Refining the chemotherapy approach for older patients with colon cancer

Journal of Clinical Oncology

Volumn 32, Issue 24, 2014, Pages 2570-2580

  McCleary, Nadine J ^a   Dotan, Efrat ^b   Browner, Ilene ^c  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b FOX CHASE CANCER CENTER   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AFLIBERCEPT; ANTINEOPLASTIC AGENT; BEVACIZUMAB; CAPECITABINE; CETUXIMAB; FLUOROPYRIMIDINE; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN; PANITUMUMAB; REGORAFENIB;

AGED; AGING; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER RISK; CANCER SURVIVAL; COLON CANCER; DISEASE FREE SURVIVAL; DRUG EFFICACY; FUNCTIONAL STATUS; GERIATRIC ASSESSMENT; GERIATRIC PATIENT; HUMAN; LIFE EXPECTANCY; LIVER FUNCTION; MONOTHERAPY; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; REVIEW; TREATMENT OUTCOME; TREATMENT PLANNING; ADJUVANT CHEMOTHERAPY; AGE; COLONIC NEOPLASMS; FEMALE; MALE; METASTASIS; PATHOLOGY; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); VERY ELDERLY;

AGE FACTORS; AGED; AGED, 80 AND OVER; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS, PHASE III AS TOPIC; COLONIC NEOPLASMS; FEMALE; GERIATRIC ASSESSMENT; HUMANS; MALE; NEOPLASM METASTASIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84906228912     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.55.1960     Document Type: Review

References (76)

1. National Cancer Institute: Surveillance, Epidemiology, and End Results Program: SEER Fact Sheets-Colon and Rectum Cancer. http://seer.cancer.gov/ statfacts/html/colorect.html
2. Luo R, Giordano SH, Freeman JL, et al: Referral to medical oncology: A crucial step in the treatment of older patients with stage III colon cancer. Oncologist 11:1025-1033, 2006 (Pubitemid 44564812)
3. Gross CP, Guo Z, McAvay GJ, et al: Multimorbidity and survival in older persons with colorectal cancer. J Am Geriatr Soc 54:1898-1904, 2006 (Pubitemid 44915834)
4. Schrag D, Cramer LD, Bach PB, et al: Age and adjuvant chemotherapy use after surgery for stage III colon cancer. J Natl Cancer Inst 93:850-857, 2001 (Pubitemid 32590779)
5. Sanoff HK, Carpenter WR, Stürmer T, et al: Effect of adjuvant chemotherapy on survival of patients with stage III colon cancer diagnosed after age 75 years. J Clin Oncol 30:2624-2634, 2012
6. Ho C, Ng K, O'Reilly S, et al: Outcomes in elderly patients with advanced colorectal cancer treated with capecitabine: A population-based analysis. Clin Colorectal Cancer 5:279-282, 2005
7. Centers for Disease Control and Prevention: National Vital Statistics Report: United States Life Tables, 2004. http://www.cdc.gov/nchs/data/nvsr/ nvsr56/nvsr56-09.pdf
8. Sargent DJ, Goldberg RM, Jacobson SD, et al: A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl J Med 345:1091-1097, 2001
9. D'Andre S, Sargent DJ, Cha SS, et al: 5-Fluorouracil-based chemotherapy for advanced colorectal cancer in elderly patients: A North Central Cancer Treatment Group study. Clin Colorectal Cancer 4:325-331, 2005 (Pubitemid 40309379)
10. Folprecht G, Cunningham D, Ross P, et al: Efficacy of 5-fluorouracil-based chemotherapy in elderly patients with metastatic colorectal cancer: A pooled analysis of clinical trials. Ann Oncol 15:1330-1338, 2004 (Pubitemid 39302467)
11. de Gramont A, Bosset JF, Milan C, et al: Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: A French Intergroup study. J Clin Oncol 15:808-815, 1997 (Pubitemid 27074252)
12. Product Information: XELODA oral tablets, capecitabine oral tablets. Genentech, South San Francisco, CA
13. Seymour MT, Thompson LC, Wasan HS, et al: Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): An open-label, randomised factorial trial. Lancet 377:1749-1759, 2011
14. MacLaughlin EJ, Raehl CL, Treadway AK, et al: Assessing medication adherence in the elderly: Which tools to use in clinical practice? Drugs Aging 22:231-255, 2005 (Pubitemid 40529889)
15. Product information: ELOXATIN intravenous lyophilized powder for solution, intravenous concentrate for solution, oxaliplatin intravenous lyophilized powder for solution, intravenous concentrate for solution. sanofi-aventis, Bridgewater, NJ
16. Goldberg RM, Tabah-Fisch I, Bleiberg H, et al: Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer. J Clin Oncol 24:4085-4091, 2006 (Pubitemid 46622283)
17. Folprecht G, Seymour MT, Saltz L, et al: Irinotecan/fluorouracil combination in first-line therapy of older and younger patients with metastatic colorectal cancer: Combined analysis of 2,691 patients in randomized controlled trials. J Clin Oncol 26:1443-1451, 2008
18. Van Cutsem E, Rivera F, Berry S, et al: Safety and efficacy of first-line bevacizumab with FOLFOX, XELOX, FOLFIRI, and fluoropyrimidines in metastatic colorectal cancer: The BEAT study. Ann Oncol 20:1842-1847, 2009
19. Kozloff M, Yood MU, Berlin J, et al: Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: The BRiTE observational cohort study. Oncologist 14: 862-870, 2009
20. Scappaticci FA, Skillings JR, Holden SN, et al: Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst 99:1232-1239, 2007 (Pubitemid 47299901)
21. Cassidy J, Saltz LB, Giantonio BJ, et al: Effect of bevacizumab in older patients with metastatic colorectal cancer: Pooled analysis of four randomized studies. J Cancer Res Clin Oncol 136:737-743, 2010
22. Jehn CF, Böning L, Kröning H, et al: Cetuximab-based therapy in elderly comorbid patients with metastatic colorectal cancer. Br J Cancer 106:274-278, 2012
23. Gross CP, McAvay GJ, Krumholz HM, et al: The effect of age and chronic illness on life expectancy after a diagnosis of colorectal cancer: Implications for screening. Ann Intern Med 145:646-653, 2006 (Pubitemid 46768839)
24. Koroukian SM, Xu F, Bakaki PM, et al: Comorbidities, functional limitations, and geriatric syndromes in relation to treatment and survival patterns among elders with colorectal cancer. J Gerontol A Biol Sci Med Sci 65:322-329, 2010
25. Hoppe S, Rainfray M, Fonck M, Hoppenreys L, Blanc JF, Ceccaldi J, et al: Functional decline in older patients with cancer receiving first-line chemotherapy. J Clin Oncol 31(31):3877-3882, 2013
26. Aparicio T, Jouve JL, Teillet L, et al: Geriatric factors predict chemotherapy feasibility: Ancillary results of FFCD 2001-02 phase III study in first-line chemotherapy for metastatic colorectal cancer in elderly patients. J Clin Oncol 31:1464-1470, 2013
27. Hurria A, Togawa K, Mohile SG, et al: Predicting chemotherapy toxicity in older adults with cancer: A prospective multicenter study. J Clin Oncol 29:3457-3465, 2011
28. Extermann M, Boler I, Reich R, et al: The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score: Design and validation. J Clin Oncol 28:636s, 2010 (suppl; abstr 9000)
29. Stuck AE, Siu AL, Wieland GD, et al: Comprehensive geriatric assessment: A meta-analysis of controlled trials. Lancet 342:1032-1036, 1993 (Pubitemid 23314809)
30. Kenis C, Bron D, Libert Y, et al: Relevance of a systematic geriatric screening and assessment in older patients with cancer: Results of a prospective multicentric study. Ann Oncol 24:1306-1312, 2013
31. Decoster L, Kenis C, Van Puyvelde K, et al: The influence of clinical assessment (including age) and geriatric assessment on treatment decisions in older patients with cancer. J Geriatr Oncol 4:235-241, 2013
32. Talarico L, Chen G, Pazdur R: 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, 2004 (Pubitemid 41185131)
33. Hempenius L, Slaets JP, Boelens MA, et al: Inclusion of frail elderly patients in clinical trials: Solutions to the problems. J Geriatr Oncol 4:26-31, 2013
34. Wildiers H, Mauer M, Pallis A, et al: End points and trial design in geriatric oncology research: A joint European Organisation for Research and Treatment of Cancer-Alliance for Clinical Trials in Oncology-International Society of Geriatric Oncology position article. J Clin Oncol 31:3711-3718, 2013
35. Twelves C, Wong A, Nowacki MP, et al: Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 352:2696-2704, 2005 (Pubitemid 41007824)
36. Scheithauer W, McKendrick J, Begbie S, et al: Oral capecitabine as an alternative to i.v. 5-fluorouracilbased adjuvant therapy for colon cancer: Safety results of a randomized, phase III trial. Ann Oncol 14:1735-1743, 2003 (Pubitemid 38029045)
37. André T, Boni C, Navarro M, et al: Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 27:3109-3116, 2009
38. Tournigand C, André T, Bonnetain F, et al: Adjuvant therapy with fluorouracil and oxaliplatin in stage II and elderly patients (between ages 70 and 75 years) with colon cancer: Subgroup analyses of the Multicenter International Study of Oxaliplatin, Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer trial. J Clin Oncol 30:3353-3360, 2012
39. Haller DG, Tabernero J, Maroun J, et al: Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol 29:1465-1471, 2011
40. McCleary NJ, Meyerhardt JA, Green E, et al: Impact of age on the efficacy of newer adjuvant therapies in patients with stage II/III colon cancer: Findings from the ACCENT database. J Clin Oncol 31:2600-2606, 2013
41. Iwashyna TJ, Lamont EB: Effectiveness of adjuvant fluorouracil in clinical practice: A population-based cohort study of elderly patients with stage III colon cancer. J Clin Oncol 20:3992-3998, 2002
42. Abrams TA, Brightly R, Mao J, et al: Patterns of adjuvant chemotherapy use in a population-based cohort of patients with resected stage II or III colon cancer. J Clin Oncol 29:3255-3262, 2011
43. Centers for Disease Control and Prevention: Fatalities and injuries from falls among older adults: United States, 1993-2003 and 2001-2005. MMWR Morb Mortal Wkly Rep 55:1303, 2006
44. Sargent DJ, Marsoni S, Monges G, et al: Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer. J Clin Oncol 28:3219-3226, 2010
45. Ribic CM, Sargent DJ, Moore MJ, et al: Tumor microsatellite-instability status as a predictor of benefit from fluorouracil-based adjuvant chemotherapy for colon cancer. N Engl J Med 349:247-257, 2003 (Pubitemid 36859476)
46. Bertagnolli MM, Niedzwiecki D, Compton CC, et al: Microsatellite instability predicts improved response to adjuvant therapy with irinotecan, fluorouracil, and leucovorin in stage III colon cancer: Cancer and Leukemia Group B Protocol 89803. J Clin Oncol 27:1814-1821, 2009
47. Aparicio T, Schischmanoff O, Poupardin C, et al: Deficient mismatch repair phenotype is a prognostic factor for colorectal cancer in elderly patients. Dig Liver Dis 45:245-250, 2013
48. Gray R, Barnwell J, McConkey C, et al: Adjuvant chemotherapy versus observation in patients with colorectal cancer: A randomised study. Lancet 370:2020-2029, 2007
49. Siegel R, Naishadham D, Jemal A: Cancer statistics, 2013. CA Cancer J Clin 63:11-30, 2013
50. Yothers G, O'Connell MJ, Allegra CJ, et al: Oxaliplatin as adjuvant therapy for colon cancer: Updated results of NSABP C-07 trial, including survival and subset analyses. J Clin Oncol 29:3768-3774, 2011
51. Lembersky BC, Wieand HS, Petrelli NJ, et al: Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: Results from National Surgical Adjuvant Breast and Bowel Project Protocol C-06. J Clin Oncol 24:2059-2064, 2006 (Pubitemid 46622115)
52. Twelves C, Scheithauer W, McKendrick J, et al: Capecitabine versus 5-fluorouracil/folinic acid as adjuvant therapy for stage III colon cancer: Final results from the X-ACT trial with analysis by age and preliminary evidence of a pharmacodynamic marker of efficacy. Ann Oncol 23:1190-1197, 2012
53. Koopman M, Antonini NF, Douma J, et al: Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): A phase III randomised controlled trial. Lancet 370:135-142, 2007 (Pubitemid 47042893)
54. Ducreux M, Malka D, Mendiboure J, et al: Sequential versus combination chemotherapy for the treatment of advanced colorectal cancer (FFCD 2000-05): An open-label, randomised, phase 3 trial. Lancet Oncol 12:1032-1044, 2011
55. Goldberg RM, Sargent DJ, Morton RF, et al: A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22:23-30, 2004 (Pubitemid 41095110)
56. Feliu J, Salud A, Escudero P, et al: XELOX (capecitabine plus oxaliplatin) as first-line treatment for elderly patients over 70 years of age with advanced colorectal cancer. Br J Cancer 94:969-975, 2006
57. Twelves CJ, Butts CA, Cassidy J, et al: Capecitabine/oxaliplatin, a safe and active first-line regimen for older patients with metastatic colorectal cancer: Post hoc analysis of a large phase II study. Clin Colorectal Cancer 5:101-107, 2005
58. Souglakos J, Pallis A, Kakolyris S, et al: Combination of irinotecan (CPT-11) plus 5-fluorouracil and leucovorin (FOLFIRI regimen) as first line treatment for elderly patients with metastatic colorectal cancer: A phase II trial. Oncology 69:384-390, 2005 (Pubitemid 41797914)
59. Maindrault-Goebel F, Lledo G, Chibaudel B, et al: Final results of OPTIMOX2, a large randomized phase II study of maintenance therapy or chemotherapy-free intervals (CFI) after FOLFOX in patients with metastatic colorectal cancer (MRC): A GERCOR study. J Clin Oncol 25:166s, 2007 (suppl; abstr 4013)
60. Figer A, Perez-Staub N, Carola E, et al: FOLFOX in patients aged between 76 and 80 years with metastatic colorectal cancer: An exploratory cohort of the OPTIMOX1 study. Cancer 110:2666-2671, 2007 (Pubitemid 350250335)
61. Pasetto LM, Falci C, Sinigaglia G, et al: How many colorectal cancer (CRC) patients older than 70 years may be safely treated with bevacizumab? J Clin Oncol 24:623s, 2006 (suppl; abstr 13589)
62. Kozloff M, Sugrue MM, Berlin J, et al: Safety and effectiveness of bevacizumab (BV) and chemotherapy (CT) in elderly patients (pts) with metastatic colorectal cancer (mCRC): Results from the BRiTE Prospective Cohort Study. J Clin Oncol 26, 2008 (suppl; abstr 454)
63. Kabbinavar FF, Hurwitz HI, Yi J, et al: Addition of bevacizumab to fluorouracil-based first-line treatment of metastatic colorectal cancer: Pooled analysis of cohorts of older patients from two randomized clinical trials. J Clin Oncol 27:199-205, 2009
64. Kabbinavar FF, Schulz J, McCleod M, et al: Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: Results of a randomized phase II trial. J Clin Oncol 23:3697-3705, 2005
65. Cunningham D, Lang I, Marcuello E, et al: Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): An open-label, randomised phase 3 trial. Lancet Oncol 14:1077-1085, 2013
66. Douillard JY, Siena S, Cassidy J, et al: Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: The PRIME study. J Clin Oncol 28:4697-4705, 2010
67. Abdelwahab S, Azmy A, Abdel-Aziz H, et al: Anti-EGFR (cetuximab) combined with irinotecan for treatment of elderly patients with metastatic colorectal cancer (mCRC). J Cancer Res Clin Oncol 138:1487-1492, 2012
68. Sastre J, Aranda E, Grávalos C, et al: First-line single-agent cetuximab in elderly patients with metastatic colorectal cancer: A phase II clinical and molecular study of the Spanish group for digestive tumor therapy (TTD). Crit Rev Oncol Hematol 77:78-84, 2011
69. Sastre J, Grávalos C, Rivera F, et al: First-line cetuximab plus capecitabine in elderly patients with advanced colorectal cancer: Clinical outcome and subgroup analysis according to KRAS status from a Spanish TTD Group Study. Oncologist 17:339-345, 2012
70. Grothey A, Van Cutsem E, Sobrero A, et al: Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): An international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 381:303-312, 2013
71. Tabernero J, Van Cutsem E, Lakomý R, et al: Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: Prespecified subgroup analyses from the VELOUR trial. Eur J Cancer 50:320-331, 2014
72. Van Cutsem E, Sobrero A, Siena S, et al: Regorafenib (REG) in progressive metastatic colorectal cancer (mCRC): Analysis of age subgroups in the phase III CORRECT trial. J Clin Oncol 31, 2013 (suppl 15s; abstr 3636)
73. Van Cutsem E, Rivera F, Berry S, et al: Safety and efficacy of first-line bevacizumab with FOLFOX, XELOX, FOLFIRI and fluoropyrimidines in metastatic colorectal cancer: The BEAT study. Ann Oncol 20: 1842-1847, 2009
74. Kozloff MF, Berlin J, Flynn PJ, et al: Clinical outcomes in elderly patients with metastatic colorectal cancer receiving bevacizumab and chemotherapy: Results from the BRiTE observational cohort study. Oncology 78:329-339, 2010
75. Cunningham D, Lang I, Lorusso V, et al: Bevacizumab (bev) in combination with capecitabine (cape) for the first-line treatment of elderly patients with metastatic colorectal cancer (mCRC): Results of a randomized international phase III trial (AVEX). J Clin Oncol 30, 2012 (suppl; abstr 337)
76. Extermann M, Boler I, Reich RR, et al: Predicting the risk of chemotherapy toxicity in older patients: The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score. Cancer 118:3377-3386, 2012