Establishing a radioimmunotherapy outpatient care clinic for non-Hodgkin's lymphoma

Establishing a radioimmunotherapy outpatient care clinic for non-Hodgkin's lymphoma

22 Seminars in Ontology Nursing, Vol 18, No 1, Suppl I (February), 2002: pp 22-29 ESTABLISHING A RADIOIMMUNOTHERAPY OUTPATIENT CARE CLINIC FOR NONHO...

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Seminars in Ontology Nursing, Vol 18, No 1, Suppl I (February), 2002: pp 22-29

ESTABLISHING A RADIOIMMUNOTHERAPY OUTPATIENT CARE CLINIC FOR NONHODGKIN'S LYMPHOMA CAROLYN HENDRIX AND CRISTINA DE LEON

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NEW THERAPEUTIC option for the treatment of B-cell non-Hodgkin's lymphoma now makes it possible to deliver care on an outpatient basis. With a trained treatment team and appropriate patient education, a radioimmunotherapy regimen using tositumomab and radioaetive iodine-131 (I-131) can be administered to outpatients, thus reducing the need for more costly inpatient resources. In comparison, traditional radiation regimens that use 1-131 have generally required a 3- to 4-day hospitalization. A treatment model for outpatient administration of 1-131 tositumomab was developed by the Hoag Cancer Center of Newport Beach, CA, after the Center's participation in clinical trials of 1-131 tositumomab. In addition to conserving inpatient resources, outpatient administration has the potential to significantly improve patient and caregiver morale, satisfaction, and treatment compliance. With proper foresight and preparation, establishing outpatient therapy need not be an overwhelming challenge. RADIOLOGIC ASPECTS OF TREATMENT dministration of tositumomab radioimmunotherapy on an outpatient basis is possible because of its unique radiologie properties and revised guidelines governing the release of patients receiving radioimmunotherapy. In early trials of 1-131 tositumomab therapy, patients were hospitalized in isolation for 3 to 4

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days after infusion of a therapeutic dose. T h e y were released only when their radiation emission was -< 5 mrem/hour, in accordance with existing Nuclear Regulatory Commission guidelines governing the m a n a g e m e n t of radioactive materials. But results of these trials indicated that patients did not need to be hospitalized and could be released soon after infusion of the therapeutic dose as long as earegivers were properly briefed by the radiation safety officer about appropriate precautions. Emissions from tositumomab travel relatively short distances, unlike those of other radioactive agents, thereby minimizing radiation hazards to health care professionals and earegivers. Maintaining a distance of 6 feet from the patient for up to 7 days provides adequate distanee protection. In addition, 1-131 is rapidly metabolized, with 98% clearance through the kidneys at 5 days after infusion. This reduces exposure time for other individuals. 1 In a study c o n d u c t e d at the University of Nebraska Medieal Center, 26 family members of 22 non-Hodgkin's l y m p h o m a patients treated with tositumomab and 1-131 tosit u m o m a b were monitored for radiation exposure. Based on dosimetrie readings, the average received dose was determined to be only ,32% of the predicted dose. 2 In addition to this favorable clinical data, Nuclear Regulatory Commission regulations governing the release of patients receiving radioimmunotherapy were revised in May 1997 to include dosage-based criteria. Patients can be released as long as persons exposed to t h e m receive a total effective dose equivalent to less than 5 millisieverts (0.5 rem) of radiation for each patient release (exposure). The revised limit was based on the assumption that exposure would occur in a household rather than in a hospital. Additional guidelines require broadening the distribution of instruetions to patients receiving 1-131 therapy. The purpose of the instructions is to reduce radiation exposure to the lowest reasonable dose to people in proximity to the patient, 2,3 DEVELOPING AN OUTPATIENT TREATMENT PROGRAM nee the viability of outpatient administration was established, a team of health care providers at The Hoag Cancer C e n t e r began developing a model for outpatient treatment. Team partieipants included the medical director, a elinieal

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trials nurse, a nuclear medicine director, a radiation safety officer, an institutional pharmacist, and the outpatient clinical manager. The following goals for the program were identified: • Develop an interdepartmental outpatient radioi m m u n o t h e r a p y t r e a t m e n t team. • Provide coordinated, collaborative care during all phases of treatment, ineluding follow-up. • Establish protocols that would ensure safe delivery of r a d i o i m m u n o t h e r a p y in an outpatient setting. Establish an education program for all m e m b e r s of the clinical team, the patients, and their caregivers. Develop an outpatient t h e r a p y delivery model that would include a model t r e a t m e n t room, necessary clinical instruments, and logistics for coordinating the m o v e m e n t of therapeutic agents, personnel, and patients.

Treatment Team The first step in creating a eollaborative approach to care was establishing an interdepartmental t r e a t m e n t team and defining responsibilities for each member. The therapeutic regimen dictates the roles of each health care provider, thus the following responsibilities have been established: Medicaioneologist. The oneologist is responsible for identifying and screening patients who might be eligible for treatment, maintaining a liaison with the nuclear medicine physician, and initiating t r e a t m e n t with a saturated solution of potassium iodide (SSKI) to block uptake of 1-131 by the thyroid. The oncologist is also responsible for long-term follow-up. Referring oncologists at the ttoag Cancer Center assume these roles to maintain the relationships that have already been established with patients. Nuclear Medicine Department. The nuclear medicine physician is responsible for performing the gamma scans and calculating the therapeutic dose. Because the first body scan must be performed within 1 hour of administering the dosimetric dose, the nuclear medicine d e p a r t m e n t is responsible for scheduling treatments and determining the release time for the patient. Therefore, close coordination between the nuclear medicine d e p a r t m e n t and the outpatient clinic is necessary. If the patient requires inpatient care, the nuclear medicine physician also monitors the patient during hospitalization. A nuclear medicine technologist may assist the physician in calculating thera-

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peutic doses and collecting whole body gamma counts. Radiation Safety Officer. The radiation safety officer monitors delivery of the therapy and ensures that all personnel involved are educated with regard to the storage, movement, and handling of radioactive agents. Radiation safety instructions are also provided to the patient. Compliance with safety protocols is also the responsibility of the radiation safety officer. Radiopharmacy. A commercial radiopharmacy provides both the dosimetric and therapeutic radioactive doses of the agent. Clinic staff. Staff nurses educate patients about procedures, administer the nonradioactive antibody, and assist the nuclear medicine technician with the administration of the dosimetric and therapeutic doses. They also monitor patients for infusion-related reactions during all phases of treatment. The medical director oversees treatment and ensures that all specialists involved collaborate to promote accurate communication. Coordinator. The coordinator is responsible for providing unit-specific staff education to outpatient and inpatient nurses, nuclear medicine technologists, schedulers, oncologists, and staff nurses.

Staff Education Education of the treatment team starts by providing basic information about protection from radiation exposure and treatment administration procedures. Radiation protection involves three principles: time, distance, and shielding. Staff are instructed to keep radiation exposure time to a minimum and to maximize their distance from the radiation source. The general guideline is to double the distance between a staff member and the radiation source to reduce radiation exposure by a factor of four. Radiation exposure is also reduced through shielding. Lead shields absorb 90% to 99% of radiation. Specific safety guidelines for procedures related to administration of 1-131 tositumomab are presented in Table 1. All staff who are directly or peripherally involved in treatment are educated about the safe handling of radioactive substances. Those involved in administering treatment are provided with additional education about the safe storage, handling, and administration of the dosimetric and therapeutic doses. Although staff members may have some experience in handling radioactive substances, working around radiation can induce anxiety. It is

best to ensure that all staff members are thoroughly familiar with safety procedures and know whom to call with questions. In addition to educating staff about radiation safety, specific protocols for administering 1-131 tositumomab arc covered in detail. Concepts underlying the biological activity of antibodies and the clinical activity of immunotherapy are reviewed along with side effects associated with immunotherapy in general, and 1-131 tositumomab in particular. The immunology review given to staff consists of a general discussion of normal immunologic functions in relation to both the disease and therapy. A detailed overview of the administration procedures for 1-131 tositumomab is also provided.

1-131 Tositumomab Administration Procedure Twenty-four hours before initiation of therapy, patients begin treatment with a saturated solution of SSKI to block uptake of 1-131 by the thyroid (Fig 1). Daily SSKI administration is continued for 14 days. Unconjugated antibodies are administered to clear circulating B cells and to improve

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SSKI given daily from days 1 through 14

Dosimetric dose: 450 mg tositumomab followed by 5 mCi (35 rag) or 1-131 tositumomab

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Radiation counts taken within one hour after completion o f the dosimetric infusion and twice over the next 7 days

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Therapeutic dose: 450 mg tositumomab, followed by a patientspecific dose o f I- 131 tositumomab given daily from days 7 though 14

FIGURE 1.1-131 tositumomab treatment regimen. Patients are given SSKI daily throughout the 14-day treatment period to block uptake of 1-131 by the thyroid. The dosimetric dose is then administered to determine therapeutic dosage levels. Radiation counts are determined by gamma camera scan over the next 7 days. The therapeutic dose is administered daily from days 7 through 14.

the biodistribution of the antibody to tumor sites. Approximately 30 minutes before the first infusion of the dosimetrie dose, patients are given 650 mg oral acetaminophen and 50 mg of diphenhydramine. The dosimetrie dose, which is administered to determine therapeutic dosage levels and clearance, is 450 mg of unlabeled tositumomab infused intravenously over 1 hour, followed by a 20-minute infusion of 5 mCi (35 mg) of 1-131 tositumomab. The first whole body radiation count by gamma camera scan is taken within 1 hour after the completion of the dosimetrie infusion. Two more scans are taken during the next 7 days. On the seventh day, a therapeutic dose of 450 mg of unlabeled tositumomab is infused over a 1-hour period, followed by an infusion of a patient-specific mCi active dose, calculated by body weight, of 1-131 tositumomab. Daily administration of the therapeutic dose continues through day 14. Neither the dosimetrie nor therapeutic doses should be administered as an intravenous bolus. A 30-mL saline flush is administered for 10 minutes following each intravenous administration of the dosimetrie and therapeutic infusions.

Patient and Caregiver Education Education reinforces and supplements the clinical staffs knowledge as well as ensures that nurses are able to answer patient and earegiver questions about treatments and procedures. Additionally, because most radioimmunotherapy is administered on an outpatient basis, patient and

earegivers need to receive instructions on radiation safety precautions to be followed at home (Fig 2). Once patients have been selected for treatment, they and their earegivers are provided with detailed information about treatment objectives, administration of the drug, precautions that should be taken, and side effects that might occur. Patient educators receive a checklist to ensure that every aspect of therapy is discussed (Table 2). Although many patients are generally familiar with the clinical aspects of their disease, few have the knowledge, at least initially, required for sueeessful compliance with the regimen. Disease etiology, immune system functions, and the principles behind immunologic and radiologic therapy are incorporated into two patient education sessions, each lasting about 30 minutes to 1 hour. Patient caregivers are required to attend. During the initial session, the staff member conducting the session collects a broad range of information from the patient. This includes not only the patient's clinical status but diverse information, such as travel arrangements, the layout of living quarters, the presence of pets, and the proximity of family members and caregivers (Fig 3). 4 This is important because patients are advised to maintain a minimum 6-foot distance from others for approximately 1 week after administration of therapy. In addition to educational sessions, patients are given brochures and data sheets to study, emphasizing the necessity of adhering to testing and

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t r e a t m e n t schedules and safety precautions. Compliance is emphasized because a missed test or failure to initiate SSKI administration u n d e r m i n e s the therapeutic effect and m a y cause a delay in treatment. The i m p o r t a n c e of safety precautions is emphasized by either the radiation safety officer or the nuclear medicine physician, who either attends or conducts one of the sessions. After t r e a t m e n t and before release, safety precautions are again reviewed and a checklist is signed by the nuclear medicine physician or the radiation safety officer and the patient (Fig 2). 4 Treatment Facilities In addition to establishing a team and ensuring p r o p e r education for staff and patients, facilities providing outpatient t r e a t m e n t with radioactive substances n e e d to d e t e r m i n e where t r e a t m e n t will be administered and how the facility will be safeguarded against radiation contamination. Gen-

erally, radioactive material is stored and transported by the radiopharmacy. Once the t r e a t m e n t is prepared, it can be administered at various locations. Unlabeled infusions can be provided in standard c h e m o t h e r a p y rooms, inpatient or outpatient t r e a t m e n t areas, nuclear medicine facilities, or any oncology facility or office. Dosimetric radiolabeled infusions can be administered in nuclear medicine or radiation-oncology facilities. At the Hoag Cancer Center, the initial dosimetric infusion is given in the nuclear medicine departm e n t because of the need to c o n d u c t a scan within an hour of the infusion. Facilities administering radioactive infusions will need to consider the possibility of delays in transporting patients after treatment. This problem did not occur at Hoag, so procedures were modified to allow the dosimetric infusion in the outpatient clinic. Procedural refinements should be expected as outpatient t r e a t m e n t protocols are established. Procedures also will depend on whether a facility assigns responsibility for the patient to the referring oneologist or relies on staff physicians. The m a n n e r of record-keeping, required by Nuclear Regulatory Commission guidelines, will also vary depending on the decisions of responsible team members. Because therapy is delivered in an outpatient setting, precautions against spills must be taken. Everything that might be exposed to spills or conc e n t r a t e d levels of the therapeutic agent should be covered with disposable, absorbent padding. This includes intravenous equipment, the floor, the bed and bed rails, and b a t h r o o m rails.

CONCLUSION t is reasonable to assume that outpatient radioi m m u n o t h e r a p y care will result in significant cost reductions based on fewer days of hospitalization and increased efficiency in therapy administration. Studies are u n d e r way to assess the costs, benefits, and advantages of outpatient therapy. A collaborative t r e a t m e n t team approach to patient care ensures that, in addition to treatment administration, support of patient and caregiver continues in the home. The strong focus on education for both staff and patients reduces risk while allowing the patient to return to a more comfortable environment. 5

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Patient:

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M.R.:

Administration Date: Activity administered (A): meter

mCi, Measured Dose Rate:

mrem/h at 1

To decrease exposure to your family and others please observe the following precautions: Instruction

Duration (days)

1. Sleep in a separate bed (at least 6 feet separation) 2. Stay at least 6 feet from children and pregnant women 3. Do not take a long trip (4 hours or more) sitting near others (e.g., car, train, airplane, bus) In addition, while following the above instructions, you must:

• • • • • • • • • • • • • •

Maintain a distance of at least 6 feet from others whenever possible. When taking shorter trips during the period of restricted travel, sit as far as possible from others approximately 3 feet. Limit time spent in public places. Have the sole use of a bathroom if possible. Sit while urinating and flush the toilet twice with the lid down. Wash hands frequently, including after each toilet use. Shower daily. Drink plenty of liquids. Keep dishes and utensils separate for 1 week and wash separately. Use separate towels, washcloths, and toothbrush from rest of household. Hold clothing and linen (sheets and towels) for 1 week before laundering and launder separately from rest of household's laundry. Avoid using disposable items that cannot be flushed down the toilet. Show these instructions to any physician or other healthcare provider visited. For the next 6 months, avoid pregnancy.

Signatures

Physician: Date: Radiation Safety Officer: Date: Patient/Guardian: FIGURE 2. Instructions to the released patient. After treatment and before release, safety precautions are again reviewed with the patient and a checklist is signed by the nuclear medicine physician or the radiation safety officer and the patient.

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Patient Information Checklist Patient Information Patient Identifier: Date: Sex: M F If female, is patient pregnant? Yes No Is patient breast-feeding? Yes. No Note: Pregnant women should not receive iodine-131 anti-B1 antibody; patients should discontinue breast-feeding before treatment. Person interviewed: Patient. Guardian Other .... I1.

III.

Dwelling Information Type of Dwelling: Single-family Multi-family Apartment If not single-family, possible proximity to others: meters / / Household Members (age/sex): / / I__ __/ Are any household members pregnant? Yes No

Dormitory

__

/ /

General Contact Information Are there any regular visitors to the patient's house? Would any of these visitors be pregnant? If yes, can these visiting arrangements be modified to reduce contact? Does the patient visit anyone regularly? If yes, can these visiting arrangements be modified to reduce contact? Can patient be isolated (stay at least 6 feet from other people)? Does patient understand the importance of the isolation? Does the patient suffer from incontinence? Is the patient capable of self-care? Can the patient delay return to work? Is the trip home less than 4 hours?

IV.

Items Discussed with Patient Radiation safety precautions Importance of limiting contact with individuals (distance and time) _ _ Sleeping arrangements Added precautions fo children and pregnant women Personal hygiene How long to wait before becoming pregnant Inform health care workers if hospitalized or receives medical care Other

V.

Determination Based on the above, can the patient be released? Occupancy factor used: 0.125 0.25* 0.5 Justification for occupancy factor:

Signature

Other

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

No No No No No No No No No No No

Comments

Other _ _ (*0.25 is default value)

Date

FIGURE 3. Patient education for release of patients administered 1-131 anti-B1 antibody. Patient education includes gathering information about living arrangements in the home. Health care personnel emphasize the importance of family members and caregivers maintaining a safe distance of 6 feet from the patient for 1 week after therapy.

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Outpatient care provides substantial benefits for patients and earegivers. The value of being surrounded by friends and family in a familiar environment during therapy cannot be overstated. Establishing outpatient care is not

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diffieult if all involved professional contribute, if the character of the therapy and design of the facilities are carefully considered, and if a thorough education program is created for all personnel.

REFERENCES 1. Wahl RL, Zasadny KR, MacFarlane D, et al: Iodine131 anti-B1 antibody for B-eell lymphoma: An update on the Michigan Phase 1 experience. J Nuel Med 8:$21-$27, 1998 2. Rutar FJ, Augustine SC, Colcher D, et al: Outpatient treatment with (131)I-anti-B1 antibody: Radiation exposure to family members. J Nucl Med 42:916, 2001 3. Nuclear Regulatory Commission: Criteria for the release of individuals administered radioactive material, 10 CFR Parts 20 and 3 5 : 6 2 FR 4120. Office of Nuclear Regu-

latory Research, US Nuclear Regulatory Commission, Washington, DC. Available at: http://www.nrc.gov/NRC/CFWFR/ 19970129/R29JAO.html (accessed May 31, 2001) 4. Siegel JA: Revised Nuclear Regulatory Commission regulations for release of patients administered radioactive materials: Outpatient iodine-131 anti-B1 therapy, d Nucl Med 39: 28S-33S, 1998 (suppl 8) 5. Hendrix C, Holt A, Clapp ILk Development of Bexxar treatment team. Oneol Nurs Forum 27:333, 2000 (abstr)