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Sequential High Dose Chemotherapy for Breast Cancer Linda T. Vahdat Department of Medicine, Division of Medical Oncology, Columbia University College of Physicians and Surgeons, Herbert Irving Comprehensive Cancer Center, New York, NY While breast cancer is considered a highly curable disease if detected early in its course, the disseminated disease imparts a grave prognosis with a median survival of less than 3 years. 1,2 High-dose chemotherapy increases the number of patients achieving a complete response (CR) to cytotoxic chemotherapy when compared with conventional dose chemotherapy; however, it does not appear that this increased response rate has reliably translated into a similarly increased disease-free survival rate. 3 There are several published series of sequential highdose chemotherapy regimens in breast cancer. 4-6 Early clinical trials of sequential high-dose chemotherapy were hampered by high morbidity and mortality rates due to the sole use of bone marrow as a stem cell source and lack of hematopoietic growth factors. The use of peripheral blood progenitors and growth factors hastens blood count recovery and has significantly lowered the morbidity and mortality of this approach. Many strategies have been employed to increase the complete response rate, including the incorporation of new drugs or schedules into established chemotherapy treatment regimens. Other approaches include novel posttransplant consolidation strategies with various types of immune modulation. 7-16 There are several arguments in favor of sequential high-dose chemotherapy as opposed to a single high-dose cycle. Most important among them, according to registry data, is that a CR to therapy is considered the most important prognostic factor associated with a prolonged disease-free survival. Hence, if multiple cycles can increase the CR rate, then perhaps this may translate into prolonged disease-free survival. Several trials of sequential high-dose chemotherapy have been completed over the past 8 years. A recent compilation revealed that the CR rate ranged from 23 to 93% with as many as 35% disease free at 44 months of follow-up. 17 Paclitaxel is one of the most exciting drugs to emerge in the last 20 years and has been incorporated into transplant regimens by many other investigators. Response rates vary, with some reported as high as 93%. 18 The group at Columbia has piloted a regimen that incorporated paclitaxel at doses ranging from 400 to 825 mg/m 2 as the first of three separate high-dose cycles of chemotherapy supported 338
Vahdat with peripheral blood progenitors and hematopoietic growth factors. The second cycle was melphalan at 180 mg/m 2 , administered predominantly as an outpatient, and the third and final cycle was CTCb (cyclophosphamide, thiotepa, and carboplatin). Stem cells were collected before the first intensification. Thirty-one patients completed all three cycles. Overall, the regimen was moderately well tolerated, with transient neurotoxicity observed in virtually all patients. There were no toxic deaths. The complete response rate was 68%, and 52% are progression- free with a median follow-up of 26 months. The phase II dose of paclitaxel is 825 mg/m 2 . Certainly, it appears that these regimens are uniformly active in controlling disease (even for short periods of time). The impact of paclitaxel for prolonging disease-free survival will ultimately need to be addressed in phase III studies. In addition, the role of posttransplant consolidation strategies will require better delineation. REFERENCES 1. Clark G, Sledge GW, Osborne CK, McGuire WL: Survival from first recurrence: Relative importance of prognostic factors in 1,015 breast cancer patients. / Clin Oncol 5:55-61, 1987. 2. Mick R, Begg CB, Antman K, Korzun AH, Frei E III: Diverse prognosis in metastatic breast cancer: Who should be offered alternative initial therapies? Breast Cancer Res Treat 13:33-38,1989. 3. Bezwoda W, Seymour L, Dansey R: High dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: A randomized trial. J Clin Oncol 13:2483-2489, 1995. 4. Livingston R, Collins C, Willimse M, Thompson T, Rivkin S: Determinants of outcome after consolidation for stage IV breast cancer with cyclophosphamide, etoposide and cisplatin (CEP). Proc Am Soc Clin Oncol 13:58, 1994. 5. Dunphy F, Spitzer G, Fornoff JF, et al.: Factors predicting long-term survival for metasta tic breast cancer patients treated with high-dose chemotherapy and bone marrow support. Cancer 2157-67, 1994. ó.Ayash LJ, Elias A, Wheeler C, et al.: Double dose-intensive chemotherapy with autologous marrow and peripheral blood progenitor cell support for metastatic breast cancer: A fea sibility study. / Clin Oncol 12:37—44,1994. 7. Kennedy M, Vogelsang G, Beveridge R, et al.: Phase I trial of intravenous cyclosporine- induced graft-versus-host disease in women undergoing autologous bone marrow trans plantation for breast cancer. / Clin Oncol 11:478^184,1993. 8. Kennedy M, Vogelsang G, Jones R, et al.: Phase I trial of interferon gamma to potentiate cyclosporine-induced graft-versus-host disease in women undergoing autologous bone marrow transplantation for breast cancer. J Clin Oncol 12:249-257, 1994. 9.Soiffer R, Murray C, Cochran K, et al.: Clinical and immunologic effects of prolonged infu sion of low-dose recombinant interleukin-2 after autologous and T-cell-depleted allogeneic bone marrow transplantation. Blood 79:517-526, 1992. 339
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AUTOLOGOUS BLOOD AND MARROW TRANSPL
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AUTOLOGOUS BLOOD AND MARROW TRANSPL
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ACKNOWLEDGMENTS We wish to thank Wi
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THE VAN BEKKUM STEM CELL AWARD Prof
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xii Table of Contents CHAPTER 2: AL
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xiv Table of Contents Late Non-Rela
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xvi Table of Contents Pretreatment
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xviii Table of Contents CHAPTER 7:
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XX Table of Contents Long-Term Obse
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xxii Table of Contents CHAPTER 13:
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0-9 LIST OF ABBREVIATIONS 2CDA 2-ch
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List of Abbreviations xxvii EFS eve
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List of Abbreviations MOPP mechlore
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VOD veno-occlusive disease VPC viru
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4HC-Purged Autologous Stem Cell Tra
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1.0-1 + 0.2 Miller et al. 5 Event F
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Miller et al. Adjusted probability
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Who Benefits From Autograft in AML
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Burnett 11 which to set the transpl
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Table 1. Outcome after relapse in M
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Immunotherapy in AML: No Positive E
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Simonsson et al. inhibit IL-2 induc
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Autologous Bone Marrow Transplantat
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Ball et al. 21 CD15) and AML-2-23 (
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Ball et al. 23 The ex vivo treatmen
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Ball et al. 25 Table 2. Factors inv
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Ball et al. Overall Survival for Pa
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Ball et al. Overall Survival for Pa
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Ball et al. 31 Overall Survival for
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Ball et al. Table 4. Actuarial over
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Ball et al. myeloid leukemia. The G
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Ball et al. 1993. 38. Mehta J, Powl
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Can Autologous Stem Cell Transplant
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De Witte et al. 41 novo AML. Auer r
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De Witte et al. hematopoietic engra
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De Witte et al. 23. Fenaux P, Laï
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Stein et al. and fever. No patient
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Stein et al. after doses 1, 3, and
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Stein et al. early after the transp
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autologous stem-cell rescue. / Clin
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Bone Marrow Transplantation for Acu
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Table 2. Autologous BMT in ALL in f
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Rowe 61 or adult patients with acut
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Hoelzer and Gôkbuget minitransplan
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Hoelzer and Gdkbuget 65 blood, earl
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Table 3. Risk factors for the defin
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Hoelzer and Gôkbuget treatment opt
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Hoeker and Gökbuget tical sibling
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Sierra et al. INTRODUCTION Two-thir
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Sierra et al. Table 2. Adverse char
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1,0 0,0 J Sierra et al. 0 20 40 60
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Sierra et al. Months Figure 4 < 30,
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Sierra et al. No adverse factors (n
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1994. Sierra et al. 83 10. Canals C
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Martin, Atta, and Hoelzer 85 adult
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Martin, Atta, and Hoelzer 87 Single
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100. Martin, Atta, and Hoelzer 89 P
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Martin, Atta, and Hoelzer 91 chromo
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Autologous vs. Unrelated Allogeneic
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Boyer and Yeager 95 outcomes after
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Boyer and Y eager 97 Table 2. Hypot
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Boyer and Y eager SUMMARY Most of t
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CHAPTER 3 CML
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Autograft Followed by Allograft Wit
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106 Chapter 3: CML (one low-grade a
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108 Chapter 3: CML DISCUSSION Myelo
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110 Chapter 3: CML Philadelphia-neg
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The Case for Manipulation of CML Au
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Toward a Cure by Drug Treatment? Th
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116 Chapter 3 :CML Table 1. Prolong
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118 Chapter 3: CML Table 3. German
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120 Chapter 3: CML Table 5. Normal
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122 Chapter 3: CML Table 8. Surviva
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124 Chapter 3: CML 88:3118-3122, 19
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126 Chapter 3: CML RK, Klingemann H
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The Tyrphostin AG957 Inhibits the I
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130 Chapter 3: CML mobilization. Al
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132 Chapter 3: CML A B 100 n 0 1 5
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134 Chapter 3: CML The in vitro sel
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136 Chapter 3: CML detecting leukem
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Progressive Hodglcin's Lymphoma Fol
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Reece et al. survival is observed i
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0.2 -I 0.0 0 Reece et al. 143 ii i
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Reece et al. Table 3. Causes of non
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Reece et al. carmustine, etoposide
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CD34 + Selection of Hematopoietic B
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Lazarus et al. 151 significantly de
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Lazarus et al. 153 (Sigma, St Louis
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Lazarus et al. 155 Table 2. Effect
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Lazarus et al. 157 difference. Furt
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Lazarus et al. 159 cells after myel
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The European CUP/UP Trial: A Prelim
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Table 1. Patient characteristics at
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Schouten et al. licular non-Hodgkin
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Sweetenham et al. vs. autologous pe
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Table 1. Patient characteristics, g
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Table 2. Patient characteristics, g
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Table 3. Sites of relapse, group A
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Table 4. Patterns of relapse, group
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A 100 80 %OS 60 40 20 B 100 %OS | S
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Sweetenham et al. new sites, and fi
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Sweetenham et al. Treatment options
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Molecular Remission: A Worthwhile A
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Early or Late Autotransplant in Hig
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Schenkein et al. 187 PATIENTS AND M
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Schenkein et al. 189 Toxicity Toxic
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Schenkein et al. 191 16. Glick JH,
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Santini et al. 193 to evaluate the
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Table 1. Continued Santini et al. 1
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Santini et al. 197 cytosine arabino
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1 0 0 1 90- 80- 70- (0 u. 60' o so-
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Hodgkin's lymphoma. N EnglJ Med 333
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CHAPTER 5 MYELOMA
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206 Chapter 5: Myeloma independent
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208 Chapter 5: Myeloma disease (MRD
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210 Chapter 5: Myeloma Scandinavia,
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212 Chapter 5: Myeloma (0 n o B co
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214 Chapter 5: Myeloma B cq d ? o c
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216 Chapter 5: Myeloma patients wit
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218 Chapter 5: Myeloma PBSC transpl
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220 Chapter 5: Myeloma 25. Seiden M
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Autologous Transplantation in Multi
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224 Chapter 5: Myeloma 0 52 44 U §
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226 Chapter 5: Myeloma BM ^ (CD34±
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228 Chapter 5: Myeloma IFM 94 : OS
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230 Chapter 5: Myeloma two groups a
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232 Chapter 5: Myeloma increase bot
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234 Chapter 5: Myeloma REFERENCES 1
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236 Chapter 5: Myeloma Intensified
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238 Chapter 5: Myeloma of CD34 + ce
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Chapter 5: Myeloma Table 2. Descrip
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242 Chapter 5: Myeloma o 8H 0 2 4 6
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244 Chapter 5: Myeloma ated with sh
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The Presence of Micrometastases in
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Kvalheim et al. 249 Table 1. Immuno
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Kvalheim et al. 251 Figure 1. Sixty
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Kvalheim et al. 253 DISCUSSION In t
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Kvalheim et al. 255 Bastert G: Micr
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Hood et al. 257 In an effort to inc
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#CD34 + cells in blood = Hood et al
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Hood et al. 261 Table 3. Frequency
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Hood et al. 263 REFERENCES 1. Rill
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The Clinical Significance of Breast
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Moss et al. tests, and bilateral po
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Moss et al. 269 0 15 70 143 200 400
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Moss et al. 271 0 3 6 12 18 24 30 3
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Moss et al. 273 8. Passos-Coelho J,
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Autotransplantation for Men With Br
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McCarthy et al. 277 radiation, two
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High Dose Sequential Chemotherapy W
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Viens et al. 281 3 g/m 2 and doxoru
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Table 1. Tumor characteristics Exte
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Table 4. Response Viens et al. 285
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Page 323 and 324: Viens et al. 289 apy for inoperable
Page 325 and 326: Gliick et al. 291 INTRODUCTION The
Page 327 and 328: Gluck et al. 293 RESULTS Patient de
Page 329 and 330: Glück et al. 295 Table 3. Response
Page 331 and 332: Gluck et al. 297 Overall Survival O
Page 333 and 334: Gluck et al. 299 Sudbury patients w
Page 335 and 336: Gluck et al. 301 anthracycline or t
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Page 349 and 350: M 1.0 I 0.8H s? VI o.6H S 0.2 0.0 P
Page 351 and 352: a Prince et al. days to platelets >
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Page 355 and 356: Prince et al. 321 Figure 5, continu
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Page 359 and 360: Prince et al. 325 excessive to be u
Page 361 and 362: Prince et al. 327 eight patients ha
Page 363 and 364: Prince et al. 329 marrow transplant
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Page 371: oba Q. 1.0 0.9 Dicke et al. Stage I
Page 375 and 376: Evaluation of Prognostic Factors fo
Page 377 and 378: Fields et al. 343 PATIENTS AND METH
Page 379 and 380: Table 1. Chemotherapy regimens. Fie
Page 381 and 382: Fields et al. Stage II; 4-9 Pos LN
Page 383 and 384: U U Fields et al.
Page 385 and 386: Fields et al. 351 between 1 and 2 y
Page 387 and 388: European Trends and the EBMT Databa
Page 389 and 390: 25% % 22% / 17% \ Rosti et al. 355
Page 391 and 392: Rosti et al. 357 The new Italian St
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Page 395 and 396: Rosti et al. 6. Haas R, Schmid H, H
Page 397 and 398: Bewick et al. 363 INTRODUCTION The
Page 399 and 400: Bewick et al. 365 Blood samples obt
Page 401 and 402: Bewick et al. 367 HDCT with ABSC su
Page 403 and 404: Bewick et al. Progression Free Surv
Page 405 and 406: Bewick et al. pression in MBC, i.e.
Page 407 and 408: Bewick et al. 14. Kandl HL, Seymour
Page 409: CHAPTER 7 OTHER SOLID TUMORS
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High-Dose Chemotherapy in the Manag
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390 Chapter 7: Solid Tumors followe
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392 Chapter 7: Solid Tumors Table 1
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394 Chapter 7: Solid Tumors (mucosi
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Three-Fold Intensification by Seque
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High-Dose Therapy for Small Cell Lu
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404 Chapter 7: Solid Tumors chemoth
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406 Chapter 7: Solid Tumors SCLC ha
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408 Chapter 7: Solid Tumors relapse
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410 Chapter 7: Solid Tumors 69:585-
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412 Chapter 7: Solid Tumors ogous b
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414 Chapter 7: Solid Tumors 64. Bru
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416 Chapter 7: Solid Tumors Prignot
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418 Chapter 7: Solid Tumors CO > CO
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420 Chapter 7: Solid Tumors TANDEM
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Multiple Courses of Cyclophosphamid
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424 Chapter 7: Solid Tumors and the
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426 Chapter 7: Solid Tumors Thiotep
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430 Chapter 7: Solid Tumors E 100 0
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432 Chapter 7: Solid Tumors course
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434 Chapter 7: Solid Tumors boplati
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436 Chapter 7: Solid Tumors INTRODU
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438 - Chapter 7: Solid Tumors Table
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440 Chapter 7: Solid Tumors seeded
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442 Chapter 7: Solid Tumors DISCUSS
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444 Chapter 7: Solid Tumors 10. Di
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446 Chapter 7: Solid Tumors plasma
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Autologous Stem Cell Transplantatio
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Keystone 451 hypertension, anemia,
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Fassas et al. 453 INTRODUCTION Mult
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Fassas et al. Table 2. Stem cell mo
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Table 3. Toxicity after stem cell i
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Fassas et al. Table 5. Trial 1: cha
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Fassas et al. MS PROGRESSION FREE S
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Fassas et al. ic or autologous bone
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1 2 1 6 EAE. Burt et al. 465 Becaus
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Burt et al. Since cyclophosphamide
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Burt et al. 469 toxicity study, we
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Burt et dl. All 23. Mor F, Cohen IR
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Hasler, Gratwohl, and Tyndall an ev
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Hasler, Gratwohl, and Tyndall 475 B
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Kuis, Wulffraat, and Sanders 477 st
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Kuis, Wulffraat, and Sanders neousl
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CHAPTER 9 LONG-TERM EFFECTS
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484 Chapter 9: Long-Term Effects po
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486 Chapter 9: Long-Term Effects Ta
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488 Chapter 9: Long-Term Effects ml
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490 Chapter 9: Long-Term Effects 4.
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492 Chapter 9: Long-Term Effects us
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494 Chapter 9: Long-Term Effects AB
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498 Chapter 9: Long-Term Effects En
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500 Chapter 9: Long-Term Effects Rl
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502 Chapter 9: Long-Term Effects RE
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504 Chapter 9: Long-Term Effects A,
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Long-Term Follow-Up of Autologous T
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CHAPTER 10 GRAFT MANIPULATION
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514 Chapter 10: Graft Manipulation
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Stem Cell Reinfusion Over Two Conse
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Final Report of the First Prospecti
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Canine Hematopoietic Stem Allograft
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Sandmaier et al. 603 The resultant
Page 639 and 640:
Sandmaier et al. 605 synthesis path
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Sandmaier et al. 607 interactions o
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Sandmaier et al. 1991. 2. Burchenal
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87:3508-3513,1996. Sandmaier et al.
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Giralt, Khouri, and Champlin Table
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Giralt, Khouri, and Champlin seven
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1.0 3 0.2 Giralt, Khouri, and Champ
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CHAPTER 12 GENE THERAPY
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622 Chapter 12: Gene Therapy INTROD
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624 Chapter 12: Gene Therapy RESULT
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626 Chapter 12: Gene Therapy envisi
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628 Chapter 12: Gene Therapy cer in
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A Vaccine of Melanoma Peptide Loade
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B43(anti-CD 19)-Gen i stein Immunot
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Targeting Immunotherapy for the Tre
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McGuinness andArceci 637 modified m
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McGuinness andArceci 639 leukemic c
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McGuinness and Arced 641 in G418. T
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McGuinness andArceci 643 Figure 2
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mRNA for hB7-1 (1491 bp) mRNA for C
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McGuinness and Arced CD80PE C080PE
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McGuinness andArceci 649 8. Robert
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McGuinness andArceci immune respons
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McGuinness andArceci 75. Jubinsky F
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Slavin et al. 655 up suggests, as p
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Slavin et al. 657 was a phase lib c
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Slavin et al. presented, appears to
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Antitumor Immunotherapy in Autologo
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Klingemann et al. 663 Table 3. Meth
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CHAPTER 14 RADIOIMMUNOTHERAPY
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668 Chapter 14: Radioimmunotherapy
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Selection of Radioisotopes, Chelate
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Radioimmunotherapy of Common Epithe
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CHAPTER 15 NEW AVENUES
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698 Chapter 15: New Avenues Table 1
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700 Chapter 15: New Avenues An alte
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702 Chapter 15: New Avenues who can
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704 Chapter 15: New Avenues myeloid
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706 Chapter 15: New Avenues 48. Gir
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Emerging Viral Infections in Blood
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710 Chapter 15: New Avenues influen
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712 Chapter 15: New Avenues Among a
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714 Chapter 15: New Avenues physica
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716 Chapter 15: New Avenues respira
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Minimal Therapy Models of Transplan
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CHAPTER 16 SUMMARIES
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724 Chapter 16: Summaries although
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726 Chapter 16: Summaries use of po
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728 Chapter 16: Summaries Table 1.
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736 Chapter 16: Summaries IL-15. Th
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738 Chapter 16: Summaries Patterns
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740 List of Participants Thomas L.
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742 List of Participants Sergio A.
Page 778 and 779:
744 List of Participants Hans Marti
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746 List of Participants David P. S
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748 List of Participants AUTHOR IND
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750 Author Index Hurd, D.D. 483 Kui
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752 Author Index Stiff, Patrick J.
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754 Key Word Index Hematologic mali
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ISBN 1-891524-04-6
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