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Title: Docetaxel Regimen Shows Significant Survival Benefit in Treatment of Advanced Gastric Cancer: Presented at ASCO

"Docetaxel Regimen Shows Significant Survival Benefit in Treatment of Advanced Gastric Cancer: Presented at ASCO "

By Cameron E. Johnston ORLANDO, FL -- May 23, 2005 -- Adding docetaxel (Taxotere) therapy to 5-fluorouracil (5-FU) therapy in the treatment of advanced gastric cancer appears to result in longer time to disease progression as well as better overall survival, according to results from a phase 3 study. The trial results were presented here on May 16[^th at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Continuous infusion of 5-FU has historically shown the most predictable results in treatment of gastric cancer, and it is still used as the standard of care in many places, said principal author Vladimir Moiseyenko, MD, professor, Petrov Research Institute of Oncology, St. Petersburg, Russia.

More recently, studies with docetaxel alone have produced overall response rates in the range of 19% to 24%, while a Swiss study showed a 51% response rate when docetaxel, 5-FU, and cisplatin were used in combination.

Docetaxel and cisplatin were each given at 75 mg/m² on day 1, and 5FU was given at 750 mg/m² by continuous infusion on days 1-5 over a 21-day cycle (TCF). A second group of 230 patients received cisplatin 100 mg/m² on day 1 and 5FU 1000 mg/ m² by continuous infusion on days 1-5 over a 28-day cycle (CF).

The primary endpoint of the study was time to disease progression (TTP). Secondary endpoints included overall survival, response rates, time to treatment failure, quality of life, and clinical benefit.

Time to disease progression was a mean of 5.6 months in the TCF arm and 3.7 months in the CF arm, which corresponds to a 32% risk reduction for progressive disease (P = .0004). Overall survival was slightly greater in the TCF arm, 9.2 months compared with 8.6 months in the CF arm, a 22.7% reduction in the risk of death (P = .02).

There were 162 deaths in the TCF arm compared with 172 deaths in the CF arm.

Best overall response was 36% in the TCF arm and 25% in the CF arm (P = .01).

The differences in adverse effect profiles between the 2 arms were predictable, Dr. Moiseyenko said, and for the most part favored the TCF arm.

Grade 3 and 4 nonhematologic events were similar in the 2 arms, except for diarrhea and infections, which were more common in the TCF arm, and stomatitis, which was more common in the CF arm. There were more hematologic toxicities in the TCF arm, including neutropenia and febrile neutropenia.

Quality-of-life and clinical benefit measurements favored the TCF arm on all but 2 measurements -- pain-free survival and time to requiring first opioid therapy, which both favored the CF arm.

Dr. Moiseyenko said this represents the largest trial yet to compare docetaxel- and cisplatin-based therapies in the treatment of advanced gastric cancer and the results suggest a significant advance in the management of this disease.

The study was funded by Sanofi-Aventis, maker of Taxotere.

[Presentation title: Final Results of a Randomized Controlled Phase III Trial (TAX 325) Comparing Docetaxel (T) Combined With Cisplatin (C) and 5-Fluorouracil (F) to CF in Patients (Pts) With Metastatic Gastric Adenocarcinoma (MGC). Abstract 4002]

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