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Cancer group turns adviser

Parent group formed to investigate cases of lymphoma has become broad-based advocate for clean environment

BY MITCHELL FREEDMAN
STAFF WRITER

EAST HAMPTON November 19, 2004 Seven years ago, people began to notice a disturbing number of lymphoma cases among recent graduates of East Hampton High School. Eight cases of Hodgkins and non-Hodgkins lymphoma were eventually found, a startlingly high number for a school district with fewer than 2,000 students.

Based on state averages for incidences of lymphoma, a community the size of East Hampton would on average see less than one case a year. Over the years, at least four more graduates who are now 18 to 30 were diagnosed with other types of cancer. In response, some parents formed the East Hampton Cancer Task Force in 1998, and demanded investigations by local and state health officials. But no cause was ever found.

And the people who once lobbied for the problem to be investigated have taken on a new role. They've changed their name to the East Hampton Town Environmental Health Committee and advise the town board. The group, whose members believe that pollution adds to the threat of cancer, also works to reduce environmental pollution.

Until its recent reincarnation, the group had a different focus. People were interviewed by researchers and examined by physicians, and soil and water samples were taken throughout the community. Even though the cases were officially designated by the state health department as a cancer cluster, they never found a source.

Farm chemicals in the soil were no different than the chemicals used on farms in neighboring Southampton or on the North Fork, places that did not have comparable rates of cancer. There were no distinctive airborne pollutants. "In the end, they said they couldn't find a smoking gun," said Sue Avedon, one of the community activists who lobbied for the testing. "The good news is they're all alive," said Prudence Carabine, about the students, one of whom is her son. "But they have to go for testing every three months."

On Wednesday night, the renamed committee held a forum at the East Hampton Middle School to talk about the dangers of household cleaning agents. While their guest speaker canceled at the last minute, the members still discussed ways to substitute common household cleaning agents with materials considered environmentally friendly and nontoxic, such as soaps without additives or boric acid.

On Wednesday, the group also gave its support to Suffolk Legis. Jay Schneiderman (R-Montauk), who has introduced a bill to ban the use of nonessential pesticides, including compounds used by homeowners to treat their lawns.

His bill defines nonessential pesticides as any chemicals used to control or destroy pests and registered with the Environmental Protection Agency that is used primarily for "achieving an aesthetic landscaping goal." It would not cover chemicals used for swimming pools, or on golf courses or for farm use.

Schneiderman tried to pass a similar bill in 2000 when he was East Hampton town supervisor. However, the law was not adopted because state law mandates that federally approved pesticides can be regulated only by New York State.

A spokesman for Schneiderman said the state is likely to make the same argument, but that Schneiderman wants to bring public attention to the issue again on a larger stage.


Roche gets European approval for MabThera in first line treatment of indolent non-Hodgkin’s lymphoma

Vital treatment option brings benefit to patients across Europe

10 August 2004 - Roche announced today that the European Commission has approved MabThera (rituximab) for first line use in treatment of indolent non-Hodgkin’s lymphoma (NHL) in combination with conventional chemotherapy.

The European Commission’s decision was based on phase III study results which showed MabThera in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy to be significantly superior to CVP chemotherapy alone:

• Time to treatment failure was significantly prolonged by more than 1½ years: 26 months versus 7 months
• Freedom from disease progression was nearly doubled: 27 months versus 15 months
• More patients responded to the combination treatment: overall response rate was 81% versus 57 %, and complete response rate quadrupled to 41% from 10%

“This approval is excellent news for the many indolent NHL patients suffering from this potentially fatal disease,” said William M. Burns, Head of Roche’s Pharmaceuticals division. “MabThera in combination with chemotherapy is a vital treatment option, and making it available to patients across Europe underlines its position as the standard of care in indolent NHL.”

MabThera monotherapy was approved for the treatment of relapsed or refractory indolent NHL in June 1998 and in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy for treatment of aggressive NHL in March 2002. Non-Hodgkin’s lymphoma affects 1.5 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system, and patients are prone to relapse after treatment.

“This approval for MabThera marks a major advance in the treatment of indolent NHL,” said Kapil Dhingra, Vice President Roche Oncology. “By every criterion of effectiveness, whether time to progression, disease-free survival or duration of response, patients who received MabThera in addition to chemotherapy had a superior outcome as compared to those receiving conventional chemotherapy only. This is the first time that the addition of a well tolerated biologic agent to chemotherapy has led to such a significant clinical benefit in this condition."

About the study
The filing for approval of MabThera in indolent NHL was based on final results from the multi-centre, phase III randomised study, which involved 321 patients from 11 countries and compared a treatment regimen of MabThera plus CVP chemotherapy with CVP chemotherapy alone. Patients were previously untreated and were diagnosed with advanced stage, indolent (follicular) NHL. Of the 321 patients involved, 159 were randomised into the CVP chemotherapy group and 162 into the MabThera plus CVP chemotherapy treatment group.

About MabThera
MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defence to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months. MabThera is known as Rituxan in the United States, Japan and Canada. More than 300,000 patients have been treated with MabThera worldwide to date. Genentech and BiogenIdec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Roche in Oncology
Within the last five years the Roche Group including its partners Genentech in the US and Chugai in Japan has become the world’s leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit in different major tumor indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin’s lymphoma, and Avastin in colorectal carcinoma. In the United States Herceptin, MabThera and Avastin are marketed either by Genentech alone or together with Biogen Idec Inc. Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these drugs.

The Roche oncology portfolio also includes NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of the commitment to anaemia management. The Roche Group’s cancer medicines generated sales of more than 6 billion Swiss francs in 2003.

In a recent phase III study Tarceva met its primary endpoint of improving overall survival in patients with non-small cell lung cancer. Tarceva is being developed by Roche, Genentech and OSI Pharmaceuticals. Chugai is pursuing its development and regulatory approval for the Japanese market.

Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumor markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

All trademarks used or mentioned in this release are legally protected.

Further information:
Cancer: www.health-kiosk.ch
World wide association of lymphoma groups: www.lymphomacoalition.org/home.htm

 

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