Docetaxel Approved for Advanced Stomach Cancer

Publication
Article
OncologyONCOLOGY Vol 20 No 5
Volume 20
Issue 5

Sanofi-Aventis announced that following a priority review of the supplemental new drug application (sNDA), the US Food and Drug Administration (FDA) has approved docetaxel (Taxotere) in combination with cisplatin and fluorouracil (5-FU) for the treatment of patients with advanced stomach (gastric) cancer, including cancer of the gastro-esophageal junction, who have not received prior chemotherapy for advanced disease.

Sanofi-Aventis announced that following a priority review of the supplemental new drug application (sNDA), the US Food and Drug Administration (FDA) has approved docetaxel (Taxotere) in combination with cisplatin and fluorouracil (5-FU) for the treatment of patients with advanced stomach (gastric) cancer, including cancer of the gastro-esophageal junction, who have not received prior chemotherapy for advanced disease. This is the first FDA approval of an advanced stomach cancer treatment demonstrating a survival advantage in more than a decade, thereby offering physicians and their patients an important new option for treating this disease.

The FDA based its decision on results from the TAX 325 study, the largest international phase III clinical trial in previously untreated advanced stomach cancer, involving 445 patients. Patients treated with the docetaxel-based TCF chemotherapy regimen (docetaxel plus cisplatin and 5-FU) experienced a significant 23% reduction in the risk of death compared to patients who received a current standard treatment with CF (cisplatin and 5-FU), with a median follow-up of 23 months). The median overall survival was significantly longer with the docetaxel-containing regimen (9.2 vs 8.6 months, P < .02), with a hazard ratio of 1.29 (95% confidence interval [CI] = 1.04-1.61). Time to disease progression was nearly 2 months longer in the docetaxel-containing arm (5.6 vs 3.7 months, P = .0004; hazard ratio = 1.47, CF/TCF 95% CI = 1.19-1.83).

New Standard of Treatment

"For many years, patients with gastric cancer had limited options for the treatment of their disease," said Jaffer A. Ajani, MD, professor, GI Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, Principal Investigator of the TAX 325 study "With the approval of this Taxotere-based regimen in this cancer, a new standard of treatment is now available for advanced gastric cancer patients."

ACS Launches Cancer Information Blog

The American Cancer Society has launched a Web log, or blog, authored by J. Leonard Lichtenfeld, MD, the Society's deputy chief medical officer. Dr. Len's Cancer Blog (www.cancer.org/drlen) covers breaking cancer news and provides commentary on new research, scientific developments, and other cancer breakthroughs. The blog attempts to make complex medical and scientific information understandable for a general audience and is the latest tool from the Society to raise awareness of cancer risk, prevention, and early detection through commentary on breaking news in the treatment of cancer.

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Recent Videos
Testing a patient’s genetics may influence decisions such as using longer courses of radiotherapy, says Rachit Kumar, MD.
Spatial transcriptomics and multiplex immunohistochemistry from samples may elucidate outcomes for patients who undergo surgical care for cancer.
Future work may focus on optimizing symptom management associated with percutaneous transesophageal gastrostomy placement in malignant bowel obstructions.
Post-operative length of stay ranged from 4 to 9 days for patients who underwent percutaneous transesophageal gastrostomy for malignant bowel obstructions.
Treatment with KRAS inhibitors may help mitigate a common driver of genetic alteration across a majority of pancreatic cancers.
Various methods of communication ensure that members from radiation oncology, pathology, and other departments are on the same page regarding treatment.
Updated results from the BREAKWATER study seemed to be most impactful to the CRC space, according to Michael J. Pishvaian, MD, PhD.
Related Content