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document
Paclitaxel ( 175 mg/m2 ) plus carboplatin ( 6 AUC ) versus paclitaxel ( 225 mg/m2 ) plus carboplatin ( 6 AUC ) in advanced non-small-cell lung cancer ( NSCLC ) : a multicenter randomized trial . Hellenic Cooperative Oncology Group ( HeCOG ) . PURPOSE The combination of paclitaxel and carboplatin has become a widely used regimen in NSCLC due to phase II reports of moderate toxicity , reasonable activity and easy outpatient administration . Purpose of our present prospective study was to evaluate the dose response relationship of paclitaxel . PATIENTS AND METHODS Since July 1996 , 198 patients with non-operable NSCLC and measurable disease without previous chemotherapy entered the trial . Ninety nine patients ( group A ) were randomized to receive paclitaxel 175 mg/m2 in three-hour infusion plus carboplatin dosed to an area under the concentration-time curve of 6 every 3 weeks and 99 ( group B ) to receive the same regimen with paclitaxel increased to 225 mg/m2 . Eligibility criteria included WHO performance status 0-2 , documented inoperable stage IIIA and IIIB , IV , no brain metastasis , no prior chemotherapy and adequate renal and hepatic function . Patients in both groups were well-matched with baseline disease characteristics . RESULTS In group A with 90 evaluable patients , the response rate was 25.6 % ( 6 CR , 17 PR ) whereas in group B with 88 evaluable patients , the response rate was 31.8 % ( 3 CR , 25 PR ) , P = 0.733 . Median time to progression favored the high-dose paclitaxel ( 4.3 vs. 6.4 months , P = 0.044 ) . The median survival was 9.5 months for group A versus 11.4 months for group B ( P = 0.16 ) . The one-year survival was 37 % for group A and 44 % for group B ( P = 0.35 ) . The best prognostic factor for one-year survival was the response rate ( P < 0.0001 ) . With a relative dose intensity of paclitaxel 0.94 in both groups , neurotoxicity ( P = 0.025 ) and leucopenia ( P = 0.038 ) were more pronounced in group B patients . No toxic death was observed . CONCLUSIONS Higher dose paclitaxel prolongs the median time to progression but causes more neurotoxicity and leucopenia . The better response rate , the longer overall and better one-year survival seen with the higher dose of paclitaxel are not statistically significant .
4428
Intervention_Pharmacological
Paclitaxel
4429
Intervention_Pharmacological
carboplatin
4430
Intervention_Pharmacological
paclitaxel
4431
Intervention_Pharmacological
plus carboplatin
4432
Intervention_Pharmacological
paclitaxel
4433
Intervention_Pharmacological
carboplatin
4434
Intervention_Pharmacological
chemotherapy
4435
Intervention_Pharmacological
paclitaxel
4436
Intervention_Pharmacological
plus carboplatin
4437
Intervention_Pharmacological
paclitaxel
4438
Intervention_Pharmacological
chemotherapy
4439
Outcome_Other
dose response
4440
Outcome_Physical
response rate
4441
Outcome_Physical
response rate
4442
Outcome_Other
Median time to progression
4443
Outcome_Mortality
median survival
4444
Outcome_Mortality
one-year survival
4445
Outcome_Mortality
one-year survival
4446
Outcome_Physical
response rate
4447
Outcome_Physical
neurotoxicity
4448
Outcome_Physical
leucopenia
4449
Outcome_Mortality
toxic death
4450
Participant_Condition
non-small-cell lung cancer ( NSCLC )
4451
Participant_Sample-size
198
4452
Participant_Condition
non-operable NSCLC
4453
Participant_Sample-size
Ninety nine