Postoperative Quality of Life after Total Gastrectomy Compared with Partial Gastrectomy: Longitudinal Evaluation by European Organization for Research and Treatment of Cancer-OG25 and STO22.

PURPOSE: The European Organization for Research and Treatment of Cancer quality-of-life questionnaire-OG25 was developed to evaluate the quality of life in patients with stomach and esophageal cancer. The following are included in the OG25 but not in the STO22: odynophagia, choked when swallowing, weight loss, trouble eating with others, trouble swallowing saliva, trouble talking, and trouble with coughing. In this study, we evaluated the quality of life of gastrectomized patients using both, the OG25 and the STO22.
MATERIALS AND METHODS: A total of 138 patients with partial gastrectomy (PG) (distal gastrectomy=91; pylorus-preserving gastrectomy= 47) and 44 patients with total gastrectomy (TG) were prospectively evaluated. Body weight and scores from the OG25 and STO22 were evaluated preoperatively and at 3 weeks, 3 months, and 6 months after surgery.
RESULTS: Patients with TG had significant weight loss compared to patients with PG. At 3 months, TG was associated with worse scores for dysphagia, eating, odynophagia, trouble eating with others, trouble with taste, and weight loss on the OG25. TG was also associated with dysphagia, eating restrictions, and anxiety on the STO22. The OG25 helped differentiate between the groups with respect to weight loss, odynophagia, choked when swallowing, and trouble eating with others. The OG25 scores changed over time and were significantly different.
CONCLUSIONS: The OG25 is a more sensitive and useful scale than the STO22 for evaluating the quality of life of gastrectomized patients, especially those with total gastrectomy.

Introduction

Gastric cancer is one of the most common malignancies worldwide, being the fourth most common cancer and the second leading cause of cancer-related death.12 In Korea, gastric cancer is the most common cancer in men (17.4%) and the fourth most common cancer in women (7.8%). In 1995, the proportion of early gastric cancer (EGC) cases was 28.6% among all cases of gastric cancer; however, that proportion increased to 57.6% in 2009.34 Early detection of gastric cancer allows for timely treatment and better clinical outcomes. Although alternative treatments have been developed for gastric cancer, radical surgery remains the only treatment that offers the possibility of a cure.5 Although the proportion of EGC cases has been increasing, most of them are resectable. Therefore, quality of life (QOL) after gastrectomy has become increasingly important. When evaluating treatments for cancer, health-related QOL has been acknowledged as an important outcome in addition to oncologic outcomes and safety issues.6789

In recent years, there has been significant progress in defining and measuring QOL in patients with gastric cancer and patients undergoing gastrectomy.10 The European Organization for Research and Treatment of Cancer (EORTC) developed a cancer-specific questionnaire, the EORTC quality-of-life questionnaire (QLQ)-C30, which has good reliability and validity.111213 The EORTC QLQ-C30 evaluates the general condition of cancer patients. This questionnaire has been translated into 81 languages so far and has been used in more than 3,000 studies worldwide.

The EORTC QLQ-STO22 was developed to specifically evaluate the QOL of patients with gastric cancer and esophageal cancer.14 The OG25 has different evaluation scales from the STO22 in terms of odynophagia, choked when swallowing, trouble talking, weight loss, trouble eating with others, trouble with swallowing saliva, and trouble with coughing. The aim of this study was to evaluate the accuracy of OG25 over the STO22 in assessing the QOL of patients who underwent gastrectomy, especially total gastrectomy.

Materials and Methods

1. Patients

In this prospective study, patients with gastric cancer in the Department of Surgery, Seoul National University Hospital were investigated from July 2014 to October 2015. Patients who were scheduled to undergo gastrectomy were included. A total of 182 patients were enrolled.

The patients were asked to fill out each questionnaire (STO22, OG25) 4 times: preoperatively, and at 3 weeks, 3 months, and 6 months after surgery by a tablet-PC based QOL assessment. The tablet-PC based QOL assessment system allows for changing the pattern display in the electronic medical record and an automatic height, body weight, and a body mass index (BMI) check system. At each visit, the patients checked their body weight.

The study was approved by the Institutional Review Board of the Seoul National University Hospital (1406-108-590), and informed consent was obtained from all participating patients.

2. Treatment details

A prospective analysis of the medical charts was performed considering, in particular, the age, sex, comorbidities, operation method (open vs. laparoscopy or robotic), surgical procedures (total gastrectomy [TG] vs. partial gastrectomy [PG] and pylorus-preserving gastrectomy [PPG]), length of postoperative hospital stay, postoperative complications, and cancer stage.

3. Korean translation of the OG25

We developed a Korean version of the EORTC QLQ-OG25, translating the English version of the QLQ-OG25 into Korean and adapting it for use in Korea. We performed a pilot study of the entire cultural adaptation process using a two-phase process to translate the questionnaire, according to the guidelines of the EORTC QLQ-OG25. Phase 1 represents the iterative forward-backward translation/linguistic process and phase 2 describes the results of qualitative and quantitative evaluation with Korean patients. Ten patients with gastric cancer participated in the pilot study and subsequently, our translated OG25 was approved by the EORTC (Appendix 1).

4. Assessment of quality of life

The EORTC QLQ-STO22 includes 22 questions related to gastric cancer. The questionnaire items included five scales (dysphagia, chest and abdominal pain, reflux, eating restrictions, and anxieties) and four single items (dry mouth, body image, trouble with taste, and hair loss), reflecting disease symptoms, treatment side effects, and psychological issues. Higher scores indicated worse symptomatic problems.15

The EORTC QLQ-OG25 is a 25-item module designed to increase the sensitivity and specificity of the QLQ-C30. This module comprises six multi-item scales: dysphagia, eating restrictions, reflux, odynophagia, pain, and anxiety, and 10 single-item symptoms, with higher scores indicating worse symptomatic problems for both the multi- and single-item scales.

5. Statistical analysis

Data analysis was performed independently for the QLQ-STO22 and OG25 questionnaires. The mean scores of the global health status and functional scales were compared between the TG and PG patients by Student's t-test. The score changes during the 4 time points (preoperatively, 3 weeks, 3 months, and 6 months after surgery) of each questionnaire were analyzed by analysis of variance. Finally, the differences between the QLQ-STO22 and QLQ-OG25 scores were evaluated. A P-value of <0.05 was considered statistically significant. IBM SPSS Statistics ver. 22 (IBM Co., Armonk, NY, USA) for Windows was used for the statistical analysis.

Results

From July 2014 to October 2015, 182 patients with gastrectomy were included in this study; 72 patients were men (39.6%), and 110 patients were women (60.4%), with a mean age of 56.0 years (standard deviation [SD], 9.3 years; range, 31 to 76 years). Mean preoperative BMI was 24.1 kg/m2 (SD, 2.9 kg/m2; range, 16.0 to 35.0 kg/m2). During the study period, 138 patients underwent PG (75.8%), 91 distal gastrectomy (DG), 47 PPG, and 44 underwent TG (24.2%). A total of 155 patients underwent gastrectomy with laparoscopy or a robot-assisted method (85.2%) and 27 patients underwent gastrectomy using an open method (14.8%). Among them, 134 patients had no complications during their hospital stay (73.6%). The mean hospital stay was 12.5 days (SD, 6.7 days; range, 8 to 51 days). The patients' demographic and clinical information is described in Table 1.

Table 1

Demographic features and clinical information of patients

Values are presented as mean±standard deviation (range) or number (%). The sum of the percentages does not equal 100% because of rounding. PG = partial gastrectomy; TG = total gastrectomy; BMI = body mass index. *Classification according to the American Joint Committee on Cancer 7th edition. †Classification according to the Clavien-Dindo classification.

2. Body weight change according to operation type

Patients had their body weight checked preoperatively and at 3 weeks, 3 months, and 6 months after surgery. Mean body weight preoperatively and at 3 weeks, 3 months, and 6 months after surgery was 65.2 kg, 60.6 kg, 59.5 kg, and 59.4 kg, respectively. Mean BMI preoperatively and at 3 weeks, 3 months, and 6 months after surgery was 24.1 kg/m2, 22.4 kg/m2, 22.0 kg/m2, and 21.9 kg/m2, respectively. Body weight loss at 3 weeks, 3 months, and 6 months after surgery was 4.27 kg, 4.96 kg, and 4.84 kg in the PG group and 5.70 kg, 7.86 kg, and 9.4 kg in the TG group, respectively. Patients who underwent TG showed significantly more body weight loss compared to those who underwent PG at 3 weeks, 3 months, and 6 months after surgery (P<0.001) (Fig. 1). The TG group had a mean weight decrease of 8.47% whereas the PG group had a mean 6.52% decrease (P<0.001) at 3 weeks; 3 months after surgery, the TG group had a mean weight decrease of 11.7%, whereas the PG group had a mean weigh decrease of 7.53% (P<0.001).

Fig. 1

TG showed significantly more weight loss compared to PG. PG = partial gastrectomy; TG = total gastrectomy. *Significant differences (P<0.001).

3. Comparison of preoperative OG25 and STO22 scores

There were no significant differences in preoperative scores between the TG and PG groups on either the OG25 or STO22 (Table 2). There was also no significant difference in each individual score of either the OG25 or STO22 between the PG (n=122) and the TG (n=38) groups.

Table 2

Preoperative mean scores of functional scales and symptom scales of OG25 and STO22

Values are presented as mean scores. PG = partial gastrec tomy; TG = total gastrectomy.

4. Comparison of postoperative 3 weeks OG25 and STO22 scores

Table 3 shows the significant differences between the PG (n=135) and TG (n=43) in the OG25 and STO22 scores at postoperative 3 weeks. TG was associated with worse scores for dysphagia (OGDYS, TG 22.56; PG 13.54, P<0.01), reflux (OGRFX, TG 8.51; PG 14.68, P<0.05), pain and discomfort (OGPD, TG 17.35; PG 24.76, P<0.05) and weight loss (OGWL, TG 34.67; PG 21.15, P<0.05) in OG25. TG was also associated with worse scales for dysphagia (STODYS, TG 22.56; PG 13.54, P<0.01) and reflux symptoms (STORFX, TG 11.26; PG 17.27, P<0.05) on the STO22. Both the reflux scale and dysphagia scale are included in the OG25 and STO22, but pain and discomfort and weight loss scales are included only in the OG25. In subgroup analysis, the PPG group showed a significantly better score on odynophagia than the DG group at postoperative 3 weeks on the OG25 (PPG 23.06; DG 15.74, P<0.05).

Table 3

Postoperative 3 weeks mean scores on functional scales and symptom scales in OG25 and STO22

Values are presented as mean scores. PG = partial gastrec tomy; TG = total gastrectomy. *Significant differences (P<0.05).

5. Comparison of postoperative 3 months OG25 and STO22 scores

Table 4 shows the significant differences between the PG (n=132) and TG (n=43) in the OG25 and STO22 scores at postoperative 3 months. The TG was associated with worse scores for dysphagia (OGDYS, TG 16.14; PG 10.70, P<0.05), eating (OGEAT, TG 29.26; PG 19.39, P<0.01), odynophagia (OGODYN, TG 26.74; PG 14.42, P<0.01), eating with others (OGEO, TG 29.33; PG 16.53, P<0.05), trouble with taste (OGTA, TG 18.51; PG 9.51, P<0.05), and weight loss (OGWL, TG 40.26; PG 22.64, P<0.01) on the OG25. TG was also associated with worse scores for dysphagia (STODYS, TG 14.54; PG 10.29, P<0.05), eating restrictions (STOEAT, TG 27.91; PG 18.39, P<0.01) and anxiety (STOANX, TG 40.23; PG 31.22, P<0.05) on the STO22. Odynophagia, trouble with taste, and weight loss scales were included only in the OG25, not in the STO22.

Table 4

Postoperative 3 months mean scores on functional scales and symptom scales in OG25 and STO22

Values are presented as mean scores. PG = partial gastrec tomy; TG = total gastrectomy. *Significant differences (P<0.05).

6. Comparison of postoperative 6 months OG25 and STO22 scores

Table 5 shows the significant differences between PG (n=133) and TG (n=42) in OG25 and STO22 scores at postoperative 6 months. TG was associated with worse scores including body image (OGBI, TG 65.17; PG 76.56, P<0.05), dysphagia (OGDYS, TG 16.26; PG 9.35, P<0.05), odynophagia (OGODYN, TG 17.14; PG 13.09, P<0.05), pain and discomfort (OGPD, TG 7.55; PG 15.88, P<0.05), anxiety (OGANX, TG 34.10; PG 34.50, P<0.01) and weight loss (OGWL, TG 40.43; PG 23.48, P<0.01) in OG25. TG was associated with worse scores for body image (STOBI, TG 65.71; PG 76.56, P<0.05), dysphagia (STODYS, TG 16.26; PG 9.35, P<0.05), reflux symptoms (STORFX, TG 6.57; PG 12.04, P<0.05) and eating restrictions (STOEAT, TG 21.05; PG 15.05, P<0.05) on the STO22. The odynophagia and weight loss scales were included only on the OG25, not the STO22. In subgroup analysis, the PPG group showed a significantly better score for reflux than the DG group on the STO22 (PPG 16.80; DG 9.52, P<0.05).

Table 5

Postoperative 6 months mean scores of functional scales and symptom scales in OG25 and STO22

Values are presented as mean scores. PG = partial gastrec tomy; TG = total gastrectomy. *Significant differences (P<0.05).

7. Scales discriminating total gastrectomy from partial gastrectomy on the OG25

The change in each of the scales according to time was analyzed. TG patients showed worse symptom scores including pain and discomfort, reflux, weight loss, dysphagia, anxiety, body image, eating, odynophagia, and trouble with taste symptoms than PG patients, as expected.

Only the OG25 can recognized the difference between the two groups for weight loss, odynophagia, choked when swallowing, and difficulty eating with others. The scores on these scales changed over time and the changes were significantly different (Fig. 2).

Fig. 2

Scales discriminating total from partial gastrectomy with the OG25. (A) Odynophagia. (B) Weight loss. (C) Checked when swallowing. (D) Eating with others. PG = partial gastrectomy; TG = total gastrectomy; Preop. = preoperative.

Discussion

In this study, the EORTC QLQ-STO22 and QLQ-OG25 were used to evaluate differences in the preoperatively and postoperatively reported outcomes between the TG and PG groups.

Worldwide, the incidence of esophageal cancer (EC) and gastric cardia cancer is increasing, whereas the incidence of noncardiac adenocarcinomas of the stomach is decreasing.1617 The growing incidence of EC and gastric cardia cancer demonstrates the need for valid methods to measure health-related QOL in patients with esophagogastric junction cancer and proximal gastric cancer.18

This study aimed to identify differences between the TG and PG groups during the pre- and postoperative periods using the EORTC QLQ-STO22 and QLQ-OG25, and to evaluate the QOL of gastrectomized patients. The study also examined changes in weight between the two groups over time to determine which group showed a significant weight change.

Although significant differences were not observed in reported symptoms between the two groups in the pre-operative period, significant differences did occur postoperatively. In particular, 3 weeks after surgery, symptoms of pain and discomfort, reflux, weight loss, and dysphagia were worse in the TG group than in the PG group, as confirmed by the OG25. The two items of pain/discomfort and weight loss could only be confirmed by the OG25, not the STO22. Likewise, body image, eating, odynophagia, odynophagia, trouble with taste, weight loss, and dysphagia were worse 3 months after surgery in the TG group than in the PG group. Among these symptoms, body image, odynophagia, trouble with taste, and weight loss could only be confirmed by the OG25. Similarly, 6 months after surgery, the symptoms of body image, eating, odynophagia, weight loss, and dysphagia were confirmed by the OG25 to be worse in the TG group than in the PG group. Among these symptoms, odynophagia and weight loss cannot be identified by the STO22. Furthermore, differences in symptoms observed between groups over time were confirmed only by the OG25, which includes scales for odynophagia, weight loss, choked when swallowing, and trouble eating with others.

Six months after surgery, the TG group had a weight decrease of 12.71% whereas the PG group had a 7.35 % decrease (P<0.001). Similar to our results, Kim et al.19 showed that QOL of patients in the TG group was lower than that of patients in the PG group, reporting that QOL of patients in the TG group remained worse than that of the patients in the PG group, even after adjusting for cancer stage and other potential confounders. Their study found that QOL varies depending on the presence of the gastroesophageal junction (i.e., the upper third of the stomach) after surgery, which the OG25 accounts for better than the STO22. Similarly, Oñate-Ocaña et al.20 evaluated QOL in 163 esophagogastric cancer patients and reported that the OG25 accurately reflects the health related postoperative QOL of esophagogastric cancer patients.

However, a new QOL method to evaluate post-gastrectomy symptoms is required. Recently, new QOL assessment tools were developed. The Japan Postgastrectomy Syndrome Working Party developed and validated an assessment scale, the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45). This tool can be used to comprehensively evaluate the outcomes of gastrectomized patients. The PGSAS-45 has 45 items in total, 6 items from the short form-8, 15 items from the Gastrointestinal Symptom Rating Scale, and an additional 22 items.21

This study had the following limitations: first, it was a prospective cohort study at a single hospital, examining a small number of patients. Also, the patients' follow-up period was 6 months, which allowed the confirmation of short-term QOL only, not long-term QOL. In conclusion, the OG25 is a more sensitive and useful scale than the STO22 for the evaluation of QOL in gastrectomized patients, especially those with total gastrectomy.