RISIKO TINGGI
VII. ANALISIS STATISTIKA
1. Untuk mengetahui peningkatan hasil pengobatan dengan protokol ini dianalisis dengan menggunakan metode Kaplan-Meier.
2. Membandingkanhasil pengobatan ALL pada anak dengan risiko biasa (standardrisk ) dan risiko tinggi (high risk) menggunakan protocol Indonesia ALL 2013 ini .
3. Analisis Kaplan-Meier untuk menghitung Overall survival(OS), Event free survival, dan juga angka relap, angka drop-out (dropout rate) dan angka kematian akibat toksisitas (toxic death rate).
4. Mengevaluasi adverse effect yang timbul pada pemberian kemoterapi. Mencatat tiap adverse efek yang muncul berdasarkan kriteria WHO. 5. Memonitor status gizi, pengendalian infeksi, hygiene, edukasi dan
32 Daftar pustaka
1. Hastings C. The Children’s Hospital Oakland Hematology/oncology handbook. St.Louis: Mosby, 2002. p. 153-9.
2. Margolin JF, Steuber CP, Poplacl DG. Acute lymphoblastic leukemia. In: Pizzo PA, Poplack DG, eds. Principles and practice of pediatric oncology. Fourth edition. Philadelphia: Lippinkot William&Wilkins,2002. p. 489-544.
3. WHO Working Group. Use and interpretation opf anthropometric indicators of nutritional status. Bulletin of the World Health Organization 1986; 64: 924-941.
4. Meija-Arangure JM, Fajardo-Gutierrez A, Reyes-Luiz NI, Bernaldez-Rios R, Meija-Dominique AM, Navarrez_Navarro S, et al. Malnutrition in childhood lymphoblastic leukemia: A predictor of early mortality during the induction-to-remission phase of treatment. Arch Med Res 1999; 30: 150-153.
5. Pui CH, Evans WE. Acute lymphoblastic leukemia. Drug Therapy 1998;339(9):605-15.
6. Khan AR, Sheikh MH, Intekhab K. Pre-existing malnutrition and treatment outcome in children with acute lymphoblastic leukemia. JPMA 2006; 556:171.
7. Khan AR, Sheikh MH, Intekhab K. Effect of hypoproteinemia on treatment outcome in children with acute lymphoblastic leukemia. J Ayub Med College 2006; 18(2).
8. Delbecque-Boussard L, Gottrand F, Nelken B, Mazingue F, Vic P, Farriaux JP. Nutritional status of children with acute lymphoblastic leukemia: a longitudinal study. Am J Clin Nutr 1997; 65: 95-100.
9. Marin M, Lopez M, Mendizabol L, Arguelles R. malnutrition as an adverse prognostic factors in the response of treatment and survival of patients with lymphoblastic leukemia. Gac Med Mex 1991; 127(2): 125-132.
10. Yu, Kuvibidila, Ducos, Warrier. Nutritional status of children with leukemia. Med Pediatr Oncol 1994; 22(2): 73-77.
11. Aksoy U, Erbay A, Akisu C, Apa H, Ozkoc S, Ozturk S. Intestinal parasites in children with neoplasms. Turkish J Pediatr 2003;45:129-132.
12. Ghavani MJ, Ashraf F, Vosough P, Rakin MB. Survey of intestinal parasitic infection in leukemic children and evaluation of their serum immunoglobulin. Iranian J Publ Health 2003;32(1):19-21.
13. Miller RA, Holnterg RE, Lansen CR. Life threatening diarrhea caused by cryptosporidium in a child undergoing therapy for acute lymphoblastic leukemia. J Pediatr 1983;103:256-9.
14. Lewis IJ, Host CA, Baxby D. Diarrhoea due to cryptosporidium in ALL. Arch Dis Child 1984;60:60-2.
15. Makled MK, Azab ME, Abdalla HM, Sherif EA, Nasef NS. Opportunistic parasitic infections in immunocompromised hosts. J Egypt Soc Parasitol 1991;21:657-68.
16. Kuper H, Adami HD, Trichopolous D. Infectious as a major preventable cause of human cancer. J Intern Med 2000;248:171-83.
17. Khan SA, Wingard JR. Infection and mucosal injury in cancer treatment. J Nat Cancer Inst Monogr 2001;29:31-6.
18. Nash, Chen, Smart. Cacrum oris-like lesions. Br J Oral Maxillaofac Surg 1991; 29(1): 51-53. 19. Rego MFN, Pinheiro GS, Metze K, Lorand-Metze I. Acute leukemias in Piaui: comparison with
features observed in other regions of Brazil. Braz J Med Biol Res 2003;36(3).
20. Advani S, Pai S, Venzon D, Kurkure PK, Nair CN, Sirohi B, et al. Acute lymphoblastic leukemia in India: An analysis of prognostic factors using single treatment regimen. Annals of Oncology 1999;10: 167-176.
21. Advani SH, Giri NK, Pai SK, Nair CN, Kurkure PA, Tapan SK, et al. Acute lymphoblastic leukemia in childhood: treatment, results and prognostic factors. Indian J Cancer 1989; 26(3): 180-188.
22. Wessels G, Hesseling PB, Buurman M, Oud C, Nel ED. An analysis of prognostic variables in acute lymphocytic leukemia in a heterogenous South African population. J Trop Med 1997; 43: 156-161.
23. Greenberg PL, Gordeuk V, Issaragrisil S, Siritanaratkul N, Fucharoen S, Ribiero RC. Major hematologic diseases in the developing world – new aspects of diagnosis and management of thalassemia, malarial anemia, and acute leukemia. American Society of Hematology 2001. 24. Lobato-Mendizabal, Ruiz-Arguelles, Hospital Universitario de Puebla. The magnitude of
maintenance chemotherapy as a prognostic factor in the survival of patients with standard risk acute lymphoblastic leukemia. Rev Invest Clin 1990; 42(2): 81-87.
33
25. Ribeiro RC, Pui CH. Saving the children –improving childhood cancer treatment in developing countries. N Engl J Med 2005; 352: 21: 2158-2160.
26. Ugrasena IDG, Sutaryo, Supriadi E, Vroling L, Cloos J, Hooijberg JH, Veerman AJP. High frequency of the 3R/3R polymorphism in the thymidylate synthease enhancer region in Indonesian childhood acute lymphoblastic leukemia. Pediatr Indones 2006; 46: 103-1123. 27. Veerman AJP, Sutaryo, Sumadiono. Commentary. Twinning: A regarding scenario for
development of oncology services in transitional countries. Pediatr Blood Cancer 2005; 45: 103-106.
28. Ito C, Evans WE, McNinch L, Coustan-Smith E, Mahmoud H, Pui CH, Campana D. Comparative cytotoxicity of dexamethasone and prednisolone in childhood acute lymphoblastic leukemia. J Clin Oncol 1996;14:2370-76.
29. Ahmed SF, Tucker P, Mushtaq T, Wallace AM, William DM, Hughes IA. Short-term effects on linear growth and bone turnover in children randomized to receive prednisolone or dexamethasone. Clin Endocrinol 2002;57(2):185-91.
30. Belgaumi AF, Al-Bakrah M, Al-Mahr M, Al-Jefri A, Al-MUsa A, Saleh M, et al. Dexamethasone-associated toxicity during induction chemotherapy for childhood acute lymphoblastic leukemia is augmented by concurrent use of daunomycin. Cancer 2003;97(11):2898-903.
31. Ulrike NG, Elvira A, Gudrun F, Dirk S, Rosmarie S, Christiane S, Ralf J. Thromboembolic events in children with acute lymphoblastic leukemia (BFM protocols): prednisone versus dexamethasone administration. Blood 2003;101(7):2529-33.
32. Vienna , Murao, Ramos, Oliviera, De-Carvalho, DE-Baltos, et al. Malnutrition as a prognostic factor in lymphoblastic leukemia: a multivariate analysis. Arch Dis Child 1994; 71(4): 304-310. 33. Pui CH, Sandlund JT, Pei D, Rivera GK, Howard SC, Ribeiro RC, et al. Results of therapy for
acute lymphoblastic leukemia in black and white children. JAMA 2003; 290(15): 2001-2007. 34. Shu XO, Linet MS, Steinburg M, Wen WQ, Buckley JD, Neglia JP, et al. Breats feeding and risk
of childhood leukemia. J Natl Cancer Inst 1999; 91: 1765-1772.
35. Veerman AJ, Hahlen K, Kamps WA, Van Leeuwen EF, De Vaan GA, Solbu G, et al. High cure rate with a moderately intensive treatment regimen in non-high risk childhood acute lymphoblastic leukemia. Results of protocol ALL VI from the Dutch Childhood Leukemia Group. J Clin Oncol 1996;114:911-8.
36. Schwartz CL, Thompson EB, Gelber RD, Young ML, Chilton D, Cohen HJ, Sallon SE. Improved response with higher corticosteroid dose in children with acute lymphoblastic leukemia. J Clin Oncol 2001;19:1040-6.
37. Igarashi S, Manabe A, Ohara A, Kumagai M, Saito T, Okimoto Y, et al. No advantage of dexamethasone over prednisolone for the outcome of standard – and intermediate risk childhood acute lymphoblastic leukemia in the Tokyo Chldren’s Cancer Study Group L95-14 Protocol. J Clin Oncol 2005;23(27):6489-98.
38. Mitchell CD, Richards SM, Kinsey SE, Lilleymen J, Vora A, Eden TOB. Benefit of dexamethasone compared with prednisolone for childhood acute lymphoblastic leukemia: resuls of the UK Medical Research Council ALL97 randomized trial. BJH 2005;129:734-45. 39. Arico M, Valsecchi MG, Conter V, Rizzari C, Pession A, Messina C, et al. Improved outcome in
high-risk childhood acute lymphoblastic leukemia defined by prednisone poor response treated with double Berlin-Frankfurt-Muenster protocol II. Blood 2002;100:420-6.
40. Bostrom BC, Sensel MS, Harland NS, Gaynon PS, La MK, Johnston LK, et al. Dexamethasone versus prednisone and daily oral versus weekly intravenous mercaptopurine for patients with standard risk acute lymphoblastic leukemia: a report from the Children’s Cancer Group. Blood 2003;101:3809-17.
41. Mostert S, Gundy GM, Sutaryo, Sitaresmi MN, Veerman AJ. Influence of socioeconomic status on childhood acute lymphoblastic leukemia treatment in Indonesia. Pediatrics 2006 Oct 30 42. Aapro M., Crawford J., Kamioner D. Prophylaxis of chemotherapy-induced febrile neutropenia
with granulocyte colony-stimulating factors: where are we now?. Support Care Cancer (2010) 18:529–541
43. Baglin TP., Gray JJ., Marcus RE., Wreghitt TG. Antibiotic resistant fever associated with herpes simplex virus infection in neutropenic patients with haematological malignancy. J Clin Pathol 1989; 42:1255–8
44. Carcillo J. What’s new in the pediatric intensive care medicine. Pediatr Crit Care Med. 2006;34:S183-190
45. Celkan T., Ozkan A., Apak H., Diren S., Can G., Yuksel L, et al. Bacteremia in childhood cancer. J Trop Pediatr. 2002;48:373-7
34
46. Danilatou V., Mantadakis E., Galanakis E., Christidou A., Stiakaki E., Kalmanti M. Three cases of viridans group streptococcal bacteremia in children with febrile neutropenia and literature review. Scand J Infect Dis. 2003;35:873-6.
47. DeSancho MT., Rand JH. Bleeding and thrombotic complications in critically ill patiensts with cancer. Crit Care Clin. 2001:17:599-622.
48. Freifeld AG., Bow EJ., Sepkowitz KA., Boeckh MJ., Ito JI., Mullen CA., Raad II., et al. Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update by the Infectious Diseases Society of America. Clinical Practice Guideline.CID 2011:52 (15 February); e56-93
49. Friese CR. Chemotherapy-induced neutropenia: Important new data to guide nursing assessment and management. Adv Stud Nurs. 2006;4(2):21-25.
50. Gabay M., Tanzi M. Guidelines for the Management of Febrile Neutropenia. Pharmacy Practice News. Desember 2009. 9-17
51. Goad KE., Gralnick HR. Coagulation disorders in cancer. Hematol Oncol Clin North Am. 1996;10:457
52. Goldstein B., Giroir B., Randolph A. International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med 2005;6(1):2–8.
53. Greenberg D., Moser A., Yagupsky P., Peled N., Hofman Y., Kapelushnik J., Leibovitz E. Microbiological spectrum and susceptibility patterns of pathogens causing bacteraemia in paediatric febrile neutropenic oncology patients: comparison between two consecutive time periods with use of different antibiotic treatment protocols. Int J Antimicrob Agents. 2005;25:469-73
54. Hughes WT., Armstrong D., Bodey GP., Bow EJ., Brown AE., Calandra T, et al. Guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002;34:730-51
55. Jaksic B., Martinelli G., Perez-Oteyza J., Hartman CS., Leonard LB., Tack KJ. Efficacy and safety of linezolid compared with vancomycin in a randomized, double-blind study of febrile neutropenic patients with cancer. Clin Infect Dis. 2006;42:597-607.
56. Johnson MJ. Bleeding, clotting, and cancer. Clin Oncol (R Coll Radiol). 1997;9:294-301
57. Lai HP., Hsueh PR., Chen YC., Lee PI., Lu CY., Lu MY, et al. Bacteremia in hematological and oncological children with febrile neutropenia: experience in a tertiary medical center in Taiwan. J Microbiol Immunol Infect. 2003;36:197-202.
58. Lehrnbecher T., Phillips R., Alexander S., Alvaro F., Carlesse F., Fisher B. Guideline for the Management of Fever and Neutropenia in Children With Cancer and/or Undergoing Hematopoietic Stem-Cell Transplantation. J Clin Oncol 30.1-12
59. Liang DC., Chen SH., Lean SF. Role of granulocyte colonystimulating factor as adjunct therapy for septicemia in children with acute leukemia. Am J Hematol. 1995;48:76-81.
60. Link H., Böhme A., Cornely OA., Höffken K., Kellner O., Kern WV, et al. Antimicrobial therapy of unexplained fever in neutropenic patients. Ann Hematol. 2003;82 Suppl 2:S105-17.
61. Lucas KG., Brown AE., Armstrong D., Chapman D., Heller G. The identification of febrile, neutropenic children with neoplasic disease low risk of bacteremia and complications of sepsis. Cancer. 1996;77:791-9.
62. Lyman GH., Lyman CH., Agboola O, for the ANC Study Group. Risk Models for Predicting Chemotherapy-Induced Neutropenia. The Oncologist 2005;10:427–437
63. Maschmeyer G., Ostermann H., Wendt S., Richter G. Guidelines of the infectious diseases working party of the German Society of Hematology and Oncology. Ann Hematol. 2003;82 Suppl 2:S105-17
64. Meckler G., Lindemulder S. Fever and Neutropenia in Pediatric Patients with Cancer. Emerg Med Clin N Am 27 (2009) 525–544
65. Mendes AVA., Sapolnik R., Mendonça N. New guidelines for the clinical management of febrile neutropenia and sepsis in pediatric oncology patients.J Pediatr (Rio J). 2007;83(2 Suppl):S54-63
66. Naurois J.D., Novitzky-Basso I, Gill M.J., Marti F.M., Cullen M.H., Roila F. On behalf of the ESMO Guidelines Working Group. Management of febrile neutropenia: ESMO Clinical Practice Guidelines. Annals of Oncology 21 (Supplement 5): 2010;v252–v256
67. Renoult E., Buteau C., Turgeon N., Moghrabi A., Duval M., Tapiero B. Is routine chest radiography necessary for the initial evaluation of fever in neutropenic children with cancer? Pediatr Blood Cancer. 2004;43:224-8
35
68. Rotstein C., Bow EG., Laverdiere M. Randomized placebo-controlled trial of fluconazole prophylaxis for neutropenic patients: benefit based on purpose and intensity of cytotoxic therapy. Clin InfectDis 1999; 28:331–40
69. Ruhnke M., Böhme A., Buchheidt D., Donhuijsen K., Einsele H., Enzensberger R, et al. Diagnosis of invasive fungal infections in hematoloy and oncology. Guidelines of the Infectious Diseases Working Party (AGIHO) of the Germany Society of Hematology and Oncology (DGHO). Ann Hematol. 2003;82 Suppl 2:S141-8.
70. Sachdeva RC., Jefferson LS., Coss-Bu J., Brody BA. Resource consumption and the extent of futile care in a pediatric intensive care setting. J Pediatr. 1996;128:742-7
71. Santolaya ME., Rabagliati R., Bidart T., Paya E., Guzman AM., Morales R, et al. Consenso manejo racional del paciente con cáncer, neutropenia y fiebre: rational approach towards the patient with cancer, fever and neutropenia. Rev Chilena Infectol. 2005;22 Supl 2:S79-S113 72. Segal BH., Almyroudis NG., Battiwalla M., Herbrecht R., Perfect JR., Walsh TJ, et al.
Prevention and early treatment of invasive fungal infection in patients with cancer and neutropenia and in stem cell transplant recipients in the era of newer broad-spectrum antifungal agents and diagnostic adjuncts. Clin Infect Dis. 2007;44:402-9.
73. Sharma A., Lokeshwar N. Febrile Neutropenia in Haematological Malignancy. J Postgrad Med. 2005;Vol 51; suppl 1; S42-S48
74. Veyradier A., Jenkins CS., Fressinaud E., Meyer D. Acquired von Willebrand syndrome: from pathophysiology to management. Thromb Haemost. 2000;84:175-82
75. Winston DJ., Hathorn JW., Schuster MG., Schiller GJ., Territo MC. A multicenter, randomized trial of fluconazole versus amphotericin B for empiric antifungal therapy of febrile neutropenic patients with cancer. Am J Med. 2000;108:282-9.