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© 2002 American Society for Clinical Oncology Pain and Quality of Life After Treatment in Patients With Locally Recurrent Rectal CancerByFrom the Departments of Surgery, Biostatistics, and Radiation, and Pain Research Group, The University of Texas M.D. Anderson Cancer Center, Houston, and Department of Surgery, The University of Texas Health Science Center, San Antonio, TX. Address reprint requests to Nestor F. Esnaola, MD, MPH, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 444, Houston, TX 77030-4009; email: nesnaola{at}mdanderson.org
PURPOSE: Because survival in patients with locally recurrent rectal cancer (LRRC) is limited, pain control and quality of life (QOL) are important parameters. The purpose of this study was to assess the prevalence of posttreatment pain and QOL of patients with LRRC treated with nonsurgical palliation or resection and identify predictors of poor outcome. PATIENTS AND METHODS: Posttreatment pain severity and QOL were prospectively assessed in 45 patients with LRRC using the Brief Pain Inventory and Functional Assessment of Cancer Therapy–Colorectal questionnaire. RESULTS: Fifteen patients received nonsurgical palliation, and 30 patients underwent resection of their pelvic tumors. There was a significant association between higher posttreatment pain scores and worse QOL (P < .001). Patients treated with nonsurgical palliation reported moderate to severe pain beyond the third month of treatment. Resected patients reported comparable levels of pain during the first 3 postoperative years, particularly after bony resections; long-term survivors (beyond 3 years), however, reported minimal pain and good QOL. Female sex, pelvic/sciatic pain at presentation, total pelvic exenteration, and bony resection were associated with higher rates of moderate to severe posttreatment pain (P = .04, P < .001, P = .04, and P = .02, respectively). Pain at presentation was an independent predictor of posttreatment pain (odds ratio, 7.4 [95% confidence interval, 1.8 to 30.3]; P = .006). CONCLUSION: Patients with LRRC treated with nonsurgical palliation or resection experience significant levels of pain after treatment. Close posttreatment pain monitoring is warranted in patients presenting with pelvic pain, and more aggressive pain management strategies may improve posttreatment QOL.
LOCAL RECURRENCE occurs in up to one third of patients after curative resection of rectal cancer1-6 and is amenable to re-resection in approximately one third of these cases.7 Although multimodality therapy for locally recurrent rectal cancer (LRRC) has resulted in 5-year survival rates of 21% to 58%, it is associated with significant morbidity and mortality.8-11 Because many patients with LRRC present with disease involving adjacent viscera or bone, curative surgery often requires multivisceral resections, multiple ostomies, and bone resection.12-15 However, despite adequate surgical margins, the majority of patients eventually succumb to recurrent local or systemic disease.9,10 Patients with LRRC who are ineligible for resection are often treated with nonsurgical palliation, including radiation therapy, chemotherapy, or chemoradiation. These patients are often unresectable because of extensive pelvic disease or concurrent distant metastases, and their posttreatment survival is poor.16 Given the limited survival after nonsurgical palliation or resection for LRRC, posttreatment pain and quality of life (QOL) are important parameters in these patients. Despite the growing emphasis on QOL in patients with colon cancer, the literature on patients with LRRC is scarce. The purpose of this study was to assess the prevalence of posttreatment pain and QOL in patients with LRRC treated with nonsurgical palliation or resection and to identify predictors of poor outcome.
Patients Between December 1999 and October 2000, we enrolled patients with LRRC observed at the Gastrointestinal Surgery Clinic at The University of Texas M.D. Anderson Cancer Center in a prospective study of pain management and QOL after treatment. Patients were eligible if a period of at least 3 months had elapsed between treatment of their primary tumor and disease recurrence; patients with concurrent distant disease were included. Patients with nonadenocarcinoma pathology, concurrent nonrectal pelvic malignancies, or a previous history of pelvic pain syndrome or chronic constipation were excluded. Fifty-one of 52 patients who fulfilled eligibility criteria agreed to participate and completed informed consent. Nonsurgical palliation was defined as treatment with supportive care alone, chemotherapy, radiation therapy, or chemoradiation without tumor resection. Pain was managed in all patients according to institutional protocols similar to those outlined in the National Comprehensive Cancer Network Practice Guidelines for Cancer Pain.17 Patients were enrolled at various time points after recurrence, and serial assessments were performed at 3-month intervals. However, to perform a cross-sectional analysis of posttreatment pain and QOL, we based our study only on each patient’s first posttreatment assessment. Six patients with incomplete posttreatment assessments were excluded, leaving 45 patients in the final study cohort. In five patients who enrolled before treatment, the first posttreatment assessments (at approximately 3 months) were used. In the remaining 40 patients who enrolled after the initiation of treatment, the assessment obtained at the time of study entry was used.
Assessment of Pain
Index of Pain Management
Assessment of QOL
Statistical Methods
The relationships between the various categorical variables were assessed using
Patient, Tumor, and Treatment Characteristics The demographic, initial treatment, and recurrent tumor characteristics of the 45 patients in the study are listed in Table 1. There was an association between pelvic or sciatic pain at presentation and the type of treatment received (P = .01). The majority of patients treated with nonsurgical palliation presented with disease involving the bony pelvis or multiple sites, whereas almost half of the resected patients presented with anastomotic or pelvic visceral recurrences (P = .04).
The treatment characteristics of the patients treated with nonsurgical palliation or resection are listed in Table 2. Fifteen patients received nonsurgical palliation consisting of chemotherapy (n = 4), chemoradiation (n = 8), or supportive care alone (n = 3). Among the eight patients treated with chemoradiation, one patient received brachytherapy and seven patients received external-beam radiation therapy (EBRT) at a median dose of 45 Gy (range, 30 to 59.4 Gy). Two of the patients treated with EBRT also received brachytherapy or intraoperative radiotherapy (IORT).
Twenty-nine of 30 patients underwent attempted curative resection of their pelvic tumors; one patient with severe pelvic pain and liver metastases unresponsive to chemoradiation underwent a total pelvic exenteration with palliative intent. Sixteen patients required bony resections, including 14 sacrectomies (all below the level of S3), two coccygectomies, and one partial resection of the right superior pubic ramus. Twenty-three patients (77%) had complete (R0) resection of their pelvic tumors, whereas seven patients had evidence of microscopically positive margins on permanent section. There were no perioperative deaths (ie, within 30 days) after resection. Among the 30 patients who underwent resection, eight patients underwent surgery alone, nine patients received adjuvant chemotherapy, and 13 patients received adjuvant chemoradiation. A total of 22 patients received chemotherapy: six before surgery and 16 after surgery. Among the 13 patients treated with chemoradiation, 11 patients were treated before surgery and two patients were treated after surgery. Patients were treated at a median dose of 45 Gy (range, 35 to 59.4 Gy). In addition, three patients received additional brachytherapy, and 10 patients received additional IORT at a median dose of 15 Gy (range, 10 to 20 Gy).
Assessment of Pain and QOL After Treatment
The median posttreatment pain and QOL scores of patients treated with nonsurgical palliation or resection are shown in Figs 1 and 2. Patients treated with nonsurgical palliation reported moderate to severe pain beyond the first 3 months of treatment, accompanied by worsening QOL during the same interval. In contrast, patients treated with resection reported mild to moderate pain during the first 3 years after treatment, with a slow improvement in QOL scores during this interval. Long-term survivors after resection (ie, beyond 3 years), however, reported minimal pain (ie, median pain score of 0) and good QOL. Differences in pain and QOL scores within each treatment group at the various time intervals were not statistically significant, likely because of sample-size limitations. Pain-management index scores were comparable in the two groups, suggesting that these observations were not caused by differences in pain management.
There was a strong association between increasing posttreatment pain and worse QOL in our cohort. The median FACT-C score of patients with no pain (n = 15) was 111 compared with 93, 89, and 76 in patients with mild (n = 10), moderate (n = 8), or severe (n = 12) pain, respectively (Fig 3; P < .001). When the analysis was stratified according to the five QOL domains of the FACT-C, increasing posttreatment pain seemed to have its greatest effect on physical well-being and functional well-being (Fig 4).
We analyzed the effects of the various demographic, tumor, and treatment factors on pain and QOL after treatment (Table 4). Female sex was associated with worse pain and QOL scores after treatment (P = .04) despite similar pain-management index scores. In addition, women reported significantly worse QOL after treatment than men (median FACT-C scores, 92 v 108, respectively; P = .006) and scored lower on the physical well-being (P = .04) and colorectal cancer subscales (P = .001) of the FACT-C.
Pelvic or sciatic pain at presentation was a strong predictor of poor outcome in our cohort. Despite comparable pain-management index scores, the posttreatment pain and QOL scores of patients who initially presented without pain were 0 and 102 compared with 7 and 86 for patients who presented with pain (P = .002 and P < .001, respectively). Although 67% of the patients treated with nonsurgical palliation reported pain at presentation compared with 27% of the patients treated with resection (P = .01), pain at presentation had a negative effect on posttreatment pain and QOL even when controlling for treatment group. Seventy-five percent of the patients who underwent total pelvic exenteration reported moderate to severe pain after treatment compared with only 32% of patients treated with low anterior resection, abdominoperineal resection, or anterior exenteration (P = .04). In addition, 63% of the patients who underwent bony resections reported moderate to severe pain after treatment compared with only 21% of their counterparts (P = .02). Because of the fact that all of the patients who underwent total pelvic exenterations also underwent bony resections, the independent effect of total pelvic exenteration versus bony resection in these patients could not be analyzed. The presence of a permanent colostomy or urine conduit at the time of assessment had no apparent impact on pain or QOL. In contrast, vaginal resection at the time of salvage therapy had a significant impact on postoperative outcomes. Pain and QOL scores in women who did not undergo vaginal resection and those who underwent vaginal resection with reconstruction were not statistically different. In contrast, pain and QOL were significantly worse in women who underwent vaginal resection without reconstruction (P = .05 and .03, respectively). There was no association between surgical margins and posttreatment outcomes. Although the pain score in the 23 patients who underwent R0 resections was slightly higher than that of the seven patients who underwent R1 resections, this difference was not statistically significant (median pain scores, 4 v 1; P = .9). In addition, the posttreatment QOL scores were similar (median FACT-C scores, 97 v 91; P = .5). Two thirds of the patients in our series received radiation, and 10 patients were reirradiated. There was no association between radiation therapy or reirradiation and posttreatment outcomes. There was however a nonsignificant trend toward less pain in patients treated with IORT (median pain scores, 4 v 1; P = .8). Interestingly, posttreatment pain was worse in seven patients who received high-dose IORT (15 to 20 Gy) compared with four patients who received 10 Gy (median pain scores, 7 v 0; P = .2). Chemotherapy had no apparent effect on posttreatment outcomes. Furthermore, disease status (ie, disease-free v recurrent disease) had no apparent effect on pain or QOL scores in our study (P = .3 and .2, respectively).
The univariate predictors of posttreatment pain (sex, symptoms at presentation, and pelvic pain at presentation) and the type of treatment received (nonsurgical palliation v resection) were entered into a stepwise logistic regression model to identify the independent predictors of pain (-2 log likelihood value, 48.655; Hosmer-Lemeshow test
Our results suggest that posttreatment pain is a common problem in patients with LRRC treated with either nonsurgical palliation or resection. Forty percent of the patients in our cohort had pelvic pain at initial presentation. Two thirds of the patients complained of pain at the time of posttreatment assessment, and of these, two thirds reported moderate to severe levels of pain. Pain had a significant negative impact on posttreatment QOL in our cohort, particularly with respect to physical and functional well-being. Female sex, symptoms at presentation, total pelvic exenteration, and bony resection were also predictive of worse pain after treatment. In a recent series of patients with metastatic primary tumor rectal cancer reported by Crane et al,25 pelvic chemoradiation alone resulted in 2-year symptomatic pelvic control and colostomy-free rates of 81% and 79%, respectively. The results of nonsurgical palliation in patients with LRRC are less encouraging. In our series, patients treated with nonsurgical palliation reported moderate to severe levels of pain beyond the third month of treatment despite acceptable pain management (based on pain-management index scores). Although other series have reported good palliation of pain in 37% to 100% of patients with LRRC treated with radiation or chemoradiation, the duration of pain control was often limited.16,26-30 Several series have found a dose-response relationship for radiotherapy. In an early report by Rafla et al,26 55% of patients with LRRC treated with radiotherapy alone who received more than 60 Gy had complete relief of pain compared with 30% and 16% of patients who received 50 to 60 Gy and less than 50 Gy, respectively. All patients treated with more than 56 Gy by Overgaard et al28 had significant relief of symptoms compared with 47% to 61% of patients treated with lower doses. Although some reports have failed to find a dose-response for radiotherapy,27 the fact that only two thirds of the patients in our series received radiotherapy (at a lower median dose than in previous reports) may explain the short duration of palliation in our study. Although a recent report of continuous, hyperfractionated, accelerated radiotherapy using 54 Gy in patients with LRRC resulted in complete relief of pain in 100% of patients,29 its safety in the setting of reirradiation remains to be determined. For patients with limited pelvic disease, radical resection can result in significant disease-free and overall survival. Despite the fact that most of our patients received acceptable pain management after resection (based on pain-management index scores), the majority of them reported mild to moderate levels of pain during the first 3 years after surgery. Other studies have looked at pain and QOL after re-resection for LRRC.31-43 Whereas several of these series have reported palliation of pain in 67% to 100% of patients after resection, many of these series were small,31,35,38,42,43 and none of them used standardized instruments or scales to measure pain or QOL. In a series reported by Maetani et al,36 18 of 25 patients reported improvement of severe pelvic pain after abdominosacral resection; however, most of them went on to develop postoperative paresthesias and pain in the denervated areas. Almost half of the patients resected by Wanebo et al37 also developed phantom pain and causalgia after extended resection. To our knowledge, this is the first report that has used previously validated instruments to assess the prevalence of posttreatment pain and QOL in patients with LRRC after resection. Our results suggest that despite apparently acceptable pain management, posttreatment pain after resection may be more prevalent and prolonged than previously reported. Given that the surgical techniques and multimodality regimens used in this study were not substantially different from those used in previous reports, the observed rate of postoperative pain was likely because of more accurate measurement rather than differences in treatment. Several patient, tumor, and treatment factors were predictive of poor outcome in our study and could be used to identify candidates for more aggressive pain management. Female sex was associated with worse posttreatment pain and QOL in our study. Although female sex has been shown to be a predictor of inadequate pain management in previous studies,20 men and women in our study had similar pain-management index scores, suggesting that discrepancies in analgesia is unlikely to be a factor. Previous reports have noted high levels of postoperative depression and significant disruptions in body image and sexual function after total pelvic exenteration for gynecologic malignancies.44,45 More specifically, patients who underwent vaginal reconstruction after exenteration had significantly better QOL outcomes compared with patients who underwent colpectomy alone.45 Vaginal reconstruction had a similar restorative effect on QOL in our study and should be strongly considered in patients undergoing multivisceral resections. Patients in our study who presented with symptoms (particularly pelvic or sciatic pain) were more likely to experience worse pain and QOL after treatment. Given that these factors have been associated with incomplete resection and poor survival in several series,46-48 re-resection in these patients should be carefully considered, particularly if total pelvic exenteration or bony resection is anticipated. Several investigators have reported modest gains in survival after palliative resection for LRRC, even with gross residual disease.49,50 Before embarking on such aggressive treatment, clinicians must weigh the benefits of resection against a significant risk of surgical morbidity, postoperative pain, and impaired QOL. Pain after treatment of LRRC can be the result of progression of pelvic disease or surgical trauma. Pain caused by lumbosacral plexopathy has also been reported after preoperative EBRT for rectal adenocarcinoma.51 Patients treated with high-dose IORT (15 to 20 Gy) in our study reported higher levels of pain after resection. This difference was not statistically significant (possibly because of the limited number of patients who received IORT) and should be interpreted with caution. The reported incidence of IORT-induced neuropathy ranges from 10% to 32% in both previously nonirradiated and irradiated patients, and there seems to be a dose-response for doses more than 15 Gy.8,52-55 Brachytherapy offers similar rates of local control compared with IORT and has a low risk of neuropathy, perhaps making it a safer choice in patients with positive margins after resection for LRRC.56 Our study has several potential limitations. Because patients were enrolled through the Gastrointestinal Surgery Clinic, our results may have been affected by selection bias. For example, patients who were treated with nonsurgical palliation may have continued to be observed in our clinic because they were doing poorly (ie, pelvic pain or impending obstruction), whereas patients who were doing well were more likely to be observed by their medical or radiation oncologist. In patients who enrolled several months after treatment, data regarding symptoms at presentation (particularly pain) could be subject to recall bias, particularly in patients who were doing poorly at the time of assessment. Patients LRRC with extensive pelvic disease or concurrent distant metastases are treated with nonsurgical palliation and have limited survival. Not surprisingly, the median time from recurrence to assessment in our nonsurgical palliation group was significantly shorter than in the resection group. The fact that patients treated with nonsurgical palliation reported minimal pain during the first 3 months of treatment, whereas patients treated with resection reported decreased pain after the first postoperative year, could have resulted in underestimation of posttreatment pain and overestimation of QOL in both groups. Finally, our study was based on 45 patients, 20 of whom experienced the outcome of interest (moderate to severe posttreatment pain). As a result, some of the reported analyses (particularly those dealing with specific surgical subgroups or adjuvant therapies) may have failed to reach statistical significance because of sample-size limitations and type II error. Our results suggest that posttreatment pain is both pervasive and prolonged in patients with LRRC, reinforcing the need for close pain monitoring in these patients. It is important to note that almost half (44%) of the patients in our study reported moderate to severe posttreatment pain despite apparently acceptable pain management. In fact, among patients who reported moderate to severe pain, 95% were receiving opioids, and more than half of these were already receiving strong opioids. Given the negative impact of posttreatment pain on QOL, and the fact that traditional analgesic regimes may not be adequate, clinicians caring for patients with LRRC should consider more aggressive or invasive modes on pain control, such as nerve blocks or intrathecal pain pumps,57 particularly because most patients survive beyond the 6 months required to make these interventions cost-effective.58 Future studies in patients with LRRC should include routine monitoring of pain and QOL after treatment and explore more aggressive pain management regimens to optimize outcomes and QOL.
Supported in part by a T-32 Surgical Oncology Training Grant from the National Institutes of Health (to N.F.E) and financial support (to J.M.S.) from Medtronic, Inc, Minneapolis, MN.
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Copyright © 2002 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
2 tests. The relationships between the categorical demographic, tumor, and treatment variables and the continuous outcome variables (Worst Pain score and FACT-C score) were analyzed using Mann-Whitney U tests and Kruskal-Wallis tests, as appropriate. The univariate predictors of moderate to severe posttreatment pain (P 
.1) were entered into a stepwise logistic regression model to identify the independent predictors of posttreatment pain. All tests were two-tailed, and statistical significance was defined as P < .05. The SPSS 10.0 software package (SPSS Inc, Chicago, IL) was used for the statistical analyses. 
Difference (P = .2) within resection group.
Difference (P = .02) within pain groups.
