Phase II proof-of-concept study of pazopanib monotherapy in treatment-naive patients with stage I/II resectable non - small-cell lung cancer

Journal of Clinical Oncology

Volumn 28, Issue 19, 2010, Pages 3131-3137

  Altorki, Nasser ^a   Lane, Maureen E ^a   Bauer, Thomas ^a   Lee, Paul C ^a   Guarino, Michael J ^a   Pass, Harvey ^a   Felip, Enriqueta ^a   Peylan Ramu, Nili ^a   Gurpide, Alfonso ^a   Grannis, Frederic W ^a   Mitchell, John D ^a   Tachdjian, Sabrina ^a   Swann, R Suzanne ^a   Huff, Anne ^a   Roychowdhury, Debasish F ^a   Reeves, Anthony ^a   Ottesen, Lone H ^a   Yankelevitz, David F ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOPOIETIN 1; ANGIOPOIETIN 2; KERATINOCYTE GROWTH FACTOR; PAZOPANIB; PLATELET DERIVED GROWTH FACTOR ALPHA RECEPTOR; PLATELET DERIVED GROWTH FACTOR BETA RECEPTOR; THROMBOSPONDIN 1; TRANSFORMING GROWTH FACTOR BETA3; VASCULOTROPIN A; VASCULOTROPIN C; VASCULOTROPIN D; VASCULOTROPIN RECEPTOR 1; VASCULOTROPIN RECEPTOR 2; PYRIMIDINE DERIVATIVE; SULFONAMIDE;

ADULT; AGED; ARTICLE; CANCER STAGING; CANCER SURGERY; CLINICAL ARTICLE; CLINICAL ASSESSMENT TOOL; COMPUTER ASSISTED TOMOGRAPHY; CORRELATION ANALYSIS; DIARRHEA; DRUG ACTIVITY; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG RESPONSE; DRUG SAFETY; FATIGUE; FEMALE; GENE EXPRESSION PROFILING; HUMAN; HYPERTENSION; LUNG EMBOLISM; LUNG NON SMALL CELL CANCER; MALE; MONOTHERAPY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RESPONSE EVALUATION CRITERIA IN SOLID TUMOR; SIDE EFFECT; TUMOR VOLUME; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; DRUG ADMINISTRATION; DRUG EFFECT; GENE EXPRESSION REGULATION; GENETICS; LUNG TUMOR; MIDDLE AGED; ORAL DRUG ADMINISTRATION; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; AGED; AGED, 80 AND OVER; CARCINOMA, NON-SMALL-CELL LUNG; DIARRHEA; DRUG ADMINISTRATION SCHEDULE; FATIGUE; FEMALE; GENE EXPRESSION PROFILING; GENE EXPRESSION REGULATION, NEOPLASTIC; HUMANS; HYPERTENSION; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PYRIMIDINES; SULFONAMIDES; TREATMENT OUTCOME;

EID: 77955503066     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.23.9749     Document Type: Article

References (48)

1. Parkin DM, Bray F, Ferlay J, et al: Global cancer statistics, 2002. CA Cancer J Clin 55:74-108, 2005
2. Carney DN, Hansen HH: Non-small-cell lung cancer - stalemate or progress? N Engl J Med 343: 1261-1262, 2000
3. Ries L, Melbert D, Krapcho M, et al: SEER Cancer Statistics Review, 1975-2005 National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/csr/ 1975-2005/
4. National Audit Office: Tackling cancer in England: Saving more lives. http://www.nao.org.uk/whats-new/0304/0304364.aspx
5. Goldstraw P, Crowley J, Chansky K, et al: The IASLC Lung Cancer Staging Project: Proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol 2:706-714, 2007 (Pubitemid 47357522)
6. Feld R, Rubinstein LV, Weisenberger TH: Sites of recurrence in resected stage I non-small-cell lung cancer: A guide for future studies. J Clin Oncol 2:1352-1358, 1984 (Pubitemid 15179536)
7. Gauger J, Patz EF Jr, Coleman RE, et al: Clinical stage I non-small cell lung cancer including FDG-PET Imaging: Sites and time to recurrence. J Thorac Oncol 2:499-505, 2007 (Pubitemid 47171803)
8. Arriagada R, Bergman B, Dunant A, et al: Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med 350:351-360, 2004 (Pubitemid 38101630)
9. Douillard JY, Rosell R, De Lena M, et al: Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): A randomised controlled trial. Lancet Oncol 7:719-727, 2006 (Pubitemid 44283661)
10. Scagliotti GV, Fossati R, Torri V, et al: Randomized study of adjuvant chemotherapy for completely resected stage I, II, or IIIA non-small-cell lung cancer. J Natl Cancer Inst 95:1453-1461, 2003 (Pubitemid 37279330)
11. Strauss GM, Herndon JE Jr, Maddaus MA, et al: Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol 26:5043-5051, 2008
12. Winton T, Livingston R, Johnson D, et al: Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. N Engl J Med 352:2589-2597, 2005 (Pubitemid 41007845)
13. Pignon JP, Tribodet H, Scagliotti GV, et al: Lung adjuvant cisplatin evaluation: A pooled analysis by the LACE Collaborative Group. J Clin Oncol 26:3552-3559, 2008
14. 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 27:1227-1234, 2009
15. Sandler A, Gray R, Perry MC, et al: Paclitaxel-carboplatin alone or with bevacizumab for non-smallcell lung cancer. N Engl J Med 355:2542-2550, 2006 (Pubitemid 44917502)
16. National Cancer Institute: Chemotherapy with or without bevacizumab in treating patients with stage IB, stage II, or stage IIA non-small lung cancer that was removed by surgery. http://clinicaltrials.gov/ct2/show/NCT00324805
17. Escudier B, Eisen T, Stadler WM, et al: Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356:125-134, 2007 (Pubitemid 46089673)
18. Motzer RJ, Hutson TE, Tomczak P, et al: Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 356:115-124, 2007 (Pubitemid 46089672)
19. Llovet JM, Ricci S, Mazzaferro V, et al: Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 359:378-390, 2008
20. Demetri GD, van Oosterom AT, Garrett CR, et al: Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: A randomised controlled trial. Lancet 368:1329-1338, 2006 (Pubitemid 44528723)
21. Betsholtz C: Insight into the physiological functions of PDGF through genetic studies in mice. Cytokine Growth Factor Rev 15:215-228, 2004
22. Ostman A: PDGF receptors-mediators of autocrine tumor growth and regulators of tumor vasculature and stroma. Cytokine Growth Factor Rev 15:275-286, 2004
23. Zwaans BM, Bielenberg DR: Potential therapeutic strategies for lymphatic metastasis. Microvasc Res 74:145-158, 2007 (Pubitemid 350051029)
24. Sonpavde G, Hutson TE: Pazopanib: A novel multitargeted tyrosine kinase inhibitor. Curr Oncol Rep 9:115-119, 2007 (Pubitemid 46332383)
25. Friedlander M, Hancock KC, Benigno B, et al: Pazopanib (GW786034) is active in women with advanced epithelial ovarian, fallopian tube and peritoneal cancers: Results of a phase II study. Ann Oncol 19:211, 2008 (suppl 8; abstr 6630)
26. Hutson TE, Davis ID, Machiels JH, et al: Predictive and prognostic factors in phase II renal cell carcinoma trial with pazopanib (GW786034), a multi-kinase angiogenesis inhibitor. Ann Oncol 19: 89, 2008 (suppl 8; abstr 5780)
27. Sleijfer S, Papai Z, Le Cesne A, et al: Phase II study of pazopanib (GW786034) in patients (pts) with relapsed or refractory soft tissue sarcoma (STS): EORTC 62043. J Clin Oncol 25:552s, 2007 (suppl; abstr 10031)
28. Hurwitz H, Dowlati A, Saini S, et al: Phase I trial of pazopanib in patients with advanced cancer. Clin Cancer Res 15:4220-4227, 2009
29. Gietema HA, Schaefer-Prokop CM, Mali WP, et al: Pulmonary nodules: Interscan variability of semiautomated volume measurements with multisection CT - influence of inspiration level, nodule size, and segmentation performance. Radiology 245:888-894, 2007
30. Goodman LR, Gulsun M, Washington L, et al: Inherent variability of CT lung nodule measurements in vivo using semiautomated volumetric measurements. Am J Roentgenol 186:989-994, 2006 (Pubitemid 46100197)
31. Reeves AP, Chan AB, Yankelevitz DF, et al: On measuring the change in size of pulmonary nodules. IEEE Trans Med Imaging 25:435-450, 2006
32. Wormanns D, Kohl G, Klotz E, et al: Volumetric measurements of pulmonary nodules at multirow detector CT: In vivo reproducibility. Eur Radiol 14:86-92, 2004 (Pubitemid 38181058)
33. Reeves AP, Biancardi AM, Apanasovich TV, et al: The Lung Image Database Consortium (LIDC): A comparison of different size metrics for pulmonary nodule measurements. Acad Radiol 14:1475-1485, 2007 (Pubitemid 350116645)
34. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors: European Organisation 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
35. Cancer Therapy Evaluation Program: Common terminology criteria for adverse events v3.0 (CTCAE).http://ctep.cancer.gov/protocolDevelopment/ electronic-applications/docs/ctcaev3.pdf
36. Yankelevitz DF, Reeves AP, Kostis WJ, et al: Small pulmonary nodules: Volumetrically determined growth rates based on CT evaluation. Radiology 217:251-256, 2000 (Pubitemid 33097610)
37. Morey JS, Ryan JC, Van Dolah FM: Microarray validation: Factors influencing correlation between oligonucleotide microarrays and real-time PCR. Biol Proced Online 8:175-193, 2006 (Pubitemid 44942143)
38. Bozcuk H, Martin C: Does treatment delay affect survival in non-small cell lung cancer? A retrospective analysis from a single UK centre. Lung Cancer 34:243-252, 2001 (Pubitemid 33010800)
39. Quarterman RL, McMillan A, Ratcliffe MB, et al: Effect of preoperative delay on prognosis for patients with early-stage non-small cell lung cancer. J Thorac Cardiovasc Surg 125:108-113, 2003; discussion 125:113-114, 2003
40. Eisenhauer EA, Therasse P, Bogaerts J, et al: New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 45:228-247, 2009
41. Marten K, Auer F, Schmidt S, et al: Automated CT volumetry of pulmonary metastases: The effect of a reduced growth threshold and target lesion number on the reliability of therapy response assessment using RECIST criteria. Eur Radiol 17:2561-2571, 2007
42. Erasmus JJ, Gladish GW, Broemeling L, et al: Interobserver and intraobserver variability in measurement of non-small-cell carcinoma lung lesions: Implications for assessment of tumor response. J Clin Oncol 21:2574-2582, 2003 (Pubitemid 46606340)
43. Sutent: Prescribing information. New York, NY, Pfizer Labs, 2008
44. Nexavar: Prescribing information. Wayne, NJ, Bayer Healthcare Pharmaceuticals Inc, 2008
45. Gatzemeier U, Blumenschein G, Fosella F, et al: Phase II trial of single-agent sorafenib in patients with advanced non-small cell lung carcinoma. J Clin Oncol 24:364s, 2006 (suppl; abstr 7002)
46. Socinski MA, Novello S, Brahmer JR, et al: Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. J Clin Oncol 26:650-656, 2008 (Pubitemid 351264362)
47. D'Cunha J, Corfits AL, Herndon JE Jr, et al: Molecular staging of lung cancer: Real-time polymerase chain reaction estimation of lymph node micrometastatic tumor cell burden in stage I non-small cell lung cancer - preliminary results of Cancer and Leukemia Group B Trial 9761. J Thorac Cardiovasc Surg 123:484-491, 2002; discussion 123:491, 2002
48. National Cancer Institute: Adjuvant pazopanib in stage I NSCLC. http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=618422&version= HealthProfessional&protocolsearchid=5998244