A Multicenter Phase II Trial of Vinorelbine Plus Gemcitabine in Previously Untreated Inoperable (Stage IIIB/IV) Non-small Cell Lung Cancer

Chen, Yuh Min; Perng, Reury Perng; Yang, Kuang Yao; Liu, Tsang Wu; Tsai, Chun Ming; Ming-Liu, Jacqueline; Whang‐Peng, Jacqueline

doi:10.1378/chest.117.6.1583

Cited by 44 publications

(24 citation statements)

References 16 publications

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“…There are at least five phase II trials (results in full paper) in which gemcitabine and vinorelbine treatment has been given to chemo-naïve patients with advanced NSCLC. The observed response rate of 18% in our study was not better than that reported in other gemcitabine-vinorelbine regimens for advanced NSCLC, which have shown responses ranging from 25 to 72.5% [16][17][18][19][20]. It should be noted, however, that not only the dosage of gemcitabine and vinorelbine but also the timing of the drug administration was variable from study to study.…”

Section: Discussioncontrasting

confidence: 72%

Combination chemotherapy of gemcitabine and vinorelbine for patients in stage IIIB–IV non-small cell lung cancer: a phase II study of the West Japan Thoracic Oncology Group (WJTOG) 9908

Katakami

Sugiura²,

Nogami³

et al. 2004

Lung Cancer

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Section: Discussioncontrasting

confidence: 72%

Combination chemotherapy of gemcitabine and vinorelbine for patients in stage IIIB–IV non-small cell lung cancer: a phase II study of the West Japan Thoracic Oncology Group (WJTOG) 9908

Katakami

Sugiura²,

Nogami³

et al. 2004

Lung Cancer

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“…Finally, the taxonomy of gemcitabine-induced lung injury is imperfect. Published literature reports describe apparently similar presentations of gemcitabine-associated lung injury with the terms capillary leak syndrome, 24,26 -30 noncardiogenic pulmonary edema, 16,31,32 interstitial pneumonitis, 16,[33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48] acute pneumonitis, 49 acute respiratory distress syndrome, 8,36,50,51 acute pulmonary toxicity, 52 or acute lung injury. 16,44,45,36,46,[53][54][55][56] In conclusion, our findings highlight the importance of consideration of the risk of lung injury from drug-drug or drug-radiotherapy interactions in designing novel therapeutic regimens for cancer patients, particularly for drugs with additive or synergistic pulmonary toxicity.…”

Section: Discussionmentioning

confidence: 99%

Clinical features and correlates of gemcitabine‐associated lung injury

Belknap

Kuzel

Yarnold

et al. 2006

Cancer

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BACKGROUNDGemcitabine is a commonly used chemotherapeutic agent structurally and pharmacologically similar to cytarabine. Recently, instances of severe gemcitabine‐associated lung injury have been reported. Herein, investigators affiliated with the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program evaluated clinical characteristics of gemcitabine‐associated severe acute lung injury from clinical trial reports, medical literature case reports, and spontaneous reports to the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS).METHODSClinical data were obtained by reviewing adverse event case reports for gemcitabine‐associated lung injury as reported in the medical literature and in the FDA AERS database. Upper limit estimates of ADE rate were derived from review of published clinical trials reporting gemcitabine‐associated lung injury rates of 10% or higher.RESULTSA total of 178 reports of gencitabine‐associated lung injury were identified; in AERS, there were 55 cases from clinical trials and 92 spontaneous reports. A comprehensive search revealed 31 medical literature reports. Clinical features of gemcitabine‐associated lung injury included dyspnea, fever, pulmonary infiltrate, and cough with recognition of toxicity occurring after a median duration of 48 (range, 1‐529) days after initiation of gemcitabine. The taxanes, docetaxel and paclitaxel, were frequently reported as coadministered therapies. Eleven Phase II or Phase III clinical trials with 317 patients identified gemcitabine‐associated lung injury rates of greater than 10%, with the highest rates (22% and 42%) being observed in Phase III clinical trials where Hodgkin disease patients were treated with a regimen that included gemcitabine and bleomycin.CONCLUSIONSHigh rates of gemcitabine‐associated severe lung injury were observed when gemcitabine was combined with other therapies known to also cause lung injury. Physicians should have a high index of suspicion for this toxicity and report the relevant clinical findings to the FDA's AERS. Cancer 2006. © 2006 American Cancer Society.

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“…Other trials of nonplatinum-containing regimens for NSCLC have been reported (table 4) [16, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39]. Combinations of vinorelbine with epirubicin [30], ifosfamide [31, 32, 33, 34], or gemcitabine [35, 36, 37, 38]proved feasible, with myelosuppression being the most frequent toxicity in all trials.…”

Section: Discussionmentioning

confidence: 99%

“…Combinations of vinorelbine with epirubicin [30], ifosfamide [31, 32, 33, 34], or gemcitabine [35, 36, 37, 38]proved feasible, with myelosuppression being the most frequent toxicity in all trials. Most phase II trials reported response rates of 20–40% and median survival rates of 7–11 months, comparable to platinum-containing regimens.…”

Section: Discussionmentioning

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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A Multicenter Phase II Trial of Vinorelbine Plus Gemcitabine in Previously Untreated Inoperable (Stage IIIB/IV) Non-small Cell Lung Cancer

Cited by 44 publications

References 16 publications

Combination chemotherapy of gemcitabine and vinorelbine for patients in stage IIIB–IV non-small cell lung cancer: a phase II study of the West Japan Thoracic Oncology Group (WJTOG) 9908

Combination chemotherapy of gemcitabine and vinorelbine for patients in stage IIIB–IV non-small cell lung cancer: a phase II study of the West Japan Thoracic Oncology Group (WJTOG) 9908

Clinical features and correlates of gemcitabine‐associated lung injury

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

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