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document
Phase III comparative study of high-dose cisplatin versus a combination of paclitaxel and cisplatin in patients with advanced non-small-cell lung cancer . PURPOSE New effective chemotherapy is needed to improve the outcome of patients with advanced non-small-cell lung cancer ( NSCLC ) . Paclitaxel administered as a single agent or in combination with cisplatin has been shown to be a potentially new useful agent for the treatment of NSCLC . PATIENTS AND METHODS Between January 1995 and April 1996 , 414 patients with stage IIIB or IV NSCLC were randomized to received either a control arm of high-dose cisplatin ( 100 mg/m ( 2 ) ) or a combination of paclitaxel ( 175 mg/m ( 2 ) , 3-hour infusion ) and cisplatin ( 80 mg/m ( 2 ) ) every 21 days . RESULTS Compared with the cisplatin-only arm , there was a 9 % improvement ( 95 % confidence interval , 0 % to 19 % ) in overall response rate for the paclitaxel/cisplatin arm ( 17 % v 26 % , respectively ; P=.028 ) . Median time to progression was 2.7 and 4.1 months in the control and paclitaxel/cisplatin arm , respectively ( P=.026 ) . The study , however , failed to show a significant improvement in median survival for the paclitaxel/cisplatin arm ( 8.6 months in the control arm v 8.1 months in the paclitaxel/cisplatin arm , P=.862 ) . There was more hematotoxicity , peripheral neuropathy , and arthralgia/myalgia on the paclitaxel/cisplatin arm , whereas the high-dose cisplatin arm produced more ototoxicity , nausea , vomiting , and nephrotoxicity . Quality of life ( QOL ) was similar overall between the two arms . CONCLUSION This large randomized phase III trial failed to show a significant improvement in survival for the paclitaxel/cisplatin combination compared with high-dose cisplatin in patients with advanced NSCLC . However , the paclitaxel/cisplatin combination did produce a better clinical response , resulting in an increased time to progression while providing a similar QOL .
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Intervention_Pharmacological
high-dose cisplatin
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Intervention_Pharmacological
paclitaxel and cisplatin
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Intervention_Pharmacological
Paclitaxel
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
high-dose cisplatin
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Intervention_Pharmacological
combination of paclitaxel
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Intervention_Pharmacological
cisplatin
4503
Intervention_Pharmacological
paclitaxel/cisplatin
4504
Intervention_Pharmacological
paclitaxel/cisplatin
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Intervention_Pharmacological
paclitaxel/cisplatin
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Intervention_Pharmacological
paclitaxel/cisplatin
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Intervention_Pharmacological
cisplatin
4508
Intervention_Pharmacological
paclitaxel/cisplatin
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
paclitaxel/cisplatin
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Outcome_Physical
overall response rate
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Outcome_Other
Median time to progression
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Outcome_Physical
median survival
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Outcome_Physical
hematotoxicity , peripheral neuropathy , and arthralgia/myalgia
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Outcome_Adverse-effects
ototoxicity , nausea , vomiting , and nephrotoxicity .
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Outcome_Other
Quality of life ( QOL )
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Participant_Condition
patients with advanced non-small-cell lung cancer .
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Participant_Condition
patients with advanced non-small-cell lung cancer ( NSCLC ) .