Phase II study of pegylated liposomal doxorubicin in heavily pretreated epithelial ovarian cancer patients. May a new treatment schedule improve toxicity profile?

Abstract

OBJECTIVE:

Pegylated liposomal doxorubicin (PLD) has shown promising activity in the treatment of recurrent ovarian cancer but skin toxicity remains the dose-limiting toxicity of the drug. The aim of this study was to investigate whether a different treatment schedule may improve the toxicity profile, especially in terms of dermatological and mucosal toxicity.

METHODS:

It is an open-label phase II study in a population of heavily pretreated ovarian cancer patients. PLD was administered at the dose of 35 mg/m2 q21 until disease progression or unacceptable toxicity.

RESULTS:

Thirty-seven heavily pretreated (median number of previous chemotherapy regimens 2, range 1-6) ovarian cancer patients were enrolled. All patients received at least two courses of chemotherapy and all were evaluated for response. No one showed complete response, while five partial responses (13.5%), 16 stabilizations of disease (48.6%) and 14 progressions of disease (37.8%) were observed. The median time to response was 12 weeks (range 8-16). The median duration of response was 22.8 weeks (range 4-68), the median duration of stabilization of disease was 17.6 weeks (range 4-28). Palmar plantar erythrodysesthesia (PPE) occurred in 8 patients (21.6%) and was of grade 3 in one patient (2.8%). Grade 1 stomatitis occurred in 3 patients (8.1%). Grade 3-4 neutropenia occurred in only 4 patients (10.8%).

CONCLUSIONS:

PLD at the dose of 35 mg/m2 q21 seems to translate into an acceptable skin toxicity profile with a response rate comparable to others obtained with a standard schedule.

• Authors: D Lorusso, A Naldini, A Testa, G D'Agostino, G Scambia, G Ferrandina
• Journal: Oncology (Oncology) Vol. 67 Issue 3-4 Pg. 243-9 ( 2004) ISSN: 0030-2414 [Print] Switzerland
• PMID: 15557785 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Antibiotics, Antineoplastic
• Drug Carriers
• Liposomes
• Surface-Active Agents
• Polyethylene Glycols
• Doxorubicin

Topics

• Adult
• Aged
• Antibiotics, Antineoplastic (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma (drug therapy)
• Doxorubicin (administration & dosage, adverse effects)
• Drug Carriers (adverse effects)
• Female
• Humans
• Liposomes (adverse effects)
• Middle Aged
• Ovarian Neoplasms (drug therapy)
• Polyethylene Glycols
• Salvage Therapy
• Surface-Active Agents (adverse effects)
• Survival Analysis
• Treatment Outcome