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Paclitaxel Polygumex (Xyotax) Used to Treat Patients With Advanced Lung Cancer and Poor Performance Status: Presented at ASCO

By Cameron E. Johnston

ORLANDO, FL -- May 17, 2005 -- A re-engineered form of paclitaxel, paclitaxel poliglumex (Xyotax) has been shown to offer the same survival benefits as the traditional formulation in patients with advanced non-small-cell lung cancer and very poor performance status scores.

The findings of the large phase 3 trial conducted in the United States, Canada, Western Europe, and Russia were presented here May 14^th at the American Society of Clinical Oncology Annual Meeting (ASCO).

Paclitaxel poliglumex is a macrodrug that links paclitaxel to poly L-glutamic acid, which is believed to allow greater penetration of the drug into the tumor cells, while at the same time reducing peak exposure to free paclitaxel, potentially making the drug less toxic.

The important feature of the study, said Corey Langer, MD, director, Thoracic and Head & Neck Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, is that this is possibly the first major trial to specifically target patients with advanced disease and very poor performance status.

The patients were at least 70 years old and had disease recurrence after treatment with either surgery or radiation. They were also deemed too weak to tolerate the toxicities associated with other combination modalities. Three-quarters of the patients had stage IV disease.

Brain metastases were present in 7% of patients and 40% in each group had lost a significant amount of weight as a result of the disease.

The researchers randomized 199 patients to treatment with Xyotax 210 mg/m² and carboplatin at an area under the curve (AUC) of 6 of every 21 days, and 201 patients to paclitaxel 225 mg/m² plus carboplatin AUC of 6 every 3 weeks.

Survival data on an intent-to-treat analysis showed no significant difference in survival between groups. Patients receiving Xyotax lived a mean of 7.8 months and those on conventional paclitaxel lived a mean of 7.9 months.

One-year survival was 31% in both arms. Although patients receiving Xyotax had an 18-month survival rate of 20% versus 11% among those receiving paclitaxel, this difference was not statistically significant.

Dr. Langer noted that patients who were recruited from Russia had significantly better outcomes than those in the US/Canada and Western Europe (mean survival 8.7 months and 6.5 months, respectively). Survival at 1 and 2 years also favored those in Russia over those in the US, Canada, and Western Europe. This was a significant finding, but might have been due to those patients from Russia being in better health at the start of the trial, Dr. Langer said.

He noted that subjects in Russia generally had less hypertension, were less likely to have stage IV disease, and were less likely to have had chronic obstructive pulmonary disease.

Also, patients in Russia were more likely to have had stable disease and less likely to have had progressive disease compared with those in the other geographical areas.

Ultimately, time to progression and overall disease control did not differ significantly between treatment groups. Median time to progression was 3.9 months in the Xyotax group and 4.6 months in the conventional paclitaxel group.

Adverse effects, with the exception of nausea and vomiting, were fewer in the Xyotax group. Time to first neuropathy was also significantly shorter in the Xyotax group.

In conclusion, Dr. Langer said that Xyotax was better tolerated than conventional paclitaxel and the administration process was easier and faster.

He added that the survival benefits seen with Xyotax were better than what has been expected with conventional paclitaxel and were superior to what has been seen in the past when patients with advanced lung cancer were treated with either vinorelbine or gemcitabine.


[Presentation title: Paclitaxel Poliglumex (PPX)/Carboplatin vs. Paclitaxel/Carboplatin for the Treatment of PS2 Patients With Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study. Abstract LBA7011]

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