Preoperative chemotherapy for osteogenic sarcoma: selection of postoperative adjuvant chemotherapy based on the response of the primary tumor to preoperative chemotherapy
N = 57
- Population
- Patients with primary osteogenic sarcoma of an extremity; 57 treated, 35 without and 22 with a good histologic response
- Design
- Non-randomised series of 57 patients with primary osteogenic sarcoma of an extremity, treated from June 1978. Preoperative high-dose methotrexate with citrovorum factor rescue, doxorubicin, and bleomycin/cyclophosphamide/dactinomycin (BCD) for 4-16 weeks, then definitive surgery. Postoperative regimen chosen by histologic effect on the resected primary tumour: continued regimen B for a good effect, regimen A (cisplatin plus doxorubicin and BCD, without high-dose methotrexate) otherwise.
- Arms
- Regimen A after a poor histologic response (experimental, n = 35): Cisplatin 120 mg/m2 with mannitol diuresis, doxorubicin and BCD (bleomycin, cyclophosphamide, dactinomycin); high-dose methotrexate omitted
- Regimen B after a good histologic response (experimental, n = 22): Continuation of the preoperative regimen: high-dose methotrexate with citrovorum factor rescue, doxorubicin and BCD
- People
- Rosen G
Show the numbers
| Endpoint | Analysis | Regimen A after a poor histologic response / Regimen B after a good histologic response | Control | Effect |
|---|---|---|---|---|
| Continuous disease-free ratePatients assigned to regimen A after a poor histologic response (35 of 57) | primaryRosen 1982 | 91% | — | 32 of 35 patients remained continuously free of recurrent or metastatic disease at 6-34 months from the start of therapy. Non-randomised; no comparison arm. |
| Endpoint | Analysis | Regimen A after a poor histologic response / Regimen B after a good histologic response | Control | Effect |
|---|---|---|---|---|
| Continuous disease-free ratePatients assigned to regimen A after a poor histologic response (35 of 57) | primaryRosen 1982 | 91% | — | 32 of 35 patients remained continuously free of recurrent or metastatic disease at 6-34 months from the start of therapy. Non-randomised; no comparison arm. |