榴莲视频

CHICAGO – Treatment of advanced cervical cancer with the combination of chemotherapy plus bevacizumab (Avastin) appears feasible, but researchers here at the cautioned that patient selection for the potent therapy is important.

In the CECILIA study, development of fistula occurred in 10% of 150 women in the study -- a rate that corresponds well to what was seen in the GOG-240 study of 1,218 patients, where the rate was 13.3%, said Andres Redondo, MD, PhD, of Hospital Universitario La Paz in Madrid.

He explained at his poster presentation that a major concern in treating women with metastatic, recurrent, or persistent cervical cancer is fistula formation, which can be life-threatening as well as deleterious to quality of life.

In the study, six women developed gastrointestinal fistulas; six developed gastrointestinal-vaginal fistulas; and six developed urogenital fistulas. The fistulas occurred overall in 15 women. The treatment regimen included carboplatin, paclitaxel, and bevacizumab.

Redondo said that among the risk factors for developing fistulas appeared to be prior chemoradiation, and 14 of the 15 women who had fistulas did have this prior treatment. Five women in the study died, and the researchers suggested that three of the deaths were related to treatment, including pneumothorax in one women and a fistula in another, both related to bevacizumab therapy. One other death was related to the chemotherapy regimen. The other two women died due to their underlying cancer.

"This is a relatively safe combination to use in these patients," Redondo told 榴莲视频. "The problem with these patients is that they can develop fistulas, and the incidence is higher when you use bevacizumab. You have to select the patients very carefully. We would avoid giving this combination to patients whose tumors infiltrate the rectum or the bladder."

The median age of the women in the study was 50; 71% were white; and more than half had Stage 3 disease. A total of 66% were in Eastern Cooperative Oncology Group Performance Status 0, and the rest were in status 1.

"We do not yet have the efficacy results for this study, but we expect it to be similar to what has been shown in treatments that use cisplatin instead of carboplatin," he said.

Symptoms Predict Outcome

If a woman with ovarian cancer has disease symptoms when she enters a clinical trial, it is likely the outcome will be far worse than for individuals who are symptom-free at baseline, researchers suggested here.

"What we have tried to highlight is that if a patient at the beginning of the trial has symptoms, then she will have a significantly different outcome," said Jalid Sehouli, MD, head of the Department of Gynecology at Charite-Universitaetsmedzin in Berlin. "We believe, based on our trial, that using our health-related quality-of-life score, patients in clinical trials should be stratified on the basis of the score."

The score was developed by the North-Eastern German Society of Gynecological Oncology and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire.

At his poster presentation, Sehouli said that on the basis of that quality-of-life score, outcomes appeared to show that in recurrent ovarian cancer, low-risk patients had an estimated median survival of 32 months, compared with 18 months for those with medium risk according to the test, and 7 months for those categorized as high risk.

"We think that discriminating by quality-of-life scores may be an even greater predictor of outcome than BRCA status," Sehouli told 榴莲视频. "Health-related quality of life combined with other risk factors is predictive for 1-year mortality. The risk score may help decision making for therapy and may be useful for stratification in randomized trials."

Validation of the score in future clinical trials is warranted, he said.

Possible Marker for Ovarian Cancer Response to PARP Inhibitors

Researchers suggested that using liquid biopsy to determine the methylation status of (HOX) can indicate if a woman with ovarian cancer caused by mutated BRCA may respond to PARP-inhibitor medications.

After performing a multivariate progression-free survival analysis, researchers noted a strong trend that patients who have methylated HOXA9 circulating tumor DNA had poorer outcomes when treated with the investigational PARP-inhibitor veliparib.

In the trial that included 32 women diagnosed with high-grade serous ovarian cancer, the risk of poorer progression-free survival was observed in the 23 women with methylated HOXA9 (P=0.046). In a multivariate analysis, the risk of poorer outcome was 2.53 times greater than in patients with non-methylated HOXA9 (P=0.055).

"These PARP-inhibitors are expensive drugs, so we want to prescribe them to patients who are more likely to benefit from them," said Karina Steffensen, MD, PhD, director of the Center for Shared Decision Making at Vejle Hospital/University of Southern Denmark. "If you are offered a drug for your cancer and if that drug won't work for you, you probably don't want to have nausea every day for months for no benefit."

The study analyzed the outcomes among women with platinum-resistant ovarian cancer or tumors with intermediate sensitivity in relapsed ovarian cancer. The women were about 57 years old and were in good performance status. A total of 26 of the 32 women were diagnosed with Stages III or IV ovarian cancer.

Speaking at his poster study, however, Steffensen cautioned that with the small numbers of patients in the study, it is difficult to say if HOXA9 is predictive of outcomes. The next step will be to expand the study to a wider population of patients.