Mixed Mesodermal (Mullerian) Tumor, Ovarian Carcinosarcoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Stage IA Fallopian Tube Cancer AJCC v6 and v7, Stage IA Ovarian Cancer AJCC v6 and v7, Stage IA Uterine Sarcoma AJCC v7, Stage IB Fallopian Tube Cancer AJCC v6 and v7, Stage IB Ovarian Cancer AJCC v6 and v7, Stage IB Uterine Sarcoma AJCC v7, Stage IC Fallopian Tube Cancer AJCC v6 and v7, Stage IC Ovarian Cancer AJCC v6 and v7, Stage IC Uterine Sarcoma AJCC v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIA Ovarian Cancer AJCC V6 and v7, Stage IIA Uterine Sarcoma AJCC v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Ovarian Cancer AJCC v6 and v7, Stage IIB Uterine Sarcoma AJCC v7, Stage IIC Fallopian Tube Cancer AJCC v6 and v7, Stage IIC Ovarian Cancer AJCC v6 and v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIA Uterine Sarcoma AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIB Uterine Sarcoma AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IIIC Uterine Sarcoma AJCC v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage I Ovarian Cancer AJCC v6 and v7, Stage IVA Uterine Sarcoma AJCC v7, Stage IVB Uterine Sarcoma AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7, Uterine Carcinosarcoma
Conditions
Brief summary
This randomized phase III trial studies paclitaxel and carboplatin see how well they work compared with paclitaxel and ifosfamide in treating patients with fallopian tube, or peritoneal cavity cancer that is newly diagnosed, persistent, or has come back (recurrent). Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients with uterine, ovarian, fallopian tube, or peritoneal cavity cancer.
Detailed description
PRIMARY OBJECTIVES: I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior death rate when compared to ifosfamide, mesna, and paclitaxel chemotherapy. SECONDARY OBJECTIVES: I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior progression-free survival when compared to ifosfamide, mesna, and paclitaxel chemotherapy. II. To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin chemotherapy is reduced compared to that of ifosfamide, mesna, and paclitaxel chemotherapy. III. To determine if treatment with combination paclitaxel and carboplatin chemotherapy is associated with superior patient-reported quality of life and neurotoxicity scores compared to that of ifosfamide, mesna, and paclitaxel chemotherapy. TERTIARY OBJECTIVES: I. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and deoxyribonucleic acid (DNA) extracted from whole blood for future research. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. ARM II: Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I. In both arms, treatment repeats every 21 days for 6-10 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Interventions
Given IV
Given IV
Given IV
Ancillary studies
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients must have newly diagnosed stage I-IV, persistent or recurrent (including unstaged) uterine carcinosarcoma (malignant mixed mullerian tumor-MMMT or with ovarian, fallopian tube or peritoneal carcinosarcoma and an enrollment date prior to 10/21/2013; pathology confirmed by site/institutional pathologist prior to enrollment) and be chemotherapy naïve as directed against their carcinosarcoma; unstaged patients (patients who have not had hysterectomy or ovarian surgery) are eligible and should be included as unstaged if the only histologic (pathology) documentation of the disease is a biopsy or curettage of the uterus; if these patients have documented metastatic disease, it should be assigned the appropriate stage (III/IV) * Patients may have received prior adjuvant external beam radiation therapy and/or vaginal brachytherapy; patients should be at least 4 weeks from the completion of external beam radiotherapy prior to beginning protocol chemotherapy; patients do not need to be delayed if receiving vaginal brachytherapy only * Gynecologic Oncology Group (GOG) performance status 0, 1, or 2 * Patients must have recovered from the effects of recent surgery, radiotherapy, or other therapy * Patients must be free of active infection requiring antibiotics * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to beginning protocol chemotherapy; continuation of hormone replacement therapy is permitted * Platelet count greater than or equal to 100,000/mcL * Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL equivalent to Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 grade 1 * Creatinine less than or equal to 1.5 times upper limit of normal (ULN), CTCAE v3.0 grade 1 * Bilirubin less than or equal to 1.5 times ULN (CTCAE v3.0 grade 1) * Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 times ULN (CTCAE v3.0 grade 1) * Alkaline phosphatase less than or equal to 2.5 times ULN (CTCAE v3.0 grade 1) * Serum albumin should be equal to or greater than 3 g/dL * Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1 * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception * Patients may have measurable disease or non-measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>= 10 mm when measured by spiral CT; measurable disease patients must have at least one target lesion to be used to assess progression on this protocol as defined by Response Evaluation Criteria In Solid Tumors (RECIST); tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Exclusion criteria
* Patients who have received prior cytotoxic chemotherapy for management of uterine or ovarian carcinosarcoma * Patients with a history of other invasive malignancies or with a concomitant invasive malignancy, with the exception of non-melanoma skin cancer, if there is any evidence of other malignancy being present within the last five years; patients are also ineligible if their previous cancer treatment contraindicates this protocol therapy * Patients for whom radiotherapy is planned after or during chemotherapy prior to progression of cancer * Patients with known hypersensitivity to Escherichia (E.) coli-derived drug preparations (pegfilgrastim and filgrastim \[G-CSF\]) * Patients with a known hypersensitivity to mesna or other thiol compounds * For enrollment prior to 10/21/2013, patients who are not biopsy proven to have carcinosarcoma of the uterus, fallopian tube, peritoneum or ovary; for enrollment after 10/21/2013, patients who are not biopsy proven to have carcinosarcoma of the uterus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months. | Measured in months from randomization to last contact or death. Primary analysis was restricted to the eligible uterine carcinosarcoma cohort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Patients were assessed for adverse events during active protocol treatment and up to 30 days after the last cycle of treatment on the protocol. | Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs. |
| Patient-Reported Quality of Life (QOL) - Baseline | Baseline - Prior to study treatment | Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life. |
| Duration of Progression-free Survival | Approximately 9 years and 7 months | Measured in months from randomization to last contact or the earlier of the date of progression or death. |
| Patient Reported Peripheral Neuropathy Symptoms - Baseline | Baseline (Pre cycle 1) | Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life. |
| Patient-reported Peripheral Neuropathy Symptoms - Post Baseline | Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1 | Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life. |
| Patient Reported Quality of Life (QOL) - Post Baseline | Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1. | Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life. |
Countries
South Korea, United States
Participant flow
Recruitment details
A total of 637 subjects were enrolled between 08/17/2009 and 3/24/14. Enrollment initially included uterine carcinosarcoma and was expanded to ovarian carcinosarcoma in June 2010 and then to include fallopian tube and peritoneal carcinosarcoma in October 2013. The primary analysis was restricted to patients with uterine carcinosarcoma.
Participants by arm
| Arm | Count |
|---|---|
| Regimen I - Uterine Carcinsarcoma Subjects Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles | 228 |
| Regimen II - Uterine Carcinsarcoma Subjects Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6 | 221 |
| Regimen III - Non-uterine Carcinsarcoma Subjects Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles | 44 |
| Regimen IV - Non-uterine Carcinsarcoma Subjects Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6 | 46 |
| Total | 539 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 28 | 23 | 4 | 9 |
| Overall Study | Death | 4 | 2 | 0 | 0 |
| Overall Study | Ineligible | 40 | 47 | 7 | 4 |
| Overall Study | Lack of Efficacy | 32 | 22 | 8 | 6 |
| Overall Study | Medical Reason | 4 | 2 | 1 | 0 |
| Overall Study | Never Treated | 4 | 17 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 14 | 10 | 4 | 3 |
Baseline characteristics
| Characteristic | Regimen IV - Non-uterine Carcinsarcoma Subjects | Total | Regimen I - Uterine Carcinsarcoma Subjects | Regimen II - Uterine Carcinsarcoma Subjects | Regimen III - Non-uterine Carcinsarcoma Subjects |
|---|---|---|---|---|---|
| Age, Customized 20-29 years | 0 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Age, Customized 30-39 years | 0 Participants | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized 40-49 years | 2 Participants | 25 Participants | 12 Participants | 8 Participants | 3 Participants |
| Age, Customized 50-59 years | 18 Participants | 121 Participants | 46 Participants | 45 Participants | 12 Participants |
| Age, Customized 60-69 years | 15 Participants | 252 Participants | 111 Participants | 111 Participants | 15 Participants |
| Age, Customized 70-89 years | 11 Participants | 134 Participants | 58 Participants | 53 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 17 Participants | 4 Participants | 8 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 503 Participants | 215 Participants | 206 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 19 Participants | 9 Participants | 7 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 24 Participants | 9 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 146 Participants | 66 Participants | 72 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 10 Participants | 1 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) White | 36 Participants | 356 Participants | 150 Participants | 133 Participants | 37 Participants |
| Sex: Female, Male Female | 46 Participants | 539 Participants | 228 Participants | 221 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 160 / 272 | 160 / 267 |
| other Total, other adverse events | 268 / 268 | 244 / 247 |
| serious Total, serious adverse events | 80 / 268 | 68 / 247 |
Outcome results
Overall Survival
Measured in months from randomization to last contact or death. Primary analysis was restricted to the eligible uterine carcinosarcoma cohort.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months.
Population: All eligible patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Regimen I- Uterine Carcinsarcoma Subjects | Overall Survival | 37.3 months |
| Regimen II - Uterine Carcinsarcoma Subjects | Overall Survival | 29 months |
Duration of Progression-free Survival
Measured in months from randomization to last contact or the earlier of the date of progression or death.
Time frame: Approximately 9 years and 7 months
Population: All eligible patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Regimen I- Uterine Carcinsarcoma Subjects | Duration of Progression-free Survival | 16.3 months |
| Regimen II - Uterine Carcinsarcoma Subjects | Duration of Progression-free Survival | 11.7 months |
| Regimen III - Non-uterine Carcinsarcoma Subjects | Duration of Progression-free Survival | 14.6 months |
| Regimen IV - Non-uterine Carcinsarcoma Subjects | Duration of Progression-free Survival | 10.3 months |
Incidence of Adverse Events as Assessed by CTCAE Version 3.0
Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
Time frame: Patients were assessed for adverse events during active protocol treatment and up to 30 days after the last cycle of treatment on the protocol.
Population: Treated and Eligible subjects. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Regimen I- Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 2 | 22 Participants |
| Regimen I- Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 4 | 130 Participants |
| Regimen I- Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 3 | 107 Participants |
| Regimen I- Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 5 | 6 Participants |
| Regimen I- Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 1 | 3 Participants |
| Regimen II - Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 5 | 3 Participants |
| Regimen II - Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 1 | 3 Participants |
| Regimen II - Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 2 | 80 Participants |
| Regimen II - Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 3 | 97 Participants |
| Regimen II - Uterine Carcinsarcoma Subjects | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Grade 4 | 61 Participants |
Patient Reported Peripheral Neuropathy Symptoms - Baseline
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time frame: Baseline (Pre cycle 1)
Population: Subjects who provided baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen I- Uterine Carcinsarcoma Subjects | Patient Reported Peripheral Neuropathy Symptoms - Baseline | 40.2 units on a scale-baseline | Standard Error 0.3 |
| Regimen II - Uterine Carcinsarcoma Subjects | Patient Reported Peripheral Neuropathy Symptoms - Baseline | 41.0 units on a scale-baseline | Standard Error 0.3 |
Patient-reported Peripheral Neuropathy Symptoms - Post Baseline
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time frame: Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1
Population: Provided baseline and ≥ 1 follow-up assessments
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen I- Uterine Carcinsarcoma Subjects | Patient-reported Peripheral Neuropathy Symptoms - Post Baseline | Prior to cycle 3 | 37.2 units on a scale | Standard Error 0.4 |
| Regimen I- Uterine Carcinsarcoma Subjects | Patient-reported Peripheral Neuropathy Symptoms - Post Baseline | Prior to cycle 6 | 34.1 units on a scale | Standard Error 0.6 |
| Regimen I- Uterine Carcinsarcoma Subjects | Patient-reported Peripheral Neuropathy Symptoms - Post Baseline | 30 weeks post cycle 1 | 34.8 units on a scale | Standard Error 0.6 |
| Regimen II - Uterine Carcinsarcoma Subjects | Patient-reported Peripheral Neuropathy Symptoms - Post Baseline | Prior to cycle 3 | 37.0 units on a scale | Standard Error 0.5 |
| Regimen II - Uterine Carcinsarcoma Subjects | Patient-reported Peripheral Neuropathy Symptoms - Post Baseline | Prior to cycle 6 | 34.2 units on a scale | Standard Error 0.6 |
| Regimen II - Uterine Carcinsarcoma Subjects | Patient-reported Peripheral Neuropathy Symptoms - Post Baseline | 30 weeks post cycle 1 | 34.9 units on a scale | Standard Error 0.6 |
Patient-Reported Quality of Life (QOL) - Baseline
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time frame: Baseline - Prior to study treatment
Population: Patients who provided baseline assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen I- Uterine Carcinsarcoma Subjects | Patient-Reported Quality of Life (QOL) - Baseline | 96.2 units on a scale (time point) | Standard Error 1.1 |
| Regimen II - Uterine Carcinsarcoma Subjects | Patient-Reported Quality of Life (QOL) - Baseline | 97.5 units on a scale (time point) | Standard Error 1.2 |
Patient Reported Quality of Life (QOL) - Post Baseline
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time frame: Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1.
Population: Provided baseline and ≥ 1 follow-up assessments
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen I- Uterine Carcinsarcoma Subjects | Patient Reported Quality of Life (QOL) - Post Baseline | Pre-cycle 3 | 93.3 units on a scale (time point) | Standard Error 0.9 |
| Regimen I- Uterine Carcinsarcoma Subjects | Patient Reported Quality of Life (QOL) - Post Baseline | Pree-cycle 6 | 91.6 units on a scale (time point) | Standard Error 1.1 |
| Regimen I- Uterine Carcinsarcoma Subjects | Patient Reported Quality of Life (QOL) - Post Baseline | 30 weeks post cycle 1 | 98.0 units on a scale (time point) | Standard Error 1.1 |
| Regimen II - Uterine Carcinsarcoma Subjects | Patient Reported Quality of Life (QOL) - Post Baseline | Pre-cycle 3 | 93.3 units on a scale (time point) | Standard Error 1 |
| Regimen II - Uterine Carcinsarcoma Subjects | Patient Reported Quality of Life (QOL) - Post Baseline | Pree-cycle 6 | 91.6 units on a scale (time point) | Standard Error 1.1 |
| Regimen II - Uterine Carcinsarcoma Subjects | Patient Reported Quality of Life (QOL) - Post Baseline | 30 weeks post cycle 1 | 97.6 units on a scale (time point) | Standard Error 1.3 |