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Phase II clinical trial of pegylated liposomal doxorubicin (JNS002) in Japanese patients with mullerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) having a therapeutic history of platinum-based chemotherapy: a Phase II Study of the Japanese Gynecologic Oncology Group.

Katsumata N, Fujiwara Y, Kamura T, Nakanishi T, Hatae M, Aoki D, Tanaka K, Tsuda H, Kamiura S, Takehara K, Sugiyama T, Kigawa J, Fujiwara K, Ochiai K, Ishida R, Inagaki M, Noda K - Jpn. J. Clin. Oncol. (2008)

Bottom Line: The median time to progression was 166 days.The major non-haematological toxicities were hand-foot syndrome (Grade 3; 16.2%) and stomatitis (Grade 3; 8.1%).Myelosuppression such as leukopenia (Grade 3; 52.7%, Grade 4; 6.8%), neutropenia (Grade 3; 31.1%, Grade 4; 36.5%) and decreased haemoglobin (Grade 3; 14.9%, Grade 4; 2.7%) were the most common haematological toxicities.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, National Cancer Center, Tokyo, Japan. nkatsuma@ncc.go.jp

ABSTRACT

Objective: This study was conducted to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in Japanese patients with Müllerian carcinoma having a therapeutic history of platinum-based chemotherapy.

Methods: Patients who were diagnosed with Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube and peritoneal carcinoma) by histological examination and had received the initial platinum-based chemotherapy were included in the study. The study drug was administered to the patients at 50 mg/m(2) every 4 weeks.

Results: Seventy-four patients were enrolled in the study. All patients had received platinum-based chemotherapy as first-line regimen and more than 90% of patients had also received taxanes. The overall response rate was 21.9% (95% confidence interval, 13.1-33.1%) and 38.4% of patients had stable disease. The median time to progression was 166 days. The major non-haematological toxicities were hand-foot syndrome (Grade 3; 16.2%) and stomatitis (Grade 3; 8.1%). Myelosuppression such as leukopenia (Grade 3; 52.7%, Grade 4; 6.8%), neutropenia (Grade 3; 31.1%, Grade 4; 36.5%) and decreased haemoglobin (Grade 3; 14.9%, Grade 4; 2.7%) were the most common haematological toxicities.

Conclusion: We confirmed that a 50 mg/m(2) every 4 weeks regimen of PLD was active in Japanese patients with Müllerian carcinoma having a therapeutic history of platinum-based chemotherapy and toxicity was manageable by dose modification of PLD or supportive care.

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Related in: MedlinePlus

Kaplan–Meier estimates of time to progression.
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HYN101F1: Kaplan–Meier estimates of time to progression.

Mentions: The median duration of overall response was 149.0 days. The median duration of overall response in the platinum-resistant group was 149.0 days, however, that in the platinum-sensitive group could not be calculated. The Kaplan–Meier curve for time to progression is shown in Fig. 1. The median time to progression was 166.0 days: 159.0 days in the platinum-sensitive group and 168.0 days in the platinum-resistant group. The median survival could not be calculated.


Phase II clinical trial of pegylated liposomal doxorubicin (JNS002) in Japanese patients with mullerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) having a therapeutic history of platinum-based chemotherapy: a Phase II Study of the Japanese Gynecologic Oncology Group.

Katsumata N, Fujiwara Y, Kamura T, Nakanishi T, Hatae M, Aoki D, Tanaka K, Tsuda H, Kamiura S, Takehara K, Sugiyama T, Kigawa J, Fujiwara K, Ochiai K, Ishida R, Inagaki M, Noda K - Jpn. J. Clin. Oncol. (2008)

Kaplan–Meier estimates of time to progression.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2572298&req=5

HYN101F1: Kaplan–Meier estimates of time to progression.
Mentions: The median duration of overall response was 149.0 days. The median duration of overall response in the platinum-resistant group was 149.0 days, however, that in the platinum-sensitive group could not be calculated. The Kaplan–Meier curve for time to progression is shown in Fig. 1. The median time to progression was 166.0 days: 159.0 days in the platinum-sensitive group and 168.0 days in the platinum-resistant group. The median survival could not be calculated.

Bottom Line: The median time to progression was 166 days.The major non-haematological toxicities were hand-foot syndrome (Grade 3; 16.2%) and stomatitis (Grade 3; 8.1%).Myelosuppression such as leukopenia (Grade 3; 52.7%, Grade 4; 6.8%), neutropenia (Grade 3; 31.1%, Grade 4; 36.5%) and decreased haemoglobin (Grade 3; 14.9%, Grade 4; 2.7%) were the most common haematological toxicities.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, National Cancer Center, Tokyo, Japan. nkatsuma@ncc.go.jp

ABSTRACT

Objective: This study was conducted to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in Japanese patients with Müllerian carcinoma having a therapeutic history of platinum-based chemotherapy.

Methods: Patients who were diagnosed with Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube and peritoneal carcinoma) by histological examination and had received the initial platinum-based chemotherapy were included in the study. The study drug was administered to the patients at 50 mg/m(2) every 4 weeks.

Results: Seventy-four patients were enrolled in the study. All patients had received platinum-based chemotherapy as first-line regimen and more than 90% of patients had also received taxanes. The overall response rate was 21.9% (95% confidence interval, 13.1-33.1%) and 38.4% of patients had stable disease. The median time to progression was 166 days. The major non-haematological toxicities were hand-foot syndrome (Grade 3; 16.2%) and stomatitis (Grade 3; 8.1%). Myelosuppression such as leukopenia (Grade 3; 52.7%, Grade 4; 6.8%), neutropenia (Grade 3; 31.1%, Grade 4; 36.5%) and decreased haemoglobin (Grade 3; 14.9%, Grade 4; 2.7%) were the most common haematological toxicities.

Conclusion: We confirmed that a 50 mg/m(2) every 4 weeks regimen of PLD was active in Japanese patients with Müllerian carcinoma having a therapeutic history of platinum-based chemotherapy and toxicity was manageable by dose modification of PLD or supportive care.

Show MeSH
Related in: MedlinePlus