ORLANDO, FL—Only about 43% of patients with invasive primary epithelial ovarian cancer receive care that is adherent to National Comprehensive Cancer Network guidelines, suggests a study of nearly 150,000 patients.
The situation appears to be similar among the subgroup of patients with advanced ovarian cancer covered by Medicare: Only about 40% underwent surgery and completed the recommended six cycles of chemotherapy, according to an analysis of NCI and Medicare claims databases.
Given that compliance with guidelines is associated with improved outcomes, the findings of both analyses are disturbing, said attendees here at the Annual Meeting on Women's Cancer of the Society of Gynecologic Oncology.
For the first study, researchers reviewed data from the National Cancer Data Base (NCDB), which covers approximately 80% of all newly diagnosed cancer patients in the United States.
A total of 144,449 patients were diagnosed with invasive primary epithelial ovarian cancer between 1998 and 2007, reported Matthew A. Powell, MD, Assistant Professor in the Division of Gynecologic Oncology at Washington University School of Medicine.
There were sufficient data to assess NCCN treatment guideline compliance for 96,802 of these women, he said.
Of these patients, only 43.2% appeared to receive care that was adherent to the guidelines; and of the 22,552 patients reported to have undergone surgery as their only therapeutic modality, only 8% received adherent care.
Reasons for Noncompliance
The researchers then took a closer look at the 54,939 women whose records had enough information on tumor stage, grade, and other factors to determine reason for noncompliance.
The primary reason for nonadherence was improper surgery (63.4% of patients), with 57.6% of patients not undergoing omenectomy and 5.8% not receiving lymph node biopsy when indicated.
Also, 15.4% of women received improper single-agent chemotherapy, 17.8% did not receive chemotherapy when it was indicated, and 1.8% received chemotherapy when it was not indicated, Dr. Powell told the audience at the late-breaking session.
Results also showed that patients with one or more medical comorbidities at diagnosis were significantly less likely to receive optimal treatment: 36.6% vs 44.6% of those with no other health conditions, he said.
For the 49,160 patients for whom there were mature five-year survival data, a multilevel survival analysis demonstrated that those who received adherent care were 44% more likely to be alive after five years, compared with patients who did not receive adherent care.
Subgroup analyses showed that optimal care was associated with improved survival rates among all groups of patients, regardless of age, year of diagnosis, tumor stage, or tumor grade.
“Adherence with guidelines is associated with improved survival and perhaps better quality of life. It's uncomfortable and somewhat embarrassing that nonadherence to guidelines is so common,” Dr. Powell said.
He also noted that the findings point to an ongoing opportunity for better documentation of care. “For a significant number of women, there was insufficient information to complete analysis under the study's protocol. Of the remaining cases, a majority lacked stage, sub-stage, or grade information.”
‘30,000 Foot View’
The Discussant for the study, David M. Gershenson, MD, Chair of Gynecologic Oncology at the University of Texas MD Anderson Cancer Center, said that the study offers a “30,000-foot view, complementing smaller studies with more detail but less power.”
The strengths include an exceptional analysis of a large cancer database covering most patients in the US, by “an outstanding group of investigators from excellent institutions,” he said.
Still, the NCDB doesn't cover 20% of patients and lacks information on some important factors such as residual disease and surgeon volume and specialty that could affect survival rates, Dr. Gershenson said.
“NCCN guidelines are intended as guidelines only and don't take into account physician judgment and patient choice…. Although nonadherence implies inappropriate care, is it possible that factors such as comorbidities, age, etc., result in nonadherent yet appropriate care?” he asked.
Dr. Powell replied that indeed, non-adherent care does not always imply inappropriate care: “It's clear, for example, that patients with comorbidities are not as compliant. But we want to set a bar to strive for and that's the NCCN guidelines. It doesn't mean there can't be exceptions,” he said.
In response to a question from the audience, Dr. Powell said that it is unlikely that the surgery rate was impacted by patients who had ovaries removed years earlier for benign disease.
The second study was designed to determine adherence to NIH recommendations in clinical practice among patients older than 65 with advanced ovarian cancer.
The retrospective analysis of more than 10 years of data showed that only 39% of patients received optimal care, and 17% received no care at all.
In 1994, the NIH issued a consensus statement indicating that the appropriate management of advanced ovarian cancer consisted of debulking surgery followed by at least six cycles of systemic chemotherapy. These same treatment recommendations are also reflected in the NCCN guidelines published since that time, said Melissa M. Thrall, MD, a gynecologic oncology fellow at the University of Washington Medical Center.
“However, little is known about how often women are actually receiving guideline therapy. We have no population-based data on the sequencing of care, specifically on how often chemotherapy is being used prior to surgery in the community and how often these women go on the receive surgery,” she said.
Guidelines Not Followed
So Dr. Thrall and colleagues linked data from the NCI SEER database with Medicare claims data to verify whether women had received appropriate treatment.
The cohort comprised 8,211 women over age 65 with newly diagnosed Stage III/IV ovarian cancer between 1995 and 2005.
Of the total, 59% underwent primary debulking surgery, 24% had primary chemotherapy, and 17% had no evidence of treatment.
Among women receiving primary surgery, 76% received adjuvant chemotherapy following surgery, but only 55% completed the recommended six cycles of chemotherapy. Among women receiving primary chemotherapy, only 24% completed six cycles and only 32% had ovarian cancer-directed surgery in the year following diagnosis.
“Of all women, only 39% had both surgery and at least six cycles of chemotherapy,” Dr. Thrall said.
Areas for Improvement
Over the study period, there was a disturbing trend toward a decrease in the proportion of patients having primary surgery, from 67.5% in 1995 to 52.8% in 2005, she said.
Multivariate analysis showed that age over 70, Stage IV disease, and having at least one comorbidity were strongly associated with receiving primary chemotherapy, she said.
Patients who received both surgery and six cycles of chemotherapy were more likely to have higher incomes, be better educated, and live in the South or West.
Women who were older, black, had more comorbidities, and lived in the Midwest were less likely to have optimal treatment.
“Demographic factors are associated with the receipt of suboptimal care and may represent areas where improvement efforts can be focused,” Dr. Thrall said.
Future research needs to address barriers to treatment, including access to care, patient refusal, timely diagnosis, and treatment complications. Additionally, there is a need to identify more tolerable, less toxic treatment regimens so more women can complete six cycles of treatment, she said.
Study Discussant Michael E. Carney, MD, Professor of Gynecologic Oncology at the University of Hawaii, called the research “very important, very timely, and enlightening.”
Noting the many efforts by SGO and other societies to improve the care of cancer patients, he said, “It is truly disappointing, shocking, and sad to hear that [only] one out of three of these patients in this study received the standard-of-care treatment.
”However the ideal of debulking surgery followed by surgery may not be optimal for all these patients, he said. “For example, neoadjuvant chemotherapy may be even more appropriate in this older, more fragile population.”
But even if patients who receive any chemotherapy are counted as being adherent, “it still means that nearly 50% of patients are not getting optimal care–all patients, regardless of age, should receive the best we have to offer.”