Randomized Phase III Trial Comparing Single-Agent Paclitaxel Poliglumex (CT-2103, PPX) with Single-Agent Gemcitabine or Vinorelbine for the Treatment of PS 2 Patients with Chemotherapy-Naïve Advanced Non-small Cell Lung Cancer
Mary O’BrienMark A. SocinskiAlexander Y. PopovichIgor BondarenkoAntoaneta TomovaBorys T. Bilynsky ̆ıYevhen HotkoV.L. GanulIppolit Y. KostinskyAmy J. EisenfeldLarissa SandalicF. B. OldhamB. BandstraAlan B. SandlerJack W. Singer
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Vinorelbine
Taxane
Clinical endpoint
Metastatic breast cancer (BC) remains an incurable disease and clinical benefit and prolongation of time to progression are the main end-points in advanced setting. A safe and feasible schedule of administration is the principal option in pre-treated and symptomatic patients, as in the elderly too. Oral vinorelbine represents a good choice for its toxicity profile and activity in anthracycline and taxane-pre-treated BC patients. A 20–30% response rate (RR) can be obtained when used as single agent. In phase II trials, involving fit patients, and when oral vinorelbine is used in combination with other agents (e.g., capecitabine) a RR of 50-60% has been observed. In HER2-positive BC a combination of oral vinorelbine and trastuzumab has a dramatic activity in first-line therapy and is a reasonable choice in trastuzumab pre-treated patients. In conclusion, oral vinorelbine represents a pivotal choice in advanced and pre-treated BC both as single agent and in combination with others.
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The complex natural product paclitaxel (Taxol), first isolated from Taxus brevifolia, is a member of a large family of taxane diterpenoids. Paclitaxel is extensively used for the treatment of solid tumors, particularly those of the breasts and ovaries. In order to obtain additional information about the mechanism of action of paclitaxel and the environment of the paclitaxel-binding site, several fluorescent analogs of paclitaxel were synthesized, and their biological activities have been evaluated. For the investigation of possible synergistic effects, concurrent modifications on selected positions have been performed and their biological evaluation were studied.
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It is reported that the single-agent administration of vinorelbine (VNR) is improper in salvage therapy for non-small cell lung cancer. However, there are few reports on its use as second line in taxane-containing chemotherapy. We used single-agent VNR administration for nine cases of taxane-resistant non-small cell lung cancer, and an antitumor effect was seen in four cases. We present three of these cases. A factor for the high response rate is considered to be that vinca alkaloid is not used as a pre-treatment. Moreover, VNR may be effective even if there is a gene mutation for beta tubulin, which causes taxane resistance.
Vinorelbine
Taxane
Vinca alkaloid
Vinca
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Metastatic breast cancer (BC) remains an incurable disease and clinical benefit and prolongation of time to progression are the main end-points in advanced setting. A safe and feasible schedule of administration is the principal option in pre-treated and symptomatic patients, as in the elderly too. Oral vinorelbine represents a good choice for its toxicity profile and activity in anthracycline and taxane-pre-treated BC patients. A 20–30% response rate (RR) can be obtained when used as single agent. In phase II trials, involving fit patients, and when oral vinorelbine is used in combination with other agents (e.g., capecitabine) a RR of 50−60% has been observed. In HER2-positive BC a combination of oral vinorelbine and trastuzumab has a dramatic activity in first-line therapy and is a reasonable choice in trastuzumab pre-treated patients. In conclusion, oral vinorelbine represents a pivotal choice in advanced and pre-treated BC both as single agent and in combination with others.
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Paclitaxel (Taxol®) and docetaxel (Taxotere®) are relatively new drugs used in cancer therapy and have shown great promise in the treatment of a variety of cancers. The taxane therapy, however, encounters two major problems. One problem is the low solubility of both paclitaxel and docetaxel; the second problem is multi-drug resistance. In the patent literature from 1995 - 1997 these two problems have been the main focus of research in the taxane field. Numerous taxoids have been disclosed with improved solubility, mainly by acylation of the C-2′ and C-7 hydroxyls. To reduce the multi-drug resistance susceptibility of the drugs, alterations on the taxane core and the phenylisoserine ring have been made. The patent literature also reports the discovery of new classes of compounds (epothilones, discodermolides, eleutherobins and sarcodictyins) that are structurally dissimilar from taxanes but have microtubule stabilisation activity and are potent inhibitors of cancer cells and paclitaxel-resistant cancer cells.
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Objective:To observe the efficacy,toxicity and side effects of gemcitable or vinorelbine cominld with cisplation in the treatment of patients with advanced non-small cell lung cancer (NSCLC). Methods: Total of 80 patients with advanced NSCLC diagnosed by pathology or cytology were enrolled into two groups randomly, 40 in each group . Group gemcitabine with 40 patients received gemcitabine 1200 mg/m2 on d1,8 and cisplatin 80mg/m2 on d1,d3; group vinorelbine received vinorelbine 25 mg/m2 on d1,8 and cisplatin 80 mg/m2 on d1,d3. Both regiments had 21 days for each cycle, three weeks repeated and the efficacy was observed after 3 periods. Results: The effective rates of group gemcitabine and vinorelbine were 47.5% (19/40) and 45.0%(18/40) respectively, there was no significant difference (P0.05) between two groups. The median ailment development time were 4.9 and 4.1 months for group gemcitabine and vinorelbine ,respectively and there was sfafastic difference (P0.05). The 1-year survival rates were 42.5% for group gemcitabine and 40.0% for group vinorelbine, no significant difference (P0.05).Thrombocytopenia with group gemcitabine was higher than that of group vinorelbine but the leucopenian and alopecia and phlebitis in group gemcitabine were apparently lower than that in group vinorelbine. Conclusion: There was no significant difference between group gemcitabine and vinorelbine on efficacy ,median survival time and 1-year survival rate ,but there was a little advantage in group gemcitabine on median ailment development time. Both regimens are effective and well tolerated for patients with advanced non-small cell lung cancer.
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Vinorelbine
Taxane
Vinca alkaloid
Vinca
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Purpose: To evaluate the effect of four taxane drugs, namely, paclitaxel, docetaxel, paclitaxel liposomes (Lipusu), and nab-paclitaxel (Keaili) on ovarian cancer cells both in vivo and in vitro.
Methods: BALB/c-nu/nu female mice were used to develop mouse xenograft models. The mice were randomized to 5 groups (4 in each group), namely, control (PBS) group, paclitaxel group, docetaxel group, liposomal paclitaxel group and nab-paclitaxel group. The effect of four taxane drugs were determined via cell proliferation and toxicity tests. Mouse xenograft models were employed to assess the efficacy of four taxane drugs in inhibiting tumor growth.
Results: Nab-paclitaxel has a significant ovarian growth-reducing effect in vitro. In vivo, no significant differences were observed in tumor volume among the four groups (p < 0.05). Nab-paclitaxel produced the lowest animal toxicity when compared with other three drugs as the mice in nab- paclitaxel treatment group showed no significant alterations in body weight (p < 0.05). Hematoxylin and eosin (H & E) staining revealed the lowest degree of liver tissue damage in mice treated with nab-paclitaxel compared to mice administered the other three paclitaxels.
Conclusion: Nab-paclitaxel is more effective in mice with ovarian cancer than traditional paclitaxels. Thus, it promises to offer a viable alternative as first- line chemotherapy for epithelial ovarian cancer in humans, as it has low systemic toxicity and fewer hypersensitivity reactions. However, further investigations, including clinical trials in humans, are required.
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