Author: Surabhi Bhatt
Burning incense is an age-old practice in many cultures’ religious and spiritual ceremonies — especially in Asia — and its use has gained popularity in Western countries as well. Researchers at the Statens Serum Institute in Copenhagen, Denmark, however, have raised concerns about the possible health risks associated with long-term exposure to incense.
Led by Dr. Jeppe T. Friborg of the Epidemiology Department, the study followed more than 61,000 cancer-free Singaporean Chinese men and women between the ages of 45 and 74 from 1993 to 2005. Participants were asked to report on their average incense use in their homes, including how often they burned it and for how long. During the study’s 12-year duration, 325 men and women developed cancer of the upper respiratory tract, such as nasal, oral or throat cancer. Another 821 developed lung cancer.
Although the overall risk of lung cancer was not found to increase with incense use, the study suggested that greater incense use can lead to a heightened risk of developing squamous cell carcinoma of the lung, which is the second most common type of lung cancer. Some supporting evidence may be that the burning materials from which incense is derived — including oils and plant materials — have been found to produce potentially cancer-causing substances, including benzene and polyaromatic hydrocarbons. Friborg’s study, though, is the first to link long-term incense use to an increased risk of developing cancer.
BioVex Agrees SPA With the FDA for a Pivotal Phase III Study With OncoVEX (GM-CSF) in Head and Neck Cancer
Source: PR Newswire
WOBURN, Mass., Sept. 15 /PRNewswire/ — BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck.
The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex’s first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial.
Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years.
Philip Astley-Sparke, President & CEO, for BioVex said:
“The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX (GM-CSF). In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX (GM-CSF) also has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are poorly served by radiation. As with tumors like head and neck cancer where loco-regional progression is the primary cause of treatment failure, treating discrete tumor masses is a major unmet need in a wide range of settings. It is our belief that, as a result, this technology has the potential to provide a broadly active new modality to substantially improve patient outcomes in a variety of hard-to-treat tumor types. “
Phase III Study Design
The Phase III study design agreed with the FDA follows directly from the design of the previous study. The Phase III study will also enroll previously untreated patients with locally advanced disease. The primary objective of the study will be to demonstrate a statistically significant increase in 2-year event free survival (i.e. relapse, progression, or death) for patients treated with chemoradiation together with OncoVEX (GM-CSF) as compared to patients treated with chemoradiation alone. The study will involve approximately 400 patients with approximately 200 in each arm.
Phase I/II Study Design and Results
In a Phase I/II study, OncoVEX (GM-CSF) was administered by direct injection, at three dose levels, into tumor containing lymph nodes in combination with standard first line chemo radiotherapy every three weeks for four cycles. All patients then went for surgery. Of the 17 patients enrolled, 16 had Stage IV N2 or N3 disease. OncoVEX (GM-CSF) was shown to be well tolerated with no significant side effects in addition to those associated with chemoradiation. With respect to efficacy, 93% of patients had a complete pathological response at surgery, with five patients achieving a complete response after only 2 or 3 virus doses. No patient to date has had a loco-regional recurrence in the neck at a median follow up of 30 months, and the disease specific survival rate is currently 82%.
Dr Robert Coffin, Founder and Chief Technology Officer, for BioVex, said:
“Loco-regional control is extremely important in head and neck cancer where loco regional progression is responsible for the majority of deaths. The two year loco-regional failure rate following front line treatment is around 30% with a further 20% of patients progressing at a distant site. The long-term loco-regional control rate of 100% combined with the high percentage of patients that remain disease free at up to 40 months from treatment is very encouraging and provides confidence that OncoVEX (GM-CSF) will significantly reduce relapse rates as compared to standard therapy alone in the pivotal study recently agreed with the FDA.”
About Head and Neck Cancer
Head and neck cancer accounts for 47,000 new cases (3% of all new cancer cases and 2% of all cancer deaths) in the United States annually; it is the fifth most common malignancy worldwide (an estimated 644,000 new cases annually).
Patients with locally advanced tumors are best treated with concurrent chemoradiation, with planned neck dissection indicated in certain patients. Despite aggressive treatment of locally advanced disease loco-regional recurrences develop in 30% of patients and distant metastases in 20%. Aggressive combined modality therapy may be frequently associated with debility, and numerous physical and psychological symptoms including pain, dysphagia, weight loss, disfigurement, depression, and xerostomia (dry mouth). As a result, new and improved, and less toxic therapies for head and neck cancer are urgently required.
BioVex is a privately held biotechnology company based in Woburn, MA where it also has an operational launch grade manufacturing facility. The Company is developing a new class of potent biologics for the treatment of cancer and prevention of infectious disease.
The Company’s lead cancer technology platform, OncoVEX (GM-CSF) is a first-in-class oncolytic, or cancer destroying virus technology. OncoVEX (GM-CSF) designed to work by; replicating and spreading within solid tumors (whilst leaving healthy cells unaffected), causing the death of cancer cells; and through stimulating the immune system to destroy un-injected metastatic deposits. Both modes of action have been clearly validated in the clinic, where multiple patients with metastatic disease progressing at enrollment have been declared disease free. BioVex believes OncoVEX (GM-CSF) has the potential to become a leading standard of care in the treatment of many solid tumors based on the strength of clinical data so far generated coupled with the relatively benign side effect profile noted to date. Previous clinical trials have enrolled patients with breast cancer, melanoma, and pancreatic cancer in addition to head and neck cancer, with indications of clinical activity being observed in each. The Company recently commenced a Phase III study in metastatic melanoma following the achievement of an unprecedented proportion of durable complete remissions in a Phase II study using OncoVEX (GM-CSF) as stand alone therapy. An overview of the Phase II melanoma results is available on our website.
The Company’s second program is a vaccine for genital herpes, ImmunoVEX (HSV2), which provides complete protection in animal models of the disease. The vaccine has been authorized to commence clinical testing in the UK.
For further information, please go to www.biovex.com.
New radiotherapy technique proven safe, less toxic for cancer patients, University Of Pittsburgh Cancer Institute study finds
A new technique known as stereotactic body radiotherapy (SBRT) is safe for patients with recurrent head and neck cancers and may improve their quality of life, according to researchers from the University of Pittsburgh Cancer Institute (UPCI). Results of the phase I study were reported today in the International Journal of Radiation Oncology, Biology, Physics.
Each year approximately 500,000 cases of squamous cell carcinoma of the head and neck are diagnosed worldwide. While treatment has improved with advances in surgery, radiation and chemotherapy, more than half of patients will die from recurrent disease. Treatment options for patients with recurrent disease are limited, and for many, surgery may not be an option, according to principal investigator Dwight E. Heron, M.D., director, Radiation Oncology Services, UPMC Cancer Centers.
“Chemotherapy alone can provide this patient population some palliation and pain relief, but it doesn’t prolong survival,” said Dr. Heron. “A few patients may be able to receive additional radiation treatments, but head and neck cancers, by their very nature, develop in very delicate areas of the body, which provide significant retreatment challenges.”
SBRT may offer these patients an alternative, noted Dr. Heron. “At the completion of our study, we found this treatment was tolerated very well. No maximum tolerated dose was reached, and no toxicities occurred that caused us to limit the dosing.”
SBRT is a relatively new technique using CyberKnife® technology, which delivers high doses of radiation with more precision than conventional techniques. The vast majority of patients complete treatment within 10 days. In the trial, 31 patients with recurrent, inoperable head and neck cancers were treated over a two-week period. PET-CT also was used to develop an individualized radiation treatment plan for each patient, allowing radiation oncologists to more accurately target the cancer while sparing healthy tissue.
“Ultimately, SBRT offers patients a better quality of life. Instead of having to go through six or seven weeks of treatments that are often associated with significant toxicities, patients can receive treatment over a shorter course and still get the same outcomes compared to the current standard of care,” said Dr. Heron.
Study co-authors include Robert L. Ferris, M.D., Ph.D., Michalis Karamousiz, M.D., Regiane S. Andrade, M.D., Erin L. Deeb, B.S., Steven Burton, M.D., William E. Gooding, M.S., Barton F. Branstetter, M.D., James M. Mountz, M.D., Ph.D., Jonas T. Johnson, M.D., Anthanassios Argiris, M.D., Jennifer R. Grandis, M.D., Stephen Y. Lai, M.D., Ph.D., all of the University of Pittsburgh Cancer Institute.
This study was funded by the University of Pittsburgh Cancer Institute.
The University of Pittsburgh Cancer Institute
NEW YORK (Reuters Health) – Even a short period of 4 to 8 weeks of smoking cessation prior to surgery to treat upper aerodigestive tract squamous cell carcinoma improves wound healing, according to a review of the literature. If the patient stays tobacco-free, the risk of cancer recurrence is substantially reduced.
However, full cessation is required — simply reducing the quantity of cigarettes smoked per day is of little benefit, Dr. Richard O. Wein from Tufts Medical Center, Boston, reports in the June Archives of Otolaryngology-Head and Neck Surgery.
Studies of the impact of smoking cessation on surgical outcomes within the field of otolaryngology are few and contradictory, Dr. Wein points out. For his review, he drew on studies of smokers operated on for non-otolaryngology conditions as well as for head and neck tumors.
The “bottom line,” he says, is that “although conflicting reports exist within the literature concerning the impact of short-term smoking cessation, it should be noted that the sheer number of articles reporting the negative impact of continued tobacco use on postoperative pulmonary function and wound healing far outweighs those minimizing this impact.”
Furthermore, multiple studies indicate increased risk of recurrence or the development of a second cancer in patients who continue to smoke after their index cancers are diagnosed. One study, for example, found that 40% of patients who kept smoking after being treated definitively for a malignant oral cavity tumor had a recurrence or developed a second malignant lesion.
Overall costs of care, the author observes, are considerable compared with those of individuals with an adequate period of preoperative cessation.
Unfortunately, patients with a diagnosis of a head and neck cancer usually don’t have the luxury of taking 2 months to stop smoking before surgery is imperative, Dr. Wein notes.
“In these scenarios,” he concludes, “although the impact of short-term (less than 2 weeks) preoperative smoking cessation on the immediate post-operative course may be modest, the long-term cardiopulmonary benefits and the potential decrease in the development of future smoking-related neoplasia with sustained cessation are undeniable.”
Source: Middlesex-London Health Unit
For Gruen Von Behrens, an encounter with chewing tobacco on a camping trip nearly two decades ago led to an addiction that not only changed his life, but the lives of hundreds of thousands of teens across North America who have heard his story. Today, the 31 year-old from Illinois tours the continent, using his life story as the backdrop for what can happen when teens get hooked on “Chew”. Once a talented young baseball player with dreams of cracking a big league lineup, Von Behrens, has undergone more than 40 surgeries to rebuild his face and jaw, all necessary after he developed squamous cell carcinoma at 17, all consequences of his addiction to chewing tobacco.
x-London Health Unit, its Youth Action Alliance, the One Life Crew, the Thames Valley District School Board and the London and District Catholic School Board are pleased to be hosting Von Behrens as he brings his “How Chew Tobacco Gave Me Cancer” presentation to London and Middlesex County next week. Von Gruen’s schedule will see him in London on Monday and Tuesday, then Strathroy on Wednesday and Thursday; a complete schedule of presentations follows this news release.
While most of the presentations Gruen Von Behrens will make are specifically aimed at the student body at local high schools, the community will be able to hear his message on Thursday, June 11th at 7:00 p.m. at A. B. Lucas Secondary School in London. Sports teams are encouraged to attend this presentation in uniform for a chance to win great prizes.
“Having Gruen speak directly to our youth is much more effective than any campaign, poster or commercial could be,” says Pat O’Connor, Public Health Nurse at the Middlesex-London Health Unit. “His message is more important than ever, now that tobacco companies are aggressively marketing chew tobacco to teenagers using brightly coloured packaging, fruit flavouring and the incorrect perception that chew tobacco is a safe alternative to smoking.”
The first-person nature of Von Behrens’ presentations and the constant reminder of the toll chewing tobacco took on his face, deliver a hard-hitting message that underscores that teens are far from indestructible and can easily have their lives, their looks and their futures altered forever by these products.
Source: ScienceDaily (www.sciencedaily.com)
Long term use of incense increases the risk of developing cancers of the respiratory tract, according to a new study. The new analysis, which the authors say is the first prospective investigation of incense and cancer risk, appears in the October 1, 2008 issue of CANCER, a peer-reviewed journal of the American Cancer Society.
Incense is an integral part of daily life in large parts of Asia. Researchers have shown that burning incense—which is made of plant materials mixed with oils—produces a mixture of possible carcinogens, including polyaromatic hydrocarbons, carbonyls and benzene. Because incense smoke is inhaled, a number of studies have looked at the possible link between incense burning and lung cancer, but results have been inconsistent. In addition, the possible association of incense use and other respiratory tract cancers has not been analyzed. To investigate this, Dr. Jeppe Friborg of the Statens Serum Institut in Copenhagen, Denmark and colleagues in Singapore and the U.S. studied the associations between exposure to incense and the whole spectrum of respiratory tract cancers in a large population in Singapore.
The study involved 61,320 Singapore Chinese who were free of cancer and aged 45-74 years in 1993-1998. At that time, they completed a comprehensive interview on living conditions and dietary and lifestyle factors. The investigators followed these individuals through 2005, noting which participants developed cancer during that time.
Dr. Friborg’s team documented a total of 325 upper respiratory tract cancers (including nasal/sinus, tongue, mouth, laryngeal and other cancers) and 821 lung cancers during follow-up. Incense use was associated with a significantly increased risk of upper respiratory tract cancer (other than nasopharyngeal), but there was no overall effect on lung cancer.
The researchers also noted that the duration and intensity of incense use were associated with an increased risk of squamous cell carcinomas in the entire respiratory tract. Squamous cells cover the internal and external surfaces of the body.
According to the study data, incense use seemed to add to the increased risk of upper respiratory tract squamous cell carcinoma in smokers. It also considerably increased the risk in never smokers, which points to an independent effect of incense smoke.
The authors note that their study is the first prospective investigation on incense and cancer risk. They stressed that incense use extends beyond the Chinese populations—it is used on a daily basis in both temples and homes in many non-Chinese, Asian communities, including those in Southeast Asia and the Indian subcontinent. Regular use also occurs in the West.
“Given the widespread and sometimes involuntary exposure to smoke of burning incense, these findings carry significant public health implications,” they wrote. “Besides initiatives to reduce incense smoke exposure, future studies should be undertaken to identify the least harmful types of incense,” they added.
1. Jeppe T. Friborg, Jian-Min Yuan, Renwei Wang, Woon-Puay Koh, Hin-Peng Lee, and Mimi C. Yu. Incense use and respiratory tract carcinomas: a prospective cohort study. CANCER, Published Online: August 25, 2008 DOI: 10.1002/cncr.23788