5 minutes to save a life

[Guest guest]

Hi All,

5 minutes to save a life is little time. CRers are less likely to smoke,

though.

See the below discussion and then parts of the pdf-available paper that

describes

why this may be so. The Discussion and paper are not in Medline yet.

Lancet 365 (9475) 4 Jun 2005-10, 1905-1906

Oral cancer screening: 5 minutes to save a life

Michele D Mignogna and Stefano Fedele

In today's Lancet, Rengaswamy Sankaranarayanan and colleagues report the first

solid

evidence that periodic examination of the oral cavity can reduce mortality from

oral

cancer in high-risk individuals. These results come from the Kerala screening

trial,

a cluster randomised trial, designed to have 80% power to detect a 35% reduction

in

oral cancer mortality within 12 years of enrolment between the intervention and

control group, through rounds of screening every 3 years. The investigators

report

that, 9 years after the start of screening, there was a significant 32%

reduction in

mortality in high-risk individuals in the intervention group (42% when only male

tobacco/alcohol users are considered). Overall, these data suggest that oral

visual

screening in high-risk patients could prevent about 40,000 deaths from oral

cancer

worldwide.

The reported data could be read in two ways. The first is the methodological

evaluation of oral cancer screening itself. From this point of view, are the

outcomes reported by Sankaranarayanan and colleagues adequately supported by the

study design or do limitations exist? For example, the restricted-block

randomisation can be potentially imbalanced when the number of clusters is

small.

Also, the recruitment of non-medical health workers raises concerns about the

sensitivity and specificity to detect lesions and patients' compliance with

referral. A screening interval of 3 years is long and the percentage of patients

who

did not get biopsy was high. Finally, clinical and histopathological diagnostic

criteria were not clearly reported and variations in definitions and management

of

oral lesions can influence screening outcomes. On the other hand, the data

suggest

perhaps the right perspective in the fight against oral cancer—supporting

prevention

through screening as a potential major target of every health organisation

worldwide. Oral cancer is a significant public-health threat, accounting for

270,000

new cases annually1 and with one of the lowest survival rates (fewer than 50% of

patients surviving more than 5 years). Furthermore, in the past few decades

despite

advances in the detection and treatment of many other malignancies, this rate

has

remained disappointingly low and relatively constant.

Rather than prevalence, the most peculiar characteristic of oral cancer is the

apparently unexplainable imbalance between its global burden and the potential

theoretical ease in decreasing morbidity and mortality with early detection.

Oral

cancer is almost always preceded by visible changes in the oral mucosa (figure,

A

and , which allows clinicians to detect and treat effectively early

intraepithelial stages of oral carcinogenesis.2 Nevertheless, most oral cancers

are

currently detected at a late stage, when treatment is complex, costly, and has

poor

outcomes (figure, C and D). Paradoxically, the percentage of oral cancers

diagnosed

in the early stages is similar to that of colon cancers (36%).3 Lack of

awareness in

the public of the signs, symptoms, and risk factors for oral cancer,4 as well as

a

disappointing absence of prevention and early detection by health-care

providers,5

are both believed to be responsible for the diagnostic delay. It is strange to

think

that, at present, pelvic examination and Pap smears appear more acceptable than

looking in the mouth,6 for both patients and physicians. Current research mainly

focuses on therapies for advanced oral cancers. As a result we have been

spending

hundreds of millions of dollars in treating patients, two-thirds of whom will

die

within 3–5 years, consuming educational and scientific resources on procedures

burdened by high costs and poor results, or on expensive molecular studies that

are

not easy to reproduce or can be applied to a small percentage of patients only.7

It

is now time for a new deal.

Figure. Oral precancer and cancer

5-min clinical examination of oral mucosa with only lighting, gauze, and gloves

can

easily detect potentially malignant lesions (A=leukoplakia of floor of mouth;

B=leukoplakia of tongue). Identification should allow clinicians to detect early

intraepithelial stages of oral carcinogenesis, such as mild, moderate, and

severe

dysplasia, and carcinoma in situ, which generally precede development of

invasive

oral squamous-cell cancer and, if appropriately managed, are often characterised

by

good prognosis. Nevertheless, most oral cancers are currently diagnosed at late

stage (C=advanced cancer of tongue; D=advanced cancer of buccal mucosa), when

local

and lymphatic spread are already present, leading to a dramatically worse

prognosis

and increased treatment costs.

A first step has already been taken by WHO, which has recently issued a

commitment

to action against the neglected burden of oral cancer, mainly by strengthening

prevention.8 Nevertheless, so far, there has been no evidence to support the use

of

visual examination as a method of screening for oral cancer.9 Sankaranarayanan

and

colleagues' data should lead health organisations to change, at least in part,

their

policy, transferring resources from conventional fields to new methods of

preventive

intervention with greater effectiveness and lower cost. We have to remember that

screening for oral cancer is a simple non-invasive procedure, which needs only a

5-min visual inspection of the oral mucosa with lighting, gauze, and gloves,

whereas

the detection of most solid malignancies in their early asymptomatic stages

almost

always requires special, costly, and often invasive techniques. Visual screening

for

oral cancer is easy, effective, cheap, and saves lives.

Lancet 365 (9475) 4 Jun 2005-10, 1927-1933

Effect of screening on oral cancer mortality in Kerala, India: a

cluster-randomised

controlled trial,

Rengaswamy Sankaranarayanan, Kunnambath Ramadas, Gigi , Muwonge,

Somanathan Thara, Babu Mathew, Balakrishnan Rajan and for the Trivandrum Oral

Cancer

Screening Study Group

.... oral visual inspection by trained health workers at 3-year intervals and six

to

a control group during 1996–2004 ...screened at least once, 53 312 (55%) twice,

and

29 102 (30%) three times. Of the 5145 individuals who screened positive, 3218

(63%)

complied ... 205 oral cancer cases and 77 oral cancer deaths were recorded in

the

intervention group compared with 158 cases and 87 deaths in the control group

(mortality rate ratio 0·79 [95% CI 0·51–1·22]). 70 oral cancer deaths took place

in

users of tobacco or alcohol, or both, in the intervention group, compared with

85 in

controls (0·66 [0·45–0·95]). The mortality rate ratio was 0·57 (0·35–0·93) in

male

tobacco or alcohol users and 0·78 (0·43–1·42) in female users.

Table 5. Oral cancer incidence and mortality rates in all eligible individuals

and

eligible individuals with or without tobacco or alcohol drinking habits, or both

-----------------------------------

----Intervention group Control group Rate ratio (95% CI)

----------------------------------

Overall

Person-years of observation 469 089 419 748 ..

Number of oral cancer cases 205 158 ..

Incidence rate (per 100,000) 43·7 37·6 1·16 (0·70–1·92)

Number of deaths 77 87 ..

Mortality rate (per 100,000) 16·4 20·7 0·79 (0·51–1·22)

Tobacco or alcohol users, or both

Person-years of observation 234 405 187 281 ..

Number of oral cancer cases 190 156 ..

Incidence rate (per 100,000) 81·1 83·3 0·97 (0·66–1·44)

Number of deaths 70 85 ..

Mortality rate (per 100,000) 29·9 45·4 0·66 (0·45–0·95)

People with no habits

Person-years of observation 234 684 232 467 ..

Number of oral cancer cases 15 2 ..

Incidence rate (per 100,000) 6·4 0·9 7·43 (0·29–192·11)

Number of deaths 7 2 ..

Mortality rate (per 100,000) 3·0 0·9 3·47 (0·12–96·51)

Table 6. Oral cancer incidence and mortality rates in all eligible individuals

and

eligible individuals with or without tobacco or alcohol drinking habits, or

both,

stratified by sex

----Men Women

----Intervention Control Rate ratio (95% CI) Intervention Control Rate ratio

(95%

CI)

-----------------------------------

Overall

Person-years of observation 190 926 173 646 278 164 246 102

Number of oral cancer cases 107 104 98 54

Incidence rate (per 100,000) 56·0 59·9 0·94 (0·54–1·61) 35·2 21·9 1·61

(1·04–2·47)

Number of deaths 39 55 38 32

Mortality rate (per 100,000) 20·4 31·7 0·64 (0·38–1·09) 13·7 13·0 1·05

(0·59–1·86)

Tobacco or alcohol users, or both

Person-years of observation 150 702 128 102 83 703 59 179

Number of oral cancer cases 99 104 91 52

Incidence rate (per 100,000) 65·7 81·2 0·81 (0·48–1·35) 108·7 87·9 1·24

(0·83–1·86)

Number of deaths 37 55 33 30

Mortality rate (per 100,000) 24·6 42·9 0·57 (0·35–0·93) 39·4 50·7 0·78

(0·43–1·42)

People with no habits

Person-years of observation 40 223 45 544 194 461 186 923

Number of oral cancer cases 8 0 7 2

Incidence rate (per 100,000) 19·9 n/a n/a 3·6 1·1 3·36 (0·14–80·16)

Number of deaths 2 0 5 2

Mortality rate (per 100,000) 5·0 n/a n/a 2·6

Al Pater, PhD; email: old542000@...

__________________________________________________