Trial Outcomes & Findings for Temozolomide Alone or With Pegylated Interferon-Alpha 2b (PGI) in Melanoma Patients (NCT NCT00525031)
NCT ID: NCT00525031
Last Updated: 2020-09-23
Results Overview
Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD). Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or \> decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): \> 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Evaluated after a total of 8 weeks of therapy before definitive surgery.
Results posted on
2020-09-23
Participant Flow
Recruitment Period: August 31, 2006 to May 10, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.
Three participants of 55 enrolled were excluded due to ineligibility prior to assignment to groups.
Participant milestones
| Measure |
Temozolomide (TMZ)
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
|
Temozolomide (TMZ) + Pegylated Interferon-alpha 2b (PGI)
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Temozolomide (TMZ)
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
|
Temozolomide (TMZ) + Pegylated Interferon-alpha 2b (PGI)
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
|
|---|---|---|
|
Overall Study
Disease Progression
|
1
|
1
|
Baseline Characteristics
Temozolomide Alone or With Pegylated Interferon-Alpha 2b (PGI) in Melanoma Patients
Baseline characteristics by cohort
| Measure |
TMZ Alone
n=27 Participants
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
|
TMZ + PGI
n=25 Participants
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=39 Participants
|
62 years
n=41 Participants
|
60 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
52 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Evaluated after a total of 8 weeks of therapy before definitive surgery.Population: Of the 52 registered, two were not evaluable for response. Each
Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD). Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or \> decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): \> 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.
Outcome measures
| Measure |
TMZ Alone
n=26 Participants
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
|
TMZ + PGI
n=24 Participants
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
|
|---|---|---|
|
Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD)
CR, PR, SD
|
4 Participants
|
7 Participants
|
|
Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD)
PD
|
14 Participants
|
11 Participants
|
|
Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD)
Missing
|
8 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Evaluated after a total of 8 weeks of therapy before definitive surgery.Population: Two participants of 52 enrolled were not evaluable for response.
Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or \> decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): \> 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.
Outcome measures
| Measure |
TMZ Alone
n=50 Participants
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
|
TMZ + PGI
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
|
|---|---|---|
|
Response to Neoadjuvant Therapy: Overall Clinical Responses
Complete Response
|
1 Participants
|
—
|
|
Response to Neoadjuvant Therapy: Overall Clinical Responses
Partial Response
|
15 Participants
|
—
|
|
Response to Neoadjuvant Therapy: Overall Clinical Responses
Stable Disease
|
3 Participants
|
—
|
|
Response to Neoadjuvant Therapy: Overall Clinical Responses
Progressive Disease
|
31 Participants
|
—
|
Adverse Events
TMZ Alone
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
TMZ + PGI
Serious events: 8 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TMZ Alone
n=27 participants at risk
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
|
TMZ + PGI
n=25 participants at risk
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
LEUKOCYTES INCREASED/Leukocytosis
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
NEUTROPHILS INCREASED (ANC/AGC)
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
LYMPHOPENIA
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
PLATELETS DECREASED
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
Other adverse events
| Measure |
TMZ Alone
n=27 participants at risk
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
|
TMZ + PGI
n=25 participants at risk
TMZ 150 mg/m\^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
ALANINE TRANSAMINASE (ALT) INCREASED
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
24.0%
6/25 • Number of events 6 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
37.0%
10/27 • Number of events 10 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
36.0%
9/25 • Number of events 9 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE (AST) INCREASED
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
24.0%
6/25 • Number of events 6 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Gastrointestinal disorders
CONSTIPATION
|
40.7%
11/27 • Number of events 11 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
56.0%
14/25 • Number of events 14 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Renal and urinary disorders
CYSTITIS
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
20.0%
5/25 • Number of events 5 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Nervous system disorders
DIZZINESS
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
0.00%
0/25 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
ELEVEVATED Serum Glutamic-Oxaloacetic Transaminase (SGOT)
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
General disorders
FATIGUE
|
44.4%
12/27 • Number of events 12 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
68.0%
17/25 • Number of events 17 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
General disorders
FEVER WITHOUT NEUTROPENIA
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
General disorders
FLU-LIKE SYNDROME
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
28.0%
7/25 • Number of events 7 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
General disorders
HEARTBURN
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
HEMOGLOBIN INCREASED
|
11.1%
3/27 • Number of events 3 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Injury, poisoning and procedural complications
INJECTION SITE REACTION
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
56.0%
14/25 • Number of events 14 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Gastrointestinal disorders
INDIGESTION
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
0.00%
0/25 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Blood and lymphatic system disorders
LEUKOCYTES INCREASED/Leukocytosis
|
7.4%
2/27 • Number of events 2 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
28.0%
7/25 • Number of events 7 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
LEUKOPENIA
|
7.4%
2/27 • Number of events 2 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
20.0%
5/25 • Number of events 5 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
LYMPHOPENIA
|
18.5%
5/27 • Number of events 5 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
28.0%
7/25 • Number of events 7 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Psychiatric disorders
MOOD ALTERATION
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
General disorders
NAUSEA
|
40.7%
11/27 • Number of events 11 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
64.0%
16/25 • Number of events 16 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
NEUTROPHILS DECREASED (Absolute neutrophil count/ANC)
|
7.4%
2/27 • Number of events 2 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
28.0%
7/25 • Number of events 7 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
PAIN (EXTREMITY-LIMBS)
|
7.4%
2/27 • Number of events 2 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Nervous system disorders
PAIN (HEAD/HEADACHE)
|
29.6%
8/27 • Number of events 8 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
64.0%
16/25 • Number of events 16 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Musculoskeletal and connective tissue disorders
PAIN (MUSCLE)
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Skin and subcutaneous tissue disorders
PAIN (SKIN)
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
PLATELETS DECREASED
|
18.5%
5/27 • Number of events 5 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
40.0%
10/25 • Number of events 10 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
General disorders
RIGORS/CHILLS
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Skin and subcutaneous tissue disorders
SWEATING
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Nervous system disorders
TASTE ALTERATION
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Gastrointestinal disorders
VOMITING
|
14.8%
4/27 • Number of events 4 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
24.0%
6/25 • Number of events 6 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
0.00%
0/27 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
|
Additional Information
Wen-Jen Hwu, MD/Professor, Melanoma Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place