Colorectal Cancer Prevalence and Survival in Castilla La Mancha (Spain). A Pilot Study

doi:10.21203/rs.3.rs-926142/v1

Background: Colorectal cancer is the most commonly diagnosed cancer type and the second cause of cancer death in Spain. The primary risk factor for colorectal cancer is age, with 90% of all diagnosed patients aged over 50 years. Prognosis mainly depends on tumour stage.

Aim: Conduct a pilot Colorectal Cancer prevalence and survival study in Cuenca (Spain) since there are almost no studies based on small populations. This is the first pilot study about survival in screening of colorectal cancer carried out in hospitals in Castilla La Mancha.

Methods and Results: Retrospective descriptive cohort study was performed to include patients with colorectal cancer diagnosed by colonoscopy between May 2015 and April 2016, and who were followed up for 48 months. The study considered sociodemographic and clinical data of the patients. Survival curves were estimated using the Kaplan-Meier method. The proportional hazard rate associated with age, gender, stage and presence of metastasis was calculated using the Cox regression method. 57 patients were included in the study. The mean follow-up was 45.5 months. Ten patients died during the study, in seven cases the cause was colorectal cancer. The percentage of patients alive at 48-month follow-up were 82.4%.

Conclusion: Colon cancer is a high-prevalence pathology, with adenocarcinoma being the most common histology. The results seem to indicate that it affects men more frequently, mortality rises with tumour stage at diagnosis and declines with use of chemotherapy. We present a pilot study that could justify large-scale epidemiological studies for the regional surveillance and evolution of colorectal cancer in Spain.

Gastrointestinal Surgery

Gastroenterology & Hepatology

colorectal cancer

screening

survival

stage

chemoterapy

Cancer continues to be one of the primary causes of morbidity and mortality in the world. ^[1]

World data shows that the incidence of cancer has increased from 14 million cases in 2012 to 18.1 million in 2018. Population estimates suggest that the number of new cases will increase over the next two decades, reaching 29.5 million in 2040.^[2]It is important to note that in Spain over the last 20 years the number of tumours have grown due to an increase in population, early detection programmes and the rise in life expectancy (given that ageing is a fundamental risk factor for the development of tumours).^[2.3] This increased incidence has been detected across the world, being especially associated with ageing population in all countries, including Spain.^[1]

Globally, colorectal cancer (CRC) ranks third behind breast and lung cancer in the number of new cases (10.2% of all neoplasms),^[1] with an incidence of 9.7% and a prevalence of 10.9%,^[4] being the cancer of the digestive tract more frequent in most countries of the world.^[5]

In Spain, colorectal cancer is the most commonly diagnosed cancer (14% of total cancer diagnoses – 37,172 cases detected in 2018), followed by prostate (12%), lung (12%) and breast cancer (10%). CRC is considered to be the seventh global cause of death in Spain. The Autonomous Communities with the highest mortality rate are Asturias and the Basque Country; at the opposite extreme are Ceuta, Melilla and Castilla-La Mancha.^[6.7]With regard to mortality associated with neoplastic pathology, both in Spain and in the world, colorectal cancer ranks second after lung cancer in both genders. Favourable CRC trends have been reported as a result of improved treatment and screening programmes.^[3,8]

Castilla La Mancha is a region in central Spain with a population of approximately 2 million inhabitants. In 2018, 600 new CRC cases were diagnosed in Castilla-La Mancha, accounting for 4.19% of the total cases in Spain, with 145 deaths recorded from this cause (3.74% of the national total).^[9]

Cuenca is a small Castilla La Mancha province of 197,222 inhabitants, of which 41,780 are between 50 and 70 years old. It is made up of 238 townships distributed in 17.141km² with a single referral hospital (Virgen de la Luz Hospital) that covers medical care for almost the entire province, so the vast majority of colorectal cancer cases are diagnosed there. In 2019, according to statistical data, the CRC incidence rate in Cuenca for persons aged 45 to 70 was 69 new cases per 100,000 inhabitants, with a mortality rate of 17 per 100,000 inhabitants.^[10]

The leading risk factor for CRC is age, with 90% of cases diagnosed in persons aged over 50. Hence, population over this age is considered of intermediate risk, even when presenting no symptoms, and that is the reason why most guides consider 45-50 years as the ideal age to start screening programs.^[11-14]

Other risk factors associated with colorectal cancer are the intake of processed meats, the consumption of alcohol and sugar, the lack of physical activity, obesity and tobacco.^[1,5,15]

The characteristics of colorectal cancer mean that population screening programmes have managed to reduce incidence and mortality. As such programmes are based on secondary prevention, that is, early diagnosis of disease before symptoms appear, early treatment is enabled and hence the number of cured cases has increased. Multiple studies have shown that any colorectal cancer screening strategy is cost-effective compared to not screening.^[16-19]

Screening is by biannual immunological testing for faecal occult blood in stool of the intermediate-risk population (people aged over 50 with no other risk factors). If the test is positive, a colonoscopy is performed.^[20-22]

In Spain, the population-based colorectal cancer screening program was implemented in Catalonia Region in 2000. In Castilla La Mancha, it began in April 2015 as a pilot program in three hospitals, one of which was the Virgen de la Luz Hospital in Cuenca. This program, that continuous in progress, is done to women and men between the ages of 50 and 69, who have no previous colorectal pathology and do not have had a colonoscopy in the last 5 years. Modifiable CRC risk factors include overweight and obesity, smoking, excessive alcohol consumption, low physical activity and certain types of food, such as processed meat.^[9,23]

The main prognostic factor is tumour stage at diagnosis, with a 5-year survival rate of 74% for stage I, which declines to 5.7% for stage IV. Hence, early detection is of vital importance.^[4]

The cornerstone of CRC is surgery, although adjuvant chemotherapy has been shown to increase general survival and disease-free time in selected populations.^[24,25] The evolution of treatments in recent decades and the progressive implementation of CRC population screening programmes have led to improved long-term survival rates, despite which CRC continues to be one of the leading causes of death in Europe and the United States.^[26-30] High-risk adenomas have been found to be associated with a higher risk of CRC and related death in comparison to low-risk adenomas,^[31] which underlines the importance of implementing screening programmes and subsequent surveillance.

The purpose of the pilot study is to present the behavior of colon cancer in a small population (Cuenca), with a single reference hospital, and a supposed low prevalence and mortality from colorectal cancer and assess whether colorectal cancer behaves differently in small populations from that observed in large cities, since there are few studies based on cities with small populations. Hospital of Cuenca was the hospital used in the Program Population Screening Pilot for Colorectal Cancer in Castilla La-Mancha.

This pilot study can serve as a guide to carry out others at the regional or state level.

The study aims were to carry out a descriptive study of colorectal cancer in Cuenca (Spain) which estimate 48 moths’ survival after diagnosis of colorectal cancer (period between the start of the CRC population screening programme and the pilot study), study the deaths due to colorectal cancer produced during the period of study and if there was a relationship with sex, age, tumor stage at diagnosis.

2.1. Source of Data and Materials

A descriptive and observational retrospective cohort study was conducted in the Department of Digestive Medicine at the Virgen de la Luz Hospital in Cuenca (Castilla-La Mancha, Spain).

We reviewed the medical records of 2,707 patients who had undergone a colonoscopy between 1 May 2015 and 1 May 2016. The inclusion criteria were having been diagnosed with colorectal cancer by colonoscopy and being aged from 45 to 70 years at the time of the procedure. The patients were divided into 4 groups according to the reason for colonoscopy:

Group 1: patients in the CRC population screening programme

Group 2: patients whose colonoscopy was performed for reasons of familial colorectal cancer

Group 3: patients whose colonoscopy was performed due to clinical signs of alarm

Group 4: patients whose colonoscopy was performed due to history of polyps or colonic neoplasia.

Patients were followed up for 48 months from the time of diagnosis. Patients’ data were obtained from the information and clinical history using Mambrino XXI (Data Base from Hospital archive of clinical documentation records) creating a definitive list of patients with colorectal cancer. For each case, we reviewed sociodemographic data (age at diagnosis, gender), clinical data (symptoms at diagnosis), results of diagnostic tests and treatment received. Overall survival was considered as the time from diagnosis until death from any cause. To avoid a competing risk bias, all causes of death other than CRC were excluded. Similarly, to avoid initial diagnosis bias, given that the study takes histological results into account, we only included lesions that endoscopically presented an image compatible with neoplasm, thus avoiding the initial number of cases being different to that after the histological results.

2.3. Data analysis

A descriptive analysis of the data collected at the time of diagnosis and at 48-month follow-up was conducted, calculating the means and confidence intervals. The data analysed were age at diagnosis, age at death, follow-up time, reason for referral, location of lesion, tumour stage at diagnosis and treatment received.

As sample size was small, we performed the Shapiro-Wilk test to determine whether the quantitative variables (age, stage at diagnosis) follow-up time met the criteria of normality. As normality of variables was not demonstrated, we used the Kruskal-Wallis test for K samples and Pearson’s chi-squared test to identify significant differences in tumour stage at diagnosis between the different groups or depending on location, gender or age.

For the survival analysis, we used the Kaplan-Meier test, comparing the differences in the survival curve with the log-rank test and the actuarial method. In addition, Cox regression analysis was conducted to assess the proportional hazard rates related to age, tumour location, stage at diagnosis and treatment received. A p-value of <0.05 was considered statistically significant.

The results were analysed using SPSS^® version 22 (SPSS Inc., Chicago, Illinois, US.).

Of the initial 2,707 patients, 50.8% were men and 49.2% were women, 80 patients were diagnosed with CRC, which corresponds to a prevalence of 2.9%. Of these patients, 57 met the inclusion criteria (aged 45 to 70 years and CRC diagnosed by colonoscopy) and participated in the study. Of these, 61.4% were men (35) and 38.6% were women (22). Mean age for the overall sample at diagnosis was 61.43 years, 61.52 years in the men (CI 95%:59.09 - 63.95) and 57.69 years in the women (CI 95%: 54.07 – 61.32). The distribution by age groups and sex is shown in Figure 1.

As regards the reasons for undergoing colonoscopy, 35 patients corresponded to Group 1 (61.4%), 3 to Group 2 (5.3%), 14 to Group 3 (24.6%) and 5 to Group 4 (8.8%). At 48-month follow up, 82.4% of patients were alive, with a mean survival time of 45.5 months. Anatomic pathology revealed 98.27% of the tumours were of adenocarcinomas, while one case presented histology compatible with lymphoma. As regards tumour location, 45.6% (26) were located in the rectum, 33.3% (19) in the left colon and 21.1% (12) in the right colon. No lesions were located in the transverse colon.

With regard to clinical variables, at diagnosis of CRC, early-stage tumours were more common than advanced-stage ones. The most frequently found stage was 0 (28.6%), followed by stages I and II (21.4 and 25%, respectively), stage III (17.9%) and stage IV (7.1%).

Table 1 shows the sociodemographic, histopathological and clinical characteristics of the sample.

Table 1. Sociodemographic, histopathological and clinical characteristics

Characteristics

Right Colon

12

n(%)

Left Colon

19

n(%)

Rectum

26

n(%)

Total

57

n(%)

Age (till year complete)

45-50 years

51-55 years

56-60 years

61-65 years

66-70 years

3 (25)

1 (8.3)

4 (33.3)

3 (25)

3 (15.8)

4 (21.1)

1 (5.2)

4 (21.1)

7 (36.8)

2 (7.7)

7 (26.9)

5 (19.2)

6 (23.1)

8 (14)

12 (21)

7 (12.3)

14 (24.6)

16 (28.1)

Gender

Female

Male

5 (41.7)

7 (58.3)

7 (36.8)

12 (63.2)

10 (38.5)

16 (61.5)

22 (38.6)

35 (61.4)

Histological Type

Adenocarcinoma

Other

11 (91.7)

1 (8.3)

19 (100)

0

26 (100)

0

56 (98.2)

1 (1.8)

Stage

Stage 0

Stage I

Stage II

Stage III

Stage IV

1 (8.3)

4 (33.3)

5 (41.7)

0 (0)

2 (16.7)

7 (36.8)

4 (21.1)

3 (15.8)

1 (5.2)

8 (30.8)

4 (15.4)

6 (23.1)

7 (26.9)

1 (3.8)

16 (28.1)

12 (21)

15 (26.3)

10 (17.6)

4 (7)

Location of metastasis

Liver

Lung

Peritoneum

Other

2 (16.7)

0 (0)

1 (5.2)

0 (0)

1 (3.8)

0 (0)

4 (7)

1 (1.8)

0 (0)

We compared the stage at diagnosis across the groups, finding that stage 0 tumours were the most common in Group 1, stage II in Groups 2 and 3 and stage I in group 4. The differences were not statistically significant (p=0.633). No statistically significant differences were found in tumour stage by gender or age (p=0.895 and p=0.382, respectively). Analysis of the difference between the location of the neoplasm and its stage revealed that the most common stage in the right colon was stage II, while in the left colon and rectum the most frequent stage was 0, with these differences being statistically non-significant (p=0.250). (Table 2)

Table 2. Characteristics of Colorectal Cancer Patients classified by Stage.

Stage 0

n(%)

Stage I

n(%)

Stage II

n(%)

Stage III

n(%)

Stage IV

n(%)

Group

1

2

3

4

12(75)

2(13)

1(6)

7(50)

4(30)

0

2(2)

8(60)

4(30)

2(10)

0

6(60)

3(30)

0

1(10)

2(50)

1(25)

0

1(25)

Gender

Male

Female

10(60)

6(40)

8(60)

5(40)

9(60)

5(40)

5(50)

3(75)

1(25)

Mean Age

(years)

60.73

61.20

62.08

59.23

58.83

Location

Right colon

Left colon

Rectum

1(6)

7(44)

8(50)

4(30)

5(40)

4(20)

5(40)

0

3(30)

7(70)

2(50)

1(25)

Treatment

None

Endoscopic resection

Surgery

0

14(90)

2(10)

0

2(20)

11(80)

0

14(100)

0

10(100)

1(25)

0

3(75)

Deceased

CRC

Other tumours

0

3(20)

1(7)

0

2(20)

0

4(100)

0

As regards treatment depending on tumour stage, the majority (87.5%) of patients with stage 0 lesions were treated by endoscopic resection, with 2 patients requiring surgery. None of these patients received cancer treatment. Patients with stage I neoplasms were all treated by curative surgical resection, with none requiring oncological treatment. All stage II and III patients were treated by curative resection, with 57.8% of stage II patients and 100% of stage III patients requiring neo-adjuvant or adjuvant chemotherapy. Two of the stage IV patients were treated by curative resection with associated oncological treatment for both primary tumour and hepatic metastases. One of the cases required palliative surgery and, in the remaining case, treatment was only symptomatic due to the advanced state of the tumour. (Table 3)

Table 3. Summary of treatment for neoplasms and recurrence after treatment

Treatment	Right Colon 12 n(%)	Left Colon 19 n(%)	Rectum 26 n(%)	Total 57 n(%)
Chemotherapy
Neoadjuvant
No	12 (100)	18 (94.7)	16 (61.6)	46 (80.7)
Capecitabine	0	1 (5.2)	8 (30.8)	9 (15.8)
Fluorouracil + oxaliplatin + leucovorin	0	0	1 (3.8)	1 (1.75)
5-Fluorouracil	0	0	1 (3.8)	1 (1.75)
Adjuvant
No	8 (66.7)	14 (73.7)	15 (57.7)	38 (66.7)
Capecitabine	1(8.3)	1 (5.2)	3 (11.5)	5 (8.7)
Oxaliplatin + Capecitabine	0	1 (5.2)	3 (11.5)	4 (7.1)
Fluorouracil + oxaliplatin + leucovorin	2(16.7)	3 (15.9)	5 (19.3)	10 (17.5)
Palliative	1(8.3)	0	0	1 (1.8)
Radiotherapy
No	12 (100)	19 (100)	14 (53.8)	45 (78.9)
Neoadjuvant	0	0	10 (38.5)	10 (17.6)
Adjuvant	0	0	2 (7.7)	2 (3.5)
Endoscopic Resection	2(167)	5 (26.3)	10 (38.4)	17 (29.8)
Surgery
Radical	9 (75)	14 (73.7)	16 (61.6)	39 (68.4)
Palliative	1 (8.3)	0	0	1 (1.8)
Relapse	1 (8.3)	1 (8.3)	3 (11.5)	4 (7.1)

During the study period, 10 patients died, 7 men and 3 women, with a mean age of 58.98 years (CI 95% 54.47 – 63.50) at time of death. Seven of these patients died from colorectal cancer, 5 men and 2 women, while cause of death in the rest was a second primary tumour, with CRC diagnosed at stage I in all of those cases.

Figure 3 shows the incidence and mortality from CRC in Castilla La-Mancha and the different provinces of this autonomous community. Data obtained from the records of the Cancer Observatory of

the Spanish Association against Cancer.

Five of those who died from colorectal cancer belonged to the screening group, one to the family history of colorectal cancer group and one to the group under follow-up due to a personal history of colon polyps. For the study, non-deceased patients and the patient whose death did not result from CRC were censored. (Table 4)

Table 4. Characteristics of patients deceased from colorectal cancer

	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5	Patient 6	Patient 7
Group	1	4	2	1	1	1	1
Gender	Male	Male	Female	Male	Female	Male	Male
Age (years)	66	53	65	52	57	61	60
Location	Rectum	Left colon	Right colon	Right colon	Rectum	Left colon	Right colon
Stage at diagnosis	IV	IV	IV	IV	III	III	II
Metastasis	Hepatic	Hepatic + lung	Hepatic	Hepatic	No	No	No
Treatment	Paliative	Surgery + CT	Paliative	Surgery + CT	CT + RT+ Surgery	Surgery + CT	Surgery + CT

CT: Chemotherapy. RT: Radiotherapy

The overall 48 months’ survival rate was 80.70%. Mean survival time in Group 1 was 45.76 months (IC 95% 42.67 – 48.85), in Group 2 was 47.36 (IC 95% 45.97 – 48.75) and in Group 4 was 45 months (IC 95% 35.45 – 54.55). For Group 3 mean survival time was 48 months (maximum study period) as no patient died from CRC.

The reason for performing colonoscopy showed no statistically significant relationship with survival (p= 0.247).

Analysis of the relationship between tumour location and survival shows that the mean survival time for the right colon was 45.27 months (CI 95% 41.22 – 49.23), lower than for left colon, which was 47.26 months (CI 95% 45.93 – 48.60) and rectum, 45.46 months (CI 95% 41.66 – 49.26). These differences were not statistically significant (p= 0.336).

Tumour stage at diagnosis, however, did show a statistically significant relationship with survival (p <0.0001) when analysed using the Kaplan-Meier test, that is, tumour stage had an impact on survival time.

Figure 4 shows the overall Kaplan Meier survival curves of colorectal cancer at

48 months and the curves stratified by stage, gender, age of patients and location, respectively

Cox proportional hazard regression analysis revealed that tumour stage presented a higher risk at more advanced stages (HR: 36.35), although the results were not statistically significant (p=0.153). Advanced stage tumours treated with chemotherapy showed higher survival (p= <0.001).

Subsequently, we analysed whether the presence of metastasis at diagnosis might be related to survival time or mortality risk found a proportionally increased hazard rate (HR: 11.27) which was statistically significant (p<0.001). It was also analyzed how age and gender related to the risk of mortality. An increase in the hazard rate was observed, although in no case it was statistically significant.

The incidence of colorectal cancer in Spain is increasing, and hence it is important to understand its clinical characteristics, diagnosis and treatment, as well as survival.

The main objective of this study was to assess the clinical, epidemiological and survival characteristics of colorectal cancer in a city with a small population and a single referral hospital.

In our study, there were no significant differences in the mean age of the patients, 61.43 years, similar to patient ages reflected in other studies, nor in the predominant sex, masculine, which could be related to their higher exposure to risk factors and the protective effect of female hormones.^[4,32] However, overall survival at 48 months was 84.2%, higher than that reported in other studies.^[4,33,34]

As regards anatomic pathology, 98.27% of the tumours showed histology compatible with adenocarcinoma, and only one with lymphoma.

In contrast to what was observed in studies carried out in other countries, in which the main stage at diagnosis was stage II- III, with few cases of stage 0, in our study, early-stage tumours were more common at diagnosis than locally advanced or metastatic ones.^[4,35] This is arguably because most of the colonoscopies were conducted under the CRC population screening programme, which helped the lesions to be diagnosed at an early stage, data that would support the usefulness of the population screening programs of colorectal cancer for the early diagnosis of malignant colon lesions.^[22]

Recent studies have reported that the location of the tumour in the colon may have a significant effect on survival, finding that left-sided colon cancers have a significantly higher survival rate because right-sided colon cancers typically present poor differentiation and are diagnosed at later stages.^[4,36,37] This lower survival in right-sided colon lesions is also present in our study, although other studies conflict on this point, finding no relationship between location and survival.^[37]

The present study also shows the influence of age, sex and stage on survival of CRC. This relation has been reported in studies conducted in populations with different characteristics to that of our sample in the province of Cuenca.^[38] Survival in tumours with stage IV was lower, and tumour stage at diagnosis presenting a statistically significant relationship to survival time. We also found an increase in proportional hazard rate associated with stage and increased risk related to the presence of metastasis at diagnosis. As in other studies, improved survival was found in tumours with advanced-stage (III and IV) that were treated with chemotherapy.^[24,25,29]

The main limitation of this study is the size of the sample (n: 57), as it is a pilot study carried out in a single hospital in a small city, despite including the entire population of the health area. This could be the reason why our findings did not reveal statistical significance in all the analyzes performed, since the findings from other studies with larger samples are statistically significant. However, as we have previously indicated, the objective of the same was to know the behavior of colorectal cancer in a small city to assess whether it is similar to that observed in studies previously performed with larger populations.

Another limitation is the possibility of a loss of follow-up during the study, which might have led to significant data being missed, such as death or cause of death.

In conclusion, it is the first study on colorectal cancer survival carried out in a small city in Castilla La-Mancha and one of the first carried out in Spain.

Despite the particular characteristics of the province of Cuenca (Spain), with a single reference hospital and a great geographical dispersion of small towns (238 townships distributed in 17.141km²) with distant health resources, the findings of our study are similar to those in other studies carried out in important hospitals, which leads us to believe these data can be extrapolated to a general population.

In Spain there are many provinces with characteristics similar to Cuenca, so the results of our study could help achieve improvements in the health care of patients with colon cancer, not only Castilla La-Mancha, but in other communities of Spain, being important in this case to improve the communication between primary and specialized care to achieve an early diagnosis and treatment that can increase colorectal cancer survival.

The study carried out is a pilot study that leaves open research areas that can expand the information provided therein.

Funding

The present study received no funding from the public, private or non-profit sectors. Francisco Escribano Sotos was funded by the University of Castilla-La Mancha “Support for Research Groups 2019- Economy, Food and Society Group”

Conflicts of Interest

The authors declare that there is not conflict of interest.

Data Availability Statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

Authorship Contribution Statement

Conceptualization: Laura Valiente González, Francisco Escribano Sotos.

Methodology: Laura Valiente González, Ricardo de Miguel Ibáñez, Francisco Escribano Sotos.

Software: Laura Valiente González, Francisco Escribano Sotos.

Validation: Laura Valiente González, Ricardo de Miguel Ibáñez, Francisco Escribano Sotos.

Investigation: Laura Valiente González.

Formal analysis: Laura Valiente González.

Resources: Laura Valiente González

Data curation: Laura Valiente González.

Writing - original draft: Laura Valiente González.

Writing - review and editing: Laura Valiente González, Ricardo de Miguel Ibáñez, Francisco Escribano Sotos.

Visualization: Laura Valiente González.

Supervision: Laura Valiente González, Ricardo de Miguel Ibáñez, Francisco Escribano Sotos.

Project Administration: Laura Valiente González, Ricardo de Miguel Ibáñez, Francisco Escribano Sotos.

Funding Acquisition: Francisco Escribano Sotos

Ethical Statement

This study was approved by the Ethics Committee for Clinical Research of the Health Services Area of Cuenca (REG: 2019/PI1919) in December 2019.

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Colorectal Cancer Prevalence and Survival in Castilla La Mancha (Spain). A Pilot Study

Status:

Version 1

Abstract

Figures

1. Introduction

2. Material And Methods

3. Results

4. Discussion

5. Conclusions

Declarations

References

Status:

Version 1