Combination chemotherapy with intermittent erlotinib and pemetrexed for pretreated patients with advanced non-small cell lung cancer: a phase I dose-finding study

BMC Cancer

Volumn 12, Issue , 2012, Pages

  Minami, Seigo ^a   Kijima, Takashi ^b   Takahashi, Ryo ^b   Kida, Hiroshi ^b   Nakatani, Takeshi ^a   Hamaguchi, Masanari ^a   Takeuchi, Yoshiko ^a   Nagatomo, Izumi ^b   Yamamoto, Suguru ^a   Tachibana, Isao ^b   Komuta, Kiyoshi ^a   Kawase, Ichiro ^b,c  

^a OSAKA POLICE HOSPITAL   (Japan)

^b OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c OSAKA PREFECTURAL MEDICAL CENTER FOR RESPIRATORY AND ALLERGIC DISEASES   (Japan)

Author keywords

Combination; Erlotinib; NSCLC; Pemetrexed; Phase I

Indexed keywords

CYANOCOBALAMIN; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; FOLIC ACID; PEMETREXED;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CLINICAL ARTICLE; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG INTERMITTENT THERAPY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; HICCUP; HUMAN; INTERSTITIAL LUNG DISEASE; LEUKOPENIA; LUNG ADENOCARCINOMA; LUNG NON SMALL CELL CANCER; MALAISE; MALE; NAUSEA; NEUTROPENIA; OPEN STUDY; ORAL MUCOSITIS; PARONYCHIA; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PRURITUS; RECOMMENDED DRUG DOSE; SIDE EFFECT; THROMBOCYTOPENIA; VOMITING;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; GLUTAMATES; GUANINE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; QUINAZOLINES; RISK FACTORS; TREATMENT OUTCOME;

EID: 84865988616     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-12-296     Document Type: Article

References (24)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010, 60(5):277-300. 10.3322/caac.20073, 20610543.
2. Azzoli CG, Baker S, Temin S, Pao W, Aliff T, Brahmer J, Johnson DH, Laskin JL, Masters G, Milton D, et al. American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol 2009, 27(36):6251-6266. 10.1200/JCO.2009.23.5622, 2793036, 19917871.
3. Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, 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(8):1227-1234. 10.1200/JCO.2007.14.5466, 19188680.
4. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006, 355(24):2542-2550. 10.1056/NEJMoa061884, 17167137.
5. Scagliotti GV, Parikh P, von Pawel J, Biesma B, Vansteenkiste J, Manegold C, Serwatowski P, Gatzemeier U, Digumarti R, Zukin M, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008, 26(21):3543-3551. 10.1200/JCO.2007.15.0375, 18506025.
6. Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, von Pawel J, Gatzemeier U, Tsao TC, Pless M, Muller T, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004, 22(9):1589-1597. 10.1200/JCO.2004.08.163, 15117980.
7. Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000, 18(10):2095-2103.
8. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005, 353(2):123-132. 10.1056/NEJMoa050753, 16014882.
9. Hanauske AR, Chen V, Paoletti P, Niyikiza C. Pemetrexed disodium: a novel antifolate clinically active against multiple solid tumors. Oncologist 2001, 6(4):363-373. 10.1634/theoncologist.6-4-363, 11524555.
10. Cullen MH, Zatloukal P, Sorenson S, Novello S, Fischer JR, Joy AA, Zereu M, Peterson P, Visseren-Grul CM, Iscoe N. A randomized phase III trial comparing standard and high-dose pemetrexed as second-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer. Ann Oncol 2008, 19(5):939-945. 10.1093/annonc/mdm592, 18283036.
11. Ohe Y, Ichinose Y, Nakagawa K, Tamura T, Kubota K, Yamamoto N, Adachi S, Nambu Y, Fujimoto T, Nishiwaki Y, et al. Efficacy and safety of two doses of pemetrexed supplemented with folic acid and vitamin B12 in previously treated patients with non-small cell lung cancer. Clin Cancer Res 2008, 14(13):4206-4212. 10.1158/1078-0432.CCR-07-5143, 18594001.
12. Dancey J, Sausville EA. Issues and progress with protein kinase inhibitors for cancer treatment. Nat Rev Drug Discov 2003, 2(4):296-313. 10.1038/nrd1066, 12669029.
13. Giovannetti E, Lemos C, Tekle C, Smid K, Nannizzi S, Rodriguez JA, Ricciardi S, Danesi R, Giaccone G, Peters GJ. Molecular mechanisms underlying the synergistic interaction of erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, with the multitargeted antifolate pemetrexed in non-small-cell lung cancer cells. Mol Pharmacol 2008, 73(4):1290-1300. 10.1124/mol.107.042382, 18187583.
14. Li T, Ling YH, Goldman ID, Perez-Soler R. Schedule-dependent cytotoxic synergism of pemetrexed and erlotinib in human non-small cell lung cancer cells. Clin Cancer Res 2007, 13(11):3413-3422. 10.1158/1078-0432.CCR-06-2923, 17545550.
15. Furugaki K, Iwai T, Shirane M, Kondoh K, Moriya Y, Mori K. Schedule-dependent antitumor activity of the combination with erlotinib and docetaxel in human non-small cell lung cancer cells with EGFR mutation, KRAS mutation or both wild-type EGFR and KRAS. Oncol Rep 2010, 24(5):1141-1146.
16. Yoshimura M, Nakamura S, Imamura F, Ueno K, Yamamoto S, Igarashi T. Severe myelotoxicity in a combination of gefitinib and vinorelbine. Lung Cancer 2004, 45(1):121-123. 10.1016/j.lungcan.2004.01.006, 15196742.
17. Ranson M, Reck M, Anthoney A, Hanauske AR, Dean E, Melezinek I, Klingelschmitt G, Kletzl H, Blatter J, Twelves C. Erlotinib in combination with pemetrexed for patients with advanced non-small-cell lung cancer (NSCLC): a phase I dose-finding study. Ann Oncol 2010, 21(11):2233-2239. 10.1093/annonc/mdq246, 20444843.
18. Davies AM, Ho C, Beckett L, Lau D, Scudder SA, Lara PN, Perkins N, Gandara DR. Intermittent erlotinib in combination with pemetrexed: phase I schedules designed to achieve pharmacodynamic separation. J Thorac Oncol 2009, 4(7):862-868. 10.1097/JTO.0b013e3181a94b08, 19494788.
19. Kubota K, Nishiwaki Y, Tamura T, Nakagawa K, Matsui K, Watanabe K, Hida T, Kawahara M, Katakami N, Takeda K, et al. Efficacy and safety of erlotinib monotherapy for Japanese patients with advanced non-small cell lung cancer: a phase II study. J Thorac Oncol 2008, 3(12):1439-1445. 10.1097/JTO.0b013e31818d6702, 19057270.
20. Takahashi T, Yamamoto N, Nukiwa T, Mori K, Tsuboi M, Horai T, Masuda N, Eguchi K, Mitsudomi T, Yokota S, et al. Phase II study of erlotinib in Japanese patients with advanced non-small cell lung cancer. Anticancer Res 2010, 30(2):557-563.
21. von Pawel J, Papai-Szekely Z, Vinolas N, Sederholm C, Klima M, Desaiah D, Leschinger MI, Dittrich C. A randomized phase II study of pemetrexed versus pemetrexed plus erlotinib in second-line treatment for locally advanced or metastatic, nonsquamous NSCLC [abstract]. J Clin Oncol 2011, 29:s7526.
22. Mitsudomi T, Yatabe Y. Mutations of the epidermal growth factor receptor gene and related genes as determinants of epidermal growth factor receptor tyrosine kinase inhibitors sensitivity in lung cancer. Cancer Sci 2007, 98(12):1817-1824. 10.1111/j.1349-7006.2007.00607.x, 17888036.
23. Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, 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(6):521-529. 10.1016/S1470-2045(10)70112-1, 20493771.
24. Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet 2009, 374(9699):1432-1440. 10.1016/S0140-6736(09)61497-5, 19767093.