Table 1.
Agents and Schedule | Primary Toxicities | Cumulative No. | Estimated or Communicated PFS at 4 mo | Median Time to Progression | Combined Response Rate | Partial Response | Complete Response | Toxicitya | |
---|---|---|---|---|---|---|---|---|---|
Osteosarcoma | Ifosfamide + etoposide: iv, inpatient, d 1‐5 of 21‐d cycle17, 18, 20, 21 | Myelosuppression (requires myeloid growth factor), neurotoxicity, alopecia | 83 | 80% | N/A | 27% | 25% | <5% without surgery | Very high |
Sorafenib: po, bid, continuously22 | Rash (hand‐foot skin reaction), hypertension, mucositis | 35 | 46% (mean, 4 mo) | 4 mo | 9% | 9%b | 0 | Low | |
Gemcitabine + docetaxel: iv, outpatient, d 1 and 8 of 21‐d cycle23, 24, 25, 26, 27 | Myelosuppression (requires myeloid growth factor), cumulative neurotoxicity, allergic reactions, alopecia | 68 | 40% | 4 mo | 16% | 16% | <5% without surgery | High | |
Ewing sarcoma | Cyclophosphamide + topotecan: iv, outpatient, d 1‐5 of 21‐d cycle28, 29 | Myelosuppression (requires myeloid growth factor), alopecia | 71 | Early progression: < 25% Late progression: > 75% | N/A | 35% | 10% | 25% | Medium |
Temozolomide + irinotecan ± vincristine: outpatient, po or iv and d 1‐5 for irinotecan, po and d 1‐5 for temozolomide (vincristine on d 1)30, 31 | Diarrhea (treated with loperamide and antibiotic pretreatment) | 102 | 55%‐70% | N/A | 53% | 27% | 26% | Medium | |
High‐dose ifosfamide: iv, inpatient, d 1‐5 of 21‐d cycle32 | Myelosuppression (requires myeloid growth factor), neurotoxicity, alopecia | 35 | N/A | N/A | 34% | 29% | 5% | Very high | |
Gemcitabine + docetaxel: iv, outpatient, d 1 and 8 of 21‐d cycle23, 24, 33 | Myelosuppression (requires myeloid growth factor), cumulative neurotoxicity, allergic reaction, alopecia | 24 | >25% | 5 mo | 29% | 25% | <5% without radiation | High | |
Oral etoposide: po, daily for several weeks on, 1‐ to 2‐wk break as tolerated34 | Myelosuppression, secondary malignancy | 58 | 33% | N/A | 19% | 19% | <5% | Low |
Abbreviations: bid, twice daily; iv, intravenous; N/A, not available; PFS, progression‐free survival; po, by mouth; d, day.
Very high, high, medium, or low.
Response Evaluation Criteria in Solid Tumors.