Tandem high-dose chemotherapy followed by autologous transplantation in patients with locally advanced or metastatic sarcoma.
BACKGROUND
Patients with locally advanced or metastatic/recurrent soft tissue and Ewing's sarcoma (EWS) have few treatment options. The purpose of our phase II study was to assess the feasibility, safety and efficacy of tandem high-dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) in such patients.


METHODS
Thirteen patients were enrolled onto this study. The first cycle of HDCT consisted of doxorubicin (150 mg/m(2)) and ifosfamide (14 g/m(2)) mixed with mesna (14 g/m(2)), while the second cycle consisted of melphalan (150 mg/m(2)) and cisplatin (200 mg/m(2)).


RESULTS
Eleven out of 13 patients were able to complete both cycles of HDCT. No treatment-related mortality occurred and grade 3 or 4 toxicity was clinically tolerable. The 5-year progression-free survival (PFS) and overall survival (OS) for all patients was 23% (confidence interval, CI: 0-46%) and 31% (CI: 14-70%), respectively. Out of the four patients still alive, two had EWS and measurable disease at the time of ASCT and achieved a complete remission, remaining progression free 126 and 155 months after ASCT.


CONCLUSIONS
Our study demonstrates the feasibility and safety of tandem HDCT in patients with high-risk or metastatic/recurrent sarcoma, with some patients achieving long-term PFS and OS.
Lashkari
Ashkan
A
City of Hope Comprehensive Cancer Center, Division of Medical Oncology, 1500 E. Duarte Road, Duarte, CA 91010, USA.
Chow
Warren A
WA
Valdes
Frances
F
Leong
Lucille
L
Phan
Vu
V
Twardowski
Przemyslaw
P
Kapoor
Neena
N
Molina
Arturo
A
Al-Kadhimi
Zaid
Z
Frankel
Paul
P
Somlo
George
G
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000556:secondary / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007124:Immunoenzyme Techniques; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D015080:Mesna / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D018241:Neuroectodermal Tumors, Primitive, Peripheral / Q000473:pathology / Q000628:therapy; D012516:Osteosarcoma / Q000473:pathology / Q000628:therapy; D011379:Prognosis; D011446:Prospective Studies; D020011:Protective Agents / Q000008:administration & dosage; D012074:Remission Induction; D012208:Rhabdomyosarcoma / Q000473:pathology / Q000628:therapy; D012449:Safety; D012509:Sarcoma / Q000473:pathology / Q000628:therapy*; D012512:Sarcoma, Ewing / Q000473:pathology / Q000628:therapy; D015996:Survival Rate; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult
D020011:Protective Agents; D004317:Doxorubicin; D015080:Mesna; D002945:Cisplatin; D008558:Melphalan; D007069:Ifosfamide