Symptoms from treatment with sunitinib or sorafenib: A multicenter explorative cohort study to explore the influence of patient-reported outcomes on therapy decisions

Supportive Care in Cancer

Volumn 22, Issue 9, 2014, Pages 2371-2380

  Koldenhof, J J ^a   Witteveen, P O ^a   De Vos, R ^b   Walraven, M ^a   Tillier, C N ^c   Verheul, H M W ^d   Teunissen, S C C M ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c ANTONI VAN LEEUWENHOEK HOSPITAL   (Netherlands)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Advanced cancer; Dose modifications; Patient reported outcome; Sorafenib; Sunitinib; Symptom intensity

Indexed keywords

SORAFENIB; SUNITINIB; ANGIOGENESIS INHIBITOR; CARBANILAMIDE DERIVATIVE; INDOLE DERIVATIVE; NICOTINAMIDE; PYRROLE DERIVATIVE;

ADULT; ADVANCED CANCER; ANOREXIA; ARTICLE; BONE MARROW DEPRESSION; CANCER PATIENT; CLINICAL ARTICLE; COHORT ANALYSIS; CONSTIPATION; COUGHING; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DRUG DOSE REDUCTION; DRUG ERUPTION; DRUG INDUCED DISEASE; DRY SKIN; DYSPNEA; FATIGUE; FEMALE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL STROMAL TUMOR; HAND FOOT SYNDROME; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERTENSION; KIDNEY CARCINOMA; LIVER CELL CARCINOMA; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROENDOCRINE TUMOR; OUTCOME ASSESSMENT; PAIN; PRIORITY JOURNAL; PROSPECTIVE MEMORY; PRURITUS; QUALITY OF LIFE; RECOMMENDED DRUG DOSE; SEIZURE; SELF REPORT; SIDE EFFECT; SKIN MANIFESTATION; SYMPTOM ASSESSMENT; TREATMENT DURATION; VOMITING; WEIGHT REDUCTION; WELLBEING; AGED; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DECISION MAKING; MIDDLE AGED; MULTICENTER STUDY; NEOPLASMS; NETHERLANDS; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; COHORT STUDIES; DECISION MAKING; FEMALE; HUMANS; INDOLES; MALE; MIDDLE AGED; NEOPLASMS; NETHERLANDS; NIACINAMIDE; PHENYLUREA COMPOUNDS; PYRROLES; QUALITY OF LIFE; SELF REPORT; TREATMENT OUTCOME;

EID: 84906305647     PISSN: 09414355     EISSN: 14337339     Source Type: Journal    
DOI: 10.1007/s00520-014-2223-2     Document Type: Article

References (37)

1. Porta C, Szczylik C (2009) Tolerability of first-line therapy for metastatic renal cell carcinoma. Cancer Treat Rev 35:297-307
2. Hutson TE (2007) Safety and tolerability of sorafenib in clear-cell renal cell carcinoma: a Phase III overview. Expert Rev Anticancer Ther 7:1193-1202
3. van der Veldt AA, Boven E, Helgason HH et al (2008) Predictive factors for severe toxicity of sunitinib in unselected patients with advanced renal cell cancer. Br J Cancer 99:259-265
4. Houk BE, Bello CL, Poland B et al (2010) Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol 66:357-371
5. Maluf FC, Fernandes GS, Kann AG et al (2008) Exploring the role of novel agents in the treatment of renal cell carcinoma. Cancer Treat Rev 34:750-760
6. Wolter P, Schoffski P (2010) Targeted therapies in the treatment of GIST: adverse events and maximising the benefits of sunitinib through proactive therapy management. Acta Oncol 49:13-23
7. Abou-Alfa GK, Schwartz L, Ricci S et al (2006) Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol 24:4293-4300 (Pubitemid 46630787)
8. Gupta K, Miller JD, Li JZ et al (2008) Epidemiologic and socioeconomic burden of metastatic renal cell carcinoma (mRCC): a literature review. Cancer Treat Rev 34:193-205
9. Costa LJ, Drabkin HA (2007) Renal cell carcinoma: new developments in molecular biology and potential for targeted therapies. Oncologist 12:1404-1415
10. Escudier B, Eisen T, StadlerWM et al (2007) Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356:125-134 (Pubitemid 46089673)
11. La Vine DB, Coleman TA, Davis CH et al (2010) Frequent dose interruptions are required for patients receiving oral kinase inhibitor therapy for advanced renal cell carcinoma. Am J Clin Oncol 33:217-220
12. Herrmann E, Bierer S, Gerss J et al (2008) Prospective comparison of sorafenib and sunitinib for second-line treatment of cytokinerefractory kidney cancer patients. Oncology 74:216-222
13. Motzer RJ, Hutson TE, Tomczak P et al (2007) Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 356:115-124 (Pubitemid 46089672)
14. CTCAE version3.0; http://ctep.cancer.gov/protocoldevelopment/electronic- applications/docs/ctcaev3.pdf . 2011. 15-2-2011. Ref Type: Online Source
15. McCaffery M, Ferrell BR (1997) Nurses' knowledge of pain assessment and management: how much progress have we made? J Pain Symptom Manag 14:175-188 (Pubitemid 27377601)
16. Gill A, Daines P, Selby D (2010) What do symptom scores mean: observations on discrepancies when defining symptoms using words and numbers. Eur J Oncol Nurs 14:435-438
17. Selby D, Cascella A, Gardiner K et al (2010) A single set of numerical cutpoints to define moderate and severe symptoms for the Edmonton Symptom Assessment System. J Pain Symptom Manag 39:241-249
18. Bruera E, Kuehn N, Miller MJ et al (1991) The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care 7:6-9
19. Richardson LA, Jones GW (2009) A review of the reliability and validity of the Edmonton Symptom Assessment System. Curr Oncol 16:55
20. Philip J, Smith WB, Craft P et al (1998) Concurrent validity of the modified Edmonton Symptom Assessment System with the Rotterdam Symptom Checklist and the Brief Pain Inventory. Support Care Cancer 6:539-541 (Pubitemid 28520469)
21. Teunissen SC, de Graeff A, de Haes HC et al (2006) Prognostic significance of symptoms of hospitalised advanced cancer patients. Eur J Cancer 42:2510-2516 (Pubitemid 44442939)
22. Teunissen SC, Wesker W, Kruitwagen C et al (2007) Symptom prevalence in patients with incurable cancer: a systematic review. J Pain Symptom Manag 34:94-104 (Pubitemid 46970881)
23. Investigator 's brochure BAY43-9006. 1-4-2007
24. Investigator 's brochure sunitinib malate. 1-4-2007
25. de Boer AG, van Lanschot JJ, Stalmeier PF et al (2004) Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life? Qual Life Res 13:311-320 (Pubitemid 38392259)
26. Bonett DG, Price RM(2002) Statistical inference for a linear function of medians: confidence intervals, hypothesis testing, and sample size requirements. Psychol Methods 7:370-383
27. Agresti A, Coull BA (1998) Approximate is better than "exact" for interval estimation of binomial proportions. Am Stat Assoc 52:119-126
28. Cella D (2009) Quality of life in patients with metastatic renal cell carcinoma: the importance of patient-reported outcomes. Cancer Treat Rev 35:733-737
29. Wagner LI, Wenzel L, Shaw E et al (2007) Patient-reported outcomes in phase II cancer clinical trials: lessons learned and future directions. J Clin Oncol 25:5058-5062 (Pubitemid 350237601)
30. Wood LS (2009) Management of vascular endothelial growth factor and multikinase inhibitor side effects. Clin J Oncol Nurs 13(Suppl):13-18
31. Bhojani N, Jeldres C, Patard JJ et al (2008) Toxicities associated with the administration of sorafenib, sunitinib, and temsirolimus and their management in patients with metastatic renal cell carcinoma. Eur Urol 53:917-930
32. McKeage K, Wagstaff AJ (2007) Sorafenib: in advanced renal cancer. Drugs 67:475-483 (Pubitemid 46425553)
33. Mokkink LB, Terwee CB, Patrick DL et al (2010) The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res 19:539-549
34. Blay JY(2010) Pharmacologicalmanagement of gastrointestinal stromal tumours: an update on the role of sunitinib. Ann Oncol 21:208-215
35. Charles C, Gafni A, Whelan T (1999) Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med 49:651-661 (Pubitemid 29314682)
36. Stacey D, Samant R, Bennett C (2008) Decisionmaking in oncology: a review of patient decision aids to support patient participation. CA Cancer J Clin 58:293-304
37. Rini BI (2007) Vascular endothelial growth factor-targeted therapy in renal cell carcinoma: current status and future directions. Clin Cancer Res 13:1098-1106