Nav: Home

Taxotere (R) offers significant survival benefits for head and neck cancer patients

June 05, 2004

BRIDGEWATER, NJ - June 5, 2004 - Aventis announced today the results of a phase III trial using Taxotere® (docetaxel) Injection Concentrate when added to a standard therapy for nonresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, LA. Investigators reported that the Taxotere®-based regimen demonstrated superior overall survival rates, and patients also benefited from significantly improved progression-free survival and cancer response rates, as well as a lower rate of severe side effects compared to the standard therapy.

The trial, conducted by the European Organization for Research and Treatment of Cancer (EORTC) Head and Neck Cooperative Group, involved 358 patients and demonstrated that patients receiving Taxotere® plus cisplatin and 5-fluorouracil (5-FU) had significant prolongation of progression-free survival, the trial's primary endpoint, (12.7 months vs. 8.4 months, p=0.006) compared to those who received the standard treatment of cisplatin and 5-fluorouracil (5-FU). The Taxotere® combination also resulted in significantly improved overall survival (18.6 months vs. 14.5 months, p=0.016) and significantly increased overall response rates (67.8 percent vs. 53.6 percent, p=0.007), the trial's secondary endpoints.

"Head and neck cancer patients have very limited treatment options. The addition of Taxotere® to this standard treatment regimen is very encouraging and may change the paradigm by which we treat this disease," said Jan B. Vermorken, MD, PhD, EORTC Principal Investigator, Professor of Oncology and Head of the Department of Medical Oncology at the University Hospital of the University of Antwerp in Belgium. "The trial findings provide new important information for oral surgeons, medical oncologists and radiation oncologists."

Head and neck cancer is the seventh most frequently occurring cancer worldwide with an incidence rate of 390,000 cases annually. In the United States, it is estimated that more than 38,000 cases will occur in 2004.

"We are encouraged by today's results that suggest a benefit with Taxotere® for patients with advanced head and neck cancer, a difficult to treat disease," said Frank Douglas, MD, PhD, Executive Vice President of Drug Innovation and Approval and a Member of the Board of Management at Aventis.

Study Results and Protocol

Patients in the multicenter trial were randomly assigned to receive one of two treatments. Of the 358 participants, 177 received an infusion of Taxotere® plus cisplatin on day one and a five-day continuous infusion of 5-fluorouracil (5-FU) and 181 patients received an infusion of a standard treatment consisting of cisplatin on day one followed by a five-day continuous infusion of 5-fluorouracil (5-FU). Treatment cycles were to be repeated every three weeks for a total of four cycles. All patients received radiation therapy following chemotherapy within four to seven weeks after completing the last cycle of chemotherapy. Radiation therapy was administered five days a week for up to seven weeks.

In this trial, investigators reported that Taxotere® regimen was well tolerated and had a generally predictable and manageable safety profile. Patients receiving the cisplatin and 5-fluorouracil (5-FU) regimen showed greater grade 3-4 nausea (7.3 percent vs. 0.6 percent), vomiting (5.0 percent vs. 0.6 percent) stomatitis (11.2 percent vs. 4.6 percent) and more toxic deaths (5.5 percent vs. 2.3 percent) when compared to the Taxotere® regimen.

These results are one of three large randomized phase III Taxotere® studies highlighted at this premier oncology meeting from which investigators reported survival advantages for cancer patients. Also two landmark phase III trials, TAX 327 (abstract 4) and SWOG 9916 (abstract 3), demonstrated a Taxotere®-based regimen yielded a statistically significant survival benefit for men with androgen-independent (hormone-refractory) metastatic prostate cancer.

About Taxotere

Taxotere®, a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere® promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in cancer cell death.

Taxotere® is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not received prior chemotherapy. It also is approved for patients with unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. On May 19, 2004, the U.S. Food and Drug Administration granted approval of Taxotere® for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer.

Among patients receiving Taxotere® the most common severe adverse events were low blood cell count, fatigue, diarrhea, and mouth and throat irritation.

The most common non-severe side effects include hair loss, numbness, a tingling and/or burning sensation, rash, nail changes, nausea, vomiting, and muscle pain.

Less common severe or potentially life threatening side effects include fluid retention, infections, and allergic reactions.

Patients 65 years of age or older may experience some side effects more frequently. For more information about Taxotere®, visit or see full prescribing information including boxed WARNING.
For more information about ongoing clinical trials, please call 1-800-RxTrial or visit

About Aventis

Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of € 16.79 billion (US $18.99), invested € 2.86 billion (US $3.24) in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information, please visit:

Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de Référence"- on file with the "Commission des Opérations de Bourse" in France, recently renamed "Autorité des marchés financiers".

Additional Contact:

Marisol Peron, U.S. Product Communications, 908-243-7592,

Abstract #5508

Porter Novelli

Related Cancer Articles:

Radiotherapy for invasive breast cancer increases the risk of second primary lung cancer
East Asian female breast cancer patients receiving radiotherapy have a higher risk of developing second primary lung cancer.
Cancer genomics continued: Triple negative breast cancer and cancer immunotherapy
Continuing PLOS Medicine's special issue on cancer genomics, Christos Hatzis of Yale University, New Haven, Conn., USA and colleagues describe a new subtype of triple negative breast cancer that may be more amenable to treatment than other cases of this difficult-to-treat disease.
Metabolite that promotes cancer cell transformation and colorectal cancer spread identified
Osaka University researchers revealed that the metabolite D-2-hydroxyglurate (D-2HG) promotes epithelial-mesenchymal transition of colorectal cancer cells, leading them to develop features of lower adherence to neighboring cells, increased invasiveness, and greater likelihood of metastatic spread.
UH Cancer Center researcher finds new driver of an aggressive form of brain cancer
University of Hawai'i Cancer Center researchers have identified an essential driver of tumor cell invasion in glioblastoma, the most aggressive form of brain cancer that can occur at any age.
UH Cancer Center researchers develop algorithm to find precise cancer treatments
University of Hawai'i Cancer Center researchers developed a computational algorithm to analyze 'Big Data' obtained from tumor samples to better understand and treat cancer.
New analytical technology to quantify anti-cancer drugs inside cancer cells
University of Oklahoma researchers will apply a new analytical technology that could ultimately provide a powerful tool for improved treatment of cancer patients in Oklahoma and beyond.
Radiotherapy for lung cancer patients is linked to increased risk of non-cancer deaths
Researchers have found that treating patients who have early stage non-small cell lung cancer with a type of radiotherapy called stereotactic body radiation therapy is associated with a small but increased risk of death from causes other than cancer.
Cancer expert says public health and prevention measures are key to defeating cancer
Is investment in research to develop new treatments the best approach to controlling cancer?
UI Cancer Center, Governors State to address cancer disparities in south suburbs
The University of Illinois Cancer Center and Governors State University have received a joint four-year, $1.5 million grant from the National Cancer Institute to help both institutions conduct community-based research to reduce cancer-related health disparities in Chicago's south suburbs.
Leading cancer research organizations to host international cancer immunotherapy conference
The Cancer Research Institute, the Association for Cancer Immunotherapy, the European Academy of Tumor Immunology, and the American Association for Cancer Research will join forces to sponsor the first International Cancer Immunotherapy Conference at the Sheraton New York Times Square Hotel in New York, Sept.

Related Cancer Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Moving Forward
When the life you've built slips out of your grasp, you're often told it's best to move on. But is that true? Instead of forgetting the past, TED speakers describe how we can move forward with it. Guests include writers Nora McInerny and Suleika Jaouad, and human rights advocate Lindy Lou Isonhood.
Now Playing: Science for the People

#527 Honey I CRISPR'd the Kids
This week we're coming to you from Awesome Con in Washington, D.C. There, host Bethany Brookshire led a panel of three amazing guests to talk about the promise and perils of CRISPR, and what happens now that CRISPR babies have (maybe?) been born. Featuring science writer Tina Saey, molecular biologist Anne Simon, and bioethicist Alan Regenberg. A Nobel Prize winner argues banning CRISPR babies won’t work Geneticists push for a 5-year global ban on gene-edited babies A CRISPR spin-off causes unintended typos in DNA News of the first gene-edited babies ignited a firestorm The researcher who created CRISPR twins defends...