Phase II study of erlotinib in Japanese patients with advanced non-small cell lung cancer

Anticancer Research

Volumn 30, Issue 2, 2010, Pages 557-563

  Takahashi, Toshiaki ^a   Yamamoto, Nobuyuki ^a   Nukiwa, Toshihiro ^b,c   Mori, Kiyoshi ^d   Tsuboi, Masahiro ^e,f   Horai, Takeshi ^g   Masuda, Noriyuki ^h   Eguchi, Kenji ^i,j   Mitsudomi, Tetsuya ^k   Yokota, Soichiro ^l   Segawa, Yoshihiko ^m,n   Ichinose, Yukito ^o   Fukuoka, Masahiro ^p   Saijo, Nagahiro ^p,q  

^a SHIZUOKA CANCER CENTER   (Japan)

^b TOHOKU UNIVERSITY   (Japan)

^c TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^d TOCHIGI CANCER CENTER   (Japan)

^e TOKYO MEDICAL UNIVERSITY   (Japan)

^f KANAGAWA CANCER CENTER   (Japan)

^g CANCER INSTITUTE HOSPITAL   (Japan)

^h KITASATO UNIVERSITY GRADUATE SCHOOL OF MEDICAL SCIENCES   (Japan)

ⁱ TOKAI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^j TEIKYO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^k AICHI CANCER CENTER HOSPITAL   (Japan)

^l TONEYAMA NATIONAL HOSPITAL   (Japan)

^m NATIONAL HOSPITAL ORGANIZATION   (Japan)

ⁿ NATIONAL SANYO HOSPITAL   (Japan)

^o NATIONAL KYUSHU CANCER CENTER   (Japan)

^p KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^q NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

more..

Author keywords

EGFR mutation; EGFR TKIs; Erlotinib; Non small cell lung cancer; Phase II; Tarceva

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB;

ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; FATIGUE; FEMALE; HISTOLOGY; HUMAN; HUMAN TISSUE; INTERSTITIAL PNEUMONIA; LUNG NON SMALL CELL CANCER; MALE; MULTICENTER STUDY; OVERALL SURVIVAL; PARONYCHIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; SIDE EFFECT; STOMATITIS; TREATMENT RESPONSE;

ADENOCARCINOMA; ADULT; AGED; CARCINOMA, ADENOSQUAMOUS; CARCINOMA, LARGE CELL; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; FEMALE; HUMANS; JAPAN; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; SURVIVAL RATE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77950538966     PISSN: 02507005     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (29)

1. Parkin DM, Bray F, Ferlay J and Pisani P: Global cancer statistics 2002. CA Cancer J Clin 55: 74-108, 2005.
2. Ferlay J, Autier P, Boniol M, Heanue M, Colombet M and Boyle P: Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 18: 581-592, 2007.
3. Molina JR, Yang P, Cassivi SD, Schild SE and Adjei AA: Non-small cell lung cancer: epidemiology, risk factors, treatments and survivorship. Mayo Clin Proc 83: 584-594, 2008.
4. Lara PN Jr, Lau DHM and Gandara DR: Non-small cell lung cancer progression after first-line chemotherapy. Curr Treat Options Oncol 3: 53-58, 2002.
5. Vincent MD: Optimizing the management of advanced non-small cell lung cancer: a personal view. Current Oncology 16: 9-21, 2009
6. Pignon JP, Tribodet H, Scagliotti GV, Douillard JY, Shepherd FA, Stephens RJ, Dunant A, Torri V, Rosell R, Seymour L, Spiro SG, Rolland E, Fossati R, Aubert D, Ding K, Waller D and Chevalier TL: Lung adjuvant cisplatin evaluation: A pooled analysis by the LACE Collaborative Group. J Clin Oncol 26: 3552-3559, 2008
7. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH and Eastern Cooperative Oncology Group: Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med 346: 92-98, 2002.
8. Ohe Y, Ohashi Y, Kubota K, Tamura T, Nakagawa K, Negoro S, Nishiwaki Y, Saijo N, Ariyoshi Y and Fukuoka M: Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small cell lung cancer: four arm cooperative study in Japan. Ann Oncol 18: 317-323, 2007.
9. Kubota K, Nishiwaki Y, Tamura T, Nakagawa K, Matsui K, Watanabe K, Hida T, Kawahara M, Katakami N, Takeda K, Yokoyama A, Noda K, Fukuoka M and Saijo N: Efficacy and safety of erlotinib monotherapy for Japanese patients with advanced non-small cell lung cancer. J Thorac Oncol 3: 1439-1445, 2008.
10. Shepherd FA, Pereira JR, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabárbara P, Seymour L and National Cancer Institute of Canada Clinical Trials Group: Erlotinib in previously treated non-small cell lung cancer. N Engl J Med 353: 123-132, 2005.
11. Ahn MJ, Park BB, Ahn JS, Kim SW, Kim HT, Lee JS, Kang JH, Cho JY, Song HS, Park SH, Sohn CH, Shin SW, Choi JH, Ki CS, Park CK, Holmes AJ, Jänne PA and Park K: Are there any ethnic differences in molecular predictors of erlotinib efficacy in advanced non-small cell lung cancer? Clin Cancer Res 14: 3860-3866, 2008.
12. Fukuoka M, Wu Y, Thongprasert S, Yang C, Chu D, Saijo N, Watkins C, Duffield E, Armour A and Mok T: Biomarker analysis from a phase III, randomized, open-label, first-line study of gefitinib (G) versus carboplatin/paclitaxel (C/P) in clinically selected patients (pts) with advanced non-small cell lung cancer (NSCLC) in Asia (IPASS). J Clin Oncol 27: 15s, (abstr 8006) 2009.
13. Kobayashi K, Inoue A, Maemondo M, Sugawara S, Isobe H, Oizumi S, Saijo Y, Gemma A, Morita S, Hagiwara K and Nukiwa T : First-line gefitinib versus first-line chemotherapy by carboplatin (CBDCA) plus paclitaxel (TXL) in non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations: A phase III study (002) by North East Japan Gefitinib Study Group. J Clin Oncol 27: 15s, (abstr 8016) 2009.
14. Pérez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabárbara P and Bonomi P: Determinants of tumor response and survival with erlotinib in patients with non-small cell lung cancer. J Clin Oncol 22: 3238-3247, 2004.
15. Ding K, Pater J, Whitehead M, Seymour L and Shepherd FA: Validation of treatment-induced specific adverse effect as a predictor of treatment benefit: a case study of NCIC CTG BR21. Contemp Clin Trials 29: 527-536, 2008.
16. Cedrés S, Prat A, Martínez P, Pallisa E, Sala G, Andreu J, Del Campo JM, Quispe I, Baselga J and Felip E: Clinical surrogate markers of survival in advanced non-small cell lung cancer (NSCLC) patients treated with second-third line erlotinib. Lung Cancer 66: 257-261, 2009.
17. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC and Gwyther SG: New guidelines to evaluate the response to treatment in solid tumours. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92: 205-216, 2000.
18. Cella DF, Bonomi AE, Lloyd SR, Tulsky DS, Kaplan E and Bonomi P: Reliability and validity of the functional assessment of cancer therapy-lung (FACT-L) quality of life instrument. Lung Cancer 12: 199-220, 1995.
19. Ling J, Fettner S, Lum BL, Riek M and Rakhit A: Effect of food on the pharmacokinetics of erlotinib, an orally active epidermal growth factor receptor tyrosine-kinase inhibitor, in healthy individuals. Anti-Cancer Drugs 19: 209-216, 2008.
20. Kaneda H, Tamura K, Kurata T, Uejima H, Nakagawa K and Fukuoka M: Retrospective analysis of the predictive factors associated with the response and survival benefit of gefitinib in patients with advanced non-small cell lung cancer. Lung Cancer 46: 247-254, 2004.
21. Engelman JA and Jänne PA: Factors predicting response to EGFR tyrosine kinase inhibitors. Semin Respir Crit Care Med 26: 314-322, 2005.
22. Kris MG: How today's developments in the treatment of non-small cell lung cancer will change tomorrow's standards of care. The Oncologist 10(Suppl 2): 23-29, 2005.
23. Yamamoto N, Horiike A, Fujisaka Y, Murakami H, Shimoyama T, Yamada Y and Tamura T: Phase I dose-finding and pharmacokinetic study of the oral epidermal growth factor receptor tyrosine kinase inhibitor Ro50-8231 (erlotinib) in Japanese patients with solid tumors. Cancer Chemother Pharmacol 61: 489-496, 2008.
24. Hidalgo M and Bloedow D: Pharmacokinetics and pharmacodynamics: maximizing the clinical potential of erlotinib (Tarceva). Semin Oncol 30(Suppl 7): 25-33, 2003.
25. Hamilton M, Wolf JL, Rusk J, Beard SE, Clark GM, Witt K and Cagnoni PJ: Effects of smoking on the pharmacokinetics of erlotinib. Clin Cancer Res 12: 2166-2171, 2006
26. Wacker B, Nagrani T, Weinberg J, Witt K, Clark G and Cagnoni PJ: Correlation between development of rash and efficacy in patients treated with the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib in two large phase III studies. Clin Cancer Res 13: 3913-3921, 2007.
27. Uramoto H and Mitsudomi T: Which biomarker predicts benefit from EGFR-TKI treatment for patients with lung cancer? Br J Cancer 96: 857-863, 2007.
28. Hida T, Ogawa S, Park JC, Park JY, Shimizu J, Horio Y and Yoshida K: Gefitinib for the treatment of non-small cell lung cancer. Expert rev Anticancer Ther 9: 17-35, 2009.
29. Yano S, Wang W, Li Q, Yamada T, Matsumoto K, Mitsudomi T, Yatabe Y, Hanibuchi M, Nishioka Y and Sone S: Hepatocyte growth factor as inducer of gefitinib resistance in non-small cell lung cancer harboring EGFR activating mutations. J Clin Oncol 27: 15S (abstr e19034), 2009.