Phase II clinical trial with pegylated liposomal doxorubicin (CAELYX®/Doxil®) and quality of life evaluation (EORTC QLQ-C30) in adult patients with advanced soft tissue sarcomas: A study of the Spanish Group for Research in Sarcomas (GEIS)

Sarcoma

Volumn 9, Issue 3-4, 2005, Pages 127-132

  Poveda, A ^a   Lopez Pousa A ^b   Martin J ^c   Garcia Del Muro J ^d   Bernabe R ^e   Casado, A ^f   Balana C ^g   Sanmartin O ^a   Menendez M D ^h   Escudero, P ⁱ   Cruz, J ^j   Belyakova, Elena ^k   Menendez D ^b   Buesa, J M ^l  

^a INSTITUTO VALENCIANO DE ONCOLOGÍA   (Spain)

^b HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^c HOSPITAL UNIVERSITARIO SON ESPASES   (Spain)

^d CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^e HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^f HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^g HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^h HOSPITAL DE CONXO   (Spain)

ⁱ HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA   (Spain)

^j HOSPITAL UNIVERSITARIO DE CANARIAS   (Spain)

^k DEPARTAMENTO DE BIOQUÍMICA Y BIOLOGÍA MOLECULAR   (Spain)

^l HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS   (Spain)

more..

Author keywords

Pegylated liposomal doxorubicin; Quality of life; Soft tissue sarcomas

Indexed keywords

DOXORUBICIN;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER REGRESSION; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DOSE RESPONSE; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG SAFETY; ERYTHEMA; ESOPHAGITIS; FEMALE; GRANULOCYTOPENIA; HAND FOOT SYNDROME; HEART DISEASE; HEART FAILURE; HUMAN; INFECTION; LICHENOID; MALE; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; PSORIASIS; QUALITY OF LIFE; RELIABILITY; SKIN DISEASE; SOFT TISSUE SARCOMA; STATISTICAL SIGNIFICANCE; STOMATITIS; TOXIC EPIDERMAL NECROLYSIS;

EID: 31444443149     PISSN: 1357714X     EISSN: 13691643     Source Type: Journal    
DOI: 10.1080/13577140500287024     Document Type: Article

References (24)

1. Brennan MF, Casper ES, Harrison LB. Soft tissue sarcoma. In DeVita VT, Hellman S, Rosenberg SA, editors. Cancer: Principles and practice of oncology. 5th ed. Philadelphia, PA: Lippincott-Raven, 1997. pp 1738-1853.
2. Coukell AJ, Spencer CM. Polyethylene glycolliposomal doxorubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the management of AIDS-related Kaposi's sarcoma. Drugs 1997;53:520-538.
3. Gabizon A, Shmeeda H, Barenholz Y. Pharmacokinetics of pegylated liposomal doxorubicin: Review of animal and human studies. Clin Pharmacokinet 2003;42:419-436.
4. Uziely B, Jeffers S, Isacson R, et al. Liposomal doxorubicin: Antitumor activity and unique toxicities during two complementary phase I studies. J Clin Oncol 1995;13:1777-1785.
5. Ranson MR, Carmichael J, O'Bryne K, et al. Treatment of advanced breast cancer with sterically-stabilized liposomal doxorubicin: Results of a multicenter phase II trial. J Clin Oncol 1997;15:3185-3191.
6. Alberts DS, García DJ. Safety aspects of pegylated liposomal doxorubicin in patients with cancer. Drugs 1997; 54(Suppl 4):30-35.
7. Berry G, Billingham M, Alderman E, et al. The use of cardiac biopsy to demonstrate reduced cardiotoxicity in AIDS Kaposi's sarcoma patients treated with pegylated liposomal doxorubicin. Ann Oncol 1998;9:711-716.
8. Muggia FM, Hainsworth JD, Jeffers S, et al. Phase II study of liposomal doxorubicin in refractory ovarian cancer: Antitumor activity and toxicity modification by liposomal encapsulation. J Clin Oncol 1997;15:987-993.
9. Miller AB, Hoogstraten B, Staquet M. Reporting results of cancer treatment. Cancer 1981;47:207-214.
10. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international trials in oncology. J Natl Cancer Inst 1993;85:363-376.
11. Fayers PM, Aaronson NK, Bjordal K, et al. The EORTC QLQ-C30 Scoring Manual. 3rd ed. Brussels: European Organization for Research and Treatment of Cancer. 2001.
12. Simon R. Optimal two-stage designs for phase II trials. Control Clin Trials 1989;10:1-10.
13. Cronbach LJ. Coefficient alfa and the internal structure of test. Psychometrika 1951:16;297-334.
14. Fitzpatrick JE. The cutaneous histopathology of chemotherapeutic reactions. J Cutan Pathol 1993;20:1-14.
15. Toma S, Tuccie A, Villani G, et al. Liposomal doxorubicin (Caelyx) in advanced pretreated soft tissue sarcomas: A phase II study of the Italian Sarcoma Group (ISG). Anticancer Res 2000;20:485-492.
16. Skubitz KM. Phase II trial of pegylated-liposomal doxorubicin (Doxil™) in sarcoma. Cancer Invest 2003;21:167-176.
17. Garcia AA, Kempf RA, Rogers M, et al. A phase II study of Doxil (liposomal doxorubicin): Lack of activity in poor prognosis soft tissue sarcomas. Ann Oncol 1998;9:1131-1133.
18. Chidiac T, Budd GT, Pelley F, et al. Phase II trial of liposomal doxorubicin (Doxil®) in advanced soft tissue sarcomas. Invest New Drugs 2000;18:253-259.
19. Judson I, Radford JA, Harris M, et al. Randomised phase II trial of pegylated liposomal doxorubicin (DOXIL®/CAELYX®) versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma: A study by the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer 2001;37:870-877.
20. van Glabbeke M, Verweij J, Judson I, et al. Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer 2002;38:543-549.
21. Gordon AN, Granai CO, Rose PG, et al. Phase II study of liposomal doxorubicin in platinum- and paclitaxel-refractory epithelial ovarian cancer. J Clin Oncol 2000;18:3093-3100.
22. Lyass O, Uziely B, Ben-Yosef R, et al. Correlation of toxicity with pharmacokinetics of pegylated liposomal doxorubicin (Doxil®) in metastatic breast carcinoma. Cancer 2000;89:1037-47.
23. Hamilton A, Biganzoli L, Coleman R, et al. EORTC 10968: A phase I clinical and pharmacokinetic study of polyethylene glycol liposomal doxorubicin (Caelyx®, Doxil®) at a 6-week interval in patients with metastatic breast cancer. Ann Oncol 2002;13:910-918.
24. O'Brien MER, Wigler N, Inbar M, et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX™/Doxil®) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004;15:440-449.