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Year in Review: HPV vaccine approval a top 10 story in 2007
Vaccines emerge as a new prevention modality.
The number one story in 2007 was the FDA approval of human papillomavirus quadrivalent vaccine to prevent cervical cancer.
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Human papillomavirus quadrivalent vaccine (Gardasil, Merck) prevents the most common types of human papillomavirus infection, including the four types that cause about 70% of cervical cancer (strains 6, 11, 16 and 18) and 90% of genital warts. In 2007, questions related to implementation discussed in an “Ask the Experts” panel webcast were who should receive it and at what age, who will pay for it and the best way to ensure access to the vaccine. The consensus was that the vaccine would work best before the onset of sexual activity; the vaccine cannot treat HPV that is already present. The Advisory Committee on Immunization Practices recommended routine vaccination for girls aged 11 to 12 and catch up vaccination for all girls and women aged 9 to 26.
Financing the $360 for the series of three vaccinations is an important issue for some. A federal entitlement program, Vaccines for Children, covers children who are on Medicaid; are American Indian, Native Alaskan or uninsured; and underinsured children seeking care at Federally Qualified Health Centers or Rural Health Centers.
Several states, including New Hampshire and South Dakota, provide the vaccine for free to girls. Merck also has a vaccine assistance program for those with low incomes and who lack insurance. The importance of educating providers as well as the general public was discussed by Renee Jenkins, MD, professor and chair of the department of Pediatrics and Child Health at Howard University College of Medicine, Washington. Only 40% of women in the United States have heard of HPV, and only 20% of these women know it is associated with cervical cancer.
Three stories in HemOnc Today dealing with breast cancer were included as top 10 news items of 2007.
Based on a randomized trial in which lapatinib (Tykerb, GlaxoSmithKline) plus capecitabine was compared with capecitibine alone for patients with advanced or metastatic HER2 overexpressing breast cancer after chemotherapy and trastuzumab failure, this small molecule inhibitor that targets HER2 and epidermal growth factor receptor was approved by the FDA in March 2007.
Charles Geyer, MD, director of breast oncology at the Allegheny Cancer Center in Pittsburgh, pointed out that lapatinib blocks HER2 in a completely different way than trastuzumab and resulted in an average progression time of 8.4 months in combination compared with 4.4 months in the capecitibine alone group. It will be of importance to compare anti-tumor effects and cardiac toxicity of lapatinib with trastuzumab in earlier disease and possibly the combination of these two agents alone or with chemotherapy.
The second news item published in HemOnc Today covered new guidelines from the American Cancer Society that showed that magnetic resonance imaging can detect cancer in the contralateral breast that is missed by mammography and clinical examination. The NIH-sponsored study included 969 women with a recent diagnosis of unilateral breast cancer and no abnormalities on mammographic and/or clinical examination of the contralateral breast. Biopsies performed on 121 women with a positive MRI finding showed that 30 were positive for cancer and 18 were positive for invasive cancer. Constance Lehman, MD, section head of breast imaging at the Fred Hutchinson Cancer Research Cancer, pointed out that if the MRI is negative, the chance of cancer in the contralateral breast is extremely low, and this could lead to fewer bilateral mastectomies. Should MRI replace mammography as a screening tool? The consensus is that if a woman has a 20% to 25% or greater lifetime risk for breast cancer, it may be recommended.
The third news item from the San Antonio Breast Cancer Symposium received a great amount of publicity. There was an overall relative decline in breast cancer incidence between 2002 and 2003, and the steepest decline (12%) occurred in women aged 50 to 69 with estrogen receptor–positive breast cancer. Peter Ravdin, MD, PhD, a professor in the department of biostatistics at The University of Texas M.D. Anderson Cancer Center, attributed this decline to the decrease in the use of hormone therapy (HT). Ravdin said that about 30% of women older than 50 had been taking HT and about one-half stopped using HT in late 2002, after the results of the Women’s Health Initiative were published. The study was prematurely stopped in July 2002 when the combination of estrogen and progestin was found to significantly increase the risk for developing invasive breast cancer. This is certainly good news; it translates to as many as 14,000 fewer women being diagnosed with breast cancer in 2003 as compared with 2002.
An important story in the June issue, discussed by Samuel M. Silver, MD, PhD, director of the University Cancer Center Network at the University of Michigan Cancer Center and editor of HemOnc Today’s Health Policy, Patient and Practice Issues section, was that the Centers for Medicare and Medicaid Services has proposed revisions to its clinical trial reimbursement policy that could expand coverage for patients enrolled in these trials. Based on Medicare law, the government agency will not pay for care that is not deemed medically necessary or care that should be paid for by another party. “Under these new proposed rules, the CMS has changed the language so that phase-1 trials will be qualified for reimbursement,” Silver said.
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- Joseph R. Bertino, MD, is interim director of the Cancer Institute of New Jersey and the associate medical editor of HemOnc Today.