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Quality of Life After Curative Resection for Rectal Cancer in Patients Treated With Adjuvant Chemotherapy Compared With Observation

Results of the Randomized Phase III SCRIPT Trial

van der Valk, Maxime J.M., M.D.1; Hilling, Denise E., M.D., Ph.D.1; Meershoek-Klein Kranenbarg, Elma, M.Sc.1; Peeters, Koen C.M.J., M.D., Ph.D.1; Kapiteijn, Ellen, M.D., Ph.D.2; Tsonaka, Roula, Ph.D.3; van de Velde, Cornelis J.H., M.D., Ph.D.1; Marang-van de Mheen, Perla J., Ph.D.4

Diseases of the Colon & Rectum: June 2019 - Volume 62 - Issue 6 - p 711–720
doi: 10.1097/DCR.0000000000001336
Original Contributions: Colorectal Cancer
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BACKGROUND: Adjuvant chemotherapy after curative resection for rectal cancer is the standard of care in several American and European guidelines.

OBJECTIVE: The aim of this study was to examine the differences in health-related quality of life over time between patients with rectal cancer who were treated with adjuvant chemotherapy or observation.

DESIGN: This is a randomized controlled phase III trial.

SETTINGS: Health-related quality-of-life assessments were conducted in Dutch patients from 43 institutes.

PATIENTS: Patients with stage II or III rectal cancer who underwent preoperative (chemo)radiotherapy followed by curative surgery (the SCRIPT trial) were included.

INTERVENTIONS: Patients were randomly assigned to adjuvant capecitabine monotherapy for 8 cycles or observation. Health-related quality of life was assessed using the European Organization for Research and Treatment of Cancer C30 and CR38 questionnaires at 1 month after surgery (before the start of chemotherapy), and 3, 6, and 12 months after surgery.

MAIN OUTCOME MEASURES: The primary outcome measure was the difference in quality of life at 6 months after surgery, just after completion of adjuvant chemotherapy for patients in the treatment group. Second, the difference in health-related quality of life at 12 months after surgery was examined. A statistically significant difference of 5 points was considered clinically relevant.

RESULTS: Health-related quality-of-life results of 226 of 233 patients were available. At T3, overall quality of life (C30 summary score) was worse for patients treated with chemotherapy compared with observation (mean 82.3 versus 86.9, p = 0.006), but the difference was not clinically relevant. Patients treated with adjuvant chemotherapy reported clinically relevant worse physical functioning (mean 78.3 versus 87.0, p < 0.001) and more reports of fatigue and dyspnea (35.7 versus 21.0 and 17.1 versus 6.7, p < 0.001). All differences were resolved at 12 months postsurgery.

LIMITATIONS: A selection of relatively fit patients willing to be randomly assigned may limit the generalizability of the results.

CONCLUSIONS: Although inferior health-related quality of life was reported just after completion of adjuvant chemotherapy, no persistent deterioration in quality of life was detected. See Video Abstract at http://links.lww.com/DCR/A907.

1Department of Surgery, Leiden University Medical Center, Leiden, Netherlands

2Department of Medical oncology, Leiden University Medical Center, Leiden, Netherlands

3Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, Netherlands

4Medical Decision Making, Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, Netherlands

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in HTML and PDF versions of this article on the journal’s Web site (www.dcrjournal.com).

Funding/Support: The SCRIPT trial was funded in part by the Dutch Cancer Society, CKTO 2003–16.

Financial Disclosures: None reported.

Presented at the meeting of the European Society of Surgical Oncology, October 2018.

Correspondence: Perla J. Marang-van de Mheen, Ph.D., Postbus 9600, 2300 RC Leiden. E-mail: p.j.marang-van_de_mheen@lumc.nl

© 2019 The American Society of Colon and Rectal Surgeons