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Phase I/II study of tandem high-dose chemotherapy with autologous peripheral blood stem cell transplantation for advanced multiple myeloma |
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| Authors: | Kazutaka Sunami Katsuji Shinagawa Morio Sawamura Akira Sakai Yoshio Saburi Yutaka Imamura Ishikazu Mizuno Shigehisa Tamaki Tomohiko Kamimura Hiroyuki Tsuda Hisashi Gondo Norihiko Hino Chihiro Shimazaki Akira Miyata Fumihito Tajima Yoshinobu Takemoto Akiyoshi Miwa Takaaki Chou Mine Harada |
| Institution: | 1. Division of Hematology, Department of Internal Medicine, National Hospital Organization Okayama Medical Center, 1711-1 Tamasu, Kitaku, Okayama, 701-1192, Japan 2. Division of Hematology/Oncology, Okayama University Medical School, Okayama, Japan 3. Department of Internal Medicine, Nishigunma National Hospital, Shibukawa, Gunma, Japan 4. Department of Hematology/Oncology, Institute for Rad. Biology and Medicine, Hiroshima University, Hiroshima, Japan 5. Department of Hematology, Oita Prefectural Hospital, Oita, Japan 6. Division of Hematology, St. Mary’s Hospital, Kurume, Fukuoka, Japan 7. Hematology Division, Department of Medicine, Hyogo Cancer Center, Akashi, Hyogo, Japan 8. Department of Internal Medicine, Yamada Red Cross Hospital, Ise, Mie, Japan 9. Department of Hematology, Harasanshin Hospital, Fukuoka, Japan 10. Division of Hematology/Oncology, Kumamoto City Hospital, Kumamoto, Japan 11. Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan 12. Department of Internal Medicine, Kure Kyosai Hospital, Kure, Hiroshima, Japan 13. Division of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan 14. Department of Internal Medicine, Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuyama, Hiroshima, Japan 15. Division of Blood Transfusion, Tottori University Hospital, Yonago, Tottori, Japan 16. Medical Corporation Kouryokai CPC Clinic, Kagoshima, Japan 17. Department of Hematology, International Medical Center of Japan, Tokyo, Japan 18. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan 19. Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, Fukuoka, Japan |
| Abstract: | The efficacy and safety of high-dose chemotherapy with tandem autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in a multicenter clinical study of patients with advanced multiple myeloma. Eligible patients (n = 40) were consecutively enrolled in the phase I/II study and received 2–4 cycles of vincristine–adriamycin–dexamethasone regimen. The responding patients underwent PBSC harvesting following high-dose cyclophosphamide and filgrastim administration. The first auto-PBSCT (n = 32) following high-dose melphalan (200 mg/m2) was performed within 2 months of PBSC harvesting; the second auto-PBSCT (n = 28) was scheduled 3–6 months later. Treatment-related mortality was 2.5% (n = 1) throughout the protocol. Grade 4 nonhematologic toxicity occurred in 12.5 and 14.3% of the first and second auto-PBSCT patients, respectively. All but one patient (who died) achieved hematopoietic recovery. For the 28 patients completing the second auto-PBSCT, the results were favorable with a response rate of 65% (complete response rate = 27.5%, n = 11); the five-year progression-free survival and overall survival were 20.3 and 66.5%, respectively. In conclusion, high-dose chemotherapy with tandem auto-PBSCT is feasible and safe with a favorable response rate in treating advanced multiple myeloma in Japan. |
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