Navigation Links
Eloxatin (oxaliplatin injection)-Based Chemotherapy Sets New,Treatment Benchmark in Patients With Metastatic Colorectal Cancer

FOLFOX4 Chemotherapy Results in Improved Long-term [Five-years] Overall Survival for these Seriously Ill Patients

CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- FOLFOX4, an Eloxatin(R)-based chemotherapy regimen, provided significant improvements in long-term [five- years] overall survival (OS) and time to disease progression (TTP) - a longer period of stable disease - in patients with metastatic (advanced) colorectal cancer. Importantly, the FOLFOX4 results were significantly better than those achieved with irinotecan-based chemotherapy, known as IFL, and IROX, a combination of irinotecan and Eloxatin(R). These data were presented today at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago in an updated analysis of the N9741 study.

FOLFOX4 (Eloxatin(R) combined with infusional 5-FU/LV) was established in the United States as first line treatment for advanced colorectal cancer after the initial presentation of the N9741 study results in 2003 and subsequent Food and Drug Administration (FDA) approval in January 2004. The updated analysis confirms the earlier results and identifies FOLFOX4 chemotherapy as the strongest predictor of improvement in both overall survival and time to disease progression.

N9741 Five-Year Analysis

This study evaluated several chemotherapy regimens using various combinations of Eloxatin(R), 5-FU/LV and irinotecan in 1,691 previously untreated patients with metastatic colorectal cancer who were randomized to seven arms.

Metastatic colorectal cancer patients given the Eloxatin(R)-based regimen FOLFOX4 were almost twice as likely to survive at least five years as those on irinotecan-based therapy (IFL). Five-year survival and time-to-progression rates were calculated using Kaplan-Meier methods for each treatment arm. Patients treated with FOLFOX4 had a 9.2% overall chance of surviving for five years after treatment, the best of all the results reported. In comparison, the chance of living five years was 5.4% among patients treated with Eloxatin(R) plus irinotecan (IROX) (p=.016) and 3.8% (p<.001) among patients treated with the combination of 5-FU/LV and irinotecan (IFL).

FOLFOX4 slowed the progression of the disease compared to IROX and IFL. The median TTP was significantly longer among FOLFOX4-treated patients at 9.2 months compared to 6.5 months with IROX (p=<.001) and 6 months with IFL (p=<.001). FOLFOX4 patients were significantly more likely to experience any grade 3 or greater side effects (odds ratio of 1.65, p<.001) and were lower in men than in women (OR 0.63, p<0.001). The most common side effects were peripheral sensory neuropathy, fatigue, neutropenia, nausea, vomiting, and diarrhea.

"Our five-year overall survival results with first-line FOLFOX4 set a new benchmark for treating metastatic colorectal cancer," said lead investigator Richard Goldberg, MD, University of North Carolina School of Medicine, Chapel Hill, NC. "Adding Eloxatin(R) to standard chemotherapy significantly prolonged survival for these patients and also delayed disease progression."

Treatment with FOLFOX4 Predicts Important Benefits

Receiving FOLFOX4 was found to be the most powerful prognostic factor for predicting overall survival as well as time to progression. Those factors that were predictive of a worse outcome were: higher baseline performance status, neutrophil count, and alkaline phosphatase, as well as a greater number of disease sites. While being 70 years or older was associated with poorer survival, it was not predictive of time to progression, response rate or grade 3 or greater toxicity.

For more information about Eloxatin(R) or for full prescribing information, including BOXED WARNING, visit

About Colorectal Cancer

Strides have been made in the management of colorectal cancer but it is still the second leading cause of cancer-related deaths in the United States. At Stage II, the cancer has grown through the wall of the colon or rectum but has not yet spread to nearby lymph nodes. In Stage III, the cancer has invaded one or more of the local lymph nodes but has not spread to distant sites. Metastatic colorectal cancer means that the cancer has spread to other nodes and/or organs in the body. The American Cancer Society estimates that in 2007 there will be about 112,340 new cases of colon cancer and 41,420 new cases of rectal cancer in the United States.

About sanofi-aventis

Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris and in New York .

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict a nd generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward- looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

    Contact:  Noelle Boyd, sanofi-aventis, (908) 981-6489

             Lisa Kennedy, sanofi-aventis, (908) 981-6569

    ABSTRACT #4067

CONTACT: Noelle Boyd, sanofi-aventis, +1-908-981-6489, or Lisa Kennedy,sanofi-aventis, +1-908-981-6569

Web site:

Company News On-Call: /

Ticker Symbol: (NYSE:SNY)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


Related medicine technology :

1. The Eloxatin-Based Regimen (FOLFOX4) Significantly Improved Progression Free Survival When Given Before and After Surgery in Patients With Resectable Liver Metastases From Colorectal Cancer
2. Pharmacyclics Announces Interim Results From Two Ongoing Phase 2 Trials Supporting Potential of Xcytrin Plus Chemotherapy to Treat Recurrent Non-Small Cell Lung Cancer
3. July Issue of Journal of Antimicrobial Chemotherapy Highlights Study of Factive Tablets for Five-Day Treatment of Community-Acquired Pneumonia
4. New Data Show Pfizers Axitinib Prolonged Overall Survival in Advanced Pancreatic Cancer When Combined with Standard of Care Chemotherapy
5. Hyperthermia Plus Chemotherapy Nearly Doubles Disease-Free Survival Compared to Chemotherapy Alone for Sarcoma Cancer Patients
6. Promising Results with Epratuzumab and Chemotherapy in Children with Acute Lymphoblastic Leukemia
7. MabThera Significantly Extends Survival And Cures More Patients With Aggressive Lymphoma Than Chemotherapy Alone
8. Prostate Cancer: Clinical Study Demonstrates Superior Efficacy of Docetaxel Chemotherapy
9. MabThera Significantly Increases Survival of Lymphoma Patients Regardless of Chemotherapy Regimen
10. Abraxis BioScience Presents Data from Pre-Clinical Study That Provide Evidence for Chemotherapy-Induced Angiogenesis and Rationale for Combining nab-Paclitaxel (Abraxane) with Anti-Angiogenic Agents to Increase Tumor Response
11. Aranesp Phase 3 Study in Patients with Active Cancer Not Receiving Concurrent Chemotherapy or Radiotherapy Presented at AACR Annual Meeting
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 ... Juntendo universitetssjukhus ser potential att använda ... magnetresonansbilder (MR-bilder) för patienter med multipel ... ett forskningsavtal med SyntheticMR AB för att ... forskningsprojekt på sjukhuset. Med SyMRI kan man ...
(Date:11/26/2015)... PUNE, India , November 26, ... --> --> ... Research Report" and "Investigation Report on ... 2019 and 2021 forecasts data and ... library. . ...
(Date:11/26/2015)... 2015 ) ... "Radioimmunoassay Market by Type (Reagents & Kits, ... Clinical Diagnostic Labs), Application (Research, Clinical Diagnostics), ... report to their offering. --> ... of the "Radioimmunoassay Market by Type ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... ... toilets were," said an inventor from Hillside, N.J. "Many people catch diseases simply ... so that individuals will always be protected from germs." , He developed the ...
(Date:11/27/2015)... ... November 27, 2015 , ... Consistent ... sharing, the 2016 Building Better Radiology Marketing Programs meeting will showcase ... Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a pre-conference ...
(Date:11/27/2015)... ... November 27, 2015 , ... CBD College is proud to announce ... (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. CBD College is honored to ... of twelve colleges and universities in the state of California make the cut. CBD ...
(Date:11/26/2015)... MI (PRWEB) , ... November 26, 2015 , ... ... for substance abuse located in central Michigan, have come together on Thanksgiving Day ... specially produced video, available for viewing on the Serenity Point YouTube channel, patients ...
(Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical laboratories ... and offered by healthcare staffing agency Aureus Medical Group . These ... October 2015 among those searching for healthcare jobs through the company’s website, ...
Breaking Medicine News(10 mins):