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10119Background: We examined longitudinal changes in symptom severity and symptom interference with activity-related (WAW: work, general activity, walking) and mood-related (REM: relations with oth...

10100 Background: Patients with multiple myeloma (MM) experience substantial pain that may be from disease and/or post autologous stem cell transplant condition, and exacerbated by maintenance therapy. Minocycline is a readily available, low-cost antibiotic with anti-inflammatory properties. We conducted a phase II randomized, double-blinded, placebo controlled clinical trial to investigate the effect of minocycline in reducing patient-reported symptoms during maintenance therapy. Methods: Adults with MM scheduled for maintenance therapy at a single-institution were consented and randomized to receive either minocycline (100 mg twice daily) or placebo over the first 3 cycles maintenance therapy. Feasibility, toxicity, and patient-reported outcome data were prospectively collected. The MD Anderson Symptom Inventory-MM (0–10 scale) was used to assess pain and other symptoms weekly during 3 months trial. The longitudinal analysis for pain was compared between the minocycline and control groups to examine minocycline’s efficacy. Results: From April 2013 to Aug 2016, 88 patients were enrolled and 69 (78%) were evaluable: 33 were randomized to minocycline and 36 to placebo. There were no grade 3+ study medication-related adverse events. The worst 5 symptoms on MDASI-core during the trial were fatigue, pain, numbness/tinging, drowsiness, and disturbed sleep, followed by two MM module item bone aches and muscle weakness. Demographic and disease characteristics were not significantly different between groups. Longitudinal modelling of revealed a significant reduction on pain in minocycline group than placebo group (time and treatment group interaction, estimate=-0.068, P=.003). The favorite pain reduction in minocycline group vs placebo arm was represented by a moderate effect size (Cohen’s d =0.48). Conclusions: Minocycline during maintenance therapy for MM was feasible, had a low toxicity profile, and yielded a statistically significant positive signal on pain reduction. These preliminary results are encouraging and warrant a Phase III trial to test its efficacy. Clinical trial information: NCT01793051.

e21636Background: In patients with newly diagnosed pancreatic cancer, symptom burden can be driven by both rapid disease progression and aggressive cancer therapy. Abatement of symptoms is a highly...

9611 Background: Clinical practice and research often solely rely on clinician ratings of treatment toxicities, where a simple “symptomatic/not symptomatic” question to the patient is typically use...

e20699 Background: The high symptom burden reported by patients being treated for advanced pancreatic cancer could be driven by both disease and treatment. Few clinical studies have addressed the a...

7574 Background: Concurrent chemoradiation (CXRT) for stage III non-small-cell lung cancer (NSCLC) patients is associated with the development of systemic self-reported symptom burden as well as radiation esophagitis (RE). This longitudinal study aims to provide a profile of the symptom burden among 3 radiation techniques concurrently used with chemotherapy: 3-dimensional conformal radiation therapy (3DCRT), intensity- modulated radiation therapy (IMRT) and proton beam therapy (PBT). Methods: NSCLC patients (N=164) treated at MD Anderson Cancer Center rated symptoms via the M. D. Anderson Symptom Inventory (MDASI) weekly from pre-therapy up to 20 weeks post-therapy. Descriptive analysis identified major symptom burden, and mixed effect modeling examined change over time in symptom outcomes among the 3 types of CXRT. Results: Average total radiation dose was higher (p=.0003) for PBT (N=30, 71.6 Gy) and IMRT (N=67, 66.3 Gy) than for 3DCRT (N=24, 62.1 Gy). Over time, all patients reported a cluster of symptoms that increased as the dose accumulated, including fatigue, drowsiness, pain, difficulty swallowing, poor appetite and sore throat; symptoms generally peaked at week 7-9 and returned to pre-therapy levels at week 13. The IMRT group had significant less-severe sore throat (p=.03), while there were no significant differences in symptom severity among the 3 types of CXRT for the other major symptoms before, during and after CXRT. However, there was a trend of more patients reporting moderate to severe sickness symptoms as a component score (fatigue, pain, sore throat, poor appetite and drowsiness) in the 3DCRT group than in the IMRT or PBT groups at end of CXRT (50% vs. 44%, 31%) and at 13 weeks (53% vs. 23%, 25%). Also, there was a trend of more patients under 3DCRT than IMRT or PBT had moderate to severe sore throat (RE symptom) by end of CXRT (60% vs. 44%, 46%) and no different by 13 weeks (27% vs. 25%, 31%). Conclusions: Although clinical studies have reported the toxicities of CXRT, this is the first longitudinal study that compared symptom profiles for NSCLC patients receiving PBT, IMRT and 3DCRT. There is an impression of more severe treatment-related symptoms for 3DCRT (although in lower radiation dose) than IMRT or PBT.

370 Background: The symptoms reported by patients being treated for advanced pancreatic cancer (PC) could be driven by disease and treatment. Few clinical studies have addressed the interaction between disease, treatment, and symptom burden. We conducted a longitudinal study tracking multiple symptoms to provide an evidence-based symptom profile for patients with advanced PC receiving gemcitabine-based chemotherapy. Methods: From start of the first chemotherapy cycle (baseline), patients rated symptoms weekly during chemotherapy via the M. D. Anderson Symptom Inventory (MDASI), then continued symptom assessment every two weeks for up to 40 weeks. Longitudinal symptom responses were analyzed by mixed-effect modeling. Results: Among 100 PC patients enrolled, 87% were treatment-naïve. The median age was 65 yrs old (range 35-85). Half of the sample was female; 32% received opioids for severe pain. The three most severe MDASI symptoms at baseline were fatigue, lack of appetite, and pain. Poor performance status and opioid use were significantly related to severity of these baseline symptoms (all P Conclusions: Our results suggest that standard gemcitabine-based chemotherapy plus active palliative care for advanced PC was associated with significant improvement in appetite. However, worsening fatigue suggests a need to provide active intervention to minimize this symptom for PC patients. Patients suffering from greater symptom burden at baseline and overtime, seems consistent with greater disease burden, may be expected to discontinue treatment earlier.