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Health-Related Quality-of-Life Parameters as Independent Prognostic Factors in Advanced or Metastatic Bladder Cancer

D.F. Roychowdhury, A. Hayden, A.M. Liepa

From Eli Lilly and Company, Indianapolis, IN.

Address reprint requests to Debasish Roychowdhury, MD, Lilly Corporate Center, Indianapolis, IN 46285, email: dfr{at}lilly.com.

	ABSTRACT

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
Purpose: This retrospective analysis examined prognostic significance of health-related quality-of-life (HRQoL) parameters combined with baseline clinical factors on outcomes (overall survival, time to progressive disease, and time to treatment failure) in bladder cancer.

Patients and Methods: Outcome and HRQoL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30) data were collected prospectively in a phase III study assessing gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in locally advanced or metastatic bladder cancer. Prespecified baseline clinical factors (performance status, tumor-node-metastasis staging, visceral metastases [VM], alkaline phosphatase [AP] level, number of metastatic sites, prior radiotherapy, disease measurability, sex, time from diagnosis, and sites of disease) and selected HRQoL parameters (global QoL; all functional scales; symptoms: pain, fatigue, insomnia, dyspnea, anorexia) were evaluated using Cox’s proportional hazards model. Factors with individual prognostic value (P < .05) on outcomes in univariate models were assessed for joint prognostic value in a multivariate model. A final model was developed using a backward selection strategy.

Results: Patients with baseline HRQoL were included (364 of 405, 90%). The final model predicted longer survival with low/normal AP levels, no VM, high physical functioning, low role functioning, and no anorexia. Positive prognostic factors for time to progressive disease were good performance status, low/normal AP levels, no VM, and minimal fatigue; for time to treatment failure, they were low/normal AP levels, minimal fatigue, and no anorexia. Global QoL was a significant predictor of outcome in univariate analyses but was not retained in the multivariate model.

Conclusion: HRQoL parameters are independent prognostic factors for outcome in advanced bladder cancer; their prognostic importance needs further evaluation.

	INTRODUCTION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
IT IS well known that baseline patient and disease characteristics are predictive of outcome in cancer patients. Baseline conditions associated with adverse outcome in bladder cancer include poor performance status, non-transitional-cell histology, presence of visceral metastases, and elevated alkaline phosphatase level.^1–4

Baseline health-related quality of life (HRQoL) has been associated with clinical outcome in cancer treatment; parameters such as good global QoL, good physical functioning, low pain, and low fatigue can be prognostic of better clinical outcome. Several studies have investigated baseline HRQoL parameters and baseline clinical characteristics in multivariate models for prognostic significance on clinical outcome. This multivariate analysis approach has been used in melanoma,^5,6 lung cancer,^7–9 breast cancer,^10–12 esophageal cancer,¹³ and mixed cancer populations.^14–16 These studies used a variety of HRQoL instruments, and different combinations of factors were included in the models; thus, it is difficult to make direct comparisons. However, global QoL and good physical functioning at baseline were the most common predictors of good outcome.

Bladder cancer is a common tumor, occurring most frequently in elderly male patients. To date, there have been no published studies investigating the relationship between baseline HRQoL, baseline clinical characteristics, and outcome in bladder cancer.

Studies have found that observer ratings of HRQoL (eg, performance score) do not correlate well with patient ratings of HRQoL and that there is greater variability in observer-rated HRQoL than in self-ratings.^17,18 A subjective self-reported measure of the patient’s feelings is more accurate and more sensitive in describing HRQoL than an observer-rated performance score.

This retrospective analysis was performed to determine the prognostic significance of HRQoL parameters in the presence of prespecified clinical prognostic factors on time-to-event end points (overall survival, time to progressive disease, and time to treatment failure) in patients with locally advanced or metastatic bladder cancer who participated in a phase III randomized study comparing gemcitabine and cisplatin (GC) with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC).⁴

	PATIENTS AND METHODS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
Patients and Study Treatment
Patients included in this analysis were those enrolled in an active-controlled, open-label, multinational, multicenter, randomized phase III study⁴ of GC versus standard MVAC who completed an HRQoL questionnaire at baseline.

To be eligible for the phase III trial, patients had measurable or assessable and histologically proven locally advanced (T4b, N2, N3) or metastatic (M1) transitional-cell carcinoma of the urothelium. Prior systemic chemotherapy or immunotherapy was not allowed. Patients were required to have a Karnofsky performance status (KPS) 70, adequate bone marrow reserve and renal function, and an estimated life expectancy of at least 12 weeks. Patients with central nervous system metastases, a secondary primary malignancy, or clinically significant pleural effusions or ascites were also not eligible.

Patients were randomly assigned to receive treatment with GC (gemcitabine 1,000 mg/m² on days 1, 8, and 15; cisplatin, 70 mg/m² on day 2) or standard MVAC every 28 days for a maximum of six cycles. Patients received treatment unless they developed progressive disease or unacceptable toxicity or if the patient, attending physician, or sponsor requested discontinuation.

The phase III study was conducted according to the ethical principles stated in the latest version of the Declaration of Helsinki, the applicable guidelines for good clinical practice, or the applicable laws and regulations of the countries in which the study was conducted, whichever represented the greater protection of the individual. Written informed consent was obtained from all patients before random assignment.

QoL Assessment
QoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) instrument¹⁹ (version 2.0),²⁰ which was administered at baseline and before each cycle. Validated bladder cancer–specific questionnaires were not available at the time the study was started. The EORTC QLQ-C30 is a relatively short (30 questions), multidimensional, cancer-specific questionnaire designed for self-administration and intended for use across a range of cancer diagnoses. It has also been translated into and validated in several languages, which was important in this multinational study. The EORTC QLQ-C30 consists of five function subscales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), five single items assessing symptoms (dyspnea, anorexia, insomnia, constipation, and diarrhea), a global health status/QoL scale, and a financial impact item. Higher scores on the functional and global QoL scales represent better functioning. Higher scores on the symptom scales represent a greater degree of symptoms. For this analysis, nausea and vomiting, constipation, and diarrhea were not considered because they are not commonly associated with bladder cancer itself; financial impact also was not considered.

Prespecified Baseline Clinical Factors
Baseline clinical factors that were assessed for prognostic significance were the same as those predefined in the protocol and previously reported.⁴ The factors and groupings were KPS (80 to 100 v < 80), tumor-node-metastasis stage (M₀ [no distant metastasis] v M₁ [distant metastasis] disease and N₀ [no regional lymph node metastasis] or any N [regional lymph node metastasis]), presence of visceral metastases (yes v no), alkaline phosphatase level (low/normal v high), number of metastatic sites of disease ( 3 v > 3), prior radiotherapy (yes v no), disease measurability (measurable v nonmeasurable), age ( 70 v > 70 years), sex (male v female), and time from diagnosis ( 12 v > 12 months).

Time-to-Event End Points
Overall survival was measured from the date of random assignment until death, and time to progressive disease was measured from the date of assignment until death or progression. Because there was a significant number of patients who had discontinuations as a result of toxicity on the MVAC arm, time to treatment failure was considered an important outcome to evaluate. Time to treatment failure was measured from the date of assignment until discontinuation of treatment, progression, or death.

Statistical Considerations
The prespecified baseline clinical factors and HRQoL parameters from patients with baseline data were evaluated for prognostic significance. A 5% level of significance was used for all variables.

HRQoL data were scored according to EORTC guidelines and reported on a scale of 0 to 100. If at least 50% of the items within a scale were answered, then the missing item was imputed on the basis of the average of the other completed items. Baseline HRQoL scores were dichotomized at the median to give a "good" and a "poor" score for each HRQoL parameter (Table 1). For dyspnea and anorexia, scores were dichotomized on the basis of the presence or absence of the symptom.

This analysis was originally performed only for the clinical parameters as specified in the protocol for this study. In this retrospective analysis, it was of interest to see whether the HRQoL parameters were significant and independent prognostic factors and to investigate whether some of the clinical parameters lost prognostic value in the presence of HRQoL parameters. Because this was a retrospective hypothesis-generating study, no alpha adjustments were deemed necessary.

	RESULTS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
The details of the efficacy and toxicity results from this trial have been published.⁴ The study was conducted in multiple European countries, Canada, the United States, South Africa, and Taiwan. The centers were primarily hospitals based in academic centers. A total of 405 patients were randomly assigned between November 1996 and September 1998. The results showed that the overall survival was comparable on both arms (hazard ratio [HR], 1.04; 95% confidence interval [CI], 0.82 to 1.32; P = .75), as were the time to progressive disease (HR, 1.05; 95% CI, 0.85 to 1.30; P = .66) and the time to treatment failure (HR, 0.89; 95% CI, 0.72 to 1.10, P = .27). The GC arm was considered to be more tolerable and safer than the MVAC arm.

Patient Characteristics
Of the 405 randomly assigned patients, 364 (90%) completed HRQoL questionnaires at baseline and are included in this analysis. The most commonly reported reason for not completing the questionnaire at baseline was failure by the investigative site to administer the questionnaire to the patient. The baseline characteristics of the 364 patients are presented in Table 2.

Univariate Analysis: Prognostic Factors for Overall Survival
In the univariate model for prespecified baseline clinical factors, performance status, tumor-node-metastasis staging, visceral metastases, alkaline phosphatase level, and number of metastatic sites were significant prognostic factors for overall survival (Table 3). In the univariate model for HRQoL factors, global QoL; physical, social, cognitive, and role functioning; and pain, fatigue, insomnia, and anorexia were significant predictors of overall survival (Table 4).

View larger version (14K): [in this window] [in a new window]   Fig 1. Overall survival: physical functioning (univariate analysis).

View larger version (14K): [in this window] [in a new window]   Fig 2. Overall survival: role functioning (univariate analysis).

View larger version (14K): [in this window] [in a new window]   Fig 3. Overall survival: anorexia (univariate analysis).

Significant favorable clinical prognostic factors for time to treatment failure were good performance status, M₀ disease, no visceral metastases, no measurable disease, low/normal alkaline phosphatase level, and age 70 years or younger (Table 3). Significant HRQoL prognostic factors for time to treatment failure were global QoL; emotional, physical, social, and emotional functioning; and pain, fatigue, dyspnea, and anorexia (Table 4).

Multivariate Analysis: Prognostic Factors for Time to Progressive Disease and Time to Treatment Failure
The multivariate analysis for time to progressive disease retained three clinical factors (good performance status, low/normal alkaline phosphatase level, and no visceral metastases) and one HRQoL factor (minimal fatigue; Table 5). The multivariate analysis for time to treatment failure retained only one clinical factor (low/normal alkaline phosphatase level) and two HRQoL factors (minimal fatigue and absence of anorexia).

	DISCUSSION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
The purpose of this retrospective analysis was to examine the prognostic significance of HRQoL parameters combined with prespecified baseline clinical factors for time-to-event end points in patients with locally advanced or metastatic bladder cancer. We found HRQoL parameters (physical and role functioning, anorexia, and fatigue) to be significant and independent prognostic factors for time-to-event end points.

In this study, physical and role functioning and anorexia were identified as significant and independent prognostic factors for overall survival. Studies in other tumor types have found similar results for physical function^11,13,15 and appetite.⁵ One study of metastatic breast cancer found that patients with a good appetite did not live as long as those with a poor appetite;¹² this study used a different HRQoL instrument, the linear analog self-assessment (LASA), than that used in our study, and the authors could not adequately explain this finding. In the present study, higher role functioning was a positive prognostic factor in the univariate analysis; however, in the multivariate analysis, longer survival was associated with lower role functioning. Similar contradictory results were found for emotional functioning in a study of a heterogeneous population of cancer patients.¹⁴

The paradoxical results of this study for role functioning may be explained by a greater perception of decreased ability to work or participate in leisure activities by patients who were more active before the diagnosis of bladder cancer. Sociodemographic data were not available to explore this explanation. To further explore the apparent discordant effect, interaction terms were added to the model. This showed that there was no difference between role functioning for patients with visceral metastasis, but patients without visceral metastasis and a high role-functioning score lived longer than patients without visceral metastasis and a low role-functioning score (data not shown).

Most studies have reported HRQoL only as prognostic factors for survival, although one study included response to treatment as an outcome.¹⁰ In this study, prognostic factors for time to progressive disease and time to treatment failure were also analyzed. Fatigue was identified as an independent prognostic factor for both time to progressive disease and time to treatment failure. Anorexia was a significant predictor of time to treatment failure.

For all three time-to-event end points assessed in our study, global QoL was a significant predictor of outcome in the univariate analyses but was not retained in the multivariate model. This is contrary to several studies in other tumor types, which found baseline global QoL scores to be significant predictors of survival in multivariate analyses.^5,8,9,14,16 This may be explained by differences in methodology and in patient populations. Some of these studies assessed global QoL as a single scale,^5,8,14,16 as in this study, whereas others assessed global QoL as a summation of other scales.^5,9 Three of these studies included the QLQ-C30.^8,14,16 In the study of malignant melanoma, both the global QoL item and the global summation score were significant in the univariate analyses, but only the global summation score was significant in the multivariate analysis.⁵ The lung cancer sample assessed by Ganz et al⁹ was limited to only 40 patients and required a different analysis approach. Dancey et al¹⁴ dichotomized HRQoL scores on the basis of mean scores rather than medians. Median scores reported by Coates et al¹⁶ were much lower for functional scales than those of the present sample, with the exception of the global QoL scale. The lung cancer population assessed by Montazeri et al⁸ was primarily those patients with limited disease.

Performance score was also a significant predictor of outcome for all three time-to-event end points in the univariate analyses, but it was retained only for time to progressive disease in the multivariate analyses. Performance score has been found to be a prognostic indicator in other studies^3,5,10 but it is being replaced in importance by HRQoL self-assessment of physical functioning. Patient self-assessment is seen as being a more accurate and reliable measure of HRQoL than a physician-rated performance score. Coates et al¹¹ found that patient well-being (measured on the LASA) was more important than performance status (using the Eastern Cooperative Oncology Group scale). These findings indicate either that the traditional assessment of performance status can be made a more powerful prognostic factor by incorporating some of the elements that are assessed by the patient or that the use of patient-assessed physical functioning could add to the prognostic importance of performance status as assessed by physicians. In a recent article by Velikova et al,²² it was found that there is an overall higher proportion of patients reporting symptoms and functional problems on the EORTC QLQ-C30 instrument than are mentioned in medical records. This may help explain why the HRQoL parameters could be so important in the assessment of prognosis and, in some cases, better than routinely used clinical parameters.

In our study, alkaline phosphatase levels and visceral metastases were significant predictors for time-to-event end points. These results are consistent with those found for survival in other bladder cancer studies. Bajorin et al³ found that performance status and presence of visceral metastases were independent predictors of survival in patients with metastatic bladder cancer. Elevated alkaline phosphatase levels (an indirect measure of visceral metastasis to bone or liver) were found to be prognostically important as well.¹

Although this study raises interesting questions, it suffers from the flaws of retrospective analysis. There were no statistical corrections performed for the multiple comparisons, but this is acceptable for hypothesis-generating retrospective studies. We should point out that the significance values (Table 5) for the HRQoL parameters indicate that poor physical functioning and the presence of anorexia may be negative prognostic factors for survival that are as strong as the presence of visceral metastasis and elevated alkaline phosphatase. In addition, dichotomizing the HRQoL parameters may have negatively biased against these parameters because a dichotomous predictor is less likely to prove significant, with all else remaining unchanged, than a continuous predictor. We also did not investigate the prognostic importance of the changes in the HRQoL parameters¹¹ or include sociodemographic parameters.^6,7,9,12,15

However, this study has many strengths, including a large number of patients from a multicenter study; high compliance with the completion of the questionnaire; a consistent population of patients, most of whom had metastatic bladder cancer and were from western European countries; the use of an instrument that has been translated and validated in numerous languages; the availability of clinical parameters in nearly all of the patients; and availability of mature and reliable time-to-event data.

This retrospective analysis found that HRQoL parameters are significant and independent prognostic factors for time-to-event end points in patients with locally advanced or metastatic bladder cancer. Some clinical factors deemed to be prognostically important may lose prognostic value when HRQoL factors are also considered. The prognostic importance of HRQoL should be evaluated in further studies in patients with bladder cancer.

	ACKNOWLEDGMENTS

 
We thank Professor Hans von der Maase, the PI for the study.

	NOTES

 
Supported by Eli Lilly and Company.

	REFERENCES

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
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Submitted April 23, 2002; accepted October 27, 2002.

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