Response of children with stage IV soft tissue sarcoma to topotecan and carboplatin: a phase II window trial of the cooperative soft tissue sarcoma group.
To investigate antitumor activity and toxicity associated with combined topotecan and carboplatin treatment in children and adolescents with metastasized, untreated soft tissue sarcoma (STS).Patients (n=34) less than 21 years old and untreated, stage IV STS. Patients were treated with topotecan (1 mg/m²/d for 4 days) and carboplatin (150 mg/m²/d for 4 days) (TC course) during week 1 and 4 of a chemotherapy window trial, which was followed by chemotherapy and local therapy from week 6 on. We evaluated the side effects, toxicity and tumor response (using RECIST criteria) 6 weeks after starting the 2 TC chemotherapy courses.The objective response rate (ORR) was 38% (n=13 patients with a partial response (PR)), and a stable disease (SD) was reached in 11 cases. No patient showed a complete response (CR) of all metastatic lesions, although 1 patient showed a CR of the target lesion. 2 patients died of progress of disease (PD). Toxicity was mainly hematological (grade III/IV toxicity 79%), and nonhematological toxicities mainly included infection, fever, nausea,and vomiting. Regarding adverse events, 4 probable and 8 possible events related to study medication occurred among the 66 courses of TC.In conclusion, TC was potent against high-risk STS, but results and toxicity data were not superior to former published monotherapeutic topotecan therapies.
Pediatric Hematology and Oncology, University Hospital of J. W. Goethe University, Frankfurt/Main, Germany.
K
K
Bochennek
T
T
Dantonello
E
E
Koscielniak
A
A
Claviez
U
U
Dirksen
A
A
Sauerbrey
A
A
Beilken
T
T
Klingebiel
D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D003131:Combined Modality Therapy; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D012208:Rhabdomyosarcoma / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D012509:Sarcoma / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D012512:Sarcoma, Ewing / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D013584:Sarcoma, Synovial / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D012983:Soft Tissue Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D019772:Topotecan / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D019772:Topotecan; D016190:Carboplatin