Objective. This is a phase II group- wide study of liposomal doxorubicin chemotherapy in patients with advanced or recurrent uterine leiomyosarcomas. The aim was to evaluate clinical response and toxicity. Methods. Pa...Objective. This is a phase II group- wide study of liposomal doxorubicin chemotherapy in patients with advanced or recurrent uterine leiomyosarcomas. The aim was to evaluate clinical response and toxicity. Methods. Patients with histologically confirmed persistent or recurrent leiomyosarcomas of the uterus with documented disease progression after appropriate local therapy were invited to participate in this study. Bidimensionally measurable disease, GOG performance status of 0, 1, or 2 (Karnofsky 80- 100) was required; all patients must have failed local therapeutic measures and be considered incurable. Other eligibility criteria included adequate hepatic, renal, and hematologic function. Patients were ineligible if they had received previous chemotherapy or had other noncutaneous malignancies. Patients received liposomal doxorubicin 50 mg/m2 IV over 1 h. Courses were repeated every 4 weeks until disease progression or adverse side effects supervened. Results. Thirty- five patients were entered into this study between May 2000 and June 2001. Three patients were determined ineligible because of wrong pathological cell type or inadequate pathology information and one was inevaluable for lack of data. Median age was 52 years (range 36- 78 years). GOG performance status was 2 in 1 instance, 1 in 15 cases, and 0 in 15 others. Eleven patients (35.5% ) had received radiotherapy. A median of 2.0 courses was given (range 1- 8). Five patients (16.1% )- experienced grade 3 or 4 neutropenia, and seven (22.6% ) had grade 3 or 4 anemia. Two patients developed grade 3 and one patient developed grade 4 cardiovascular adverse events, not necessarily drug related. There were seven cases of grade 3 or 4 gastrointestinal toxicity and two patients developed grade 3 dermatologic toxicity. One complete (3.2% ) and four partial (12.9% ) responses were reported. Ten patients (32.3% ) had stable disease, 15 (48.4% ) had increasing disease, and response could not be assessed in 1 (3.2% ). Conclusion. The dose and schedule of liposomal doxorubicin employed in this trial showed no advantage over historical results with doxorubicin in the treatment of uterine leiomyosarcoma.展开更多
Objectives. To determine progression- free survival (PFS) and overall survival (OS) in women with completely resected stage I or II carcinosarcoma of the uterus treated with adjuvant ifosfamide and cisplatin, and to a...Objectives. To determine progression- free survival (PFS) and overall survival (OS) in women with completely resected stage I or II carcinosarcoma of the uterus treated with adjuvant ifosfamide and cisplatin, and to assess the toxicity of this regimen. Methods. Eligible patients had histologically confirmed carcinosarcoma (mixed mesodermal tumor) and no postoperative radiotherapy following complete resection for clinical stage I or II disease. They were to have adequate renal, hepatic, and hematologic functions and performance status of 2 or less. Study entry was to be within 8 weeks of hysterectomy. Patients with previous chemotherapy, or other noncutaneous malignancies, were ineligible. Ifosfamide was administered 1.5 g/m2 intravenously (IV) over 1 h and cisplatin was given 20 mg/m2 over 15 min followed by mesna 120 mg/m2 IV bolus, then 1.5 g/m2/24 h as a continuous infusion. Initial doses (daily × 5 every 21 days × 3 cycles) were reduced by 20% (to 4 days) for myelotoxicity. Results. Nine of seventy- six patients enrolled were deemed ineligible and another two who did not receive protocol treatment were inevaluable. Of the 65 evaluable patients, median age was 65 years; 50 patients (77% ) were stage I and 15 (23% ) were stage II. PFS and OS, respectively, were 69% and 82% at 24 months, and 54% and 52% at 84 months. Overall 5- year survival was 62% . Leukopenia was the most commonly reported, but manageable, toxicity. Conclusion. Adjuvant ifosfamide and cisplatin after primary surgery for stage I or II carcinosarcoma of the uterus is tolerable. In the absence of concurrent controls, the impact on PFS and OS is unclear. Pelvic relapse remains problematic.展开更多
文摘Objective. This is a phase II group- wide study of liposomal doxorubicin chemotherapy in patients with advanced or recurrent uterine leiomyosarcomas. The aim was to evaluate clinical response and toxicity. Methods. Patients with histologically confirmed persistent or recurrent leiomyosarcomas of the uterus with documented disease progression after appropriate local therapy were invited to participate in this study. Bidimensionally measurable disease, GOG performance status of 0, 1, or 2 (Karnofsky 80- 100) was required; all patients must have failed local therapeutic measures and be considered incurable. Other eligibility criteria included adequate hepatic, renal, and hematologic function. Patients were ineligible if they had received previous chemotherapy or had other noncutaneous malignancies. Patients received liposomal doxorubicin 50 mg/m2 IV over 1 h. Courses were repeated every 4 weeks until disease progression or adverse side effects supervened. Results. Thirty- five patients were entered into this study between May 2000 and June 2001. Three patients were determined ineligible because of wrong pathological cell type or inadequate pathology information and one was inevaluable for lack of data. Median age was 52 years (range 36- 78 years). GOG performance status was 2 in 1 instance, 1 in 15 cases, and 0 in 15 others. Eleven patients (35.5% ) had received radiotherapy. A median of 2.0 courses was given (range 1- 8). Five patients (16.1% )- experienced grade 3 or 4 neutropenia, and seven (22.6% ) had grade 3 or 4 anemia. Two patients developed grade 3 and one patient developed grade 4 cardiovascular adverse events, not necessarily drug related. There were seven cases of grade 3 or 4 gastrointestinal toxicity and two patients developed grade 3 dermatologic toxicity. One complete (3.2% ) and four partial (12.9% ) responses were reported. Ten patients (32.3% ) had stable disease, 15 (48.4% ) had increasing disease, and response could not be assessed in 1 (3.2% ). Conclusion. The dose and schedule of liposomal doxorubicin employed in this trial showed no advantage over historical results with doxorubicin in the treatment of uterine leiomyosarcoma.
文摘Objectives. To determine progression- free survival (PFS) and overall survival (OS) in women with completely resected stage I or II carcinosarcoma of the uterus treated with adjuvant ifosfamide and cisplatin, and to assess the toxicity of this regimen. Methods. Eligible patients had histologically confirmed carcinosarcoma (mixed mesodermal tumor) and no postoperative radiotherapy following complete resection for clinical stage I or II disease. They were to have adequate renal, hepatic, and hematologic functions and performance status of 2 or less. Study entry was to be within 8 weeks of hysterectomy. Patients with previous chemotherapy, or other noncutaneous malignancies, were ineligible. Ifosfamide was administered 1.5 g/m2 intravenously (IV) over 1 h and cisplatin was given 20 mg/m2 over 15 min followed by mesna 120 mg/m2 IV bolus, then 1.5 g/m2/24 h as a continuous infusion. Initial doses (daily × 5 every 21 days × 3 cycles) were reduced by 20% (to 4 days) for myelotoxicity. Results. Nine of seventy- six patients enrolled were deemed ineligible and another two who did not receive protocol treatment were inevaluable. Of the 65 evaluable patients, median age was 65 years; 50 patients (77% ) were stage I and 15 (23% ) were stage II. PFS and OS, respectively, were 69% and 82% at 24 months, and 54% and 52% at 84 months. Overall 5- year survival was 62% . Leukopenia was the most commonly reported, but manageable, toxicity. Conclusion. Adjuvant ifosfamide and cisplatin after primary surgery for stage I or II carcinosarcoma of the uterus is tolerable. In the absence of concurrent controls, the impact on PFS and OS is unclear. Pelvic relapse remains problematic.
