Clinical impact of chemotherapy dose escalation in patients with hematologic malignancies and solid tumors

Journal of Clinical Oncology

Volumn 15, Issue 8, 1997, Pages 2981-2995

  Savarese, Diane M F ^a   Hsieh, Chung Cheng ^a   Stewart, F Marc ^a  

^a UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; COLONY STIMULATING FACTOR; CYCLOPHOSPHAMIDE; CYTARABINE; DOXORUBICIN; PREDNISONE;

ACUTE GRANULOCYTIC LEUKEMIA; BONE MARROW SUPPRESSION; CANCER SURVIVAL; CLINICAL TRIAL; DOSE RESPONSE; HUMAN; HUMAN CELL; HUMAN TISSUE; META ANALYSIS; MULTIPLE MYELOMA; NONHODGKIN LYMPHOMA; OUTCOMES RESEARCH; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; REVIEW; SOLID TUMOR; STEM CELL TRANSPLANTATION;

EID: 0030755761     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1997.15.8.2981     Document Type: Review

References (84)

1. Schabel FM Jr, Griswold DP, J, Corbett TH, et al: Increasing the therapeutic response rate to anticancer drugs by applying the basic principles of pharmacology. Cancer 50:1160-1167, 1984
2. Frei E III, Canellos GP: Dose: A critical factor in cancer chemotherapy. Am J Med 69:585-594, 1980
3. Hryniuk WM, Bush H: The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol 2:1281-1288, 1984
4. Hryniuk WM: The importance of dose intensity in the outcome of chemotherapy. Imp Adv Oncol 121-141, 1988
5. Livingston RB: Dose intensity and high dose therapy. Cancer 74:1177-1182, 1994
6. Zelen M: Guidelines for publishing papers on cancer clinical trials: Responsibilities of editors and authors. J Clin Oncol 1:164-166, 1983
7. Fisher RI, Gaynor ER, Dahlberg S, et al: Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma. N Engl J Med 328:1002-1006, 1993
8. Cooper IA, Wolf MM, Robertson TI, et al: Randomized comparison of MACOP-B with CHOP in patients with intermediate-grade non-Hodgkin's lymphoma. J Clin Oncol 12:769-778, 1994
9. Gordon LI, Harrington D, Andersen J, et al: Comparison of a second-generation combination chemotherapeutic regimen (m-BACOD) with a standard regimen (CHOP) for advanced diffuse non-Hodgkin's lymphoma. N Engl J Med 327:1342-1349, 1992
10. Mayer RJ, Davis RB, Schiffer CA, et al: Intensive postremission chemotherapy in adults with acute myeloid leukemia. N Engl J Med 331:896-903, 1994
11. Bishop JF, Young GA, Szer J, et al: Randomized trial of high dose cytosine arabinoside (Ara-C) combination in induction in acute myeloid leukemia (AML). Proc Am Soc Clin Oncol 11:260, 1992 (abstr 849)
12. Weick J, Kopecky K, Appelbaum F, et al: A randomized investigation of high-dose (HDAC) versus standard dose (SDAC) cytosine arabinoside with daunorubicin (DNR) in patients with acute myelogenous leukemia. Proc Am Soc Clin Oncol 11:261, 1992 (abstr 856)
13. Weick J, Kopecky K, Appelbaum F, Head D, et al: A randomized investigation of high-dose versus standard-dose cytosine arabinoside with daunorubicin in patients with previously untreated acute myeloid leukemia: A Southwest Oncology Group study. Blood 88:2841-2851, 1996
14. Samson MK, Rivkin SE, Jones SE, et al: Dose-response and dose-survival advantage for high versus low-dose cisplatin combined with vinblastine and bleomycin in disseminated testicular cancer. A Southwest Oncology Group study. Cancer 53:1029-1035, 1984
15. Nichols CR, Williams SD, Loehrer PJ, et al: Randomized study of cisplatin dose intensity in poor-risk germ cell tumors: A Southeastern Cancer Study Group and Southwest Oncology Group protocol. J Clin Oncol 9:1163-1172, 1991
16. Hryniuk WM, Levine MN: Analysis of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol 4:1162-1170, 1986
17. Bonadonna G, Valagussa P: Dose-response effect of adjuvant chemotherapy in breast cancer. N Engl J Med 304:10-15, 1981
18. Henderson IC, Hayes DF, Gelman R: Dose-response in the treatment of breast cancer: A critical review. J Clin Oncol 6:1501-1515, 1988
19. Hrynuik WM: Dose intensity: A critique of a critical review. J Clin Oncol 7:681-682, 1989 (letter)
20. Wood WC, Budman DR, Korzun AH, et al: Dose and dose intensity of adjuvant chemotherapy for stage II, node-positive breast carcinoma. N Engl J Med 330:1253-1259, 1994
21. Dimitrov N, Anderson S, Fisher B, et al: Dose intensification and increased total dose of adjuvant chemotheapy for breast cancer (BC): Findings from NSABP B-22. Proc Am Soc Clin Oncol 13:64, 1994 (abstr 58)
22. Muss HB, Thor AD, Berry DA, et al: c-erbB-2 expression and response to adjuvant therapy in women with node-positive early breast cancer. N Engl J Med 330:1260-1266, 1994
23. Engelsman E, Klijn JCM, Rubens RD, et al: "Classical" CMF versus a 3-weekly intravenous CMF schedule in postmenopausal patients with advanced breast cancer. Eur J Cancer 27:966-970, 1991
24. Carmo-Perreira J, Costa FO, Henriques E, et al: A comparison of two doses of adriamycin in the primary chemotherapy of disseminated breast cancer. Br J Cancer 5:471-473, 1987
25. Tannock IF, Boyd NF, DeBoer G, et al: A randomized trial of two dose levels of cyclophosphamide, methotrexate, and fluorouracil chemotherapy for patients with metastatic breast disease. J Clin Oncol 6:1377-1387, 1988
26. Hortobagyi GN, Bodey GP, Buzdar AU, et al: Evaluation of high-dose versus standard FAC chemotherapy for advanced breast cancer in protected environment units: A prospective randomized study. J Clin Oncol 5:354-364, 1987
27. Dodwell DJ, Gurney H, Thatcher N: Dose intensity in cancer therapy. Br J Cancer 61:789-794, 1990 (editorial)
28. Klasa RJ, Murray N, Coldman AJ: Dose-intensity meta-analysis of chemotherapy regimens in small-cell carcinoma of the lung. J Clin Oncol 9:499-508, 1991
29. Arriagada R, Le Chevalier T, Pignon J, et al: Initial chemotherapeutic doses and survival in patients with limited small-cell lung cancer. N Engl J Med 329:1848-1852, 1993
30. Ihde DC, Deisseroth AB, Lichter AS, et al: Late intensive combined modality therapy followed by autologous bone marow infusion in extensive-stage small-cell lung cancer. J Clin Oncol 4:1443-1454, 1986
31. Johnson DH, Einhorn LH, Birch R, et al: A randomized comparison of high-dose versus conventional-dose cyclophosphamide, doxorubicin, and vincristine for extensive-stage small-cell lung cancer: A phase III trial of the Southeastern Cancer Study Group. J Clin Oncol 5:1731-1738, 1987
32. Kaye SB, Lewis CR, Paul J, et al: Mature results of a randomized trial of two doses of cisplatin for the treatment of ovarian cancer. J Clin Oncol 14:2113-2116, 1996
33. Bella M, Cocconi G, Lottici R, et al: Conventional versus high dose intensity regimen of cisplatin in advanced ovarian carcinoma. A prospective randomized study. Proc Am Soc Clin Oncol 11:723, 1992 (abstr 706)
34. McGuire WP, Hoskins WJ, Brady MF, et al: A phase III trial of dose intense (DI) versus standard dose (SD) cisplatin (CDDP) and Cytoxan (CTX) in advanced ovarian cancer (AOC). Proc Am Soc Clin Oncol 11:226, 1992 (abstr 718)
35. Colombo N, Pittelli MR, Parma G: Cisplatin (P) dose intensity in advanced ovarian cancer (AOC): A randomized study of conventional dose (DC) vs dose-intense (DI) cisplatin monotherapy. Proc Am Soc Clin Oncol 12:255, 1993 (abstr 806)
36. Conte PF, Bruzzone M, Gadducci A, et al: High dose versus low dose cisplatin in combination with cyclophosphamide and epidoxorubicin in suboptimal ovarian cancer: A randomized study of the Gruppo Oncologico Nord-Ouest. J Clin Oncol 14:351-356, 1996
37. Ngan HYS, Choo YC, Cheung M, et al. A randomized study of high-dose versus low-dose cis-platinum combined with cyclophosphamide in the treatment of ovarian cancer. Chemotherapy 35:221-227, 1989
38. Jakobsen A, Bertelsen K, Andersen JE et al: Dose-effect study of carboplatin in ovarian cancer: A Danish Ovarian Cancer Group study. J Clin Oncol 15:193-198, 1997
39. Gore ME, Mainwaring PN, Macfarlane V, et al: A randomized study of high versus standard dose carboplatin in patients with advanced epithelial ovarian cancer (EOC). Proc Am Soc Clin Oncol 15:284, 1996 (abstr 769)
40. Levin L, Simon R, Hryniuk WM: Importance of multiagent chemotherapy regimens in ovarian carcinoma: Dose intensity analysis. J Natl Cancer Inst 85:1732-1742, 1993
41. Rowinsky EK, Mackey MK, Goodman SN: Meta analysis of paclitaxel (P) dose-response and dose-intensity (DI) in recurrent or refractory ovarian cancer (OC). Proc Am Soc Clin Oncol 15:284, 1996 (abstr 770)
42. Crawford J, Ozer H, Stoller R, et al: Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 325:164-170, 1991
43. Gabrilove J, Jakubowski A, Scher H, et al: Effect of granulocyte colony-stimulating factor on neutropenia and associated morbidity due to chemotherapy for transitional-cell carcinoma of the urothelium. N Engl J Med 318:1414-1422, 1988
44. Logothetis CJ, Finn LD, Smith T, et al: Escalated MVAC with or without recombinant human granulocyte-macrophage colony-stimulating factor for the initial treatment of advanced malignant urothelial tumors: Results of a randomized trial. J Clin Oncol 13:2272-2277, 1995
45. Vadhan-Raj S, Broxmeyer HE, Hittelman WN: Abrogating chemotherapy-induced myelosuppression by recombinant granulocyte-macrophage colony-stimulating factor in patients with sarcoma: Protection at the progenitor cell level. J Clin Oncol 10:1266-1277, 1992
46. Bronchud MH, Howell A, Crother D, et al: The use of granulocyte colony-stimulating factor to increase the intensity of treatment with doxorubicin in patients with advanced breast and ovarian cancer. Br J Cancer 60:121-125, 1989
47. Pettengell R, Woll PJ, Thatcher N, et al: Multicyclic dose-intensive chemotherapy supported by sequential reinfusion of hematopoietic progenitors in whole blood. J Clin Oncol 13:148-156, 1995
48. Hamm JT, Schiller JH, Oken MM, et al: Granulocyte-macrophage colony stimulating factor (GM-CSF) in small cell carcinoma of the lung (SCCL): Preliminary analysis of a randomized controlled trial. Proc Am Soc Clin Oncol 10:255, 1991 (abstr 878)
49. Fukouka M, Takada M, Masuda N, et al: Dose intensive weekly chemotherapy (CT) with or without recombinant human granulocyte colony-stimulating factor (G-CSF) in extensive-stage (ES) small-cell lung cancer (SCLC). Proc Am Soc Clin Oncol 11:290, 1992 (abstr 967)
50. Trillet-Lenoir V, Green J, Manegold C, et al: Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy. Eur J Cancer 29A:319-324, 1993
51. Miles DW, Fogarty O, Ash CM, et al: Received dose-intensity: A randomized trial of weekly chemotherapy with and without granulocyte colony-stimulating factor in small-cell lung cancer. J Clin Oncol 12:77-82, 1994
52. Woll PJ, Hodgetts J, Lamax L, et al: Can cytotoxic dose-intensity be increased by using granulocyte colony-stimulating factor? A randomized controlled trial of lenograstim in small-cell lung cancer. J Clin Oncol 13:652-659, 1995
53. Nichols CR, Fox EP, Rath BJ, et al: Incidence of neutropenic fever in patients treated with standard-dose combination chemotherapy for small-cell lung cancer and the cost impact of treatment with granulocyte colony-stimulating factor. J Clin Oncol 12:1245-1250, 1994
54. Bajorin DF, Nichols C, Schmoll H.-J, et al: Recombinant human granulocyte-macrophage colony-stimulating factor as an adjunct to conventional dose ifosfamide-based chemotherapy for patients with advanced or relapsed germ cell tumors: A randomized trial. J Clin Oncol 13:79-86, 1995
55. Omura GA, Brady MF, Delmore JE, et al: A randomized trial of paclitaxel (T) at 2 dose levels and filgrastim (G; G-CSF) at 2 doses in platinum (P) pretreated epithelial ovarian cancer (OVCA): A Gynecologic Oncology Group, SWOG, NCCTG and ECOG study. Proc Am Soc Clin Oncol 15:280, 1996 (abstr 755)
56. Pettengell R, Gurney H, Radford JA, et al: Granulocyte colony-stimulating factor to prevent dose-limiting neutropenia in non-Hodgkin's lymphoma: A randomized controlled trial. Blood 80:1430-1436, 1992
57. Behrens BC, Hamilton TC, Masuda H, et al: Characterization of cis-diamminedichloroplatinum (II)-resistant human ovarian cancer cell line and its use in evaluation of platinum analogues. Cancer Res 47:414-418, 1987
58. American Society of Clinical Oncology: Update of recommendations for the use of hematopoietic colony-stimulating factors: Evidence-based clinical practice guidelines. J Clin Oncol 14:1957-1960, 1996
59. Kohn EC, Sarosy G, Bicher A, et al: Dose-intense Taxol: High response rate in patients with platinum resistant recurrent ovarian cancer. J Natl Cancer Inst 86:18-24, 1994
60. Arbuck S: Paclitaxel: What schedule? What dose? J Clin Oncol 12:233-236, 1994 (editorial)
61. Antman K, Gale RP: Advanced breast cancer: High-dose chemotherapy and bone marrow autotransplants. Ann Intern Med 108:570-574, 1988
62. Datta YH, Adams PT, Drobyski WR, et al: Sensitive detection of occult breast cancer by the reverse-transcriptase polymerase chain reaction. J Clin Oncol 12:475-482, 1994
63. Gribben JG, Neuberg D, Barber M, et al: Detection of residual lymphoma cells by polymerase chain reaction in peripheral blood is significantly less predictive for relapse than detection in bone marrow. Blood 83:3800-3807, 1994
64. Simpson SJ, Vachula M, Kennedy MJ, et al: Detection of tumor cells in the bone marrow, peripheral blood, and apheresis products of breast cancer in patients using flow cytometry. Exp Hematol 23:1062-1068, 1995
65. Lambrechts AC, Hupkes PE, Dorssers LCJ, et al: Translocation (14-18) positive cells are present in the circulation of the majority of patients with localized (stage I and II) follicular non-Hodgkin's lymphoma. Blood 82:2510-2516, 1993
66. Gianni AM, Bregni M, Siena S, et al: High-dose chemotherapy and autologous bone marrow transplantation compared with MACOP-B in aggressive B cell lymphoma. N Engl J Med 336:1290-1297, 1997
67. Haioun C, Lepage E, Gisselbrecht C, et al: Comparison of autologous bone marrow transplantation with sequential chemotherapy for intermediate grade and high-grade non-Hodgkins's lymphoma in the first complete remission: A study of 464 patients. J Clin Oncol 12:2543-2551, 1994
68. Mazza P, Tura S, Zinzani PI, et al: A multicenter randomized study on aggressive non-Hodgkin lymphomas: An updated follow-up. Proc Am Soc Clin Oncol 12:362, 1993 (abstr 1221)
69. Hagenbeek A, Verdonck L, Sonneveld P: CHOP chemotherapy versus autologous bone marrow transplantation in slowly responding patients with intermediate- and high-grade malignant non-Hodgkin's lymphoma. Results from a prospective randomized phase III clinical trial in 294 patients. Blood 82:332a, 1993 (suppl 1, abstr 1311)
70. Verdonck LF, Van Putten WLJ, Hagenbeek A, et al: Comparison of CHOP chemotherapy with autologous bone marrow transplantation for slowly responding patients with aggressive non-Hodgkin's lymphoma. N Engl J Med 332:1045-1051, 1995
71. Martelli M, Vignetti M, Zinzani PL, et al: High-dose chemotherapy followed by autologous bone marrow transplantation versus dexamethasone, cisplatin, and cytarabine in aggressive non-Hodgkin's lymphoma with partial response to front-line chemotherapy: A prospective randomized Italian multicenter study. J Clin Oncol 14:534-542, 1996
72. Haioun D, Lepage E, Gisselbrecht C, et al: Autologous bone marrow transplantation (ABMT) versus sequential chemotherapy for aggressive non Hodgkin's lymphoma (NHL) in first complete remission (CR): A study of 542 patients (LNH87-2 protocol). Blood 86:457a, 1995 (suppl 1, abstr 1816)
73. The International Non-Hodgkin's Lymphoma Prognostic Factors Project: A predictive model for aggressive non-hodgkin's lymphoma. N Engl J Med 329:987-994, 1993
74. Philip T, Gugliemi C, Hagenbeek A, et al: Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med 333:1540-1545, 1995
75. Chopra R, McMillan AK, Linch DC, et al: The place of high-dose BEAM therapy and autologous bone marrow transplantation in poor-risk Hodgkin's disease. A single-center eight-year study of 155 patients. Blood 81:1137-1145, 1993
76. Linch DC, Winfield D, Goldstone AH, et al: Dose intensification with autologous bone marrow transplantation in relapsed and resistant Hodgkin's disease: Results of a BNLI randomized trial. Lancet 341:1051-1054, 1993
77. Gahrton G, Sante T, Tura S, et al: Allogeneic bone marrow transplantation in multiple myeloma. N Engl J Med 325:1267-1273, 1991
78. Attal M, Harousseau JL, Stoppa A-M, et al: A prospective randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. N Engl J Med 335:91-97, 1996
79. Droz JP, Pico L, Biron P, et al: No evidence of a benefit of early intensified chemotherapy (HDCT) with autologous bone marrow transplantation (ABMT) in first line treatment of poor risk non seminomatous germ cell tumors (NSGCT): Preliminary results of a randomized trial. Proc Am Soc Clin Oncol 11:192, 1992 (abstr 602)
80. Greenberg PAC, Hortobagyi GN, Smith TL, et al: Long-term follow-up of patients with complete remission following combination chemotherapy for metastatic breast cancer. J Clin Oncol 14:2197-2205, 1996
81. Bezwoda WR, Seymour L, Dansey RD: High-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: A randomized trial. J Clin Oncol 13:2483-2489, 1995
82. Peters WP, Jones RB, Vredenburgh J, et al: A large, prospective, randomized trial of high-dose combination alkylating agents (CPB) with autologous cellular support (ABMS) as consolidation for patients with metastatic breast cancer achieving complete remission after intensive doxorubicin-based induction therapy (AFM). Proc Am Soc Clin Oncol 15:121, 1996 (abstr 149)
83. Peters WP, Ross M, Vredenburgh JJ, et al: High-dose chemotherapy and autologous bone marrow support as consolidation after standard-dose adjuvant therapy for high-risk primary breast cancer. J Clin Oncol 11:1132-1143, 1993
84. Humblet Y, Symann M, Basly A: Late intensification chemotherapy with autologous bone marrow transplantation in selected small-cell carcinoma of the lung: A randomized study. J Clin Oncol 5:1864-1873, 1987