A phase II study of navelbine® (NVB) and cisplatin (CDDP) in advanced non-small cell lung cancer stage IIIb-IV (NSCLC): interim results

17100 Background: Vinorelbine (VNR)/gemcitabine (GEM) is active and well tolerated chemotherapy regimens for the treatment of patients (pts) with advanced non-small-cell lung cancer (NSCLC). UFT is composed of uracil and tegafur in a molar ratio of 4:1, and tegafur is a prodrug of 5-FU. Sequential exposure to 5-FU followed by GEM has been reported to give additive effects in vitro. For these reasons, we conducted a phase II study of triple treatment with these 3 drugs for advanced NSCLC. The objectives were to determine the tumor response rate, survival, safety and toxicity of this combination chemotherapy. Methods: Eligible pts were required to have histologically or cytologically comfirmed measurable or evaluable stage IIIB or IV NSCLC, age <75 years, no previous chemotherapy, a Karnofsky performance status (PS) 0–1, and adequate organ function and bone marrow reserve. In this study, pts received UFT (300 mg/m2 orally on days 1-5, 8–12) plus VNR (25 mg/m2 IV on days 6 and 13) and GEM (1000 mg/m2 IV on days 6 and 13). Treatment was repeated every 3 weeks. Results: Between September 2002 and November 2004, 32 pts were enrolled on this study. Characteristics of this study were as follows: male/female = 20/12; median age = 65 years (range 46–74); PS 0/1 = 11/21; stage IIIB/IV = 5/27. Median # of cycles = 2 (range 1–10). Response: PR = 7 (21.9%), SD = 14, PD = 10, NE = 1. Median survival time was 13.9 mos. 1-year survival rate was 56.7% (95% confidence interval, 38.9–74.4%). Gr 3/4 toxicity (% of pts) was as follows: leukocytes 40.6%, neutrophils 56.3%, platelets 3.1%, infection 9.4%, hypoxia 6.3%, dyspnea 3.1% and ALT/AST 3.1%. There were no treatment-related deaths. Conclusions: The combination of UFT, VNR and GEM appears effective with acceptable toxicity. No significant financial relationships to disclose.

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Phase II study of nivolumab in patients with advanced non-small cell lung cancer (NSCLC) in Korea.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.7_suppl.92 ◽

2017 ◽

Vol 35 (7_suppl) ◽

pp. 92-92

Author(s):

Keunchil Park ◽

Eun Kyung Cho ◽

Jin Hyoung Kang ◽

Ji-Youn Han ◽

Jong Seok Lee ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Phase Ii ◽

Cell Lung Cancer ◽

Phase Ii Study ◽

Objective Response ◽

Small Cell ◽

Stage Iiib ◽

Phase Iii ◽

Small Cell Lung

92 Background: Nivolumab (BMS-936558/ONO-4538), a fully human IgG4, PD-1 immune-checkpoint inhibitor antibody, has shown durable clinical activity in several tumor types. Recently, two phase III studies (CheckMate-017 and -057) demonstrated that nivolumab improved overall survival (OS) than docetaxel in second-line of squamous (SQ) and non-squamous (NSQ) Non-Small Cell Lung Cancer (NSCLC), respectively. Here, we report the results of a phase II study to evaluate the efficacy and safety of nivolumab in Korean patients (pts) with previously treated advanced SQ and NSQ NSCLC. Methods: This study requires pts aged ≥ 20 years with ECOG Performance Status (PS) of 0 or 1, stage IIIB/IV or recurrent NSCLC and at least one prior chemotherapy including platinum containing regimen. Pts received nivolumab 3 mg/kg IV Q2W until progression or unacceptable toxicity. The primary endpoint in this study was the objective response rate (ORR) (RECIST v1.1). Results: Nivolumab was administered to 100 NSCLC pts (SQ: 44, NSQ: 56), male/female: 78 (SQ: 44, NSQ: 34)/22 (SQ: 0, NSQ: 22); PS 0/1: 14 (SQ: 6, NSQ: 8)/86 (SQ: 38, NSQ: 48); aged 29 to 80 [median: 66.5] years (SQ: 40 to 80 [median: 69.5], NSQ: 29 to 77 [median: 63.5]); Stage IIIB/IV/recurrence: 6 (SQ: 5, NSQ: 1)/91 (SQ: 37, NSQ: 54)/3 (SQ: 2, NSQ: 1)). In SQ and NSQ NSCLC, ORR was 15.9% (7/44) and 23.2% (13/56), respectively. Median progression-free survival was 2.6 mo and 5.3 mo, respectively. Complete Response was observed in 2.3% (1/44) and 1.8% (1/56), respectively. Median OS was 12.3 mo and 16.3 mo, respectively. Median follow-up was 8.9 mo and 12.3 mo, respectively. Most common adverse drug reaction (ADR) was decreased appetite 15.9% (7/44), followed by pyrexia 9.1% (4/44) in SQ NSCLC, and decreased appetite 12.5% (7/56), followed by pruritus 10.7% (6/56), fatigue 8.9% (5/56), pyrexia 5.4% (3/56) and nausea 5.4% (3/56) in NSQ NSCLC. Grade 3-4 ADR was observed in 6.8% (3/44) and 10.7% (6/56) of SQ and NSQ NSCLC, respectively. No interstitial lung disease and no grade 5 ADRs were observed in this study. Conclusions: Nivolumab was considered to be effective and used safely in Korean pts with SQ and NSQ NSCLC as well as in non-Korean pts with SQ and NSQ NSCLC. Clinical trial information: NCT02175017.

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