Assessing pharmacological interventions for bone metastases: the need for more patient-centered outcomes

References

• Jensen AT, Jacobsen JB, Norgaard M et al. Incidence of bone metastases and skeletal-related events in breast cancer patients: a population-based cohort study in Denmark. BMC Cancer11, 29 (2011).
   PubMed Web of Science ®Google Scholar
• Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat. Rev.27(3), 165–176 (2001).
   PubMed Web of Science ®Google Scholar
• Bubendorf L, Schapfer A, Wagner U et al. Metastatic patterns of prostate cancer: an autopsy study of 1589 patients. Hum. Pathol.31(5), 578–583 (2000).
   PubMed Web of Science ®Google Scholar
• Norgaard M, Jensen AO, Jacobsen JB et al. Skeletal related events, bone metastasis and survival of prostate cancer: a population based cohort study in Denmark (1999 to 2007). J. Urol.184(1), 162–167 (2010).
   PubMed Web of Science ®Google Scholar
• Coleman RE. Skeletal complications of malignancy. Cancer80(8), 1588–1594 (1997).
   PubMed Web of Science ®Google Scholar
• Saad F, Gleason DM, Murray R et al. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J. Natl Cancer Inst.94(19), 1458–1468 (2002).
   PubMed Web of Science ®Google Scholar
• Rosen LS, Gordon D, Kaminski M et al. Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: a Phase III, double-blind, comparative trial. Cancer J.7(5), 377–387 (2001).
   PubMed Web of Science ®Google Scholar
• Rosen LS, Gordon D, Tchekmedyian S et al. 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(16), 3150–3157 (2003).
   PubMed Web of Science ®Google Scholar
• Henry DH, Costa L, Goldwasser F et al. Randomized, double blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J. Clin. Oncol.29(9), 1125–1132 (2011).
   PubMed Web of Science ®Google Scholar
• Stopeck AT, Lipton A, Body JJ et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J. Clin. Oncol.28(35), 5132–5139 (2010).
   PubMed Web of Science ®Google Scholar
• Fizazi K, Carducci M, Smith M et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet377(9768), 813–822 (2011).
   PubMed Web of Science ®Google Scholar
• McCawley LJ, Matrisian LM. Tumor progression: defining the soil round the tumor seed. Curr. Biol.11(1), R25–R27 (2001).
   PubMed Web of Science ®Google Scholar
• Rosen LS, Gordon DH, Dugan W Jr et al. Zoledronic acid is superior to pamidronate for the treatment of bone metastases in breast carcinoma patients with at least one osteolytic lesion. Cancer100(1), 36–42 (2004).
   PubMed Web of Science ®Google Scholar
• Roodman GD. Mechanisms of bone metastasis. N. Engl. J. Med.350(16), 1655–1664 (2004).
   PubMed Web of Science ®Google Scholar
• Coleman RE, Smith P, Rubens RD. Clinical course and prognostic factors following bone recurrence from breast cancer. Br. J. Cancer77(2), 366–340 (1998).
   PubMedGoogle Scholar
• Saad F, Lipton A, Cook R et al. Pathologic fractures correlate with reduced survival in patients with malignant bone disease. Cancer110(8), 1860–1867 (2007).
   PubMed Web of Science ®Google Scholar
• Van Poznak CH, Temin S, Yee GC et al. American Society of Clinical Oncology executive summary of the clinical practice guideline update on the role of bone-modifying agents in metastatic breast cancer. J. Clin. Oncol.29(9), 1221–1227 (2011).
   PubMed Web of Science ®Google Scholar
• Smith MR, Saad F, Coleman R et al. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a Phase 3, randomised, placebo-controlled trial. Lancet379(9810), 39–46 (2012).
   PubMed Web of Science ®Google Scholar
• Saad F, Lipton A. SRC kinase inhibition: targeting bone metastases and tumor growth in prostate and breast cancer. Cancer Treat. Rev.36(2), 177–184 (2010).
   PubMed Web of Science ®Google Scholar
• Previdi S, Abbadessa G, Dalo F et al. Breast cancer-derived bone metastasis can be effectively reduced through specific c-MET inhibitor tivantinib (ARQ 197) and shRNA c-MET knockdown. Mol. Cancer Ther.11(1), 214–223 (2012).
   PubMed Web of Science ®Google Scholar
• Buchali K, Correns HJ, Schuerer M et al. Results of a double blind study of 89-strontium therapy of skeletal metastases of prostatic carcinoma. Eur. J. Nucl. Med.14(7–8), 349–351 (1988).
   PubMedGoogle Scholar
• Elomaa I, Blomqvist C, Porkka L et al. Clodronate for osteolytic metastases due to breast cancer. Biomed. Pharmacother.42(2), 111–116 (1988).
   PubMed Web of Science ®Google Scholar
• Adami S, Mian M. Clodronate therapy of metastatic bone disease in patients with prostatic carcinoma. Recent Results Cancer Res.116, 67–72 (1989).
   PubMedGoogle Scholar
• Smith JA Jr. Palliation of painful bone metastases from prostate cancer using sodium etidronate: results of a randomized, prospective, double-blind, placebo-controlled study. J. Urol.141(1), 85–87 (1989).
   PubMed Web of Science ®Google Scholar
• Elomaa I, Kylmala T, Tammela T et al. Effect of oral clodronate on bone pain. A controlled study in patients with metastatic prostatic cancer. Int. Urol. Nephrol.24(2), 159–166 (1992).
   PubMed Web of Science ®Google Scholar
• Paterson AH, Powles TJ, Kanis JA et al. Double-blind controlled trial of oral clodronate in patients with bone metastases from breast cancer. J. Clin. Oncol.11(1), 59–65 (1993).
   PubMed Web of Science ®Google Scholar
• Kylmala T, Tammela T, Risteli L et al. Evaluation of the effect of oral clodronate on skeletal metastases with type 1 collagen metabolites. A controlled trial of the Finnish Prostate Cancer Group. Eur. J. Cancer29A(6), 821–825 (1993).
   PubMed Web of Science ®Google Scholar
• Porter AT, McEwan AJ, Powe JE et al. Results of a randomized Phase III trial to evaluate the efficacy of strontium-89 adjuvant to local field external beam irradiation in the management of endocrine resistant metastatic prostate cancer. Int. J. Radiat. Oncol. Biol. Phys.25(5), 805–813 (1993).
   PubMed Web of Science ®Google Scholar
• Quilty PM, Kirk D, Bolger JJ et al. A comparison of the palliative effects of strontium-89 and external beam radiotherapy in metastatic prostate cancer. Radiother. Oncol.31(1), 33–40 (1994).
   PubMed Web of Science ®Google Scholar
• Robertson AG, Reed NS, Ralston SH. Effect of oral clodronate on metastatic bone pain: a double-blind, placebo-controlled study. J. Clin. Oncol.13(9), 2427–2430 (1995).
   PubMed Web of Science ®Google Scholar
• O’Rourke N, McCloskey E, Houghton F et al. Double-blind, placebo-controlled, dose-response trial of oral clodronate in patients with bone metastases. J. Clin. Oncol.13(4), 929–934 (1995).
   PubMed Web of Science ®Google Scholar
• Kylmala T, Taube T, Tammela TL et al. 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. Cancer76(7), 939–942 (1997).
   PubMed Web of Science ®Google Scholar
• Strang P, Nilsson S, Brandstedt S et al. The analgesic efficacy of clodronate compared with placebo in patients with painful bone metastases from prostatic cancer. Anticancer Res.17(6D), 4717–4721 (1997).
   PubMed Web of Science ®Google Scholar
• Piga A, Bracci R, Ferretti B et al. A double blind randomized study of oral clodronate in the treatment of bone metastases from tumors poorly responsive to chemotherapy. J. Exp. Clin. Cancer Res.17(2), 213–217 (1998).
   PubMed Web of Science ®Google Scholar
• Arican A, Icli F, Akbulut H et al. The effect of two different doses of oral clodronate on pain in patients with bone metastases. Med. Oncol.16(3), 204–210 (1999).
   PubMedGoogle Scholar
• Kristensen B, Ejlertsen B, Groenvold M et al. Oral clodronate in breast cancer patients with bone metastases: a randomized study. J. Intern. Med.246(1), 67–74 (1999).
   PubMed Web of Science ®Google Scholar
• Lipton A, Theriault RL, Hortobagyi GN et al. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo- controlled trials. Cancer88(5), 1082–1090 (2000).
   PubMed Web of Science ®Google Scholar
• Berenson JR, Rosen LS, Howell A et al. Zoledronic acid reduces skeletal-related events in patients with osteolytic metastases. Cancer91(10), 1191–1200 (2001).
   PubMed Web of Science ®Google Scholar
• Jagdev SP, Purohit P, Heatley S et al. Comparison of the effects of intravenous pamidronate and oral clodronate on symptoms and bone resorption in patients with metastatic bone disease. Ann. Oncol.12(10), 1433–1438 (2001).
   PubMed Web of Science ®Google Scholar
• Small EJ, Smith MR, Seaman JJ et al. Combined analysis of two multicenter, randomized, placebo-controlled studies of pamidronate disodium for the palliation of bone pain in men with metastatic prostate cancer. J. Clin. Oncol.21(23), 4277–4284 (2003).
   PubMed Web of Science ®Google Scholar
• Ernst DS, Tannock IF, Winquist EW et al. 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(17), 3335–3342 (2003).
   PubMed Web of Science ®Google Scholar
• Dearnaley DP, Sydes MR, Mason MD et al. A double-blind, placebo-controlled, randomized trial of oral sodium clodronate for metastatic prostate cancer (MRC PR05 Trial). J. Natl Cancer Inst.95(17), 1300–1311 (2003).
   PubMed Web of Science ®Google Scholar
• Body JJ, Diel IJ, Lichinitser MR et al. Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann. Oncol.14(9), 1399–1405 (2003).
   PubMed Web of Science ®Google Scholar
• Body JJ, Diel IJ, Bell R et al. Oral ibandronate improves bone pain and preserves quality of life in patients with skeletal metastases due to breast cancer. Pain111(3), 306–312 (2004).
   PubMed Web of Science ®Google Scholar
• Kohno N, Aogi K, Minami H et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J. Clin. Oncol.23(15), 3314–3321 (2005).
   PubMed Web of Science ®Google Scholar
• Nilsson S, Strang P, Ginman C et al. Palliation of bone pain in prostate cancer using chemotherapy and strontium-89. A randomized Phase II study. J. Pain Symptom Manage.29(4), 352–357 (2005).
   PubMedGoogle Scholar
• Brown JE, McCloskey EV, Dewar JA et al. The use of bone markers in a 6-week study to assess the efficacy of oral clodronate in patients with metastatic bone disease. Calcif. Tissue Int.81(5), 341–351 (2007).
   PubMed Web of Science ®Google Scholar
• Heras P, Karagiannis S, Kritikos K, Hatzopoulos A, Mitsibounas D. Ibandronate is effective in preventing skeletal events in patients with bone metastases from colorectal cancer. Eur. J. Cancer Care (Engl.)16(6), 539–542 (2007).
   PubMed Web of Science ®Google Scholar
• Mystakidou K, Stathopoulou E, Parpa E et al. Oral versus intravenous ibandronic acid: a comparison of treatment options for metastatic bone disease. J. Cancer Res. Clin. Oncol.134(12), 1303–1310 (2008).
   PubMedGoogle Scholar
• Heras P, Kritikos K, Hatzopoulos A et al. Efficacy of ibandronate for the treatment of skeletal events in patients with metastatic breast cancer. Eur. J. Cancer Care (Engl.)18(6), 653–656 (2009).
   PubMed Web of Science ®Google Scholar
• Zaghloul MS, Boutrus R, El-Hossieny H et al. A prospective, randomized, placebo-controlled trial of zoledronic acid in bony metastatic bladder cancer. Int. J. Clin. Oncol.15(4), 382–389 (2010).
   PubMed Web of Science ®Google Scholar
• Zhao YY, Xue C, Hou X et al. Changes of bone resorption marker (NTX) in chemotherapy plus zoledronic acid versus chemotherapy alone for nasopharyngeal cancer patients with bone metastases. Eur. J. Cancer47(6), 848–853 (2011).
   PubMedGoogle Scholar
• Hortobagyi GN, Theriault RL, Porter L et al. Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases. Protocol 19 Aredia Breast Cancer Study Group. N. Engl. J. Med.335(24), 1785–1791 (1996).
   PubMed Web of Science ®Google Scholar
• Theriault RL, Lipton A, Hortobagyi GN et al. Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: a randomized, placebo-controlled trial. Protocol 18 Aredia Breast Cancer Study Group. J. Clin. Oncol.17(3), 846–854 (1999).
   PubMed Web of Science ®Google Scholar
• Andersen PK, Gill RD. Cox’s regression model for counting processes: a large sample study. Ann. Stat.10(4), 1100–1120 (1982).
   Web of Science ®Google Scholar
• Major PP, Cook RJ. Clinical end points for assessing bisphosphonate efficacy in the prevention of skeletal complications of bone metastases. Eur. Urol. Suppl.3(5), 34–39 (2004).
   Google Scholar
• Cook RJ, Lawless JF. Marginal analysis of recurrent events and a terminating event. Stat. Med.16(8), 911–924 (1997).
   PubMed Web of Science ®Google Scholar
• Ghosh D, Lin DY. Nonparametric analysis of recurrent events and death. Biometrics56(2), 554–562 (2000).
   PubMed Web of Science ®Google Scholar
• Trinkaus M, Simmons C, Myers J et al. Skeletal-related events (SREs) in breast cancer patients with bone metastases treated in the nontrial setting. Support Care Cancer18(2), 197–203 (2010).
   PubMed Web of Science ®Google Scholar
• Fallowfield L, Patrick D, Body J et al. Effects of denosumab versus zoledronic acid (ZA) on health-related quality of life (HRQL) in metastatic breast cancer: results from a randomized Phase III trial. J. Clin. Oncol.28(15S), 1025 (2010).
   PubMedGoogle Scholar
• Fallowfield L, Patrick D, Body JJ et al. The effect of treatment with denosumab or zoledronic acid on health-related quality of life in patients with metastatic breast cancer. Presented at: The 33rd Annual San Antiono Breast Cancer Symposium. San Antonio, TX, USA, 8–12 December 2010.
   Google Scholar
• Stopeck A, Fallowfield L, Patrick D et al. Effects of denosumab versus zoledronic acid (ZA) on pain in patients (pts) with metastatic breast cancer: results from a Phase III clinical trial. J. Clin. Oncol.28(15S), 1024 (2010).
   Google Scholar
• Stopeck A, Fallowfield L, Patrick D et al. Pain in patients (pts) with metastatic breast cancer: results from a Phase III trial of denosumab versus zoledronic acid (ZA). Presented at: The 33rd Annual San Antiono Breast Cancer Symposium. San Antonio, TX, USA, 8–12 December 2010.
   Google Scholar
• Brown JE, Cleeland CS, Fallowfield LJ et al. Pain outcomes in patients with bone metastases from castrate-resistant prostate cancer: results from a Phase 3 trial of denosumab vs zoledronic acid. Eur. Urol. Suppl.10(2), 336 (2011).
   Google Scholar
• Patrick D, Cleeland C, Fallowfield L et al. Effects of denosumab and zoledronic acid on pain interference with daily functioning in patients with castrate-resistant prostate cancer. J. Urol.185(4), E286 (2011).
   Google Scholar
• von Moos R, Patrick D, Fallowfield L et al. Effects of denosumab versus zoledronic acid (ZA) on pain in patients (pts) with advanced cancer (excluding breast and prostate) or multiple myeloma (MM): results from a randomized Phase III clinical trial. J. Clin. Oncol.28(15S), 9043 (2010).
   Google Scholar