Metastatic Breast Cancer (MBC)
Conditions
Brief summary
Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).
Interventions
DRUGGemcitabine
Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
DRUGDocetaxel
Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
DRUGPaclitaxel
Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic diagnosis of metastatic breast cancer (MBC). * Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen. * Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated. * Patients with measurable disease. * Previous hormonal therapy for adjuvant setting or metastatic disease.
Exclusion criteria
* Previous chemotherapy for MBC * Previous chemotherapy with gemcitabine in any setting of disease * Patient candidable to treatment with trastuzumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progressive Disease (TTPD) by Treatment Schedule | Baseline up to 49.84 months | TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions. |
| Time to Progressive Disease (TTPD) by Treatment Drug | Baseline up to 49.84 months | TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) by Treatment Schedule | Baseline up to 49.84 months | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants. |
| Overall Response Rate(ORR) by Treatment Drug | Baseline up to 49.84 months | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants. |
| Overall Survival (OS) by Treatment Schedule | Baseline up to 51.64 months | OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit). |
| Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | Baseline up to 51.64 months | RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks. |
| Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | Baseline up to 51.64 months | RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided. |
| Number of Participants With Serious and Nonserious Adverse Events (AEs) | Baseline up to 51.64 months | Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module. |
| Overall Survival (OS) by Treatment Drug | Baseline up to 51.64 months | OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit). |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Docetaxel and Gemcitabine (Tri-weekly) Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. | 60 |
| Arm B: Paclitaxel and Gemcitabine (Tri-weekly) Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. | 64 |
| Arm C: Docetaxel and Gemcitabine (Weekly) Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. | 58 |
| Arm D: Paclitaxel and Gemcitabine (Weekly) Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. | 59 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event (Not Study Related) | 3 | 3 | 4 | 7 |
| Overall Study | Adverse Event (Study Related) | 1 | 1 | 2 | 1 |
| Overall Study | Death (Not Study Related) | 2 | 0 | 0 | 0 |
| Overall Study | Death (Study Disease) | 1 | 4 | 0 | 0 |
| Overall Study | Death (Study Drug Toxicity) | 1 | 0 | 0 | 0 |
| Overall Study | Entry Criteria Exclusion | 0 | 1 | 1 | 0 |
| Overall Study | Lack of Efficacy | 18 | 18 | 25 | 23 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 7 | 8 | 7 | 6 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Satisfactory Response | 2 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 4 | 5 | 2 |
Baseline characteristics
| Characteristic | Arm A: Docetaxel and Gemcitabine (Tri-weekly) | Arm B: Paclitaxel and Gemcitabine (Tri-weekly) | Arm C: Docetaxel and Gemcitabine (Weekly) | Arm D: Paclitaxel and Gemcitabine (Weekly) | Total |
|---|---|---|---|---|---|
| Age Continuous | 56.58 years STANDARD_DEVIATION 10.21 | 56.31 years STANDARD_DEVIATION 9.84 | 55.78 years STANDARD_DEVIATION 8.99 | 54.66 years STANDARD_DEVIATION 10.04 | 55.85 years STANDARD_DEVIATION 9.76 |
| Menopausal Status Postmenopausal | 41 participants | 47 participants | 42 participants | 38 participants | 168 participants |
| Menopausal Status Premenopausal | 19 participants | 17 participants | 16 participants | 21 participants | 73 participants |
| Number of Participants with Previous Adjuvant/Neoadjuvant Taxane Therapy No | 39 participants | 40 participants | 45 participants | 40 participants | 164 participants |
| Number of Participants with Previous Adjuvant/Neoadjuvant Taxane Therapy Unknown | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Number of Participants with Previous Adjuvant/Neoadjuvant Taxane Therapy Yes | 21 participants | 24 participants | 12 participants | 19 participants | 76 participants |
| Presence or Absence of Visceral Metastases Absence | 19 participants | 19 participants | 16 participants | 23 participants | 77 participants |
| Presence or Absence of Visceral Metastases Presence | 41 participants | 45 participants | 42 participants | 36 participants | 164 participants |
| Previous Hormonal Therapy No | 16 participants | 16 participants | 17 participants | 13 participants | 62 participants |
| Previous Hormonal Therapy Unknown | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Previous Hormonal Therapy Yes | 44 participants | 48 participants | 40 participants | 46 participants | 178 participants |
| Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC) Excellent | 5 participants | 2 participants | 2 participants | 1 participants | 10 participants |
| Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC) Extremely Poor | 2 participants | 1 participants | 1 participants | 0 participants | 4 participants |
| Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC) Good | 17 participants | 15 participants | 14 participants | 13 participants | 59 participants |
| Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC) Moderately Good | 6 participants | 10 participants | 7 participants | 10 participants | 33 participants |
| Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC) Neither Good Nor Bad | 8 participants | 6 participants | 6 participants | 8 participants | 28 participants |
| Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC) No Response | 15 participants | 24 participants | 22 participants | 16 participants | 77 participants |
| Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC) Poor | 1 participants | 2 participants | 5 participants | 3 participants | 11 participants |
| Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC) Rather Poor | 6 participants | 4 participants | 1 participants | 8 participants | 19 participants |
| Race/Ethnicity, Customized Caucasian | 58 participants | 63 participants | 58 participants | 59 participants | 238 participants |
| Race/Ethnicity, Customized Other | 2 participants | 1 participants | 0 participants | 0 participants | 3 participants |
| Region of Enrollment Italy | 60 participants | 64 participants | 58 participants | 59 participants | 241 participants |
| Sex: Female, Male Female | 60 Participants | 64 Participants | 58 Participants | 59 Participants | 241 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 | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 57 / 59 | 58 / 62 | 53 / 58 | 56 / 59 |
| serious Total, serious adverse events | 9 / 59 | 10 / 62 | 7 / 58 | 11 / 59 |
Outcome results
Primary
Time to Progressive Disease (TTPD) by Treatment Drug
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Time frame: Baseline up to 49.84 months
Population: ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 33 (13.7%) participants were censored with 17 (13.68%) in the Docetaxel+Gemcitabine arm and 18 (13.71%) in the Paclitaxel+Gemcitabine arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Schedule (Weekly) | Time to Progressive Disease (TTPD) by Treatment Drug | 7.74 months |
| Treatment Schedule (3 Weekly) | Time to Progressive Disease (TTPD) by Treatment Drug | 7.80 months |
p-value: 0.1595% CI: [0.93, 1.62]Regression, Cox
Primary
Time to Progressive Disease (TTPD) by Treatment Schedule
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Time frame: Baseline up to 49.84 months
Population: Intention to treat (ITT) population is defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 33 participants were censored with 16 (13.68%)in the Weekly arm and 17 (13.71%) participants in the 3 Weekly arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Schedule (Weekly) | Time to Progressive Disease (TTPD) by Treatment Schedule | 8.33 months |
| Treatment Schedule (3 Weekly) | Time to Progressive Disease (TTPD) by Treatment Schedule | 7.51 months |
p-value: 0.34595% CI: [0.87, 1.5]Regression, Cox
Secondary
Number of Participants With Serious and Nonserious Adverse Events (AEs)
Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.
Time frame: Baseline up to 51.64 months
Population: Intent to treat (ITT) population defined as the population of all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Schedule (Weekly) | Number of Participants With Serious and Nonserious Adverse Events (AEs) | Nonserious AEs | 57 participants |
| Treatment Schedule (Weekly) | Number of Participants With Serious and Nonserious Adverse Events (AEs) | SAEs | 9 participants |
| Treatment Schedule (3 Weekly) | Number of Participants With Serious and Nonserious Adverse Events (AEs) | SAEs | 10 participants |
| Treatment Schedule (3 Weekly) | Number of Participants With Serious and Nonserious Adverse Events (AEs) | Nonserious AEs | 58 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Number of Participants With Serious and Nonserious Adverse Events (AEs) | SAEs | 7 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Number of Participants With Serious and Nonserious Adverse Events (AEs) | Nonserious AEs | 53 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Number of Participants With Serious and Nonserious Adverse Events (AEs) | Nonserious AEs | 56 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Number of Participants With Serious and Nonserious Adverse Events (AEs) | SAEs | 11 participants |
Secondary
Overall Response Rate(ORR) by Treatment Drug
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.
Time frame: Baseline up to 49.84 months
Population: All randomized participants treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Schedule (Weekly) | Overall Response Rate(ORR) by Treatment Drug | Partial Response | 38.14 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate(ORR) by Treatment Drug | Progressive Disease | 17.80 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate(ORR) by Treatment Drug | Complete Response | 5.08 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate(ORR) by Treatment Drug | Not Available | 0.85 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate(ORR) by Treatment Drug | Stable Disease | 32.20 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate(ORR) by Treatment Drug | Not Assessed | 5.93 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate(ORR) by Treatment Drug | ORR (Complete Response or Partial Response) | 43.2 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate(ORR) by Treatment Drug | Not Assessed | 9.76 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate(ORR) by Treatment Drug | ORR (Complete Response or Partial Response) | 39.8 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate(ORR) by Treatment Drug | Complete Response | 7.32 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate(ORR) by Treatment Drug | Partial Response | 32.52 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate(ORR) by Treatment Drug | Stable Disease | 32.52 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate(ORR) by Treatment Drug | Progressive Disease | 16.26 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate(ORR) by Treatment Drug | Not Available | 1.63 percentage of responses |
p-value: 0.456795% CI: [0.482, 1.389]Regression, Logistic
Secondary
Overall Response Rate (ORR) by Treatment Schedule
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.
Time frame: Baseline up to 49.84 months
Population: All randomized patients treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Schedule (Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Complete Response | 6.84 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Progressive Disease | 21.37 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate (ORR) by Treatment Schedule | ORR (Complete Response or Partial Response) | 50.43 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Not Available | 0.85 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Stable Disease | 23.93 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Not Assessed | 3.42 percentage of responses |
| Treatment Schedule (Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Partial Response | 43.59 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Not Assessed | 12.10 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Partial Response | 27.42 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate (ORR) by Treatment Schedule | ORR (Complete Response or Partial Response) | 33.06 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Complete Response | 5.65 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Stable Disease | 40.32 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Progressive Disease | 12.90 percentage of responses |
| Treatment Schedule (3 Weekly) | Overall Response Rate (ORR) by Treatment Schedule | Not Available | 1.61 percentage of responses |
p-value: 0.002895% CI: [0.259, 0.754]Regression, Logistic
Secondary
Overall Survival (OS) by Treatment Drug
OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).
Time frame: Baseline up to 51.64 months
Population: ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 109 participants were censored with 55 (46.61%) in the Docetaxel+Gemcitabine arm and 54 (43.90%) in the Paclitaxel+Gemcitabine arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Schedule (Weekly) | Overall Survival (OS) by Treatment Drug | 19.11 months |
| Treatment Schedule (3 Weekly) | Overall Survival (OS) by Treatment Drug | 23.80 months |
p-value: 0.97695% CI: [0.71, 1.42]Regression, Cox
Secondary
Overall Survival (OS) by Treatment Schedule
OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).
Time frame: Baseline up to 51.64 months
Population: Intention to treat (ITT) population defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 109 (45.2%) participants were censored with 53 (45.3%) in the Weekly arm and 56 (45.2%) participants in the 3 Weekly arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Schedule (Weekly) | Overall Survival (OS) by Treatment Schedule | 21.11 months |
| Treatment Schedule (3 Weekly) | Overall Survival (OS) by Treatment Schedule | 20.95 months |
p-value: 0.88595% CI: [0.69, 1.37]Regression, Cox
Secondary
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided.
Time frame: Baseline up to 51.64 months
Population: Intent to treat (ITT) population defined as all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 1=Excellent | 0 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 2=Good | 7 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 3=Moderately Good | 2 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 4=Neither Good Nor Bad | 3 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 5=Rather Poor | 0 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 6=Poor | 2 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 7=Extremely Poor | 1 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | No Response | 45 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 6=Poor | 0 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 5=Rather Poor | 1 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 2=Good | 7 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | No Response | 44 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 7=Extremely Poor | 0 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 4=Neither Good Nor Bad | 6 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 3=Moderately Good | 6 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 1=Excellent | 0 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 7=Extremely Poor | 2 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 3=Moderately Good | 3 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 4=Neither Good Nor Bad | 0 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 5=Rather Poor | 1 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 6=Poor | 1 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | No Response | 49 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 1=Excellent | 0 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 2=Good | 2 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 3=Moderately Good | 2 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 4=Neither Good Nor Bad | 3 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 2=Good | 4 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 1=Excellent | 0 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 5=Rather Poor | 1 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | No Response | 47 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 7=Extremely Poor | 0 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit | 6=Poor | 2 participants |
p-value: 0.293Fisher Exact
p-value: 0.476Fisher Exact
Secondary
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.
Time frame: Baseline up to 51.64 months
Population: Intent to treat (ITT) population defined as all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 1=Excellent | 3 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 2=Good | 13 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 3=Moderately Good | 6 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 4=Neither Good Nor Bad | 6 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 5=Rather Poor | 2 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 6=Poor | 0 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 7=Extremely Poor | 0 participants |
| Treatment Schedule (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | No Response | 30 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 6=Poor | 3 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 5=Rather Poor | 3 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 2=Good | 13 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | No Response | 26 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 7=Extremely Poor | 3 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 4=Neither Good Nor Bad | 7 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 3=Moderately Good | 8 participants |
| Treatment Schedule (3 Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 1=Excellent | 1 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 7=Extremely Poor | 0 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 3=Moderately Good | 9 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 4=Neither Good Nor Bad | 6 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 5=Rather Poor | 3 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 6=Poor | 7 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | No Response | 22 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 1=Excellent | 2 participants |
| Arm C: Docetaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 2=Good | 9 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 3=Moderately Good | 9 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 4=Neither Good Nor Bad | 7 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 2=Good | 5 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 1=Excellent | 4 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 5=Rather Poor | 6 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | No Response | 25 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 7=Extremely Poor | 1 participants |
| Arm D: Paclitaxel and Gemcitabine (Weekly) | Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle | 6=Poor | 2 participants |
p-value: 0.142Fisher Exact
p-value: 0.47Fisher Exact