Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients
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Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients : results from a subset analysis of the CALYPSO phase III trial. / Gladieff, L; Ferrero, A; De Rauglaudre, G; Brown, C; Vasey, P; Reinthaller, A; Pujade-Lauraine, E; Reed, N; Lorusso, D; Siena, S; Helland, H; Elit, L; Mahner, S.
In: ANN ONCOL, Vol. 23, No. 5, 01.05.2012, p. 1185-9.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients
T2 - results from a subset analysis of the CALYPSO phase III trial
AU - Gladieff, L
AU - Ferrero, A
AU - De Rauglaudre, G
AU - Brown, C
AU - Vasey, P
AU - Reinthaller, A
AU - Pujade-Lauraine, E
AU - Reed, N
AU - Lorusso, D
AU - Siena, S
AU - Helland, H
AU - Elit, L
AU - Mahner, S
PY - 2012/5/1
Y1 - 2012/5/1
N2 - BACKGROUND: To perform a subset analysis of patients with partially platinum-sensitive recurrent ovarian cancer (ROC) who received either CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) in the CALYPSO trial.PATIENTS AND METHODS: CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy. Patients were randomized to CD or CP. Patients with a treatment-free interval of >6 and ≤ 12 months were evaluated for progression-free survival (PFS), the primary end point of CALYPSO trial, and safety.RESULTS: A total of 344 partially platinum-sensitive patients were included (N = 161, CD and N = 183, CP). The hazard ratio for PFS was 0.73 (95% confidence interval: 0.58-0.90; P = 0.004 for superiority) in favor of CD. Median PFS times were 9.4 months (CD) and 8.8 months (CP). Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions. Hand-foot syndrome was more common with CD; however, grade 3/4 reactions were low (one patient in each arm).CONCLUSION: Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.
AB - BACKGROUND: To perform a subset analysis of patients with partially platinum-sensitive recurrent ovarian cancer (ROC) who received either CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) in the CALYPSO trial.PATIENTS AND METHODS: CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy. Patients were randomized to CD or CP. Patients with a treatment-free interval of >6 and ≤ 12 months were evaluated for progression-free survival (PFS), the primary end point of CALYPSO trial, and safety.RESULTS: A total of 344 partially platinum-sensitive patients were included (N = 161, CD and N = 183, CP). The hazard ratio for PFS was 0.73 (95% confidence interval: 0.58-0.90; P = 0.004 for superiority) in favor of CD. Median PFS times were 9.4 months (CD) and 8.8 months (CP). Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions. Hand-foot syndrome was more common with CD; however, grade 3/4 reactions were low (one patient in each arm).CONCLUSION: Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.
KW - Adenocarcinoma
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Carboplatin
KW - Disease-Free Survival
KW - Doxorubicin
KW - Drug Resistance, Neoplasm
KW - Female
KW - Humans
KW - Middle Aged
KW - Ovarian Neoplasms
KW - Paclitaxel
KW - Platinum Compounds
KW - Polyethylene Glycols
KW - Recurrence
KW - Treatment Outcome
KW - Young Adult
U2 - 10.1093/annonc/mdr441
DO - 10.1093/annonc/mdr441
M3 - SCORING: Journal article
C2 - 21976386
VL - 23
SP - 1185
EP - 1189
JO - ANN ONCOL
JF - ANN ONCOL
SN - 0923-7534
IS - 5
ER -