Trial Outcomes & Findings for Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00540514)
NCT ID: NCT00540514
Last Updated: 2019-10-29
Results Overview
Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1052 participants
Primary outcome timeframe
Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.
Results posted on
2019-10-29
Participant Flow
Eligible patients were randomized on Day 1 in a 1:1 ratio into 1 of 2 treatment arms and were required to start treatment within 7 days of randomization. The data below represent a cut-off of 31 January 2011. One patient was randomized twice and not included in the Intent-to-treat population.
Participant milestones
| Measure |
Albumin-bound Paclitaxel + Carboplatin
Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m\^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
Participants received 200 mg/m\^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Study
STARTED
|
521
|
531
|
|
Overall Study
Treated
|
514
|
524
|
|
Overall Study
Biomarker Population
|
35
|
36
|
|
Overall Study
COMPLETED
|
275
|
265
|
|
Overall Study
NOT COMPLETED
|
246
|
266
|
Reasons for withdrawal
| Measure |
Albumin-bound Paclitaxel + Carboplatin
Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m\^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
Participants received 200 mg/m\^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Study
Still on treatment
|
3
|
0
|
|
Overall Study
Unacceptable Toxicity
|
61
|
62
|
|
Overall Study
Adverse Event
|
20
|
24
|
|
Overall Study
Physician Decision
|
86
|
99
|
|
Overall Study
Protocol Deviation
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
65
|
67
|
|
Overall Study
Excluded prior to treatment
|
7
|
7
|
|
Overall Study
Paclitaxel not available
|
0
|
2
|
Baseline Characteristics
Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=521 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=531 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Total
n=1052 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 9.53 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
392 Participants
n=5 Participants
|
397 Participants
n=7 Participants
|
789 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
79 participants
n=5 Participants
|
80 participants
n=7 Participants
|
159 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
North American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Non Hispanic and Non Latino
|
416 participants
n=5 Participants
|
433 participants
n=7 Participants
|
849 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic or Latino
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
58 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
74 participants
n=5 Participants
|
75 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
238 participants
n=5 Participants
|
231 participants
n=7 Participants
|
469 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
120 participants
n=5 Participants
|
135 participants
n=7 Participants
|
255 participants
n=5 Participants
|
|
Smoking status
Never smoked
|
137 participants
n=5 Participants
|
144 participants
n=7 Participants
|
281 participants
n=5 Participants
|
|
Smoking status
Smoked and quit smoking
|
168 participants
n=5 Participants
|
148 participants
n=7 Participants
|
316 participants
n=5 Participants
|
|
Smoking status
Smoked and currently smokes
|
214 participants
n=5 Participants
|
234 participants
n=7 Participants
|
448 participants
n=5 Participants
|
|
Smoking status
Missing
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully active)
|
133 participants
n=5 Participants
|
113 participants
n=7 Participants
|
246 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restrictive but ambulatory)
|
385 participants
n=5 Participants
|
416 participants
n=7 Participants
|
801 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 (Ambulatory but unable to work)
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Time from Primary Diagnosis to Study Entry
|
4.3 months
STANDARD_DEVIATION 17.12 • n=5 Participants
|
4.3 months
STANDARD_DEVIATION 16.09 • n=7 Participants
|
4.3 months
STANDARD_DEVIATION 16.60 • n=5 Participants
|
|
Stage at Primary Diagnosis
I
|
16 participants
n=5 Participants
|
20 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Stage at Primary Diagnosis
II
|
18 participants
n=5 Participants
|
24 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Stage at Primary Diagnosis
IIIa
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Stage at Primary Diagnosis
IIIb
|
135 participants
n=5 Participants
|
116 participants
n=7 Participants
|
251 participants
n=5 Participants
|
|
Stage at Primary Diagnosis
IV
|
325 participants
n=5 Participants
|
344 participants
n=7 Participants
|
669 participants
n=5 Participants
|
|
Stage at Primary Diagnosis
Unknown
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Anatomic Site of Primary Diagnosis
Lung
|
480 participants
n=5 Participants
|
499 participants
n=7 Participants
|
979 participants
n=5 Participants
|
|
Anatomic Site of Primary Diagnosis
Other
|
41 participants
n=5 Participants
|
32 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Carcinoma/ Adenocarcinoma
|
254 participants
n=5 Participants
|
264 participants
n=7 Participants
|
518 participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Squamous Cell Carcinoma
|
229 participants
n=5 Participants
|
221 participants
n=7 Participants
|
450 participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Large Cell Carcinoma
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Other
|
29 participants
n=5 Participants
|
33 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Time from 1st Documented Metastasis/Relapse to Study Entry
|
0.9 months
STANDARD_DEVIATION 2.11 • n=5 Participants
|
0.8 months
STANDARD_DEVIATION 1.25 • n=7 Participants
|
0.9 months
STANDARD_DEVIATION 1.73 • n=5 Participants
|
|
Stage at Randomization
IIIb
|
108 participants
n=5 Participants
|
110 participants
n=7 Participants
|
218 participants
n=5 Participants
|
|
Stage at Randomization
IV
|
413 participants
n=5 Participants
|
421 participants
n=7 Participants
|
834 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.Population: The intent-to-treat population which includes all randomized patients regardless of whether the patient received any study drug or had any efficacy assessments collected.
Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions).
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=521 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=531 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment
|
33 percentage of participants
Interval 28.6 to 36.7
|
25 percentage of participants
Interval 21.2 to 28.5
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks until progression or death, up to 38 monthsPopulation: Intent-to-treat
Progression free survival time was defined as the time from the day of randomization to the start of disease progression or death (any cause), whichever occurred first, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the SLD of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the presence of one or more new lesions, or the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesion(s). Participants who did not have disease progression or had not died were censored at the last visit they were documented as progression free. If palliative radiotherapy or surgery at lesion sites occurred, the participant was censored at the last date without documented progression prior to radiotherapy or surgery. In follow-up, participants who began new therapy prior to progression were censored at the last documented date as progression-free.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=521 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=531 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Progression-free Survival by Blinded Radiology Assessment
|
6.3 months
Interval 5.6 to 7.0
|
5.8 months
Interval 5.6 to 6.7
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: Intent-to-treat
Overall survival was defined as the time from the day of randomization to participant death (due to any cause), as assessed by post study follow-up performed monthly for 6 months and every 3 months thereafter for 12 months. All participants who were lost to the follow-up prior to the end of the trial or who completed the 18 month follow up phase were censored at last known time the participant was alive.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=521 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=531 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Participant Survival
|
12.1 months
Interval 10.8 to 12.9
|
11.2 months
Interval 10.3 to 12.6
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks, up to 22 monthsPopulation: Intent-to-treat
Controlled disease was defined as the percentage of participants with stable disease for ≥ 16 weeks or confirmed complete or partial overall response, based on blinded radiological assessment. Stable disease was defined as neither sufficient shrinkage of target lesions to qualify for Partial Response, nor sufficient increase to qualify for Progressive Disease, or the persistence of one or more non-target lesions not qualifying for Complete Response or Progressive Disease.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=521 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=531 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants With Controlled Disease
|
53 percentage of participants
Interval 48.3 to 56.9
|
49 percentage of participants
Interval 44.7 to 53.2
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks, up to 38 monthsPopulation: Intent-to-treat patients with an objective response.
Duration of response was assessed by progression free survival for participants who achieved a confirmed complete response or partial response based on blinded radiological assessment.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=170 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=132 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Duration of Response in Responding Patients
|
9.6 months
Interval 8.3 to 10.8
|
9.5 months
Interval 8.1 to 11.0
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: Treated population
A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=514 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=524 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
At least 1 serious AE
|
93 participants
|
80 participants
|
|
Number of Participants With Adverse Events (AEs)
At least 1 treatment-related serious AE
|
37 participants
|
30 participants
|
|
Number of Participants With Adverse Events (AEs)
At least 1 AE with taxane permanently discontinued
|
80 participants
|
84 participants
|
|
Number of Participants With Adverse Events (AEs)
At least 1 AE with action of taxane dosage reduced
|
237 participants
|
120 participants
|
|
Number of Participants With Adverse Events (AEs)
At least 1 AE with action of taxane interrupted
|
0 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AEs)
At least 1 AE with action of taxane delayed
|
365 participants
|
214 participants
|
|
Number of Participants With Adverse Events (AEs)
At least 1 AE
|
483 participants
|
504 participants
|
|
Number of Participants With Adverse Events (AEs)
At least 1 grade 3 or higher AE
|
360 participants
|
355 participants
|
|
Number of Participants With Adverse Events (AEs)
At least 1 treatment-related AE
|
469 participants
|
481 participants
|
|
Number of Participants With Adverse Events (AEs)
At least 1 treatment-related grade 3 or higher AE
|
321 participants
|
315 participants
|
SECONDARY outcome
Timeframe: Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion.Population: Patients randomized to receive albumin-bound paclitaxel/carboplatin treatment in Canada, Russia, Ukraine and United States had the option to participate in sparse PK sampling in this study. Only 15 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months.Population: SPARC biomarker Population
The expression and cellular distribution of Secreted Protein Acidic and Rich in cysteine (SPARC) in biopsies of lung tumor was examined by immunohistochemistry using a 2 antibody system by an approved central laboratory and analyzed by 2 pathologists. The following tissue components were scored: tumor cells, fibroblasts, inflammatory cells, acellular stroma/matrix, and blood vessels. To classify participants into "high-SPARC" and "low-SPARC" groups, an average z-score was calculated across variables and classified "high-SPARC" (average z-scores ≥0) and "low-SPARC" (average z-scores \<0) groups. SPARC status was then correlated with overall survival (the time from the day of randomization to participant death due to any cause).
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=35 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=36 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
SPARC Status and Correlation With Overall Survival
High-SPARC
|
17 participants
Interval 3.3 to 23.1
|
22 participants
Interval 2.3 to 28.0
|
|
SPARC Status and Correlation With Overall Survival
Low-SPARC
|
18 participants
Interval 3.7 to 24.9
|
14 participants
Interval 4.7 to 22.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.Population: The intent-to-treat population. N indicates the number of participants in each histology category for each treatment arm respectively.
Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions). Histology was determined at the time of primary diagnosis.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=521 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=531 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology
Carcinoma/Adenocarcinoma [254, 264]
|
26 percentage of participants
|
27 percentage of participants
|
|
Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology
Squamous Cell Carcinoma [229, 221]
|
41 percentage of participants
|
24 percentage of participants
|
|
Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology
Large Cell Carcinoma [N=9, 13]
|
33 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology
Other [N=29, 33]
|
24 percentage of participants
|
15 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 38 monthsPopulation: Treated population where laboratory data were available.
The maximal degree of anemia (and myelosuppression) was assessed by the overall nadir of hemoglobin levels based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=508 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=514 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Maximal Degree of Anemia Based on Clinical Laboratory Values for Hemoglobin
|
90.0 g/L
Standard Deviation 17.19
|
103.9 g/L
Standard Deviation 16.90
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 38 monthsPopulation: Treated population where laboratory data were available.
The maximal degree of neutropenia (and myelosuppression) was assessed by the overall nadir of absolute neutrophil count (ANC) based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=508 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=513 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Maximal Degree of Neutropenia Based on Clinical Laboratory Values of Absolute Neutrophil Count
|
1.39 × 10^9/L
Standard Deviation 1.721
|
1.26 × 10^9/L
Standard Deviation 1.366
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 38 monthsPopulation: Treated population where laboratory data were available.
The maximal degree of thrombocytopenia (and myelosuppression) was assessed by the overall nadir of platelet count based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=508 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=513 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Maximal Degree of Thrombocytopenia Based on Clinical Laboratory Values of Platelet Count
|
114.9 × 10^9/L
Standard Deviation 82.13
|
136.6 × 10^9/L
Standard Deviation 81.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 38 monthsPopulation: Treated population with ≥ grade 3 treatment-related peripheral neuropathy.
Peripheral neuropathy was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. Improvement in peripheral neuropathy was evaluated as: * Time to improvement of grade 3 or higher peripheral neuropathy by at least one grade; * Time to improvement of grade 3 or higher peripheral neuropathy to grade 1. Time to improvement was defined as the time from the first occurrence of grade 3 or higher treatment related neuropathy to improvement, as defined. Participants not experiencing improvement were censored at the last time the participant was evaluated for adverse events.
Outcome measures
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=17 Participants
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=62 Participants
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Time to Improvement of ≥ Grade 3 Treatment Related Peripheral Neuropathy
Improvement by ≥1 grade
|
24.0 days
Interval 15.0 to
Maximum confidence interval limit not estimable due to low number of events.
|
26.0 days
Interval 15.0 to 38.0
|
|
Time to Improvement of ≥ Grade 3 Treatment Related Peripheral Neuropathy
Improvement to grade 1
|
38.0 days
Interval 19.0 to
Maximum confidence interval limit not estimable due to low number of events.
|
104.0 days
Interval 40.0 to 169.0
|
Adverse Events
Albumin-bound Paclitaxel + Carboplatin
Serious events: 93 serious events
Other events: 483 other events
Deaths: 0 deaths
Paclitaxel + Carboplatin
Serious events: 80 serious events
Other events: 499 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=514 participants at risk
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=524 participants at risk
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
19/514 • Up to 38 months
|
0.57%
3/524 • Up to 38 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.78%
4/514 • Up to 38 months
|
0.95%
5/524 • Up to 38 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.19%
1/514 • Up to 38 months
|
0.38%
2/524 • Up to 38 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Infections and infestations
Pneumonia
|
2.7%
14/514 • Up to 38 months
|
2.1%
11/524 • Up to 38 months
|
|
Infections and infestations
Cellulitis
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Infections and infestations
Cystitis
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Infections and infestations
Herpes zoster
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Infections and infestations
Injection site abscess
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Infections and infestations
Lung abscess
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Infections and infestations
Meningitis bacterial
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Infections and infestations
Meningitis
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.78%
4/514 • Up to 38 months
|
1.1%
6/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.78%
4/514 • Up to 38 months
|
1.5%
8/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.58%
3/514 • Up to 38 months
|
0.76%
4/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.39%
2/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.39%
2/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.19%
1/514 • Up to 38 months
|
0.57%
3/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Nervous system disorders
Cerebral infarction
|
0.39%
2/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.39%
2/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Nervous system disorders
Convulsion
|
0.39%
2/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Nervous system disorders
Spinal cord compression
|
0.39%
2/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Nervous system disorders
Brain oedema
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Nervous system disorders
Headache
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
2/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Arrhythmia
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Atrial flutter
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Left ventricular failure
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Cardiac disorders
Myocardial infarction
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Pericardial effusion
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/514 • Up to 38 months
|
0.38%
2/524 • Up to 38 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/514 • Up to 38 months
|
0.38%
2/524 • Up to 38 months
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Gastrointestinal disorders
Vomiting
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/514 • Up to 38 months
|
0.38%
2/524 • Up to 38 months
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.39%
2/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Vascular disorders
Hypertension
|
0.39%
2/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Vascular disorders
Embolism
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
General disorders
Asthenia
|
0.19%
1/514 • Up to 38 months
|
0.38%
2/524 • Up to 38 months
|
|
General disorders
Disease progression
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
General disorders
Multi-organ failure
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
General disorders
Pyrexia
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
General disorders
Malaise
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
General disorders
Sudden death
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.39%
2/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.19%
1/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Investigations
Influenza serology
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Psychiatric disorders
Confusional state
|
0.19%
1/514 • Up to 38 months
|
0.00%
0/524 • Up to 38 months
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Eye disorders
Cataract
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/514 • Up to 38 months
|
0.19%
1/524 • Up to 38 months
|
Other adverse events
| Measure |
Albumin-bound Paclitaxel + Carboplatin
n=514 participants at risk
Participants received albumin-bound paclitaxel 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
Paclitaxel + Carboplatin
n=524 participants at risk
Participants received 200 mg/m\^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
50.6%
260/514 • Up to 38 months
|
47.7%
250/524 • Up to 38 months
|
|
Blood and lymphatic system disorders
Anaemia
|
43.8%
225/514 • Up to 38 months
|
20.8%
109/524 • Up to 38 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.5%
208/514 • Up to 38 months
|
23.3%
122/524 • Up to 38 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
18.9%
97/514 • Up to 38 months
|
17.4%
91/524 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
55.8%
287/514 • Up to 38 months
|
59.5%
312/524 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.7%
50/514 • Up to 38 months
|
8.2%
43/524 • Up to 38 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.5%
136/514 • Up to 38 months
|
39.9%
209/524 • Up to 38 months
|
|
Nervous system disorders
Neuropathy peripheral
|
20.2%
104/514 • Up to 38 months
|
22.5%
118/524 • Up to 38 months
|
|
Nervous system disorders
Dysgeusia
|
7.0%
36/514 • Up to 38 months
|
6.3%
33/524 • Up to 38 months
|
|
Nervous system disorders
Headache
|
7.0%
36/514 • Up to 38 months
|
4.4%
23/524 • Up to 38 months
|
|
Nervous system disorders
Dizziness
|
6.0%
31/514 • Up to 38 months
|
3.8%
20/524 • Up to 38 months
|
|
General disorders
Fatigue
|
24.5%
126/514 • Up to 38 months
|
22.9%
120/524 • Up to 38 months
|
|
General disorders
Asthenia
|
16.1%
83/514 • Up to 38 months
|
14.3%
75/524 • Up to 38 months
|
|
General disorders
Oedema peripheral
|
10.3%
53/514 • Up to 38 months
|
4.0%
21/524 • Up to 38 months
|
|
General disorders
Pyrexia
|
9.3%
48/514 • Up to 38 months
|
7.8%
41/524 • Up to 38 months
|
|
General disorders
Chest pain
|
5.3%
27/514 • Up to 38 months
|
3.8%
20/524 • Up to 38 months
|
|
Gastrointestinal disorders
Nausea
|
27.2%
140/514 • Up to 38 months
|
24.8%
130/524 • Up to 38 months
|
|
Gastrointestinal disorders
Constipation
|
16.3%
84/514 • Up to 38 months
|
12.8%
67/524 • Up to 38 months
|
|
Gastrointestinal disorders
Vomiting
|
12.3%
63/514 • Up to 38 months
|
12.0%
63/524 • Up to 38 months
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
29/514 • Up to 38 months
|
3.6%
19/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.1%
62/514 • Up to 38 months
|
11.3%
59/524 • Up to 38 months
|
|
Gastrointestinal disorders
Diarrhoea
|
14.6%
75/514 • Up to 38 months
|
11.1%
58/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
44/514 • Up to 38 months
|
7.3%
38/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.0%
36/514 • Up to 38 months
|
1.5%
8/524 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.1%
21/514 • Up to 38 months
|
5.2%
27/524 • Up to 38 months
|
|
Investigations
White blood cell count decreased
|
11.7%
60/514 • Up to 38 months
|
12.2%
64/524 • Up to 38 months
|
|
Investigations
Haemoglobin decreased
|
10.9%
56/514 • Up to 38 months
|
6.5%
34/524 • Up to 38 months
|
|
Investigations
Neutrophil count decreased
|
10.7%
55/514 • Up to 38 months
|
11.1%
58/524 • Up to 38 months
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
46/514 • Up to 38 months
|
8.4%
44/524 • Up to 38 months
|
|
Investigations
Weight decreased
|
8.4%
43/514 • Up to 38 months
|
6.3%
33/524 • Up to 38 months
|
|
Investigations
Aspartate aminotransferase increased
|
8.2%
42/514 • Up to 38 months
|
5.9%
31/524 • Up to 38 months
|
|
Investigations
Platelet count decreased
|
6.6%
34/514 • Up to 38 months
|
5.0%
26/524 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.6%
65/514 • Up to 38 months
|
24.6%
129/524 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.7%
50/514 • Up to 38 months
|
18.5%
97/524 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
15/514 • Up to 38 months
|
5.3%
28/524 • Up to 38 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.3%
89/514 • Up to 38 months
|
18.3%
96/524 • Up to 38 months
|
|
Psychiatric disorders
Insomnia
|
5.4%
28/514 • Up to 38 months
|
8.0%
42/524 • Up to 38 months
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution may publish the results of its findings if a multicenter publication is not forthcoming within 18 months after study completion. Institution shall provide Celgene with a copy of the papers prior to their submission; Celgene shall complete its review within 60 days after receipt. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of patentable material.
- Publication restrictions are in place
Restriction type: OTHER