Clinical Endpoints for Assessing Bisphosphonate Efficacy in the Prevention of Skeletal Complications of Bone Metastases
Tài liệu tham khảo
Coleman, 1997, Skeletal complications of malignancy, Cancer, 80, 1588, 10.1002/(SICI)1097-0142(19971015)80:8+<1588::AID-CNCR9>3.0.CO;2-G
Cook, 2001, Methodology for treatment evaluation in patients with cancer metastatic to bone, J Natl Cancer Inst., 93, 534, 10.1093/jnci/93.7.534
Saad, 2004, Role of bisphosphonates in prostate cancer, Eur Urol., 45, 26, 10.1016/j.eururo.2003.10.003
Lipton, 2002, The new bisphosphonate, Zometa® (zoledronic acid), decreases skeletal complications in both osteolytic and osteoblastic lesions: a comparison to pamidronate, Cancer Invest., 20, 45, 10.1081/CNV-120014886
Saad, 2002, Treatment of bone complications in advanced prostate cancer: rationale for bisphosphonate use and results of a phase III trial with zoledronic acid, Semin Oncol., 29, 19, 10.1053/sonc.2002.37418
Elomaa, 1992, Effect of oral clodronate on bone pain. A controlled study in patients with metastatic prostatic cancer, Int Urol Nephrol, 24, 159, 10.1007/BF02549644
Kylmala, 1997, Concomitant i.v. and oral clodronate in the relief of bone pain—a double-blind placebo-controlled study in patients with prostate cancer, Br J Cancer., 76, 939, 10.1038/bjc.1997.488
Strang, 1997, The analgesic efficacy of clodronate compared with placebo in patients with painful bone metastases from prostatic cancer, Anticancer Res., 17, 4717
Ernst, 2003, Randomized, double-blind, controlled trial of mitoxantrone/prednisone and clodronate versus mitoxantrone/prednisone and placebo in patients with hormone-refractory prostate cancer and pain, J Clin Oncol., 21, 3335, 10.1200/JCO.2003.03.042
Major, 2002, Efficacy of bisphosphonates in the management of skeletal complications of bone metastases and selection of clinical endpoints, Am J Clin Oncol., 25, S10, 10.1097/00000421-200212001-00003
Major, 1998, Bisphosphonates for bone metastases in breast cancer patients: trial design issues and evaluation of published studies, Curr Oncol., 5, 181
Johnson, 2003, End points and United States Food and Drug Administration approval of oncology drugs, J Clin Oncol., 21, 1404, 10.1200/JCO.2003.08.072
Saad, 2004, Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer, J Natl Cancer Inst., 96, 879, 10.1093/jnci/djh141
Rosen, 2003, Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial, Cancer, 98, 1735, 10.1002/cncr.11701
Rosen, 2003, Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial—the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group, J Clin Oncol., 21, 3150, 10.1200/JCO.2003.04.105
Saad, 2002, A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma, J Natl Cancer Inst., 94, 1458, 10.1093/jnci/94.19.1458
Andersen, 1982, Cox's regression model for counting processes: a large sample study, Ann Stat., 10, 1100, 10.1214/aos/1176345976
Cook, 1996, Interim monitoring of longitudinal comparative studies with recurrent event responses, Biometrics, 52, 1311, 10.2307/2532846
Ghosh, 2000, Nonparametric analysis of recurrent events and death, Biometrics, 56, 554, 10.1111/j.0006-341X.2000.00554.x
Pelger, 2001, Strategies for management of prostate cancer-related bone pain, Drugs Aging., 18, 899, 10.2165/00002512-200118120-00002
Teske, 1983, Relationships between nurses’ observations and patients’ self-reports of pain, Pain, 16, 289, 10.1016/0304-3959(83)90117-3
Hillner, 2000, American Society of Clinical Oncology guideline on the role of bisphosphonates in breast cancer. American Society of Clinical Oncology Bisphosphonates Expert Panel, J Clin Oncol., 18, 1378, 10.1200/JCO.2000.18.6.1378
Hillner, 2003, American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer, J Clin Oncol., 21, 4042, 10.1200/JCO.2003.08.017
Body, 2003, Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases, Ann Oncol., 14, 1399, 10.1093/annonc/mdg367
Cook, 1997, Marginal analysis of recurrent events and a terminating event, Stat Med., 16, 911, 10.1002/(SICI)1097-0258(19970430)16:8<911::AID-SIM544>3.0.CO;2-I
Cook, 2004, Marginal analysis of point processes with competing risks, 349
Chen, 2004, Tests for multivariate recurrent events in the presence of a terminal event, Biostatistics, 5, 129, 10.1093/biostatistics/5.1.129
Rosen, 2004, Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, phase III, double-blind, placebo-controlled trial, Cancer, 100, 2613, 10.1002/cncr.20308
Major, 2003, Multiple event analysis of zoledronic acid trials in patients with cancer metastatic to bone [abstract], Proc Am Soc Clin Oncol., 22, 762