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Monthly Archives: December 2013

Guidelines for Follow-up of Colorectal Cancer Patients

UG has summarized the recently published guidelines on follow-up care, surveillance protocol, and secondary prevention measures for survivors of Colorectal Cancer (CRC) as published November 12, 2013 in the Journal of Clinical Oncology as a special article from the American Society of Clinical Oncology (ASCO).
These guidelines are for survivors of Colorectal Cancer (CRC), stages II and III and intended for patients who finished their treatment, as they are often discharged from specialist care to have their follow-up carried out by community-based family physicians or institution-based nurse-coordinated care.  These guidelines were adopted from the Cancer Care Ontario (CCO) Guideline on Follow-up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer.
The following questions were attempted to be addressed by the ASCO in the published guidelines:
  • Which evaluations (eg, colonoscopy, computed tomography [CT], carcinoembryonic antigen [CEA], liver function, complete blood count [CBC], chest x-ray, history, and physical examination) should be performed for surveillance for recurrence of cancer?
  • What is a reasonable frequency of these evaluations for surveillance?
  • Which symptoms and/or signs potentially signify a recurrence of CRC and warrant investigation?
  • What are the common and/or significant long-term and late effects of CRC treatment?
  • On what secondary prevention measures should CRC survivors be counseled?
  • The target population for these guidelines included CRC survivors (adult patients who have completed primary treatment for stage II or III CRC and who are without evidence of disease). Whether these recommendations are extrapolated to stage I patients or a patient with metastatic CRC who underwent metastatectomy and is currently without evidence of disease, is left to the discretion of the health care provider.
  • The target audience for these guidelines include clinicians (eg, medical oncologist, radiation oncologist, surgeon, advanced practice nurse, physician assistant, primary care provider [family physician, nurse practitioner, family practice nurse]) involved in the delivery of care for CRC patients, families of patients who have survived CRC, and health care organizations and system leaders responsible for offering, monitoring, or providing resources for CRC survivorship protocols.
ASCO Key Recommendations:
  • Surveillance should be guided by presumed risk of recurrence and functional status of patient where early detection would lead to aggressive treatment including surgery. It is especially important in the first 2 to 4 years, when the risk of recurrence is the greatest.
  • A medical history, physical examination, and CEA testing should be performed every 3 to 6 months for 5 years. The frequency of visits and testing should be driven by the data showing that 80% of recurrences occur in the first 2 to 2.5 years from date of surgery and 95% occur by 5 years. Patients at a higher risk of recurrence should be considered for testing in the more frequent end of the range.
  • Abdominal and chest imaging using a CT scan is recommended annually for 3 years. For high-risk patients, it is reasonable to consider imaging every 6 to 12 months for the first 3 years. Outside of a clinical trial, PET scans are not recommended for surveillance.
  • For patients with rectal cancer, a pelvic CT is also recommended. Clinician judgment, considering risk status, should be used to determine the frequency of pelvic scans (eg, annually for 3 to 5 years). For those patients who have not received pelvic radiation, a rectosigmoidoscopy should be performed every 6 months for 2 to 5 years.
  • A surveillance colonoscopy should be performed approximately 1 year after the initial surgery. The frequency of subsequent surveillance colonoscopies should be dictated by the findings of the previous one, but they generally should be performed every 5 years if the findings of the previous one are normal. If a complete colonoscopy was not performed before diagnosis, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point.
  • Any new and persistent or worsening symptoms warrant the consideration of a recurrence.
  • Despite the lack of high-quality evidence on secondary prevention in CRC survivors, it is reasonable to counsel patients on maintaining a healthy body weight, being physically active, and eating a healthy diet.
  • A treatment plan from the specialist should be sent to the patient’s other providers, particularly the primary care physician, and it should have clear directions on appropriate follow-up.
  • If a patient is not a surgical candidate or a candidate for systemic therapy because of severe comorbid conditions, surveillance tests should not be performed.

The ASCO Panel wants to highlight that the recommendations are primarily for patients with stage II or III cancer. There are insufficient data to provide guidance for follow-up for stage I patients or patients with resected metastatic disease with no evidence of disease. The ASCO Panel emphasizes that surveillance tests should only be performed in patients in whom the results will change treatment decisions. If a patient is not a surgical candidate or a candidate for systemic therapy because of severe co-morbid conditions, surveillance tests should not be performed.

Secondary Prevention of CRC:
There are emerging data on the role of various host factors, including diet and lifestyle, as secondary prevention for CRC survivors. Patients should seek to maintain a healthy body weight and engage in a physically active lifestyle, seeking to follow the recommendation of the American College of Sports Medicine to strive to engage in at least 150 minutes a week of moderate-intensity, or 75 minutes (1 hour and 15 minutes) a week of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity. However, any level of activity that the patient can do is considered better than being physically inactive. Patients should be advised to eat a healthy diet. There remains uncertainty regarding regular use of an aspirin; other interventions, including vitamin D, also require further study to help provide guidance for secondary prevention.

Clinical Practice Guideline for Vaccination of the Immunocompromised Host

The Infectious Diseases Society of America (IDSA), published online December 5, 2013 in Clinical Infectious Diseases an important paper which will help providers guide immunocompromised patients in choosing the right vaccinations: “2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host

The guidelines were created to provide primary care and specialty clinicians with evidence-based guidelines for active immunization of patients with altered immunocompetence and their household contacts in order to safely prevent vaccine-preventable infections. The goal of these guidelines is to decrease morbidity and mortality from vaccine-preventable infections in immunocompromised patients. This guideline addresses children and adults with primary (congenital) immune deficiencies; patients with secondary immune deficiencies due to HIV infection, cancers associated with immune deficiency, cancer chemotherapy, stem cell or solid organ transplant (SOT), sickle cell diseases, and surgical asplenia; and patients with chronic inflammatory diseases treated with systemic corticosteroid therapy, immunomodulator medications, and/or biologic agents. Vaccination of immunocompetent patients who have an anatomic host defense abnormality (eg, cerebrospinal fluid [CSF] leak) associated with vaccine-preventable infections and of individuals living in a household with immunocompromised patients is also addressed.

Utah Gastroenterology has summarized important parts of these guidelines as they pertain to patients with Inflammatory Bowel Disease or Solid Organ Transplantation. The guideline focus on vaccines available in the United States, which are often relevant to other areas.

The following clinical questions are answered:

  1. Who is responsible for vaccinating immunocompromised patients and members of their household?

  2. When should vaccines be administered to immunocompetent patients in whom initiation of immunosuppressive medications is planned?

  3. Which vaccines can be safely administered to individuals living in a household with immunocompromised patients, and what precautions should immunocompromised patients observe after vaccination of household members?

  4. Which vaccines can be administered to immunocompromised patients contemplating international travel?

  5. Should immunocompromised patients or those scheduled to receive immunosuppressive therapy receive varicella vaccine (VAR)?

  6. Should immunocompromised patients or those who will undergo immunosuppression receive zoster vaccine (ZOS)?

  7. Should immunocompromised patients receive influenza vaccine?

  8. For adult and child Solid Organ Transplantation (SOT) candidates and living donors, which vaccines should be administered during pretransplant evaluation?

  9. Which vaccines should be administered to SOT recipients?

  10. Which vaccines should be administered to patients with chronic inflammatory diseases maintained on immunosuppressive therapies?

 

RECOMMENDATIONS FOR VACCINATION

  • Specialists who care for immunocompromised patients share responsibility with the primary care provider for a) ensuring that appropriate vaccinations are administered to immunocompromised patients and b) for recommending appropriate vaccinations for members of immunocompromised patients’ household.

  • Vaccines should be administered prior to planned immunosuppression if feasible.

  • Live vaccines should be administered ≥4 weeks prior to immunosuppression and should be avoided within 2 weeks of initiation of immunosuppression.

  • Inactivated vaccines should be administered ≥2 weeks prior to immunosuppression.

  • Immunocompetent individuals who live in a household with immunocompromised patients can safely receive inactivated vaccines based on the CDC–ACIP’s annually updated recommended vaccination schedules for children and adults or for travel.

  • Individuals who live in a household with immunocompromised patients age ≥6 months should receive influenza vaccine annually. They should receive either:
    1. Inactivated influenza vaccine (IIV) or

    2. Live attenuated influenza vaccine (LAIV) provided they are healthy, not pregnant, and aged 2–49 years. Exceptions include individuals who live in a household with an immunocompromised patient who was a hematopoietic stem cell transplant (HSCT) recipient within 2 months after transplant or with graft vs host disease (GVHD) or is a patient with severe combined immune deficiency (SCID).* In these exceptions, LAIV should not be administered or, if administered, contact between the immunocompromised patient and household member should be avoided for 7 days.

  • Healthy immunocompetent individuals who live in a household with immunocompromised patients should receive the following live vaccines based on the CDC annual schedule: combined measles, mumps, and rubella (MMR) vaccines; rotavirus vaccine in infants aged 2–7 months; varicella vaccine (VAR); and zoster vaccine (ZOS). Also, these individuals can safely receive the following vaccines for travel: yellow fever vaccine and oral typhoid vaccine.

  • Oral polio vaccine (OPV) should not be administered to individuals who live in a household with immunocompromised patients.

  • Highly immunocompromised patients should avoid handling diapers of infants who have been vaccinated with rotavirus vaccine for 4 weeks after vaccination.

  • Immunocompromised patients should avoid contact with persons who develop skin lesions after receipt VAR or ZOS until the lesions clear

  • Clinicians may administer inactivated vaccines indicated for travel based on the CDC annual schedule for immunocompetent adults and children.

  • Yellow fever vaccine generally should not be administered to immunocompromised persons.
  • With certain exceptions live vaccines should not be given to immunocompromised persons.

  • VAR should be given to immunocompetent patients without evidence of varicella immunity (ie, age-appropriate varicella vaccination, serologic evidence of immunity, clinician-diagnosed or -verified history of varicella or zoster, or laboratory-proven varicella or zoster) if it can be administered ≥4 weeks before initiating immunosuppressive therapy.

  • A 2-dose schedule of VAR, separated by >4 weeks for patients aged ≥13 years and by ≥3 months for patients aged 1–12 years, is recommended if there is sufficient time prior to initiating immunosuppressive therapy.

  • VAR should not be administered to highly immunocompromised patients.

  • VAR can be considered for patients without evidence of varicella immunity who are receiving long-term, low-level immunosuppression.

  • VAR should be administered to eligible immunocompromised patients as the single antigen product, not VAR combined with MMR vaccine.

  • ZOS should be given to patients aged ≥60 years if it can be administered ≥4 weeks before beginning highly immunosuppressive therapy.

  • ZOS should be considered for varicella-positive patients (ie, persons with a history of varicella or zoster infection or who are varicella–zoster virus [VZV] seropositive with no previous doses of VAR) aged 50–59 years if it can be administered ≥4 weeks before beginning immunosuppressive therapy.

  • ZOS should be administered to patients aged ≥60 years who are receiving therapy considered to induce a low level of immunosuppression.

  • ZOS should not be administered to highly immunocompromised patients.

  • Annual vaccination with IIV is recommended for immunocompromised patients aged ≥6 months except for patients who are very unlikely to respond (although unlikely to be harmed by IIV), such as those receiving intensive chemotherapy or those who have received anti–B-cell antibodies within 6 months.

  • LAIV should not be administered to immunocompromised persons.

 

VACCINATION OF PATIENTS ON IMMUNOSUPPRESSIVE MEDICATIONS

  • Inactivated vaccines, including IIV, should be administered to patients with chronic inflammatory illness treated or about to be treated with immunosuppressive agents as for immunocompetent persons based on the CDC annual schedule.

  • Pneumococcal vaccine should be administered to adults and children with a chronic inflammatory illness that is being treated with immunosuppression.

  • VAR should be administered to patients with chronic inflammatory diseases without evidence of varicella immunity ≥4 weeks prior to initiation of immunosuppression if treatment initiation can be safely delayed.

  • VAR should be considered for patients without evidence of varicella immunity being treated for chronic inflammatory diseases with long-term, low-level immunosuppression.

  • ZOS should be administered to patients with chronic inflammatory disorders who are aged ≥60 years prior to initiation of immunosuppression or being treated with low-dose immunosuppression and those who are aged 50–59 years and varicella positive prior to initiation of immunosuppression or being treated with low-dose immunosuppression.

  • Other live vaccines should not be administered to patients with chronic inflammatory diseases on maintenance immunosuppression: LAIV, MMR vaccine in patients receiving low-level and high-level immunosuppression; and MMRV vaccine in patients receiving low-level and high-level immunosuppression.

  • Other recommended vaccines, including IIV and HepB vaccine, should not be withheld because of concerns about exacerbation of chronic immune-mediated or inflammatory illness.

 

VACCINATION OF SOLID ORGAN TRANSPLANT RECIPIENTS

  • Living donors should be current with vaccines based on age, vaccination history, and exposure history according to the CDC annual schedule; MMR, MMRV, VAR, and ZOS vaccine administration should be avoided within 4 weeks of organ donation. Vaccination of donors solely for the recipient’s benefit is generally not recommended.

  • Adults and children with chronic or end-stage kidney, liver, heart, or lung disease, including solid organ transplant (SOT) candidates, should receive all age-, exposure history-, and immune status-appropriate vaccines based on the CDC annual schedule for immunocompetent persons.

  • Adult SOT candidates; adults with end-stage kidney disease; and pediatric patients who are SOT candidates; are aged <6 years and have end-stage kidney, heart, or lung disease; or are aged 6–18 years and have end-stage kidney disease should receive pneumococcal vaccine.

  • Adults and children aged ≥2 years who are SOT candidates or have end-stage kidney disease should receive pneumococcal vaccine if they have not received a dose within 5 years and have not received 2 lifetime doses. Patients with end-stage kidney disease should receive 2 lifetime doses 5 years apart. Adults and children aged ≥2 years with end-stage heart or lung disease as well as adults with chronic liver disease, including cirrhosis, should receive a dose of pneumococcal vaccine if they have never received a dose. When both PCV13 and PPSV23 are indicated, PCV13 should be completed 8 weeks prior to PPSV23.

  • Anti-HBs–negative SOT candidates should receive the HepB vaccine series and, if on hemodialysis and aged ≥20 years, they should receive the high-dose (40 µg) HepB vaccine series. If a postvaccination anti-HBs concentration of ≥10 mIU/mL is not attained, a second 3-dose series of HepB vaccine (alternative: 1 dose of HepB vaccine after which anti-HBs is tested) should be administered, using standard dose or high dose* for children and high dose for adolescents and adults. HepA-unvaccinated, -undervaccinated, or -seronegative SOT candidates (particularly liver transplant candidates) aged 12–23 months and ≥2 years should receive a HepA vaccine series.

  • Combined HepA–HepB vaccine can be used for SOT candidates aged ≥12 years of age in whom both vaccines are indicated.

  • The HPV vaccine series should be administered to SOT candidates aged 11–26 years.

  • SOT candidates aged 6–11 months can receive MMR vaccine if they are not receiving immunosuppression and if transplantation is not anticipated within 4 weeks. If transplantation is delayed (and the child is not receiving immunosuppression), the MMR vaccine should be repeated at 12 months.

  • The VAR should be administered to SOT candidates without evidence of varicella immunity if they are not receiving immunosuppression and if transplantation is not anticipated within 4 weeks. The VAR can be administered to varicella-naive SOT candidates aged 6–11 months who are not immunosuppressed provided the timing is ≥4 weeks prior to transplant. Optimally, 2 doses should be administered ≥3 months apart.

  • SOT candidates aged ≥60 years and varicella-positive candidates aged 50–59 years who are not severely immunocompromised should receive ZOS if transplantation is not anticipated within 4 weeks.

  • Vaccination should be withheld from SOT recipients during intensified immunosuppression, including the first 2-month posttransplant period, because of the likelihood of inadequate response. However, IIV can be administered ≥1 month after transplant during a community influenza outbreak.

  • Standard age-appropriate inactivated vaccine series should be administered 2 to 6 months after SOT based on the CDC annual schedule, including IIV.

  • Pneumococcal vaccine PCV13 should be administered 2 to 6 months after SOT if not administered before SOT, with the timing based on the patient’s degree of immunosuppression.

  • For SOT patients aged ≥2 years, 1 dose of pneumococcal vaccine PPSV23 should be administered 2 to 6 months after SOT, with the timing based on the patient’s degree of immunosuppression, and ≥8 weeks after indicated doses of pneumococcal vaccine PCV13, if not given within 5 years and if the patient has received no more than 1 previous lifetime dose.

  • HepB vaccine should be considered for chronic HepB-infected recipients 2 to 6 months after liver transplant in an attempt to eliminate the lifelong requirement for HepB immune globulin (HBIG.

  • MMR vaccine and VAR should generally not be administered to SOT recipients because of insufficient safety and effectiveness data, except for varicella in children without evidence of immunity who are renal or liver transplant recipients, are receiving minimal or no immunosuppression, and have no recent graft rejection.

  • Vaccination should not be withheld because of concern about transplant organ rejection.