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Showing content from https://pubmed.ncbi.nlm.nih.gov/23816960/ below:

Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations

Clinical Trial

. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations James Chih-Hsin Yang, Nobuyuki Yamamoto, Kenneth O'Byrne, Vera Hirsh, Tony Mok, Sarayut Lucien Geater, Sergey Orlov, Chun-Ming Tsai, Michael Boyer, Wu-Chou Su, Jaafar Bennouna, Terufumi Kato, Vera Gorbunova, Ki Hyeong Lee, Riyaz Shah, Dan Massey, Victoria Zazulina, Mehdi Shahidi, Martin Schuler

Affiliations

Affiliation

¹ Lecia V. Sequist, Massachusetts General Hospital and Harvard Medical School, Boston, MA; James Chih-Hsin Yang, National Taiwan University Hospital; Chun-Ming Tsai, Taipei Veterans General Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan; Nobuyuki Yamamoto, Shizuoka Cancer Center, Shizuoka; Terufumi Kato, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan; Kenneth O'Byrne, St James' Hospital, Dublin, Ireland; Vera Hirsh, McGill University, Montreal, Quebec, Canada; Tony Mok, Prince of Wales Hospital, Hong Kong, China; Sarayut Lucien Geater, Songklanagarind Hospital, Songkla, Thailand; Sergey Orlov, Pavlov State Medical University, St Petersburg; Vera Gorbunova, GU Russian Oncological Research Centre, Moscow, Russia; Michael Boyer, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Jaafar Bennouna, Institut de Cancérologie de l'Ouest-site René Gauducheau, Nantes, France; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju, South Korea; Riyaz Shah, Maidstone and Tunbridge Wells National Health Service Trust, Maidstone Hospital, Maidstone; Dan Massey, Victoria Zazulina, and Mehdi Shahidi, Boehringer Ingelheim, Bracknell, United Kingdom; and Martin Schuler, West German Cancer Center, University of Duisburg-Essen, Essen, Germany.

PMID: 23816960
DOI: 10.1200/JCO.2012.44.2806

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Clinical Trial

Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations

Lecia V Sequist et al. J Clin Oncol. 2013.

. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1. Authors Lecia V Sequist¹, James Chih-Hsin Yang, Nobuyuki Yamamoto, Kenneth O'Byrne, Vera Hirsh, Tony Mok, Sarayut Lucien Geater, Sergey Orlov, Chun-Ming Tsai, Michael Boyer, Wu-Chou Su, Jaafar Bennouna, Terufumi Kato, Vera Gorbunova, Ki Hyeong Lee, Riyaz Shah, Dan Massey, Victoria Zazulina, Mehdi Shahidi, Martin Schuler Affiliation

¹ Lecia V. Sequist, Massachusetts General Hospital and Harvard Medical School, Boston, MA; James Chih-Hsin Yang, National Taiwan University Hospital; Chun-Ming Tsai, Taipei Veterans General Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan; Nobuyuki Yamamoto, Shizuoka Cancer Center, Shizuoka; Terufumi Kato, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan; Kenneth O'Byrne, St James' Hospital, Dublin, Ireland; Vera Hirsh, McGill University, Montreal, Quebec, Canada; Tony Mok, Prince of Wales Hospital, Hong Kong, China; Sarayut Lucien Geater, Songklanagarind Hospital, Songkla, Thailand; Sergey Orlov, Pavlov State Medical University, St Petersburg; Vera Gorbunova, GU Russian Oncological Research Centre, Moscow, Russia; Michael Boyer, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Jaafar Bennouna, Institut de Cancérologie de l'Ouest-site René Gauducheau, Nantes, France; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju, South Korea; Riyaz Shah, Maidstone and Tunbridge Wells National Health Service Trust, Maidstone Hospital, Maidstone; Dan Massey, Victoria Zazulina, and Mehdi Shahidi, Boehringer Ingelheim, Bracknell, United Kingdom; and Martin Schuler, West German Cancer Center, University of Duisburg-Essen, Essen, Germany.

PMID: 23816960
DOI: 10.1200/JCO.2012.44.2806

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Abstract

Purpose: The LUX-Lung 3 study investigated the efficacy of chemotherapy compared with afatinib, a selective, orally bioavailable ErbB family blocker that irreversibly blocks signaling from epidermal growth factor receptor (EGFR/ErbB1), human epidermal growth factor receptor 2 (HER2/ErbB2), and ErbB4 and has wide-spectrum preclinical activity against EGFR mutations. A phase II study of afatinib in EGFR mutation-positive lung adenocarcinoma demonstrated high response rates and progression-free survival (PFS).

Patients and methods: In this phase III study, eligible patients with stage IIIB/IV lung adenocarcinoma were screened for EGFR mutations. Mutation-positive patients were stratified by mutation type (exon 19 deletion, L858R, or other) and race (Asian or non-Asian) before two-to-one random assignment to 40 mg afatinib per day or up to six cycles of cisplatin plus pemetrexed chemotherapy at standard doses every 21 days. The primary end point was PFS by independent review. Secondary end points included tumor response, overall survival, adverse events, and patient-reported outcomes (PROs).

Results: A total of 1,269 patients were screened, and 345 were randomly assigned to treatment. Median PFS was 11.1 months for afatinib and 6.9 months for chemotherapy (hazard ratio [HR], 0.58; 95% CI, 0.43 to 0.78; P = .001). Median PFS among those with exon 19 deletions and L858R EGFR mutations (n = 308) was 13.6 months for afatinib and 6.9 months for chemotherapy (HR, 0.47; 95% CI, 0.34 to 0.65; P = .001). The most common treatment-related adverse events were diarrhea, rash/acne, and stomatitis for afatinib and nausea, fatigue, and decreased appetite for chemotherapy. PROs favored afatinib, with better control of cough, dyspnea, and pain.

Conclusion: Afatinib is associated with prolongation of PFS when compared with standard doublet chemotherapy in patients with advanced lung adenocarcinoma and EGFR mutations.

Trial registration: ClinicalTrials.gov NCT00949650.

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Republished in

Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations.
Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Sequist LV, et al. J Clin Oncol. 2023 Jun 1;41(16):2869-2876. doi: 10.1200/JCO.22.02547. J Clin Oncol. 2023. PMID: 37235976 Clinical Trial.

Comment in

Epidermal growth factor receptor inhibition in mutation-positive non-small-cell lung cancer: is afatinib better or simply newer?
Langer CJ. Langer CJ. J Clin Oncol. 2013 Sep 20;31(27):3303-6. doi: 10.1200/JCO.2013.49.8782. Epub 2013 Aug 26. J Clin Oncol. 2013. PMID: 23980079 No abstract available.
Do we really need another epidermal growth factor receptor tyrosine kinase inhibitor in first-line treatment for patients with non-small-cell lung cancer and EGFR mutations?
Haspinger ER, Garassino MC, Torri V, Cinquini M, De Braud F, Gelsomino F. Haspinger ER, et al. J Clin Oncol. 2014 Mar 10;32(8):859-63. doi: 10.1200/JCO.2013.52.8794. Epub 2014 Feb 3. J Clin Oncol. 2014. PMID: 24493720 No abstract available.
Afatinib-related nonhematologic adverse events: is common evaluation enough for now?
de Marinis F, Passaro A. de Marinis F, et al. J Clin Oncol. 2014 Mar 10;32(8):864-5. doi: 10.1200/JCO.2013.52.4538. Epub 2014 Feb 3. J Clin Oncol. 2014. PMID: 24493732 No abstract available.
Reply to F. De Marinis et al.
Yang JC, Sequist LV. Yang JC, et al. J Clin Oncol. 2014 Mar 10;32(8):865. doi: 10.1200/JCO.2013.54.1904. Epub 2014 Feb 3. J Clin Oncol. 2014. PMID: 24493733 No abstract available.
Reply to E.R. Haspinger et al.
Yang JC, Sequist LV. Yang JC, et al. J Clin Oncol. 2014 Mar 10;32(8):863-4. doi: 10.1200/JCO.2013.54.1920. Epub 2014 Feb 3. J Clin Oncol. 2014. PMID: 24493734 No abstract available.