Erlotinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring EGFR mutations (JO25567): An open-label, randomised, multicentre, phase 2 study

The Lancet Oncology

Volumn 15, Issue 11, 2014, Pages 1236-1244

  Seto, Takashi ^a   Kato, Terufumi ^b   Nishio, Makoto ^c   Goto, Koichi ^d   Atagi, Shinji ^e   Hosomi, Yukio ^f   Yamamoto, Noboru ^g   Hida, Toyoaki ^h   Maemondo, Makoto ⁱ   Nakagawa, Kazuhiko ^j   Nagase, Seisuke ^k   Okamoto, Isamu ^l   Yamanaka, Takeharu ^m   Tajima, Kosei ⁿ   Harada, Ryosuke ⁿ   Fukuoka, Masahiro ^o   Yamamoto, Nobuyuki ^p  

^a NATIONAL KYUSHU CANCER CENTER   (Japan)

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

^c CANCER INSTITUTE HOSPITAL   (Japan)

^d NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^e NATIONAL HOSPITAL ORGANIZATION KINKI CHUO CHEST MEDICAL CENTER   (Japan)

^f TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

^g NATIONAL CANCER CENTER HOSPITAL   (Japan)

^h AICHI CANCER CENTER HOSPITAL   (Japan)

ⁱ Miyagi Cancer Center   (Japan)

^j KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^k TOKYO MEDICAL UNIVERSITY HOSPITAL   (Japan)

^l KYUSHU UNIVERSITY HOSPITAL   (Japan)

^m NATIONAL CANCER CENTER   (Japan)

ⁿ CHUGAI PHARMACEUTICAL CO LTD   (Japan)

^o Izumi Municipal Hospital   (Japan)

^p WAKAYAMA MEDICAL UNIVERSITY   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; QUINAZOLINE DERIVATIVE;

ADVANCED CANCER; AGED; ALOPECIA; ARTICLE; BLEEDING; BODY WEIGHT DISORDER; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RECURRENCE; CANCER STAGING; CHEMOTHERAPY INDUCED EMESIS; CONJUNCTIVITIS; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; DRUG WITHDRAWAL; DRY EYE; DRY SKIN; DYSGEUSIA; DYSPHONIA; EGFR GENE; FATIGUE; FEMALE; FUNCTIONAL STATUS; GENE ACTIVATION; GENE MUTATION; HEMOPTYSIS; HUMAN; HUMAN TISSUE; HYPERTENSION; INSOMNIA; JAPAN; LIVER DISEASE; MAJOR CLINICAL STUDY; MALAISE; MALE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAIL DISEASE; NAUSEA; NON SMALL CELL LUNG CANCER; OPEN STUDY; PARONYCHIA; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; STOMATITIS; SURVIVAL RATE; SURVIVAL TIME; UPPER RESPIRATORY TRACT INFECTION; WEIGHT REDUCTION; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; CLINICAL TRIAL; CONFIDENCE INTERVAL; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECTS; GENETICS; KAPLAN MEIER METHOD; LUNG NEOPLASMS; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MORTALITY; MUTATION; PATHOLOGY; PROGNOSIS; SURVIVAL; TREATMENT OUTCOME; TUMOR INVASION;

AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; CONFIDENCE INTERVALS; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; JAPAN; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MUTATION; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PROGNOSIS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 84908127948     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70381-X     Document Type: Article

References (32)

1. 10 facts about cancer WHO, (accessed June 26, 2014). http://www.who.int/features/factfiles/cancer/en/.
2. 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.
3. NCCN Drugs & Biologics Compendium (NCCN Compendium) National Comprehensive Cancer Network, (accessed June 26, 2014). http://ww.nccn.org/professionals/drug_compendium/content/contents.asp.
4. EGFR-TK mutation positive)-erlotinib (1st line) (TA258) National Institute for Health and Care Excellence: Lung cancer (non small cell, (accessed June 26, 2014). http://guidance.nice.org.uk/TA258.
5. 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.
6. 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.
7. 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.
8. Rosell R, Carcereny E, Gervais R, et al. Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica: 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.
9. 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. 2338.
10. 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.
11. 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.
12. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006, 355:2542-2550.
13. Reck M, von Pawel J, Zatloukal P, et al. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAiL. J Clin Oncol 2009, 27:1227-1234.
14. Niho S, Kunitoh H, Nokihara H, et al. Randomized phase II study of first-line carboplatin-paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer. Lung Cancer 2012, 76:362-367. for the JO19907 Study Group.
15. Herbst RS, O'Neill VJ, Fehrenbacher L, et al. Phase II study of efficacy and safety of bevacizumab in combination with chemotherapy or erlotinib compared with chemotherapy alone for treatment of recurrent or refractory non small-cell lung cancer. J Clin Oncol 2007, 25:4743-4750.
16. Herbst RS, Ansari R, Bustin F, et al. Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial. Lancet 2011, 377:1846-1854.
17. Herbst R, Stern H, Amler L Biomarker evaluation in the phase III, placebo-controlled, randomized BeTa Trial of bevacizumab and erlotinib for patients with advanced non-small cell lung cancer (NSCLC) after failure of standard 1st-line chemotherapy: correlation with treatment outcomes. J Thorac Oncol 2009, 4:S323.
18. General Rule for Clinical and Pathological Record of Lung Cancer 2010, The Japan Lung Cancer Society, Kanehara Press, Tokyo. 7th edn.
19. Zappa F, Droege C, Betticher D, et al. Bevacizumab and erlotinib (BE) first-line therapy in advanced non-squamous non-small-cell lung cancer (NSCLC) (stage IIIB/IV) followed by platinum-based chemotherapy (CT) at disease progression: a multicenter phase II trial (SAKK 19/05). Lung Cancer 2012, 78:239-244.
20. Dingemans AM, de Langen AJ, van den Boogaart V, et al. First-line erlotinib and bevacizumab in patients with locally advanced and/or metastatic non-small-cell lung cancer: a phase II study including molecular imaging. Ann Oncol 2011, 22:559-566.
21. 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.
22. Akhtar NH, Singh B, Ocean AJ, et al. Effect of CTCAE v4 grading of hypertension on reported toxicity in advanced cancer patient receiving vascular endothelial growth factor (VEGF)-targeting agents. J Clin Oncol 2013, 31:e15600.
23. Wildiers H, Guetens G, DeBoeck G, et al. Effect of antivascular endothelial growth factor treatment on the intratumoral uptake of CPT-11. Br J Cancer 2003, 88:1979-1986.
24. Dickson PV, Hamner JB, Sims TL, et al. Bevacizumab-induced transient remodeling of the vasculature in neuroblastoma xenografts results in improved delivery and efficacy of systemically administered chemotherapy. Clin Cancer Res 2007, 13:3942-3950.
25. Furugaki K, Iwai T, Moriya Y, Harada N, Fujimoto-Ouchi K Loss of an EGFR-amplified chromosome 7 as a novel mechanism of acquired resistance to EGFR-TKIs in EGFR-mutated NSCLC cells. Lung Cancer 2014, 83:44-50.
26. Hayakawa H, Ichihara E, Ohashi K, et al. Lower gefitinib dose led to earlier resistance acquisition before emergence of T790M mutation in epidermal growth factor receptor-mutated lung cancer model. Cancer Sci 2013, 104:1440-1446.
27. Herbst RS, Johnson DH, Mininberg E, et al. Phase I/II trial evaluating the anti-vascular endothelial growth factor monoclonal antibody bevacizumab in combination with the HER-1/epidermal growth factor receptor tyrosine kinase inhibitor erlotinib for patients with recurrent non-small-cell lung cancer. J Clin Oncol 2005, 23:2544-2555.
28. Larsen AK, Ouaret D, El Ouadrani K, Petitprez A Targeting EGFR and VEGF(R) pathway cross-talk in tumor survival and angiogenesis. Pharmacol Ther 2011, 131:80-90.
29. Naumov GN, Nilsson MB, Cascone T, et al. Combined vascular endothelial growth factor receptor and epidermal growth factor receptor (EGFR) blockade inhibits tumor growth in xenograft models of EGFR inhibitor resistance. Clin Cancer Res 2009, 15:3484-3494.
30. Ichihara E, Ohashi K, Takigawa N, et al. Effects of vandetanib on lung adenocarcinoma cells harboring epidermal growth factor receptor T790M mutation in vivo. Cancer Res 2009, 69:5091-5098.
31. Wu YL, Lee JS, Thongprasert S, et al. Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2): a randomised, double-blind trial. Lancet Oncol 2013, 14:777-786.
32. Goto K, Satouchi M, Ishii G, et al. An evaluation study of EGFR mutation tests utilized for non-small-cell lung cancer in the diagnostic setting. Ann Oncol 2012, 23:291-294.