|
|
              
 |
Odds & Ends Abstracts by Tom Swartz and Bruce Shriver
In this issue:
Comprehensive Cancer Care Improvement Act and the NCCS The Comprehensive Cancer Care Improvement Act (CCCIA), H.R. 1078 and S. 2790, bears that name because it aims to ensure cancer patients’ access to care that combines primary therapy with symptom management. The Act itself is also comprehensive because it offers an aggressive and thorough set of recommendations for reform of the system of cancer care. You can read about this act on the National Coalition for Cancer Survivorship (NCCS) website by clicking here. The NCCS is, according to their website, “the oldest survivor-led cancer advocacy organization in the country, advocating for quality cancer care for all Americans and empowering cancer survivors. NCCS believes in evidence-based advocacy for systemic changes at the federal level in how the nation researches, regulates, finances, and delivers quality cancer care”. NCCS organizes a legislative advocacy network concerned with federal cancer-related issues. The NCCS website provides mechanisms to communicate with your congressional; see, for example, Ask your Senator to Cosponsor S. 2790, the Comprehensive Cancer Care Improvement Act.
NCCS (see the preceding entry) provides a free toolbox aimed at helping people develop practical tools in their daily lives as they deal with cancer. According to the NCCS website, “The Toolbox includes twelve modules. Modules 1 through 6 cover six basic skills that can help people with cancer meet the challenges of their illness. These skills are:
Modules 7-12 build on the skills learned in the first six modules and relate them to specific aspects of cancer survivorship. These modules cover:
You can order a free CD version of the Cancer Survivor Toolbox by filling in an online form.
The depth of soft-tissue masses is unrelated to likelihood of malignancy, study suggests A new study from the United Kingdom suggests that the depth of a soft tissue mass does not appear to be linked to the probability of malignancy. And the UK researchers say this key finding "is not supportive of the current guidelines on assessment of soft tissue tumours."
The researchers looked at the MRI findings of 571 consecutive patients, aged from two to 92 years, referred to a supra-regional orthopedic oncology unit with a suspected soft-tissue neoplasm. They reported that 480 of the lesions were deep. On histology, 288 lesions were malignant neoplastic, 197 benign neoplastic and 86 non-neoplastic.
They found that there was no significant relationship between lesion depth and a malignant diagnosis. A significant relationship was identified between lesion size and diagnosis; however, the authors noted that 65 per cent of benign tumors were 5cm in diameter or more and ten per cent of malignant lesions were less than 5cm.
The NICE guidelines for referral of suspected cancer, released in 2005, advised that referral for suspicion of soft tissue sarcoma should be made if a palpable lump is greater than 5cm in diameter, deep to the fascia, painful or increasing in size, or if it is a recurrence after previous excision.
The authors said: "It is important that when the probability of malignancy is being considered, a superficial relationship to the fascia and a lesion size less than 5cm should not be taken to exclude the possibility of soft-tissue sarcoma."
Dr Steven James, consultant radiologist at Royal National Orthopaedic Hospital Stanmore, UK and one of the study authors, emphasized that the findings were most relevant to tertiary care. He said the guidelines are still useful but added: "The study acts as a note of caution."
In an accompanying commentary, Dr Charles Wakely of United Bristol Healthcare NHS trust, in Bristol, UK, said the study "reminds us all of the difficulties in distinguishing between benign and malignant lesions.... It is clear that new approaches are necessary."
But Dr David Wilson, a consultant radiologist at the Nuffield Orthopaedic Centre NHS Trust in Oxford, UK, reiterated that the paper's scope included only those patients referred to a tertiary centre, thereby excluding numerous superficial benign lesions. He said the guidelines are applicable to general practice and warned that these findings "cannot be used to influence general orthopedic practice." The full study can be found in Clinical Radiology, Volume 63, Issue 4, April 2008, Pages 379-380.
Overcoming Cancer with Research (the DIRECT project) The Children's Cancer Research Institute, the German Childhood Cancer Foundation, the St. Anna Children's Hospital and the Otto Pammer Filmproductions proudly announce that their joint science communication project "Overcoming Cancer with Research" (acronym: DIRECT) in the field of paediatric oncology has been officially launched on the occasion of the symposium on paediatric brain tumors (HIT), held from 7-8 March, 2008, in Bonn, Germany. The main objective of the project is to raise public awareness for the significant impact of improved therapeutic strategies, biomedical research, and patient-oriented research on the increase in survival rates and life quality of children and youths having overcome cancer. You can download a description of the project (in German) as a PDF file by clicking here. A preliminary website is available in English and in German.
Soft tissue sarcomas (STSs) can develop at any anatomic site but 60% occur in the extremities. Initially, treatment of STS relied solely on excision. The 1970s brought the concept of compartmental resection to reduce the local failure rate. Later it was demonstrated that there was no difference in local tumor control and disease-free survival (DFS) in patients treated with amputation versus limb-saving surgery followed by external-beam radiotherapy (EBRT). A considerable proportion of patients present with locally advanced tumors as a primary or recurrent disease and cannot be resected with adequate clearance margins. These patients are threatened with amputation for complete tumor removal. Improvements in surgical techniques allow for the avoidance of limb loss in the majority of cases. However, local failure rates are still 15%–25%. High-dose preoperative EBRT for high-grade STS was developed, and its combination with chemotherapy has been effective. Recently, systemic chemotherapy combined with deep wave hyperthermia was shown to result in a longer DFS time in a large, randomized, phase III study. Treatment concepts differ significantly among centers and are influenced more by availability of technical equipment than by data. This review article explains the rationale of the different treatment regimens and analyzes their potentials as well as weaknesses.
Skeletal Complications After Bone Marrow Transplant in Childhood Sixty six percent of childhood cancer survivors have at least one adverse health effect and 33% will have a severe, chronic, or lethal health disorder. The Institute of Medicine (2003) has recognized the skeletal system to be at risk for long-term complications from treatment for childhood cancer. Bone marrow transplant is frequently used to treat childhood malignancies and is known to cause skeletal complications. Complex mechanisms contribute to skeletal outcomes after bone marrow transplant, all of which can affect optimal physical functioning. Nurses have taken an important role in providing clinical care and conducting research for this population. A thorough understanding of the mechanisms involved in skeletal complications can help the nurse provide state-of-the-art care and design studies to promote optimal results for bone marrow transplant survivors. This article reviews the literature on skeletal complications associated with allogeneic bone marrow transplant and identifies incidence, etiology, symptoms, monitoring, and treatment of specific complications.
Orthopedic Oncologist Introduces New Sarcoma Website James C. Wittig, MD, Chief of Orthopedic Oncology (Pediatric & Adult) and Associate Professor of Orthopedic Surgery at Mount Sinai Medical Center, has created an educational and user-friendly resource for orthopedic oncology, which may be of interest to sarcoma patients and caregivers. Features of the website include narrative videos to help illustrate procedures for patients, a dedicated section for shoulder tumors, special surgeries categorized by anatomy; and a patient education section.
Extracts from reishi mushroom and green tea shows synergistic effect to slow sarcoma Both the reishi mushroom and green tea have long held a place in traditional medicine in China and other Asian countries. More recent scientific studies have confirmed that both enhance the body’s immune functions and hold the potential for treatment and prevention of many types of cancer. Now a new study by Chinese scientists has demonstrated that combining the active ingredients in the mushroom and the tea creates synergetic effects that inhibit the growth of tumors and delayed the time of death in mice with sarcomas. Yan Zhang, of Pharmanex BJ Clinical Pharmacology Center in Beijing, reported the results of two studies at Experimental Biology 2008 in San Diego on Tuesday, April 8. The presentation was part of the scientific program of the American Society for Pharmacology and Experimental Therapeutics (ASPET).
Reishi grows in damp, sunless mountain areas and was once a rare commodity. Today Reishi, like green tea polyphenols, is manufactured as an extract. Zhang and her colleagues examined products sold as ReishiMax and Tegreen, made by Utah-based Nu Skin Enterprises. ReishiMax contains high concentrations of the active components in the mushroom itself and cracked spores of the mushroom, including polysaccharides (13.5 percent) and triterpenes (6 percent), and Tegreen is almost completely (98-99 percent) made of tea polyphenols.
In the first study, designed to look at cancer treatment, mice were first injected intraperitoneally with sarcoma cells and then were given either low, medium or high dosages of ReishiMax or low, medium, or high dosages of a combination of ReishiMax and Tegree. A control group received neither product. All mice died of sarcoma development after treatment for 28 days. But treatment with the combination of reishi and green tea extracts delayed the animals death within the first 12 days after sarcoma injection, compared to the animals receiving only ReishiMax.
In the second study, designed to look at cancer prevention, groups of healthy mice were given either low, medium or high dosages of ReishiMax or low, medium, or high dosages of a combination of ReishiMax and Tegreen. A control group received neither product. After receiving the specified treatment for 14 days, mice were given a suspension of sarcoma cells subcutaneously, while the treatments were continued. On day 28, the sarcoma tumors under the skin were recovered from the mice and weighed. The tumor weight was reduced by 45 percent with the combination therapy, but in a much lesser degree with only the Reishi, compared to tumors in mice receiving no treatment, further confirming the synergy of the two together. Senior author of the paper, Dr. Jia-Shi Zhu of Pharmanex research Institute in Provo, Utah, says these findings suggest the therapeutic values of the combined use of the substances in both cancer prevention and adjuvant treatment.
Many cancer survivors have cognitive impairment after cancer treatment. The impairment may be subtle, but can also be long term. In October 2006, the second international cognitive workshop was held in Venice. The workshop included neuropsychologists, clinical and experimental psychologists, medical oncologists, imaging experts, and patient advocates. The main aims of the Venice workshop were to present ongoing research, with a focus on putative mechanisms; to forge new collaborations; to discuss the methodological problems associated with cognitive research; and to establish an international task force to provide guidelines for future research, as well as information for clinicians and patients on the management of these symptoms. This article provides a summary of the 2006 cognitive workshop, and a description of the mission of the newly formed International Cognition and Cancer Task Force (ICCTF).
Epeius Biotechnologies Awarded U.S. Patent for Targeted Injectable Gene Delivery In Vivo On March 25th, Epeius Biotechnologies Corporation announced the issue of a U.S. Patent for Targeted Gene Delivery in vivo. The patent provides protection for the company’s leading anti-cancer agent - Rexin-G. Administered by simple intravenous infusion, the Epeius tumor-targeted gene delivery system enables Rexin-G to seek out and accumulate selectively in cancerous tissues and remote metastatic tumor nodules. Rexin-G thus delivers its tumor-killing payload precisely where it is needed most, by targeting cancer from the inside.
Rexin-G has demonstrated profound single agent efficacy in a broad spectrum of chemotherapy refractory cancers. The response rates seen with Rexin-G are unmatched by any other tumor-targeted gene delivery system. The U.S. FDA has granted Orphan Drug Status to Rexin-G based on its performance as a single therapeutic agent in treating chemotherapy refractory pancreatic cancer.
Currently, Rexin-G is being tested as a single therapeutic agent in three separate U.S. Phase I/II Trials for recurrent or metastatic cancers of the breast or pancreas and for bone and soft tissue sarcoma respectively. Additionally, a Phase II Registration Protocol is underway for chemo-resistant osteosarcoma in Los Angeles, California.
ZIOPHARM Presents Promising Early Data from Phase Ib Study of IndibulinOn March 20th, ZIOPHARM Oncology, Inc. announced promising early data from a Phase Ib study of Indibulin, the Company’s novel, orally administered, synthetic tubulin targeted agent. The data was present at the 6th International Symposium on Targeted Anticancer Therapies held in Bethesda, Maryland, March 20 to 22.
A total of 14 patients with a variety of cancers, including sarcomas and carcinomas, have been treated to date in the study. Indibulin has been shown to be very well tolerated, with no drug-related Grade 2 or higher toxicities reported. Of note, no neurotoxicities, a common and serious side effect typically associated with microtubule targeting agents, have been observed.
In addition to confirming Indibulin’s safety profile, the study evaluates early treatment responses by PET scans. Among 8 evaluable patients, PET scans demonstrated a substantial anti-tumor effect by Indibulin. Week 7 PET scans identified 1 complete reduction in uptake, 4 with partial reduction in uptake, and 3 with increased uptake. Tumor responses measured by PET scan are generally referred to as metabolic responses, and usually correlate with treatment responses in cancer.
“Safely and effectively targeting microtubules in cancer cells has long been a goal of researchers as it leads to a variety of anti-cancer activity, including antiangiogenesis and antimetastasis,” commented Sant P. Chawla, MD, Director, Sarcoma Oncology Center and a lead investigator of the study. “Yet to date, these agents have all demonstrated serious side effects. Oral Indibulin, by contrast, has been very well tolerated, with none of the neurotoxicity or bone marrow suppression seen with taxanes and vinca alkaloids. Indibulin has also demonstrated promising early activity by PET scan, including a complete response in Ewing’s Sarcoma and a partial response in a neuroendocrine cancer. Taken together, these results are highly compelling, making ongoing study a priority.”
Background Noise - The Experience of Chemotherapy-Induced Peripheral Neuropathy A substantial portion of people diagnosed with cancer receive neurotoxic chemotherapy that may produce distressful symptoms and changes in functional ability. However, little is known about the symptom experience and daily life effects of chemotherapy-induced peripheral neuropathy (CIPN). The author of this paper describes the CIPN symptom experience and the influence of symptoms on everyday life. The author’s method was a qualitative, exploratory, interpretive, descriptive study with semistructured interviews. A sample of 28 participants was recruited from a National Cancer Institute-designated comprehensive cancer center. Interviews were audiotaped and transcribed. Content analysis and constant comparative method were used to analyze the data.
Participants represented diversity in age (46-81 years), cancer type, time since diagnosis (3-198 months), neuropathy severity, and neurotoxic chemotherapy agents received. The author’s content analysis yielded a rich, thick description of CIPN symptoms and the influence of the symptoms on functional ability and everyday life. Further interpretive analysis provided a description of the symptom experience through an overarching metaphor, “Background Noise,” and four major themes: (a) Becoming Aware; (b) Learning New Lyrics; (c) Functional, Emotional, and Social Role Cacophony; and (d) Learning to Live With It. Participants described significant physical limitations, emotional distress, and social role impairments due to CIPN. The author concludes that having CIPN results in diverse symptom patterns and degrees of physical symptom distress from mild to severe, emotional distress, alterations in functional ability, and social role impairment. And comprehensive clinical and research measures are needed to assess the full spectrum of CIPN effects on everyday life.
Yondelis Granted Orphan Drug Status By Swiss Agency For Treatment Of Soft Tissue Sarcoma On April 4th, PharmaMar announced that Yondelis(R) has been granted orphan drug status by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of patients with soft tissue sarcoma. The European Commission and the Food and Drug Administration (FDA) granted Orphan Drug Status to Yondelis for soft tissue sarcoma in 2001 and 2004. Approval of Yondelis for patients with advanced Soft Tissue Sarcoma is expected in Switzerland in the last quarter of 2008. Switzerland will join other European countries where Yondelis is being currently commercialized, namely Germany, UK, Austria, Sweden, Norway, Finland, Denmark, Island, Greece, Ireland, Holland and Spain.
Luis Mora, PharmaMar General Manager stated: "We are very pleased to further advance in the development of Yondelis reaching those patients who may benefit from the efficacy of Yondelis, as shown in clinical trials. We therefore continue with our mission of delivering the best medicines of marine origin to cancer patients".
The Orphan Drug designation in the United States is granted to compounds with potential therapeutic value in the treatment of uncommon or rare diseases, defined as those affecting fewer than 200,000 Americans. If the company meets certain specifications of the FDA and if the drug receives marketing approval, the Orphan Drug designation entitles the company to seven years of marketing exclusivity, exemption from registration fees in the application of new drugs, and tax credits for clinical research. The designation does not shorten the duration of the regulatory process for review and approval. The Orphan Drug designation in Europe offers similar incentives, including ten years of marketing exclusivity for the treatment in question once commercialization is approved.
V5N2 ESUN Copyright © 2008 Liddy Shriver Sarcoma Initiative. |
