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Annals of Surgical Oncology 9:696-703 (2002)
© 2002 Society of Surgical Oncology

ORIGINAL ARTICLES

A Prospective Evaluation of Patients Undergoing Surgery for the Palliation of an Advanced Malignancy

Thomas J. Miner, MD, David P. Jaques, MD and Craig D. Shriver, MD

From the General Surgery Service (CDS), Walter Reed Army Medical Center, Washington, DC; and Memorial Sloan-Kettering Cancer Center (TJM, DPJ), New York, New York.

Correspondence: Address correspondence and reprint requests to: David P. Jaques, MD, Vice Chairman, Department of Surgery, Memorial Sloan-Kettering Cancer Center, 1275 York Ave., New York, NY 10021; Fax: 212-717-3645; E-mail: jaquesd{at}mskcc.org


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Background: Decisions regarding the use of surgical procedures for the palliation of symptoms caused by advanced malignancies require the highest level of surgical judgment. Prospective analysis of palliative surgical care may facilitate a more effective and representative evaluation of these patients.

Methods: Patients requiring surgery planned solely for the palliation of an advanced malignancy were offered entry onto this study. Outcome measurements were made before surgery and monthly thereafter until the patient’s death. Accepted techniques of pain assessment, quality of life, and functional status were used.

Results: Between May 1997 and December 1999, 26 patients were enrolled. Although 46% (12 of 26) of patients demonstrated improvement in pain control or quality of life after palliative surgery, these benefits lasted a median of only 3.4 months. Palliative surgery was associated with significant postoperative complications in 35% (9 of 26) patients.

Conclusions: Although many patients had no apparent demonstrable benefit from surgery, surgeons were able to identify a group of patients who experienced significant benefits after a palliative procedure. The relationships between the patient and family members and the surgeon play an important role in decision-making throughout the palliative phase of cancer treatment.

Key Words: Cancer • Outcome analysis • Pain • Palliation • Quality of life • Surgery


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Curative therapy for cancer often revolves around well-characterized surgical principles and procedures. However, in the course of their disease, cancer patients often present with surgically unresectable disease or with a recurrent malignancy that requires palliative interventions that are less clearly defined. Likewise, the well-established survival curve, appropriate for describing the curative phase of cancer care, has little value in palliation, for which resolution of chief complaints, quality of life, pain control, morbidity of therapy, resource utilization, and procedure durability are more pertinent therapeutic considerations.1–3

The treatment of cancer is often evaluated primarily on the basis of increased survival or physiologic response, depriving physicians, patients, family members, and researchers of valuable information about the risks and benefits related to a therapeutic intervention. A patient’s emotional state, psychological and functional status, pain perception, and quality of life often have been considered immeasurable and understandable only in subjective terms.4–7 Although the quantitative assessment of these factors is challenging, the use of validated, reproducible study instruments can aid researchers and practitioners alike by providing objective and reproducible means of comparing the effects of a therapeutic intervention.8–10 The importance of accurate quality of life and pain assessment as independent outcome variables is being considered with increasing significance in the oncology literature.11–13 Such information is especially worthwhile in the optimal management of cancer patients because it assists in determining the full value of different cancer treatments.14

The surgeon is in a unique position to care for patients with an advanced malignancy through the appropriate use of palliative procedures. Both operative and nonoperative procedures can be used with noncurative intent for the purpose of relieving specific symptoms. Ideally, palliative care selects the best treatment that will maximize quality of life and minimize complications. The effective palliation of complications from advanced cancer demands the highest level of surgical judgment. Because these choices can greatly affect a patient’s final days, it is critical that this complex decision-making process be better understood. The goal of this study was to follow surgical patients through the course of their palliative care until death by using accepted techniques of outcome assessment. A well-characterized and patient-focused view of the meaning, relationship, and importance of those elements associated with improved outcomes may ultimately lead to improved palliative surgical care.


   METHODS
TOP
 ABSTRACT
 INTRODUCTION
 METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
Patients in the Walter Reed Army Medical Center’s General Surgery Service requiring a general anesthetic for a major operation intended for the palliation of symptoms caused by an advanced malignancy were offered entry onto this study. The protocol was approved by the Walter Reed Army Medical Center Institutional Review Board. Informed consent was obtained from all participants. Exclusion criteria from the study included age <18 years and mental incompetency. Patient characteristics and clinical data were recorded and listed descriptively. The specific surgical procedure performed, the length of hospital stay, and postoperative complications were noted. Outcome measurements were made before surgery and monthly thereafter in the postoperative period until death.

Before surgery, the patient, a significant family member identified by the subject, and the attending surgeon were interviewed by a research physician or nurse who used a standardized written and narrative format. Each was asked to state the single problem that he or she most wanted palliated by the procedure and the expected durability of the procedure. Additional expectations, opinions, or concerns volunteered by the subjects were recorded for later review. The preoperative goals of the patient, family member, and surgeon, as well as the duration that these goals were met after surgery, were determined. All preoperative interviews were conducted in person. Postoperative assessments were made during either scheduled physician appointments or telephone interviews. Surveys were completed and sent through the mail as necessary.

The outcome measurements used in this study were defined as quality of life, functional performance, and pain perception. Quality of life was measured by the Functional Assessment of Cancer Therapy-G (FACT-G) questionnaire. This multisectioned assessment tool is designed for clinical trials involving oncology patients and has been noted in the literature for its ease of administration, brevity, reliability (Cronbach’s alpha = .69–.82), validity, and responsiveness to clinical change. This measurement includes the total and five subscales (physical, functional, social, emotional, and relationship with doctor).3,15 The patient’s pain perception was assessed with the Memorial Pain Assessment Card (MPAC). This well-established study instrument was designed to efficiently measure pain in cancer patients and has concurrent validity with several other techniques. The multidimensional pain and stress subscales (modified Tursky pain descriptor, pain intensity, pain relief, and general psychological distress [mood]) of the MPAC were evaluated in each patient.16–18 A researcher using the Karnofsky Performance Status scale assessed the subject’s functional performance. This measure has well-documented validity and interrater reliability and is often considered a "gold standard" tool for research on oncology patients.3,19 A change of 25% in any of the measured parameters demonstrated in an individual participant was considered clinically significant. Outcome measurements were analyzed for interval changes. The duration of any clinical changes was determined. The patient, family member, and surgeon were asked for their subjective impression of the patient’s status at each interval follow-up. The impression of each party was compared with the recorded outcome measurements.

Data were expressed as percentages in the case of categorical variables and as mean ± SEM in the case of continuous variables. Means were compared with the use of Student’s t-test, and frequencies were compared with the use of the {chi}2 test, as appropriate. Analysis of variance was performed where indicated. Survival and cumulative incidence curves were constructed by using the Kaplan-Meier method. Comparisons between curves were made by using the log-rank test. P values of <.05 were considered significant.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Between May 1997 and December 1999, 26 patients were enrolled in the study. All 26 patients were interviewed before surgery. Twenty-three (88%) of the participants were observed until death. The planned postoperative monthly assessment was achieved in 18 (69%) patients, whereas 4 patients (15%) missed 1, 2 (8%) missed 2, and 2 (8%) missed >=3 of the planned follow-up evaluations. Six of the eight (75%) subjects who missed any postoperative assessment died. The final evaluation before death in these patients occurred within 60 days in five patients and within 90 days in one patient. The operations were performed for gastrointestinal obstruction in 15 patients (58%); biliary obstruction in 3 (12%); pleural effusion in 3 (12%); the management of extensive, fungating, malodorous nodal disease in 3 (12%); and abdominal pain in 2 (8%). Table 1 lists each patient’s primary tumor location, chief complaint, operation performed, and survival.


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  		TABLE 1. Characteristics and outcomes of patients undergoing palliative operations
 
Before surgery, the patient, a significant family member, and the attending surgeon all expressed a primary goal that they hoped would be achieved by the operation. All of the patients expressed a desire for resolution of their chief complaint. Despite acknowledging the palliative intent of the proposed operation, 46% (12 of 26) of the patients also expressed a hope that no evidence of disease would be found at the time of surgery. Although 38% (10 of 26) stated that they additionally sought a prolongation of life, 27% (7 of 26) of the patients reported that they did not expect to survive the proposed operation. The expectation of the family member matched the preoperative goals of the patient in 81% (21 of 26) of instances. Three of the nonmatching family members expressed a hope that the patient would be found free of disease at the time of surgery, and two wished for alleviation of symptoms not reported by the patient. The goal of the patient and the surgeon matched in 73% (19 of 26) of cases. The expectations of the family member and the surgeon matched the patient’s at similar rates (P = .84). When the primary operative expectations of the patient and the surgeon did not match, the surgeon generally expressed an opinion that his or her understanding of the disease process supported addressing issues different from the patient’s primary preference to obtain a potentially greater benefit for the patient. For example, one surgeon believed that correction of the patient’s gastric obstruction as the primary aim of the surgery would provide a more durable result than addressing the patient’s primary aim of the operation (relief of jaundice). On two occasions, however, the surgeon’s nonmatching response agreed with the preoperative goals of the family member. Thus, the family member and the surgeon were in agreement 81% (21 of 26) of the time.

After a palliative operation, 54% (14 of 26) did not show clinical improvement. This group of patients was composed of (1) those who received no benefit because they died in the hospital as a result of either complications or progression of disease within 30 days of surgery (8 of 14; 57%) and (2) those who revealed neither a subjective nor objective improvement after surgery (6 of 14; 43%). In three of the six patients who got no benefit, the preoperative goals of the surgeon where more pessimistic and did not match those of either the patient or the family member. Although none of these six patients demonstrated improvement in quality of life or pain control measurements, no patient surviving through the perioperative period had a significant worsening of status in the postoperative period. Patient age, preoperative physical well-being scores, Karnofsky performance scores, pain scores, or the anticipated extent of surgery did not significantly differ among these patients and others in the study.

A clinical improvement was noted by 46% (12 of 26) of the patients after a palliative procedure. Family members and surgeons concurred that these patients were clinically improved in every case. An increase of at least 25%, defined as significant in this study, in any of the measured parameters was seen in all the subjects thought to be clinically improved by the surgeon or family member. Clinical gains were noted at 30 days after the palliative procedure in all patients who experienced a benefit. Figure 1 shows the duration that these clinical benefits were maintained. Improved quality of life or pain perception was maintained in these patients for a median of 108 days; 75% (9 of 12) patients experiencing a clinical benefit died before the termination of the study. At the time of death, these clinical gains persisted in only 44% (four of nine) of patients. Three subjects were alive and doing well at the completion of the study. Each of the surviving patients had gastrointestinal obstructive complaints that seemed to be corrected with the lysis of intra-abdominal adhesions. Although these patients had evidence of active advanced cancer at the time of surgery, none of them had evidence of disease progression. Although these patients had surgery intended to palliate an active malignancy, the actual procedure performed was not dictated by the patient’s advanced cancer.



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  		FIG. 1. Durability of clinical improvement: the time from surgery during which a benefit was maintained.

 
Table 2 shows the measured outcome parameters among the nine improved patients who died during the course of the study. Significant changes were demonstrated in the physical well-being and functional well-being sections of the FACT-G survey and the modified Tursky pain descriptor subscale of the MPAC. Other sections of the assessment tools failed to demonstrate any differences after surgery. On the social and family categories of the FACT-G survey, the patients’ scores were high before surgery (17.4 ± 2.4) and did not significantly change over time after surgery (P = .77). The patients’ relationship with the doctor (surgeon) was strong on the FACT-G before surgery (7.2 ± .4) and did not significantly change in the postoperative period (P = .92). In all 78% (seven of nine) of the patients experiencing a benefit, the surgeon preoperatively anticipated an amelioration of the chief complaint for the duration of the patients’ lives. In those who demonstrated no improvement, this conviction had been expressed significantly less often (1 of 14 patients; P = .037).


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  		TABLE 2. Measured outcome parameters in patients experiencing a benefit from a palliative operation (n = 9)a
 
Figure 2 shows the survival of patients undergoing palliative surgery in this trial. The overall median survival of all patients undergoing a palliative operation was 108 days. Patients who experienced a clinical improvement lived significantly longer. The mean length of hospital stay was 14.4 ± 3.5 days. Postoperative complications played a large role in the shorter survival time seen in patients who did not experience a clinical benefit. Thirty-five percent (9 of 26) of the patients had a significant postoperative complication, and 89% (8 of 9) of these patients were never discharged from the hospital after their surgery and died as a result of either complications (2 patients had pulmonary embolism and 2 became septic) or progression of disease (n = 4). After correcting for patients who died before the initial postoperative follow-up at 1 month, patients who experienced a clinical gain still survived longer than those who did not (median, 201 vs. 67 days; P = .016). Results did not vary on the basis of the operative indication. For example, patients operated on for the most common chief complaint, gastrointestinal obstruction, did not have significantly different clinical outcomes (P = .67) or survival (P = .94) compared with those patients with different preoperative problems.



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  		FIG. 2. (A) Survival of patients undergoing a planned palliative surgery (n = 26). (B) Survival of patients based on the success of the palliative operation. Patients with clinical improvement survived significantly longer (P < .001).

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
Palliative care has been defined by the World Health Organization as "the total active care of patients whose disease is not responsive to curative treatment. Control of pain, of other symptoms, and of psychological, social, and spiritual problems, is paramount. The goal of palliative care is achievement of the best quality of life for patients and their families."20 Others have further defined surgical palliation in roles to include (1) the initial evaluation of the disease, (2) local control of the disease, (3) control of discharge or hemorrhage, (4) control of pain, and (5) reconstruction and rehabilitation.21 Although these broad definitions provide a global understanding of the reaches of palliative care, alternate interpretations of what constitutes a palliative procedure by different clinicians and investigators render comparisons between and, at times, within studies problematic. Because ideal palliative care requires a patient approach defined in terms of the patient’s individual needs and values, identical procedures may play dramatically different roles for each patient. Thus, use of definitions based on the type of procedure performed, rather the goals and intentions of the procedure, is of limited benefit. In this study, surgical palliation was defined as a procedure used with the intention of relieving the symptoms caused by an advanced malignancy. By keeping the definition based on symptomatic control and surgical intent, primary focus on an individualized approach for palliative surgery was maintained. Although this approach may have limited the number of patients eligible for this study, it was believed that it would provide a more appropriate patient population for analysis.

Many previous reports on palliative care have stressed the influence of family members in the decision-making process regarding end-of-life care.22,23 One of the strengths of this article is that it directly examines the interactions between the patient, family member, and surgeon. This study demonstrates a close interaction between these parties throughout the palliative phase of treatment. There was general concordance before surgery on the goals of the procedure between patient, family member, and surgeon. Patients in this study seemed to have good communication and emotional support from both the family member and the surgeon. FACT-G data demonstrate social, emotional, and relationship with doctor scores that both were high in the preoperative period and were maintained until death. These responses were positive both in patients who received a benefit from the palliative surgery and in those who did not. We propose that in palliative surgical decision-making there is a critical palliative triangle (Fig. 3) between the patient, family member, and surgeon that clarifies and defines the goals of each patient’s individual treatment. Through the dynamics of the triangle, the patient’s complaints, values, and social and emotional support are considered against the medical and surgical alternatives. Although patients, family members, and surgeons may at times have unrealistic individual expectations, the dynamics of the palliative triangle help to moderate such beliefs and guide the decision-making process toward the best possible choice for the patient.



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  		FIG. 3. An ideal palliative triangle. Equal interactions between the patient, the family member, and the surgeon guide individual decisions regarding palliative care. The dynamic of this interaction is influenced by unique factors provided by each participant.

 
Despite the effective interactions between members of the palliative triangle, the majority (54%) of patients in this study did not obtain a significant benefit after undergoing a palliative operation. These patients did not experience an improvement in quality of life or pain perception nor a period of subjective improvement after surgery. Patients had relatively long hospitalizations, and many died in the hospital as a result of complications of the surgery, progression of disease, or both. The median duration of survival in these patients was relatively brief. A number of patients spent the majority of their final days in the hospital, away from their homes and family. We were unable to identify specific elements associated with patient mortality. There were no significant differences among patients who survived in the perioperative period and those who did not on the basis of factors such as the Karnofsky Performance Scale, the FACT-G patient functional status subscale, or the extent of the procedure performed. Patients who died in the perioperative period were subjectively among the most robust in the series. Before surgery, one would have predicted (and their surgeons did) that these patients would do well. Although most patients in this series did not have evidence of improved quality of life or pain control, there were no decrements in measured patient outcome variables appreciated in these patients after surgery. In patients who survived surgery, these data suggest that attempts at palliative care did not worsen the patients’ overall condition, even though they did not improve it.

The relationship of undesirable side effects (risk) to desired effects (benefits) defines the therapeutic ratio. Assessment of the therapeutic ratio, a form of risk-benefit analysis, can aid in the decision-making process by allowing physician and patient alike the opportunity to contemplate and discuss both the desired and unwanted effects of a proposed therapeutic intervention.24 Although consideration of risk in terms of treatment-related toxicity, morbidity, and mortality is an important part of the surgical decision-making process, attention to this element should not be the sole factor in making decisions about palliative therapy. The high mortality associated with palliative surgery in this series is discouraging. Although increased survival time is clearly a secondary goal of a palliative procedure, information about survival and differences in survival seen between different groups as demonstrated in this work suggests that there may be demonstrable factors that influence patient risk. Additional investigation in the future into the factors leading to postoperative complications in palliative patients will be vital to assist in optimal patient selection. Knowledge of which patients are likely to do poorly with palliative surgery would be vital in helping the surgeon decide who not to operate on. Determination of such factors will need to come from much larger series than are currently available.

Only 46% of patients were found to have benefited from surgery as documented by augmented quality-of-life or pain scores. Improved outcome measurements were associated with subjective betterment in every patient. Determination of these parameters added considerable value to this study by providing a more comprehensive understanding of this group. Significant improvement after a palliative procedure was demonstrated in patients in whom the surgeon predicted amelioration of the chief complaint for the remainder of their lives. This question was designed to evaluate the surgeon’s assessment of the potential durability of the proposed procedure. Although the span of these gains was considerably less than predicted before surgery—in fact, few patients experienced lifelong palliation—this finding suggests that surgeons have the ability to recognize elements likely to be associated with improved outcomes. Identification of those factors that assist a surgeon in determining the durability of a procedure may ultimately help in the selection of patients who could best benefit from a palliative operation. In addition, surgery occasionally provided unexpected findings that led to gains for individual patients. Some patients had surgically correctable problems not related to their advanced malignancy. Consideration of this group further expands the number of patients experiencing a benefit associated with surgical therapy.

Formal decision-making analysis, also referred to as "decision theory" or "game theory," has been developed to study a wide variety of medical, political, economic, and military problems. It has been previously described as "the science of decision-making under uncertainty."25,26 Because decisions in cancer management usually must be made under conditions of risk and uncertainty, this methodology may be well suited for studying the appropriate application of palliative procedures in the future. Research into this field is especially warranted because of the magnitude of both the potential risks and benefits associated with palliative surgery. Regardless of the anatomical site and cause leading to the need for surgical intervention, prevailing considerations relate to the medical condition and performance status of the patient, the extent and prognosis of the cancer, the availability and success of nonsurgical management, the potential durability of the procedure, and the expectancy and quality of life of the individual patient.27 An individualized palliative care plan is then developed on the basis of the interaction of the patient, family members, and surgeon. All palliative procedures must be planned and performed with these factors in mind.

When considering the appropriate and effective use of palliative procedures, a surgeon is often confronted with a full range of multidisciplinary treatment options and technical considerations that could potentially relieve some of the symptoms of an advanced malignancy.28 Practitioners must often deliberate over options that are outside their individual experience. The current medical literature commonly lacks information on the range of data required to guide sound decisions.1 Much of it condemns the flaws in the overall treatment of patients at the end of life and recognizes the inadequacies in education and training. Yet little work has been done in determining ways to improve these.29 To better understand the factors involved in palliative surgical decision-making, we sought to use validated research instruments that would allow us to explore the surgical care of patients with an advanced cancer, specifically focusing on issues essential to ideal palliative care. By prospectively observing patients undergoing surgery for the palliation of symptoms caused by an advanced malignancy, we attempted to obtain representative, comprehensive, and reproducible data that minimize problems commonly associated with retrospective trials.30 The rich 50-year history of clinical trials is principally centered on curative-intent cancer treatments and examines hundreds to thousands of patients. There have been few such trials concerned with understanding differences in palliative care.1 With nearly a million cancer deaths in the past year, this important aspect of complete patient care and the role of surgery deserve more in-depth evaluation, such as that described in this pilot study.


   Footnotes
 
The opinions and assertions herein are the private ones of the authors and are not to be construed as official policy or reflecting the views of the Department of Defense.

This pilot study was designed to prospectively observe patients selected for palliative operations by using validated study instruments to determine outcomes from a patient-oriented perspective. Throughout the palliative phase of cancer treatment, the relationships between the patient and family members and the surgeon play an important role in the decision-making process.

Received for publication January 14, 2002. Accepted for publication May 6, 2002.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

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L. E. McCahill, D. D. Smith, T. Borneman, G. Juarez, C. Cullinane, D. Z. J. Chu, B. R. Ferrell, and L. D. Wagman
A Prospective Evaluation of Palliative Outcomes for Surgery of Advanced Malignancies
Ann. Surg. Oncol., July 1, 2003; 10(6): 654 - 663.
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T. J. Miner, D. P. Jaques, P. B. Paty, J. G. Guillem, and W. D. Wong
Symptom Control in Patients With Locally Recurrent Rectal Cancer
Ann. Surg. Oncol., January 1, 2003; 10(1): 72 - 79.
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