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High risk of second cancers in survivors of childhood soft tissue sarcomas

25 Apr 2005 - Children treated for soft tissue sarcomas have a significantly higher risk of developing subsequent cancers later in life, according to a new study. The study appears in the June 1, 2005 issue of CANCER , a peer-reviewed journal of the American Cancer Society, and indicates children treated with combined chemotherapy and radiation therapy, in particular, had greater risks of developing a new malignancy.

http://www.interscience.wiley.com/cancer-newsroom

With improvements in cancer treatments over the last two decades, children with soft tissue sarcomas are living longer. Several investigations have reported that these children have an increased risk of second cancer, but estimates of the risk have varied widely, ranging from three to thirteen times the risk among the general population. Moreover, due to the small size of many previous studies, few have evaluated risk by type of soft tissue sarcoma or have estimated risks for specific second cancers.

Randi J. Cohen, M.S. and a team of researchers from the National Cancer Institute (NCI) evaluated data from 1499 children included in one of the largest, most comprehensive cancer databases in the U.S., called the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute. Their goal was to quantify the risk of developing a second malignancy in soft tissue sarcoma patients by second cancer site, initial therapy, histologic type of the primary sarcoma, age at primary cancer diagnosis, and gender.

The investigators found that survivors of pediatric soft tissue sarcomas had a six-fold increased risk of developing a second cancer, as compared to the general population. However, the authors noted that while the relative risk appears high, the absolute risk is quite low. The NCI study found that approximately 3 percent of children with soft tissue sarcoma would be expected to develop a second malignancy by 20 years after their initial diagnosis. The relative risk was highest within the first five years of post-treatment follow-up. Females had slightly higher risks of second cancers than males; however, when gender-specific cancers of the breast and genital tract were excluded, the risks were identical.

Cohen et al. also found that second cancer risks were increased for all subtypes of childhood soft tissue sarcoma, with estimates ranging from 6-fold elevations in risk for fibromatous neoplasms to nearly 8-fold risks for rhabdomyosarcoma. Children initially treated with radiation or those with radiation combined with chemotherapy had substantially higher risks of second cancers than those treated with surgery alone.

Previous studies have reported increased risks of acute myelogenous leukemia following treatment of children with soft tissue sarcoma, particularly in those receiving chemotherapy for rhabdomyosarcoma. In addition, both clinical and registry-based surveys have reported that these children have an increased risk of second bone or soft tissue sarcoma, many of which were related to high dose radiation and chemotherapy or, in some cases, to genetic predisposition. In the current NCI study, the research team confirmed the excess of subsequent leukemia and sarcomas, but also found an increased risk of melanoma and cancers of the breast and oral cavity, although the results were based on small numbers. For several children the pattern of multiple cancers including soft tissue sarcomas was consistent with underlying genetic syndromes, particularly Li-Fraumeni syndrome and neurofibromatosis type 1.

The authors concluded, "both treatment effects and genetic factors contributed to the increased risk of second cancers in this series of children with soft tissue sarcomas."

Article: "The Risk of Developing Second Cancers among Survivors of Childhood Soft Tissue Sarcoma," Randi J. Cohen, Rochelle E. Curtis, Peter D. Inskip, Joseph F. Fraumeni, Jr., CANCER; Published Online: April 25, 2005 (DOI: 10.1002/cncr.21040); Print Issue Date: June 1, 2005.

John Wiley & Sons, Inc.
http://www.interscience.wiley.com

The U.S. Food and Drug Administration grants orphan drug status to Lorus' GTI-2040 in acute myeloid leukemia

Lorus to Present at Rodman & Renshaw Annual Global Healthcare Conference in Paris, May 4th
TSX: LOR AMEX: LRP

TORONTO, May 4 /PRNewswire-FirstCall/ - Lorus Therapeutics Inc. ('Lorus'), a biopharmaceutical company specializing in the development and commercialization of pharmaceutical products and technologies for the management of cancer, today announced that the U.S. Food and Drug Administration (FDA) has awarded orphan drug status to GTI-2040, the company's lead anticancer drug for the treatment of acute myeloid leukemia (AML).
This most recent orphan drug status designation in AML, together with an ongoing clinical study program using GTI-2040 in different drug combinations, indicates potential for efficacy in a number of different tumor types. GTI- 2040 was also granted orphan drug status for renal cell carcinoma in 2004.

The significance of orphan drug status is that it can result in the opportunity to obtain additional financial support from the U.S government for clinical study costs, exemption from certain fees at the time of submission of GTI-2040 to the FDA for marketing approval, and a grant of seven years of market exclusively in the U.S. Orphan drug designation typically means that FDA marketing review times are expedited in comparison to other drugs since orphan drug status denotes serious or life-threatening diseases that afflict less than 200,000 patients annually in the U.S.

"The commitment of the U.S. FDA is important to companies like Lorus, whose business strategy includes advancing new treatments in clinical development for debilitating diseases like AML," said Dr. Jim Wright, CEO, Lorus. "This support helps Lorus optimize the commercial potential of GTI-2040 in this cancer indication, and enhances our continuing track-record of success as an innovative cancer research and drug development company."

In partnership with the United States National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) under a clinical trials agreement, GTI 2040 is being investigated in a Phase II clinical trials program for AML, breast cancer, lung cancer, prostate cancer, colon cancer and a variety of solid tumors.

While significant progress has been made in treating other leukemias, AML has the lowest five-year survival rate. The poor prognosis for AML is associated with a high number of patients refractory to initial treatment and a high relapse coupled with the development of resistance to standard therapy, typically cytarabine. Given the poor prognosis and limited treatment options available to patients with relapsed disease, novel therapeutics that can act cooperatively with chemotherapy and have the potential to increase efficacy of standard drugs by decreasing resistance stand to have a significant impact on the treatment of AML.

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RODMAN & RENSHAW TECHVEST 2ND ANNUAL GLOBAL HEALTHCARE CONFERENCE
IN PARIS, FRANCE

On Wednesday, May 4th, 2005, at 9:30 a.m., Dr. Jim Wright, President and CEO, Lorus Therapeutics, will present a corporate overview of the company at the Rodman & Renshaw Techvest 2nd Annual Global HealthCare Conference in Paris, France. The conference, which runs May 4th and 5th provides an informational service and networking opportunity for healthcare companies and investors.

About Lorus

Lorus is a biopharmaceutical company focused on the development and commercialization of cancer therapies. Lorus' goal is to capitalize on its research, preclinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in combination, to successfully manage cancer. Through its own discovery efforts and an acquisition and in-licensing program, Lorus is building a portfolio of promising anticancer drugs. Late-stage clinical development and marketing may be done in cooperation with strategic pharmaceutical partners. Lorus currently has three products in human clinical trials with a pipeline of eight clinical trials in phase II clinical trial programs and one phase III registration clinical trial. Lorus Therapeutics Inc. is a public company listed on the Toronto Stock Exchange under the symbol LOR, and on the American Stock Exchange under the symbol LRP. Virulizin® is a registered trademark of Lorus Therapeutics Inc.

About GTI-2040

GTI-2040 is an antisense drug that specifically targets the R2 component of ribonucleotide reductase, which is required for DNA synthesis and cell proliferation. R2 has also been described as a malignant determinant that is elevated in a wide range of tumors, and through deregulation can cooperate with a variety of cellular cancer causing genes known as oncogenes to enhance tumor growth and metastatic potential. GTI-2040 showed significant antitumor activity against many different human tumors in preclinical studies, and successfully completed a Phase I clinical trial in the U.S. GTI-2040 is currently the subject of a Clinical Trials Agreement with the United States National Cancer Institute (NCI) under which GTI-2040 is being tested in combination chemotherapy in six different clinical trials. All six of these trials have been initiated. GTI 2040 recently completed a phase II study in combination chemotherapy for the treatment of renal cell carcinoma. In this study of late stage patients 52% of the patient population displayed disease stabilizations with few unexpected side effects and tumor regressions were observed in some patients.

Forward Looking Statements

Except for historical information, this press release contains forward- looking statements, which reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties, including, but not limited to, changing market conditions, the Company's ability to obtain patent protection and protect its intellectual property rights, commercialization limitations imposed by intellectual property rights owned or controlled by third parties, intellectual property liability rights and liability claims asserted against the Company, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, product development delays, the Company's ability to attract and retain business partners and key personnel, future levels of government funding, the Company's ability to obtain the capital required for research, operations and marketing and other risks detailed from time-to-time in the Company's ongoing quarterly filings, annual information form, annual reports and 40 -F filings. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Lorus Therapeutics Inc.'s press releases are available through the Company's Internet site: http://www.lorusthera.com.

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Source: Lorus Therapeutics Inc.

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