scholarly journals Pegylated liposomal doxorubicin for platinum-resistant or refractory Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of Fallopian tube and peritoneal carcinoma): A single-institutional experience

2012 ◽  
Vol 5 (1) ◽  
pp. 35-38 ◽  
Author(s):  
TAKESHI FUKUDA ◽  
TOSHIYUKI SUMI ◽  
MASATOMO TERAMAE ◽  
YUSUKE NAKANO ◽  
MASANARI MORISHITA ◽  
...  
Keyword(s):  
Ovarian Carcinoma ◽  
Fallopian Tube ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Primary Carcinoma ◽  
Epithelial Ovarian Carcinoma ◽  
Peritoneal Carcinoma ◽  
Platinum Resistant ◽  
Institutional Experience ◽  
Müllerian Carcinoma

A feasibility study of intravenous (IV) paclitaxel, intraperitoneal (IP) carboplatin, and IP paclitaxel in patients with epithelial ovarian carcinoma, fallopian tube carcinoma, or peritoneal carcinoma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16549-e16549
Author(s):  
S. Nagao ◽  
R. Oishi ◽  
N. Iwasa ◽  
M. Shimizu ◽  
K. Hasegawa ◽  
...  
Keyword(s):  
Ovarian Carcinoma ◽  
Fallopian Tube ◽  
Feasibility Study ◽  
Epithelial Ovarian Carcinoma ◽  
Clear Cell Adenocarcinoma ◽  
Endometrioid Adenocarcinoma ◽  
Fallopian Tube Carcinoma ◽  
Peritoneal Carcinoma ◽  
Stage Iiic ◽  
Grade 3

e16549 Background: This is a feasibility study for a future trial to assess the feasibility of intravenous (IV) paclitaxel, intraperitoneal (IP) carboplatin and IP paclitaxel (TCipTip therapy) in patients with epithelial ovarian carcinoma, fallopian tube carcinoma or peritoneal carcinoma. Methods: The patients eligible for this study had histologically confirmed, stage IC-IV epithelial ovarian carcinoma, fallopian tube carcinoma or peritoneal carcinoma. IV paclitaxel was administered at 135 mg/m2 followed by IP carboplatin administration based on the area under the curve =6 on day1, and IP paclitaxel was administered at 60 mg/m2 on day 8. To ensure the safety, the three initial patients received 45 mg/m2 of IP paclitaxel on day 8. The toxicity grade was determined by CTCAE version 3. This study has been approved by the institutional review committee. Results: During November 2007 and December 2008, 10 patients were entered in this study. The patients included 7 epithelial ovarian carcinoma (stage IC, 2; stage IIIC, 5), 2 stage IIIC primary peritoneal carcinoma, and 1 stage IIA fallopian tube carcinoma. There were 7 serous adenocarcinoma, 2 endometrioid adenocarcinoma, 1 clear cell adenocarcinoma. The incidences of grade 3/4 hematological toxicities were 48% for neutropenia, 28% for thrombocytopenia, and 48% for anemia. Grade 3/4 neurotoxicity, abdominal pain nor IP catheter related toxicity was not observed. IP paclitaxel at 2nd or 3rd cycle was skipped in 4 patients by grade 3/4 neutropenia (grade 3, 3; grade 4, 1 ). Conclusions: TCipTip therapy is feasible for patients with epithelial ovarian carcinoma, fallopian tube carcinoma or peritoneal carcinoma. No significant financial relationships to disclose.

Randomized phase III trial comparing pegylated liposomal doxorubicin (PLD) 50 mg/m2 and 40 mg/m2 in patients with platinum-resistant Müllerian carcinoma (JGOG3018).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5550-5550
Author(s):  
Akira Yabuno ◽  
Tsutomu Tabata ◽  
Hirofumi Michimae ◽  
Tetsuro Oishi ◽  
Miwa Nonaka ◽  
...  
Keyword(s):  
Liposomal Doxorubicin ◽  
Standard Dose ◽  
Performance Status ◽  
Single Agent ◽  
Pegylated Liposomal Doxorubicin ◽  
Phase Iii ◽  
Skin Reactions ◽  
Platinum Resistant ◽  
Number Of Patients ◽  
Müllerian Carcinoma

5550 Background: The standard dose of single-agent pegylated liposomal doxorubicin (PLD) is 50 mg/m2 every 4 weeks, but 40 mg/m2 has recently been used in clinical practice, though there is no evidence available to support its use. Methods: A Phase III, randomized, multicenter, non-inferiority study comparing progression-free survival (PFS) of patients with platinum-resistant Mullerian carcinoma (epithelial ovarian, fallopian tube, or primary peritoneal carcinoma) treated with an experimental arm (40 mg/m2 PLD) versus a standard arm (50 mg/m2 PLD) until 10 courses, disease progression, or unacceptable toxicity was conducted. Eligible patients had ≤ 2 prior lines. Stratification was by performance status (PS) and PFS of prior chemotherapy (<3 months versus ≥3 months). The primary endpoint was PFS, and secondary endpoints were overall survival (OS), toxicity profile, clinical response, and tolerability. The target total number of patients was 412. Results: The trial was closed due to accrual futility as patient recruitment was slow , with 272 patients randomized to the experimental arm (n=137) and the standard arm (n=135). The final analysis was performed with 234 deaths and 269 events for PFS. Median patient age was 62 years; 58% of patients had a treatment-free interval less than 3 months, and 81% of patients had PS 0. In the experimental versus standard arm, median PFS was 4.0 months versus 4.0 months (HR 1.065, 95.8%CI: 0.830-1.366), and median OS was 14.0 months versus 14.0 months (HR 1.078, 95%CI: 0.831-1.397). Adverse events ≥Grade 2 including oral cavity mucositis were more frequent in the standard arm than in the experimental arm (26.7% vs. 13.5%, respectively; p=0.0089), but there was no difference in ≥Grade 2 hand-foot-skin reactions (19.8% vs. 15.0%, respectively; p=0.333). Conclusions: The non-inferiority of PFS with the reduced dosing schedule was not confirmed because the trial was closed prematurely, but PFS and OS were similar. These results suggest a reduction of the standard dose of PLD because of the low rate of oral mucositis in patients with platinum-resistant ovarian cancer treated with the lower dose regimen. Clinical trial information: UMIN000003130.

A Case-Control Analysis of Primary Carcinoma of the Fallopian Tube and Epithelial Ovarian Carcinoma

2003 ◽  
Vol 101 (Supplement) ◽  
pp. 103S
Author(s):  
John P. Geisler ◽  
Kelly J. Manahan ◽  
Melissa S. Dunn ◽  
B. Anderson ◽  
Richard E. Buller ◽  
...  
Keyword(s):  
Ovarian Carcinoma ◽  
Fallopian Tube ◽  
Case Control ◽  
Primary Carcinoma ◽  
Epithelial Ovarian Carcinoma ◽  
Control Analysis ◽  
Case Control Analysis
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