Trial Outcomes & Findings for Neoadjuvant Pembrolizumab (NCT NCT02818920)
NCT ID: NCT02818920
Last Updated: 2024-06-18
Results Overview
A patient who meets the eligibility criteria, has received at least 1 dose of pembrolizumab, and undergone surgery in the window of 29-56 days after initiation of pembrolizumab is considered surgically feasible. All other situations are considered infeasible.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
29-56 days after initiation of pembrolizumab
Results posted on
2024-06-18
Participant Flow
Thirty-five subjects consented to the study. Two subjects withdrew consent before receiving protocol treatment and three were deemed ineligible.
Participant milestones
| Measure |
Pembrolizumab Prior to and After Surgery
Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 \& 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles
-Note: Standard radiation therapy in selected patients for standard clinical indications
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Completed Surgery
|
25
|
|
Overall Study
Received Adjuvant Therapy
|
17
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Pembrolizumab Prior to and After Surgery
Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 \& 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles
-Note: Standard radiation therapy in selected patients for standard clinical indications
|
|---|---|
|
Overall Study
Unresectable
|
4
|
|
Overall Study
Progressed After Neoadjuvant Therapy
|
1
|
|
Overall Study
Went Off Study Prior to Adjuvant Therapy
|
8
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Developed Other Disease
|
1
|
|
Overall Study
Refused Further Treatment
|
1
|
Baseline Characteristics
Neoadjuvant Pembrolizumab
Baseline characteristics by cohort
| Measure |
Pembrolizumab Prior to and After Surgery
n=25 Participants
Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 \& 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles
-Note: Standard radiation therapy in selected patients for standard clinical indications
|
|---|---|
|
Age, Continuous
|
71 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=93 Participants
|
|
Histological Diagnosis
Adenocarcinoma
|
8 Participants
n=93 Participants
|
|
Histological Diagnosis
Squamous cell carcinoma
|
15 Participants
n=93 Participants
|
|
Histological Diagnosis
Non-small cell lung cancer NOS
|
2 Participants
n=93 Participants
|
|
Clinical Stage
Stage IB
|
7 Participants
n=93 Participants
|
|
Clinical Stage
Stage IIA
|
6 Participants
n=93 Participants
|
|
Clinical Stage
Stage IIB
|
5 Participants
n=93 Participants
|
|
Clinical Stage
Stage IIIA
|
7 Participants
n=93 Participants
|
|
History of Smoking
Never
|
3 Participants
n=93 Participants
|
|
History of Smoking
Current user
|
4 Participants
n=93 Participants
|
|
History of Smoking
Quit < or = 1 month
|
4 Participants
n=93 Participants
|
|
History of Smoking
Quit > 1 month to 1 year
|
2 Participants
n=93 Participants
|
|
History of Smoking
Quit > 1 year
|
12 Participants
n=93 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Score
0
|
14 Participants
n=93 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Score
1
|
11 Participants
n=93 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Score
2
|
0 Participants
n=93 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Score
3
|
0 Participants
n=93 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Score
4
|
0 Participants
n=93 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Score
5
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 29-56 days after initiation of pembrolizumabPopulation: Subjects who completed surgery.
A patient who meets the eligibility criteria, has received at least 1 dose of pembrolizumab, and undergone surgery in the window of 29-56 days after initiation of pembrolizumab is considered surgically feasible. All other situations are considered infeasible.
Outcome measures
| Measure |
Pembrolizumab Prior to and After Surgery
n=25 Participants
Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 \& 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles
-Note: Standard radiation therapy in selected patients for standard clinical indications
|
|---|---|
|
Surgical Feasibility Rate as Measured by the Number of Subjects Who Undergo Surgery Following Neoadjuvant Pembrozulimab
|
24 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 2 cycles of neoadjuvant pembrolizumab (29-55 days after initiation)The percentage of patients having a complete response or a partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Until disease recurrence or death (up to 5 years)DFS is defined as the time from surgical resection to disease recurrence (first disease recurrence or death, whichever comes first) after surgery.The Kaplan-Meier estimator will be used to estimate median DFS and its confidence interval.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (day 0), before surgery (days 29-56), 3-6 weeks after surgery, and after completion of adjuvant pembrolizumab (estimated at 10.5 months from start depending on treatment components received by patient)Changes in levels of blood-based biomarkers before and after protocol treatment and correlated with clinical outcomes, such as objective response, overall survival, and disease-free survival.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of protocol treatment (Estimated at 10.5 months from start depending on treatment components received by patient)Percentage of patients with detectable TILs, defined as greater than or equal to 0.05% (with each value also being at least twice that of the background unstimulated control value TIL)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of protocol treatment (estimated at 10.5 months from start depending on treatment components received by patient)Safety will be evaluated for all treated patients using CTCAE V 4.0.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of protocol treatment (estimated at 10.5 months from start depending on treatment components received by patient)Proportion of patients with detectable circulating T cells specific against TAA after protocol treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At surgery (day 29-56)Pathologic response rate for neoadjuvant pembrolizumab
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (day 0), before surgery (days 29-56), 3-6 weeks after surgery, and after completion of adjuvant pembrolizumab (estimated at 10.5 months from start depending on treatment components received by patient)Determine if the immunomodulatory effects of neoadjuvant pembrolizumab have an impact on the suppressive mechanisms, restoring functional reactivity to important anti-tumor effects cell populations. Functional TAA-specific T cell reactivities will measured at 4 time points.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of protocol treatment ((Estimated at 10.5 months from start depending on treatment components received by patient)Percentage of patients with circulating T cells meeting the new definition of detectable.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of protocol treatment ((Estimated at 10.5 months from start depending on treatment components received by patient)Elucidate genes associated with function and modulation of the PD-1/PD-L1 axis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At surgery (day 29-56)A Fisher exact test will be used to evaluate the association of the presence of TILs with pathologic tumor response to neoadjuvant therapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At surgery (day 29-56)A Fisher exact test will be used to evaluate the association of the quality of TILs with pathologic tumor response to neoadjuvant therapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At surgery (days 29-56)A Wilcoxon rank sum test will be used to test the association of the quantity of TILs and pathologic response to neoadjuvant therapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Until disease recurrence or death (up to 5 years)]The Kaplan-Meier estimator will be used to estimate median DFS and its confidence interval. The frequencies of metastases by site will be tabulated
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab Prior to and After Surgery
Serious events: 6 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab Prior to and After Surgery
n=30 participants at risk
Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 \& 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles
-Note: Standard radiation therapy in selected patients for standard clinical indications
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.0%
1/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Vascular disorders
Thromboembolic event
|
4.0%
1/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
Other adverse events
| Measure |
Pembrolizumab Prior to and After Surgery
n=30 participants at risk
Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 \& 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles
-Note: Standard radiation therapy in selected patients for standard clinical indications
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
2/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Psychiatric disorders
Agitation
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
3/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Blood and lymphatic system disorders
Anemia
|
23.3%
7/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
5/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
5/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
12.0%
3/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Cardiac disorders
Atrial fibrillation
|
24.0%
6/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Bloating
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Infections and infestations
Bronchial infection
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
General disorders
Chills
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Nervous system disorders
Concentration impairment
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Psychiatric disorders
Confusion
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
4/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
3/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Investigations
Creatinine increased
|
10.0%
3/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
12/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Nervous system disorders
Dizziness
|
16.7%
5/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Eye disorders
Dry eye
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
6/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
General disorders
Edema limbs
|
10.0%
3/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Endocrine disorders
Endocrine disorders - Other
|
16.7%
5/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Eye disorders
Eye disorders - Other
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
General disorders
Fatigue
|
40.0%
12/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
General disorders
Fever
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
General disorders
Flu like symptoms
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
General disorders
Gait disturbance
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
General disorders
General disorders and administration site conditions - Other
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
3/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Vascular disorders
Hypertension
|
17.6%
3/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Endocrine disorders
Hyperthyroidism
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
6/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
6/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
26.7%
8/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.3%
7/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
3/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
5/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.0%
4/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Psychiatric disorders
Insomnia
|
20.0%
6/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Infections and infestations
Lung infection
|
8.0%
2/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.8%
2/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
4/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Investigations
Neutrophil count decreased
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
3/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
General disorders
Pain
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Nervous system disorders
Paresthesia
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.8%
2/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Investigations
Platelet count decreased
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.8%
2/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
16.0%
4/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
4/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
5/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
11.8%
2/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Infections and infestations
Scrotal infection
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Cardiac disorders
Sinus bradycardia
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Cardiac disorders
Sinus tachycardia
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
10.0%
3/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Infections and infestations
Skin infection
|
8.0%
2/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.0%
1/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
4.0%
1/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Vascular disorders
Thromboembolic event
|
8.0%
2/25 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
11.8%
2/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Eye disorders
Watering eyes
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Investigations
Weight gain
|
5.9%
1/17 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Investigations
Weight loss
|
3.3%
1/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
2/30 • Approximately 10.5 months
30 patients received neoadjuvant therapy. Among them, 25 patients underwent surgery. 17 out of those 25 patients received adjuvant therapy. Therefore, the number of patients at risk was different at different treatment phases.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place