Patients and Methods: Patients with advanced, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received a maximum of one prior treatment for recurrent cancer were randomly assigned to gemcitabine plus either pertuzumab or placebo. Collection of archival tissue was mandatory to permit exploration of biomarkers that would predict benefit from pertuzumab in this setting.

Results: One hundred thirty patients (65 per arm) were treated. Baseline characteristics were similar between arms. The adjusted hazard ratio (HR) for PFS was 0.66 (95% CI, 0.43 to 1.03; P = .07) in favor of gemcitabine + pertuzumab. The objective response rate was 13.8% in patients who received gemcitabine + pertuzumab compared with 4.6% in patients who received gemcitabine + placebo. In patients whose tumors had low HER3 mRNA expression (< median, n = 61), an increased treatment benefit was observed in the gemcitabine + pertuzumab arm compared with the gemcitabine alone arm (PFS HR = 0.32; 95% CI, 0.17 to 0.59; P = .0002). Grade 3 to 4 neutropenia, diarrhea, and back pain were increased in patients treated with gemcitabine + pertuzumab. Symptomatic congestive heart failure was reported in one patient in the gemcitabine + pertuzumab arm.

Conclusion: Pertuzumab may add activity to gemcitabine for the treatment of platinum-resistant ovarian cancer. Low HER3 mRNA expression may predict pertuzumab clinical benefit and be a valuable prognostic marker.

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Methods. A retrospective review of sonographic findings was conducted on 16 patients with surgically proven ovarian GCTs. Patients’ ages ranged from 10 to 64 years (mean, 37.7 years). We evaluated the sizes and morphologic appearances of the ovarian tumors. The blood flow patterns of the tumors were assessed with Doppler sonography (n = 6). Sonographic findings were compared with pathologic findings.

Results. The maximal diameters of the masses were 2.0 to 15.4 cm (mean, 8.2 cm). The morphologic appearances of the masses were classified into 3 patterns; solid and cystic (n = 10), solid with a sponge form appearance (n = 4), and entirely solid (n = 2). The measured resistive index and pulsatility index of the solid portions were 0.23 to 0.5 and 0.26 to 0.62, respectively. Pathologic diagnoses of 13 adult ovarian GCTs and 3 juvenile GCTs were obtained. The solid and cystic masses had GCTs with macrofollicular and microfollicular patterns pathologically. The solid masses with a sponge form appearance had prominent hemorrhagic necrosis and diffuse proliferation of granulosa cells with trabecular and microfollicular patterns. The entirely solid masses had diffuse cellular proliferation with a trabecular pattern without cystic changes or hemorrhagic foci.

Conclusions. Sonographic findings of ovarian GCTs included solid and cystic masses, solid masses with a sponge form appearance, and entirely solid masses, and the sonographic findings correlated well with the histopathologic findings.

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Experimental Design: Blood samples were obtained from 325 women with invasive epithelial ovarian cancer diagnosed at the Mayo Clinic from 1999 to 2006. During a median follow-up of 3.8 years (range, 0.1-8.6 years), 157 deaths were observed. Germline DNA was analyzed at 1,416 single nucleotide polymorphisms (SNP). For all patients, and for 203 with serous subtype, we assessed the overall significance of each gene and pathway, and estimated risk of death via hazard ratios (HR) and 95% confidence intervals (CI), adjusting for known prognostic factors.

Results: Variation within angiogenesis was most strongly associated with survival time overall (P = 0.03) and among patients with serous cancer (P = 0.05), particularly for EIF2B5 rs4912474 (all patients HR, 0.69; 95% CI, 0.54-0.89; P = 0.004), VEGFC rs17697305 (serous subtype HR, 2.29; 95% CI, 1.34-3.92; P = 0.003), and four SNPs in VHL. Variation within the inflammation pathway was borderline significant (all patients, P = 0.09), and SNPs in CCR3, IL1B, IL18, CCL2, and ALOX5 which correlated with survival time are worthy of follow-up.

Conclusion: An extensive multiple-pathway assessment found evidence that inherited differences may play a role in outcome of ovarian cancer patients, particularly in genes within the angiogenesis and inflammation pathways. Our work supports efforts to target such mediators for therapeutic gain.

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Methods. White Leghorn laying hens were scanned transvaginally at 15-week intervals up to 45 weeks. Gray scale ovarian morphologic characteristics and Doppler indices were recorded. Hens were euthanized at diagnosis for ultrasonographic morphologic/vascular abnormalities or at the end of the study (those that remained normal). Ovarian morphologic and histologic characteristics were evaluated. Vascular endothelial growth factor (VEGF) and _vβ₃-integrin expression was assessed by immunohistochemical analysis. Doppler ultrasonographic observations were compared with histologic and immunohisto-chemical findings to determine the ability of DUS to detect ovarian TAN.

Results. Significant changes in ovarian blood flow parameters were observed during transformation from normal to tumor development in the ovary (P < .05). Tumor-related changes in ovarian vascularity were identified by DUS before the tumor became detectable by gray scale imaging. Increased expression of VEGF and _vβ₃-integrins was associated with tumor development. Ovarian TAN preceded tumor progression in hens.

Conclusions. The results suggest that ovarian TAN may be an effective target for the detection of early-stage OVCA. The laying hen may also be useful for studying the detection and inhibition of ovarian TAN using various means, including the efficacy of contrast agents, targeted molecular imaging, and antiangiogenic therapies.

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The programs, run mainly by nonprofit and charitable groups, offer financial aid to patients with specific life-threatening or chronic diseases to help cover the cost of co-payments, deductibles and other medical expenses. Patients usually must meet specific income and treatment guidelines.

Patients typically are referred to the programs by the financial counseling or patient-advocate offices of big hospitals and treatment centers. But you also can seek them out online.

Cutting Cancer-Care Costs

The CancerCare Co-Payment Assistance Foundation (at 1-866-552-6729 or CancerCareCopay.org) helps eligible patients cover the cost of insurance co-payments for treatment of specific cancers. The program, founded in April 2008, now lists seven diagnoses eligible for assistance: breast cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, pancreatic and renal cancer and glioblastoma.

Some diseases have a $10,000 annual limit on aid, others have a $5,000 limit, says John Rutigliano, chief operating officer of nonprofit CancerCare. Most people who qualify receive between $2,500 and $5,000.

He says these days more employees are bearing a larger share of the cost of care, with higher co-pays and deductibles.

Since the CancerCare program began, about 7,000 people have applied for co-pay assistance, and about 80% of them have received aid. Half of those who received aid were on Medicare and the other half were privately insured.

The foundation rejects less than 7% of applications, mostly because applicants’ income exceeds guidelines. The cutoff for assistance is 400% of the federal poverty level — slightly above $43,000 for an individual and $58,000 for a family of two.

Nancy Francisco of Crystal Falls, Mich., received financial help from CancerCare when she was diagnosed with glioblastoma, a type of malignant brain tumor, early in 2009.

Mrs. Francisco, a 45-year-old registered nurse and electronic medical records technician, became disabled as a result of the illness and treatment. Her husband is her full-time caregiver. She continued her health-insurance coverage under her former employer’s Cobra plan, but out-of-pocket expenses for treatment exceeded $10,000. CancerCare helped her with a $10,000 grant, says the mother of three, which helped cover co-pays for chemotherapy and IV transfusions.

“I couldn’t believe there was help,” says Mrs. Francisco, who learned of the program from her hospital social worker and pharmacist, who also helped her fill out the application.

Other Options

Other groups offering financial assistance for the treatment of cancer and other diseases: HealthWell Foundation HealthWellFoundation.org, which helps with co-pays and premiums for patients with group and individual insurance, Medicare and Medicaid. The Leukemia & Lymphoma Society’s Co-Pay Assistance Program (leukemia-lymphoma.org) helps with private-insurance premiums.

The Patient Advocate Foundation Co-Pay Relief Program (copays.org) provides pharmaceutical co-pay help to insured patients, including Medicare Part D recipients.

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Research shows that women with ovarian cancer are much more likely than healthy women to report symptoms such as abdominal pain, bloating, feeling full quickly after eating and urinary urgency, especially if the symptoms are relatively new and persistent, said study author Mary Anne Rossing, a member of the Program in Epidemiology at Fred Hutchinson Cancer Research Center in Seattle.

But because ovarian cancer is fairly rare, while the symptoms are relatively common and possibly explained by less serious conditions, the ability to predict who has cancer based on symptoms alone is limited, Rossing said.

Researchers found that for every 100 women in the general population whose symptoms matched those in a widely accepted ovarian cancer symptom index, only one would actually have early-stage ovarian cancer.

“The rarity of ovarian cancer in the general population results in the positive predictive value of these symptoms in detecting ovarian cancer as being quite low,” Rossing said. The disease strikes about one in 72 women.

The study is published in the Jan. 28 online issue of the Journal of the National Cancer Institute.

Finding ways to detect early-stage ovarian cancer is an ongoing challenge, said Cara Tenenbuam, vice president of policy and external affairs for the Ovarian Cancer National Alliance.

Ovarian cancer sometimes is found during a pelvic exam, but tumors are often too deep within the body for doctors to detect. In addition, the symptoms of ovarian cancer are often missed or misdiagnosed as other less serious conditions, including menopause, lactose intolerance, irritable bowel syndrome or even depression, Tenenbaum said

While nine of 10 women whose ovarian cancer is caught early are alive five years after diagnosis, only about 20 percent of ovarian cancers are found at their early stage, according to the American Cancer Society.

To address this, in 2007, three major cancer organizations — the American Cancer Society, the Gynecologic Cancer Foundation and the Society of Gynecologic Oncologists — released a consensus statement that included a constellation of symptoms women and their doctors should be aware of, including swelling of the stomach or bloating, pelvic pressure or stomach pain and trouble eating.

Rossing and her colleagues interviewed 812 women aged 35 to 74 who had epithelial ovarian cancer, the most common type of ovarian cancer, about their symptoms during the year leading up to diagnosis and compared them to 1,313 who didn’t have cancer.

Women who were diagnosed with cancer were 10 times more likely to experience the symptoms than women without cancer, according to the study. Among patients with early-stage disease, about 27 percent experienced the symptoms for at least five months before diagnosis.

Yet the symptoms aren’t much use in identifying cases of ovarian cancer in the general population because in 99 out of 100 cases, a women with the symptoms would not have ovarian cancer, Rossing said.

“We need to understand more about the benefits and risks for women who receive evaluations for ovarian cancer because of these symptoms,” Rossing said. “Risks may include the worry and expense of unnecessary testing, ultrasound and even unnecessary surgery.”

Last year, 21,550 new cases of ovarian cancer were diagnosed among U.S. women; 14,600 deaths were attributed to the disease.

In the absence of more precise screening techniques, Tenenbaum said women and their doctors should be aware of possible signs of ovarian cancer, and women should not hesitate to see their doctors if their symptoms are persistent or are clearly not how they usually feel.

“We talk a lot about symptom awareness, but what this study shows is we still need a reliable early detection test,” Tenenbaum said. “The symptoms index is the best we have right now for early detection. You need to know what’s normal for you. If it’s new for you and you’re not feeling good, we want you to have good access to medical care and to avail yourself of it.”

Meanwhile, scientists continue to experiment with better detection methods. According to a study in the February issue of the American Journal of Roentgenology, researchers are working on developing better early-stage cancer detection through the use of contrast-enhanced ultrasound combined with blood tests that look for tumor biomarkers.

More information

The Ovarian Cancer National Alliance has more on ovarian cancer and a downloadable symptom diary.

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“Although finding effective screening tools remains a priority, new treatment options for women with ovarian cancer such as the ones outlined in the updated NCCN Guidelines, remains imperative to making steady progress against the disease.”

Key updates to the NCCN Guidelines include the addition of carboplatin (Paraplatin^®, Bristol-Myers Squibb)/weekly paclitaxel (Taxol^®, Bristol-Myers Squibb) and carboplatin/liposomal doxorubicin (Doxil^®, Centocor Ortho Biotech) for cytotoxic therapy for patients with platinum-sensitive epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has recurred.

These modifications made to the NCCN Guidelines for Ovarian Cancer are based on results from recent studies in The Lancet and The Journal of Clinical Oncology demonstrating that both combination regimens improved median progression-free survival in women with specific types of recurring ovarian cancer as compared to conventional regimens. In addition, the carboplatin/weekly paclitaxel regimen improved overall survival.

“Ovarian cancer is a challenge to treat because by the time the majority of the women are diagnosed with the disease, it has already progressed to stage III or IV,” says Robert J. Morgan, MD, of City of Hope Comprehensive Cancer Center and the chair of the NCCN Guidelines Panel for Ovarian Cancer. “Although finding effective screening tools remains a priority, new treatment options for women with ovarian cancer such as the ones outlined in the updated NCCN Guidelines, remains imperative to making steady progress against the disease.”

Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and the country’s fifth most common cause of cancer mortality in women. In the year 2009, there were more than 21,000 new diagnoses and nearly 15,000 deaths from this neoplasm in the United States.

The NCCN Clinical Practice Guidelines in Oncology^™ are developed and updated through an evidence-based process with explicit review of the scientific evidence integrated with expert judgment by multidisciplinary panels of physicians from NCCN Member Institutions. The most recent version of this and all the NCCN Guidelines are available free of charge at NCCN.org.

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CONCLUSION. The goal of imaging in ovarian cancer detection is to expeditiously distinguish benign adnexal lesions from those requiring further pathologic evaluation for malignancy. For lesions indeterminate on ultrasound, MRI increases the specificity of imaging evaluation, thus decreasing benign resections. CT is useful in diagnosis and treatment planning of advanced cancer. Although ¹⁸F-FDG-avid ovarian lesions in postmenopausal women are considered suspicious for malignancy, PET/CT is not recommended for primary cancer detection because of high false-positive rates.

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CONCLUSION. A patient’s medical history, physical examination, CA-125 level, and imaging characteristics are all factors that impact the ultimate decision of whether a patient can be observed with repeat imaging or should proceed to surgical evaluation.

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