Oncofertility Preserving the Future Nicole C. Rosipal, RN, MSN, PNP Objectives Incidence of cancer and survivorship among Adolescent and Young Adult (AYA) population Survivorship and significance of fertility Effects of cancer and cancer treatment on fertility Assessment of fertility Age appropriate fertility preservation options – Standard and Experimental Key considerations when discussing fertility with patients and families Cancer and Survivorship Among Adolescent and Young Adults Approximately 70,000 Adolescent and Young Adult (1539) and 10,000 children (<15) are diagnosed with cancer each year Childhood cancer survivorship > 70% 1 of 900 individuals in U.S. between 15-45 is a childhood cancer survivor Approximately 270,000 cancer survivors originally diagnosed less than 21 years of age are currently living in the United States Infertility “Inability to conceive after 1 year of intercourse without contraception” Azoospermia – No measurable level of sperm in semen – Obstructive vs. issue with spermatogenesis Damage to oocyte, follicles or uterus – Immediate menopause – Premature menopause Infertility and General Population Statistics – 6.1 million Americans – In 2002, 7% of women infertile Multi-factorial causes – Men – Women – Both Sexually transmitted diseases Lifestyle factors – smoking, alcohol, obesity American Society of Clinical Oncology (ASCO) Guidelines Panel reviewed literature spanning 1997 to 2005 Fertility preservation is of great importance Lack of knowledge and comfort of health care team Effects of infertility resulting from cancer treatment: – Psychosocial and emotional distress – Loss of masculinity or femininity – Most survivors prefer to have biological children Survivors as Parents – Experience with illness can enrich their role – High value on family closeness 2006 ASCO Guidelines “Oncologists should address the possibility of infertility with patients treated during their reproductive years and should be considered as early as possible in the treatment planning” Urban Legends and Caution Males Azoospermia is potentially for life, not short term Can still get someone pregnant! – Sperm production can return immediately or many years after cancer treatments Pubertal development does not equal fertility Caution! – Sexually transmitted diseases Urban Legends and Caution Females A “period” does not define fertility – Amenorrhea is not a definite sign of infertility – Return of a period does not equal fertility Cancer treatment can take years off of the biological clock Caution! – STD’s Cancer and Infertility Men Risk is multifactorial – – – – Age Disease Cancer treatment regimen Pre-existing conditions Function of testicle effected Currently 15-30% of survivors are sterile Cancer has been documented to have effect on quantity and quality of sperm. A Word About Prepubertal Males Radiation less damaging than chemotherapy No protective effect against chemotherapy induced gonadal damage Assessment of Fertility Prior to Beginning Cancer Treatment Male Tanner Staging – Related to secondary sexual characteristics – Average age Spermatogenesis - 13 y.o. Completion of puberty - 15 y.o. Semen Analysis Proportion of Patients with a Normal Semen Analysis Overall – 21.1% with normal semen analysis Diagnosis % Nl Brain 0 HL 33.3 Leukemia 9.1 Testicular 22.5 Sarcoma/ST 25 NHL 18 Other 0 Grey 14-18 yo White >18 yo High Risk for Azoospermia Total Body Irradiation (TBI) Testicular radiation >2.5 gy men >6 gy boys Stem Cell Transplant (SCT) Testicular Cancer, ALL, Non-Hodgkin Lymphoma Alkylating Chemotherapy SCT for SCT conditioning Allogeneic Cyclophosphamide Autologous Busulfan Melphalan High Risk for Azoospermia Any alkylating agent + TBI, pelvic or testicular radiation Testicular Cancer, SCT, ALL, NHL, sarcoma, Hodgkin, neuroblastoma Any protocol with Procarbazine Hodgkin Lymphoma Cyclophosphamide 7.5gm/m2 Sarcoma, NHL, neuroblastoma, ALL Cranial brain radiation >40 Gy Brain Tumor Intermediate Risk for Azoospermia Bleomycin, Etoposide, Cisplatin Testicular Cancer (BEP) X 2-4 cycles Cumulative Cisplatin dose <400 mg/m2 Testicular Cancer Cumulative Carboplatin dose < 2 g/m2 Testicular Cancer Intermediate Risk for Azoospermia Testicular radiation dose Wilm’s tumor and 1-6 Gy neuroblastoma Due to scatter from abdominal/pelvic radiation Low Risk for Azoospermia Non-alkylating chemotherapy Hodgkin Lymphoma, Non-Hodgkin Lymphoma ABVD, OEPA, NOVP, COP, CHOP Testicular radiation 0.2-0.7 Gy Testicular Cancer Very Low/No Risk for Azoospermia Testicular radiation <0.2 Gy Multiple Cancers Interferon a Multiple Cancers Radioactive Iodine Thyroid Unknown Risk for Azoospermia Irinotecan Bevacizumab (Avastin) Cetuximab (Erbitux) Erlotinib (Tarceva) Imatinib (Gleevec) Preventative Measures Shielding during radiation – Pre and post pubertal Hormonal manipulation (GnRH analogs) has not proven successful in gonadoprotection Banking Options Pre vs. Post Pubertal Standard vs. Experimental Banking Options: Post Pubertal Male Standard Sperm Banking: – – – – Most effective Obtained through masturbation then frozen Outpatient procedure Success rate is generally high Reports of 50% successful pregnancy rate – Potentially compromised sperm count and increased risk of genetic damage after a single treatment Banking Options: Post Pubertal Males Standard Sperm Banking Process – MD/APN/PA order – Collection PRIOR to chemotherapy and/or radiation is vital – 2-3 samples are recommended – A sample can be provided every 24 hours. – Collected in a sterile container At clinic location, hospital, home Kept at body temperature and brought to lab within one hour Sperm Banking Process Continued Semen Analysis – Sperm count and movement – Morphology – Semen is placed in individual plastic vials for freezing Cost – $125-$250 for analysis – $225-$375 for one year storage Mandatory Infectious Disease Testing Serum: – – – – – – – HIV Hepatitis A, B and C RPR (Syphilis) HTLV 1 and 2 (Human T-lymphotropic virus) CMV IgG and IgM Gonorrhea and Chlamydia (IgG and IgM) AST Cost – Approximately $325 Banking Options: Post Pubertal Males Experimental Electroejaculation – Penile or Rectal Mechanical vibrator is placed at the base of the penis or in rectum and set to vibrate at a designated frequency and wave amplitude. Vibration travels along the sensory nerves to the spinal cord and may induce a reflex ejaculation. – Approx 50 - 100% success rate of ejaculation – Cost varies greatly Banking Options: Post Pubertal Males Experimental Testicular sperm extraction – Outpatient procedure – Testicular mapping – Success Rate 30-70% 45% of azoospermic ejaculate after cancer treatment – Cost $4,000 - $16,000 Banking Options: Prepubertal Males Experimental Only Cryopreservation of testicular tissue and stem cells – Tissue obtained via biopsy and frozen – In Vitro culture Maturation of testicular stem cells – Animal studies only – Autotransplantation Risk of recurrence? Options after Cancer Treatment Use of Frozen Sperm – In Vitro Fertilization (IVF) – Intra Cytoplasmic Sperm Injection (ICSI) Donor Sperm – $200 - 500 per vial Adoption – $2,500 - $35,000 Options in Houston Baylor College of Medicine – Urology Medical Center Houston IVF Memorial City Advanced Fertility Center Medical Center, Katy, of Texas Memorial City, Cy Fair, The Woodlands Assessment of Fertility After Cancer Treatment Semen analysis Blood Work FSH Inhibin B Cancer and Infertility Women Cancer itself does not appear to affect fertility in women. Cancer treatments pose spectrum of risk Immediate infertility Premature menopause Compromised ability to carry a pregnancy Multifactoral process Drug type & dose Radiation location & dose Patient age & pubertal status Pre-treatment fertility A Word About Prepubertal Females Early age at time of cancer treatment has a protective effect – Younger age with larger number of oocytes requiring more radiation to cause damage – Less mitotic activity Cancer and Infertility Women Surgery can impair ability to become pregnant and/or carry pregnancy Radiation can damage uterus and increase risk of miscarriage Advise survivors who have received pelvic radiation should seek high-risk OB Cancer and Infertility Women Damage to oocytes and follicles can lead to immediate menopause or premature menopause years after treatment. Menstruation does not equal fertility Treatment affect on stromal function and ovarian blood vessels High Risk >80% of women develop amenorrhea post-treatment Whole abdominal or pelvic radiation doses > 6 Gy in adult women Multiple cancers Whole abdominal or pelvic radiation doses Wilms’ tumor, neuroblastoma, > 15 Gy in pre-pubertal girls sarcoma, Hodgkin lymphoma > 10 Gy in post-pubertal girls TBI radiation doses Stem cell transplant CMF, CEF, CAF x 6 cycles in women 40 + Breast cancer Cyclophosphamide 5 g/m2 in women 40+ Multiple cancers Cyclophosphamide 7.5 g/m2 in girls < 20 Non-Hodgkin lymphoma, neuroblastoma, ALL, sarcoma High Risk >80% of women develop amenorrhea post-treatment Alkylating chemotherapy (cyclophosphamide, busulfan, melphalan) conditioning for transplant Stem cell transplant Any alkylating agent (e.g.cyclophosphamide, ifosfamide, busulfan, BCNU,CCNU) + TBI or pelvic radiation Stem cell transplant, ovarian cancer, sarcoma, neuroblastoma, Hodgkin lymphoma Protocols containing procarbazine: MOPP, COPP, BEACOPP, MOPP/ABVD,COPP/ABVD Hodgkin lymphoma Cranial/brain radiation >40 Gy Brain tumor Intermediate Risk ~30-70% of women develop amenorrhea post-treatment CMF or CEF or CAF x 6 cycles in women 30-39 Breast cancer Anthracycline & cyclophosphamide women 40 + Breast cancer Whole abdominal or pelvic radiation 10-<15 Gy in prepubertal girls Wilm’s tumor Whole abdominal or pelvic radiation 5-<10 Gy in postpubertal girls Wilm’s tumor, neuroblastoma Spinal radaition >25 Gy Spinal tumor, brain tumor, neuroblastoma, relapse ALL or NHL Low Risk <20% of women develop amenorrhea post-treatment AC (anthracycline, cytarabine) in women 30-39 Breast cancer CMF, CEF or CAF x6 cycles in Breast cancer women 30-39 Non-akylating Hodgkin lymphoma, NHL chemotherapy: ABVD, CHOP, COP AC AML Multi-agent therapies ALL Very Low Risk Negligible effect on menses Methotrexate, 5 FU Breast cancer Vincristine (used in multiagent therapies) Leukemia, NHL, Hodgkin lymphoma, neuroblastoma, rhabdomyosarcoma, Wilm’s tumor, Kaposi sarcoma Thyroid cancer Radioactive Iodine Unknown Risk Paclitaxel, docetaxel Breast cancer Oxaliplatin Ovarian cancer Irinotecan Colon cancer Bevacizumab (Avastin) Colon, non-small cell lung Ceftuximab (Erbitux) Colon, head & neck Trastuzamab (Herceptin) Breast cancer Erlotinib (Tarceva) Non-small cell lung, pancreatic CML, GIST Imatinib (Gleevec) Standard Female Reproductive Options Embryo freezing Radiation shielding of ovaries Ovarian transposition Radical trachelectomy Donor embryos Donor eggs Gestational surrogacy Adoption Embryo Freezing Eggs are harvested and undergo in vitro fertilization. Embryos are frozen for later implantation. Time requirement Cost: ~ $8,000-12,000 per cycle / $350/year storage fees – Donor sperm $200-$500 / vial Success rate: 20-33%, babies born Special considerations: partner, donor sperm Radiation Shielding of Ovaries Shielding reduces scatter to reproductive options Time requirement: non-issue Cost: included in cost of radiation Success rate: limited to selected radiation fields Special considerations: No protection from chemotherapy Ovarian Transposition Surgical repositioning of ovaries away from radiation field Time requirement: Outpatient procedure Cost: Maybe covered by insurance Success rate: Approximately 50% Special considerations: Expertise required Radical Trachelectomy Surgical removal of the cervix with preservation of uterus Time requirement: During treatment Cost: Included in treatment cost Success rate: No evidence of higher recurrence rate Special considerations: Early stage cervical cancer, limited centers Standard Female Reproductive Options Donor embryos – Not biologic child Donor eggs – Offers opportunity for biologic child for father Gestational surrogacy – Legal implications Adoption – Inaccessibility to cancer survivors Experimental Options Egg/oocyte freezing Ovarian tissue preservation GnRH Experimental Options for Females Oocyte cryopreservation Process the same, sperm not needed Oocytes are more sensitive to freeze/thaw process and more prone to damage Average 2% (range 1-5%) chance of pregnancy per oocyte (3-4 times less than with embryo) 200+ live births to date ~$12,000/cycle Experimental Options for Females Ovarian Tissue cryopreservation Laparoscopic procedure Benefits: – Ovarian stimulation not performed – Acquire hundreds of immature oocytes – Less delay in commencement of cancer treatment HOWEVER – not a location available in Texas! Concerns – Reimplantation increase risk of recurrence? How to develop the immature oocytes? Autotransplantation - Orthotopic vs. heterotopic Xenotransplantation Two live births reported (2005) ~$12,000 for procedure; storage and reimplantation with additional cost Retrieval of immature oocytes with in vitro maturation (5 y.o. youngest reported) Post chemotherapy preservation possible; however, lower yield Assessment of Fertility Difficult to predict reproductive horizon post treatment Regaining menses post treatment does not imply intact fertility Risk of premature ovarian failure is real Current assessment is: – Day 3 of cycle FSH LH Transvaginal ultrasound to assess antral follicle count – AMH (anti-mullerian hormone): determine ovarian reserve Experimental Options for Females GnRH agonist Lupron – 1 month or 3 month injection Creates a prepubertal state, suppressing ovulation When to give? – 2-3 weeks prior to chemotherapy to prevent breakthrough bleeding from occurring during time of cytopenia. – Give up to 2 doses or 6 months total – bone demineralization What does the literature say? – Potential risks in hormone sensitive tumors unknown – Does not protect follicles from radiation – Mixed review No benefit vs. Menses resuming with or without pregnancy achievement – 98% vs. 40% resumption of menses 6 months post chemotherapy Do agree – decrease risks associated with menses during time of cytopenia Window of opportunity Cost - $500/month Options in Houston Embryo freezing- Fertile Hope referrals Radiation shielding- Radiation Oncologist Ovarian transposition- Surgery Radical Trachelectomy- MDACC, Pedro Ramirez, MD Exploring option with Baylor group for ovarian tissue preservation Potential Barriers for Men and Women Lack of information of treating oncologist Lack of referral network Perceived financial burden to families Facility not adolescent friendly Time Parental anxiety Spiritual concerns Resources Fertility Consult Service – Anna Franklin, MD – Donna Herrera-Bell – Nicole Rosipal, RN, MSN, CPNP Services Provided – Discussion of infertility risk and available options – Referral Process – Consult Request – Wednesday, Thursday and Friday afternoons Resources LIVESTRONG Survivor Care – www.LIVESTRONG.org/survivorcare – Information about fertility preservation, financial, insurance and employment concerns – LIVE:ON Fertile Hope – www.fertilehope.org – Sharing Hope program – Self referral Oncofertility Consortium Heroes for children – up to 22 – http://www.heroesforchildren.org/ – Social worker completes assessment and application – Assistance is based on financial need ($750 towards expenses) Current Research at MD Anderson Banking on Fatherhood St. Jude’s Questionnaire – Attitude about sperm banking Discussion References Biro, F. M., et al. (2010) Normal Puberty. Up to Date. www.uptodate.com Blumenfeld, Z. (2008). GnRH-agoinst in fertility preservation. Curr Opin Endocrinol Diabetes Obes, 15, 523-26. Blumenfeld, Z. & Eckman, A. (2005). J Natl Cancer Inst Monogr, (34), 403. Boss, E. A., van Golde, R. J., & Massuger, L. F. (2005). Pregnancy after radical trachelectomy: a real option? Gynecol Oncol, 99(3 supp 1), 152-6. Fertility preservation and reproduction in cancer patients. (2005). Fertil Steril, 83(6), 1622-1628. Green, D. M., Sklar, C. A., Boice, J. D., Jr., Mulvihill, J. J., Whitton, J. A., Stovall, M., et al. (2009). Ovarian failure and reproductive outcomes after childhood cancer treatment: results from the Childhood Cancer Survivor Study. J Clin Oncol, 27(14), 2374-2381. Lee, S. J., Schover, L. R., Partridge, A. H., Patrizio, P., Wallace, W. H., Hagerty, K., et al. (2006). American Society of Clinical Oncology recommendations on fertility preservation in cancer patients. J Clin Oncol, 24(18), 2917-2931. References Neal, M. S., Nagel, K., Duckworth, J., Bissessar, H., Fischer, M. A., Portwine, C., et al. (2007). Effectiveness of sperm banking in adolescents and young adults with cancer: a regional experience. Cancer, 110(5), 1125-1129. Author, A. A., & Author, B. B. (Year of publication). Late effects of childhood cancer and its treatment. In Pizzo, P. A. & Poplack, D.G. (Eds.), Prinicples and Practices of Pediatric Oncology (1503-06). Philadelphia, PA: Lippincott Williams & Wilkins. Revel, A., Revel-Vilk, S., Aizenman, E., Porat-Katz, A., Safran, A., Ben-Meir, A., et al. (2009). At what age can human oocytes be obtained? Fertil Steril, 92(2), 458-463. Schover, L. R. (1999). Psychosocial aspects of infertility and decisions about reproduction in young cancer survivors: a review. Med Pediatr Oncol, 33(1), 53-59. www.fertilehope.org www.livestrong.org Zakak, N. N. (2009). Fertility issues of childhood cancer survivors: the role of the pediatric nurse practitioner in fertility preservation. J Pediatr Oncol Nurs, 26(1), 4859.