Randomized study of vinorelbine (VRB) versus vindesine (VDS) in previously untreated stage IIIB or IV non-small-cell lung cancer (NSCLC)

Furuse, Kiyoyuki; Fukuoka, Masahiro; Kuba, Mutsuo; Yamori, Sadaaki; Nakai, Yushi; Negoro, Shunichi; Katagami, Nobuyuki; Takada, Yoshiki; Kinuwaki, E.; Kawahara, Mutsuto; Kubota, Keiichi; Sakuma, Atsushi; Niitani, Hisanobu

doi:10.1093/oxfordjournals.annonc.a010760

Cited by 38 publications

(13 citation statements)

References 17 publications

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“…Vinorelbine has shown single-agent activity against NSCLC [4, 8, 9, 10, 11, 12, 13, 14]. The main phase II and III trials conducted with single agent vinorelbine are summarized in table 1 [4, 9, 11, 15, 16, 17].…”

Section: Introductionmentioning

confidence: 99%

Is Cisplatin Required for the Treatment of Non-Small-Cell Lung Cancer? Experience and Preliminary Results of a Phase I/II Trial with Topotecan and Vinorelbine

Stupp¹,

Bodmer

Duvoisin

et al. 2001

Oncology

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Platinum-based chemotherapy is considered standard treatment for advanced non-small-cell lung cancer (NSCLC). However, toxicity of most platinum-based regimens is substantial and requires close monitoring and supportive care. Over the past decade, paclitaxel, docetaxel, vinorelbine, gemcitabine, irinotecan, and topotecan have been introduced into the clinic. These newer agents have shown promising activity against NSCLC with a favorable toxicity profile as single agents. For patients with metastatic NSCLC, palliation is the main goal of therapy. Therefore, treatment should be easy to administer on an outpatient basis. We explored a novel combination therapy avoiding platinum. Patients with recurrent or metastatic NSCLC were treated with intravenous (i.v.) topotecan (0.5–1.0 mg/m²/day × 5) and i.v. vinorelbine (20–30 mg/m²/day on day 1 and day 5) in 21-day cycles. Dose-limiting toxicity (DLT) was defined separately with or without the addition of granulocyte colony-stimulating factor (G-CSF) support. Twenty-nine patients have been enrolled to date. At i.v. topotecan doses of 0.75–1.0 mg/m²/day and i.v. vinorelbine of 25 mg/m²/day, neutropenia was frequent but of short duration (<7 days). The DLT of i.v. topotecan (0.85 mg/m²) in the absence of G-CSF support was based on myelosuppression with neutropenic fever. With the addition of G-CSF, a DLT has not been reached. Nonhematologic toxicities included mild to moderate fatigue and constipation. An overall clinical response rate of 42% was achieved, with responses noted at all dose levels. At a short median follow-up of 15 months, the median survival for all patients is 13 months. In conclusion, the combination regimen of topotecan and vinorelbine is feasible for outpatient administration and is well tolerated with less toxicity than platinum-based regimens. Preliminary response data demonstrate good tumor activity, suggesting that this regimen could make an excellent palliative treatment for advanced NSCLC.

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Section: Introductionmentioning

confidence: 99%

Is Cisplatin Required for the Treatment of Non-Small-Cell Lung Cancer? Experience and Preliminary Results of a Phase I/II Trial with Topotecan and Vinorelbine

Stupp¹,

Bodmer

Duvoisin

et al. 2001

Oncology

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“…The efficacy of VNB-C compares favorably to the results of other phase II studies of VNB in combination with agents such as gemcitabine, docetaxel or paclitaxel, given as salvage treatment in patients with NSCLC [26, 27, 28]. In a randomized cross-over study by Furuse et al [29], the VNB-C combination induced 26% major responses in NSCLC patients failing previous vindesine front-line treatment. However, in that trial, almost 50% of the patients had stage III B disease, and the great majority (80%) had WHO PS 0–1.…”

Section: Discussionmentioning

confidence: 92%

Vinorelbine-Based Regimens as Salvage Treatment in Patients with Advanced Non-Small Cell Lung Cancer: Two Parallel Multicenter Phase II Trials

Agelaki

Bania²,

Kouroussis³

et al. 2001

Oncology

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Two parallel phase II trials were conducted in order to evaluate the efficacy and toxicity of vinorelbine-ifosfamide (VNB-IFX) and vinorelbine-carboplatin (VNB-C) combinations as salvage treatment in patients with advanced non-small cell lung cancer (NSCLC). Patients and Methods: Patients failing platinum-based front-line chemotherapy were enrolled in the VNB-IFX trial while patients failing non-platinum-containing chemotherapy were treated with VNB-C. Twenty-nine patients were treated with VNB-IFX [median age: 59 years; performance status, PS (WHO) 0–1: 72% and disease stage IV: 79%] and 37 with VNB-C [median age: 61 years; PS (WHO) 0–1: 51% and stage IV: 84%]. Patients received vinorelbine 25 mg/m² i.v. on days 1 and 8 and ifosfamide 1.6 g/m² i.v. on days 8–10 with uroprotective mesna, in cycles of 28 days. G-CSF (5 µg/kg/day s.c.) was administered prophylactically on days 11–16 or until hematological recovery. The VNB-C regimen consisted of carboplatin 300 mg/m² on day 1 and vinorelbine 30 mg/m² on days 1 and 8 every 28 days. Results: Twenty-six patients were evaluable for response in the VNB-IFX trial and 29 in the VNB-C. Overall response rates (intent-to-treat analysis) were 3% (1 patient; duration of response: 3 months) for the VNB-IFX and 16% (median duration of response: 7.5 months) for the VNB-C combination. The median time to progression and survival for patients receiving VNB-IFX were 4.5 and 6 months (1-year survival: 19%), respectively; the corresponding values for VNB-C were 9.0 and 8.5 months (1-year survival: 38%). The median survival of patients achieving stable disease was 10 (VNB-IFX) and 14.5 (VNB-C) months. Grade 3–4 neutropenia occurred in 4 (13%) of the patients treated with VNB-IFX; all cases were complicated with fever. Grade 3–4 neutropenia was documented in 13 (35%) patients in the VNB-C trial; 6 (16%) developed neutropenic fever. There were no treatment-related deaths. Non-hematologic toxicity for the VNB-IFX and VNB-C regimens was mild with grade 2–3 peripheral neurotoxicity occurring in 3 (10%) and 7 (19%) patients, and grade 2–3 asthenia in 11 (38%) and 18 (48%) patients, respectively. Conclusion: Both combinations were associated with a tolerable toxicity profile. VNB-C demonstrated notable activity in patients previously treated with a taxane-based regimen, whilst VNB-IFX failed to produce a significant response rate in patients treated with platinum-containing chemotherapy. Stabilization of disease was associated with a favorable survival in both studies.

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“…The major toxicity was leukopenia. The toxicity of VRB in our randomized phase II study of VRB versus vindesine (VDS) for untreated advanced non-SCLC was moderate [18]. Especially, neurotoxicity, which is the ma jor toxicity of VDS or VCR, was milder than with VDS.…”

Section: Toxicitymentioning

confidence: 84%

Phase II Study of Vinorelbine in Heavily Previously Treated Small Cell Lung Cancer

et al. 1996

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Twenty-four previously treated patients with refractory or relapsed small cell lung cancer (SCLC) were entered into a prospective, multicenter phase II study. All 24 patients had been pretreated with some form of cisplatin-based chemotherapy. The median time of chemotherapy was 4.2 months (range 1.4–9.4 months). Patients were treated with a dose of 25 mg/m² of vinorelbine weekly. Twenty-four patients were eligible for response and for toxicity. Partial response was observed in 3 out of 24 eligible patients (12.5%; 95% confidence interval, 2.7–32.4%). All 3 patients who responded had previous chemotherapy including vincristine. The most common toxicity was leukopenia (91.7%, 66.7% in WHO 3-4 grade) and anemia (70.8%, 20.8% in WHO 3 grade). Nonhematological toxicities were moderate and mild. These results support a two-stage sequential study design of previously untreated patients for further phase II study in SCLC.

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Randomized study of vinorelbine (VRB) versus vindesine (VDS) in previously untreated stage IIIB or IV non-small-cell lung cancer (NSCLC)

Cited by 38 publications

References 17 publications

Is Cisplatin Required for the Treatment of Non-Small-Cell Lung Cancer? Experience and Preliminary Results of a Phase I/II Trial with Topotecan and Vinorelbine

Is Cisplatin Required for the Treatment of Non-Small-Cell Lung Cancer? Experience and Preliminary Results of a Phase I/II Trial with Topotecan and Vinorelbine

Vinorelbine-Based Regimens as Salvage Treatment in Patients with Advanced Non-Small Cell Lung Cancer: Two Parallel Multicenter Phase II Trials

Phase II Study of Vinorelbine in Heavily Previously Treated Small Cell Lung Cancer

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