Around the world, every year more than 200,000 women between 15 and 49 year of age die of cervical cancer, nearly 80% of them living in the developing countries. With more than nearly 500,000 new cases each year, cervical cancer isthe third most common cancer in women, and the seventh overall. [1] In the United States estimates from the U.S. National Cancer Institute predict 12,340 new cases of cervical cancer and 4,030 deaths in the United States in 2013. [2]
Cervical cancer, a cancer that forms in tissues of the cervix, is usually a slow-growing cancer that may not have symptoms but can be found with regular Pap smears. It is almost always caused byhuman papillomavirus(HPV) infection. The disease, when it is detected early, and before it spreads beyond the cervix, can, in 95% of cases curable.
A systemic analysis published in The Lancet [3] showed an increase of the global cervical cancer incidence from 378,000 cases per year in 1980 to 454,000 cases per year in 2010, a 0.6% annual rate of increase.And while cervical cancer death rates have been decreasing, the disease is still the leading cause of death among women in many countries, where there is little or no access to Pap screening. The lack of large-scale Pap smear screening or HPV DNA testing in developing countries is generally caused due to limited resources, a poor medical infrastructure, no access to high-qualaty laboratories, and lack medicalprofessionals and primary healthcare workers.
Importance of screening
While a majority of women (70 – 80%) in industrialized nations are screened for cervical cancer, only a limited number (5 – 10%) of women in the developing world are screened for the disease. And screening has shown to be important. In industrialized countries, including the US and most European Countries,screening for pre-cancerous and cancerous cells using Pap smears has reducedcervical cancer incidence and deaths by 80%.
Biennial cervical cancer screening using visual inspection
with acetic acid – delivered by trained primary healthcare workers – implemented on a broad scale, has shown to be effective in reducing cervical cancer death rates.
With a Pap smear, a doctor takes a scraping from the cervix. This is then sent to a laboratory to be scanned by a pathologist. While limited access high-quality laboratories may be available in developing nations, the results often take weeks to arrive. And in many cases, women who have returned to distant, rural, areas where they live or work are often hard to reach. This causes problems if it the results require further treatment.
A reasonable alternative to Pap smears
But today, women in developing countries have a reason to be optimistic. Aremarkably simple and inexpensive proceduredevelopedin the 1990s by medical experts at theJohns Hopkins medical schooland the University of Zimbabwe [4, 5]can do for them what the Pap smear did for women in industrialized nations. The procedure, endorsed by the World Health Organization(WHO) is calledcervicoscopy or VIA [*] and consists of a visual examination afteracetic acid or vinegarisbrushed on a woman?s cervix with a cotton swab. After 60 seconds, the cervix is examined with the naked eye using a lamp. Pre-cancerous tissueturns white when vinegar is applied, whereas healthy tissue does not change color. The results are knownimmediately and lesions can be immediately removed,a very important advantage in rural areas where women might otherwise have to travel forhours to see a doctor.The procedure,delivered byprimary healthcare workers,is a reasonable, inexpensive but effective procedure that isalready beginning to save lives.
Large randomized trial
A large, randomized study conducted among 150,000 women in India over a period of 15years reports that the VIA test reduced cervical cancer mortality by nearly one-third (31%). Based on these results, theresearchers estimate this strategy may help prevent 22,000 cervical cancer deaths every year in India and close to 73,000in other developing countries worldwide.
Commenting on the strategy, lead author of a study, presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago, USA, May 31 – June 4, 2013,Surendra Srinivas Shastri, MD (photo),noted: ?We hope our results will have a profound effect in reducing the burden of cervical cancer in India andaround the world.?
Shastri, professor of preventiveoncology at Tata Memorial Hospitalin Parel, Mumbai, India, further said: ?This is the first trial to identify a cervical cancerscreening strategy that reduces mortality and is feasible to implement on a broad scale throughout Indiaand in other developing countries. Our trial used primary healthcare workers who can easily accesswomen in the community, which is critical in India and other countries that lack sufficient nurses,physicians, and laboratory facilities. We are already working with state and national health authorities inIndia to make this screening strategy and health education available to women throughout the country.?
Study design
In this study, which supported in part by the National Institutes of Health and Women?s Cancer Initiative,women aged 35-64 years with no prior history of cancer were randomly assigned to biennialscreening with VIA (75,360 women) or no screening (76,178 women), which is the current standard ofcare in India given that the infrastructure does not allow for country-wide Pap screening. According tothe study’s authors, in accordance with international standards for clinical research (including cancer screeningtrials), interventions were tested against the local standard of care. The control group received one round ofcancer education, at enrollment. Women in the control group were asked to report to the primary healthworkers any signs/symptoms of cervical cancer that they noticed on the basis of what they had learntduring the initial cancer education sessions. The health workers then directed them to the Tata MemorialHospital where they received diagnosis and treatment at no cost or to other nearby facilities of theirchoice. The screening group received four rounds of VIA screening and cancer education at 24-monthintervals between 1998 and 2010. All trial participants were offered free cervical cancer treatment, ifdiagnosed.
Concern notwarranted
Previous studies, have shown that the high sensitivity of the VIA test make this screening method a valuable tool in detection of precancerous lesions of the cervix. However,researchers conducting these studieswere concerned that lack of specificity would result in system costs associated with high numbers of false-positive results, limitingsuccessfulimplementation of the test. [4] In this study, the incidence of invasive cervical cancer was comparable in the two groups, (26.7 per 100,000 in thescreening group and 27.5 per 100,000 in the control group), suggesting that screening did not lead toover-diagnosis.Screening with VIA resulted in a 31% reduct
ion in cervical cancer-specific deathrates (11.1 and 16.2 per 100,000, respectively). There was also a 7% reduction in the overalldeath rate, because cancer was often diagnosed at an earlier stage in the screening group, although thedifference in the overall death rate was not statistically significant.
Based on the results of their study, the authors confirmed that Indian health officials in Maharashtra state,where the trial was conducted, are preparing to train primary health care workers to provide VIAscreening to all women aged 35-64 years ? including women who participated in the study ? atthe same 24 month interval as was explored in the trial. The authors also stated that the Indian government is working to implement VIA screening country-wide and has plans to reach out to other developing countries to inform them of these results and offer them training resources.
A simple, community based, procedure
In this clinical trial, VIA test was performed by primary health workers ? community-based,non-medical personnel who received special training and provide basic healthcare services in areas wherephysicians and nurses are unavailable.In 1996, around the time this study was initiated, the Indian Council of Medical Research estimated that,even if the number of existing Pap smear facilities in India were multiplied 12 times, they would only beable to provide a single round of screening to 25% of eligible women in 10 years. In 2006, theGovernment of India constituted a committee with assistance from World Health Organization to developguidelines for population wide cervical cancer screening in India. This committee again observed that Papsmear based cervical screening was not feasible in India except at a few centers. Given that cervicalcancer is the leading cause of cancer death in women in India, a strategy implementing early detectionand treatment of the disease could have a profound impact on the state of women?s health in world?ssecond largest country.
Two randomized population-based clinical trials of VIA screening were conducted in parallel with thepresent study in India but the strategies proposed in those studies are not implementable at the nationallevel due to their requirement for trained nurses or sophisticated laboratory facilities. In the first study, asingle round of VIA screening provided by trained nurses led to reduced cervical cancer mortality. Thesecond study compared four cervical cancer prevention strategies: primary health workers delivering asingle round of VIA screening, technicians delivering a single round of HPV DNA testing, techniciansdelivering a single round of Pap screening, and cancer education. That study found that a single round ofHPV DNA testing reduced cervical cancer mortality, but a single round of VIA screening by primaryhealth workers did not, nor did a single round of Pap testing.
The present study used primary health care workers, who are, according to Shastri, the only healthprofessionals available to deliver VIA screening in remote and rural parts of India. The current trial thusaddresses a critical gap in women?s health in India and similar settings. The primary health workers thatperformed the screenings for this study were local women with at least 10th grade education and goodcommunication skills. The workers received four weeks of intensive training at the beginning of thestudy, and one-week refresher courses every year.
Other countries – other studies
The result of the India trial is very similar to previous trials. A report discussing results op using VIA in Bangladesh, one of the first countries in the world to introduce VIA as the screening test for its national cervical cancer screening program, shows that a VIA-based program facilitates improves the development of screening, diagnosis, and treatment of cervical neoplasia and creates more awareness of cervical cancer prevention.[6]
This study, conducted from January 2005 to June 2008, enrolled 104,098 women in a VIA-based screening program. A total of 5,013 (4.8%) women were positive – a very low rate, which was attributed to the extensive training of primary healthcare workers. A total of 4,371 (87.2%) women were treated different hospitals. Among these women, 2,188 who underwent colposcopy at Bangabandhu Sheikh Mujib Medical University Hospital, Dhaka, Bangladesh, 157 were diagnosed with cervical intraepithelial neoplasia (CIN) 2-3 and 123 with invasive cancer. For 2,065 women (excluding the cancer cases), results for sensitivity, specificity, and positive predictive value of VIA to detect CIN 2-3 lesions were 93.6%, 58.3%, and 15.6%, respectively. Almost half the women with CIN 2 or 3 lesions had treatment, increasing their change of survival.
[*] VIA or Visual Inspection of the cervix with Acetic-acid wash
For more information:
Recent Evidence on Cervical Cancer Screening in Low-Resource Settings (Alliance for Cervical Cancer Prevention ACCP) Cervical Cancer Prevention Fact Sheet. [Full Article]
References:
[1] Cervical Cancer Incidence and Mortality Worldwide in 2008
Summary. GLOBOCAN 2008 (IARC) , Section of Cancer Information (3/6/2013) Last accessed on June 2, 2013.
[2] National Cancer Institute, Cancer Awareness in Focus: Cervical Cancer [Web based article] Last accessed in June 2, 2013.
[3] Forouzanfar MH, Foreman KJ, Delossantos AM, Lozano R, Lopez AD, Murray CJ, Naghavi M. Breast and cervical cancer in 187 countries between 1980 and 2010: a systematic analysis.Lancet. 2011 Oct 22;378(9801):1461-84. doi: 10.1016/S0140-6736(11)61351-2. Epub 2011 Sep 14 [Abstract][PubMed]
[4] Visual inspection with acetic acid for cervical-cancer screening: test qualities in a primary-care setting. University of Zimbabwe/JHPIEGO Cervical Cancer Project.Lancet. 1999 Mar 13;353(9156):869-73.[Abstract][PubMed]
[5]Kitchener HC, Symonds P. Detection of cervical intraepithelial neoplasia in developing countries. Lancet. 1999 Mar 13;353(9156):856-7.[Abstract][PubMed]
[6]Basu P, Nessa A, Majid M, Rahman JN, Ahmed T. Evaluation of the National Cervical Cancer Screening Programme of Bangladesh and the formulation of quality assurance guidelines. J Fam Plann Reprod Health Care. 2010 Jul;36(3):131-4. doi: 10.1783/147118910791749218 [Full Article][PubMed]
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