Quality of Life in a Prospective, Multicenter Phase 2 Trial of Neoadjuvant Full-Dose Gemcitabine, Oxaliplatin, and Radiation in Patients With Resectable or Borderline Resectable Pancreatic Adenocarcinoma

Journal Article · Wed Oct 01 04:00:00 EDT 2014 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/J.IJROBP.2014.05.053· OSTI ID:22423810

Serrano, Pablo E. ^[1]; Herman, Joseph M. ^[2]; Griffith, Kent A.; Zalupski, Mark M. ^[3]; Kim, Edward J. ^[4]; Bekaii-Saab, Tanios S. ^[5]; Ben-Josef, Edgar ^[4]; Dawson, Laura A. ^[6]; Ringash, Jolie ^[6]

---

1. Department of Surgery, University Health Network, University of Toronto, Toronto, ON (Canada)
2. Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States)
3. Center for Cancer Biostatistics, Biostatistics Unit, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan (United States)
4. Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan (United States)
5. Division of Medical Oncology, Department of Internal Medicine, The Ohio State University Medical Center, Columbus, Ohio (United States)
6. Princess Margaret Cancer Center, University Health Network, Toronto, ON (Canada)

Purpose: To determine the health-related quality of life (QOL) during and after neoadjuvant chemoradiation therapy and surgery for patients with pancreatic adenocarcinoma. Methods and Materials: Participants of a prospective, phase 2 multi-institutional trial treated with neoadjuvant chemoradiation followed by surgery completed QOL questionnaires (European Organization for Research and Treatment in Cancer Quality of Life Questionnaire version 3.0 [EORTC-QLQ C30], EORTC-Pancreatic Cancer module [EORTC-PAN 26], and Functional Assessment of Cancer Therapy Hepatobiliary and Pancreatic subscale [FACT-Hep]) at baseline, after 2 cycles of neoadjuvant therapy, after surgery, at 6 months from initiation of therapy, and at 6-month intervals for 2 years. Mean scores were compared with baseline. A change >10% was considered a minimal clinically important difference. Results: Of 71 participants in the trial, 55 were eligible for QOL analysis. Compliance ranged from 32% to 74%. The EORTC-QLQ C30 global QOL did not significantly decline after neoadjuvant therapy, whereas the Functional Assessment of Cancer Therapy global health measure showed a statistically, but not clinically significant decline (−8, P=.02). This was in parallel with deterioration in physical functioning (−14.1, P=.001), increase in diarrhea (+16.7, P=.044), and an improvement in pancreatic pain (−13, P=.01) as per EORTC-PAN 26. Because of poor patient compliance in the nonsurgical group, long-term analysis was performed only from surgically resected participants (n=36). Among those, global QOL returned to baseline levels after 6 months, remaining near baseline through the 24-month visit. Conclusions: The study regimen consisting of 2 cycles of neoadjuvant therapy was completed without a clinically significant QOL deterioration. A transient increase in gastrointestinal symptoms and a decrease in physical functioning were seen after neoadjuvant chemoradiation. In those patients who underwent surgical resection, most domains returned back to baseline levels by 6 months.

• OSTI ID: 22423810
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 2 Vol. 90; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
CARCINOMAS
CHEMOTHERAPY
CLINICAL TRIALS
COMBINED THERAPY
COMPARATIVE EVALUATIONS
DIARRHEA
PAIN
PANCREAS
PATIENTS
RADIOTHERAPY
STANDARD OF LIVING
SURGERY