Victoria ^y   Sequist, Lecia V ^z   more..

^a NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^b GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL   (China)

^c UNIVERSITY HOSPITAL ESSEN   (Germany)

^d UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^e ROYAL MARSDEN HOSPITAL   (United Kingdom)

^f WAKAYAMA MEDICAL UNIVERSITY   (Japan)

^g TONGJI UNIVERSITY   (China)

^h CENTRAL SOUTH UNIVERSITY   (China)

ⁱ QUEENSLAND UNIVERSITY OF TECHNOLOGY   (Australia)

^j JIANGSU CANCER HOSPITAL   (China)

^k SHANGHAI JIAO TONG UNIVERSITY   (China)

^l KUNMING MEDICAL UNIVERSITY   (China)

^m PRINCE OF SONGKLA UNIVERSITY   (Thailand)

ⁿ Konkuk University Hospital   (South Korea)

^o TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^p N N BLOKHIN RUSSIAN CANCER RESEARCH CENTER   (Russian Federation)

^q MCGILL UNIVERSITY   (Canada)

^r Institut de Cancérologie de l Ouest René Gauducheau   (France)

^s PAVLOV FIRST SAINT PETERSBURG STATE MEDICAL UNIVERSITY   (Russian Federation)

^t CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^u ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^v NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

^w Chungbuk National University Hospital   (South Korea)

^x Kanagawa Prefectural Cardiovascular and Respiratory Center Hospital   (Japan)

^y BOEHRINGER INGELHEIM LTD   (United Kingdom)

^z MASSACHUSETTS GENERAL HOSPITAL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AFATINIB; CISPLATIN; EPIDERMAL GROWTH FACTOR RECEPTOR; GEMCITABINE; PEMETREXED; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; EGFR PROTEIN, HUMAN; GLUTAMIC ACID DERIVATIVE; GUANINE; QUINAZOLINE DERIVATIVE;

ACNE; ADULT; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER STAGING; CANCER SURVIVAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DIARRHEA; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; EGFR GENE; ETHNIC GROUP; FATIGUE; FEMALE; GENE MUTATION; HUMAN; LEUKOPENIA; LUNG ADENOCARCINOMA; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NUCLEAR MAGNETIC RESONANCE IMAGING; OVERALL SURVIVAL; PARONYCHIA; PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; STOMATITIS; VOMITING; ADENOCARCINOMA; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; COMPARATIVE STUDY; FOLLOW UP; GENETICS; LUNG NEOPLASMS; MIDDLE AGED; MORTALITY; MUTATION; PATHOLOGY; PHASE 3 CLINICAL TRIAL; PROGNOSIS; SURVIVAL RATE; VERY ELDERLY;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DEOXYCYTIDINE; FEMALE; FOLLOW-UP STUDIES; GLUTAMATES; GUANINE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; MUTATION; NEOPLASM STAGING; PROGNOSIS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; SURVIVAL RATE;

EID: 84921892043     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)71173-8     Document Type: Article

References (30)

1. Mok T, Yang JJ, Lam KC Treating patients with EGFR-sensitizing mutations: first line or second line-is there a difference?. J Clin Oncol 2013, 31:1081-1088.
2. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009, 361:947-957.
3. Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010, 362:2380-2388.
4. Mitsudomi T, Morita S, Yatabe Y, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol 2010, 11:121-128.
5. Rosell R, Carcereny E, Gervais R, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol 2012, 13:239-246.
6. Zhou C, Wu YL, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 2011, 12:735-742.
7. Wu Y-L, Liam C-K, Zhou C, et al. First-line erlotinib versus cisplatin/gemcitabine (GP) in patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC): Interim analyses from the Phase 3, open-label, ENSURE study. J Thorac Oncol 2013, 8:S603. (abstr).
8. Han JY, Park K, Kim SW, et al. First-SIGNAL: first-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. J Clin Oncol 2012, 30:1122-1128.
9. Fukuoka M, Wu YL, Thongprasert S, et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol 2011, 29:2866-2874.
10. Yang J, Wu YL, Saijo S, et al. Efficacy outcomes in first-line treatment of advanced NSCLC with gefitinib (G) vs carboplatin/paclitaxel (C/P) by epidermal growth factor receptor (EGFR) gene-copy number score and by most common EGFR mutation subtypes-exploratory data from IPASS. Eur J Cancer 2011, 47:S633. (abstr).
11. Inoue A, Kobayashi K, Maemondo M, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naive non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol 2013, 24:54-59.
12. Mitsudomi T, Morita S, Yatabe Y, et al. Updated overall survival results of WJTOG 3405, a randomized phase III trial comparing gefitinib (G) with cisplatin plus docetaxel (CD) as the first-line treatment for patients with non-small cell lung cancer harboring mutations of the epidermal growth factor receptor (EGFR). Proc Am Soc Clin Oncol 2012, 30(suppl):7521. (abstr).
13. TARCEVA (erlotinib) tablets, for oral use [prescribing information] 2014 (accessed Aug 14, 2014). http://www.gene.com/download/pdf/tarceva_prescribing.pdf.
14. Zhou C, Wu YL, Liu X, et al. Overall survival (OS) results from OPTIMAL (CTONG0802), a phase III trial of erlotinib (E) versus carboplatin plus gemcitabine (GC) as first-line treatment for Chinese patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 2012, 30(suppl):7520. (abstr).
15. Yoshioka H, Mitsudomi T, Morita S, et al. Final overall survival results of WJTOG 3405, a randomized phase 3 trial comparing gefitinib (G) with cisplatin plus docetaxel (CD) as the first-line treatment for patients with non-small cell lung cancer (NSCLC) harboring mutations of the epidermal growth factor receptor (EGFR). Proc Am Soc Clin Oncol 2014, 32(suppl):8117. (abstr).
16. Lee CK, Brown C, Gralla RJ, et al. Impact of EGFR inhibitor in non-small cell lung cancer on progression-free and overall survival: a meta-analysis. J Natl Cancer Inst 2013, 105:595-605.
17. Yang JC, Shih JY, Su WC, et al. Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial. Lancet Oncol 2012, 13:539-548.
18. Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol 2013, 31:3327-3334.
19. Wu YL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol 2014, 15:213-222.
20. Yang JC, Hirsh V, Schuler M, et al. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol 2013, 31:3342-3350.
21. Collett D Modelling Survival Data in Medical Research 2003, Chapman & Hall/CRC CRC Press LLC, USA. Second Edition.
22. Shuster JJ Median follow-up in clinical trials. J Clin Oncol 1991, 9:191-192.
23. Rosell R, Moran T, Queralt C, et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009, 361:958-967.
24. Sharma SV, Bell DW, Settleman J, Haber DA Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer 2007, 7:169-181.
25. Jackman DM, Yeap BY, Sequist LV, et al. Exon 19 deletion mutations of epidermal growth factor receptor are associated with prolonged survival in non-small cell lung cancer patients treated with gefitinib or erlotinib. Clin Cancer Res 2006, 12:3908-3914.
26. Jackman DM, Miller VA, Cioffredi LA, et al. Impact of epidermal growth factor receptor and KRAS mutations on clinical outcomes in previously untreated non-small cell lung cancer patients: results of an online tumor registry of clinical trials. Clin Cancer Res 2009, 15:5267-5273.
27. Riely GJ, Pao W, Pham D, et al. Clinical course of patients with non-small cell lung cancer and epidermal growth factor receptor exon 19 and exon 21 mutations treated with gefitinib or erlotinib. Clin Cancer Res 2006, 12:839-844.
28. Ding PN, Gralla R, Inoue A, et al. Exon 19 deletions, smoking history and gender as additional predictive factors for treatment benefit with EGFR tyrosine kinase inhibitors in patients harbouring activating EGFR mutations: a meta-analysis of 1432 patients in six randomised trials. J Thorac Oncol 2013, 8. P1.11-003 (abstr).
29. Okabe T, Okamoto I, Tamura K, et al. Differential constitutive activation of the epidermal growth factor receptor in non-small cell lung cancer cells bearing EGFR gene mutation and amplification. Cancer Res 2007, 67:2046-2053.
30. Zhu JQ, Zhong WZ, Zhang GC, et al. Better survival with EGFR exon 19 than exon 21 mutations in gefitinib-treated non-small cell lung cancer patients is due to differential inhibition of downstream signals. Cancer Lett 2008, 265:307-317.