Efficacy and safety of sunitinib in elderly patients with metastatic renal cell carcinoma

British Journal of Cancer

Volumn 110, Issue 5, 2014, Pages 1125-1132

  Hutson, T E ^a   Bukowski, R M ^b   Rini, B I ^b   Gore, M E ^c   Larkin, J M ^c   Figlin, R A ^d   Barrios, C H ^e   Escudier, B ^f   Lin, X ^g   Fly, K ^g   Martell, B ^h   Matczak, E ^h   Motzer, R J ⁱ  

^a BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^b TAUSSIG CANCER INSTITUTE   (United States)

^c INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^d CEDARS SINAI MEDICAL CENTER   (United States)

^e PONTIFICAL CATHOLIC UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^f INSTITUT GUSTAVE ROUSSY   (France)

^g PFIZER INC   (United States)

^h Pfizer Ltd   (United States)

ⁱ MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Age; Metastatic; Renal cell carcinoma; Retrospective analysis; Sunitinib

Indexed keywords

SUNITINIB; ALPHA INTERFERON; CYTOKINE;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; CHILL; CONSTIPATION; COUGHING; DECREASED APPETITE; DEHYDRATION; DEPRESSION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRY SKIN; DYSGEUSIA; DYSPEPSIA; DYSPNEA; EPISTAXIS; ERYTHEMA; FATIGUE; FEMALE; FEVER; FLATULENCE; GASTROESOPHAGEAL REFLUX; GERIATRIC PATIENT; HAND FOOT SYNDROME; HEADACHE; HUMAN; HYPERTENSION; HYPOTHYROIDISM; INSOMNIA; KAPLAN MEIER METHOD; KIDNEY METASTASIS; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MOUTH PAIN; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PERIPHERAL EDEMA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; SKIN DISCOLORATION; STOMATITIS; THORAX PAIN; THROMBOCYTOPENIA; URINARY TRACT INFECTION; VERY ELDERLY; VOMITING; WEIGHT REDUCTION; XEROSTOMIA; YOUNG ADULT; AGE DISTRIBUTION; CANCER PATIENT; HYPONATREMIA; LIMB PAIN; MULTICENTER STUDY (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; UPPER ABDOMINAL PAIN;

ADULT; AGED; AGED, 80 AND OVER; CARCINOMA, RENAL CELL; CLINICAL TRIALS, PHASE III AS TOPIC; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; INDOLES; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PYRROLES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84895808946     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2013.832     Document Type: Article

References (50)

1. Aapro MS, Köhne CH, Cohen HJ, Extermann M (2005) Never too old? Age should not be a barrier to enrollment in cancer clinical trials. Oncologist 10: 198-204. (Pubitemid 40463157)
2. Altekruse SF, Kosary CL, Krapcho M, Neyman N, Aminou R, Waldron W, Ruhl J, Howlader N, Tatalovich Z, Cho H, Mariotto A, Eisner MP, Lewis DR, Cronin K, Chen HS, Feuer EJ, Stinchcomb DG, Edwards BK (eds). (2010) SEER Cancer Statistics Review, 1975-2007. National Cancer Institute: Bethesda, MD. http://seer.cancer.gov/csr/1975-2007/, based on November 2009 SEER data submission, posted to the SEER website 2010.
3. Anisimov VN (2006) Effect of host age on tumor growth rate in rodents. Front Biosci 11: 412-422. (Pubitemid 43253503)
4. Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY (2012) Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer 118: 1252-1259.
5. Bouchardy C, Rapiti E, Fioretta G, Laissue P, Neyroud-Caspar I, Schäfer P, Kurtz J, Sappino AP, Vlastos G (2003) Undertreatment strongly decreases prognosis of breast cancer in elderly women. J Clin Oncol 21: 3580-3587. (Pubitemid 46594049)
6. Delva F, Marien E, Fonck M, Rainfray M, Demeaux JL, Moreaud P, Soubeyran P, Sasco AJ, Mathoulin-Pélissier S (2011) Factors influencing general practitioners in the referral of elderly cancer patients. BMC Cancer 11: 5.
7. Denzinger S, Otto W, Burger M, Hammerschmied C, Junker K, Hartmann A, Wieland WF, Walter B (2007) Sporadic renal cell carcinoma in young and elderly patients: are there different clinicopathological features and disease specific survival rates? World J Surg Oncol 5: 16.
8. Doherty JG, Rüfer A, Bartholomew P, Beaumont DM (1999) The presentation, treatment and outcome of renal cell carcinoma in old age. Age Ageing 28: 359-362. (Pubitemid 29346830)
9. Earle CC, Neumann PJ, Gelber RD, Weinstein MC, Weeks JC (2002) Impact of referral patterns on the use of chemotherapy for lung cancer. J Clin Oncol 20: 1786-1792. (Pubitemid 34273267)
10. Easson AM, Cotterchio M, Crosby JA, Sutherland H, Dale D, Aronson M, Holowaty E, Gallinger S (2002) A population-based study of the extent of surgical resection of potentially curable colon cancer. Ann Surg Oncol 9: 380-387. (Pubitemid 34496726)
11. Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, Anderson S, Shah S, Bukowski R, Escudier B. on behalf of the TARGET Study Group (2008) Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial. J Natl Cancer Inst 100: 1454-1463.
12. Escudier B, Roigas J, Gillessen S, Harmenberg U, Srinivas S, Mulder SF, Fountzilas G, Peschel C, Flodgren P, Maneval EC, Chen I, Vogelzang NJ (2009) Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol 27: 4068-4075.
13. Extermann M (2007) Interaction between comorbidity and cancer. Cancer Control 14: 13-22. (Pubitemid 46168962)
14. Fox MH, Reichard A (2013) Disability, health, and multiple chronic conditions among people eligible for both Medicare and Medicaid, 2005-2010. Prev Chronic Dis 10: E157.
15. Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, Hariharan S, Lee SH, Haanen J, Castellano D, Vrdoljak E, Schöffski P, Mainwaring P, Nieto A, Yuan J, Bukowski R (2009) Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol 10: 757-763.
16. Houterman S, Janssen-Heijnen ML, Hendrikx AJ, van den Berg HA, Coebergh JW (2006) Impact of comorbidity on treatment and prognosis of prostate cancer patients: a population-based study. Crit Rev Oncol Hematol 58: 60-67.
17. Janssen-Heijnen ML, Gondos A, Bray F, Hakulinen T, Brewster DH, Brenner H, Coebergh JW (2010) Clinical relevance of conditional survival of cancer patients in Europe: age-specific analyses of 13 cancers. J Clin Oncol 28: 2520-2528.
18. Jung EJ, Lee HJ, Kwak C, Ku JH, Moon KC (2009) Young age is independent prognostic factor for cancer-specific survival of low-stage clear cell renal cell carcinoma. Urology 73: 137-141.
19. Karakiewicz PI, Jeldres C, Suardi N, Hutterer GC, Perrotte P, Capitanio U, Ficarra V, Cindolo L, de La Taille A, Tostain J, Mulders PF, Salomon L, Zigeuner R, Schips L, Chautard D, Valeri A, Lechevallier E, Descots JL, Lang H, Mejean A, Verhoest G, Patard JJ (2008) Age at diagnosis is a determinant factor of renal cell carcinoma-specific survival in patients treated with nephrectomy. Can Urol Assoc J 2: 610-617.
20. Kornblith AB, Kemeny M, Peterson BL, Wheeler J, Crawford J, Bartlett N, Fleming G, Graziano S, Muss H, Cohen HJ. on behalf of the Cancer and Leukemia Group B (2002) Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials. Cancer 95: 989-996. (Pubitemid 34925347)
21. Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R, Montello MJ, Housman MG, Escarce JJ (2003) Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol 21: 1383-1389. (Pubitemid 46606420)
22. Ljungberg B, Cowan NC, Hanbury DC, Hora M, Kuczyk MA, Merseburger AS, Patard JJ, Mulders PF, Sinescu IC, on behalf of the European Association of Urology Guideline Group (2010) EAU guidelines on renal cell carcinoma: the 2010 update. Eur Urol 58: 398-406.
23. Meehan B, Appu S, St Croix B, Rak-Poznanska K, Klotz L, Rak J (2011) Age-related properties of the tumour vasculature in renal cell carcinoma. BJU Int 107: 416-424.
24. Mor V, Masterson-Allen S, Goldberg RJ, Cummings FJ, Glicksman AS, Fretwell MD (1985) Relationship between age at diagnosis and treatments received by cancer patients. J Am Geriatr Soc 33: 585-589. (Pubitemid 16238707)
25. Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M (2002) Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol 20: 289-296. (Pubitemid 34032623)
26. Motzer RJ, Hutson TE, Olsen MR, Hudes GR, Burke JM, Edenfield WJ, Wilding G, Agarwal N, Thompson JA, Cella D, Bello A, Korytowsky B, Yuan J, Valota O, Martell B, Hariharan S, Figlin RA (2012) Randomized phase II trial of sunitinib on an intermittent versus continuous dosing schedule as first-line therapy for advanced renal cell carcinoma. J Clin Oncol 30: 1371-1377.
27. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA (2009) Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 27: 3584-3590.
28. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA (2007) Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 356: 115-124. (Pubitemid 46089672)
29. Motzer RJ, Michaelson MD, Redman BG, Hudes GR, Wilding G, Figlin RA, Ginsberg MS, Kim ST, Baum CM, DePrimo SE, Li JZ, Bello CL, Theuer CP, George DJ, Rini BI (2006a) Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol 24: 16-24. (Pubitemid 46630489)
30. Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD (2006b) Sunitinib in patients with metastatic renal cell carcinoma. JAMA 295: 2516-2524. (Pubitemid 43854967)
31. National Comprehensive Cancer Network (NCCN) (2011) Clinical Practice Guidelines in Oncology: Senior Adult Oncology, Version 2.2011. Available at http://www.nccn.org/professionals/physician-gls/f-guidelines.asp, accessed July 11, 2011.
32. Nelson RA, Vogelzang N, Pal SK (2013) A gap in disease-specific survival between younger and older adults with de novo metastatic renal cell carcinoma: results of a SEER database analysis. Clin Genitourin Cancer 11: 303-310.
33. Pal SK, Vanderwalde A, Hurria A, Figlin RA (2011) Systemic therapies for metastatic renal cell carcinoma in older adults. Drugs Aging 28: 635-649.
34. Pal SK, Hsu J, Hsu S, Hu J, Bergerot P, Carmichael C, Saikia J, Liu X, Lau C, Twardowski P, Figlin RA, Yuh BE (2013) Impact of age on treatment trends and clinical outcome in patients with metastatic renal cell carcinoma. J Geriatr Oncol 4: 128-133.
35. Petignat P, Fioretta G, Verkooijen HM, Vlastos AT, Rapiti E, Bouchardy C, Vlastos G (2004) Poorer survival of elderly patients with ovarian cancer: a population-based study. Surg Oncol 13: 181-186. (Pubitemid 40029613)
36. Pili R, Guo Y, Chang J, Nakanishi H, Martin GR, Passaniti A (1994) Altered angiogenesis underlying age-dependent changes in tumor growth. J Natl Cancer Inst 86: 1303-1314. (Pubitemid 24276792)
37. Quaglia A, Tavilla A, Shack L, Brenner H, Janssen-Heijnen M, Allemani C, Colonna M, Grande E, Grosclaude P, Vercelli M, on behalf of the EUROCARE Working Group (2009) The cancer survival gap between elderly and middle-aged patients in Europe is widening. Eur J Cancer 45: 1006-1016.
38. Reed MJ, Karres N, Eyman D, Cruz A, Brekken RA, Plymate S (2007) The effects of aging on tumor growth and angiogenesis are tumor-cell dependent. Int J Cancer 120: 753-760. (Pubitemid 46175393)
39. Scoll BJ, Wong YN, Egleston BL, Kunkle DA, Saad IR, Uzzo RG (2009) Age, tumor size and relative survival of patients with localized renal cell carcinoma: a surveillance, epidemiology and end results analysis. J Urol 181: 506-511.
40. Talarico L, Chen G, Pazdur R (2004) Enrollment of elderly patients in clinical trials for cancer drug registration: a 7-year experience by the US Food and Drug Administration. J Clin Oncol 22: 4626-4631. (Pubitemid 41185131)
41. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92: 205-216. (Pubitemid 30099779)
42. Thompson RH, Ordonez MA, Iasonos A, Secin FP, Guillonneau B, Russo P, Touijer K (2008) Renal cell carcinoma in young and old patients: is there a difference? J Urol 180: 1262-1266.
43. Townsley CA, Selby R, Siu LL (2005) Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol 23: 3112-3124. (Pubitemid 46224135)
44. Tyldesley S, Zhang-Salomons J, Groome PA, Zhou S, Schulze K, Paszat LF, Mackillop WJ (2000) Association between age and the utilization of radiotherapy in Ontario. Int J Radiat Oncol Biol Phys 47: 469-480. (Pubitemid 30236390)
45. US Department of Health and Human Services (2009) Administration on Aging. A Profile of Older Americans. Available at http://www.aoa.gov/ aoaroot/aging-statistics/profile/2009/, accessed November 21, 2013.
46. Verhoest G, Veillard D, Guillé F, De La Taille A, Salomon L, Abbou CC, Valéri A, Lechevallier E, Descotes JL, Lang H, Jacqmin D, Tostain J, Cindolo L, Ficarra V, Artibani W, Schips L, Zigeuner R, Mulders PF, Mejean A, Patard JJ (2007) Relationship between age at diagnosis and clinicopathologic features of renal cell carcinoma. Eur Urol 51: 1298-1304.
47. Vulto AJ, Lemmens VE, Louwman MW, Janssen-Heijnen ML, Poortmans PH, Lybeert ML, Coebergh JW (2006) The influence of age and comorbidity on receiving radiotherapy as part of primary treatment for cancer in South Netherlands, 1995 to 2002. Cancer 106: 2734-2742.
48. Yee KW, Pater JL, Pho L, Zee B, Siu LL (2003) Enrollment of older patients in cancer treatment trials in Canada: why is age a barrier? J Clin Oncol 21: 1618-1623. (Pubitemid 46594117)
49. Yildiz E, Ayan S, Goze F, Gokce G, Gultekin EY (2008) Relation of microvessel density with microvascular invasion, metastasis and prognosis in renal cell carcinoma. BJU Int 101: 758-764. (Pubitemid 351270001)
50. Yonemori K, Hirakawa A, Komiyama N, Kouno T, Ando M, Fujiwara Y, Urano T, Akagawa H, Maruyama H, Toyoshima S (2010) Participation of elderly patients in registration trials for oncology drug applications in Japan. Ann Oncol 21: 2112-2118.