Clinical Investigation
The Quality-of-Life Effects of Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer

Presented at the 2011 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology, January 20-22, 2011 in San Francisco, CA.
https://doi.org/10.1016/j.ijrobp.2012.09.006Get rights and content

Purpose

Existing studies that examine the effect of neoadjuvant chemoradiation (CRT) for locally advanced rectal cancer on patient quality of life (QOL) are limited. Our goals were to prospectively explore acute changes in patient-reported QOL endpoints during and after treatment and to establish a distribution of scores that could be used for comparison as new treatment modalities emerge.

Methods and Materials

Fifty patients with locally advanced rectal cancer were prospectively enrolled at 2 institutions. Validated cancer-specific European Organization for Research and Treatment of Cancer (EORTC QLQ-CR30) and colorectal cancer-specific (EORTC QLQ-CR38 and EORTC QLQ-CR 29) QOL questionnaires were administered to patients 1 month before they began CRT, at week 4 of CRT, and 1 month after they had finished CRT. The questionnaires included multiple symptom scales, functional domains, and a composite global QOL score. Additionally, a toxicity scale was completed by providers 1 month before the beginning of CRT, weekly during treatment, and 1 month after the end of CRT.

Results

Global QOL showed a statistically significant and borderline clinically significant decrease during CRT (−9.50, P=.0024) but returned to baseline 1 month after the end of treatment (−0.33, P=.9205). Symptoms during treatment were mostly gastrointestinal (nausea/vomiting +9.94, P<.0001; and diarrhea +16.67, P=.0022), urinary (dysuria +13.33, P<.0001; and frequency +11.82, P=.0006) or fatigue (+16.22, P<.0001). These symptoms returned to baseline after therapy. However, sexual enjoyment (P=.0236) and sexual function (P=.0047) remained persistently diminished after therapy.

Conclusions

Rectal cancer patients undergoing neoadjuvant CRT may experience a reduction in global QOL along with significant gastrointestinal and genitourinary symptoms during treatment. Moreover, provider-rated toxicity scales may not fully capture this decrease in patient-reported QOL. Although most symptoms are transient, impairment in sexual function may persist after the completion of therapy and merits further investigation.

Introduction

In 2012, approximately 40,300 patients will receive a diagnosis of rectal cancer in the United States (1). Although surgical resection remains the mainstay of curative therapy for these patients, it risks significant gastrointestinal and genitourinary morbidity. Although the introduction of newer surgical techniques such as total mesorectal excision has decreased surgical side effects through greater preservation of pelvic autonomic nerves, treatment regimens have also intensified through broader application of multimodality therapy, inasmuch as recent trials have shown benefit in local control and complete pathologic response rates when patients are treated with neoadjuvant radiation with or without concurrent chemotherapy 2, 3, 4. At our institutions, for example, neoadjuvant chemoradiation (CRT) is the standard of care for rectal cancer patients with locally advanced disease.

Given the significant adverse normal tissue effects from pelvic radiation therapy across multiple cancers (5), it is imperative that clinicians accurately characterize the morbidity of neoadjuvant chemoradiation so as to assess the risk-benefit profiles of treatment regimens and provide patients with more accurate expectations of likely complications. Although toxicity rates have been reported from major trials for locally advanced rectal cancer, patient-reported outcomes such as quality of life (QOL) are often underestimated or are not captured by physician-reported measures (6). Moreover, the current literature regarding health-related QOL for rectal cancer patients treated with pelvic radiation therapy is sparse and suffers from several limitations, including retrospective, cross-sectional study designs; the use of QOL instruments that have not been validated; and a lack of emphasis on the effects of nonsurgical treatment modalities on QOL (7).

We therefore sought to examine the QOL of rectal cancer patients undergoing neoadjuvant CRT for locally advanced disease using validated QOL questionnaires and a prospective study design. Our goals were to assess acute changes in QOL and symptoms during and after therapy and to establish a baseline of QOL scores in this population for future comparison as new treatment protocols emerge.

Section snippets

Study participants

The study was approved by the institutional review boards of the institutions at which the study was conducted. Patients with rectal cancer who were scheduled to receive concurrent neoadjuvant CRT and who did not have a history of pelvic radiation were eligible for the study. At our institutions, neoadjuvant CRT is generally administered for patients with locally advanced disease, defined as T3/T4 primary tumor stage, node-positive disease, or both. Patients were initially evaluated with

Results

From 2006 to 2010, 53 patients were enrolled, of whom 50 completed QOL questionnaires at all 3 time points and therefore served as our study population. The mean age was 59.2 years (range, 32.1-85.2 years), and 36 (72%) were men. Ninety-one percent of the sample (n=40) was Caucasian, 7% was African American (n=3), and 2% was Asian (n=1), with 6 participants missing racial data.

Figure 1 summarizes the scores from the QLQ-C30. Global QOL demonstrated a statistically significant and borderline

Discussion

Despite the importance of patient-reported QOL endpoints for appreciating patient perspectives on treatment side effects, the current literature on the QOL effects of neoadjuvant CRT for rectal cancer is limited (7). We therefore conducted a prospective analysis examining QOL during neoadjuvant CRT in patients with locally advanced rectal cancer using validated QOL measures.

Notably, patients in our cohort experienced a clinically significant decline in global QOL during treatment as defined in

References (20)

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J. M. Herman and A. K. Narang contributed equally to this article.

Supported in part by the National Cancer Institute core grant to the University of Michigan Comprehensive Cancer Center 5 P30 CA 46592.

Conflict of interest: none.

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