Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer
Brief summary
This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES: I. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX) have longer time to local recurrence as compared to the patients treated by SR (local recurrence includes recurrence within the same lobe or hilum \[N1 nodes\], or progression at the staple line after treatment effects such as scarring have subsided). SECONDARY OBJECTIVES: I. To compare procedure specific morbidity and mortality between study arms. II. To compare overall survival and failure-free survival between study arms. III. To assess freedom from regional or distant recurrence. IV. To assess the effect of histological or cytologic positive resection margins on time to local recurrence. V. To determine the effect of brachytherapy on quality of life (QoL). VI. To determine the effect of brachytherapy on pulmonary function. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy. ARM II: Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising iodine I 125 implant at the resection margin. After completion of study treatment, patients are followed at 3, 6, 12, 18, 24, 30, and 36 months and then yearly for 2 years.
Interventions
PROCEDUREsurgery
RADIATIONbrachytherapy
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
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
* PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION) * Patients must have a suspicious lung nodule for clinical stage I non-small cell lung cancer (NSCLC) * Patient must have a mass =\< 3 cm maximum diameter by computed tomography (CT) size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement) * Patient must have a CT scan of the chest with upper abdomen within 60 days prior to date of pre-registration * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2 * Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below: * Major criteria * Forced expiratory volume in 1 second (FEV1) =\< 50% predicted * Diffusing capacity of the lungs for carbon monoxide (DLCO) =\< 50% predicted * Minor criteria * Age \>= 75 * FEV1 51-60% predicted * DLCO 51-60% predicted * Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization * Poor left ventricular function (defined as an ejection fraction of 40% or less) * Resting or exercise partial pressure of oxygen (pO2) =\< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =\< 88% * Partial pressure of carbon dioxide (pCO2) \> 45 mm Hg * Modified Medical Research Council (MMRC) Dyspnea Scale \>= 3 * Patient must not have had previous intra-thoracic radiation therapy * Women of child-bearing potential must have negative serum or urine pregnancy test * No prior invasive malignancy, unless disease-free for \>= 5 years prior to pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers) * PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION) * Patient must have biopsy-proven NSCLC * Patient must have all suspicious mediastinal lymph nodes (\> 1 cm short-axis dimension on CT scan or positive on positron emission tomography \[PET\] scan) assessed by one of the following methods to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Local Recurrence | Up to 3 years | Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reported Local Recurrence at 3 Years | 3 years | Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided. |
| Number of Participants Reported Regional Recurrence at 3 Years | 3 years | Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes. |
| Number of Participants Reported Distant Recurrence at 3 Years | 3 years | Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant\> metastatic disease (other organs). |
| Mortality Rates at 30- and 90-day After Sublobar Resection | 90 days | — |
| Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection | 90 days | Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. |
| Overall Survival (OS) | Up to 5 years | OS was defined as the time from randomization to death due to any cause. |
| Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | 24 months | Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores \<50 indicate below-average health status. |
| Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 | 24 months | Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life.. |
| FEV1% Measured at Baseline and Month 3 | 3 months | Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms |
| DLCO% Measured at Baseline and Month 3 | 3 months | Pulmonary function tests included percentage predicted carbon \> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms. |
| Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection | 90 days | The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0. |
Countries
Canada, United States
Participant flow
Recruitment details
Two hundred twenty-four (224) participants were accrued between January 2006 and January 2010.
Pre-assignment details
One participant on SR arm was enrolled from a site with a regulatory violation and 1 participant on SR+BX arm had no surgery. These two participants were excluded from all analyses.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (SR) Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy. | 114 |
| Arm B (SR + BX) Patients undergo sublobar resection plus brachytherapy (SR + BX) | 108 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Other Reason | 4 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Arm A (SR) | Arm B (SR + BX) | Total |
|---|---|---|---|
| Age, Continuous | 70 years | 72 years | 71 years |
| Baseline diffusing capacity of the lung for carbon monoxide (DLCO) | 47 Percentage of predicted | 45 Percentage of predicted | 46 Percentage of predicted |
| Baseline Forced Expiratory Volume in 1 second (FEV1) | 48 Percentage of Predicted | 53 Percentage of Predicted | 50 Percentage of Predicted |
| Clinical Nodule Size (cm) <= 2 cm | 73 participants | 67 participants | 140 participants |
| Clinical Nodule Size (cm) > 2 cm | 41 participants | 41 participants | 82 participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status 0 = Asymptomatic and fully active | 20 participants | 25 participants | 45 participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status 1= Symptomatic and fully ambulatory | 66 participants | 60 participants | 126 participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status 2= Symptomatic and ambulatory | 28 participants | 23 participants | 51 participants |
| Metastatis stage, M0 | 114 participants | 108 participants | 222 participants |
| Nodal Stage, N0 | 114 participants | 108 participants | 222 participants |
| Region of Enrollment Canada | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 114 participants | 107 participants | 221 participants |
| Sex: Female, Male Female | 65 Participants | 59 Participants | 124 Participants |
| Sex: Female, Male Male | 49 Participants | 49 Participants | 98 Participants |
| Tumor Stage T1=Tumor <=3cm | 114 participants | 104 participants | 218 participants |
| Tumor Stage T2=Tumor > 3cm | 0 participants | 3 participants | 3 participants |
| Tumor Stage T3=Tumor of any size | 0 participants | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 45 / 114 | 50 / 108 |
| serious Total, serious adverse events | 8 / 114 | 4 / 108 |
Outcome results
Primary
Time to Local Recurrence
Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.
Time frame: Up to 3 years
Population: All intent-to-treat (ITT) participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (SR) | Time to Local Recurrence | NA years |
| Arm B (SR + BX) | Time to Local Recurrence | NA years |
Comparison: The competing risk analysis accounting for death/regional and distant recurrence as competing events was performed.p-value: 0.9895% CI: [0.51, 1.98]Log Rank
Secondary
DLCO% Measured at Baseline and Month 3
Pulmonary function tests included percentage predicted carbon \> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms.
Time frame: 3 months
Population: All participants with complete pulmonary function test data at baseline and month 3.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A (SR) | DLCO% Measured at Baseline and Month 3 | Baseline DLCO% | 46 Percentage of Predicted |
| Arm A (SR) | DLCO% Measured at Baseline and Month 3 | Month 3 DLCO% | 48 Percentage of Predicted |
| Arm B (SR + BX) | DLCO% Measured at Baseline and Month 3 | Baseline DLCO% | 46 Percentage of Predicted |
| Arm B (SR + BX) | DLCO% Measured at Baseline and Month 3 | Month 3 DLCO% | 43 Percentage of Predicted |
Comparison: Compare the percentage change from baseline to 3-month value for SR arm.p-value: 0.38Wilcoxon Signed Rank
Comparison: Compare the percentage change from baseline to 3-month value for SR + BX arm.p-value: 0.16Wilcoxon Signed Rank
Secondary
Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24
Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..
Time frame: 24 months
Population: Participants who met the eligibility criteria and had SOBQ data at baseline, month 3, 12 or 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A (SR) | Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 | Baseline SOBQ Scores | 72.9 units on a scale |
| Arm A (SR) | Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 | Month 3 SOBQ Scores | 75.8 units on a scale |
| Arm A (SR) | Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 | Month 12 SOBQ Scores | 72.5 units on a scale |
| Arm A (SR) | Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 | Month 24 SOBQ Scores | 70.8 units on a scale |
| Arm B (SR + BX) | Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 | Month 24 SOBQ Scores | 63.8 units on a scale |
| Arm B (SR + BX) | Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 | Baseline SOBQ Scores | 70.0 units on a scale |
| Arm B (SR + BX) | Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 | Month 12 SOBQ Scores | 72.1 units on a scale |
| Arm B (SR + BX) | Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 | Month 3 SOBQ Scores | 69.2 units on a scale |
Secondary
FEV1% Measured at Baseline and Month 3
Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms
Time frame: 3 months
Population: All participants with complete pulmonary function test data at baseline and month 3.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A (SR) | FEV1% Measured at Baseline and Month 3 | Baseline FEV1% | 49 Percentage of Predicted |
| Arm A (SR) | FEV1% Measured at Baseline and Month 3 | Month 3 FEV1% | 53 Percentage of Predicted |
| Arm B (SR + BX) | FEV1% Measured at Baseline and Month 3 | Baseline FEV1% | 51 Percentage of Predicted |
| Arm B (SR + BX) | FEV1% Measured at Baseline and Month 3 | Month 3 FEV1% | 53 Percentage of Predicted |
Comparison: Compare the percentage change from baseline to 3-month value for SR arm.p-value: 0.03Wilcoxon Signed Rank
Comparison: Compare the percentage change from baseline to 3-month value for SR + BX arm.p-value: 0.18Wilcoxon Signed Rank
Secondary
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores \<50 indicate below-average health status.
Time frame: 24 months
Population: Participants who met the eligibility criteria and had SF 36 data at baseline, month 3, 12 or 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A (SR) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 3 MCS Scores | 51.8 units on a scale |
| Arm A (SR) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 12 PCS Scores | 42.8 units on a scale |
| Arm A (SR) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Baseline MCS Scores | 51.4 units on a scale |
| Arm A (SR) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 12 MCS Scores | 52.5 units on a scale |
| Arm A (SR) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 3 PCS Scores | 43.2 units on a scale |
| Arm A (SR) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 24 PCS Scores | 44.6 units on a scale |
| Arm A (SR) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 24 MCS Scores | 54.1 units on a scale |
| Arm A (SR) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Baseline PCS Scores | 43.2 units on a scale |
| Arm B (SR + BX) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 24 MCS Scores | 51.2 units on a scale |
| Arm B (SR + BX) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 24 PCS Scores | 42.4 units on a scale |
| Arm B (SR + BX) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Baseline PCS Scores | 41.8 units on a scale |
| Arm B (SR + BX) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 3 PCS Scores | 42.4 units on a scale |
| Arm B (SR + BX) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 3 MCS Scores | 52.2 units on a scale |
| Arm B (SR + BX) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 12 PCS Scores | 42.8 units on a scale |
| Arm B (SR + BX) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Month 12 MCS Scores | 51.3 units on a scale |
| Arm B (SR + BX) | Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 | Baseline MCS Scores | 50.5 units on a scale |
Secondary
Mortality Rates at 30- and 90-day After Sublobar Resection
Time frame: 90 days
Population: All Intent-to-Treat (ITT) participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A (SR) | Mortality Rates at 30- and 90-day After Sublobar Resection | 0 - 30 days | 0.9 percentage of participants |
| Arm A (SR) | Mortality Rates at 30- and 90-day After Sublobar Resection | 0 - 90 days | 2.6 percentage of participants |
| Arm B (SR + BX) | Mortality Rates at 30- and 90-day After Sublobar Resection | 0 - 30 days | 1.9 percentage of participants |
| Arm B (SR + BX) | Mortality Rates at 30- and 90-day After Sublobar Resection | 0 - 90 days | 2.8 percentage of participants |
Secondary
Number of Participants Reported Distant Recurrence at 3 Years
Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant\> metastatic disease (other organs).
Time frame: 3 years
Population: All intent-to-treat participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (SR) | Number of Participants Reported Distant Recurrence at 3 Years | 10 participants |
| Arm B (SR + BX) | Number of Participants Reported Distant Recurrence at 3 Years | 12 participants |
Secondary
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Time frame: 90 days
Population: All Intent-to-Treat (ITT) participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A (SR) | Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection | 0 - 90 days | 34 participants |
| Arm A (SR) | Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection | 0 - 30 days | 29 participants |
| Arm B (SR + BX) | Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection | 0 - 90 days | 40 participants |
| Arm B (SR + BX) | Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection | 0 - 30 days | 33 participants |
Comparison: Compare the grade 3+ adverse events incidence reported from day 0 to 30 between arms.p-value: 0.37Fisher Exact
Comparison: Compare the grade 3+ adverse events incidence reported from day 0 to 90 between arms.p-value: 0.25Fisher Exact
Secondary
Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection
The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.
Time frame: 90 days
Population: All Intent-to-Treat (ITT) participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A (SR) | Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection | 0 - 30 days | 17 participants |
| Arm A (SR) | Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection | 0 - 90 days | 22 participants |
| Arm B (SR + BX) | Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection | 0 - 30 days | 4 participants |
| Arm B (SR + BX) | Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection | 0 - 90 days | 6 participants |
Comparison: Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 30 between arms.p-value: 0.35Fisher Exact
Comparison: Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 90 between arms.p-value: 0.31Fisher Exact
Secondary
Number of Participants Reported Local Recurrence at 3 Years
Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.
Time frame: 3 years
Population: All intent-to-treat participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (SR) | Number of Participants Reported Local Recurrence at 3 Years | 14 participants |
| Arm B (SR + BX) | Number of Participants Reported Local Recurrence at 3 Years | 13 participants |
Secondary
Number of Participants Reported Regional Recurrence at 3 Years
Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.
Time frame: 3 years
Population: All intent-to-treat participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (SR) | Number of Participants Reported Regional Recurrence at 3 Years | 8 participants |
| Arm B (SR + BX) | Number of Participants Reported Regional Recurrence at 3 Years | 9 participants |
Secondary
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: Up to 5 years
Population: All intent-to-treat (ITT) participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (SR) | Overall Survival (OS) | 5.3 years |
| Arm B (SR + BX) | Overall Survival (OS) | 4.7 years |
p-value: 0.7595% CI: [0.71, 1.61]Log Rank