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A randomized phase II feasibility study of adjuvant cisplatin/docetaxel (CisD) or cisplatin/vinorelbine (CisV) in patients (pts) resected stage IB-II non-small cell lung cancer (NSCLC): Interim analysis



A randomized phase II feasibility study of adjuvant cisplatin/docetaxel (CisD) or cisplatin/vinorelbine (CisV) in patients (pts) resected stage IB-II non-small cell lung cancer (NSCLC): Interim analysis



Journal of Clinical Oncology 26(15_Suppl): 7594-7594



NlmCategory="UNASSIGNED">7594 Background: Several randomized phase III trials in early-stage NSCLC, have shown that Cis-VRB adjuvant chemotherapy improves survival; however, compliance with adjuvant chemotherapy has been problematic. A recent meta-analysis in pts with advanced NSCLC found a significant survival benefit associated with docetaxel-based therapy relative to vinca alkaloid-based therapy. Eligibility criteria included completely resected pathologic stage IB-II NSCLC, age 28-75 years, start of chemotherapy within 60 days of resection, Karnofsky performance status (KPS) 70-100, adequate organ function, and informed consent. Patients were randomized (2:1) to treatment with adjuvant Cis-Doc (Cis and Doc both 75 mg/m2 on day 1) or Cis-VRB (Cis 80 mg/m2 on day 1; VRB 25 mg/m2 on days 1 and 8) every 3 weeks for 4 cycles. The primary endpoint was success of treatment delivery (defined as at least 3 cycles of chemo with a relative dose intensity of ≥80%). A two-staged Bryant and Day design was (total sample size 99 pts) used. The results of the pre-planned interim analysis are presented here. From Dec 2005 to May 2007, 38 pts (29 males, 9 females; median age, 62 years) were randomized (Cis-Doc 26/ Cis-VRB 12). Histologic types included adenocarcinoma (n=22), squamous cell carcinoma (n=12), large cell carcinoma (n=3), and adenosquamous carcinoma (n=1). Pathologic stages included stage IB (n=26), stage IIA (n=5), stage IIB (n=7). Resection consisted of lobectomy (n=29), sleeve lobectomy (n=2) and pneumonectomy (n=7). In arm Cis-Doc 21 pts (81%) and in arm Cis-VRB 12 pts (100%) completed ≥3 cycles. Dose intensity (mg/m2.wk) was: Cis 24.2 and Doc 24.3 in Cis-Doc arm and Cis 23.8 and VRB 15.4 in Cis-VRB arm. Relative dose intensity was Cis-Doc 97%/97% and Cis-VRB 89%/92%. Reasons for discontinuing treatment before the third cycle: pt withdrew from treatment (n=4), renal failure (n=1). Therapy was well tolerated and no treatment-related deaths were observed. These findings indicate that adjuvant therapy with 3-weekly shedules of Cis-Doc or Cis-VRB results in a good chemotherapy compliance and dose intensity. No significant financial relationships to disclose.

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Accession: 057090702

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PMID: 27947399


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