Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): A randomised, double-blind, phase 3 trial

The Lancet Oncology

Volumn 15, Issue 12, 2014, Pages 1369-1378

  Ramalingam, Suresh S ^a   Jänne, Pasi A ^b   Mok, Tony ^c   O'Byrne, Kenneth ^d   Boyer, Michael J ^e   Von Pawel, Joachim ^f   Pluzanski, Adam ^g   Shtivelband, Mikhail ^h   Docampo, Lara Iglesias ⁱ   Bennouna, Jaafar ^j   Zhang, Hui ^k   Liang, Jane Q ^k   Doherty, Jim P ^l   Taylor, Ian ^k   Mather, Cecile B ^k   Goldberg, Zelanna ^k   O'Connell, Joseph ^l   Paz Ares, Luis ^m  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^d PRINCESS ALEXANDRA HOSPITAL   (Australia)

^e ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^f Asklepios Fachkliniken   (Germany)

^g INSTITUTE OF ONCOLOGY   (Poland)

^h Ironwood Cancer and Research Center   (United States)

ⁱ HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^j Institut de Cancerologie de I'Ouest ^*  (France)

^k PFIZER INC   (United States)

^l Pfizer Ltd   (United States)

^m HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DACOMITINIB; ERLOTINIB; K RAS PROTEIN; PLACEBO; EGFR PROTEIN, HUMAN; EPIDERMAL GROWTH FACTOR RECEPTOR; KRAS PROTEIN, HUMAN; ONCOPROTEIN; PROTEIN KINASE INHIBITOR; QUINAZOLINE DERIVATIVE; QUINAZOLINONE DERIVATIVE; RAS PROTEIN;

ACNE; ADULT; ADVANCED CANCER; AGED; ARTICLE; ASIAN; CANCER GROWTH; CANCER STAGING; CONTROLLED STUDY; DECREASED APPETITE; DERMATITIS; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG WITHDRAWAL; DRY SKIN; ETHNIC DIFFERENCE; FATIGUE; FEMALE; FOLLOW UP; HEART ARREST; HISTOPATHOLOGY; HUMAN; INDIAN; INTERSTITIAL LUNG DISEASE; KARNOFSKY PERFORMANCE STATUS; LUNG ADENOCARCINOMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PARONYCHIA; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SMOKING; STOMATITIS; SURVIVAL TIME; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; WILD TYPE; ANTAGONISTS AND INHIBITORS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; DISEASE FREE SURVIVAL; GENETICS; MIDDLE AGED; PATHOLOGY;

ADULT; AGED; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM STAGING; PROTEIN KINASE INHIBITORS; PROTO-ONCOGENE PROTEINS; QUINAZOLINES; QUINAZOLINONES; RAS PROTEINS; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 84908616654     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70452-8     Document Type: Article

References (16)

1. Johnson DH, Schiller JH, Bunn PA Recent clinical advances in lung cancer management. J Clin Oncol 2014, 32:973-982.
2. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005, 353:123-132.
3. Cappuzzo F, Ciuleanu T, Stelmakh L, et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 2010, 11:521-529.
4. Lynch TJ, Bell DW, Sordella R, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004, 350:2129-2139.
5. 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.
6. 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.
7. Kobayashi S, Boggon TJ, Dayaram T, et al. EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. N Engl J Med 2005, 352:786-792.
8. Engelman JA, Zejnullahu K, Mitsudomi T, et al. MET amplification leads to gefitinib resistance in lung cancer by activating ERBB3 signaling. Science 2007, 316:1039-1043.
9. Gonzales AJ, Hook KE, Althaus IW, et al. Antitumor activity and pharmacokinetic properties of PF-00299804, a second-generation irreversible pan-erbB receptor tyrosine kinase inhibitor. Mol Cancer Ther 2008, 7:1880-1889.
10. Engelman JA, Zejnullahu K, Gale CM, et al. PF00299804, an irreversible pan-ERBB inhibitor, is effective in lung cancer models with EGFR and ERBB2 mutations that are resistant to gefitinib. Cancer Res 2007, 67:11924-11932.
11. Reckamp KL, Giaccone G, Camidge DR, et al. A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung cancer after failure of prior chemotherapy and erlotinib. Cancer 2014, 120:1145-1154.
12. Ellis PM, Shepherd FA, Millwaråd M, et al. Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): a double-blind, randomised, phase 3 trial. Lancet Oncol 2014, published online Oct 14. http://dx.doi.org/10.1016/S1470-2045(14)70472-3.
13. Ramalingam SS, Blackhall F, Krzakowski M, et al. Randomized phase II study of dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor inhibitor, versus erlotinib in patients with advanced non-small-cell lung cancer. J Clin Oncol 2012, 30:3337-3344.
14. Kris MG, Mok T, Ou SH, et al. First-line dacomitinib (PF-00299804), an irreversible pan-HER tyrosine kinase inhibitor, for patients with EGFR-mutant lung cancers. Proc Am Soc Oncol 2012, 30:7530. (abstr).
15. Garassino MC, Martelli O, Broggini M, et al. Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): a randomised controlled trial. Lancet Oncol 2013, 14:981-988.
16. Lee JK, Hahn S, Kim DW, et al. Epidermal growth factor receptor tyrosine kinase inhibitors vs conventional chemotherapy in non-small cell lung cancer harboring wild-type epidermal growth factor receptor: a meta-analysis. JAMA 2014, 311:1430-1437.