Phase 2 trial of two courses of cyclophosphamide and etoposide for relapsed high-risk osteosarcoma patients

Cancer

Volumn 115, Issue 13, 2009, Pages 2980-2987

  Massimo, Berger ^a   Giovanni, Grignani ^b   Stefano, Ferrari ^c   Eleonora, Biasin ^a   Adalberto, Brach Del Prever ^a   Sandra, Aliberti ^b   Francesco, Saglio ^a   Massimo, Aglietta ^b   Franca, Fagioli ^a  

^a REGINA MARGHERITA CHILDREN S HOSPITAL   (Italy)

^b CANDIOLO CANCER INSTITUTE   (Italy)

^c RIZZOLI ORTHOPAEDIC INSTITUTE   (Italy)

Author keywords

Cyclophosphamide; Etoposide; Osteosarcoma relapse

Indexed keywords

CISPLATIN; CYCLOPHOSPHAMIDE; DOXORUBICIN; ETOPOSIDE; GRANULOCYTE COLONY STIMULATING FACTOR; IFOSFAMIDE; MESNA; METHOTREXATE;

ADOLESCENT; ADULT; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD TOXICITY; BONE METASTASIS; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG DOSE SEQUENCE; DRUG EFFICACY; DRUG MEGADOSE; DRUG TOLERABILITY; FEMALE; FEVER; HEMORRHAGIC CYSTITIS; HIGH RISK PATIENT; HUMAN; HUMAN CELL; HUMAN TISSUE; MALE; MUCOSA INFLAMMATION; OSTEOSARCOMA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RELAPSE; SCHOOL CHILD; TREATMENT RESPONSE;

ADOLESCENT; ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE NEOPLASMS; CHILD; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; ETOPOSIDE; FEMALE; HEMATOPOIETIC STEM CELL MOBILIZATION; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM RECURRENCE, LOCAL; OSTEOSARCOMA;

EID: 67649591810     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.24368     Document Type: Article

References (42)

1. Meyers PA, Gorlick R, Heller G, et al. Intensification of preoperative chemotherapy for osteogenic sarcoma: results of the Memorial Sloan-Kettering (T12) protocol. J Clin Oncol. 1998;16:2452-2458. (Pubitemid 28309040)
2. Provisor AJ, Ettinger LJ, Nachman JB, et al. Treatment of nonmetastatic osteosarcoma of the extremity with preoperative and postoperative chemotherapy: a report from the Children's Cancer Group. J Clin Oncol. 1997;15:76-84. (Pubitemid 27020560)
3. Souhami RL, Craft AW, Van der Eijken JW, et al. Randomised trial of 2 regimens of chemotherapy in operable osteosarcoma: a study of the European Osteosarcoma Intergroup. Lancet. 1997;350:911-917. (Pubitemid 27420527)
4. Bacci G, Ferrari S, Mercuri M, et al. Neoadjuvant chemotherapy for extremity osteosarcoma - preliminary results of the Rizzoli's 4th study. Acta Oncol. 1998;37:41-48. (Pubitemid 28179799)
5. Longhi A, Errani C, De Paolis M, Mercuri M, Bacci G. Primary bone osteosarcoma in the pediatric age: state of the art. Cancer Treat Rev. 2006;32:423-436. (Pubitemid 44309249)
6. Bacci G, Longhi A, Versari M, Mercuri M, Briccoli A, Picci P. Prognostic factors for osteosarcoma of the extremity treated with neoadjuvant chemotherapy: 15-year experience in 789 patients treated at a single institution. Cancer. 2006;106:1154-1161. (Pubitemid 43297356)
7. Ferrari S, Smeland S, Mercuri M, et al. Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate, cisplatin, and doxorubicin for patients with localized osteosarcoma of the extremity: a joint study by the Italian and Scandinavian Sarcoma Groups. J Clin Oncol. 2005;23:8845-8852. (Pubitemid 46211531)
8. Ferrari S, Briccoli A, Mercuri M, et al. Postrelapse survival in osteosarcoma of the extremities: prognostic factors for long-term survival. J Clin Oncol. 2003;21:710-715. (Pubitemid 46621907)
9. Fagioli F, Aglietta M, Tienghi A, et al. High-dose chemotherapy in the treatment of relapsed osteosarcoma: an Italian sarcoma group study. J Clin Oncol. 2002;20:2150-2156. (Pubitemid 34408807)
10. Ward WG, Mikaelian K, Dorey F, et al. Pulmonary metastases of stage IIB extremity osteosarcoma and subsequent pulmonary metastases. J Clin Oncol. 1994;12:1849-1858. (Pubitemid 24349387)
11. Patel SR, Vadhan-Raj S, Papadopulos N, et al. High-dose ifosfamide in bone and soft tissue sarcomas: results of phase II and pilot studies-dose response and schedule dependence. J Clin Oncol. 1997;15:2378-2384. (Pubitemid 27251141)
12. Kebudi R, Gorgun O, Ayan I. Oral etoposide for recurrent/ progressive sarcomas of childhood. Pediatr Blood Cancer. 2004;42:320-324. (Pubitemid 38327624)
13. Gentet J-C, Brunat-Mentigny M, Demaille MC, et al. Ifosfamide and etoposide in childhood osteosarcoma. A phase II study of the French Society of Pediatric Oncology. Eur J Cancer. 1997;33:232-237. (Pubitemid 27117720)
14. Goorin AM, Harris MB, Bernstein M, et al. Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: a pediatric oncology group trial. J Clin Oncol. 2002;20:426-433. (Pubitemid 34072525)
15. Anderson PM, Wiseman GA, Dispenzieri A, et al. Highdose samarium-153 ethylene diamine tetramethylene phosphonate: low toxicity of skeletal irradiation in patients with osteosarcoma and bone metastases. J Clin Oncol. 2002; 20:189-196. (Pubitemid 34032611)
16. Franzius C, Bielack S, Flege S, et al. High-activity samarium-153-EDTMP therapy followed by autologous peripheral blood stem cell support in unresectable osteosarcoma. Nuklearmedizin. 2001;40:215-220. (Pubitemid 34019438)
17. Anderson P. Samarium for osteoblastic bone metastases and osteosarcoma. Expert Opin Pharmacother. 2006;7:1475-1486. (Pubitemid 44173209)
18. Seibel NL, Krailo M, Chen Z, et al. Upfront window trial of topotecan in previously untreated children and adolescents with poor prognosis metastatic osteosarcoma: children's Cancer Group (CCG) 7943. Cancer. 2007;109:1646-1653.
19. Crews KR, Stewart CF, Liu T, Rodriguez-Galindo C, Santana VM, Daw NC. Effect of fractionated ifosfamide on the pharmacokinetics of irinotecan in pediatric patients with osteosarcoma. J Pediatr Hematol Oncol. 2004;26:764-767. (Pubitemid 39577728)
20. Anderson PM, Wiseman GA, Erlandson L, et al. Gemcitabine radiosensitization after high-dose samarium for osteoblastic osteosarcoma. Clin Cancer Res. 2005;11:6895-6900. (Pubitemid 41428746)
21. McTierman A, Whelan JS. A phase II of docetaxel for the treatment of recurrent osteosarcoma. Sarcoma. 2004;8:71-76. (Pubitemid 40006658)
22. Bond M, Bernstein ML, Pappo A, et al. A phase II study of imatinib mesylate in children with refractory or relapsed solid tumors. A children's oncology group study. Pediatr Blood Cancer. 2008;50:254-258.
23. De Sio L, Milano GM, Castellano A, et al. Temozolamide in resistant or relapsed pediatric solid tumors. Pediatr Blood Cancer. 2006;47:30-36. (Pubitemid 43787905)
24. Mantadakis E, Herrera L, Leavey PJ, Bash RO, Winick NJ, Kamen BA. Fractionated cyclophosphamide and etoposide for children with advanced or refractory solid tumors: a phase II window study. J Clin Oncol. 2000;18:2576-2581. (Pubitemid 30432524)
25. Saleh RA, Graham-Pole J, Cassano W, et al. Response of osteogenic sarcoma to the combination of etoposide and cyclophosphamide as neoadjuvant chemotherapy. Cancer. 1990;65:861-865. (Pubitemid 20063485)
26. Rodriguez-Galindo C, Daw NC, Kaste SC, et al. Treatment of refractory osteosarcoma with fractionated cyclophosphamide and etoposide. J Pediatr Hematol Oncol. 2002;24:250-255. (Pubitemid 34506610)
27. Shadduck RK, Zeigler ZR, Andrews DF 3rd, Gilmore GL, Lister J. Mobilization and transplantation of peripheral blood stem cells. Stem Cells 1998;16:145-158.
28. Link MP, Goorin AM, Miser AW, et al. The effect of adjuvant chemotherapy on event-free survival in patients with osteosarcoma of the extremity. N Engl J Med. 1986;314: 1600-1606. (Pubitemid 16118216)
29. Link MP, Gebhardt MC, Meyers PA. Osteosarcoma. In: Pizzo PA, Poplack DG, eds. Principles and practice of pediatric oncology, 4th ed. Philadelphia: Williams and Wilkins; 2002:1051-1090.
30. Meyers PA, Heller G, Healey J, et al. Chemotherapy for nonmetastatic osteogeneic sarcoma. The Memorial Sloan- Kettering experience. J Clin Oncol. 1992;10:5-15.
31. Van Glabbeke M, Verweeij J, Judson I, Nielsen OS. EORTC Soft tissue and Bone Sarcoma Group. Progression-free rate as the principal end-point for phase II trials in soft tissue sarcomas. Eur J Cancer. 2002;38:543-549.
32. Dileo P, Morgan JA, Zahrieh D, et al. Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas: results of a phase II trial. Cancer. 2007;109:1863-1869. (Pubitemid 46668552)
33. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92:205-216. (Pubitemid 30099779)
34. Therasse P, Eisenhauer EA, Verweij J. RECIST revisited: a review of validation studies on tumour assessment. Eur J Cancer. 2006;42:1031-1039.
35. World Health Organization. WHO Handbook for Reporting Results in Cancer Treatment. Geneva, Switzerland: World Health Organization; 1979. Offset publication No. 48.
36. Kaplan EL, Meier P. Non parametric estimation from incomplete observation. J Am Stat Assoc. 1958;53: 457-481.
37. Cox DR. Regression models and life tables. J R Stat Soc. 1972;34:187-202.
38. Schuler U, Ehninger G, Wagner T. Repeated high-dose cyclophosphamide administration in bone marrow transplantation: exposure to activated metabolites. Cancer Chemother Pharmacol. 1987;20:248-252. (Pubitemid 17163404)
39. Sladek NE, Doeden D, Powers JF, Krivit W. Plasma concentration of 4-hydroxycyclophosphamide and phosphoramide mustard in patients repeatedly given high doses of cyclophosphamide in preparation for bone marrow transplantation. Cancer Treat Rep. 1984;68:1247-1254. (Pubitemid 14017155)
40. Kurowski V, Wagner T. Comparative pharmacokinetics of ifosfamide, 4-hydroxyifosfamide, chloroacetylaldehyde, and 2- and 3-dechloroethylifosfamide in patients on fractionated intravenous ifosfamide therapy. Cancer Chemother Pharmacol. 1993;33:36-42. (Pubitemid 23336498)
41. Boddy AV, Yule SM, Wyllie R, Price L, Pearson AD, Idle JR. Pharmacokinetics and metabolism of ifosfamide administered as a continuous infusion in children. Cancer Res. 1993;53:3758-3764. (Pubitemid 23252039)
42. Comandone A, Leone L, Oliva C, et al. Pharmacokinetics of ifosfamide administered according to 3 different schedules in metastatic soft tissue and bone sarcomas. J Chemother. 1998;10:385-393. (Pubitemid 28500234)