Bladder Cancer
Conditions
Keywords
Bladder Cancer, Neoadjuvant Chemotherapy, Coexpression Extrapolation, COXEN, S1314, SWOG
Brief summary
The primary focus of this study is to see if looking at tumor biomarkers using a program called coexpression extrapolation or COXEN may predict a patient's response to chemotherapy before surgery.
Detailed description
The COXEN program will not select a patient's therapy, but the type of chemotherapy that he/she will receive will be randomly decided. The patient's response to chemotherapy will be used to test the usefulness of the COXEN program, which is the main goal of this trial. Other potential tests to predict a patient's response to chemotherapy will also be evaluated. In this study, the patient may receive the treatment in Arm 1 (gemcitabine and cisplatin) or the treatment in Arm 2 \[methotrexate, vinblastine, doxorubicin, cisplatin, and filgrastim (or pegfilgrastim)\]. There will be about 230 people taking part in this study (115 in each arm).
Interventions
DRUGGemcitabine
Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
DRUGCisplatin
Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
DRUGMethotrexate
Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
DRUGVinblastine
Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
DRUGDoxorubicin
Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
DRUGFilgrastim
Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven bladder cancer (pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma histologies are excluded). * Stage cT2-T4a N0 M0 disease. * Documented muscle invasive disease with at least one of the following: disease measuring at least 10 mm on cross-sectional imaging OR the presence of tumor-associated hydronephrosis. * Staging scans with abdominal/pelvic CT or MRI scan and CT scan or x-ray of the chest within 56 days prior to registration. If alkaline phosphatase is above the treating institution's upper limit of normal (ULN), presence of suspicious bone pain, or if other clinical suspicion, a whole body bone scan is required within 56 days prior to registration. * Performance status = 0 or 1 * 18 years of age or older * Must have tumor tissue from transurethral resection of the bladder tumor (TURBT) available for submission that is sufficient for COXEN testing and must agree to submission of 20 (10 micron) slides plus 2 (5 micron) slides from the start and end of the 20 slides for a total of 22 unstained slides. * Must agree to collection of tissue (if residual disease is present), urine, and whole blood. * Must agree to participate in the translational medicine studies outlined in the protocol
Exclusion criteria
* Prior systemic cytotoxic chemotherapy or systemic anthracycline * Peripheral neuropathy \>/= Grade 2 * Class III/IV heart failure or known left ventricular ejection fraction (LVEF) \< 50% * Clinically relevant hearing impairment \> Grade 2 * Renal function, calculated creatinine clearance \< 60 mL/min * Hepatic function, total bilirubin \> 1.5 x institutional upper limit of normal (IULN) (or \> 2.5 x IULN with Gilbert's disease); AST & ALT \> 2 X IULN * Hematologic function, absolute neutrophil count (ANC) \< 1,500/mcL, hemoglobin \< 9 g/dL, and platelets \< 100,000/mcL * Hypersensitivity to cisplatin, gemcitabine, doxorubicin, vinblastine, methotrexate, or filgrastim/pegfilgrastim * Incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) * Pregnant or nursing females * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. However, patients with localized prostate cancer who are being followed by an active surveillance program are eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between GC-and ddMVAC-COXEN Score | up to 5 years post-registration | The Pearson and Spearman correlation coefficients for GC-and ddMVAC-COXEN score were calculated and are reported below. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score. |
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Up to 5 years post registration | The proportion of participants achieving pT0 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved pT0 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score. |
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | up to 5 years post-registration | The proportion of participants achieving \<=pT1 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved \<= pT1 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score. |
| Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC | up to 5 years post-registration | To assess in a hypothesis generating fashion, the ability of COXEN to select for an individual chemotherapy regimen (GC vs DDMVAC) P-values are reported as a measure of whether COXEN can select between GC/DDMVAC and to determine the significance of interactions between treatment specific COXEN scores and treatment arms in models predicting either pT0 or \<= pT1. Interactions with p-values \> 0.05 are interpreted as not significant. \_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Up to 5 years post registration | In addition to stratification factors and dichotomous COXEN GEM score, an indicator for treatment arm and the interaction of treatment arm with COXEN GEM score was also included in a logistic regression model. A significant interaction would suggest that the respective COXEN GEM score was able to differentiate whether a patient was more likely to respond to one chemotherapy regimen over another. \*note that this is the same objective at Primary Outcome #3 above - this was erroneously listed twice in the protocol. |
| Value of Gene Expression Profiling in Predicting Overall Survival (OS) | Up to 5 years post registration | 5-year OS curve was estimated using the Kaplan-Meier method. Included all COXEN evaluable participants regardless of arm assignment. The report groups were favorable vs. unfavorable COXEN status. |
| Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Up to 5 years post-registration | Pathologic complete response rate at the time of cystectomy following GC or DDMVAC treatment |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up until death or 5 years post registration | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Grade 3 is less severe than Grade 5. Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\* (bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE \*ADL- Activities of Daily Living |
Countries
United States
Participant flow
Pre-assignment details
237 participants were enrolled, but 10 were ineligible due to missing tissue, inadequate disease assessment and inadequate kidney function.
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine & Cisplatin Gemcitabine, 1000 mg/m2, IV, Days 1&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. | 115 |
| Dose Dense MVAC Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. | 112 |
| Total | 227 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| ITT Analysis | Ineligible | 5 | 5 |
| Primary COXEN Analysis | inadequate tissue submitted | 5 | 6 |
| Primary COXEN Analysis | insufficient amount of chemotherapy received | 15 | 8 |
| Primary COXEN Analysis | Pathologic response not evaluated | 13 | 13 |
Baseline characteristics
| Characteristic | Gemcitabine & Cisplatin | Dose Dense MVAC | Total |
|---|---|---|---|
| Age, Continuous | 64.9 years | 64.8 years | 64.8 years |
| Clinical stage T2 | 102 Participants | 98 Participants | 200 Participants |
| Clinical stage T3 or T4a | 13 Participants | 14 Participants | 27 Participants |
| ddMVAC-COXEN score Favorable | 23 Participants | 30 Participants | 53 Participants |
| ddMVAC-COXEN score Not Favorable | 59 Participants | 55 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants | 105 Participants | 209 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| GC-COXEN score Favorable | 18 Participants | 25 Participants | 43 Participants |
| GC-COXEN score Not favorable | 64 Participants | 60 Participants | 124 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) White | 94 Participants | 107 Participants | 201 Participants |
| Sex: Female, Male Female | 23 Participants | 13 Participants | 36 Participants |
| Sex: Female, Male Male | 92 Participants | 99 Participants | 191 Participants |
| Zubrod performance status 0 | 88 Participants | 86 Participants | 174 Participants |
| Zubrod performance status 1 | 27 Participants | 26 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 28 / 115 | 25 / 112 |
| other Total, other adverse events | 112 / 115 | 108 / 112 |
| serious Total, serious adverse events | 1 / 115 | 4 / 112 |
Outcome results
Primary
Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC
To assess in a hypothesis generating fashion, the ability of COXEN to select for an individual chemotherapy regimen (GC vs DDMVAC) P-values are reported as a measure of whether COXEN can select between GC/DDMVAC and to determine the significance of interactions between treatment specific COXEN scores and treatment arms in models predicting either pT0 or \<= pT1. Interactions with p-values \> 0.05 are interpreted as not significant. \_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
Time frame: up to 5 years post-registration
Population: Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine & Cisplatin | Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC | P-value of interaction term (GCscore*treatment arm) in model predicting pT0 | 0.88 p-value |
| Gemcitabine & Cisplatin | Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC | P-value of interaction term (GCscore*treatment arm) in logistic regression model predicting <=pT1 | 0.43 p-value |
| Gemcitabine & Cisplatin | Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC | P-value of interaction term (MVACscore*treatment arm) in logistic regression model predicting pT0 | 0.66 p-value |
| Gemcitabine & Cisplatin | Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC | P-value of interaction term (MVACscore*treatment arm) in logistic regression model predicting <=pT1 | 0.85 p-value |
Primary
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate
The proportion of participants achieving pT0 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved pT0 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
Time frame: Up to 5 years post registration
Population: Eligible participants that were evaluable for COXEN analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gemcitabine & Cisplatin | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Favorable treatment-COXEN score | 8 Participants |
| Gemcitabine & Cisplatin | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Unfavorable treatment-COXEN score | 20 Participants |
| Dose Dense MVAC | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Unfavorable treatment-COXEN score | 17 Participants |
| Dose Dense MVAC | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Favorable treatment-COXEN score | 10 Participants |
Comparison: To determine the relationship of GC COXEN scores to pT0, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the GC treatment group.p-value: 0.195% CI: [0.82, 8.36]Regression, Logistic
Comparison: To determine the relationship of ddMVAC COXEN scores to pT0, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the ddMVAC treatment group.p-value: 0.8295% CI: [0.42, 2.95]Regression, Logistic
Primary
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate
The proportion of participants achieving \<=pT1 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved \<= pT1 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
Time frame: up to 5 years post-registration
Population: Eligible participants that were evaluable for COXEN analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gemcitabine & Cisplatin | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | Favorable treatment-COXEN score | 10 Participants |
| Gemcitabine & Cisplatin | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | Unfavorable treatment-COXEN score | 30 Participants |
| Dose Dense MVAC | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | Favorable treatment-COXEN score | 16 Participants |
| Dose Dense MVAC | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | Unfavorable treatment-COXEN score | 31 Participants |
Comparison: To determine the relationship of GC COXEN scores to \<= pT1, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the GC treatment group.p-value: 0.0295% CI: [1.11, 4.89]Regression, Logistic
Comparison: To determine the relationship of ddMVAC COXEN scores to \<=pT1, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the ddMVAC treatment group.p-value: 0.7695% CI: [0.46, 1.75]Regression, Logistic
Primary
Correlation Between GC-and ddMVAC-COXEN Score
The Pearson and Spearman correlation coefficients for GC-and ddMVAC-COXEN score were calculated and are reported below. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
Time frame: up to 5 years post-registration
Population: Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine & Cisplatin | Correlation Between GC-and ddMVAC-COXEN Score | Pearson correlation coefficient | 0.385 correlation coefficient |
| Gemcitabine & Cisplatin | Correlation Between GC-and ddMVAC-COXEN Score | Spearman correlation coefficient | 0.386 correlation coefficient |
Secondary
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Grade 3 is less severe than Grade 5. Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\* (bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE \*ADL- Activities of Daily Living
Time frame: Duration of treatment and follow up until death or 5 years post registration
Population: Participants who received at least one dose of protocol treatment, submitted toxicity data and were included in the ITT analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Insomnia | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fall | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Investigations - Other, specify | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Creatinine increased | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Kidney infection | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fatigue | 3 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lung infection | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac arrest | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lymphocyte count decreased | 2 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Febrile neutropenia | 2 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mucositis oral | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dehydration | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nausea | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Acute kidney injury | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neutrophil count decreased | 20 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Headache | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Phlebitis infective | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Diarrhea | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Platelet count decreased | 11 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Heart failure | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Proteinuria | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Alanine aminotransferase increased | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dizziness | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Sepsis | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyperglycemia | 3 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Syncope | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac disorders - Other, specify | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Thromboembolic event | 4 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyperkalemia | 2 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tinnitus | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Enterocolitis infectious | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urinary tract infection | 4 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypertension | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urinary tract obstruction | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypocalcemia | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vestibular disorder | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Bronchial infection | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vomiting | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypokalemia | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | White blood cell decreased | 5 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Erectile dysfunction | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypomagnesemia | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Chronic kidney disease | 2 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dyspnea | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hematuria | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Esophagitis | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyponatremia | 5 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infections and infestations - Other, specify | 0 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypophosphatemia | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Renal and urinary disorders - Other, specify | 1 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Anemia | 10 Participants |
| Gemcitabine & Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Upper gastrointestinal hemorrhage | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nausea | 3 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Acute kidney injury | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Alanine aminotransferase increased | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Anemia | 9 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Bronchial infection | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac arrest | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac disorders - Other, specify | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Chronic kidney disease | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Creatinine increased | 5 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Diarrhea | 2 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dyspnea | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Enterocolitis infectious | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Erectile dysfunction | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Esophagitis | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fall | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fatigue | 5 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Febrile neutropenia | 2 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Headache | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Heart failure | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hematuria | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyperglycemia | 2 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyperkalemia | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypocalcemia | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypokalemia | 3 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypomagnesemia | 2 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypophosphatemia | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infections and infestations - Other, specify | 3 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Insomnia | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Investigations - Other, specify | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Kidney infection | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lung infection | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lymphocyte count decreased | 3 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mucositis oral | 5 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neutrophil count decreased | 10 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Phlebitis infective | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Platelet count decreased | 5 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Proteinuria | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Renal and urinary disorders - Other, specify | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Sepsis | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Syncope | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Thromboembolic event | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Upper gastrointestinal hemorrhage | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urinary tract infection | 3 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urinary tract obstruction | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vestibular disorder | 1 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vomiting | 3 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | White blood cell decreased | 6 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dehydration | 2 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dizziness | 0 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypertension | 3 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyponatremia | 2 Participants |
| Dose Dense MVAC | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tinnitus | 0 Participants |
Secondary
Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
Pathologic complete response rate at the time of cystectomy following GC or DDMVAC treatment
Time frame: Up to 5 years post-registration
Population: Participants who received treatment in Gemcitabine \& Cisplatin and Dose Dense MVAC arms.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine & Cisplatin | Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | 36 percentage of participants |
| Dose Dense MVAC | Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | 42 percentage of participants |
Secondary
Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
In addition to stratification factors and dichotomous COXEN GEM score, an indicator for treatment arm and the interaction of treatment arm with COXEN GEM score was also included in a logistic regression model. A significant interaction would suggest that the respective COXEN GEM score was able to differentiate whether a patient was more likely to respond to one chemotherapy regimen over another. \*note that this is the same objective at Primary Outcome #3 above - this was erroneously listed twice in the protocol.
Time frame: Up to 5 years post registration
Population: Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine & Cisplatin | Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Pvalue of interaction term (GCscore*treatment arm) in model predicting pT0 | 0.88 p-value |
| Gemcitabine & Cisplatin | Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Pvalue of interaction term (GCscore*treatment arm) in model predicting <=pT1 | 0.43 p-value |
| Gemcitabine & Cisplatin | Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Pvalue of interaction term (MVACscore*treatment arm) in model predicting pT0 | 0.66 p-value |
| Gemcitabine & Cisplatin | Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Pvalue of interaction term (MVACscore*treatment arm) in model predicting <=pT1 | 0.85 p-value |
Secondary
Value of Gene Expression Profiling in Predicting Overall Survival (OS)
5-year OS curve was estimated using the Kaplan-Meier method. Included all COXEN evaluable participants regardless of arm assignment. The report groups were favorable vs. unfavorable COXEN status.
Time frame: Up to 5 years post registration
Population: Eligible participants across both arms that were evaluable for COXEN analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine & Cisplatin | Value of Gene Expression Profiling in Predicting Overall Survival (OS) | Favorable COXEN Status | 76 Percent of Participants |
| Gemcitabine & Cisplatin | Value of Gene Expression Profiling in Predicting Overall Survival (OS) | Unfavorable COXEN Status | 71 Percent of Participants |