Tags: CA-125, chemotherapy, endometrial cancer, HIPEC, HITEC, malignant tumors malignant tissue, ovarian cancer, remission, surgery, treatment
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Targeted treatment for ovarian cancer to be studied at University Hospitals
Tuesday, February 28, 2012
CLEVELAND, Ohio — Physicians at University Hospitals Case Medical Center are developing four clinical trials to test a therapy that has been around for several decades, but which only recently has been used to treat ovarian, endometrial (uterine) and select other gynecologic cancers.
The studies, which physicians hope to begin this spring, have been designed for a very specific patient population — no more than a couple dozen women with ovarian or endometrial cancer will be enrolled in each one. The trials will help researchers compare and learn relatively quickly how to use heated intraperitoneal chemotherapy, or HIPEC, as effectively as possible, said Dr. Robert DeBernardo, a gynecologic oncologist at UH and assistant professor at Case Western Reserve University School of Medicine.
The procedure, administered in the operating room right after surgery to remove malignant tumors or tissue, flows a hyperthermic — or heated — sterilized chemotherapy solution through catheters directly into a patient’s abdominal cavity. The heat makes cancer cells “leak” so chemotherapy can enter the cells more effectively.
The effect of chemotherapy delivered directly to the abdomen is more potent than intravenous delivery, which takes longer to reach the intended area. And because the targeted delivery of HIPEC minimizes the rest of the body’s exposure to the treatment, it helps reduce some side effects, such as hair loss.
“Giving chemotherapy in the [operating room] is complicated, but it’s not something that can’t be done,” DeBernardo said. “We need to really show: Is this a beneficial therapy?”
Not only will the studies shed light on how well HIPEC controls when and where the cancer recurs, but they will also focus closely on side effects, costs and the length of hospital stays.
Here are the Phase 1 trials:
• A study involving the use of heated chemotherapy for ovarian cancer that has spread to the chest. What the surgical team has dubbed HITEC (the “T” coming from the word intrathoracic) is performed after minimally invasive lung surgery. “To my knowledge, no one has treated ovarian cancer [that has spread to] the chest like this,” DeBernardo said.
• A study for advanced ovarian-cancer patients whose cancer is in remission following surgery and chemotherapy. The patients will undergo HIPEC to prevent recurrence.
• A study for patients whose cancer recurs; HIPEC will be performed following surgery.
• A study for patients who undergo chemotherapy prior to surgery and HIPEC during the surgery.
Ovarian cancer is especially challenging to treat, as it is often not detected until it has spread. The cancer antigen 125 blood test, which can detect elevated levels of CA-125 — a trait often found in women with ovarian cancer — is not recommended as a screening test in women with an average risk of the disease because elevated levels can signal many other conditions.
Over the past two decades, treatments have evolved and improved, says DeBernardo.
Not only has it become easier to perform aggressive tissue-removing surgery (the primary way to diagnose ovarian cancer), but surgeons have become more specialized in cancer-tissue removal. Women also are able to better tolerate treatment.
“The thing about women with ovarian cancer [is,] we don’t cure very many people with ovarian cancer,” DeBernardo said. “We can control it, we can keep it at bay. But it almost always comes back. That’s where HIPEC comes in. It may improve things.”
The Cleveland Clinic began treating abdominal cancers — appendix, colorectal, gastric, ovarian and peritoneal mesolthelioma (a cancer of the lining of the abdominal cavity) with HIPEC in 2010. UH followed suit last summer, with DeBernardo working with other surgical oncologists and general surgeons to launch the program at UH Seidman Cancer Center.
Buoyed by the results of a national study that appeared in 2006 in the New England Journal of Medicine that showed a higher rate of survival for women with ovarian cancer who were treated with HIPEC versus intravenous chemotherapy, hospitals began to explore the HIPEC option.
“The unfortunate fact is, even though it’s good science, there is still only a minority of women getting offered that treatment,” DeBernardo said. The reasons are varied, and include that not all women have ready access to a hospital with a gynecologic on-
cologist or other skilled staff who are able to integrate HIPEC as part of treatment.
Last August, led by DeBernardo, UH launched a dedicated HIPEC program for gynecological cancers. The surgical team performed its first HIPEC treatment in August 2011. Since then, there have been more than two dozen cases.
Jan Belleville of Hubbard was DeBernardo’s first HIPEC patient.
Other than feeling something — not pain, but something — in her lower abdomen in the summer of 2006, Belleville had no reason to think it was ovarian cancer.
“I had had fibroids and thought that was all it was,” said Belleville, 68. But it wasn’t.
Belleville was diagnosed with Stage 4 ovarian cancer, which by then had spread through her abdominal cavity to her liver. Her first surgery included radiation therapy. Chemotherapy followed.
After being in remission for a year, Belleville’s cancer returned to her liver. She had another operation, followed by more chemotherapy and radiation. The cancer went into remission for six months, then came back. After more chemotherapy, remission again for three months. But the cancer came back again. This time it had spread to her lungs.
After treating Belleville with different types of chemotherapy that proved ineffective, DeBernardo and his colleague, Dr. Jason Robke, decided to do something else.
Last summer, they approached her about having HIPEC/HITEC surgery. She would be their first case.
“I never have doubted that I was being guided in the right direction,” Belleville said.
In late July, she had the first of two HIPEC/HITEC operations, on the left side of her chest. Four weeks later, surgeons operated on the right side. Those surgeries — which were each roughly three hours long, including about 90 minutes for administering the chemotherapy — were the seventh and eighth since she was first diagnosed.
The surgeries stabilized Belleville’s levels of CA-125, the protein in the blood that is found in ovarian cancer cells at a much higher level than in normal cells.
Shortness of breath and lack of energy earlier this month prompted more tests; X-rays detected spots on her lungs, evidence that the cancer had returned there.
Despite the news, Belleville and her husband went ahead with a planned vacation to Florida. Last week, she started intravenous chemotherapy.
“I think it bought me a really nice Thanksgiving, a beautiful holiday over Christmas,” an upbeat Belleville said about the six-month remission that followed her HIPEC/HITEC procedure. “I don’t consider this [recurrence] a setback.”
Leg Swelling (Lymphedema) in a Patient With Gynecologic Cancer November 14, 2008Posted by patoconnor in cancer, gynecological cancer, ovarian cancer, tubal cancer, uterine cancer, vaginal cancer.
Tags: cancer, cancer of the vulva, cernival cancer, chemotherapy, endometrial cancer, Fallopian Tube Cancer, gynecologic cancer, immune system, leg lymphedema, leg swelling, lymph nodes, lymph vessels, lymphatic system, ovarian cancer, quality of life, radiation, uterine cancer, vaginal cancer
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Leg Swelling (Lymphedema) in a Patient With Gynecologic Cancer
Lower-Extremity Lymphedema in a Patient With Gynecologic Cancer
Kathleen Appollo, RN, BSN, OCN
Oncology Nursing Forum – Vol 34, No. 5, 2006
H.F. is a 56-year-old woman who presented to the gynecologic oncology department at a major comprehensive cancer center after an endometrial biopsy revealed an International Federation of Gynecology and Obstetrics grade III serous carcinoma of the endometri- um. In addition to relevant endometrial cancer statistics, she received information about choices for treatment. The standard surgical treatment at the cancer center consists of a total abdominal hysterectomy with bilateral salpingo-oophorectomy, pelvic lymph node dissection, and para-aortic lymph node sampling. The acute and chronic side effects of surgery were discussed, including develop- ment of lower-extremity lymphedema. H.F. was informed that the lymphedema could occur anytime after surgery and she would need to monitor for lymphedema development for the rest of her life.
After preoperative testing, H.F. had an uneventful surgical procedure and routine postoperative course. The ﬁnal pathology showed high-grade stage IIIC papillary serous carcinoma deeply invading the endometrium, with spread to a left para-aortic lymph node. As result, her oncologist recommended both radiation and chemotherapy.
H.F. completed all therapy and was scheduled to return every three months for evaluation. She was cautioned to maintain skin integrity by applying moisturizers and sunscreen as needed and to avoid sources of trauma, injury, infection, and constriction to the lower extremities. In addition, she was encouraged to maintain her weight with a healthy diet and she was advised to return to the lymphedema specialist for lymphedema control.
She understands that she must be diligent in her care to maintain control. H.F. knows that she should be joyous that she is free from cancer but often wonders about the sacriﬁces that she has made in the quality of her per- sonal life. She did not feel the need to seek professional psychiatric help but did join a support group. Although the members of the group all have cancer, none has lymphedema.
Even so, H.F. has found that sharing difﬁculties with others has helped her to cope, and she feels good when she has helped another deal with a difﬁcult issue. Although she has not returned to her former music activities, she has found that helping others in the support group has given her the same satisfaction that she felt when her music brought happiness to others.
Lymphatic System and Lymphedema
Lymph is extracellular fluid composed of water, fats, proteins, bacteria, and waste products. The lymphatic system is an inter connected network of organs, lymph vessels, and lymph nodes that transports lymph from body tissues to the bloodstream, helping to maintain body ﬂuid balance. It also is a major component of the body’s immune system.
The superficial lymphatic capillaries are made up of endothelial cells that overlap but do not form a continuous connection. Each cell is anchored to surrounding tissue by ﬁlaments that pull on the cells in response to changes in tissue pressure. As the cell is pulled by the ﬁlament, ﬂuid drains into the vessel. Pressure changes occur during muscle contraction, respiration, and arterial pulsation and when the skin is stretched. Lymph ﬂows into progressively larger deep vessels that have one-way valves to ensure that the ﬂuid moves away from tissues in a slow, steady, low-pressure system. Afferent vessels carry lymph into lymph nodes, where the lymph is ﬁltered of cellular waste products, pathogens, and cancer cells and where lymphocytes are added.
Efferent vessels carry lymph out of the lymph nodes to return to circulation. Lymph drains from the lower limbs into the lumbar lymphatic trunk, joining the intestinal lymphatic trunk and cisterna chyli to form the thoracic duct that empties lymph into the left subclavian vein (Casely-Smith & Casely-Smith, 1997; Mortimer, 1998).
Lymphedema occurs when lymph remains in the tissues because the lymphatic system is unable to transport interstitial ﬁltrate (Foldi, 1998; International Society of Lymphology, 2003). Primary lymphedema is a result of an absence of or abnormalities in lymphatic tissue. Secondary lymphedema, which is the focus of this discussion, results when the ﬂow of lymph is interrupted because of malignancies, surgery, infection, trauma, or postradiation ﬁbrosis and the lymph remains in the tissue.
Incidence and Risk Factors
Although much has been written about upper-extremity lymphedema after breast surgery, information about lower-extremity lymphedema is lacking. The literature varies widely about the number of patients affected. In one study, the incidence of lymphedema in patients after a hysterectomy with lymph node removal was 20% (Ryan, Stainton, Slaytor, et al., 2003). Another study reported a 3.4% incidence rate in patients following endometrial staging surgery, including hysterectomy, bilateral salpingo-oophorectomy, and lymph node dissection (Abu-Rustum et al., 2006). A retrospective series of staging surgery for endometrial cancer followed by radiation therapy reported an incidence of 4.6% (Nunns, Williamson, Swaney, & Davy 2000).
H.F. was at risk to develop lymphedema after her surgery for endometrial cancer because of the disruption of lymphatics and lymph nodes during staging surgery. She was at additional risk because of the postoperative radiation. Other risk factors are believed to include injury, trauma, heat changes, infection to the extremity, and weight gain and decreased mobility (Brewer, Hahn, Rohrbach, Bell, & Baddour, 2000; Mortimer, 1998).
Although research is lacking to support many recommendations for the prevention of lymphedema (Ridner, 2002), education regarding measures that are believed to reduce risk include protecting the skin from trauma and infection. Those measures were discussed with H.F. postoperatively and at each ofﬁce visit. The plan is based on the concept that any action or condition that predisposes a patient to or increases swelling may disrupt the ﬁne balance of drainage after surgery (Mortimer, 1998). In addition, open skin may lead to infection, which can occur more easily in stagnant, protein-rich lymph ﬂuid, a perfect medium for bacteria growth (Brewer et al., 2000). Because deep vein thrombosis and cancer recurrence can cause swelling, they were ruled out before H.F. was referred for complex decongestive therapy. Her treatment began with manual lymphatic drainage, a gentle massage that starts proximally to encourage the flow of lymph from the distal extremity. More lymph is encouraged to move into the normally functioning lymphatics (Cheville et al., 2003; Foldi, 1998; Lerner, 1998).
Massage was followed by padding of the extremity and application of short stretch compression bandages with gradual pressure changes distally to proximally. That type of bandaging helps the ﬂow of lymph to the nodal basins (Cheville et al.; International Society of Lymphology, 2003).
H.F. was taught the techniques so that she could continue maintenance therapy at home. She was encouraged to practice manual lymphatic drainage, use compression bandages at night, wear a ﬁtted compression garment, follow meticulous skin care guidelines, protect the leg from trauma and injury, and perform muscle-building exercises. H.F. also was taught to wear the compression garment especially during air travel because changes in atmospheric pressure may increase the pressure balance in the leg (National Lymphedema Network, 2005).
Quality of Life
Lymphedema may have a profound effect on the lives of cancer survivors (Kwan et al., 2002; Ryan, Stainton, Jaconelli, et al., 2003). H.F. described a heavy, achy feeling in her leg, which has been reported in patients with breast cancer before swelling occurred (Armer, Radina, Porock, & Culbertson, 2003). Pain assessment is crucial in helping patients to cope. An over-the-counter medication may sufﬁce, but some patients may need prescription-strength pain medication, making individual assessment critical.
H.F. stated that her pace was slower in her walks. In patients with breast cancer, fatigue often is a troublesome symptom affecting quality of life (Armer & Porock, 2002). Pacing activities or decreasing distances may help to maintain stamina. Pacing also may deter swelling that is associated with strenuous or long-distance exercise. The need for sleep medication should be evaluated because insomnia caused by leg discomfort or worry may contribute to fatigue.
Changes in wardrobe often are necessary when swelling occurs (Ryan, Stainton, Jaconelli, et al., 2003). Alteration in body image may result in changes to regular social activities and may lead to social isolation (Tobin, Lacey, Meyer, & Mortimer, 1993). Referrals to support groups or individual therapy sessions may be indicated depending on patient preference. H.F. found that she gained much by participating in a support group and thereby moved from one type of social interaction to another. Healthcare professionals must be sensitive to lifestyle changes as well as the ﬁnancial burden that may result from a forced change in wardrobe.
With increased survival after cancer treatment, the long-term sequelae caused by cancer treatment should be recognized and treated. Patients must be informed about the potential lifelong side effects of treatment. Although H.F. was informed about the possibility of lymphedema development, many patients have reported that they were not informed about this life-alterating condition until they developed symptoms (Beesley, Janda, Eakin, Obermair, & Battistutta, 2007; Ryan, Stainton, Jaconelli, et al., 2003). Continued research is needed to determine the best interventions to decrease the side effects of treatment and maximize quality of life.
Kathleen Appollo, RN, BSN, OCN can be reached at appollok @mskcc.org, with copy to editor at ONF Editor@ons.org.