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Cancer chemotherapy in the United States has been delivered mostly in an office-based setting since the late 1980s. However, in the past 5 years, more patients have been treated in hospitals as a result of reimbursement changes. Intraperitoneal (IP) chemotherapy for ovarian cancer has been similarly affected. This report examines changes in care of women treated with IP chemotherapy in an office- versus hospital-based setting.
Over 10 years, 140 women with ovarian cancer were identified as candidates for IP chemotherapy. Of these patients, 92 were treated in an oncology-dedicated infusion center in the office of a physicians' group; 48 were treated in a local hospital. Location was determined based on insurance coverage and reimbursement. Data collected included demographics, number of treatment cycles completed, length of each treatment, and adverse events.
The age and ethnicity of patients treated in the office versus hospital were similar. All six doses of intravenous IP chemotherapy were completed by 73 (79%) of 92 patients treated in the office versus 23 (48%) of 48 patients treated in the hospital (P < .001). The time of each infusion was longer in the hospital-versus office-based setting (P < .001). There were more adverse events associated with treatment in the hospital.
IP chemotherapy is associated with worse outcomes in the hospital- compared with office-based setting. The reason seems to involve a relative lack of resources directed specifically to chemotherapy administration. If current reimbursement trends continue, this could result in decreased survival for women with ovarian cancer.
The delivery of cancer care, including care for women with ovarian cancer, in the United States has evolved over the last 50 years from being largely hospital based (inpatient) to office based (outpatient). This evolution has been a function of several factors:
As a result of these factors, oncology physicians were effectively incentivized by the mid 1990s to deliver chemotherapy in physician-owned offices or clinics. The income of oncologists could be supplemented, often dramatically, by entering the chemotherapy administration business. Many physicians realized the majority of their profits from chemotherapy revenues in what amounted to a golden age of oncology specialization.
That trend has reversed itself in the last 5 years based almost entirely on financial concerns. As use of chemotherapy soared between 1990 and 2005, the cost to Medicare grew explosively as well. This cost was considered unsustainable at the federal level, and Medicare reimbursement for chemotherapy has stabilized or fallen since then.6 Predictably, as chemotherapy administration has become unprofitable, private physicians have begun to discontinue offering it. Ironically, in many areas, this has resulted in a return to the hospital-based cancer treatment model. Unfortunately, many community- and university-based hospitals may not be equipped to handle this influx of patients and may be unable to offer the same level of convenience and efficiency that these patients have come to expect.
This problem is particularly acute when the chemotherapy regimen prescribed is unusually complex or uncommon, an apt description of intraperitoneal (IP) chemotherapy. IP chemotherapy has recently become the standard treatment for selected patients with ovarian cancer.7 Nursing and pharmacy staffs are often unfamiliar with the time-consuming nature of this technique. Not only do the agents require time- and temperature-dependent administration, but patients also require closer monitoring than those receiving IV drugs.8
This report presents a comparison of IP chemotherapy administered in an outpatient, office-based versus community hospital–based setting. Method of reimbursement was the sole determinant of site of chemotherapy administration. Those whose insurance covered outpatient therapy were treated in the office setting, whereas those without such coverage were treated in the hospital.
From January 1, 2000, to December 31, 2009, 140 women were identified at the Harrington Cancer Center/Texas Tech University in Amarillo, Texas, who met the following criteria: first, International Federation of Gynecology and Obstetrics stage III ovarian, fallopian tube, or primary peritoneal cancer who underwent surgery that included optimal debulking (no residual visible lesions > 1 cm in diameter); second, histologically documented epithelial adenocarcinoma; third, National Cancer Institute performance status of 0 to 1; fourth, adequate access to peritoneal cavity; and fifth, consented to combined IP/IV chemotherapy.
All patients underwent surgery performed by board-certified gynecologic oncologists within 6 weeks of chemotherapy. Semi-permanent IP ports were placed in all patients.9 The same gynecologic oncologists prescribed chemotherapy. All 140 patients were prescribed IV/IP chemotherapy (hereafter referred to as IP). The IP regimen consisted of the following: day 1, IV paclitaxel 135 mg/m2; day 2, IP cisplatin 75 mg/m2; and day 8, IP paclitaxel 60 mg/m2 (based on a 28-day cycle). Six cycles were recommended.
Patients' insurance coverage was determined without the knowledge of physicians. The policy of the institution was that no patient seeking care would be turned away, regardless of reimbursement status. Therefore, physicians were not made aware of insurance status until after treatment recommendations had been made. Ninety-two patients received treatment in the office, and 48 patients were treated in the hospital. A majority of patients were treated in the office setting between 2000 and 2004, whereas between 2005 and 2009, more patients were treated in the hospital. This change occurred as a result of reimbursements falling below the break-even level for outpatient chemotherapy.
The 92 office-based patients began treatment in an outpatient infusion area with an adjacent oncology-dedicated pharmacy. The pharmacy met all local and federal regulatory criteria, and all chemotherapies were prepared by licensed pharmacists with extensive chemotherapy experience in sterile conditions using vented hoods. The infusion center included a 12-chair open area with a central nursing station. Adjacent private rooms were available as needed. Oncology-certified and chemotherapy-trained nurses administered and monitored all infusions. Administration of IP infusions required additional onsite training and supervision by nurses experienced in this technique. Physicians were immediately available in the suite.
Forty-eight patients were sent to one of two nearby (< .5 miles) hospitals for treatment. Both hospitals had similar infusion areas, containing four to eight chairs. Patients requiring privacy were admitted to regular hospital rooms. Drugs were prepared at the regular hospital pharmacies, which met all local and federal regulatory criteria. Licensed pharmacists handled the preparation of all chemotherapies under sterile, vented hoods. All nurses handling and administering chemotherapy were required to be chemotherapy trained as per institutional guidelines. Physicians were available by telephone.
Data collected included number of cycles completed, total treatment time, reasons for noncompletion, and adverse events (both before and after treatment). These data were collected prospectively as part of a quality assurance project at the institution, but they were not initially part of a specific clinical research study. The database was reviewed retrospectively and approved by the local institutional review board. Statistical analyses were performed using SigmaStat software (Version 2.0, Systat, San Jose, CA).
One hundred forty patients received 653 cycles of chemotherapy. Age range was 35 to 78 years (median, 59.4 years). Ethnicity was as follows: 116 (83%) of 140 patients were white; 14 (10%), Hispanic; six (4%), Asian; and four (3%), black. Of 140 patients, 92 (66%) received office-based treatment, and 48 (34%) were treated in the hospital. Age and ethnicity were similar in both groups. The 92 patients treated in the office received 475 doses of medication (mean, 5.2 doses). The 48 patients treated in the hospital received 178 doses (mean, 3.7 doses). Seventy-three (79%) of 92 office-treated patients compared with 23 (48%) of 48 hospital-treated patients completed six prescribed doses (P < .001). Reasons for noncompletion included port occlusion, infection of the port or port site, port tubing rupture, disease progression, and patient refusal to continue (summarized in Table 1).
Intratreatment adverse events confirmed in nursing notes as at least grade 2 according to the National Cancer Institute common toxicity scale included hypersensitivity reactions, extraperitoneal leakage of chemotherapy, abdominal pain, and nausea or vomiting. Patient-reported post-treatment adverse events included abdominal pain (not at port site), nausea or vomiting, fever with or without neutropenia, and port site warmth, redness, or pain. There were three treatment-related deaths, all secondary to febrile neutropenia and sepsis. Data are summarized in Table 2.
Nursing notes were reviewed to determine total time of treatment (ie, time spent in the infusion chair or bed in minutes). Treatment times for the office- versus hospital-based group, respectively, were as follows: day 1, 201 minutes (range, 189 to 218 minutes) versus 245 minutes (range, 202 to 305 minutes); day 2, 153 minutes (range, 139 to 171 minutes) versus 185 minutes (range, 155 to 296 minutes); and day 8, 96 minutes (range, 85 to 107 minutes) versus 114 minutes (range, 101 to 211 minutes). The differences on each day were highly significant (P < .001).
IP chemotherapy for the treatment of ovarian cancer should be considered standard therapy for selected patients. However, acceptance of this technique has been quite slow in the United States for a variety of reasons. IP therapy is more toxic than IV therapy. Furthermore, the scientific rationale for IP chemotherapy has been debated extensively in gynecologic and general oncology circles.10 Although most physicians now acknowledge the appropriateness of IP therapy in the proper circumstances, the practical limitations of establishing IP programs, particularly in the outpatient setting, can be discouraging.
Not only do patients struggle more with IP therapy, most caregivers find it difficult as well. It requires more effort on the part of the nursing staff and pharmacy to prepare for and administer an IP regimen, and complex schedules mean that patients spend more days and more time per day in the treatment facility. Additionally, an IP chemotherapy infusion typically requires near one-on-one nursing care. In contrast, a nurse supervising IV chemotherapy can (and is often expected to) handle three to four patients at a time. Overall, IP chemotherapy requires more time, expertise, and dedication on the part of caregivers to produce optimal results.
Current data suggest that use of hospital-based chemotherapy infusion services may result in poorer outcomes than those that can be achieved in office-based settings. In this report, patients treated in the hospital completed fewer courses of IP chemotherapy, had more adverse events, and required longer times to complete individual treatments than those treated in an outpatient center. In addition, the reason for noncompletion of an IP chemotherapy regimen is more likely to be patient refusal (rather than technical problems) when a patient is treated in a hospital as opposed to office setting. Patient compliance with an IP treatment regimen has been reported to be largely a function of adequate communication with and emotional support from the nursing staff.11
These findings imply that hospital-based infusion centers are not currently devoting sufficient resources to this highly specialized task. IP chemotherapy is a relatively new technique and is therefore not as well understood by caregivers. Nursing staff, even certified oncology nurses, may have little or no training or experience in the technique. Previous reports from this center have suggested that similar to those of many other procedures, outcomes of IP chemotherapy improve with experience.12 Furthermore, many hospitals currently face the same budget constraints as physicians and may have to make difficult choices regarding funding of specific programs. It would also be of interest to compare community hospitals with academic and teaching hospitals, which do not exist in the community in which the current study was performed.
More subtle reasons for the differences in outpatient versus hospital treatment may exist as well. In the settings of this particular study, the hospital-based infusion areas were not routinely staffed by oncology-certified nurses, in contrast with the office-based facility, because of a relative shortage of these professionals in the community. Furthermore, the hospital-based nurses did not undergo any specific training in IP chemotherapy administration, in contrast with the office-based nursing staff. Anecdotal conversations with patients revealed a difference in perception of the two sites. Nursing staff were seen as more stable in the outpatient setting and perhaps more competent. In fact, many patients expressed satisfaction about seeing the same nurse for each cycle, with whom they often emotionally bonded. In contrast, the hospital nursing staff were seen as less consistent. Different nurses were seen at each visit, which was perceived negatively. Of note, there were three episodes of dislodgement or deaccession of an IP port in the hospital-treated group, resulting in subcutaneous leakage of chemotherapy, as compared with none in the office-based setting. Although the numbers are too small to make a definitive statement, it must be acknowledged that the sequelae of subcutaneous leakage of chemotherapy around an implanted IP port can be serious, typically resulting in significant local scarring and pain and precluding continued use of the port.
If current reimbursement patterns continue, these data suggest that patients who were previously treated in oncologists' offices or clinics may need to go to their local community hospitals for chemotherapy. The differences in these venues may be particularly apparent with the administration of complex and relatively uncommon treatments like IP chemotherapy and may result in an actual decline in outcome. If fewer patients complete all prescribed cycles of treatment, the proven survival advantage of IP therapy may not be achieved. Ironically, the golden age of oncology care for physicians, which arose based on financial reimbursement, may also represent a lost golden age of quality of care from the patient perspective. To avoid this, hospitals must commit the necessary resources to ensure that outcome in women with ovarian cancer (and all other malignancies) is not compromised. These potential issues should be considered by all parties involved in the current health care reform debate as well.
The authors indicated no potential conflicts of interest.
Conception and design: William R. Robinson, Julie Beyer
Provision of study materials or patients: William R. Robinson, Julie Beyer
Collection and assembly of data: William R. Robinson, Julie Beyer
Data analysis and interpretation: William R. Robinson
Manuscript writing: William R. Robinson, Julie Beyer
Final approval of manuscript: William R. Robinson, Julie Beyer