Efficacy, Non-small Cell Lung Cancer
Conditions
Brief summary
A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.
Interventions
DRUGcisplatin, dexamethasone,vitamin B12, folic acid
Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV 2. With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors; 3. with an Eastern CooperativeOncology Group performance status of 0 or 1, 4. At least 18 years of age 5. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula. 6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment 7. patients had fully recovered from its acute effects.
Exclusion criteria
1. peripheral neuropathy \> National Cancer Institute Common Toxicity Criteria grade 1 2. progressive brain metastases, 3. uncontrolled third-space fluid retention before study entry. 4. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | 36months |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate | 6 weeks |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment | 144 |
| Group B cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8 | 144 |
| Total | 288 |
Baseline characteristics
| Characteristic | Group A | Group B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 24 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 129 Participants | 120 Participants | 249 Participants |
| Region of Enrollment China | 144 participants | 144 participants | 288 participants |
| Sex: Female, Male Female | 60 Participants | 73 Participants | 133 Participants |
| Sex: Female, Male Male | 84 Participants | 71 Participants | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 131 / 144 | 140 / 144 |
| serious Total, serious adverse events | 5 / 144 | 5 / 144 |
Outcome results
Primary
Progression Free Survival (PFS)
Time frame: 36months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A | Progression Free Survival (PFS) | 168 day |
| Group B | Progression Free Survival (PFS) | 140 day |
Secondary
Response Rate
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Response Rate | 24.41 percentage |
| Group B | Response Rate | 14.17 percentage |