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A randomized phase III trial of adjuvant chemotherapy with cisplatin and vindesine followed by UFT for completely resected pathologic (p-) stage IIIA-N2 non-small cell lung cancer (NSCLC): West Japan Study Group for Lung Cancer Surgery (WJSG) - the 5 th Study



A randomized phase III trial of adjuvant chemotherapy with cisplatin and vindesine followed by UFT for completely resected pathologic (p-) stage IIIA-N2 non-small cell lung cancer (NSCLC): West Japan Study Group for Lung Cancer Surgery (WJSG) - the 5 th Study



Journal of Clinical Oncology 23(16_Suppl): 7262-7262



NlmCategory="UNASSIGNED">7262 Background: Recent clinical evidence has shown that postoperative administration of UFT, an oral 5-fluorouracil derivative agent, is an effective chemotherapy regimen for early-stage NSCLC (NEJM 2004 and ASCO 2004), but not for advanced disease. This trial was conducted to determine whether a cisplatin-based doublet (cisplatin and vindesine, PV) followed by UFT was superior to UFT alone as an adjuvant therapy for pIIIA-N2 NSCLC. Patients who underwent complete resection for pIIIA-N2 adenocarcinoma (Ad) or Squamous cell carcinoma (Sq) without any preoperative therapy were randomized to either receive 1 or 2 cycles of cisplatin (80mg/m2, day1; q4weeks) and vindesine (2-3mg/body, days 1, 8, and 15) followed by UFT (400mg/body, daily for one year) administration (PVUft group) or UFT (400mg/body, daily for one year) administration alone (UFT group). Between March/1991 and March/1994, 58 eligible patients (mean age, 61 years; male percentage, 57%; Ad percentage, 78%; pT1/T2/T3, 38%/55%/7%) were randomized. Among 28 patients assigned to PVUft group, 27 (96%) and 15 (26) patients completed 1 and 2 cycles of PV, respectively; one patient did not received PV. There was no significant difference in the mean UFT dose administered to patients between both groups. Chemotherapy was well tolerated and there was no-chemotherapy related death. The 5-year overall survival rates for PVUft and UFT groups were 46% and 47%, respectively (p=0.401); the 5-year recurrence-free survival rates were 31% and 18%, respectively (p=0.163). No significant survival advantage was achieved by addition of PV over UFT administration alone for pIIIA-N2 NSCLC patients, whereas patients who received PV followed by UFT seemed somewhat favorable prognosis. New platinum doubles followed by UFT might be a candidate of postoperative regimen in future adjuvant trials for pIIIA-N2 NSCLC. No significant financial relationships to disclose.

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Accession: 057090758

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PMID: 27945476


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