Serious ethical dilemma of single-agent pegylated liposomal doxorubicin employed as a control arm in ovarian cancer chemotherapy trials

Journal of Clinical Oncology

Volumn 28, Issue 19, 2010, Pages

  Markman, Maurie ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DOXORUBICIN; GEMCITABINE; PLATINUM; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; MACROGOL DERIVATIVE;

BLEEDING; BLISTER; CANCER CHEMOTHERAPY; CLINICAL ASSESSMENT; CLINICAL TRIAL (TOPIC); DAILY LIFE ACTIVITY; DISEASE SEVERITY; DRUG APPROVAL; DRUG DOSE REDUCTION; DRUG EFFICACY; EDEMA; FOOD AND DRUG ADMINISTRATION; HAND FOOT SYNDROME; HUMAN; HYPERKERATOSIS; LETTER; OVARY CANCER; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SKIN MANIFESTATION; STANDARD; CHEMICALLY INDUCED DISORDER; FEMALE; NOTE; OVARY TUMOR; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SKIN DISEASE; TREATMENT OUTCOME;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DOXORUBICIN; FEMALE; HUMANS; OVARIAN NEOPLASMS; POLYETHYLENE GLYCOLS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SKIN DISEASES; TREATMENT OUTCOME;

EID: 77955489524     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.28.9934     Document Type: Letter

References (13)

1. Gordon AN, Fleagle JT, Guthrie D, et al: Recurrent epithelial ovarian carcinoma: A randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol 19:3312-3322, 2001 (Pubitemid 32642183)
2. Gordon AN, Tonda M, Sun S, et al: Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol 95:1-8, 2004 (Pubitemid 39286270)
3. 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 18:3093-3100, 2000
4. Keller AM, Mennel RG, Georgoulias VA, et al: Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer. J Clin Oncol 22:3893-3901, 2004 (Pubitemid 41079870)
5. National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.02, page 72, May 28, 2009 http://ctep.cancer.gov/ protocolDevelopment/electronic-applications/ctc.htm
6. Rose PG, Maxson JH, Fusco N, et al: Liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: A retrospective comparative study of single-agent dosages. Gynecol Oncol 82:323-328, 2001 (Pubitemid 32730611)
7. Campos SM, Penson RT, Mays AR, et al: The clinical utility of liposomal doxorubicin in recurrent ovarian cancer. Gynecol Oncol 81:206-212, 2001 (Pubitemid 32424162)
8. Markman M, Kennedy A, Webster K, et al: Phase 2 trial of liposomal doxorubicin (40 mg/m(2)) in platinum/paclitaxel-refractory ovarian and fallopian tube cancers and primary carcinoma of the peritoneum. Gynecol Oncol 78:369-372, 2000
9. Kim RJ, Peterson G, Kulp B, et al: Skin toxicity associated with pegylated liposomal doxorubicin (40 mg/m2) in the treatment of gynecologic cancers. Gynecol Oncol 97:374-378, 2005 (Pubitemid 40614877)
10. Ferrandina G, Ludovisi M, Lorusso D, et al: Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer. J Clin Oncol 26:890-896, 2008 (Pubitemid 351398081)
11. Mutch DG, Orlando M, Goss T, et al: Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol 25:2811-2818, 2007 (Pubitemid 47123191)
12. Tanyi JL, Smith JA, Ramos L, et al: Predisposing risk factors for palmarplantar erythrodysesthesia when using liposomal doxorubicin to treat recurrent ovarian cancer. Gynecol Oncol 114:219-224, 2009
13. The Nuremberg Code. http://ohsr.od.nih.gov/guidelines/nuremberg.html