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Title: No Difference in Efficacy, Big Difference in Toxicity, Seen With Gemcitabine and Docetaxel in Combination Versus Sequentially: Presented at ASCO

"No Difference in Efficacy, Big Difference in Toxicity, Seen With Gemcitabine and Docetaxel in Combination Versus Sequentially: Presented at ASCO"

By Cameron E. Johnston ORLANDO, FL -- May 20, 2005 -- There is no difference in overall survival between concurrent or sequential administration of gemcitabine and docetaxel in patients with non-small-cell lung cancer (NSCLC). There is, however, a significant benefit in using sequential dosing of these 2 agents rather than combined dosing in terms of treatment-related toxicity. In a poster presentation here May 16[^th at the American Society of Clinical Oncology Annual Meeting (ASCO), Christian Manegold, MD, medical oncologist, University Medical Center, Mannheim, Germany, reported the findings from the latest analysis of a trial involving 292 patients with advanced lung cancer.

Among these patients, 152 received gemcitabine 1000 mg/m² on days 1 and 8 with docetaxel 75 mg/m² on day 8 for 6 cycles; 140 patients received the same doses of the drugs administered sequentially -- gemcitabine for 3 cycles, followed by 3 cycles of docetaxel, again for 6 cycles.

Toxicity was evaluated by a combination of scores encompassing grade 3 or 4 thrombocytopenia, grade 3 and 4 anemia, and the need for more than 1 blood transfusion per cycle, febrile neutropenia, and need for IV antibiotic. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria.

Approximately 45% of patients in each group had adenocarcinomas and 30% had squamous cell carcinomas. Fifteen percent in each group had stage IIIb and IV NSCLC.

There were no differences in overall survival or response rates between the treatment groups. Thirty-one percent in each group responded to therapy, overall survival in both groups was 214 days, and 1-year survival was 18% in both arms.

However, toxicity rates were significantly different between the groups. Nineteen percent of patients in the concurrent arm required blood transfusions amounting to a total of 81 units throughout the 6 treatment cycles, compared with 10% of patients in the sequential arm (51 units).

Antibiotics were required in 30% of the concurrent group for a total of 426 treatment days, compared with 22% of the sequential arm for a total of 261 treatment days.

Patients who received sequential administration required 66% and 46% of the doses of gemcitabine and docetaxel, respectively, of those in the combined therapy group.

The only impact seen on outcomes not related to toxicity was time to progression, which was shorter in the sequential therapy group (142 days vs 184 days).

These data suggest that sequential dosing of these 2 agents is associated with less clinically relevant toxicity than with concurrent administration, Dr. Manegold concluded.

However, he added, if the patient is able to tolerate the 2 drugs in combination, there is no reason not to offer treatment in that way, as the survival outcomes between the 2 groups are more or less identical.

[Presentation title: A Phase II/III Randomized Study in Advanced Non-Small-Cell Lung Cancer (NSCLC) With First Line Combination Versus Sequential Gemcitabine (G) and Docetaxel (D): Update on Quality of Life (QoL), Toxicity, and Costs. Abstract 7057]

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