A randomised phase II study of weekly paclitaxel or vinorelbine in combination with cisplatin against inoperable non-small-cell lung cancer previously untreated

Ym, Chen; Rp, Perng; Shih, Jen‐Fu; Lee, Gary; Cs, Lee; Cm, Tsai; Whang‐Peng, Jacqueline

doi:10.1038/sj.bjc.6601526

Cited by 23 publications

(58 citation statements)

References 18 publications

(34 reference statements)

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“…24 In contrast, the current results indicated that gefitinibbased treatment produced no change in symptom scores after 2 months of treatment, indicating that there was better effective prolongation of symptom deterioration.…”

Section: Discussioncontrasting

confidence: 54%

Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

Chen

Liu

Chou

et al. 2007

Cancer

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BACKGROUND.The objective of this study was to assess the efficacy of adding chronic, intermittent, low‐dose vinorelbine to gefitinib treatment for patients who had adenocarcinoma of the lung who failed ≥2 regimens of chemotherapy.METHODS.Patients were randomized into 2 arms: Oral gefitinib 250 mg daily (the G arm) or vinorelbine 15 mg/m2 as an intravenous infusion on Day 1 and oral gefitinib 250 mg daily on Days 2 through 14 every 2 weeks (the GV arm). From August 2004 to October 2005, 48 patients were enrolled. Epidermal growth factor receptor (EGFR) exon 18 through 21 nucleotide sequence analysis and fluorescence in situ hybridization were performed in patients who had tumor tissue specimens available for analysis.RESULTS.After randomization, each arm had 24 patients. However, 3 patients refused vinorelbine treatment and were given gefitinib treatment only. Thus, 27 patients received G treatment, and 21 patients received GV treatment. Objective response rates were 55.6% in the G arm and 52.4% in the GV arm. All toxicities in both arms were mild. The 1‐year progression‐free survival rate was 57.1% in the GV arm and 21.2% in the G arm (P = .008). The median survival was 13.3 months in the G arm and 23.4 months in the GV arm (P = .1231). Three of 6 patients (50%) had an exon 19 in‐frame deletion, and 2 of 10 patients had EGFR gene high polysomy or amplification (20%).CONCLUSIONS.Gefitinib was highly effective in ethnic Chinese patients with adenocarcinoma of the lung who failed previous platinum and taxane treatment. The addition of low‐dose vinorelbine every 2 weeks produced a significantly better 1‐year progression‐free survival rate. Cancer 2007. © 2007 American Cancer Society.

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Section: Discussioncontrasting

confidence: 54%

Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

Chen

Liu

Chou

et al. 2007

Cancer

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“…The schedule was vinorelbine 23 mg/m 2 IV on days 1, 8, and 15 plus cisplatin 60 mg/m 2 on day 1 of every 4 weeks [21]. The vinorelbine dose intensity was slightly lower, while the cisplatin dose intensity was higher in the present study.…”

Section: Discussionmentioning

confidence: 52%

A randomized phase II study of docetaxel or vinorelbine in combination with cisplatin against inoperable, chemo-naïve non-small-cell lung cancer in Taiwan

Chen¹,

Perng²,

Shih³

et al. 2007

Lung Cancer

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“…Between 2003 and 2004, the activity/toxicity of weekly paclitaxel combined with cisplatin has been reported in three consecutive studies [27][28][29].…”

Section: Time To Treatment Failure and Survivalmentioning

confidence: 99%

“…A few weeks later, a phase III study comparing weekly paclitaxel plus cisplatin vs. vinorelbine plus cisplatin in 140 chemo-naïve NSCLC patients was reported [28]. The treatment dose [28] was paclitaxel 66 mg/m 2 on days 1, 8, and 15, and cisplatin 60 mg/m 2 on day 15, or vinorelbine 23 mg/ m 2 on days 1, 8, and 15, and cisplatin 60 mg/m 2 on day 15, every 4 weeks.…”

Section: Time To Treatment Failure and Survivalmentioning

confidence: 99%

“…The treatment dose [28] was paclitaxel 66 mg/m 2 on days 1, 8, and 15, and cisplatin 60 mg/m 2 on day 15, or vinorelbine 23 mg/ m 2 on days 1, 8, and 15, and cisplatin 60 mg/m 2 on day 15, every 4 weeks. There were 26 partial responses and one complete response (overall 38.6%) in the paclitaxel arm, and 27 partial responses (overall 38.6%) in the vinorelbine arm.…”

Section: Time To Treatment Failure and Survivalmentioning

confidence: 99%

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Weekly chemotherapy with cisplatin and paclitaxel in advanced NSCLC: a phase II study

Buccheri

Ferrigno

Giordano

2016

Monaldi Arch Chest Dis

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Background. This phase II study was designed to assess the activity and toxicity of administration of the cisplatin/ paclitaxel combination in advanced non-small cell lung cancer (NSCLC). Methods. Eligibility criteria included: age up to 70 years, pathological diagnosis of NSCLC, inoperable disease or post-operative tumour recurrence, performance status </=2, no severe co-morbidity, no previous chemotherapy, and informed consent. Treatment consisted of intravenous infusion of cisplatin, 25 mg/m2, and paclitaxel, 80 mg/m2, every week. Chemotherapy was continued until completion of a 22-week treatment plan, disease progression, persistent toxicity, or patient refusal. Results. Forty-nine patients entered the study. They received a median of 14 cycles (range 0-22). For both drugs, the median dose-intensity was 75% of projected. Toxicity was generally acceptable, and never life threatening. Alopecia was the most common side effect, followed by anemia, leukopenia, and nausea/vomiting. Twenty patients responded (40.8% response rate), with three complete, pathologically documented responses. The estimated median time to progression was 35 weeks (95% CI: 29-41); the median survival time was 56 weeks (95% CI: not calculable), with a 2-year survival rate of 46.1%. Conclusions. When given on a weekly basis, the cisplatin/ paclitaxel combination is well tolerated, active, and associated to remarkably long survivals.

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A randomised phase II study of weekly paclitaxel or vinorelbine in combination with cisplatin against inoperable non-small-cell lung cancer previously untreated

Cited by 23 publications

References 18 publications

Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

A randomized phase II study of docetaxel or vinorelbine in combination with cisplatin against inoperable, chemo-naïve non-small-cell lung cancer in Taiwan

Weekly chemotherapy with cisplatin and paclitaxel in advanced NSCLC: a phase II study

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