CPAA: Ovarian Cancer Symptoms, Information on Ovarian Cancer India

Frequently Asked Questions
Articles
Reports
Useful Links
Book Review
Clipping Files
Cancer Brochures
Chat Transcripts

Clippings

The following are extracts of recent cancer-related news items from local daily newspapers.
Do you see something you want to know more about? Would you like to be sent the whole article? Please contact us.

Ovarian Cancer

Companies Race to Perfect Early Ovarian Cancer Test (Yahoo News-16/09/2008)

Does a test that promises to find ovarian cancer sooner really do so? Could other tests nearing the market prolong survival by getting patients the right care faster? A race is on for blood tests to better detect this intractable killer, but the Food and Drug Administration is probing whether to crack down on the first one to sell. It's a time of both hope and confusion. First, the question is whether testing giant LabCorp jumped the gun in selling OvaSure as an ovarian cancer screening test before researchers proved that it catches the tumor in an early, treatable stage without falsely alarming too many healthy women. A legal quirk let sales begin without formal FDA approval. In fact, U.S. and British scientists are just beginning studies specially designed to prove if signs of ovarian cancer can be measured reliably in blood months, even a year, before a tumor becomes life-threatening. "You really need evidence that screening actually saves lives, or at least prolongs survival," cautions Dr. Robert Bast Jr., an ovarian biomarker expert at M.D. Anderson Cancer Center. While the FDA won't discuss its ongoing probe of OvaSure, it is watching the field closely. "It's not a question of if, it's a question of when the right test will come along with the right credentialing to help improve health care in this important area," says Dr. Steven Gutman, FDA's diagnostic testing chief. At the same time, competing companies are seeking FDA approval for a different approach: Blood tests to help identify which women with an ovarian lump or cyst are most likely to have cancer, so they can have their crucial first surgery — the one that diagnoses malignancy — done by a specialist.

Thousands of women get cysts but only an unlucky fraction turn out to be cancer. Studies show even advanced patients can live many months longer if that very first operation is done by a gynecologic oncologist, who knows where cancer hides and how to remove pelvic lymph nodes, instead of the general surgeon most see today. "That's a big, big step forward for women because it allows them to get the proper care," says Dr. Richard Moore of Brown University, who led a study of Fujirebio Diagnostics Inc.'s so-called triage test that correctly predicted cancerous cysts more than 90 percent of the time. "It really is an unmet need," agrees Bast. Nearly 22,000 U.S. women will be diagnosed with ovarian cancer this year. Most see a doctor for symptoms — bloating, a swollen abdomen, pelvic pain, frequent urination — that strike after the cancer has spread, when long-term survival plummets. More than 15,000 patients die each year. Women at high risk because of BRCA gene mutations are advised to have their ovaries removed for protection. For the general population, the goal is a blood test to detect early cancer signs such as molecules that tumor cells shed, or perhaps unusual hormone changes, without sending too many women to unnecessary surgery. In the pipeline:
— Two tumor markers, CA125 and one just approved by FDA called HE4, used to track if chemotherapy is working or cancer is returning. A one-time CA125 test can't screen seemingly healthy women because levels rise with benign cysts, endometriosis, even normal menstruation. But Fujirebio's triage test uses HE4 and CA125 to assess who most likely has a benign cyst and whose may be cancer.
— LabCorp in June began marketing to high-risk women a screening test developed by Yale University, under a law that allows a single laboratory to offer testing without FDA review. Yale researchers used OvaSure on blood samples stored from cancer patients and healthy women, and found it correctly identified cancer 95 percent of the time with few false alarms. But specialists say that doesn't prove OvaSure can detect when cancer is forming — just that it spotted tumors in the already diagnosed few with early stage disease.
"We believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health," the FDA warned LabCorp last month. The FDA several years ago forced a similarly marketed ovarian test off the market. LabCorp spokesman Eric Lindblom wouldn't disclose results of a recent FDA meeting, but said Yale is working to validate OvaSure and "we're continuing to offer the test at this time."
— Tracking seemingly healthy women well before they're diagnosed is the only way to prove a test finds cancer early, says Dr. Michael Birrer of the National Cancer Institute — work just beginning.
Dr. Nicole Urban of Seattle's Fred Hutchinson Cancer Center is heading a multi-hospital test of blood stored a full year before 120 women were diagnosed with ovarian cancer, to see which biomarkers are most promising.
"The thing we did not know is how early these markers give a signal," said Urban, whose hunt is joined by Yale, M.D. Anderson and other leading ovarian cancer centers. Also, British researchers have enrolled 200,000 women in a study to see if annual CA125 testing plus transvaginal ultrasounds will spot simmering tumors. The idea: High jumps in CA125 levels might give a better signal than a one-time test.

[Back]

Zeltia drug delays progression of ovarian cancer (Yahoo News-15/09/2008)

Women with recurrent ovarian cancer given Zeltia's drug Yondelis in combination with chemotherapy go longer before their disease progresses than those on chemo alone, researchers said on Monday. The news is a boost for the Spanish biotech company, which already sells Yondelis as a treatment for soft tissue sarcoma, a rare disease, and now hopes to address a much bigger commercial opportunity. Bradley Monk, an oncologist from the University of California Irvine Medical Center who led a Phase III trial of the drug, said Yondelis could be added to a short list of active drug therapies for recurrent ovarian cancer. "These are exciting results because positive trials in recurrent ovarian cancer are rare and have almost always led to federally approved treatments," Monk said in a statement. "This treatment undoubtedly will be evaluated carefully by the U.S. Food and Drug Administration and, if approved, will give women with ovarian cancer another much-needed option." Zeltia's drug, which it is developing with Johnson & Johnson, is unusual in that it is a synthetic version of a compound isolated from a type of sea squirt, a tubular marine animal. It works by binding to the DNA of cancer cells and blocking their ability to multiply. The Spanish company had already announced that Yondelis, its first product to reach the market, had shown positive results in the pivotal trial. But the actual results of the study, involving 672 women whose ovarian cancer had progressed after first-line treatment, were only disclosed at the annual meeting of the European Society of Medical Oncology (ESMO) in Stockholm.

Monk said the results showed those women given a combination of Yondelis and Johnson & Johnson's chemotherapy drug Doxil had no progression of their cancer for an average of 7.3 months, against 5.8 months for women treated only with Doxil. In the case of women who had relapsed more than six months after getting first-line therapy, the median progression-free time was 9.2 months with Yondelis versus 7.5 months. In common with other anti-cancer agents, this suggests Yondelis is most active in patients who have gone a long time since receiving initial chemotherapy treatment. Yondelis, whose generic name is trabectedin, is currently approved for soft tissue sarcoma in Europe but not the U.S. The product is also being studied in smaller, Phase II trials for prostate, breast and childhood cancers.

[Back]

Hope, confusion in hunt for ovarian cancer tests (Yahoo News-15/09/2008)

Does a test that promises to find ovarian cancer sooner really do so? Could other tests nearing the market prolong survival by getting patients the right care faster? A race is on for blood tests to better detect this intractable killer, but the Food and Drug Administration is probing whether to crack down on the first one to sell. It's a time of both hope and confusion. First, the question is whether testing giant LabCorp jumped the gun in selling OvaSure as an ovarian cancer screening test before researchers proved that it catches the tumor in an early, treatable stage without falsely alarming too many healthy women. A legal quirk let sales begin without formal FDA approval. In fact, U.S. and British scientists are just beginning studies specially designed to prove if signs of ovarian cancer can be measured reliably in blood months, even a year, before a tumor becomes life-threatening. "You really need evidence that screening actually saves lives, or at least prolongs survival," cautions Dr. Robert Bast Jr., an ovarian biomarker expert at M.D. Anderson Cancer Center. While the FDA won't discuss its ongoing probe of OvaSure, it is watching the field closely. "It's not a question of if, it's a question of when the right test will come along with the right credentialing to help improve health care in this important area," says Dr. Steven Gutman, FDA's diagnostic testing chief. At the same time, competing companies are seeking FDA approval for a different approach: Blood tests to help identify which women with an ovarian lump or cyst are most likely to have cancer, so they can have their crucial first surgery — the one that diagnoses malignancy — done by a specialist.

Thousands of women get cysts but only an unlucky fraction turn out to be cancer. Studies show even advanced patients can live many months longer if that very first operation is done by a gynecologic oncologist, who knows where cancer hides and how to remove pelvic lymph nodes, instead of the general surgeon most see today. "That's a big, big step forward for women because it allows them to get the proper care," says Dr. Richard Moore of Brown University, who led a study of Fujirebio Diagnostics Inc.'s so-called triage test that correctly predicted cancerous cysts more than 90 percent of the time. "It really is an unmet need," agrees Bast. Nearly 22,000 U.S. women will be diagnosed with ovarian cancer this year. Most see a doctor for symptoms — bloating, a swollen abdomen, pelvic pain, frequent urination — that strike after the cancer has spread, when long-term survival plummets. More than 15,000 patients die each year. Women at high risk because of BRCA gene mutations are advised to have their ovaries removed for protection. For the general population, the goal is a blood test to detect early cancer signs such as molecules that tumor cells shed, or perhaps unusual hormone changes, without sending too many women to unnecessary surgery. In the pipeline:
_Two tumor markers, CA125 and one just approved by FDA called HE4, used to track if chemotherapy is working or cancer is returning. A one-time CA125 test can't screen seemingly healthy women because levels rise with benign cysts, endometriosis, even normal menstruation. But Fujirebio's triage test uses HE4 and CA125 to assess who most likely has a benign cyst and whose may be cancer.
_LabCorp in June began marketing to high-risk women a screening test developed by Yale University, under a law that allows a single laboratory to offer testing without FDA review. Yale researchers used OvaSure on blood samples stored from cancer patients and healthy women, and found it correctly identified cancer 95 percent of the time with few false alarms. But specialists say that doesn't prove OvaSure can detect when cancer is forming — just that it spotted tumors in the already diagnosed few with early stage disease.
"We believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health," the FDA warned LabCorp last month. The FDA several years ago forced a similarly marketed ovarian test off the market. LabCorp spokesman Eric Lindblom wouldn't disclose results of a recent FDA meeting, but said Yale is working to validate OvaSure and "we're continuing to offer the test at this time." _Tracking seemingly healthy women well before they're diagnosed is the only way to prove a test finds cancer early, says Dr. Michael Birrer of the National Cancer Institute — work just beginning.
Dr. Nicole Urban of Seattle's Fred Hutchinson Cancer Center is heading a multi-hospital test of blood stored a full year before 120 women were diagnosed with ovarian cancer, to see which biomarkers are most promising. "The thing we did not know is how early these markers give a signal," said Urban, whose hunt is joined by Yale, M.D. Anderson and other leading ovarian cancer centers. Also, British researchers have enrolled 200,000 women in a study to see if annual CA125 testing plus transvaginal ultrasounds will spot simmering tumors. The idea: High jumps in CA125 levels might give a better signal than a one-time test.

[Back]

Analgesic drugs don't reduce ovarian cancer risk (Reuters Health-17/07/2008)

The regular use of over-the-counter analgesic drugs, such as aspirin and ibuprofen, does not appear to reduce the risk of ovarian cancer, according to findings published in the American Journal of Epidemiology. It has been suggested that inflammation may be involved in the development of ovarian cancer, "possibly acting in concert with ovulation," Dr. Mary Anne Rossing, of Fred Hutchinson Cancer Research Center, Seattle, and colleagues write. Drugs with anti-inflammatory effects, such as aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), have been suggested as possible treatment to prevent the development of ovarian cancer. In a population-based study, the researchers evaluated the analgesic use in 812 women diagnosed with ovarian cancer and in 1313 "control" subjects who acted as a comparison group. In-person interviews were used to assess analgesic use, excluding use within the previous year. A total of 1007 women (47 percent) reported previous use of acetaminophen, aspirin, ibuprofen, or other NSAIDs on 5 or more days per month for at least 6 consecutive months. In contrast, an association was observed between acetaminophen and aspirin and a slightly increased risk of ovarian cancer. The increased risk was found mainly in women who had used the drugs for more than 10 years, with an increased risk of 80 percent for acetaminophen and 60 percent for aspirin. However, among women who used aspirin, those who began regular use within the previous 5 years had a reduced risk of ovarian cancer of about 40 percent, as did those who took aspirin for heart disease prevention at about 30 percent. "These results, in the context of prior findings, do not provide compelling evidence of a true increase in risk of ovarian cancer among women who use these drugs," Rossing and colleagues conclude. "However, they add to the weight of evidence that, in the aggregate, provides little support for the use of analgesic drugs as chemoprevention for this disease."

[Back]

Symptoms Plus Blood Test Boost Ovarian Cancer Detection (HealthDay News-23/07/2008)

U.S. researchers boosted the level of early-stage ovarian cancer detection by 20 percent through use of a blood test to detect a tumor marker as well as a woman's report of new-onset symptoms. Using either test alone only uncovered about 60 percent of early-stage ovarian cancers in a high-risk group of women, while the two techniques together found 80 percent of early-stage tumors, according to finding published Monday in the online version of the journal Cancer. "They appear to act complementary, and appear to be able to identify women who would not be identified by a blood sample alone, and conversely would not be identified by symptoms alone," said the study's lead author, M. Robyn Andersen, an associate member of the Public Health Sciences Division at the Fred Hutchinson Cancer Research Center in Seattle. More than 21,000 women are diagnosed with ovarian cancer annually, and more than 15,000 women die from the disease each year, according to the American Cancer Society (ACS). Currently, only about 20 percent of ovarian cancers are caught in their earliest, potentially curable stages, according to Andersen. In 2006, Andersen's colleague, Dr. Barbara Goff, director of gynecologic oncology at the University of Washington School of Medicine, published the ovarian cancer symptom-screening index tool, in an effort to help women and doctors clarify which women might have a heightened risk of ovarian cancer. Important symptoms include pelvic or abdominal pain, bloating, increased abdominal size, difficulty eating, or feeling full quickly. These symptoms must occur more than 12 times per month, and have just recently begun occurring (within the past year), to be considered positive on the symptom-screening tool. For example, if a woman has had abdominal pain for the past 10 years, it's probably not related to ovarian cancer, but to another disorder, such as irritable bowel syndrome.

For the current study, Andersen and her colleagues used the symptom-screening index and a blood test that looks for CA 125, a protein that is often elevated in ovarian cancer. However, CA 125 can sometimes be elevated in women who don't have ovarian cancer, the researchers noted. The study involved 254 healthy women at high-risk for ovarian cancer because of family history, as well as 75 women about to undergo surgery to remove an ovarian cancer. The women were asked to fill out a questionnaire about their symptoms. All of the women also gave a blood sample to have their levels of CA 125 measured. The two methods together correctly identified almost 90 percent of the ovarian cancers -- 80.6 percent of the early cancers and 95.1 percent of the later-stage cancers. About 14 percent of women who had symptoms and had elevated levels of CA 125 did not have ovarian cancer, according to Andersen. These women received transvaginal ultrasound tests for follow-up, according to Andersen. "This study continues to add on to the work that's been done, but we still have a long way to go with ovarian cancer," commented Debbie Saslow, director of breast and gynecologic cancer for the American Cancer Society. None of the current screening tools is as accurate as the ACS and other experts would like them to be, she explained. Any of the tests alone misses a significant number of cancers, and unnecessarily worries women who don't have cancer. Saslow said transvaginal ultrasound can be a good test, but it has to be done by an experienced sonographer, and there are no current guidelines to define how much experience is enough. Additionally, Saslow said that no research has been done to prove that early detection saves lives. Andersen said the researchers recommend that if you have any of the symptoms of ovarian cancer, and they're new-onset symptoms, that you should discuss them with your doctor. But, she added that, "even with this specific pattern of symptoms, most women probably don't have ovarian cancer, just as most women with a breast lump don't have breast cancer."

[Back]