Rectal Cancer and Quality of Life

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Introduction

It is very difficult to divide epidemiological data of colon and rectal cancer as they are traditionally reported together. In 2002, there were 1 million new cases of colon and rectum cancer [1] (9.4% of the world total of new cancers). This means that it is fourth in incidence frequency in men and third in women. Among all large bowel tumours, rectal cancer accounts for about 30–40% of cases. Although the incidence is higher in developed countries, changes in environmental exposure, mainly dietary, have led to an increase in developing countries too. The high socioeconomic impact and increasing attention is easy understandable not only in the treatment but in prevention and early detection too, as demonstrated by the number of screening programmes developed.

The modern history of rectal cancer treatment began in 1908, when Miles [2] wrote “Method for performing abdominoperineal excision for carcinoma of the rectum and the terminal portion of the pelvic colon”. This paper was the milestone of surgical treatment of rectal cancer and it was based on the concept of the “cylindrical spread of rectal cancer”.

Miles suggested that the location of the tumour in rectum was not important for the surgeon because only mutilating surgery (based on abdominal and perineal approach) could be an efficient treatment.

The high impact of this kind of operation pushed surgeons into finding a new surgical approach.

In the 1940s, Dixon [3] described the anterior resection (AR) for rectal cancer, in order to avoid a definitive stoma, but the high incidence of technical failure and the lack of information about the biolog- ical history of cancer contributed to make the abdominoperineal procedure more popular than other procedures and it was not outdated for a long time. Only at the end of 1970s did the exponential growth in oncologic knowledge and technical devices begin to lead to dramatic change in the treatment of rectal cancer. First, the introduction of mechanical stapling devices overcame the technical problems of handsaw anastomosis at the distal rectum and anal

canal. Also, the introduction of the “mesorectum” [4]

concept (the milestone of rectal cancer behaviour) and the introduction of an efficient adjuvant and neoadjuvant therapy have dramatically reduced the incidence of Miles procedure.

Rectal surgery has shifted from the idea that “rectal surgery means permanent colostomy” to the new idea of surgery with sphincter saving, as there is a “consen- sus” that avoiding a permanent stoma is now generally regarded as favourable. This can be easily under- stood from the title of a recent review: “Do we still need a permanent colostomy in 21st century?” [5].

In our experience, as described in another chapter of the book, the introduction of triple neoadjuvant therapy (hyperthermia, radio- and chemotherapy) allows us to treat very low rectal cancer with a sphincter-saving procedure, but we do think that technical feasibility should not be the only parameter that surgeons consider when planning surgery.

The main end-points for judging the results of rectal surgery should include survival, recurrence and complication, but also quality of life (QoL).

Quality of Life Assessment

It is very difficult to define QoL, as it is a multidimensional construct. As poetically written by Mount and Scott [6], try to define QoL is like assessing the beauty of a rose: no matter how many measurements are made (for example size, smelling, colour), the full beauty of the rose is never captured. Having in mind this concept, it is easy to understand why, in the literature, there are many definitions of QoL:

- The extent to which hopes and ambitions are matched by experience [7].

- An individual’s perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a wide- ranging concept affected in a complex way by the person’s physical health, psychological state, personal beliefs, social relationships and their

Gian Gaetano Delaini, Gianluca Colucci

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relationship to salient features of their environ- ment [8].

- Appraisal of one’s current state against some ideal [9].

- The things people regard as important in their life [10].

- An individual’s sense of well-being in the somatic, emotional and social domains [11].

Even if we can presume the existence of some

“universal features”, QoL is an individual concept, which was born as an interaction between expectations, experience, social influence and pressure. Each of these points can weigh differently in different people. We can find patients heavily affected by health and functional problems that can report a better QoL than the general population. This was called the “disability paradox” by Albrecht and Devlieger [12].

Also, QoL is a dynamic concept that changes not only among people but also in the same individual and in different stages of life. Coping strategies are likely to change during life in response to ageing, stress and difficulties. For all these reasons, the first researchers felt like they were in front of the tower of Babel [13].

As will be discussed in more detail later in the chapter, researchers’ efforts to create tests to measure QoL have been successful and there is a consen- sus among clinicians about which domains can be explored by QoL tests: physical, emotional, social and cognitive functions.

How to Test QoL

In the recent past, there was diffuse scepticism among researchers on using QoL tests in their trials or a trend towards using non-standardised questionnaires [14]. The former is due to the high number of methods for testing QoL: by interviews (structured, semi-structured, non-structured), by questionnaires (standardised, non-standardised) and by ad hoc questions. Theoretically speaking, most of them can be easily and efficiently used in clinical practice but as already explained, cannot be comparable and useful in a clinical research setting. In fact, the ideal instrument for achieving this target should have the following characteristics: able to analyse the four

“important” domains, standardised, validated, easy to be completed and cross-cultural.

During the last 15 years, different kinds of questionnaires have been developed. They range from generic instruments, designed to test QoL in almost all kinds of patients, to specific for a particular kind of cancer. In the following, we briefly summarise these tests.

The SF-36 [15] and the EuroQoL instruments [16]

represent generic health state index. They are well

validated and are useful especially in testing QoL in chronically ill patients. They do not take into account specific problems for cancer patients and symptoms correlated to therapy.

The next reasonable step was to develop cancer- specific QoL questionnaires. So far, the most used cancer-specific questionnaires have been: the Rotter- dam Symptoms Checklist (RSCL) [17], the Cancer Rehabilitation Evaluation System Short Form (CARES-SF) [18], the Functional Living Index-Can- cer (FLIC) [19] and the European Organization for Research and Quality of Life Core 30 Questionnaire (EORTC QLC-C30) [20, 21].

The latter is, so far, the most widely used and validated questionnaire. The first studies started in 1986 and the final version was published in 1993. It is a multidimensional questionnaire, self-administrated and available in different languages. It contains 30 items that explore various aspect of QoL. In the fist part, the QLC-C30 explores “generic” and various aspects of QoL by five functional scales (role, emotional, physical, cognitive and social) and 3 symptom scales (fatigue, pain nausea and vomiting). In the sec- ond part, the influence of cancer-specific manifesta- tions (such as sleep disturbance, financial impact of the disease, appetite loss) is analysed. The third part summarises the global results by two items on global health and QoL on a 7-point Likert scale.

The unique feature of this test is that it represents a “core instrument” for oncologic trials as it allows collection of a broad spectrum of information on all kinds of cancer patients. In fact, during the following years, the European Organization for Research and Treatment of Cancer developed detailed guidelines for creation of a new supplemental questionnaire [22, 23] to study the effect of particular types of cancer on QoL. Modules related to brain cancer [24], breast cancer [25] and lung cancer [26] were set up. In 1999, Sprangers et al. [27] published the Colorectal Cancer- specific Quality of Life Questionnaire Module (QLQ- CR38). It is structured as 38 items, employing the four category response options as the core instrument (QLC-C30). Nineteen questions are completed by all patients and they test function (body imagine, sexual functioning) and symptoms (micturition and gastrointestinal problems, chemotherapy side effects and weight loss). The other 19 are completed only by a subgroup and check sexual problems in male or female, defecation (only in patients with intact sphincter) or stoma-related problems (only in patients with stoma). In this way, the QLQ-CR38 explores symptoms and side effects of all different treatments for colorectal cancer (surgery with or without a temporary/permanent stoma, radio- and/or chemotherapy), becoming a tailored questionnaire for all rectal cancer patients.

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In our experience, as in the literature, the QLQ- CR38 plus QLC-C30 can be easily completed by most of the patients without assistance, even if they have a low education level or old age. The average time to complete both tests is 12 minutes.

QoL: Research or Clinical Instrument?

As already stated, there is a diffuse resistance in using QoL assessment in surgical practice. Most surgeons believe they can be useful only for research, but even in this field QoL is an add-on rather than an internal part of most trials. There is a common perception among surgical oncology specialists that this parameter is useful, especially in the comparison of different therapies for advance stage disease where there are low chances of improving survival. In other words, the concept of “QoL” is strictly linked to pal- liative care.

Nowadays, evidence is accumulating to suggest that QoL per se plays a role as a prognostic factor.

Baseline QoL predicts survival in different types of cancer, such as myeloma [28], head and neck cancer [29], breast cancer [30] and oesophageal carcinoma [31]. Also, two large cohort studies [32, 33] reached the same results by analysing different malignancies.

The first studies on rectal cancer obtained the same results. Earlam [34] demonstrated that a better QoL (measured by the Rotterdam Symptom Check- list Score) was associated with improved survival in patients with colorectal liver metastasis. Maisey et al.

[35] retrospectively analysed patients with advanced colorectal cancer enrolled in 4 different clinical trials for testing different chemotherapy regimens. They found that baseline QoL was an independent prognostic indicator in all the patients involved in these four phase III clinical trials. Both previous studies take account of patients with advanced stage disease (inoperable cancer) and the QoL assessment was done only before therapeutic manoeuvres.

In2001, Camilleri-Brennan et al. [36] published an interesting study where they analysed the change of QoL score among 65 patients undergoing curative surgical resection. They found two important far- reaching conclusions:

1. The QoL scores are dynamic and should be checked over time. A worsening in specific items could suggest the presence of specific problems (for example: loss in appetite can be associated with early bowel obstruction because of recurrence).

2. In their work, the combination of sociodemo- graphic and QoL scores could predict 1-year survival with an accuracy of 76.8%.

Even if larger trials are needed to confirm these results, these conclusions are very important. Col- lecting information by routine use of QoL scores can help physicians to follow patients over time and plan treatment on specific areas affected by the disease. In our experience (unpublished data), weight loss and gastrointestinal symptoms (such as nausea and vomiting) are early predictors of tumour recurrence and, sometimes, they start 3–4 months before radiological finding or increase in neoplastic markers.

QoL and Stoma

Progress in neoadjuvant therapy and the use of mechanical staplers have led to a dramatic reduction in the number of abdominoperineal extirpations (APE) during the last 20 years. So far, whenever fea- sible, the golden standard in the treatment of rectal cancer is a sphincter-saving procedure such as AR. In many of the works in the literature, a definitive stoma is generally associated with a reduced QoL [37–40], with an increase in social isolation [41] and deterio- ration of body image.

In2001, Grumann et al. [42] published a prospective study to evaluate QoL in patients undergoing APE or AR. For the first time, surprisingly, the Authors concluded that patients undergoing APE do not have a poorer QoL than patients undergoing AR.

Also, after low AR, patients have a poorer QoL than after undergoing APE. Jess et al. [43] demonstrated that stoma influences QoL only slightly, while faecal incontinence after low AR can seriously affect QoL.

These data were partially confirmed by a recent Cochrane review [44]. Among 25 potential studies, Pachler included only eight of these (with 620 patients enrolled). It was claimed that it is not possi- ble to come to the conclusion that QoL measures for stoma patients were poorer than for non-stoma patients.

The4-year prospective study by Engel et al. [45]

drew a completely different picture. Patients after APE had a lower overall QoL than after AR. Also, over time the scores improved only in AR and not in APE patients.

Moreover, Engel et al. took into account the problem of temporary stoma. The results of this study suggested that a stoma, even if temporary, affects QoL and the reversal of it can be one of the explana- tions of improvement in QoL scores in patients undergoing AR.

In our experience, we test anal sphincter function before planning surgery, especially in old patients or in patients with previous anal surgery. As reported in the literature [46], we do think that faecal incontinence can influence QoL more than the presence of a

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stoma. Correct instructions about how to manage the stoma and how to perform colonic irrigation can reduce the problems connected to the presence of a stoma. As demonstrated by Hamashima [47], long- term QoL could be recognised according to the characteristics of rectal cancer patients, independent of the presence of a stoma.

Also, we think that a temporary stoma, especially in patients undergoing low AR with colonic J-pouch, can be useful. In our unit, these patients follow some training sessions (sometimes using pouch filling) in order to develop confidence in new perceptions and to increase sphincter tone in response to pouch dis- tension. The stoma is usually reversed 60 days after surgery.

Bowel Dysfunction

These adverse effects after rectal cancer surgery on bowel function are related to sphincter or innerva- tion damage [48] and the loss of rectal reservoir. The type of resection and the level of anastomosis may also play a role [49, 50]. Frequency of bowel motion, urgency, faecal leakage and incontinence are the most reported symptoms. Diarrhoea, constipation and flatus [51, 52] are also reported. Usually, these problems improve over time [53], but, especially in older patients, it can take a long time [54].

In stoma patients, there is much concern about flatus and foul odour [51, 55] but intensive pre-operative education about colostomy irrigation seems to reduce the incidence of these side effects.

The incidence of diarrhoea in patients with or without a stoma seems to be equal [55], while constipation is a more common problem in patients undergoing APE [45].

The introduction of a colonic J-pouch after low AR may improve the QoL of patients [56] by increasing the volume of the neo-rectum [57]. It decreases mean stool frequency without a rise in faecal incontinence or surgical complications [58]. The use of a temporary proximal diversion is preferred by many Authors [59].

Sexual and Urological Dysfunction

Sexual and urologic problems are common both in men and women after rectal cancer surgery, although they are more common in men. They are due to damage of pelvic autonomic nerves and pelvic floor sus- tained during rectal dissection [60]. The introduction of the TME technique with nerve-sparring technique has reduced the incidence of urological and sexual dysfunction [50].

Regarding the sexual sphere, in these patients it is very important (but sometimes it can be difficult) to distinguish problems due to anatomic damage from other symptoms linked to psychological distur- bances because of depression, alteration of body perception and distress from the presence of a stoma.

This evaluation permits us to help and improve the life of these patients with appropriate support. There are contradictory reports in the literature but it seems that patients’ lives are likely to be beset by a poorly functional stoma or by a bad coping strategy more than the stoma per se.

The incidence of erectile and ejaculation dysfunction after surgery is reported to be very high after APE, ranging from 18 to 92% [40, 51, 61], while it is lower after AR (ranging from 9 to 30%) [45, 62, 63].

Loss of desire, diminished sexual activity and anorgasmia are also reported.

The prevalence of sexual problems in men seems to be higher in the elderly, but there is still debate about this, as it seems that, over time, older patients (>70 years old) recover continuously, while younger patient still complain of problems after 2 years [54].

Sexual problems in females are less investigated but cessation of intercourse, anorgasmia and dys- pareunia are the most common problems [64]. The incidence of sexual dysfunction is higher after APE also in women.

The major urologic problems are incontinence, retention and dysuria. These are more commonly associated with APE than AR [65]. Supraradical lymphadenectomy affects urinary function in more than 30% of patients and in 20% of patients long-term use of a urinary catheter is needed [66].

Conclusions

The debate on QoL should not confuse the important topic of the correct management of rectal cancer, focusing evaluation only on patients rather than disease. First, it is very important to take care on pri- mary end-points such as survival, disease free and tumour recurrence. Rectal cancer is a complex disease to deal with and it is clear that subspecialisation is becoming necessary. Subspecialty training in colorectal surgery and subsequent specialist board cer- tification has a long tradition in the USA where the American Society of Colon and Rectal Surgeons was founded in 1899.

Hospital and surgeon’s caseload are the key points for a successful outcome for patients, as uncorrected surgery is the first cause of high local recurrence rate [63, 67]. Porter et al. [68] stressed the importance of specific surgical competence and high caseload, as he demonstrated a higher risk of local recurrence in

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patients operated on by low-caseload and non-colorectal-trained surgeons (hazard ratio for local recurrence of 4.29). As a direct consequence, there is a controversial debate about surgical training in rectal surgery [69, 70] as it is mandatory to offer the best treatment for all patients.

We do think that dedicated colorectal units represent the best way to manage this problem. In the experience of our team, a multidisciplinary approach is the golden standard. In dedicated and scheduled meetings, different specialists (surgeon, oncologist, radiologist, pathologist, WOC/ET nurses, psycholo- gists) discuss cases and plan the patients’ treatment.

This approach guarantees a high level of care and increases the patients’ compliance with suggested medical/surgical therapy. In fact, they feel involved in a good “curative project” and this reduces the stress of approaching the different specialists.

In these specialised colorectal units, QoL assessment can help physicians and should be inserted in patients’ charts [71]. It can improve comprehension of patients’ needs and expectations. Only in this way can every treatment be tailored to the patient and offer the best care for each patient.

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