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DOI: 10.4103/2278-330X.202573
Efficacy of erlotinib as first-line maintenance therapy in patients with locally advanced or metastatic nonsmall cell lung cancer who have not experienced disease progression or unacceptable toxicity during chemotherapy
Financial support and sponsorship: This study was funded by Roche Products (India) Pvt. Ltd. (ClinicalTrials.gov number, NCT01230710 and Roche Protocol ID, ML25478).![](https://www.thieme-connect.de/media/10.1055-s-00049561/201701/lookinside/thumbnails/10-4103_2278-330x-202573_001-1.jpg)
Abstract
Bacground: First-line maintenance with erlotinib in nonsmall cell lung cancer (NSCLC) patients without progression after four cycles of chemotherapy was well tolerated and significantly prolonged progression-free survival (PFS) compared with placebo. Aim and Design: This open-label, single arm, Phase IV, interventional study was designed to evaluate erlotinib as first-line maintenance after chemotherapy in Indian NSCLC patients. Primary efficacy objective was to evaluate PFS rate (PFSR) at week 52 and secondary objectives were determination of PFS, overall survival (OS), overall response rate (ORR), disease control rate, and safety. Subjects and Methods: Patients were treated with erlotinib until disease progression/death/unacceptable toxicity or end of study. Patients with disease progression underwent scheduled clinical assessments every 12 weeks thereafter. Kaplan–Meier estimates were used to evaluate PFSR, PFS, and OS. The ORR was summarized using number and percentage along with two-sided 95% Clopper–Pearson confidence interval. The incidence of adverse events (AEs) and serious AEs (SAEs) was tabulated according to severity, outcome, and relationship to erlotinib. Results: Of the 51 enrolled patients, 47 patients completed the study (2: Continuing treatment, 41: Disease progression, and 4: Death) and four patients discontinued treatment (3: Lost to follow-up; 1: Withdrew consent). PFSR was 22.5% at 12 months, median PFS 99 days (14.14 weeks), and median OS was 671 days (22 months). The probability of OS was 74.5% at 14 months. The ORR was 25.5%, and disease control rate was 55.3%. AEs were reported in 62.7% and SAE in 7.8% of patients. Common AEs were diarrhea and rash. Conclusions: Erlotinib was well tolerated by Indian patients in first-line maintenance setting and resulted in median PFS of 14 weeks and median OS of 22 months better than previously reported and with no new safety concerns in this population.
Key words
Epidermal growth factor receptor-tyrosine kinase inhibitor - first-line maintenance therapy - nonsmall cell lung cancer - progression-free survival rate - targeted therapyPublikationsverlauf
Artikel online veröffentlicht:
22. Dezember 2020
© 2017. MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)
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References
-
1 Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://www.globocan.iarc.fr. [Last accessed on 2016 Jul 04].
-
2 Behera D, Balamugesh T. Lung cancer in India. Indian J Chest Dis Allied Sci 2004;46:269-81.
-
3 Tyldesley S, Boyd C, Schulze K, Walker H, Mackillop WJ. Estimating the need for radiotherapy for lung cancer: An evidence-based, epidemiologic approach. Int J Radiat Oncol Biol Phys 2001;49:973-85.
-
4 Chan BA, Hughes BG. Targeted therapy for non-small cell lung cancer: Current standards and the promise of the future. Transl Lung Cancer Res 2015;4:36-54.
-
5 Giaccone G, Gallegos Ruiz M, Le Chevalier T, Thatcher N, Smit E, Rodriguez JA, et al. Erlotinib for frontline treatment of advanced non-small cell lung cancer: A phase II study. Clin Cancer Res 2006;12 (20 Pt 1):6049-55.
-
6 Jackman DM, Yeap BY, Lindeman NI, Fidias P, Rabin MS, Temel J, et al. Phase II clinical trial of chemotherapy-naive patients>or=70 years of age treated with erlotinib for advanced non-small-cell lung cancer. J Clin Oncol 2007;25:760-6.
-
7 Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005;353:123-32.
-
8 Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczésna A, Juhász E, et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: A multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 2010;11:521-9.
-
9 Brand TM, Dunn EF, Iida M, Myers RA, Kostopoulos KT, Li C, et al. Erlotinib is a viable treatment for tumors with acquired resistance to cetuximab. Cancer Biol Ther 2011;12:436-46.
-
10 Gatzemeier U, Pluzanska A, Szczesna A, Kaukel E, Roubec J, De Rosa F, et al. Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: The Tarceva Lung Cancer Investigation Trial. J Clin Oncol 2007;25:1545-52.
-
11 Bareschino MA, Schettino C, Rossi A, Maione P, Sacco PC, Zeppa R, et al. Treatment of advanced non small cell lung cancer. J Thorac Dis 2011;3:122-33.
-
12 EPAR Assessment Report Tarceva Procedure No. EMEA/H/C/000618/II/0043; 17 December, 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-Variation/human/000618/WC500203053.pdf. [Last accessed on 2016 Jul 05].