International Journal of Radiation Oncology*Biology*Physics
Clinical InvestigationQuality 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
Introduction
Approximately 20% to 30% of patients who undergo pancreatectomy for pancreatic adenocarcinoma do not receive adjuvant therapy, often owing to slow recovery after surgery. Although adjuvant chemotherapy and/or radiation therapy has been shown to improve local recurrence and survival, it is associated with treatment-related morbidity and mortality 1, 2, 3, 4. Neoadjuvant therapy increases the likelihood that patients will receive chemotherapy and radiation, without incurring delays resulting from postoperative recovery. Further, the potential for therapy-related downstaging of the primary tumor might allow higher rates of margin-negative resection, a particularly important issue in borderline resectable cases (5). Specific benefits for the incorporation of neoadjuvant radiation therapy include the ability to treat with smaller radiation therapy volumes, thus limiting toxicity. By limiting toxicity, neoadjuvant radiation therapy can be delivered concurrently with full-dose chemotherapy 6, 7.
The impact of neoadjuvant chemoradiation on the quality of life (QOL) of patients with pancreatic cancer is not known, because prospective QOL data in this patient population are limited. Given the short life expectancy of these patients and the high potential for treatment-related toxicity, it is important to understand how QOL can be affected during and after completion of neoadjuvant treatment. Preservation of function and well-being in everyday life has become a key component of the health care goals for cancer patients 8, 9. This is especially important in the neoadjuvant setting, where deterioration of health-related QOL and performance status may impact patients' ability to tolerate a major pancreatectomy. The working hypothesis of this study was that global QOL did not decrease from baseline to re-evaluation after 2 cycles of neoadjuvant chemoradiation.
Section snippets
Study design
This was a substudy of a prospective, multi-institutional, phase 2 trial (10). Patients with untreated pancreatic adenocarcinoma consented to receive neoadjuvant chemoradiation with full-dose gemcitabine and oxaliplatin, with accrual occurring between July 2007 and February 2010. Eligible participants were required to have pathologic confirmation of pancreatic adenocarcinoma and resectable or borderline resectable staging according to the National Comprehensive Cancer Network guidelines (11).
Patient description
There were 71 participants enrolled onto the clinical trial. The QOL component of this study was started after 7 participants were already included into the trial. Of 64 potential participants eligible for QOL, 57 completed at least 1 QOL instrument, and 55 were included in the final analysis (Fig. 1). All further references below relate to these 55 participants.
There were 29 men and 26 women, median age 64 (range, 42-82) years. At diagnosis, 36 of 55 patients (65%) had borderline resectable
Discussion
There is limited literature evaluating the impact of neoadjuvant therapy on QOL in pancreatic cancer (16). This prospective analysis examined the QOL outcomes of patients with pancreatic adenocarcinoma who received neoadjuvant full-dose gemcitabine and oxaliplatin with concomitant conformal radiation, followed by surgery and 2 postoperative cycles of chemotherapy (10). Our results indicate that although this neoadjuvant treatment protocol is associated with an initial decrease in global
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Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib
2019, Annals of OncologyCitation Excerpt :The analysis was carried out using a linear mixed model for repeated measures, adjusted for score at baseline, time, and treatment-by-time interaction to estimate the cumulative effect of olaparib versus placebo on GHS. Between-group differences were compared using adjusted mean estimates for each treatment group with a between-group difference of ≥10 points defined as clinically meaningful, based on published literature [17–19]. A change of ≥10 points from baseline was also predefined as clinically meaningful [17–19].
Chapter 28 - Quality of life and hepatobiliary tumors
2016, Blumgart's Surgery of the Liver, Biliary Tract and Pancreas: Sixth EditionPatient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer
2016, Practical Radiation OncologyCitation Excerpt :We did not include a QoL time point on day 5 of SBRT given unlikely onset of symptoms within this timeframe. In a recent study by the University of Michigan,20 borderline resectable and LAPC patients were treated with 1 cycle of gemcitabine and oxaliplatin followed by 30 Gy in 15 fractions CRT with concurrent gemcitabine and oxaliplatin. The QLQ-C30 and QLQ-PAN26 questionnaires were administered at baseline and following chemotherapy and CRT at 6 months, limiting the ability to capture acute side effects associated with CRT.
This research is supported (in part) by the National Institutes of Health through the University of Michigan's Cancer Center Support Grant (5 P30 CA46592) by the use of the Cancer Center Clinical Trials Office and Biostatistics Core and (in part) by Sanofi.
Conflict of interest: M.M.Z. received research support from Sanofi for his reported clinical trial. T.S.B.-S. receives support from Sanofi as a consultant. A.C.W. has received honoraria from Sanofi.