- Email: [email protected]
Mass screening for colorectal cancer
Mass Screening for Colorectal Cancer
James B. Hastings, MD, FACS,* Princeton,
New Jersey
Mass screening has long been practiced for detecting common diseases such as tuberculosis and venereal disease. More recently, diabetes and uterine cancer have been attacked successfully this way. Each program has been made possible by the development of a simple, rapid, relatively accurate test to select from the general population those persons who would benefit from further diagnostic studies. After Greegor [I] presented results with multiple stool testing for occult blood, the Mercer County Medical Society’s Cancer Committee adapted the method to a mass screening program for colorectal cancer. Except for skin cancer, colorectal cancer is the most common single malignancy encountered in males and females alike. (Table I.) More than 47,000 people will die of the disease this year (1972), accounting for 13.6 per cent of all deaths from cancer, or 2.4 per cent of all deaths in the United States. Statistics on population and incidence can be broken down in a way that emphasizes the problem at a local level. (Table II.) Extrapolation from these figures shows that the normal annual rate of detection of colorectal cancer is 1 in every 2,700 people, or about 1 in every 900 persons over the age of forty. This would be the lowest detection rate expected of any good screening procedure. From the Mercer County Medical Society, New Jersey, and the Department of Surgery, Medical Center at Princeton, Princeton, New Jersey. This project was supported by grants from the New Jersey Division of the American Cancer Society and from Smith Kline Diagnostics. Reprint requests should be addressed to Dr Hastings, Princeton Medical Group, Medical Arts Building-Suite B, Witherspoon and Franklin Streets, Princeton, New Jersey 08540. Presented at the Fourteenth Annual Meeting of the Society for Surgery of the Alimentary Tract, New York, New York, May 22 and 23. 1973. * By invitation.
228
There has been a lack of improvement in the survival rate in colorectal cancer over the last thirty years. When detected at a noninvasive stage, as with uterine cancer, colorectal cancer should be surgically curable. The present high mortality must then be attributed to failure to improve the methods of early diagnosis. Although physicians now urge routine physical examination and proctosigmoidoscopy, not everyone undergoes the annual physical, and proctosigmoidoscopy is neither truly adaptable to mass screening nor as acceptable as the Pap test. Furthermore, sigmoidoscopy covers at best only 14 per cent of the surface of the colon, and supplemental routine barium enema or colonoscopy would be quite impractical. Greegor [I] studied patients with known asymptomatic colorectal cancer and found in all but one patient a common factor, the presence of blood in at least one of three stool specimens. He also noted the tendency of early tumors to bleed intermittently. He discovered, however, that repeated stool tests for occult blood in unprepared patients returned positive results in 23 per cent, although well over 50 per cent of these persons, after complete investigation, showed no colonic abnormality. He then developed a special test diet which decreased false-positive results to 1 per cent and yielded significant results in 4 per cent. The diet was free of meat, fish, and chicken to reduce falsepositive results and high in roughage and irritating foods to stimulate bleeding from existing lesions. Greegor used guaiac-impregnated filter-paper slides (Hemoccult@), which made preparation and handling of specimens by the patient and the laboratory personnel simple and aesthetically tolera-
The American
Journal of Surgery
Mass
TABLE
I
Leading Cancer Sites* Estimated New Cases (1972)
S!ie Skin Colon
and
rectum
Lung Breast Uterus Prostate Kidney-bladder Lymphomas Leukemia Stomach Oral Larynx * ‘72 Cancer
Facts
and
Figures
TABLE
II
Incidence
Screening
of Colorectal
5,000 47,000
76,000 71,000 43,000 36,000 32,000 26,000 19,000 17,000 15,000 7,000
69,000 32,000 12,000 18,000 16,000 20,000 15,000 15,000 7,500 3,000
[PI.
ble. Since this preparation is less sensitive than is either orthotolidine (Hemate@) or the standard bench guaiac test, a positive reading should be considered a significant discovery. Ostrow et al [5] studied healthy volunteers and found the test slide preparation would regularly give positive results with 25 cc of ingested blood and usually with as little as 10 cc; false-positive results were found to be far fewer with the slide preparation. (Table III.)
United States New Jersey Mercer County * United t Births TABLE
._____
Cancer
Cancer
Total 1970 Population*
Estimated New Cases of Colonic Cancer
Estimated Deaths from Col~nic Cancer
203,211.926 7,168,164 303,968
76,000 2,680 114
47,000 1,658 70
Estimated Deaths (1972)
118 (000 76,000
for Colorect,al
Total 1971 Deathst (all causes) 1,926,144 67,136 2.847
States Population [3]. and Deaths by States [d].
III
Sensitivity of Various Tests for Fecal Occult Blood*
..___~____.~
Minimum cubic centimeters of instilled blood uniformly detected Minimum milligrams of hemoglobin/gram stool usually detected Per cent of false-positive reactions, unrestricted diet Per cent of false-positive reactions, meatfree diet .-____-_-. * Ostrow JD et al [5].
Guaiac Test Slide
Bench Guaiac
Orthotolidine
25 cc
5 cc
15 cc
10 mg/gm
2 mglgm
2 mg/gm
1%
56%
32%
1%
32%
23%
Method The Cancer Committee with the cooperation of the local unit of the American Cancer Society organized fifteen test centers in Mercer County. An intensive campaign of public education and publicity preceded the event, and lay and professional volunteers were recruited to service the centers. Detailed registry forms (Figure l), information sheets, and instructions were drafted, revised, and printed. Supplies were ordered and distributed. Training sessions were held. On Cancer Detection Day, June 1, 1972, a free rectal examination and an on-the-spot stool guaiac test were offered. Each participant was given a kit containing dietary instructions and three guaiac test slides to be utilized on three sequential days and returned by mail. No age limit was set, but attention was directed to persons over forty.
Results In a single day 3,450 men and women registered for the test (over 1 per cent of the county popula2,933 were examined and tested (the retion), maining 517 simply took the test kit home), and 2,625 returned the test slides. Of these, 159 (6 per cent) showed a positive reaction for blood in at least one of’ three specimens and were referred to
Volume
127,
February
1974
their family physician. With completed follow-up reports in 121 persons (76 per cent) we know that only 51 have received a complete examination, including a physical examination, proctosigmoidoscopy, and barium enema. Among these 51, five persons who were asymptomatic were discovered to have cancer and treated; three were considered surgically cured. Since all these cases of cancer were in persons over forty years of age, we examined the same statistics, eliminating all persons under forty. Of the 2,272 persons over forty that registered (2.3 per cent of the population over forty), 2,045 were examined, 1,835 returned the test slides, and 114 of these (6.2 per cent) had positive re.actions for blood. With follow-up reports in 89 cases (78 per cent), we know that only 41 received a complete evaluation. This is a cancer yield of 1 in every 450 persons over forty, twice the yield that would normally have been anticipated. It is disturbing to speculate what t,he yield might have been if all 114 persons had undergone a complete investigation or if all 2,27:2 original registrants, had completed the slide test .
229
Hastings
Of the 2,933 people examined, 220 (7.5 per cent) had physical findings considered significant enough for referral for immediate follow-up examination, Many of these persons never returned the test slides. Although no attempt has been made to trace these persons, we know that several have undergone surgery for benign diseases such as polyps, hemorrhoids, and fissures. Of the same 2,933 people examined on June 1, 363 (12.4 per cent) had a guaiac-positive stool. Of the 363, 308 returned the test slides and only 34 (1.2 per cent) had positive confirmation. This would suggest that 89 per cent of the positive reactions for blood obtained on June 1 were “false.” We have tried to trace the 55 persons who did not return the test slides. Slides and instructions were again sent to them, and only an additional 31 persons have been heard from, 20 of whom returned the slides. Four additional positive reactions were found in this group, and reports have been received from all of them. No new cases of cancer were found. (Tables IV to VII and Figure 2.)
Case Reports
Case I. A fifty-three year old asymptomatic man (D-112) examined on June 1 was found to have external skin tags and a trace guaiac-positive stool. Two of three test slides were positive for blood. On August 1 sigmoidoscopy revealed a lesion 7 cm from the mucocutaneous anal margin. His general condition was unremarkable, and abdominoperineal resection was performed. The 3.5 cm primary tumor had penetrated muscle, but there were no nodal or distant metastases.
Case II. A sixty-five year old diabetic woman (P-58) examined on June 1 was found to have external skin tags and guaiac-negative stool. One of three test slides was positive for blood. Although she had checked our history form as negative, in retrospect she recalled having had vague left abdominal discomfort of five months’ duration, relieved by defecation. Hospital workup on July 5 showed no abnormalities except for a lesion of the descending colon demonstrated on barium enema. At operation she had an 8 by 6 cm tumor penetrating the pericolic fat. Resection and anastomosis were performed. Although there was no evidence of distant spread, histologic examination revealed tumor emboli in the regional nodes.
Case III. A forty-five year old man (H-312) who had had hemorrhoids with bleeding and had a family history of colonic cancer (mother) was examined on June 1 and found to have hemorrhoids and guaiac-positive stool. One of three test slides was positive for blood. Sigmoidoscopy on August 21 revealed a 1 cm sessile polyp at 12 cm. Subsequent barium enema showed nothing abnormal. Transsigmoidoscopic excision of the polyp was performed. Histologic examination revealed noninvasive cancer in the mucosa which did not invade the base of the polyp. He has subsequently undergone hemorrhoidectomy and has no evidence of residual tumor.
Case IV. A sixty-six year old man (P-608) who had undergone surgery for duodenal ulcer, had hemorrhoids with bleeding, and had a family history of cancer (mother) was examined on June 1 and noted to have external skin tags and guaiac-positive stool. All three test slides were positive for blood. He was examined by an internist on June 29 and studies including sigmoidoscopy were negative. Guaiac studies persisted positive and a barium enema was recommended. The patient deferred this study until the first follow-up letter was received at the end of September. On October 18, four and a half months after the test day, a barium study demonstrated a lesion of the sigmoid colon. He underwent resection of the sigmoid for a 3 cm tumor which only penetrated the submucosa. No distant metastases or positive nodes were found.
230
The American Journal of Surgery
Mass
TABLE
Results ._
IV
of Mass Screening
for Colorectal
Physical
Screening
Test Slides Guarac Test
Total
Return
Per cent of Return
Negative Positive Negative Positive
Negative Negative Positive Positive
2,175 395 280 83
1,748 321 236 72
80 81 84 87
86 14 23 11
2,933 517
2,377 248
81 48
3,450
2,625
76
Total
TABLE __~_
test
registered
Screening
V
Posrtrve Test Shdes
Per cent of Yield
Number wrth Cancer
4.9 4 ? 9 -7 15.3
1 0 3 0
134 25
5.6 10.1
4 1
159
6.1
5
for Colon and Rectal Cancer: Age and Sex Distribution Number Examined
Hemoccult: Follow-up Data
Positive
Follow-up Letters
Total Patients
Sex
Total
Exam
Guaiac
Returned
Positrve
Returned
Under 30 30-39
508
40-49
808
50-59
858
60-69
444
70 and over Not stated Total
162
M 202 F 306 M 321 F 298 M 406 F 406 M 389 F 469 M 199 F 245 M 76 F 86 M 18 F 29 M 1,611 F 1,839 3,450
162 202 267 225 366 345 348 422 182 235 72 75 15 17 1,412 1,521 2,933
8 15 24 23 40 66 65 77 41 62 37 17 2 1 217 261 478
16 26 35 20 64 29 56 44 20 23 13 11 1 0 205 153 358
121 I86 225 227 299 312 304 392 ‘164 :223 68 73 11 20 1,192 1,433 2,625
7 10 16 7 25 18 14 17 16 12 5 7 1 4 84 75 159
5 8 12 3 19 11 12 13 15 8 3 6 1 3 68 53 121
Age (yr)
Grand
619
47 3,450 total
Screening
TABLE VI
Cancer
Cancer
Examinatron
Total examined No exam-guaiac
for Colorectal
for Colon and Rectal Cancer: Follow-Up
Information
Cancer Found
1 1 1 1 1
3 2 5
from Patients and Physicians Physician Examinatron
Age (yr) Under 30 30-39
Total Patients 13 15
40-49
30
50-59
26
60-69
23 10
70 and over Not stated Total Grand
Volume
4 121 total
127, February
1974
Sex M F M F M F M F M F M F M F M F
5 8 12 3 19 11 12 14 15 8 4 6 1 3 68 53 121
No Medical Examination
... ... 1
... 1 1 1
... 2
...
Repeated Hemoccult Test Only
Alone
...
...
1 1
2 4 2
... ... 1 ... 1 1
... ,..
1 1
...
... . .
.. . ...
6 2 8
2 3 5
. .. 2 3 3 2 3
.. 1 ... ... 9 13 22
With Proctosigmoidoscopy
With Barium Enema
4 4 ... 1 1 1
... 1 2 1 2 1 1 3 3 2
.
...
2 4 1
...
.. ... ... 8 10 18
1
.. ... 8 9 17
With Proctosigmoidscopy and Barium Enema 3 3
. 12 2 7 6 6 2 3 3 1 3 35 16 51
Cancer Found
... ... . ... 1 . . 1
... 1 1 1
. . 3 2 5
231
Hastings
TABLE VII
Mass Screening
for Colorectal
OccultBlood
Location of Tumor
Case
Rectum Descending
I II III IV V
Cancer: Cancer Cases Detected
colon
Rectum Sigmoid colon Rectum
611
I
tr 0
+ 0
REGIONAL DISTANT
SILENT
2. Stages
of cancer
REVEALED
OTHER
detected.
0 0
0 0
+ +
0 0
+ +
0
0 + +
DETECTED P-608
P-479
: ; . ...
CANCER WITH
0 0
+ 0
”
NODES
=CASES
232
H-312
BY SLlOE
DIAGNOSTIC
ONLY
CLUES
Family History
0 0
+
METASTASIS 0
Figure
OF CANCERS
P-58
Pain
0 0
+ +
The three major difficulties encountered in any mass screening program are: (1) standardizing the methods used; (2) controlling the extent of followup evaluation; (3) obtaining accurate follow-up data. Despite careful instructions and simplified methods of recording (Figure l), there is no certainty, when almost one hundred physicians are involved, that notations on physical findings or interpretation of the on-the-spot guaiac test will be comparable. This is very strikingly evident from the results obtained from the four hospital laboratories which processed the returned slides in
Bleeding
+ 0
+
Comments
STAGES
0 +
III
+
Case V. A seventy-nine year old woman (P-479) who did not complete the registration questionnaire or undergo physical examination on June 1 had two of three test slides positive for blood. Examination by an internist demonstrated three additional random guaiac-negative stools, and neither sigmoidoscopy nor barium enema was carried out. Seven months later, on January 2, she was hospitalized because of obstipation and abdominal distention for three weeks. A rectal mass which could readily be felt with the examining finger proved to be cancerous. Because of many physical problems, including right hemiplegia, cardiac disease, hypertension, and chronic bronchitis, she was not judged a fit candidate for resection. She has received palliative radiotherapy and the obstruction has been relieved. She is currently in a nursing home for terminal care and has pain and bleeding. It should be noted that she had had a negative proctosigmoidoscopy at complete examination in October 1970, only twenty months before Cancer Detection Day.
D-112
II
Changein Bowel Habits
equal quantities. One laboratory reported 59 per cent of all the positive results whereas the other three laboratories shared equally the remaining 41 per cent. Even though three of the five cancerous lesions detected were among the returns from the first laboratory, a difference must be postulated in the sensitivity of interpreting the test slides. Although each person with a positive test result had been sent a letter suggesting a complete physical examination including a proctosigmoidoscopy and barium enema, we know of only fifty-one persons who received such a workup. (Table VI.) This represents less than a third of the total and is of special concern since no lesions were detected by simple rectal examination and two of the five were found only by barium enema. We are certain that among the remaining 108 persons in the group with positive results, there are more occult lesions to be found. Our follow-up data were obtained with great effort. Three sequential letters after the first notification were needed to accumulate even the present incomplete figures. Two cancerous lesions were reported within weeks of the initial report by direct communication with the committee. One case was reported as a result of the first follow-up letter and the patient had already been treated. The fourth case was discovered as a direct result of the first follow-up letter when the patient was finally stimulated to receive the previously recommended barium enema. The last case of cancer was not discovered until progressive symptoms lasting almost a month forced the patient to be hospitalized seven months after the test day. This last patient had followed instructions but simply had not received complete evaluation until too late. Although professional reaction to Pap test screening has been mixed, the colorectal cancer detection program brought many unsolicited favorable comments from physicians and laymen alike. Publicity associated with the project apparently reached a much wider audience than that suggested by the statistics. Area physicians report
The American Journal of Surgery
Mass
many of their patients are now requesting this examination. and many physicians have started using the screening protocol routinely. The only consistent criticism expressed was that the physical examination on Cancer Detection Day was believed superfluous. Although no malignant lesions were discovered by physical examination alone. it is apparent that physical contact was an important and effective part of the program. Of those examined, 81 per cent returned the test slides whereas less than 50 per cent of those not examined completed the test. Summary
An innovative screening program for the detection of colorectal cancer was conducted in a county of 300.000. In fifteen centers a free rectal examination was offered and each participant received a kit with dietary instructions and three stool guaiac test slides to be returned by mail. The project was based on a study suggesting that bleeding from early tumors can be effected by a high roughage, irritating diet. False-positive results are reduced by eliminating meat, fish, and chicken from the diet. In a single day 3,450 people registered for the test. Of these, 2,625 returned the test slides and 159 had a positive reaction for blood. Five persons were discovered to have cancer and treated; all had been asymptomatic at the time of the screening test. Three of these patients are now probably cured. As an effort in mass education, the project appeared highly successful and was well received. As an accurate method for screening, it cannot be determined whether significant disease was overlooked; however, despite its obvious defects the program detected twice the number of cancerous
Volume
127, February
1974
Screening
for
i‘olnrecial
Cancer
lesions expected. \Ve strongly urge’ thy use of sequential guaiac testing with diet ar>- preparation both as a mass screening effort and as a routine office procedure. It should be easl’ lo p:.ve each patient a packet of test slides with diet.ltr> instructions either at the time of the annual office visit or in advance of it. This will add another parameter to determining how extensively to pursue investigation of the gastrointestinal tract and may lead to the discovery of many unsuspected and hopefully curable cancerous lesions. Acknowlegment: I wish to thank Mre Martha Raer, American Cancer Society lay chairman of Cancer Detection Day, without whose tireless efforts this project could not have succeeded. I wish also to thank the hundreds of lay and professional volunteers from the Cancer Society, the Medical Society, the Auxiliaries, the community service organizations, and the community at large who participated. I am grateful to Drs +John H. Powers and James J. Chandler for their assistance and suggestions in preparing this report References
1.
Greegor DH: Occult blood testing for detection tomatic colon cancer. Cancer 28: 131, 1971. 2. Reference Chart: L.eadlng Cancer Sites, 1972. Facts & Figures. American Cancer Societv. pll. -
3. 4.
5.
of asymp‘72 Cancer Inc. 1970.
United States Population (Official Census). The 1973 World Almanac and Book of Facts, New York. Newspaper Enterprise Association. Inc. 1972. D 135. Biiths and Dkaths by States. The 1973 \Rforld Almanac and Book of Facts, New York. Newspaiper Enterprise Association, Inc, 1972, p 952. Ostrow JD. Mulvanev CA. Hansell JR. Rhodes RS: Sensitivity and reprodudibility of chemical test’s for fecal occult blood, with an emphasis on false-positive reactions. Presented In part at the Annual Meeting of the American College of Physicians, Atlantic City. New Jersey. April 19. 1972. To be published.
233
James B. Hastings, MD, FACS,* Princeton,
New Jersey
Mass screening has long been practiced for detecting common diseases such as tuberculosis and venereal disease. More recently, diabetes and uterine cancer have been attacked successfully this way. Each program has been made possible by the development of a simple, rapid, relatively accurate test to select from the general population those persons who would benefit from further diagnostic studies. After Greegor [I] presented results with multiple stool testing for occult blood, the Mercer County Medical Society’s Cancer Committee adapted the method to a mass screening program for colorectal cancer. Except for skin cancer, colorectal cancer is the most common single malignancy encountered in males and females alike. (Table I.) More than 47,000 people will die of the disease this year (1972), accounting for 13.6 per cent of all deaths from cancer, or 2.4 per cent of all deaths in the United States. Statistics on population and incidence can be broken down in a way that emphasizes the problem at a local level. (Table II.) Extrapolation from these figures shows that the normal annual rate of detection of colorectal cancer is 1 in every 2,700 people, or about 1 in every 900 persons over the age of forty. This would be the lowest detection rate expected of any good screening procedure. From the Mercer County Medical Society, New Jersey, and the Department of Surgery, Medical Center at Princeton, Princeton, New Jersey. This project was supported by grants from the New Jersey Division of the American Cancer Society and from Smith Kline Diagnostics. Reprint requests should be addressed to Dr Hastings, Princeton Medical Group, Medical Arts Building-Suite B, Witherspoon and Franklin Streets, Princeton, New Jersey 08540. Presented at the Fourteenth Annual Meeting of the Society for Surgery of the Alimentary Tract, New York, New York, May 22 and 23. 1973. * By invitation.
228
There has been a lack of improvement in the survival rate in colorectal cancer over the last thirty years. When detected at a noninvasive stage, as with uterine cancer, colorectal cancer should be surgically curable. The present high mortality must then be attributed to failure to improve the methods of early diagnosis. Although physicians now urge routine physical examination and proctosigmoidoscopy, not everyone undergoes the annual physical, and proctosigmoidoscopy is neither truly adaptable to mass screening nor as acceptable as the Pap test. Furthermore, sigmoidoscopy covers at best only 14 per cent of the surface of the colon, and supplemental routine barium enema or colonoscopy would be quite impractical. Greegor [I] studied patients with known asymptomatic colorectal cancer and found in all but one patient a common factor, the presence of blood in at least one of three stool specimens. He also noted the tendency of early tumors to bleed intermittently. He discovered, however, that repeated stool tests for occult blood in unprepared patients returned positive results in 23 per cent, although well over 50 per cent of these persons, after complete investigation, showed no colonic abnormality. He then developed a special test diet which decreased false-positive results to 1 per cent and yielded significant results in 4 per cent. The diet was free of meat, fish, and chicken to reduce falsepositive results and high in roughage and irritating foods to stimulate bleeding from existing lesions. Greegor used guaiac-impregnated filter-paper slides (Hemoccult@), which made preparation and handling of specimens by the patient and the laboratory personnel simple and aesthetically tolera-
The American
Journal of Surgery
Mass
TABLE
I
Leading Cancer Sites* Estimated New Cases (1972)
S!ie Skin Colon
and
rectum
Lung Breast Uterus Prostate Kidney-bladder Lymphomas Leukemia Stomach Oral Larynx * ‘72 Cancer
Facts
and
Figures
TABLE
II
Incidence
Screening
of Colorectal
5,000 47,000
76,000 71,000 43,000 36,000 32,000 26,000 19,000 17,000 15,000 7,000
69,000 32,000 12,000 18,000 16,000 20,000 15,000 15,000 7,500 3,000
[PI.
ble. Since this preparation is less sensitive than is either orthotolidine (Hemate@) or the standard bench guaiac test, a positive reading should be considered a significant discovery. Ostrow et al [5] studied healthy volunteers and found the test slide preparation would regularly give positive results with 25 cc of ingested blood and usually with as little as 10 cc; false-positive results were found to be far fewer with the slide preparation. (Table III.)
United States New Jersey Mercer County * United t Births TABLE
._____
Cancer
Cancer
Total 1970 Population*
Estimated New Cases of Colonic Cancer
Estimated Deaths from Col~nic Cancer
203,211.926 7,168,164 303,968
76,000 2,680 114
47,000 1,658 70
Estimated Deaths (1972)
118 (000 76,000
for Colorect,al
Total 1971 Deathst (all causes) 1,926,144 67,136 2.847
States Population [3]. and Deaths by States [d].
III
Sensitivity of Various Tests for Fecal Occult Blood*
..___~____.~
Minimum cubic centimeters of instilled blood uniformly detected Minimum milligrams of hemoglobin/gram stool usually detected Per cent of false-positive reactions, unrestricted diet Per cent of false-positive reactions, meatfree diet .-____-_-. * Ostrow JD et al [5].
Guaiac Test Slide
Bench Guaiac
Orthotolidine
25 cc
5 cc
15 cc
10 mg/gm
2 mglgm
2 mg/gm
1%
56%
32%
1%
32%
23%
Method The Cancer Committee with the cooperation of the local unit of the American Cancer Society organized fifteen test centers in Mercer County. An intensive campaign of public education and publicity preceded the event, and lay and professional volunteers were recruited to service the centers. Detailed registry forms (Figure l), information sheets, and instructions were drafted, revised, and printed. Supplies were ordered and distributed. Training sessions were held. On Cancer Detection Day, June 1, 1972, a free rectal examination and an on-the-spot stool guaiac test were offered. Each participant was given a kit containing dietary instructions and three guaiac test slides to be utilized on three sequential days and returned by mail. No age limit was set, but attention was directed to persons over forty.
Results In a single day 3,450 men and women registered for the test (over 1 per cent of the county popula2,933 were examined and tested (the retion), maining 517 simply took the test kit home), and 2,625 returned the test slides. Of these, 159 (6 per cent) showed a positive reaction for blood in at least one of’ three specimens and were referred to
Volume
127,
February
1974
their family physician. With completed follow-up reports in 121 persons (76 per cent) we know that only 51 have received a complete examination, including a physical examination, proctosigmoidoscopy, and barium enema. Among these 51, five persons who were asymptomatic were discovered to have cancer and treated; three were considered surgically cured. Since all these cases of cancer were in persons over forty years of age, we examined the same statistics, eliminating all persons under forty. Of the 2,272 persons over forty that registered (2.3 per cent of the population over forty), 2,045 were examined, 1,835 returned the test slides, and 114 of these (6.2 per cent) had positive re.actions for blood. With follow-up reports in 89 cases (78 per cent), we know that only 41 received a complete evaluation. This is a cancer yield of 1 in every 450 persons over forty, twice the yield that would normally have been anticipated. It is disturbing to speculate what t,he yield might have been if all 114 persons had undergone a complete investigation or if all 2,27:2 original registrants, had completed the slide test .
229
Hastings
Of the 2,933 people examined, 220 (7.5 per cent) had physical findings considered significant enough for referral for immediate follow-up examination, Many of these persons never returned the test slides. Although no attempt has been made to trace these persons, we know that several have undergone surgery for benign diseases such as polyps, hemorrhoids, and fissures. Of the same 2,933 people examined on June 1, 363 (12.4 per cent) had a guaiac-positive stool. Of the 363, 308 returned the test slides and only 34 (1.2 per cent) had positive confirmation. This would suggest that 89 per cent of the positive reactions for blood obtained on June 1 were “false.” We have tried to trace the 55 persons who did not return the test slides. Slides and instructions were again sent to them, and only an additional 31 persons have been heard from, 20 of whom returned the slides. Four additional positive reactions were found in this group, and reports have been received from all of them. No new cases of cancer were found. (Tables IV to VII and Figure 2.)
Case Reports
Case I. A fifty-three year old asymptomatic man (D-112) examined on June 1 was found to have external skin tags and a trace guaiac-positive stool. Two of three test slides were positive for blood. On August 1 sigmoidoscopy revealed a lesion 7 cm from the mucocutaneous anal margin. His general condition was unremarkable, and abdominoperineal resection was performed. The 3.5 cm primary tumor had penetrated muscle, but there were no nodal or distant metastases.
Case II. A sixty-five year old diabetic woman (P-58) examined on June 1 was found to have external skin tags and guaiac-negative stool. One of three test slides was positive for blood. Although she had checked our history form as negative, in retrospect she recalled having had vague left abdominal discomfort of five months’ duration, relieved by defecation. Hospital workup on July 5 showed no abnormalities except for a lesion of the descending colon demonstrated on barium enema. At operation she had an 8 by 6 cm tumor penetrating the pericolic fat. Resection and anastomosis were performed. Although there was no evidence of distant spread, histologic examination revealed tumor emboli in the regional nodes.
Case III. A forty-five year old man (H-312) who had had hemorrhoids with bleeding and had a family history of colonic cancer (mother) was examined on June 1 and found to have hemorrhoids and guaiac-positive stool. One of three test slides was positive for blood. Sigmoidoscopy on August 21 revealed a 1 cm sessile polyp at 12 cm. Subsequent barium enema showed nothing abnormal. Transsigmoidoscopic excision of the polyp was performed. Histologic examination revealed noninvasive cancer in the mucosa which did not invade the base of the polyp. He has subsequently undergone hemorrhoidectomy and has no evidence of residual tumor.
Case IV. A sixty-six year old man (P-608) who had undergone surgery for duodenal ulcer, had hemorrhoids with bleeding, and had a family history of cancer (mother) was examined on June 1 and noted to have external skin tags and guaiac-positive stool. All three test slides were positive for blood. He was examined by an internist on June 29 and studies including sigmoidoscopy were negative. Guaiac studies persisted positive and a barium enema was recommended. The patient deferred this study until the first follow-up letter was received at the end of September. On October 18, four and a half months after the test day, a barium study demonstrated a lesion of the sigmoid colon. He underwent resection of the sigmoid for a 3 cm tumor which only penetrated the submucosa. No distant metastases or positive nodes were found.
230
The American Journal of Surgery
Mass
TABLE
Results ._
IV
of Mass Screening
for Colorectal
Physical
Screening
Test Slides Guarac Test
Total
Return
Per cent of Return
Negative Positive Negative Positive
Negative Negative Positive Positive
2,175 395 280 83
1,748 321 236 72
80 81 84 87
86 14 23 11
2,933 517
2,377 248
81 48
3,450
2,625
76
Total
TABLE __~_
test
registered
Screening
V
Posrtrve Test Shdes
Per cent of Yield
Number wrth Cancer
4.9 4 ? 9 -7 15.3
1 0 3 0
134 25
5.6 10.1
4 1
159
6.1
5
for Colon and Rectal Cancer: Age and Sex Distribution Number Examined
Hemoccult: Follow-up Data
Positive
Follow-up Letters
Total Patients
Sex
Total
Exam
Guaiac
Returned
Positrve
Returned
Under 30 30-39
508
40-49
808
50-59
858
60-69
444
70 and over Not stated Total
162
M 202 F 306 M 321 F 298 M 406 F 406 M 389 F 469 M 199 F 245 M 76 F 86 M 18 F 29 M 1,611 F 1,839 3,450
162 202 267 225 366 345 348 422 182 235 72 75 15 17 1,412 1,521 2,933
8 15 24 23 40 66 65 77 41 62 37 17 2 1 217 261 478
16 26 35 20 64 29 56 44 20 23 13 11 1 0 205 153 358
121 I86 225 227 299 312 304 392 ‘164 :223 68 73 11 20 1,192 1,433 2,625
7 10 16 7 25 18 14 17 16 12 5 7 1 4 84 75 159
5 8 12 3 19 11 12 13 15 8 3 6 1 3 68 53 121
Age (yr)
Grand
619
47 3,450 total
Screening
TABLE VI
Cancer
Cancer
Examinatron
Total examined No exam-guaiac
for Colorectal
for Colon and Rectal Cancer: Follow-Up
Information
Cancer Found
1 1 1 1 1
3 2 5
from Patients and Physicians Physician Examinatron
Age (yr) Under 30 30-39
Total Patients 13 15
40-49
30
50-59
26
60-69
23 10
70 and over Not stated Total Grand
Volume
4 121 total
127, February
1974
Sex M F M F M F M F M F M F M F M F
5 8 12 3 19 11 12 14 15 8 4 6 1 3 68 53 121
No Medical Examination
... ... 1
... 1 1 1
... 2
...
Repeated Hemoccult Test Only
Alone
...
...
1 1
2 4 2
... ... 1 ... 1 1
... ,..
1 1
...
... . .
.. . ...
6 2 8
2 3 5
. .. 2 3 3 2 3
.. 1 ... ... 9 13 22
With Proctosigmoidoscopy
With Barium Enema
4 4 ... 1 1 1
... 1 2 1 2 1 1 3 3 2
.
...
2 4 1
...
.. ... ... 8 10 18
1
.. ... 8 9 17
With Proctosigmoidscopy and Barium Enema 3 3
. 12 2 7 6 6 2 3 3 1 3 35 16 51
Cancer Found
... ... . ... 1 . . 1
... 1 1 1
. . 3 2 5
231
Hastings
TABLE VII
Mass Screening
for Colorectal
OccultBlood
Location of Tumor
Case
Rectum Descending
I II III IV V
Cancer: Cancer Cases Detected
colon
Rectum Sigmoid colon Rectum
611
I
tr 0
+ 0
REGIONAL DISTANT
SILENT
2. Stages
of cancer
REVEALED
OTHER
detected.
0 0
0 0
+ +
0 0
+ +
0
0 + +
DETECTED P-608
P-479
: ; . ...
CANCER WITH
0 0
+ 0
”
NODES
=CASES
232
H-312
BY SLlOE
DIAGNOSTIC
ONLY
CLUES
Family History
0 0
+
METASTASIS 0
Figure
OF CANCERS
P-58
Pain
0 0
+ +
The three major difficulties encountered in any mass screening program are: (1) standardizing the methods used; (2) controlling the extent of followup evaluation; (3) obtaining accurate follow-up data. Despite careful instructions and simplified methods of recording (Figure l), there is no certainty, when almost one hundred physicians are involved, that notations on physical findings or interpretation of the on-the-spot guaiac test will be comparable. This is very strikingly evident from the results obtained from the four hospital laboratories which processed the returned slides in
Bleeding
+ 0
+
Comments
STAGES
0 +
III
+
Case V. A seventy-nine year old woman (P-479) who did not complete the registration questionnaire or undergo physical examination on June 1 had two of three test slides positive for blood. Examination by an internist demonstrated three additional random guaiac-negative stools, and neither sigmoidoscopy nor barium enema was carried out. Seven months later, on January 2, she was hospitalized because of obstipation and abdominal distention for three weeks. A rectal mass which could readily be felt with the examining finger proved to be cancerous. Because of many physical problems, including right hemiplegia, cardiac disease, hypertension, and chronic bronchitis, she was not judged a fit candidate for resection. She has received palliative radiotherapy and the obstruction has been relieved. She is currently in a nursing home for terminal care and has pain and bleeding. It should be noted that she had had a negative proctosigmoidoscopy at complete examination in October 1970, only twenty months before Cancer Detection Day.
D-112
II
Changein Bowel Habits
equal quantities. One laboratory reported 59 per cent of all the positive results whereas the other three laboratories shared equally the remaining 41 per cent. Even though three of the five cancerous lesions detected were among the returns from the first laboratory, a difference must be postulated in the sensitivity of interpreting the test slides. Although each person with a positive test result had been sent a letter suggesting a complete physical examination including a proctosigmoidoscopy and barium enema, we know of only fifty-one persons who received such a workup. (Table VI.) This represents less than a third of the total and is of special concern since no lesions were detected by simple rectal examination and two of the five were found only by barium enema. We are certain that among the remaining 108 persons in the group with positive results, there are more occult lesions to be found. Our follow-up data were obtained with great effort. Three sequential letters after the first notification were needed to accumulate even the present incomplete figures. Two cancerous lesions were reported within weeks of the initial report by direct communication with the committee. One case was reported as a result of the first follow-up letter and the patient had already been treated. The fourth case was discovered as a direct result of the first follow-up letter when the patient was finally stimulated to receive the previously recommended barium enema. The last case of cancer was not discovered until progressive symptoms lasting almost a month forced the patient to be hospitalized seven months after the test day. This last patient had followed instructions but simply had not received complete evaluation until too late. Although professional reaction to Pap test screening has been mixed, the colorectal cancer detection program brought many unsolicited favorable comments from physicians and laymen alike. Publicity associated with the project apparently reached a much wider audience than that suggested by the statistics. Area physicians report
The American Journal of Surgery
Mass
many of their patients are now requesting this examination. and many physicians have started using the screening protocol routinely. The only consistent criticism expressed was that the physical examination on Cancer Detection Day was believed superfluous. Although no malignant lesions were discovered by physical examination alone. it is apparent that physical contact was an important and effective part of the program. Of those examined, 81 per cent returned the test slides whereas less than 50 per cent of those not examined completed the test. Summary
An innovative screening program for the detection of colorectal cancer was conducted in a county of 300.000. In fifteen centers a free rectal examination was offered and each participant received a kit with dietary instructions and three stool guaiac test slides to be returned by mail. The project was based on a study suggesting that bleeding from early tumors can be effected by a high roughage, irritating diet. False-positive results are reduced by eliminating meat, fish, and chicken from the diet. In a single day 3,450 people registered for the test. Of these, 2,625 returned the test slides and 159 had a positive reaction for blood. Five persons were discovered to have cancer and treated; all had been asymptomatic at the time of the screening test. Three of these patients are now probably cured. As an effort in mass education, the project appeared highly successful and was well received. As an accurate method for screening, it cannot be determined whether significant disease was overlooked; however, despite its obvious defects the program detected twice the number of cancerous
Volume
127, February
1974
Screening
for
i‘olnrecial
Cancer
lesions expected. \Ve strongly urge’ thy use of sequential guaiac testing with diet ar>- preparation both as a mass screening effort and as a routine office procedure. It should be easl’ lo p:.ve each patient a packet of test slides with diet.ltr> instructions either at the time of the annual office visit or in advance of it. This will add another parameter to determining how extensively to pursue investigation of the gastrointestinal tract and may lead to the discovery of many unsuspected and hopefully curable cancerous lesions. Acknowlegment: I wish to thank Mre Martha Raer, American Cancer Society lay chairman of Cancer Detection Day, without whose tireless efforts this project could not have succeeded. I wish also to thank the hundreds of lay and professional volunteers from the Cancer Society, the Medical Society, the Auxiliaries, the community service organizations, and the community at large who participated. I am grateful to Drs +John H. Powers and James J. Chandler for their assistance and suggestions in preparing this report References
1.
Greegor DH: Occult blood testing for detection tomatic colon cancer. Cancer 28: 131, 1971. 2. Reference Chart: L.eadlng Cancer Sites, 1972. Facts & Figures. American Cancer Societv. pll. -
3. 4.
5.
of asymp‘72 Cancer Inc. 1970.
United States Population (Official Census). The 1973 World Almanac and Book of Facts, New York. Newspaper Enterprise Association. Inc. 1972. D 135. Biiths and Dkaths by States. The 1973 \Rforld Almanac and Book of Facts, New York. Newspaiper Enterprise Association, Inc, 1972, p 952. Ostrow JD. Mulvanev CA. Hansell JR. Rhodes RS: Sensitivity and reprodudibility of chemical test’s for fecal occult blood, with an emphasis on false-positive reactions. Presented In part at the Annual Meeting of the American College of Physicians, Atlantic City. New Jersey. April 19. 1972. To be published.
233