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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 1/2015

01-07-2015 | Original Article

Phase II study of erlotinib in elderly patients with non-small cell lung cancer harboring epidermal growth factor receptor mutations

Authors: Yusuke Inoue, Naoki Inui, Kazuhiro Asada, Masato Karayama, Hiroyuki Matsuda, Koshi Yokomura, Naoki Koshimizu, Shiro Imokawa, Takashi Yamada, Toshihiro Shirai, Norio Kasamatsu, Takafumi Suda

Published in: Cancer Chemotherapy and Pharmacology | Issue 1/2015

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Abstract

Purpose

Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors are key drugs in the treatment of non-small cell lung cancer (NSCLC) harboring EGFR activating mutations. We assessed the efficacy and safety of one EGFR tyrosine kinase inhibitor, erlotinib, in elderly Japanese patients with EGFR-mutated NSCLC.

Methods

Elderly patients aged 75 or older with advanced or recurrent NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) were enrolled in this prospective phase II trial. Patients received 150 mg erlotinib per day orally. The primary end point was the overall response rate.

Results

Between March 2013 and November 2014, 32 patients were enrolled with median age 80 years. All tumors had adenocarcinoma histology, and 20 patients (62.5 %) had an L858R mutation. The response rate was 56.3 % [95 % confidence interval (CI) 39.4–72.0 %], and the disease control rate was 90.6 % (95 % CI 75.2–97.6 %). Median progression-free survival was 15.5 months (95 % CI 11.2–not reached). Skin disorder was the most common adverse event, and grade 4 drug-related interstitial lung disease occurred in one patient.

Conclusions

Erlotinib is effective and tolerated in elderly patients with EGFR mutation-positive NSCLC.
Literature
1.
Torre LA, Bray F, Siegel RL et al (2015) Global cancer statistics, 2012. CA Cancer J Clin 65:87–108PubMedCrossRef
2.
3.
Ershler WB, Longo DL (1997) Aging and cancer: issues of basic and clinical science. J Natl Cancer Inst 89:1489–1497PubMedCrossRef
4.
Gridelli C, Shepherd FA (2005) Chemotherapy for elderly patients with non-small cell lung cancer: a review of the evidence. Chest 128:947–957PubMedCrossRef
5.
Owonikoko TK, Ragin CC, Belani CP et al (2007) Lung cancer in elderly patients: an analysis of the surveillance, epidemiology, and end results database. J Clin Oncol 25:5570–5577PubMedCrossRef
6.
Lynch TJ, Bell DW, Sordella R et al (2004) Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 350:2129–2139PubMedCrossRef
7.
Serizawa M, Koh Y, Kenmotsu H et al (2014) Assessment of mutational profile of Japanese lung adenocarcinoma patients by multitarget assays. Cancer 120:1471–1481PubMed
8.
Mitsudomi T, Morita S, Yatabe Y et al (2010) 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 11:121–128PubMedCrossRef
9.
Maemondo M, Inoue A, Kobayashi K et al (2010) Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 362:2380–2388PubMedCrossRef
10.
Zhou C, Wu YL, Chen G et al (2011) 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 12:735–742PubMedCrossRef
11.
Rosell R, Carcereny E, Gervais R et al (2012) 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 13:239–246PubMedCrossRef
12.
Yang JC, Wu YL, Schuler M et al (2015) 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. Lancet Oncol 16:141–151PubMedCrossRef
13.
Maemondo M, Minegishi Y, Inoue A et al (2012) First-line gefitinib in patients aged 75 or older with advanced non-small cell lung cancer harboring epidermal growth factor receptor mutations: NEJ 003 study. J Thorac Oncol 7:1417–1422PubMedCrossRef
14.
Tateishi K, Ichiyama T, Hirai K et al (2013) Clinical outcomes in elderly patients administered gefitinib as first-line treatment in epidermal growth factor receptor-mutated non-small-cell lung cancer: retrospective analysis in a Nagano Lung Cancer Research Group study. Med Oncol 30:450PubMedCrossRef
15.
Takahashi K, Saito H, Hasegawa Y et al (2014) First-line gefitinib therapy for elderly patients with non-small cell lung cancer harboring EGFR mutation: Central Japan Lung Study Group 0901. Cancer Chemother Pharmacol 74:721–727PubMedCrossRef
16.
Shepherd FA, Rodrigues Pereira J et al (2005) Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123–132PubMedCrossRef
17.
Matsuura S, Inui N, Ozawa Y et al (2011) Phase II study of erlotinib as third-line monotherapy in patients with advanced non-small-cell lung cancer without epidermal growth factor receptor mutations. Jpn J Clin Oncol 41:959–963PubMedCrossRef
18.
Cappuzzo F, Ciuleanu T, Stelmakh L et al (2010) Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 11:521–529PubMedCrossRef
19.
Horiike A, Nishio M, Goto K et al (2012) A phase II study of erlotinib as first-line treatment in Japanese advanced NSCLC patients harboring EGFR mutations. Ann Oncol 23:ix413
20.
Kusagaya H, Inui N, Karayama M et al (2012) Biweekly combination therapy with gemcitabine and carboplatin compared with gemcitabine monotherapy in elderly patients with advanced non-small-cell lung cancer: a randomized, phase-II study. Lung Cancer 77:550–555PubMedCrossRef
21.
Sakakibara T, Inoue A, Sugawara S et al (2010) Randomized phase II trial of weekly paclitaxel combined with carboplatin versus standard paclitaxel combined with carboplatin for elderly patients with advanced non-small-cell lung cancer. Ann Oncol 21:795–799PubMedCrossRef
22.
23.
Langer CJ, Manola J, Bernardo P et al (2002) Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: implications of Eastern Cooperative Oncology Group 5592, a randomized trial. J Natl Cancer Inst 94:173–181PubMedCrossRef
24.
Jackman DM, Yeap BY, Lindeman NI et al (2007) Phase II clinical trial of chemotherapy-naive patients ≥70 years of age treated with erlotinib for advanced non-small-cell lung cancer. J Clin Oncol 25:760–766PubMedCrossRef
25.
Wheatley-Price P, Ding K, Seymour L et al (2008) Erlotinib for advanced non-small-cell lung cancer in the elderly: an analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 26:2350–2357PubMedCrossRef
26.
Chen YM, Tsai CM, Fan WC et al (2012) Phase II randomized trial of erlotinib or vinorelbine in chemonaive, advanced, non-small cell lung cancer patients aged 70 years or older. J Thorac Oncol 7:412–418PubMedCrossRef
27.
Fujita S, Katakami N, Masago K et al (2012) Customized chemotherapy based on epidermal growth factor receptor mutation status for elderly patients with advanced non-small-cell lung cancer: a phase II trial. BMC Cancer 12:185PubMedCentralPubMedCrossRef
28.
De Ruysscher D, Botterweck A, Dirx M et al (2009) Eligibility for concurrent chemotherapy and radiotherapy of locally advanced lung cancer patients: a prospective, population-based study. Ann Oncol 20:98–102PubMedCrossRef
29.
Goto K, Nishio M, Yamamoto N et al (2013) A prospective, phase II, open-label study (JO22903) of first-line erlotinib in Japanese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small-cell lung cancer (NSCLC). Lung Cancer 82:109–114PubMedCrossRef
30.
Yoshioka H, Komuta K, Imamura F et al (2014) Efficacy and safety of erlotinib in elderly patients in the phase IV POLARSTAR surveillance study of Japanese patients with non-small-cell lung cancer. Lung Cancer 86:201–206PubMedCrossRef
31.
Fukuhara T, Maemondo M, Inoue A et al (2015) Factors associated with a poor response to gefitinib in the NEJ002 study: smoking and the L858R mutation. Lung Cancer 88:181–186PubMedCrossRef
32.
Rosell R, Moran T, Queralt C et al (2009) Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 361:958–967PubMedCrossRef
33.
Kudoh S, Kato H, Nishiwaki Y et al (2008) Interstitial lung disease in Japanese patients with lung cancer—a cohort and nested case–control study. Am J Respir Crit Care Med 177:1348–1357PubMedCrossRef
Metadata
Title
Phase II study of erlotinib in elderly patients with non-small cell lung cancer harboring epidermal growth factor receptor mutations
Authors
Yusuke Inoue
Naoki Inui
Kazuhiro Asada
Masato Karayama
Hiroyuki Matsuda
Koshi Yokomura
Naoki Koshimizu
Shiro Imokawa
Takashi Yamada
Toshihiro Shirai
Norio Kasamatsu
Takafumi Suda
Publication date
01-07-2015
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 1/2015
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-015-2784-x

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