Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Conditions
Brief summary
This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron emission tomography (PET)/computed tomography (CT) works in predicting response in patients receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may help in learning how well chemotherapy works to kill breast cancer cells before surgery and help doctors plan the best treatment.
Detailed description
PRIMARY OBJECTIVES: I. To correlate the percentage change in standardized uptake value at 60 minutes (SUV60) between baseline (FLT-1) and early-therapy (FLT-2) with pathologic complete response to neoadjuvant chemotherapy of the primary tumor in patients with locally advanced breast cancer. SECONDARY OBJECTIVES: I. To demonstrate correlation between FLT-1 and post-therapy (FLT-3) uptake parameters and tumor proliferation markers in locally advanced breast cancer. II. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and pathologic complete response of the primary tumor and residual cancer burden (RCB). III. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and non-response of the primary tumor (stable or progressive disease) to therapy. IV. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and pathologic complete response to neoadjuvant chemotherapy in patients with regional disease in the lymph nodes in patients with locally advanced breast cancer. V. To compare the changes of FLT-2 and FLT-3 uptake parameters to changes in tumor sizes from other serial imaging modalities such as mammograms, magnetic resonance imaging (MRI), and ultrasound. VI. To compare the changes of FLT-2 and FLT-3 uptake parameters to metabolic changes from \[18F\] fludeoxyglucose (FDG)-PET, as available. VII. To continue to monitor for potential safety issues and define any physiologic effects associated with 18F FLT administration. OUTLINE: Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Interventions
PROCEDURECT
Undergo 18F-FLT PET/CT
DRUG18F-FLT
Undergo 18F-FLT PET/CT
PROCEDUREPET
Undergo 18F-FLT PET/CT
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy * Locally advanced breast cancer, not stage IV, and with a tumor size \>= 2 cm (as measured on imaging or estimated by physical exam) * No obvious contraindications for primary chemotherapy * Residual tumor planned to be removed surgically following completion of neoadjuvant therapy * Able to lie still for 1.5 hours for PET scanning * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Leukocytes \>= 3,000/ul * Absolute neutrophil count \>= 1,500/ul * Platelets \>= 100,000/ul * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 times the institutional upper limit of normal * Creatinine within normal institutional limits OR creatinine clearance \>= 30 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by institutional standard of care (SOC) pregnancy test, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation * Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Exclusion criteria
* Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Medically unstable * Condition requiring anesthesia for PET scanning and/or unable to lie still for 1.5 hours * History of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine * Pregnant or nursing * Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years * Currently on hormone therapy as the primary systemic neoadjuvant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response | Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2) | The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between SUVmax and Ki-67 LI at FLT3 (Post-NAC) | Post-NAC (FLT3) | For the purposes of reporting, SUVmax @ FLT-3 will be considered the outcome. correlation between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT-3 Ki-67 labeling index (LI) was calculated as the number of Ki-67 positive tumor cells per one thousand tumor cells. |
| SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | Baseline (FLT-1) | While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the Standardized Uptake Values the measurement of interest and report those values herein. Mean Standard Uptake Values (max) at Baseline (FLT-1) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III |
| SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | early treatment (FLT2) | While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the uptake values the measurement of interest and report those values herein. Mean Standard Uptake Values (max) after one cycle of NAC (FLT2) were compared for Participants with Residual Cancer Burden (RCB) 0/I vs RCB II/III |
| Correlation Between SUVmax and Ki-67 LI at FLT1(Baseline PET) | Baseline (FLT-1) | For the purposes of reporting, SUVmax @ FLT1 will be considered the outcome. the correlation is measured between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT1 . Ki-67 labeling index (LI) was calculated as the number of Ki-67 positive tumor cells per one thousand tumor cells. |
| Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor | Baseline (FLT-1) and post-NAC (FLT-3) | To evaluate the relationship between the change in uptake between FLT1 and FLT3 and pathologic complete response, an ROC curve will be estimated and the area under the curve (AUC), along with its 90% confidence interval, will be determined. For the purposes of reporting, we will consider the percent change in uptake between FLT1 and FLT3 to be the outcome. Reported values in the Outcome Measure table represent Change in uptake between FLT1 and FLT3, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT3 and pathological complete response was assessed by using ROC analysis. The Area Under the ROC Curve is reported in the Statistical Analysis section |
| %Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery | Baseline (FLT-1) and Early Therapy (FLT-2) | Reported values in the Outcome Measure table represent %Change in uptake between FLT1 and FLT2, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT2 and lymph node (LN) status. For the purposes of reporting, the % Change in SUV will be considered the outcome. |
| %Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery | Baseline (FLT-1) and post-NAC (FLT-3) | %change in SUVmax from FLT1-FLT3 will be compared by lymph node status at surgery For the purposes of reporting, %change in SUVmax from FLT1-FLT3 will be consider the outcome. |
| SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | post-NAC (FLT-3) | The Standard Uptake Values (max) after completion of NAC (FLT-3) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the mean of the uptake values the measurement of interest and report those values herein. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (18F-FLT) Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Enrolled under Amendment 4 | 5 |
| Overall Study | First Chemotherapy not initiated | 2 |
| Overall Study | FLT1 not completed | 4 |
| Overall Study | FLT2 after second chemotherapy initiated | 7 |
| Overall Study | FLT2 not completed | 5 |
| Overall Study | Ineligible | 3 |
| Overall Study | Offstudy due to complicating disease | 1 |
| Overall Study | Pathology missing | 1 |
| Overall Study | Second chemotherapy not initiated | 1 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Diagnostic (18F-FLT) |
|---|---|
| Age, Continuous | 51 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Gender Female | 90 Participants |
| Gender Male | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment United States | 90 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
%Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response
The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies
Time frame: Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)
Population: Percent Change in Maximum Standardized FLT uptake between the baseline (pre-therapy, FTL-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (18F-FLT) | %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response | 38.78 percentage change of SUVmax | Standard Deviation 26.07 |
Comparison: A receiver operating characteristic (ROC) analysis was performed to assess the significance of the Area Under the Curve (AUC) under the Null Hypothesis with a one sided alpha=0.05 (95% one-sided CL):~H0: AUC = 0.50 (no difference from guessing) given the alternative hypothesis: Ha:AUC \>= 0.75 AUC = ROC(%ΔSUVmax\| path response) where percent change (%ΔSUVmax ) was defined as (SUVmax at FLT1 -SUVmax at FLT2)/SUVmax at FLT1 x 100p-value: 0.046Delong method
Secondary
Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor
To evaluate the relationship between the change in uptake between FLT1 and FLT3 and pathologic complete response, an ROC curve will be estimated and the area under the curve (AUC), along with its 90% confidence interval, will be determined. For the purposes of reporting, we will consider the percent change in uptake between FLT1 and FLT3 to be the outcome. Reported values in the Outcome Measure table represent Change in uptake between FLT1 and FLT3, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT3 and pathological complete response was assessed by using ROC analysis. The Area Under the ROC Curve is reported in the Statistical Analysis section
Time frame: Baseline (FLT-1) and post-NAC (FLT-3)
Population: 43 patients who had both FLT1 and FLT3 scans
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic (18F-FLT) | Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor | All Data | 38.8 percentage change in SUVmax | Standard Deviation 26.1 |
| Diagnostic (18F-FLT) | Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor | pCR | 52.7 percentage change in SUVmax | Standard Deviation 22.8 |
| Diagnostic (18F-FLT) | Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor | no-pCR | 35.8 percentage change in SUVmax | Standard Deviation 26 |
Comparison: ROC analysis was used to compute the AUC and evaluate if %ΔSUVmax FLT1-FLT3 is predictive of pCR with alpha=0.05.~The Null Hypothesis assumes that the P(%ΔSUVmax FLT1-FLT3\|pCR)= 1 - P(%ΔSUVmax FLT1-FLT3\|non-pCR) that is: H0: AUC =0.5 (guessing)p-value: <0.00190% CI: [0.72, 0.94]Delong Method
Secondary
%Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery
Reported values in the Outcome Measure table represent %Change in uptake between FLT1 and FLT2, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT2 and lymph node (LN) status. For the purposes of reporting, the % Change in SUV will be considered the outcome.
Time frame: Baseline (FLT-1) and Early Therapy (FLT-2)
Population: Data on 38 patients having FLT1 and FLT2 were available for histopathological LN evaluation after NAC: 14 with negative nodes, 15 with 1-3 LN metastases and 9 with \>3 LN metastases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic (18F-FLT) | %Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery | All Data | 44.9 percent change in SUVmax from FLT1-FLT2 | Standard Deviation 26 |
| Diagnostic (18F-FLT) | %Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery | 0 Positive Nodes | 47.7 percent change in SUVmax from FLT1-FLT2 | Standard Deviation 29 |
| Diagnostic (18F-FLT) | %Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery | 1-3 Positive Nodes | 43.8 percent change in SUVmax from FLT1-FLT2 | Standard Deviation 23.8 |
| Diagnostic (18F-FLT) | %Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery | 3+ Positive Nodes | 42.6 percent change in SUVmax from FLT1-FLT2 | Standard Deviation 27.4 |
Comparison: Kruskal-Wallis one-way ANOVA was used to test whether there was a difference in %SUVmax (FLT1-FLT2) among LN statuses.~H0: no difference between the 3 LN status.p-value: 0.86Kruskal-Wallis
Secondary
%Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery
%change in SUVmax from FLT1-FLT3 will be compared by lymph node status at surgery For the purposes of reporting, %change in SUVmax from FLT1-FLT3 will be consider the outcome.
Time frame: Baseline (FLT-1) and post-NAC (FLT-3)
Population: Data on 30 patients with FLT3 were available for histopathological LN evaluation after NAC: 11 with negative nodes, 13 with 1-3 LN metastases and 6 with \>3 LN metastases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic (18F-FLT) | %Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery | All Data | 71.4 percent change in SUVmax from FLT1-FLT3 | Standard Deviation 29.1 |
| Diagnostic (18F-FLT) | %Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery | 0 Positive Nodes | 65.2 percent change in SUVmax from FLT1-FLT3 | Standard Deviation 42.2 |
| Diagnostic (18F-FLT) | %Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery | 1-3 Positive Nodes | 77.6 percent change in SUVmax from FLT1-FLT3 | Standard Deviation 18.1 |
| Diagnostic (18F-FLT) | %Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery | 3+ Positive Nodes | 69.5 percent change in SUVmax from FLT1-FLT3 | Standard Deviation 19.5 |
p-value: 0.67Kruskal-Wallis
Secondary
Correlation Between SUVmax and Ki-67 LI at FLT1(Baseline PET)
For the purposes of reporting, SUVmax @ FLT1 will be considered the outcome. the correlation is measured between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT1 . Ki-67 labeling index (LI) was calculated as the number of Ki-67 positive tumor cells per one thousand tumor cells.
Time frame: Baseline (FLT-1)
Population: 1 of the 73 participants did not have both FLT-1 and Ki-67 LI available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (18F-FLT) | Correlation Between SUVmax and Ki-67 LI at FLT1(Baseline PET) | 5.71 Standard Uptake Values (SUVmax) | Standard Deviation 3.2 |
Comparison: H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-1 and Ki-67 LI a Fisher's z Transformation was applied to adjust for bias in the Spearman Correlation Statisticp-value: 0.00295% CI: [0.13, 0.54]spearman correlation method
Secondary
Correlation Between SUVmax and Ki-67 LI at FLT3 (Post-NAC)
For the purposes of reporting, SUVmax @ FLT-3 will be considered the outcome. correlation between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT-3 Ki-67 labeling index (LI) was calculated as the number of Ki-67 positive tumor cells per one thousand tumor cells.
Time frame: Post-NAC (FLT3)
Population: 43 patients who had suitable post-NAC tissue samples for correlation between surgical specimens and FLT3 SUVs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (18F-FLT) | Correlation Between SUVmax and Ki-67 LI at FLT3 (Post-NAC) | 1.88 Standard Uptake Values (SUVmax) | Standard Deviation 1.88 |
Comparison: H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-3 and Ki-67 LIp-value: <0.000195% CI: [0.47, 0.81]Spearman Correlation method
Secondary
SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III
While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the Standardized Uptake Values the measurement of interest and report those values herein. Mean Standard Uptake Values (max) at Baseline (FLT-1) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III
Time frame: Baseline (FLT-1)
Population: @ Baseline: 35 patients with FLT-1 were evaluable for RCB: 14 patients with RCB 0/I and 21 patients with RCB II/III
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic (18F-FLT) | SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | All Data | 5.9 Standard Uptake Values (SUVmax) | Standard Deviation 3.2 |
| Diagnostic (18F-FLT) | SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | RCB 0,I | 6.2 Standard Uptake Values (SUVmax) | Standard Deviation 2.9 |
| Diagnostic (18F-FLT) | SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | RCB II,III | 5.8 Standard Uptake Values (SUVmax) | Standard Deviation 3.5 |
Comparison: H0: Mean SUVmax (RCB 0,I) = Mean SUVmax (RCB II,III) After dichotomization, Wilcoxon two-sample test was used to compare uptake values between RCB groups.~In other words, we are comparing the means (of SUVmax) @ FLT1 between the RCB 0,I and the RCB II,III groups..p-value: 0.66Wilcoxon (Mann-Whitney)
Secondary
SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III
While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the uptake values the measurement of interest and report those values herein. Mean Standard Uptake Values (max) after one cycle of NAC (FLT2) were compared for Participants with Residual Cancer Burden (RCB) 0/I vs RCB II/III
Time frame: early treatment (FLT2)
Population: after one cycle of NAC (FLT2): 35 patients had FLT-2 and RCB evaluation: 14 patients with RCB 0/I and 21 patients with RCB II/III
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic (18F-FLT) | SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | All Data | 3.3 Standard Uptake Values (SUVmax) | Standard Deviation 2 |
| Diagnostic (18F-FLT) | SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | RCB 0,I | 3.5 Standard Uptake Values (SUVmax) | Standard Deviation 2.3 |
| Diagnostic (18F-FLT) | SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | RCB II,III | 3.2 Standard Uptake Values (SUVmax) | Standard Deviation 1.9 |
Comparison: H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT2 between the RCB 0,I and the RCB II,III groups.p-value: 0.86Wilcoxon (Mann-Whitney)
Secondary
SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III
The Standard Uptake Values (max) after completion of NAC (FLT-3) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the mean of the uptake values the measurement of interest and report those values herein.
Time frame: post-NAC (FLT-3)
Population: After completion of NAC (FLT-3): only 31 patients had both FLT3 and RCB evaluation: 11 patients with RCB 0/I and 20 patients with RCB II/III
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic (18F-FLT) | SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | All Data (FLT3) | 1.8 Standard Uptake Values (SUVmax) | Standard Deviation 1.8 |
| Diagnostic (18F-FLT) | SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | RCB 0/I (FLT3) | 0.7 Standard Uptake Values (SUVmax) | Standard Deviation 0.3 |
| Diagnostic (18F-FLT) | SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | RCB II/III (FLT3) | 2.4 Standard Uptake Values (SUVmax) | Standard Deviation 2 |
Comparison: H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT3 between the RCB 0,I and the RCB II,III groups.p-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: H0: %SUVmax FLT1-FLT3 (RCB 0,I) = %SUVmax FLT1-FLT3 (RCB II,III) A logistic regression model is used to determine if a larger percent change in SUVmax is associated with (RCB 0,I); the null hypothesis assumes that there is no association.p-value: 0.01395% CI: [0.76, 0.97]Regression, Logistic