Tumor Shrinkage and Objective Response Rates: Gold Standard for Oncology Efficacy Screening Trials, or an Outdated End Point?
暂无分享,去创建一个
[1] Sigrid Stroobants,et al. Revised response criteria for malignant lymphoma. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[2] L. Schwartz,et al. Lung cancer: computerized quantification of tumor response--initial results. , 2006, Radiology.
[3] Daniel J Sargent,et al. Alternate Endpoints for Screening Phase II Studies , 2009, Clinical Cancer Research.
[4] A. Mehlsen,et al. Spontaneous regression of metastases from malignant melanoma: a case report , 2008, Melanoma research.
[5] L. Schwartz,et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). , 2009, European journal of cancer.
[6] P. Dupont,et al. Prognostic value of positron emission tomography (PET) with fluorine-18 fluorodeoxyglucose ([18F]FDG) after first-line chemotherapy in non-Hodgkin's lymphoma: is [18F]FDG-PET a valid alternative to conventional diagnostic methods? , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[7] K. Choi,et al. Neoplastic and nonneoplastic conditions of serosal membrane origin: CT findings. , 2008, Radiographics : a review publication of the Radiological Society of North America, Inc.
[8] H. Kauczor,et al. Therapy response in malignant pleural mesothelioma-role of MRI using RECIST, modified RECIST and volumetric approaches in comparison with CT , 2008, European Radiology.
[9] K. Pienta,et al. Circulating Tumor Cells Predict Survival Benefit from Treatment in Metastatic Castration-Resistant Prostate Cancer , 2008, Clinical Cancer Research.
[10] M Paesmans,et al. Response to chemotherapy has predictive value for further survival of patients with advanced non-small cell lung cancer: 10 years experience of the European Lung Cancer Working Party. , 1997, European journal of cancer.
[11] J. García-Foncillas,et al. Assessment of the value of confirming responses in clinical trials in oncology. , 2005, European journal of cancer.
[12] E. Eisenhauer,et al. Multinomial phase II cancer trials incorporating response and early progression. , 1999, Journal of biopharmaceutical statistics.
[13] P. Philip,et al. Phase III study of gemcitabine [G] plus cetuximab [C] versus gemcitabine in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]: SWOG S0205 study , 2007 .
[14] L. Seymour,et al. Phase I and pharmacokinetic study of daily oral AZD2171, an inhibitor of vascular endothelial growth factor tyrosine kinases, in combination with carboplatin and paclitaxel in patients with advanced non-small-cell lung cancer: the National Cancer Institute of Canada clinical trials group. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[15] Roy S Herbst,et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial--INTACT 2. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[16] E. Eisenhauer,et al. Review of phase II trial designs used in studies of molecular targeted agents: outcomes and predictors of success in phase III. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[17] Jonathan W. Uhr,et al. Tumor Cells Circulate in the Peripheral Blood of All Major Carcinomas but not in Healthy Subjects or Patients With Nonmalignant Diseases , 2004, Clinical Cancer Research.
[18] Stephanie Green,et al. Southwest Oncology Group standard response criteria, endpoint definitions and toxicity criteria , 1992, Investigational New Drugs.
[19] Apurva A Desai,et al. Sorafenib in advanced clear-cell renal-cell carcinoma. , 2007, The New England journal of medicine.
[20] A. Bezjak,et al. Randomized phase III study of matrix metalloproteinase inhibitor BMS-275291 in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: National Cancer Institute of Canada-Clinical Trials Group Study BR.18. , 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[21] Richard Pazdur,et al. Accelerated approval of oncology products: a decade of experience. , 2004, Journal of the National Cancer Institute.
[22] P. Lavin,et al. An alternative model for the evaluation of antitumor activity. , 1981, Cancer clinical trials.
[23] I. Kola,et al. Can the pharmaceutical industry reduce attrition rates? , 2004, Nature Reviews Drug Discovery.
[24] E. McFadden,et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group , 1982, American journal of clinical oncology.
[25] M Van Glabbeke,et al. 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. , 2000, Journal of the National Cancer Institute.
[26] Michael L Maitland,et al. Design of phase II cancer trials using a continuous endpoint of change in tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. , 2007, Journal of the National Cancer Institute.
[27] Dongsheng Tu,et al. Objective Responses in Patients with Malignant Melanoma or Renal Cell Cancer in Early Clinical Studies Do Not Predict Regulatory Approval , 2005, Clinical Cancer Research.
[28] R. Pazdur,et al. Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia. , 2002, Clinical cancer research : an official journal of the American Association for Cancer Research.
[29] Masahiro Fukuoka,et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial) [corrected]. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[30] Haesun Choi,et al. Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[31] J. Schiller,et al. Randomized phase III trial of paclitaxel/carboplatin with or without PF-3512676 as first line treatment of advanced non-small cell lung cancer (NSCLC) , 2008 .
[32] E. Eisenhauer,et al. Application of a new multinomial phase II stopping rule using response and early progression. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[33] A. Miller,et al. Reporting results of cancer treatment , 1981, Cancer.
[34] Mehmet Toner,et al. Detection of mutations in EGFR in circulating lung-cancer cells. , 2008, The New England journal of medicine.
[35] Daniel J Sargent,et al. Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[36] Renato Martins,et al. Erlotinib in previously treated non-small-cell lung cancer. , 2005, The New England journal of medicine.
[37] Richard L Schilsky,et al. Cetuximab in the treatment of colorectal cancer. , 2004, Clinical advances in hematology & oncology : H&O.
[38] L. Broemeling,et al. Interobserver and intraobserver variability in measurement of non-small-cell carcinoma lung lesions: implications for assessment of tumor response. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[39] G. Giaccone. The Role of Gefitinib in Lung Cancer Treatment , 2004, Clinical Cancer Research.
[40] F Barkhof,et al. Interobserver variability in the radiological assessment of response to chemotherapy in glioma , 2003, Neurology.
[41] E. Gehan,et al. The determinatio of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. , 1961, Journal of chronic diseases.
[42] M. Parmar,et al. Speeding up the Evaluation of New Agents in Cancer , 2008, Journal of the National Cancer Institute.
[43] M. Mita,et al. A phase II and pharmacological study of the matrix metalloproteinase inhibitor (MMPI) COL-3 in patients with advanced soft tissue sarcomas , 2007, Investigational New Drugs.
[44] David Cella,et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. , 2003, JAMA.
[45] R. W. Hansen,et al. The price of innovation: new estimates of drug development costs. , 2003, Journal of health economics.
[46] L. Seymour,et al. Tumor cavitation: impact on objective response evaluation in trials of angiogenesis inhibitors in non-small-cell lung cancer. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[47] J. Dancey,et al. Comparison of gemcitabine versus the matrix metalloproteinase inhibitor BAY 12-9566 in patients with advanced or metastatic adenocarcinoma of the pancreas: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[48] M. Byrne,et al. Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. , 2004, Annals of oncology : official journal of the European Society for Medical Oncology.
[49] J O Barentsz,et al. Beyond RECIST: molecular and functional imaging techniques for evaluation of response to targeted therapy. , 2009, Cancer treatment reviews.
[50] T R Fleming,et al. One-sample multiple testing procedure for phase II clinical trials. , 1982, Biometrics.
[51] Joel Karp,et al. Consensus recommendations for the use of 18F-FDG PET as an indicator of therapeutic response in patients in National Cancer Institute Trials. , 2006, Journal of nuclear medicine : official publication, Society of Nuclear Medicine.
[52] A. Shaw,et al. Response assessment in lymphoma. , 2008, Clinical radiology.
[53] G. Rosner,et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[54] M. Ratain. Phase II Oncology Trials: Let's Be Positive , 2005, Clinical Cancer Research.
[55] E. Eisenhauer,et al. A phase II and pharmacokinetic study of SB-715992, in patients with metastatic hepatocellular carcinoma: a study of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG IND.168) , 2008, Investigational New Drugs.
[56] J. Berkhof,et al. Thallium-201 SPECT: the optimal prediction of response in glioma therapy , 2006, European Journal of Nuclear Medicine and Molecular Imaging.
[57] Alison Stopeck,et al. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. , 2004, The New England journal of medicine.
[58] S. Vasanthan,et al. Journal of Medical Case Reports Spontaneous Regression of Metastatic Renal Cell Carcinoma: Case Report Case Presentation , 2022 .
[59] L. Schwartz,et al. Prostate Cancer Clinical Trial End Points: “RECIST”ing a Step Backwards , 2005, Clinical Cancer Research.