Patient-reported outcome instruments used to assess pain and functioning in studies of bisphosphonate treatment for bone metastases

Supportive Care in Cancer

Volumn 20, Issue 4, 2012, Pages 657-677

  Matza, Louis S ^a   Fallowfield, Lesley J ^b   Chung, Karen C ^c   Currie, Brooke M ^a   Van Brunt, Kate ^a   Patrick, Donald L ^d  

^a UNITED BIOSOURCE CORPORATION   (United States)

^b UNIVERSITY OF SUSSEX   (United Kingdom)

^c AMGEN INC   (United States)

^d UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Bisphosphonate; Bone metastases; Bone pain; Pain assessment; Patient reported outcomes

Indexed keywords

ANALGESIC AGENT; CLODRONIC ACID; ETIDRONIC ACID; IBANDRONIC ACID; PAMIDRONIC ACID; ZOLEDRONIC ACID;

BONE METASTASIS; BONE PAIN; BRIEF PAIN INVENTORY; CANCER PATIENT; FUNCTIONAL STATUS; HUMAN; NUMERICAL RATING SCALE; PAIN ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; RATING SCALE; REVIEW; SYSTEMATIC REVIEW; VERBAL RATING SCALE; VISUAL ANALOG SCALE;

BONE DENSITY CONSERVATION AGENTS; BONE NEOPLASMS; DATA COLLECTION; DIPHOSPHONATES; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PAIN; PAIN MEASUREMENT; QUALITY OF LIFE; RESEARCH DESIGN;

EID: 84863486618     PISSN: 09414355     EISSN: 14337339     Source Type: Journal    
DOI: 10.1007/s00520-011-1356-9     Document Type: Review

References (121)

1. Coleman RE (2001) Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev 27:165-176
2. Coleman RE (2006) The role of bone markers in metastatic bone disease. Cancer Treat Rev 32:1-2
3. Costa L, Lipton A, Coleman RE (2006) Role of bisphosphonates for the management of skeletal complications and bone pain from skeletal metastases. Support Cancer Ther 3:143-153
4. Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, De Boer R, Berardi R, Gascon P, Tonkin KS, Coleman R, Paterson AHG, Peterson MC, Fan M, Kinsey A, Jun S (2007) Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol 25:4431-4437
5. Hitron A, Adams V (2009) The pharmacological management of skeletal-related events from metastatic tumors. Orthopedics 32:188
6. Chow E, Hird A, Velikova G, Johnson C, Dewolf L, Bezjak A, Wu J, Shafiq J, Sezer O, Kardamakis D, Linden Y, Ma B, Castro M, Arnalot PF, Ahmedzai S, Clemons M, Hoskin P, Yee A, Brundage M, Bottomley A (2009) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for patients with bone metastases: the EORTC QLQ-BM22. Eur J Cancer 45:1146-1152
7. Weinfurt KP, Li Y, Castel LD, Saad F, Timbie JW, Glendenning GA, Schulman KA (2005) The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer. Ann Oncol 16:579-584
8. Coleman RE (2004) Bisphosphonates: clinical experience. Oncologist 9(Suppl 4):14-27
9. Coleman RE (2008) Risks and benefits of bisphosphonates. Br J Cancer 98:1736-1740
10. Diel IJ, Body JJ, Lichinitser MR, Kreuser ED, Dornoff W, Gorbunova VA, Budde M, Bergstrom B (2004) Improved quality of life after long-term treatment with the bisphosphonate ibandronate in patients with metastatic bone disease due to breast cancer. Eur J Cancer 40:1704-1712
11. Smith MR (2003) Bisphosphonates to prevent skeletal complications in men with metastatic prostate cancer. J Urol 170:S55-S57, discussion S57-S58
12. Wong R, Wiffen PJ (2002) Bisphosphonates for the relief of pain secondary to bone metastases. Cochrane Database Syst Rev: CD002068
13. Clemons MJ, Dranitsaris G, Ooi WS, Yogendran G, Sukovic T, Wong BY, Verma S, Pritchard KI, Trudeau M, Cole DE (2006) Phase II trial evaluating the palliative benefit of second-line zoledronic acid in breast cancer patients with either a skeletalrelated event or progressive bone metastases despite first-line bisphosphonate therapy. J Clin Oncol 24:4895-4900
14. Weinfurt KP, Anstrom KJ, Castel LD, Schulman KA, Saad F (2006) Effect of zoledronic acid on pain associated with bone metastasis in patients with prostate cancer. Ann Oncol 17:986-989
15. Food and Drug Administration (FDA) (2009) Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist 74:65132-65133
16. Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP, Dawisha S, O'Neill R, Kennedy DL (2007) Patient-reported outcomes to support medical product labeling claims: FDA perspective value. Health 10(Suppl 2):S125-S137
17. European Medicines Agency (2005) Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. European Medicines Agency, London
18. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655
19. Karnofsky DA, Burchenal JH (1949) The clinical evaluation of chemotherapeutic agents in cancer. In: Macleod CM (ed) Evaluation of chemotherapeutic agents. Columbia University Press, New York, pp 191-205
20. Lipton A, Theriault RL, Hortobagyi GN, Simeone J, Knight RD, Mellars K, Reitsma DJ, Heffernan M, Seaman JJ (2000) 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, placebocontrolled trials. Cancer 88:1082-1090
21. Small EJ, Smith MR, Seaman JJ, Petrone S, Kowalski MO (2003) 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 21:4277-4284
22. Body JJ, Diel IJ, Bell R, Pecherstorfer M, Lichinitser MR, Lazarev AF, Tripathy D, Bergstrom B (2004) Oral ibandronate improves bone pain and preserves quality of life in patients with skeletal metastases due to breast cancer. Pain 111:306-312
23. Body JJ, Diel IJ, Lichinitser MR, Kreuser ED, Dornoff W, Gorbunova VA, Budde M, Bergstrom B (2003) Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann Oncol 14:1399-1405
24. Tripathy D, Lichinitzer M, Lazarev A,MacLachlan SA, Apffelstaedt J, Budde M, Bergstrom B (2004) Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial. Ann Oncol 15:743-750
25. Berruti A, Dogliotti L, Tucci M, Tarabuzzi R, Guercio S, Torta M, Tampellini M, Dovio A, Poggio M, Scarpa RM, Angeli A (2002) Metabolic effects of single-dose pamidronate administration in prostate cancer patients with bone metastases. Int J Biol Markers 17:244-252
26. Jagdev SP, Purohit P, Heatley S, Herling C, Coleman RE (2001) Comparison of the effects of intravenous pamidronate and oral clodronate on symptoms and bone resorption in patients with metastatic bone disease. Ann Oncol 12:1433-1438
27. Mitsiades CS, Bogdanos J, Karamanolakis D, Milathianakis C, Dimopoulos T, Koutsilieris M (2006) Randomized controlled clinical trial of a combination of somatostatin analog and dexamethasone plus zoledronate vs. zoledronate in patients with androgen ablation-refractory prostate cancer. Anticancer Res 26:3693-3700
28. Wang RF, Zhang CL, Zhu SL, Zhu M (2003) A comparative study of samarium-153-ethylenediaminetetramethylene phosphonic acid with pamidronate disodium in the treatment of patients with painful metastatic bone cancer. Med Princ Pract 12:97-101
29. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J (2005) Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 113:9-19
30. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S (2008) Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 9:105-121
31. Jensen MP (2003) The validity and reliability of pain measures in adults with cancer. J Pain 4:2-21
32. Cleeland CS, Ryan KM (1994) Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 23:129-138
33. Berenson JR, Rosen LS, Howell A, Porter L, Coleman RE, Morley W, Dreicer R, Kuross SA, Lipton A, Seaman JJ (2001) Zoledronic acid reduces skeletal-related events in patients with osteolytic metastases. Cancer 91:1191-1200
34. Mystakidou K, Stathopoulou E, Parpa E, Kouloulias V, Kouskouni E, Vlahos L (2008) Oral versus intravenous ibandronic acid: a comparison of treatment options for metastatic bone disease. J Cancer Res Clin Oncol 134:1303-1310
35. Cleeland C (2009) The Brief Pain Inventory user guide. The University of Texas MD Anderson Cancer Center, Houston
36. Berenson JR, Vescio R, Henick K, Nishikubo C, Rettig M, Swift RA, Conde F, Von Teichert JM (2001) A phase I, open label, dose ranging trial of intravenous bolus zoledronic acid, a novel bisphosphonate, in cancer patients with metastatic bone disease. Cancer 91:144-154
37. Daut RL, Cleeland CS, Flanery RC (1983) Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain 17:197-210
38. Ernst DS, Tannock IF, Winquist EW, Venner PM, Reyno L, Moore MJ, Chi K, Ding K, Elliott C, Parulekar W (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 21:3335-3342
39. Melzack R (1975) TheMcGill Pain Questionnaire:major properties and scoring methods. Pain 1:277-299
40. Melzack R (1987) The short-form McGill Pain Questionnaire. Pain 30:191-197
41. Theriault RL, Lipton A, Hortobagyi GN, Leff R, Gluck S, Stewart JF, Costello S, Kennedy I, Simeone J, Seaman JJ, Knight RD, Mellars K, Heffernan M, Reitsma DJ (1999) 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 17:846-854
42. Vitale G, Fonderico F, Martignetti A, Caraglia M, Ciccarelli A, Nuzzo V, Abbruzzese A, Lupoli G (2001) Pamidronate improves the quality of life and induces clinical remission of bone metastases in patients with thyroid cancer. Br J Cancer 84:1586-1590
43. Huskisson EC (1974) Measurement of pain. Lancet 2:1127-1131
44. Huskisson EC (1982) Measurement of pain. J Rheumatol 9:768-769
45. Scott J, Huskisson EC (1976) Graphic representation of pain. Pain 2:175-184
46. Iwamoto J, Takeda T, Ichimura S (2002) Transient relief of metastatic cancer bone pain by oral administration of etidronate. J Bone Miner Metab 20:228-234
47. Nelson E, Wasson J, Kirk J, Keller A, Clark D, Dietrich A, Stewart A, Zubkoff M (1987) Assessment of function in routine clinical practice: description of the COOP Chart method and preliminary findings. J Chronic Dis 40(Suppl 1):55S-69S
48. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376
49. Fayers P, Bottomley A (2002) Quality of life research within the EORTC-the EORTC QLQ-C30. Eur Org Res Treat Cancer Eur J Cancer 38(Suppl 4):S125-S133
50. Manas A, Casas F, Ciria JP, Lopez C, Saez J, Palacios A, de las Heras M, Porto C, Sanchez E, Martin C, Esco R, Veiras C, Martinez JC, Marquez M, Ramos A, Calvo F, Fuertes J, Andreu FJ, Contreras J, Perez L, Romero J, Vayreda J, Victoria C (2008) Randomised study of single dose (8 Gy vs. 6 Gy) of analgesic radiotherapy plus zoledronic acid in patients with bone metastases. Clin Transl Oncol 10:281-287
51. Wardley A, Davidson N, Barrett-Lee P, Hong A, Mansi J, Dodwell D, Murphy R, Mason T, Cameron D (2005) Zoledronic acid significantly improves pain scores and quality of life in breast cancer patients with bone metastases: a randomised, crossover study of community vs hospital bisphosphonate administration. Br J Cancer 92:1869-1876
52. Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L,Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK (1996) The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol 14:2756-2768
53. Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J et al (1993) The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 11:570-579
54. Webster K, Cella D, Yost K (2003) The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: properties, applications, and interpretation. Health Qual Life Outcomes 1:79
55. FACIT (2009) FACIT (Functional Assessment of Chronic Illness Therapy). FACIT, Elmhurst
56. Facchini G, Caraglia M, Santini D, Nasti G, Ottaiano A, Striano S, Maiolino P, Ruberto M, Fiore F, Tonini G, Budillon A, Iaffaioli RV, Zeppetella GL (2007) The clinical response on bone metastasis from breast and lung cancer during treatment with zoledronic acid is inversely correlated to skeletal related events (SRE). J Exp Clin Cancer Res 26:307-312
57. Saad F, Gleason DM, Murray R, Tchekmedyian S, Venner P, Lacombe L, Chin JL, Vinholes JJ, Goas JA, Chen B (2002) A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst 94:1458-1468
58. Brooks R, Rabin R, de Charro F (2003) The measurement and valuation of health status using EQ-5D: a European perspective. Kluwer Academic Publishers, Dordrecht
59. EuroQol Group (1990) EuroQol-a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 16:199-208
60. Stockler MR, Osoba D, Goodwin P, Corey P, Tannock IF (1998) Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. Eur Org Res Treat Cancer J Clin Epidemiol 51:137-145
61. Tannock I, Gospodarowicz M, Meakin W, Panzarella T, Stewart L, Rider W (1989) Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response. J Clin Oncol 7:590-597
62. Mancini I, Dumon JC, Body JJ (2004) Efficacy and safety of ibandronate in the treatment of opioid-resistant bone pain associated with metastatic bone disease: a pilot study. J Clin Oncol 22:3587-3592
63. Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K (1991) The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care 7:6-9
64. Chang VT, Hwang SS, Feuerman M (2000) Validation of the edmonton symptom assessment scale. Cancer 88:2164-2171
65. Mystakidou K, Katsouda E, Parpa E, Kouskouni E, Chondros C, TsiatasML, Galanos A, Vlahos L (2006) A prospective randomized controlled clinical trial of zoledronic acid for bone metastases. AmJ Hosp Palliat Care 23:41-50
66. Cella DF (1995) Measuring quality of life in palliative care. Semin Oncol 22:73-81
67. Higgins JPT, Green S (2008) Cochrane handbook for systematic reviews of interventions. The Cochrane Collaboration. Wiley, Chichester
68. Breivik H, Cherny N, Collett B, de Conno F, Filbet M, Foubert AJ, Cohen R, Dow L (2009) Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol 20:1420-1433
69. Leidy NK, Revicki DA, Geneste B (1999) Recommendations for evaluating the validity of quality of life claims for labeling and promotion value. Health 2:113-127
70. Scientific Advisory Committee of the Medical Outcomes Trust (2002) Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res 11:193-205
71. Leidy NK, Vernon M (2008) Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. Pharmaco Economics 26:363-370
72. Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD (2009) Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR good research practices for evaluating and documenting content validity for the use of existing instruments and their modification PRO task force report. Value Health 12:1075-1083
73. Jensen MP, Mardekian J, Lakshminarayanan M, Boye ME (2008) Validity of 24-h recall ratings of pain severity: biasing effects of "Peak" and "End" pain. Pain 137:422-427
74. Broom R, Du H, Clemons M, Eton D, Dranitsaris G, Simmons C, Ooi W, Cella D (2009) Switching breast cancer patients with progressive bone metastases to third-generation bisphosphonates: measuring impact using the functional assessment of cancer therapy-bone pain. J Pain Symptom Manage 38:244-257
75. Tharmalingam S, Chow E, Harris K, Hird A, Sinclair E (2008) Quality of life measurement in bone metastases: a literature review. J Pain Res 1:49-58
76. Carteni G, Bordonaro R, Giotta F, Lorusso V, Scalone S, Vinaccia V, Rondena R, Amadori D (2006) Efficacy and safety of zoledronic acid in patients with breast cancer metastatic to bone: a multicenter clinical trial. Oncologist 11:841-848
77. Clemons M, Dranitsaris G, Ooi W, Cole DE (2008) A phase II trial evaluating the palliative benefit of second-line oral ibandronate in breast cancer patients with either a skeletal related event (SRE) or progressive bone metastases (BM) despite standard bisphosphonate (BP) therapy. Breast Cancer Res Treat 108:79-85
78. Di Lorenzo G, Autorino R, Perdona S, De Laurentiis M, D'Armiento M, Cancello G, Mirone V, Imbimbo C, Longo N, Altieri V, Tortora G, Figg WD, De Placido S (2007) Docetaxel, vinorelbine, and zoledronic acid as first-line treatment in patients with hormone refractory prostate cancer: a phase II study. Eur Urol 52:1020-1027
79. Hong SJ, Cho KS, Cho HY, Ahn H, Kim CS, Chung BH (2007) A prospective, multicenter, open-label trial of zoledronic acid in patients with hormone refractory prostate cancer. Yonsei Med J 48:1001-1008
80. Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, Apffelstaedt J, Hussein M, Coleman RE, Reitsma DJ, Seaman JJ, Chen BL, Ambros Y (2001) 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 7:377-387
81. Rosen LS, Gordon D, Tchekmedyian S, Yanagihara R, Hirsh V, Krzakowski M, Pawlicki M, de Souza P, Zheng M, Urbanowitz G, Reitsma D, Seaman JJ (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 21:3150-3157
82. Foley KM (1997) Supportive care and quality of life. In: DeVita VT, Hellman S, Rosenberg SA (eds) Cancer: principles and practice of oncology. Lippincott-Raven Publishers, Philadelphia, pp 2807-2812
83. Coleman RE (1994) Evaluation of bone disease in breast cancer. Breast 3:73-78
84. Addeo R, Nocera V, Faiola V, Vincenzi B, Ferraro G, Montella L, Guarrasi R, Rossi E, Cennamo G, Tonini G, Capasso E, Santini D, Caraglia M, Del Prete S (2008) Management of pain in elderly patients receiving infusion of zoledronic acid for bone metastasis: a single-institution report. Support Care Cancer 16:209-214
85. Serlin RC, Mendoza TR, Nakamura Y, Edwards KR, Cleeland CS (1995) When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain 61:277-284
86. Arican A, Icli F, Akbulut H, Cakir M, Sencan O, Samur M, Acikgoz N, Demirkazik A (1999) The effect of two different doses of oral clodronate on pain in patients with bone metastases. Med Oncol 16:204-210
87. Sriwantanakul K et al (1983) Studies with different types of visual analog scales for measurement of pain. Clin Pharmacol Ther 34:234-239
88. Hultborn R, Gundersen S, Ryden S, Holmberg E, Carstensen J, Wallgren UB, Killany S, Andreassen L, Carlsson G, Fahl N, Hatschek T, Sommer HH, Hessman Y, Hornmark-Stenstam B, Johnsborg S, Klepp R, Laino R, Niklasson LG, Rudenstam CM, Sundbeck A, Soderberg M, Tejler G (1999) Efficacy of pamidronate in breast cancer with bone metastases: a randomized, double-blind placebo-controlled multicenter study. Anticancer Res 19:3383-3392
89. Vogel CL, Yanagihara RH, Wood AJ, Schnell FM, Henderson C, Kaplan BH, Purdy MH, Orlowski R, Decker JL, Lacerna L, Hohneker JA (2004) Safety and pain palliation of zoledronic acid in patients with breast cancer, prostate cancer, or multiple myeloma who previously received bisphosphonate therapy. Oncologist 9:687-695
90. Fulfaro F, Leto G, Badalamenti G, Arcara C, Cicero G, Valerio MR, Di Fede G, Russo A, Vitale A, Rini GB, Casuccio A, Intrivici C, Gebbia N (2005) The use of zoledronic acid in patients with bone metastases from prostate carcinoma: effect on analgesic response and bone metabolism biomarkers. J Chemother 17:555-559
91. Santangelo A, Testai M, Barbagallo P, Manuele S, Di Stefano A, Tomarchio M, Trizzino G, Musumeci G, Panebianco P, Maugeri D (2006) The use of bisphosphonates in palliative treatment of bone metastases in a terminally ill, oncological elderly population. Arch Gerontol Geriatr 43:187-192
92. Kaplan RM, Bush JW, Berry CC (1979) Health status index: category rating versus magnitude estimation for measuring levels of well-being. Med Care 17:501-525
93. Heidenreich A, Hofmann R, Engelmann UH (2001) The use of bisphosphonate for the palliative treatment of painful bone metastasis due to hormone refractory prostate cancer. J Urol 165:136-140
94. Heidenreich A, Elert A, Hofmann R (2002) Ibandronate in the treatment of prostate cancer associated painful osseous metastases. Prostate Cancer Prostatic Dis 5:231-235
95. Leto G, Badalamenti G, Arcara C, Crescimanno M, Flandina C, Tumminello FM, Incorvaia L, Gebbia N, Fulfaro F (2006) Effects of zoledronic acid on proteinase plasma levels in patients with bone metastases. Anticancer Res 26:23-26
96. Bruera E, Michaud M, Vigano A, Neumann CM, Watanabe S, Hanson J (2001) Multidisciplinary symptom control clinic in a cancer center: a retrospective study. Support Care Cancer 9:162-168
97. Jacox A, Carr DB, Payne R et al (1994) Management of cancer pain: quick reference guide for clinicians. Clinical Practice Guideline No. 9, AHCPR Publication No. 94-0592. Agency for Health Care Policy and Research, United States Department of Health and Human Services, Public Health Service, Washington
98. Rodrigues P, Hering F, Campagnari JC (2004) Use of bisphosphonates can dramatically improve pain in advanced hormonerefractory prostate cancer patients. Prostate Cancer Prostatic Dis 7:350-354
99. Storto G, Klain M, Paone G, Liuzzi R, Molino L, Marinelli A, Soricelli A, Pace L, Salvatore M (2006) Combined therapy of Sr- 89 and zoledronic acid in patients with painful bone metastases. Bone 39:35-41
100. Serafini AN, Houston SJ, Resche I, Quick DP, Grund FM, Ell PJ, Bertrand A, Ahmann FR, Orihuela E, Reid RH, Lerski RA, Collier BD, McKillop JH, Purnell GL, Pecking AP, Thomas FD, Harrison KA (1998) Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a doubleblind placebo-controlled clinical trial. J Clin Oncol 16:1574-1581
101. Vassiliou V, Kalogeropoulou C, Christopoulos C, Solomou E, Leotsinides M, Kardamakis D (2007) Combination ibandronate and radiotherapy for the treatment of bone metastases: clinical evaluation and radiologic assessment. Int J Radiat Oncol Biol Phys 67:264-272
102. Vassiliou V, Kalogeropoulou C, Giannopoulou E, Leotsinidis M, Tsota I, Kardamakis D (2007) A novel study investigating the therapeutic outcome of patients with lytic, mixed and sclerotic bone metastases treated with combined radiotherapy and ibandronate. Clin Exp Metastasis 24:169-178
103. Efstathiou E, Bozas G, Kostakopoulos A, Kastritis E, Deliveliotis C, Antoniou N, Skarlos D, Papadimitriou C, Dimopoulos MA, Bamias A (2005) Combination of docetaxel, estramustine phosphate, and zoledronic acid in androgen-independent metastatic prostate cancer: efficacy, safety, and clinical benefit assessment. Urology 65:126-130
104. Coleman RE (1991) Assessment of response to treatment. In: Rubens RD, Forgelman I (eds) Bone metastases: diagnosis and treatment. Springer, New York, pp 99-120
105. Groff L, Zecca E, De Conno F, Brunelli C, Boffi R, Panzeri C, Cazzaniga M, Ripamonti C (2001) The role of disodium pamidronate in the management of bone pain due to malignancy. Palliat Med 15:297-307
106. Martinetti A, Seregni E, Ripamonti C, Ferrari L, De Conno F, Miceli R, Pallotti F, Coliva A, Biancolini D, Bombardieri E (2002) Serum levels of tartrate-resistant acid phosphatase-5b in breast cancer patients treated with pamidronate Int. J Biol Markers 17:253-258
107. Martinetti A, Ripamonti C, Miceli R, Seregni E, Mariani L, De Conno F, Bajetta E, Bombardieri E (2007) Short-term effects of pamidronate on bone turnover: can bone markers be considered predictive of the analgesic response? Oncol Rep 17:1533-1540
108. Ripamonti C, Fagnoni E, Campa T, Giardina V, Brunelli C, Pigni A, De Conno F (2007) Decreases in pain at rest and movementrelated pain during zoledronic acid treatment in patients with bone metastases due to breast or prostate cancer: a pilot study. Support Care Cancer 15:1177-1184
109. Berenson JR, Vescio RA, Rosen LS, VonTeichert JM, Woo M, Swift R, Savage A, Givant E, Hupkes M, Harvey H, Lipton A (2001) A phase I dose-ranging trial of monthly infusions of zoledronic acid for the treatment of osteolytic bone metastases. Clin Cancer Res 7:478-485
110. Tong D, Gillick L, Hendrickson FR (1982) The palliation of symptomatic osseous metastases: final results of the study by the Radiation Therapy Oncology Group. Cancer 50:893-899
111. Kouloulias VE, Dardoufas CE, Kouvaris JR, Antypas CE, Sandilos PH, Matsopoulos GK, Vlahos LJ (2002) Use of image processing techniques to assess effect of disodium pamidronate in conjunction with radiotherapy in patients with bone metastases. Acta Oncol 41:169-174
112. Kouloulias V,Matsopoulos G, Kouvaris J, Dardoufas C, Bottomley A, Varela M, Uzunoglu N, Antypas C, Metafa A, Moulopoulos A, Sandilos P, Vlahos L (2003) Radiotherapy in conjunction with intravenous infusion of 180 mg of disodium pamidronate in management of osteolytic metastases from breast cancer: clinical evaluation, biochemical markers, quality of life, and monitoring of recalcification using assessments of gray-level histogram in plain radiographs. Int J Radiat Oncol Biol Phys 57:143-157
113. Hillner BE, Weeks JC, Desch CE, Smith TJ (2000) Pamidronate in prevention of bone complications in metastatic breast cancer: a cost-effectiveness analysis. J Clin Oncol 18:72-79
114. Kouloulias VE, Kouvaris JR,Mystakidou K,VarelaMN,Kokakis J, Pistevou-Gombaki K, Balafouta M, Gennatas C, Vlahos LJ (2004) Duration of bisphosphonate treatment: results of a non-randomised study in patients previously treated with local irradiation for bone metastases from breast cancer. Curr Med Res Opin 20:819-826
115. Purohit OP, Anthony C, Radstone CR, Owen J, Coleman RE (1994) High-dose intravenous pamidronate for metastatic bone pain. Br J Cancer 70:554-558
116. Coleman RE, Woll PJ, Miles M, Scrivener W, Rubens RD (1988) Treatment of bone metastases from breast cancer with (3-amino- 1-hydroxypropylidene)-1,1- bisphosphonate (APD). Br J Cancer 58:621-625
117. Hortobagyi GN, Theriault RL, Porter L, Blayney D, Lipton A, Sinoff C, Wheeler H, Simeone JF, Seaman J, Knight RD (1996) 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 335:1785-1791
118. Price DD, Bush FM, Long S, Harkins SW (1994) A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain 56:217-226
119. Lorish CD, Maisiak R (1986) The face scale: a brief, nonverbal method for assessing patient mood. Arthritis Rheum 29:906-909
120. Hortobagyi GN, Theriault RL, Lipton A, Porter L, Blayney D, Sinoff C, Wheeler H, Simeone JF, Seaman JJ, Knight RD, Heffernan M, Mellars K, Reitsma DJ (1998) Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate. Protocol 19 Aredia Breast Cancer Study Group. J Clin Oncol 16:2038-2044
121. Fayers PM, Aaronson NK, Bjordal K et al (2001) European Organization for Research and Treatment of Cancer QLQ-C30 scoring manual. EORTC Quality of Life Group, Brussels