Patient-reported symptoms from patients with advanced pancreatic cancer undergoing gemcitabine-based chemotherapy.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 370-370 ◽  
Author(s):  
Xin Shelley Wang ◽  
David R. Fogelman ◽  
Qiuling Shi ◽  
Cathy Eng ◽  
Raza H Bokhari ◽  
...  

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<.05%). The marginal means of severity for these three symptoms were significantly higher over time in patients who discontinued therapy < 9 weeks, compared with those who remained on study for 26-40 weeks (fatigue, P=.028; lack of appetite, P=.012; pain, P<.0001). Over time, lack of appetite improved significantly (P=.039), while pain and fatigue tended to worsen (P=NS). Compared with patients who remained on study, patients discontinued treatment earlier had significantly worse baseline pain (P=.005) and a non-significant trend towards greater fatigue and lack of appetite. 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.

2017 ◽  
Vol 13 (3) ◽  
pp. 157-166 ◽  
Author(s):  
Lauren M. Rosati ◽  
Joseph M. Herman

Literature on the management of nonmetastatic pancreatic ductal adenocarcinoma in patients who are elderly or have poor performance status is sparse. The median survival of this unique cohort of patients is < 6 months, and most patients are only offered single-agent gemcitabine or supportive care. Recently, adding nanoparticle albumin-bound paclitaxel to gemcitabine was shown to improve survival of patients with metastatic disease with Eastern Cooperative Group performance status of 2. Although standard chemoradiotherapy provides long-term locoregional control in locally advanced pancreatic cancer, it is difficult for this group of patients to tolerate 6 weeks of therapy. Stereotactic body radiotherapy (SBRT) can be delivered in only 3 to 5 days, does not require concurrent chemotherapy, and has limited toxicity, and tumor control rates appear to be equivalent to or better than those achieved with standard chemoradiotherapy. Additionally, SBRT has been shown to improve cancer-related pain and patient-reported quality of life. Given the favorable toxicity profile, SBRT seems like an obvious choice for patients who are elderly, have multiple comorbidities, or have poor performance status. Herein, we review the literature on SBRT in this unique patient population and discuss future directions.


2020 ◽  
Vol 13 ◽  
pp. 175628482097491
Author(s):  
Hasan Rehman ◽  
Jeffrey Chi ◽  
Nausheen Hakim ◽  
Shreya Prasad Goyal ◽  
Coral Olazagasti ◽  
...  

Background: Treatment with gemcitabine/nab-paclitaxel confers a survival benefit over gemcitabine monotherapy in patients with advanced pancreatic cancer (APC). However, such treatment can be associated with significant toxicities especially in older patients and carries practical disadvantages related to a weekly schedule along with financial cost. We retrospectively analyzed patients >65 years of age with APC who received a modified biweekly regimen of gemcitabine/nab-paclitaxel to evaluate efficacy and toxicity. Methods: Patients aged >65 years with chemo-naïve APC with Eastern Cooperative Oncology Group performance status ⩽2 were studied. Patients were treated with a modified regimen of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 every 2 weeks on days 1 and 15 of a 28-day cycle. Patients were evaluated for progression-free survival (PFS) and overall survival (OS) with analyses performed using the Kaplan–Meier method. Adverse events were recorded on the day of chemotherapy. Cancer antigen 19.9 was measured in every cycle and restaging scans were performed every two cycles. Results: A total of 73 patients (median age: 73 years; range: 66–93) were treated with biweekly gemcitabine/nab-paclitaxel as first-line treatment. The median OS and PFS were 9.1 months and 4.8 months, respectively. Around 66% of patients received growth-factor support based on American Society of Clinical Oncology guidelines and no patient developed neutropenic fever. The incidences of grade ⩾3 toxicity for neutropenia, anemia, thrombocytopenia, and neurotoxicity were 2%, 7%, 3%, and 5%, respectively. Dose reductions of gemcitabine/nab-paclitaxel were required in 10% and 4% patients, respectively. Conclusion: In patients older than >65 years of age with APC, a modified regimen of biweekly gemcitabine/nab-paclitaxel was found to be effective when compared with the historical control from the MPACT study. This regimen allowed for fewer dose reductions, reduced healthcare costs from additional appointments, travel-related cost, as well as a favorable side-effect profile while maintaining efficacy. Though retrospective in nature, this study underlines the need for further investigation, particularly in elderly patients with poor performance status, such as those with pancreatic cancer, and in order to combine with a third agent, such as a targeted treatment or immunotherapy.


2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 183-183 ◽  
Author(s):  
I. Ohno ◽  
S. Mitsunaga ◽  
K. Nakachi ◽  
S. Shimizu ◽  
H. Takahashi ◽  
...  

183 Background: Alkaline phosphatase (ALP) is an enzyme that is elevated by various hepatobiliary diseases. Generally its elevation is thought to indicate bile stasis. There are some reports that show ALP is an important prognostic factor for several cancers such as colon, lung, and gastric cancer. Often it is speculated that ALP elevation indicates bile stasis caused by liver metastasis. However, the significance of ALP elevation in advanced pancreatic cancer (APC) patients is not well evaluated. The aim of this study was to determine the significance of elevated serum ALP as a prognostic factor in patients with APC even without jaundice and liver metastasis. Methods: Serum ALP levels were measured in 393 patients with APC receiving gemcitabine monotherapy before treatment, and according to those levels, patients were subgrouped (ALP<upper normal limit (UNL), UNL-500 U/L, 501-700 U/L, 701-1000 U/L, 1000U/L < ALP). The clinical data of each group were analyzed to see characteristics of elevated ALP patients. The relationship between ALP level and survival, response were also examined. Results: The elevated ALP group included poor performance status (PS>1) patients (41.3%, p=0.001), and associated with low serum albumin (3.31±0.38, p<0.01). The elevated ALP group (median survival time (MST) 112 days) showed significantly worse prognosis and lower disease control rate compared to the normal ALP group (MST 217days) (p<0.001, p<0.001). Multivariate analysis revealed ALP (p<0.001), CRP (p<0.001), ascites (p<0.001), distant metastasis (p=0.003), white blood cell count (p=0.005), PS (p=0.020), AST (p=0.020), and ALT (p=0.020) were independent prognostic factors. Similar results were seen in liver metastasis free patients without jaundice. Conclusions: Elevated serum ALP level correlated with poor performance status and low serum albumin. ALP was also the independent prognostic factor in liver metastasis free APC patients without jaundice. No significant financial relationships to disclose.


2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 84-84
Author(s):  
Lauren M. Rosati ◽  
Zhi Cheng ◽  
Scott P. Robertson ◽  
Megan N. Kummerlowe ◽  
Amy Hacker-Prietz ◽  
...  

84 Background: Prospective evaluation of correlations between patient- (PROs) and physician-reported outcomes (PhROs) was conducted among a group of patients receiving stereotactic body radiation therapy (SBRT) for recurrent or locally advanced pancreatic cancer (PCA). Methods: Forty-two patients were treated with 25-33 Gy using SBRT in 5 fractions on a single-institution study. Eight outcomes (performance status, fatigue, pain, anorexia, nausea, vomiting, constipation, and diarrhea) were consistently evaluated by patients and providers prior to SBRT and 4-6 weeks post-SBRT. Patient-reported quality of life (QOL) metrics were assessed using the EORTC QLQ-C30 and QLQ-PAN26, while physician-reported toxicities were graded using the NCI CTCAE v4.0.A Pearson’s correlation was used to determine the relationship between PROs and PhROs. Results: Of the 42 enrolled patients, 36 had both PROs and PhROs collected before (median, 2.9 weeks) SBRT. Physician-reported pain, nausea, constipation, and diarrhea did not show a correlation with patient-reported overall health or QOL. Physician-reported fatigue showed a correlation with patient-reported pain (r > 0.5, p < 0.001) and QOL (r > -0.5, p < 0.001) but not fatigue (r < 0.3, p > 0.05). Nausea and constipation were the only PROs that did not correlate with their respective PhROs (nausea, r < 0.3, p > 0.05; constipation, r < 0.5, p = 0.07) or any of the other 7 PhROs. Only 24 had both PROs and PhROs collected 4-6 weeks after (median, 5.1 weeks) SBRT. Vomiting, constipation, and diarrhea were PhROs that demonstrated no correlation with patient-reported overall health or QOL. Physician-reported vomiting did not correlate with patient-reported vomiting (r < 0.3, p > 0.05) or any of the 7 other PROs. The correlation between patient- and physician-reported pain increased from pre- (r > 0.3, p = 0.03) to post- (r > 0.7, p < 0.0001) SBRT. Conclusions: Discrepancies among PROs and PhROs appear to exist in pancreatic-specific outcomes of interest such as constipation and diarrhea. Future health care teams may find it helpful to consider PROs to better manage symptoms and deliver more personalized care. Clinical trial information: NCT01781728.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5557-5557 ◽  
Author(s):  
Larissa Meyer ◽  
Qiuling Shi ◽  
Maria Iniesta ◽  
Melinda Harris ◽  
Charlotte C. Sun ◽  
...  

5557 Background: Patient-reported outcomes (PROs) are important in comparative effectiveness research. We compared symptom burden and functional recovery in pts undergoing primary cytoreductive surgery (PCS) or neoadjuvant chemotherapy (NACT) and interval cytoreductive surgery (ICS) within an enhanced recovery after surgery program (ERAS). Methods: Perioperative PROs were measured for women with ovarian cancer undergoing PCS or ICS using the MD Anderson Symptom Inventory- Ovarian Cancer, a 27-item validated tool which was administered preoperatively, daily in hospital, and at least weekly for 8 weeks post-op. Mixed-effect modeling was performed. Results: 108 pts (45 PCS, 63 ICS) participated. There was no difference in median age, Charlson comorbidity index, ASA status, history of chronic opioid use, length of stay or readmission rate. At pre-op baseline assessment, the mean pain score was higher in the PCS group (3.8 vs. 1.8, p = .0005). ICS pts had a lower median surgical complexity score (4.0 vs. 2.0, p = .03), and shorter median surgical time (260 min vs. 223 min, p = .05). During hospitalization, pts undergoing PCS reported significantly more bloating, urinary urgency, distress, sadness and mood disturbance. Women who received NACT had a significantly higher symptom burden of neuropathy, leg cramps and memory disturbances. There was no difference in pain, fatigue, drowsiness, nausea, or emesis within the first 5 days postoperatively. While there was no significant differences in the physical interference composite score, (walking, work, activity), those who underwent ICS had improved affective interference scores (mood, relations, enjoyment of life). Conclusions: Within an ERAS program, there were few significant differences in surgery related symptoms related to physical recovery between pts undergoing PCS or ICS. The differences in overall symptom burden suggest that disease related symptoms (pain, bloating, urinary urgency) and emotional symptoms may be related to recent diagnosis and higher tumor burden in pts undergoing PCS while the increased numbness, leg cramps and memory issues reflect chemo-related effects in the ICS cohort.


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 205-205
Author(s):  
Wei Fang Dai ◽  
Jaclyn Marie Beca ◽  
Helen Guo ◽  
Lucy Qiao ◽  
Wanrudee Isaranuwatchai ◽  
...  

205 Background: Advanced pancreatic cancer (APC) patients often have a substantial symptom burden. In Ontario, patients visiting cancer clinics routinely complete the Edmonton Symptom Assessment Scale (ESAS), which screens for 9 symptoms (scale: 0-10). Using ESAS, we explored the association between baseline patient-reported outcomes and overall survival (OS). Methods: APC Patients with ESAS records prior to receiving publicly-funded drugs from November 2008 to March 2016 were identified from Cancer Care Ontario’s New Drug Funding Program and Symptom Management databases. We examined 3 baseline composite ESAS scores: Total Symptom Distress Score (TSDS: all 9 symptoms), Physical Symptom Score (PHS: 6/9 symptoms), and Psychological Symptom Score (PSS: 2/9 symptoms); Composite scores greater than a threshold (defined as number of symptoms in composite score multiplied by clinically relevant score (≥4)) were categorized as High Symptom Burden (TSDS ≥ 36, PHS ≥ 24, PSS ≥ 8). The primary endpoint, OS, was assessed using Kaplan-Meier. Multivariable Cox models were used to adjust for age, gender, income, prior therapies (surgery, adjuvant gemcitabine, radiation), and Charlson's comorbidity. Analysis was repeated in a sub-cohort with identifiable ECOG status and stage. Results: We identified 2,199 APC patients (mean age 64 years, 55% male) with ESAS records prior to receiving gemcitabine (54%), FOLFIRINOX (40%) or gemcitabine/nab-paclitaxel (6%). Crude median survival was 4.5 and 7.3 months for patients with high and low TSDS burden, respectively (HR = 1.50, 95% CI: 1.36, 1.66). After adjustment with multivariable Cox model, high TSDS burden was associated with lower OS (HR = 1.47, 95% CI: 1.33, 1.63). Similar trends were observed for PHS and PSS. When adjusting for both PHS and PSS in a Cox model, only the effect of PHS remained significant. In the sub-cohort (n = 393), high TSDS burden (HR = 1.34, 95% CI: 1.04, 1.73) was associated with lower OS, after adjusting for ECOG and stage. Conclusions: Among APC patients, a higher burden of patient-reported symptoms, via ESAS, at baseline was associated with reduced OS. The effect was prominent for physical symptoms, even after adjusting for treatment, stage and ECOG.


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 405-405
Author(s):  
Se Jun Park ◽  
Myung Ah Lee

405 Background: There is few data for effective second-line treatment in advanced pancreatic cancer, and most patients have poor performance status after progressive disease. We evaluated the efficacy, toxicity, and median dose intensity of oral chemotherapy, capecitabine, or TS-1 in gemcitabine-refractory advanced pancreatic cancer for second-line treatment. Methods: Patients who have progressive disease after first-line gemcitabine-based chemotherapy were retrospectively analyzed between Jan. 2011 and Nov. 2017. These patients were treated with capecitabine or TS-1 as second-line treatment. Capecitabine were administered as 2,500 mg/m2 divided dose on day 1-14, followed by one week rest. In TS-1 group, TS-1 was taken orally based on patient’s BSA (60mg twice daily in BSA > 1.5, 50mg twice daily in BSA 1.25-1.5, and 40mg twice daily in BSA < 1.25) through 28 days, by two week rest. Median dose intensity was compared by calculating a percent of target dose achieved in the average cycle for each patient. Results: Of the total 62 patients, 41 patients were treated with capecitabine and 21 patients were treated with TS-1. The median age was 61 years for the capecitabine group compared with 62 years for the TS-1 group. In capecitabine group, males were 56%, and in TS-1 group, males were 66%. 29% of capecitabine group received prior fluorouracil base therapy, and 47% of TS-1 group were receiving such therapy. The objective response rate was similar in the two groups: 12.2% with capecitabine and 4.8% with TS-1 (p = 0.358). There was no difference in median progression free survival between capecitabine and TS-1 (2.1 months vs. 2.7 months, p = 0.102), however, TS-1 group showed better median overall survival time than capecitabine group (6.9 months vs. 4.6 months, p = 0.048). Most of the adverse events were similar in both group, except that grade 3 or 4 mucositis was more common in TS-1 group. There was no significant difference in median dose intensity between two groups. (Capecitabine 91.5% vs. TS-1 90.1%, p = 0.216). Conclusions: Oral agents such as TS-1 or capecitabine can be second-line treatment for advanced pancreatic cancer patients with poor performance status after progression to gemcitabine-based regimen.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7574-7574
Author(s):  
Xin Shelley Wang ◽  
Zhongxing X. Liao ◽  
Ritsuko Komaki ◽  
James D. Cox ◽  
Daniel Richard Gomez ◽  
...  

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.


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