TY - JOUR
T1 - A phase II randomized controlled study of pegylated liposomal doxorubicin and carboplatin vs. gemcitabine and carboplatin for platinum-sensitive recurrent ovarian cancer (GOTIC003/intergroup study)
AU - Fujiwara, Hiroyuki
AU - Ushijima, Kimio
AU - Nagao, Shoji
AU - Takei, Yuji
AU - Shimada, Muneaki
AU - Takano, Masashi
AU - Yoshino, Kiyoshi
AU - Kawano, Yoshiaki
AU - Hirashima, Yasuyuki
AU - Nagase, Satoru
AU - Nishio, Shin
AU - Nishikawa, Tadaaki
AU - Ito, Kimihiko
AU - Shoji, Tadahiro
AU - Kimura, Eizo
AU - Takano, Tadao
AU - Sugiyama, Toru
AU - Kigawa, Junzo
AU - Fujiwara, Keiichi
AU - Suzuki, Mitsuaki
N1 - Funding Information:
We thank Izumi Kohara, Yoshie Ueki and staff of Global Clinical Research Coordinating Center of Kitasato University Hospital for general support of this trial, and Toshiharu Yamashita and Takaaki Takenaga for statistical support. We also gratefully acknowledge the participation of 100 women in this trial. This study was presented in part at the 20thBiennial meeting of the European Society of Gynaecological Oncology (ESGO2017), November 4?7, 2017, Vienna, Austria and the 17th biennial meeting of the international gynecologic cancer society (IGCS2018), September 14?16, 2018, Kyoto, Japan.
PY - 2019/10/1
Y1 - 2019/10/1
N2 - Purpose: To compare the efficacy, safety, and tolerability profiles of pegylated liposomal doxorubicin and carboplatin (PLDC) with those of gemcitabine and carboplatin (GC) for the treatment of patients with platinum-sensitive recurrent ovarian cancer. Methods: Ovarian cancer patients with recurrence > 6 months after first-line platinum and taxane-based therapies were randomly assigned to PLDC [pegylated liposomal doxorubicin 30 mg/m2 plus carboplatin area under the curve (AUC) 5 mg/mL/min on day 1] every 4 weeks or GC (gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin AUC 4 mg/mL/min on day 1) every 3 weeks for at least 6 cycles. The primary endpoint was progression-free survival, and overall response rate, overall survival, toxicity, and dose administration were secondary endpoints. Results: One-hundred patients (49 PLDC; 51 GC) were randomly assigned. Over a median follow-up of 24 months, the median progression-free survival was 12.0 months (95% CI 9.2–15.0) for PLDC and 9.8 months (8.9–12.3) for GC [HR 0.69 (0.455–1.047)] with a difference of 2.2 months. The response rate was 57.1% (41.0–72.3) for PLDC and 56.4% (39.6–72.2) for GC. No obvious differences in toxicity (G3/4) were noted between arms. The median relative dose intensity of planned dose per week was 88.9% for pegylated liposomal doxorubicin and 53.1% for gemcitabine (p < 0.0001). Conclusions: PLDC and GC are both good treatment candidates for platinum-sensitive recurrent ovarian cancer patients; however, the dose intensity was lower for GC than for PLDC. PLDC had a more favorable risk–benefit profile than that of GC for patients.
AB - Purpose: To compare the efficacy, safety, and tolerability profiles of pegylated liposomal doxorubicin and carboplatin (PLDC) with those of gemcitabine and carboplatin (GC) for the treatment of patients with platinum-sensitive recurrent ovarian cancer. Methods: Ovarian cancer patients with recurrence > 6 months after first-line platinum and taxane-based therapies were randomly assigned to PLDC [pegylated liposomal doxorubicin 30 mg/m2 plus carboplatin area under the curve (AUC) 5 mg/mL/min on day 1] every 4 weeks or GC (gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin AUC 4 mg/mL/min on day 1) every 3 weeks for at least 6 cycles. The primary endpoint was progression-free survival, and overall response rate, overall survival, toxicity, and dose administration were secondary endpoints. Results: One-hundred patients (49 PLDC; 51 GC) were randomly assigned. Over a median follow-up of 24 months, the median progression-free survival was 12.0 months (95% CI 9.2–15.0) for PLDC and 9.8 months (8.9–12.3) for GC [HR 0.69 (0.455–1.047)] with a difference of 2.2 months. The response rate was 57.1% (41.0–72.3) for PLDC and 56.4% (39.6–72.2) for GC. No obvious differences in toxicity (G3/4) were noted between arms. The median relative dose intensity of planned dose per week was 88.9% for pegylated liposomal doxorubicin and 53.1% for gemcitabine (p < 0.0001). Conclusions: PLDC and GC are both good treatment candidates for platinum-sensitive recurrent ovarian cancer patients; however, the dose intensity was lower for GC than for PLDC. PLDC had a more favorable risk–benefit profile than that of GC for patients.
KW - Gemcitabine
KW - Pegylated liposomal doxorubicin
KW - Platinum-sensitive recurrent ovarian cancer
KW - Randomized clinical trial
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U2 - 10.1007/s10147-019-01471-5
DO - 10.1007/s10147-019-01471-5
M3 - Article
C2 - 31127479
AN - SCOPUS:85067680702
VL - 24
SP - 1284
EP - 1291
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
SN - 1341-9625
IS - 10
ER -