Gefitinib in combination with irradiation with or without cisplatin in patients with inoperable stage III non-small cell lung cancer: A phase i trial

International Journal of Radiation Oncology Biology Physics

Volumn 80, Issue 1, 2011, Pages 126-132

  Rothschild, Sacha ^a   Bucher, Stephan E ^b   Bernier, Jacques ^c   Aebersold, Daniel M ^d   Zouhair, Aberrahim ^e   Ries, Gerhard ^f   Lombrieser, Norbert ^g   Lippuner, Thomas ^h   Lütolf, Urs M ^a   Glanzmann, Christoph ^a   Ciernik, I Frank ^a  

^a UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^b Statistical and Language Services   (Switzerland)

^c CLINIQUE DE GENOLIER   (Switzerland)

^d UNIVERSITY OF BERN   (Switzerland)

^e LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^f Kantonsspital ^*  (Switzerland)

^g Klinik für Radiotherapie   (Switzerland)

^h CANTONAL HOSPITAL WINTERTHUR   (Switzerland)

Author keywords

Chemoradiation; Cisplatin; Gefitinib; NSCLC; Phase I study

Indexed keywords

CHEMORADIATION; CIS-PLATIN; GEFITINIB; NSCLC; PHASE I STUDY;

BIOLOGICAL ORGANS; DISEASE CONTROL; PLATINUM COMPOUNDS; PULMONARY DISEASES; TOXICITY;

PATIENT TREATMENT;

CISPLATIN; GEFITINIB;

ACNE LIKE SKIN RASH; ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BLOOD DISEASE; BONE PAIN; BREAST DISEASE; CANCER CONTROL; CANCER RADIOTHERAPY; CANCER SURVIVAL; CATARACT; CLINICAL ARTICLE; CONNECTIVE TISSUE DISEASE; CONSTIPATION; COUGHING; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPHAGIA; DYSPNEA; EPILEPSY; ESOPHAGITIS; EYE DISEASE; FATIGUE; FEMALE; GASTROINTESTINAL DISEASE; GENITAL SYSTEM DISEASE; HUMAN; INFECTION; INFESTATION; LEUKOPENIA; LUNG NON SMALL CELL CANCER; LYMPHATIC SYSTEM DISEASE; MALE; MEDIASTINUM DISEASE; METABOLIC DISORDER; MUCOSA INFLAMMATION; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; NUTRITIONAL DISORDER; PHASE 1 CLINICAL TRIAL; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; RADIATION DOSE; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SKIN TOXICITY; THORAX DISEASE; THROMBOCYTOPENIA; THROMBOSIS; VASCULAR DISEASE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DRUG ADMINISTRATION SCHEDULE; FEASIBILITY STUDIES; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; QUINAZOLINES;

EID: 79251603976     PISSN: 03603016     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2010.01.048     Document Type: Article

References (39)

1. Chemotherapy in non-small cell lung cancer A meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group BMJ 311 1995 899 909
2. F. Blackhall, M. Ranson, and N. Thatcher Where next for gefitinib in patients with lung cancer? Lancet Oncol 7 2006 499 507 (Pubitemid 43779172)
3. J. Baselga, and C.L. Arteaga Critical update and emerging trends in epidermal growth factor receptor targeting in cancer J Clin Oncol 23 2005 2445 2459 (Pubitemid 47050835)
4. R. Pirker, J.R. Pereira, and A. Szczesna Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): An open-label randomised Phase III trial Lancet 373 2009 1525 1531
5. J.B. Vermorken, R. Mesia, and F. Rivera Platinum-based chemotherapy plus cetuximab in head and neck cancer N Engl J Med 359 2008 1116 1127
6. J.A. Bonner, P.M. Harari, and J. Giralt Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck N Engl J Med 354 2006 567 578 (Pubitemid 43209104)
7. H.Q. Zhuang, J. Sun, and Z.Y. Yuan Radiosensitizing effects of gefitinib at different administration times in vitro Cancer Sci 100 2009 1520 1525
8. J.S. Ochs Rationale and clinical basis for combining gefitinib (IRESSA, ZD1839) with radiation therapy for solid tumors Int J Radiat Oncol Biol Phys 58 2004 941 949 (Pubitemid 38221154)
9. C.C. Olsen, T.E. Schefter, and H. Chen Results of a Phase I trial of 12 patients with locally advanced pancreatic carcinoma combining gefitinib, paclitaxel, and 3-dimensional conformal radiation: Report of toxicity and evaluation of circulating K-ras as a potential biomarker of response to therapy Am J Clin Oncol 32 2009 115 121
10. G. Joensuu, T. Joensuu, and P. Nokisalmi A Phase I/II trial of gefitinib given concurrently with radiotherapy in patients with nonmetastatic prostate cancer Int J Radiat Oncol Biol Phys 78 2010 42 49
11. F. Caponigro, C. Romano, and A. Milano A Phase I/II trial of gefitinib and radiotherapy in patients with locally advanced inoperable squamous cell carcinoma of the head and neck Anticancer Drugs 19 2008 739 744
12. T.E. Stinchcombe, D.E. Morris, and C.B. Lee Induction chemotherapy with carboplatin, irinotecan, and paclitaxel followed by high dose three-dimension conformal thoracic radiotherapy (74 Gy) with concurrent carboplatin, paclitaxel, and gefitinib in unresectable Stage IIIA and Stage IIIB non-small cell lung cancer J Thorac Oncol 3 2008 250 257 (Pubitemid 351654324)
13. R.W. Byhardt Toxicities in RTOG combined-modality trials for inoperable non-small-cell lung cancer Oncology (Williston Park) 13 1999 116 120
14. P. Therasse, S.G. Arbuck, and E.A. Eisenhauer New guidelines to evaluate the response to treatment in solid tumors. 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 2000 205 216
15. E.E. Vokes, J.E. Herndon II, and M.J. Kelley Induction chemotherapy followed by chemoradiotherapy compared with chemoradiotherapy alone for regionally advanced unresectable Stage III non-small-cell lung cancer: Cancer and Leukemia Group B J Clin Oncol 25 2007 1698 1704 (Pubitemid 46797950)
16. J. Baselga, D. Rischin, and M. Ranson Phase I safety, pharmacokinetic, and pharmacodynamic trial of ZD1839, a selective oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with five selected solid tumor types J Clin Oncol 20 2002 4292 4302 (Pubitemid 35266289)
17. R.S. Herbst, A.M. Maddox, and M.L. Rothenberg Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: Results of a Phase I trial J Clin Oncol 20 2002 3815 3825
18. P. Fournel, G. Robinet, and P. Thomas Randomized Phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study J Clin Oncol 23 2005 5910 5917
19. T. Akimoto, N.R. Hunter, and L. Buchmiller Inverse relationship between epidermal growth factor receptor expression and radiocurability of murine carcinomas Clin Cancer Res 5 1999 2884 2890 (Pubitemid 29493967)
20. C. Bianco, G. Tortora, and R. Bianco Enhancement of antitumor activity of ionizing radiation by combined treatment with the selective epidermal growth factor receptor-tyrosine kinase inhibitor ZD1839 (Iressa) Clin Cancer Res 8 2002 3250 3258 (Pubitemid 35155038)
21. H. Wu, J. Kim, and Q. Cao Combined modality therapy of NCI-H460 human lung cancer using epidermal growth factor receptor inhibitor, OSI-774, and ionizing radiation in vitro and in vivo Int J Radiat Oncol Biol Phys 54 2002 176
22. P. Chinnaiyan, S. Huang, and G. Vallabhaneni Mechanisms of enhanced radiation response following epidermal growth factor receptor signaling inhibition by erlotinib (Tarceva) Cancer Res 65 2005 3328 3335 (Pubitemid 40524617)
23. E. Martinez, M. Martinez, and N. Viñolas Feasibility and tolerability of the addition of erlotinib to 3D thoracic radiotherapy (RT) in patients (p) with unresectable NSCLC: A prospective randomized Phase II study J Clin Oncol 26 2008 abstr 7563
24. D. Rischin, B. Burmeister, and P. Mitchell Phase I trial of gefitinib (ZD1839) in combination with concurrent carboplatin, paclitaxel and radiation therapy in patients with Stage III non-small cell lung cancer J Clin Oncol 22 2004 7077
25. M. Fukuoka, S. Yano, and G. Giaccone Multi-institutional randomized Phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial) [corrected] J Clin Oncol 21 2003 2237 2246 (Pubitemid 46621858)
26. N. Thatcher, A. Chang, and P. Parikh Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer) Lancet 366 2005 1527 1537 (Pubitemid 41540110)
27. A. Chang, P. Parikh, and S. Thongprasert Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: Subset analysis from the ISEL study J Thorac Oncol 1 2006 847 855 (Pubitemid 47181391)
28. X. Zhang, and A. Chang Somatic mutations of the epidermal growth factor receptor and non-small-cell lung cancer J Med Genet 44 2007 166 172 (Pubitemid 46580525)
29. P.A. Bunn Jr., R. Dziadziuszko, and M. Varella-Garcia Biological markers for non-small cell lung cancer patient selection for epidermal growth factor receptor tyrosine kinase inhibitor therapy Clin Cancer Res 12 2006 3652 3656 (Pubitemid 44000246)
30. L.V. Sequist, R.G. Martins, and D. Spigel First-line gefitinib in patients with advanced non-small-cell lung cancer harbouring somatic EGFR mutations J Clin Oncol 26 2008 2442 2449
31. R. Rosell, T. Moran, and C. Queralt Screening for epidermal growth factor receptor mutations in lung cancer N Engl J Med 361 2009 958 967
32. K. Furuse, M. Fukuoka, and M. Kawahara Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable Stage III non-small-cell lung cancer J Clin Oncol 17 1999 2692 2699 (Pubitemid 29415225)
33. T.S. Mok, Y.L. Wu, and S. Thongprasert Gefitinib or carboplatin- paclitaxel in pulmonary adenocarcinoma N Engl J Med 361 2009 947 957
34. E.S. Kim, V. Hirsh, and T. Mok Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): A randomised Phase III trial Lancet 372 2008 1809 1818
35. K. Kelly, K. Chansky, and L.E. Gaspar Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable Stage III non-small-cell lung cancer: SWOG S0023 J Clin Oncol 26 2008 2450 2456
36. P. Matar, F. Rojo, and R. Cassia Combined epidermal growth factor receptor targeting with the tyrosine kinase inhibitor gefitinib (ZD1839) and the monoclonal antibody cetuximab (IMC-C225): Superiority over single-agent receptor targeting Clin Cancer Res 10 2004 6487 6501 (Pubitemid 39346544)
37. R.B. Natale, D. Bodkin, and R. Govindan Vandetanib versus gefitinib in patients with advanced non-small-cell lung cancer: Results from a two-part, double-blind, randomized Phase II study J Clin Oncol 27 2009 2523 2529
38. M.J. Donovan, A. Kotsianti, and V. Bayer-Zubek A systems pathology model for predicting overall survival in patients with refractory, advanced non-small-cell lung cancer treated with gefitinib Eur J Cancer 45 2009 1518 1526
39. C.J. Langer The "Lazarus response" in treatment-naive, poor performance status patients with non-small-cell lung cancer and epidermal growth factor receptor mutation J Clin Oncol 27 2009 1350 1354