Donor deferral for cancer and for foreign travel

What is current practice for accepting blood/platelet donations by individuals who had cancer in the past, but are apparently free of disease currently? Specifically, what are centers doing regarding deferral of individuals who have had a history of cancer of breast, prostate, melanomas, invasive cancer of cervix, renal cell carcinomas, etc. The blood banker submitting this question states that his center is constantly confronted by donors who claim to be "cured" and demand the right(?) to donate blood and /or platelets.

What is current practice for accepting blood donations from individuals who have lived or traveled in Latin America, specifically in areas known for Chagas and other diseases?

The following replies were submitted:

1. A blood banker in California wrote that his center takes donors with a history of cancer if they are "asymptomatic" one year following their therapy, whatever that therapy might have been. The only exceptions are for patients who have had a diagnosis of multiple myeloma, leukemia or malignant melanoma, since one does not know if the patient has really been "cured" of these types of cancer. The responding blood banker attended a Blood Products Advisory Committee meeting where this topic was discussed a few years ago. He states that an excellent summary of the data on this was presented. Perhaps an e-Network member has a copy of the BPAC report and would be willing to share it? (See Reply #6 below) The bottom line was that there was no evidence of cancer transmission, despite experiments that specifically looked for this possibility. Further, a significant proportion of men over 65 have prostate cancer, whether they know it or not, and at least one in nine women have, or will have, breast cancer. The responding member asks a very provocative question, namely, if we do not defer men with undiagnosed prostate cancer and women with undiagnosed breast cancer, why should we defer them after they have gone a year without a recurrence of cancer following therapy?
   
   
2. Several e-network links address additional donor deferral issues:
   • Is the 12-month Deferral for Donors Who've Had Tattoos Still in Effect?
   • Donor deferral for allergy symptoms?
   • Should persons who've had acupuncture be deferred as donors?
   • Does the "rationale" for deferral after receiving a tattoo apply to ear/skin piercing, acupuncture, and electrolysis?
   • Donor Eligibility After Herpes Meningitis?
   • Desert Storm Veterans Still Banned from Donating Blood?
   • Eating and Blood Donation
   • Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts-DRAFT GUIDANCE
   • If a CBC before plateletpheresis reveals an abnormal WBC count, should the donor be deferred?
   • Can a regular plasma donor donate their tissues and organs if they participate in a red cell immunization program?
   • Collecting allogeneic units from donors with hemochromatosis?
   • NIH News Release-Study Finds Hemochromatosis Patients' Blood is as Safe as Other Donated Blood

ADDENDA Oct. 24, 2001

3. A blood banker in Texas suggested that the e-Network forum review an abstract that appeared in TRANSFUSION in 2000 as part of the AABB annual meeting [Land KJ, Sutor LJ, Sayers MH.  Survey results of donor cancer deferral criteria.  Transfusion 2000;40(Suppl):73S]. The abstract summarizes a survey of independent blood centers on donor deferrals for cancer and draws the following conclusion: Most independent blood centers will accept donors with a history of non-hematological cancer in addition to non-melanotic skin and in-situ carcinomas. In fact, of 62 centers responding to the survey, 87% reported permanently deferring donors for leukemia/lymphoma, 65% reported permanently deferring donors with malignant melanoma, 21% reported deferring for 5 years breast cancer patients and solid organ cancer patients, and none reported deferring donors for in-situ cancers and other skin cancers. These findings have implications as the number of eligible donors decreases and as the percentage of donors surviving their cancers increases.

ADDENDA Oct. 24, 2001

4. An e-Network member at a very prestigious institution near our nation's capital wrote: "Your query on policies for deferral of donors for a history of cancer arrived just as we had re-throught and rewritten our own policy. We are a moderate-sized hospital-based collection center and transfusion service. Here is our new policy:

Individuals with a history of cancer should be evaluated in the following manner:

1. Individuals with a history of (1) non-melanoma skin cancer (i.e. basal or squamous cell), (2) carcinoma in-situ of the cervix, or (3) any cancer, including melanoma, that dates back to greater than 10 years, are acceptable for donation without a personal physician's note or transfusion service physician's approval, if treatment was limited to surgical excision without chemotherapy, radiotherapy or hormonal therapy.
2. Any individual who has ever received chemotherapy, radiation therapy, or hormonal therapy as treatment for cancer is permanently deferred. This includes persons taking Tamoxifen for a history of breast cancer. It also includes persons with a history of leukemia, lymphoma, and Hodgkin's disease.
3. Individuals with a history of melanoma are deferred for 10 years.
4. Individuals who had cancer other than melanoma within the past 10 years, for which neither chemotherapy, radiation therapy or hormonal therapy was recommended or given, and who have been disease-free for at least one year from the date of surgical removal of the cancer, are eligible for donation if they present a note from their private physician stating: the type of cancer, the approximate date of surgery, and an opinion as to how likely the donor is to be cured of this process. A transfusion serivce physician consult and review of this note are optional, at the discretion of Donor Room staff.
5. All other persons with a history of cancer: If the donor is uncertain of the type or cancer or test results are pending, the donor should be deferred until they can provide a note from their personal physician.

ADDENDA Oct. 25, 2001

5. A blood banker who is well connected commented that if one searches the CBER website for "Workshop on blood donor suitability - December 9, 1999" one will find some of the most lucid and pithy reviews of the subject heretofore presented. According to this blood banker, "Drs. Sayers, Newman and Toby Simon give elegant presentations describing the fact that despite amazing opportunities to transmit cancer, if cancer was transfusion transmissable, such as using granulocytes from CML patients for therapuetic transfusions, that there are no examples that imply that cancer is, in fact, transfusion transmissable. Hence, the de facto practice of 5 year deferrals for cancer that stemmed from a chart in an older edition of the Technical Manual (see p 286 of the transcript, where a "Dr. Grolin" waxes poetic on the subject). In short, this is a wonderful example of where there is a community standard, but not one based on a particularly sound scientific basis and certainly shorter deferrals for certain types of solid tumors (thyroid Ca etc) are perfectly safe for donor and recipient alike!"

ADDENDA Oct. 26, 2001

6. A blood banker at a large cancer center in Texas reports that "when doing some of research on this subject, which included looking for the BPAC meeting minutes related in one of the answers to this question and contacting a friend at FDA, here is what he found. The reference to the FDA's position on donors with a history of cancer can be found in a Donor Suitability Workshop held by FDA in December, 1999; not in a BPAC minutes. Also, FDA sent an internal memorandum to their regional offices wherein they discontinued the practice of initiating a "Recall" when a unit was found to have come from a cancer survivor. According to the memo, a "Market Withdrawal" could be initiated by the firm issuing the blood product if the situation violated their own internal policy, but there was no regulatory position on the part of the FDA. They said their decision was based on the lack of consensus and scientific proof of any possible detriment to the recipients. " The responding blood banker continues to say that "beside the medico-legal implications of this issue, we are also discussing the ethical ramifications and the latest scientific work that claims the presence of circulating cancer cells in some "disease-free" survivors. The issues of public relations and customer service also must be evaluated in light of the lack of consensus on the subject."
   
   
7. A blood banker in Central California commented that regarding the discussion of donor eligbility/history of Cancer, "...minutes (actually a transcript) of the FDA/CBER workshop on this topic mentioned by one of the previous responders can be read in its entirety (308 pages!) at CBER's Workshops & Open Public Meetings page (scroll down to the Dec. 9, 1999 meeting). Our center debated/discussed this issue over a 12 month period, including the information presented at the Dec. 1999 workshop, and settled on the following new policy (the previous policy allowed only skin CA, excluding melanoma and in-situ cervical CA):

I. Permanent Deferral

1. Kaposi Sarcoma
2. Hematologic malignancy (leukemia, lymphoma, myeloma)

II. Acceptable

1. Skin cancer (Basal Cell CA, Squamous Cell CA, iin-situ melanoma)
2. In-situ carcinoma (ie CA in-situ of breast, CA in-situ of colon, CA in-situ of uterine cervix, etc)
3. Benign tumor(s) (lipoma, adenoma, neuroma, meningioma, etc)

III. Five-year temporary deferral or note from personal physician

1. All other cancer/malignancy not described in I or II above (i.e. breast CA, lung CA, colon CA, prostate CA, melanoma, etc) as long as conditions in B or C below are met.
2. Date of last treatment is 5 years or more prior to date of donation and there are no physician suggested or other restrictions/limitations in activities. NOTE: If less than 5 years since date of last treatment, blood donation will be allowed only with written permission from the attending Hem/Onc or primary care M.D.
3. No ongoing or planned anti-tumor radiation/chemotherapy or other anti-tumor therapy. (Topical agents for skin cancer acceptable.)

The main reason for the 5-year deferral (or requirement for a note from M.D.) was for the protection of the DONOR, not the potential recipient. Note that donation is permitted before 5 years (even before 1 year) as long as the donor is judged (in part thru requiring the M.D. note) to be otherwise in good health."

ADDENDA Oct. 27, 2001

The following is an excerpt from the from the AABB's Collected Questions and Answers, 6th edition, pg 16-17

Question 99-013: We have a frequent donor who had a hysterectomy 10 years ago for endometrial carcinoma; she has had no evidence of recurrence. The medical director of the blood bank has approved her to donate blood; however, the other members of our institution's blood utilization committee want more information, specifically the scientific data that addresses this issue. I have been unable to find the relevant articles with a Medline search. Can you help?

Response:
There are basically three questions to be answered:

1. Can a malignancy be transmitted by transfusion?
2. Is it safe for the blood donor with a history of malignancy to donate
3. What is the standard of care regarding the donation of a donor with a history of malignancy.

The pertinent AABB Standard is: B1.700 Medical illness: Prospective donors with disease of the heart, liver, or lungs or with a history of cancer or abnormal bleeding tendency shall be excluded unless determined to be suitable to donate by the blood bank medical director.

Although there are multiple reports of direct transmission of malignancies by organ transplantation, no such reports are available regarding transfusion. Reports of organ transplantation associated with transmission of malignancy include:

• Conlon PJ, Smith SR. Transmission of cancer with cadaveric donor organs. Journal of the American Society of Nephrology. 6(1):54-60, 1995.
• Jonas S, Bechstein WO, Lemmens HP et al. Liver graft-transmitted glioblastoma multiforme. A case report and experience with 13 multiorgan donors suffering from primary cerebral neoplasia Transplant International. 9(4):426-9, 1996.
• Frank S, Muller J, Bonk C, Haroske G et al. Transmission of glioblastoma multiforme through liver transplantation [letter] Lancet. 352(9121):31, 1998.

However, it is known that certain malignancies are associated with viruses, for example, HTLV-I is associated with adult T-cell leukemia/lymphoma. It is possible that other, as yet undescribed viruses may also be associated with malignancies. Therefore transmission of a virus by transfusion may place a patient at a "indirect" risk of a malignancy. There is one case report that suggested that HTLV-I had been transmitted through blood transfusion in a patient who subsequently developed adult T-cell leukemia/lymphoma. (Kanno M, Nakamura S,; Matsuda T. Adult T-Cell Leukemia with HTLV-I-Associated Myelopathy after Complete Remission of Acute Myelogenous Leukemia [Letter] NEJM , 338;1998:333)

Past editions of the AABB Technical Manual have specifically addressed this issue. See the 11th edition (1993; page 6):
"Prospective donors who have had cancer, other than localized skin cancer, or carcinoma-in-situ of the cervix should be evaluated by a qualified physcian before being accepted as a blood donor. Individuals who have definitive therapy and are free of disease for at least 5 years may be acceptable donors. Donors who have or have had leukemia or lymphoma must be permanently deferred ..." More recently, on December 9, 1999 the Food and Drug Administration held a workshop on blood donor suitability. One of the topics discussed was donor deferral based on a history of cancer. Data presented at this meeting by officials representing America's Blood Centers indicated that of 62 ABC blood centers surveyed, 78% permanently defer former leukemia and lymphoma patients and 77% accept donors with organ cancer after a disease-free period of 5 years. The rationale for excluding patients with a distant history of leukemia and lymphoma is that relapses can occur many years after treatment.

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Ira A. Shulman, MD
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