Biweekly pegylated liposomal doxorubicin in patients with relapsed ovarian cancer:results of a multicenter phase-II trial
Standard
Biweekly pegylated liposomal doxorubicin in patients with relapsed ovarian cancer:results of a multicenter phase-II trial. / Sehouli, J; Oskay-Ozcelik, G; Kühne, J; Stengel, D; Hindenburg, H-J; Klare, P; Heinrich, G; Schmalfeldt, B; Mertens, H; Camara, O; Lichtenegger, W; Ovarian Cancer Study Group of the North-Eastern Germany Society of Gynecological Oncology (NOGGO).
In: ANN ONCOL, Vol. 17, No. 6, 06.2006, p. 957-61.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Biweekly pegylated liposomal doxorubicin in patients with relapsed ovarian cancer:results of a multicenter phase-II trial
AU - Sehouli, J
AU - Oskay-Ozcelik, G
AU - Kühne, J
AU - Stengel, D
AU - Hindenburg, H-J
AU - Klare, P
AU - Heinrich, G
AU - Schmalfeldt, B
AU - Mertens, H
AU - Camara, O
AU - Lichtenegger, W
AU - Ovarian Cancer Study Group of the North-Eastern Germany Society of Gynecological Oncology (NOGGO)
PY - 2006/6
Y1 - 2006/6
N2 - BACKGROUND: The obvious benefit of pegylated liposomal doxorubicin (PLD) for tumour control in recurrent ovarian cancer is frequently offset by severe palmar-plantar erythrodysesthesia (PPE). There is evidence that dose reduction from 50 to 40 mg/m(2) reduces the incidence of PPE without compromising cytotoxic activity. We set out to investigate whether biweekly application further improves the therapeutic index of PLD.PATIENTS AND METHODS: Patients with recurrent ovarian cancer after surgery and adjuvant chemotherapy with platinum and taxane compounds were eligible to participate in this multi-institutional phase II study. PLD was administered at a dose of 20 mg/m(2) every two weeks. Eligible patients had ECOG performance status of < or =2, and sufficient organ function. We employed an optimized two-stage design to test the hypothesis that biweekly application of PLD reduces the frequency of grade III and IV PPE from 25% to 10%. Response and survival were addressed descriptively.RESULTS: Between October 2001 and February 2004, 64 patients with median age of 59 (range 38-81) years were recruited onto this trial. We evaluated 553 (median 7, range 1-25) courses of PLD treatment. Most patients were in their third or fourth line of chemotherapy. PPE was noted in 30 patients (47.6%), but only three participants progressed to grade 3 severity (4.7%, 95% confidence interval 1.0-13.1%). Partial response, stable disease, and tumour progression were observed in 5, 13, and 24 patients, respectively. Median overall and progression-free survival were 18.2 (range, 1.4-34.0) and 4.3 (range 0.5-22.3) months.CONCLUSIONS: Biweekly PLD may reduce the incidence of PPE while retaining efficacy in relapsed ovarian cancer. Our data support the need for a randomized trial to strengthen these assumptions.
AB - BACKGROUND: The obvious benefit of pegylated liposomal doxorubicin (PLD) for tumour control in recurrent ovarian cancer is frequently offset by severe palmar-plantar erythrodysesthesia (PPE). There is evidence that dose reduction from 50 to 40 mg/m(2) reduces the incidence of PPE without compromising cytotoxic activity. We set out to investigate whether biweekly application further improves the therapeutic index of PLD.PATIENTS AND METHODS: Patients with recurrent ovarian cancer after surgery and adjuvant chemotherapy with platinum and taxane compounds were eligible to participate in this multi-institutional phase II study. PLD was administered at a dose of 20 mg/m(2) every two weeks. Eligible patients had ECOG performance status of < or =2, and sufficient organ function. We employed an optimized two-stage design to test the hypothesis that biweekly application of PLD reduces the frequency of grade III and IV PPE from 25% to 10%. Response and survival were addressed descriptively.RESULTS: Between October 2001 and February 2004, 64 patients with median age of 59 (range 38-81) years were recruited onto this trial. We evaluated 553 (median 7, range 1-25) courses of PLD treatment. Most patients were in their third or fourth line of chemotherapy. PPE was noted in 30 patients (47.6%), but only three participants progressed to grade 3 severity (4.7%, 95% confidence interval 1.0-13.1%). Partial response, stable disease, and tumour progression were observed in 5, 13, and 24 patients, respectively. Median overall and progression-free survival were 18.2 (range, 1.4-34.0) and 4.3 (range 0.5-22.3) months.CONCLUSIONS: Biweekly PLD may reduce the incidence of PPE while retaining efficacy in relapsed ovarian cancer. Our data support the need for a randomized trial to strengthen these assumptions.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antibiotics, Antineoplastic
KW - Doxorubicin
KW - Drug Administration Schedule
KW - Female
KW - Humans
KW - Infusions, Intravenous
KW - Middle Aged
KW - Neoplasm Staging
KW - Ovarian Neoplasms
KW - Patient Selection
KW - Polyethylene Glycols
KW - Recurrence
U2 - 10.1093/annonc/mdl079
DO - 10.1093/annonc/mdl079
M3 - SCORING: Journal article
C2 - 16600975
VL - 17
SP - 957
EP - 961
JO - ANN ONCOL
JF - ANN ONCOL
SN - 0923-7534
IS - 6
ER -