Predicting survival in resected pancreatic cancer: A Canadian provincial experience.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 361-361
Author(s):  
Gillian Gresham ◽  
Sylvia Ng ◽  
Anderson Chang ◽  
Shannon Valdez ◽  
Sharlene Gill

361 Background: Surgical resection offers the only hope for long-term disease control in patients (pts) with pancreatic adenocarcinoma. Randomized trials (ESPAC 1, ESPAC3) further support a role for adjuvant chemotherapy (AC) in the management of pancreatic cancer (PC). Trial outcomes may not reflect clinical reality due to pt selection bias, and it is often difficult to predict which pts are most likely to benefit from adjuvant intervention. Methods: Consecutive pts between 2003 and 2008 referred to the BC Cancer Agency (BCCA) with operative intent at diagnosis (dx) were retrospectively reviewed. Results: 145 pts were identified; median age 65 years (y) (range 38-84), male/female (45.5%, 54.5%). EUS/PET staging was performed in 21% of pts. Median CA19-9 value at dx was 210 ku/L. Pancreaticoduodenectomy was performed in 65% of pts. Complete resection (RO) of tumours occurred in 87 pts (60%) overall. 66% of pts were node positive. 43% of pts were subsequently treated with adjuvant therapy (AT) where 5% of these pts received chemoradiotherapy and 95% received AC (65% gemcitabine). There was no statistically significant difference in either OS (p=0.39) or DFS (p=0.28) amongst resected pts who were treated by sx alone versus pts who received AC. In subgroup analysis, AC was associated with significantly improved OS in pts (n=58) with positive margins (R1) (median 17.3 mos vs 8.9 mos, p=0.0045) but benefit was not seen in R0 pts (n=87) (22.9 mos vs 22.4 mos, p=0.20). In multivariate analysis, poor performance status (ECOG 3-4), weight loss of more than 10% of initial body weight, baseline CA19-9 value greater than 210 ku/L, positive nodes, R1 status and histological grade 3-4 were significant adverse prognostic factors. Conclusions: PC continues to have poor outcomes with a 5yOS of 5% in pts treated with sx alone. Among pts with resectable PC treated at the BCCA, AC tended towards increased DFS and OS. Although R1 status was associated with inferior OS, the benefit of AT was greater in this subgroup. [Table: see text]

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.


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.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5035-5035
Author(s):  
Daniel Castellano ◽  
Craig Gedye ◽  
Giuseppe Fornarini ◽  
Andre P. Fay ◽  
Jens Voortman ◽  
...  

5035 Background: Pts with PS > 1 have a poor prognosis and are often excluded from clinical trials. The single-arm SAUL study (NCT02928406) evaluated atezo in a ‘real-world’ population. Overall, safety and efficacy were consistent with prior trials. However, ECOG PS 2 pts had worse overall survival (OS) but fewer adverse events (AEs) than ECOG PS 0/1 pts [Sternberg, 2019], likely reflecting shorter treatment duration and warranting exploration. Methods: Pts with mUTC received atezo 1200 mg q3w until loss of clinical benefit or unacceptable toxicity. The primary endpoint was safety. Post hoc analyses compared baseline factors, AEs and efficacy in pts with ECOG PS 2 vs 0/1. In this analysis, AE incidences were restricted to the first 45 days of atezo to adjust for differing treatment exposure. Results: None of the baseline factors explored was significantly associated with worse OS or disease control rate (DCR) in ECOG PS 2 pts. However, pts with visceral metastases and ECOG PS 2 had particularly poor outcomes. Safety appeared similar between subgroups. Conclusions: ECOG PS 2 pts have a dismal prognosis. The higher proportion with poor prognostic factors despite similar age in ECOG PS 2 vs 0/1 pts may suggest that poor PS was related to disease rather than comorbidities. Risk/benefit should be considered especially carefully when treating pts with ECOG PS 2 due to high-burden/visceral disease. Clinical trial information: NCT02928406 . [Table: see text]


Author(s):  
Nimish A. Mohile ◽  
Hans Messersmith ◽  
Na Tosha Gatson ◽  
Andreas F. Hottinger ◽  
Andrew Lassman ◽  
...  

PURPOSE To provide guidance to clinicians regarding therapy for diffuse astrocytic and oligodendroglial tumors in adults. METHODS ASCO and the Society for Neuro-Oncology convened an Expert Panel and conducted a systematic review of the literature. RESULTS Fifty-nine randomized trials focusing on therapeutic management were identified. RECOMMENDATIONS Adults with newly diagnosed oligodendroglioma, isocitrate dehydrogenase (IDH)–mutant, 1p19q codeleted CNS WHO grade 2 and 3 should be offered radiation therapy (RT) and procarbazine, lomustine, and vincristine (PCV). Temozolomide (TMZ) is a reasonable alternative for patients who may not tolerate PCV, but no high-level evidence supports upfront TMZ in this setting. People with newly diagnosed astrocytoma, IDH-mutant, 1p19q non-codeleted CNS WHO grade 2 should be offered RT with adjuvant chemotherapy (TMZ or PCV). People with astrocytoma, IDH-mutant, 1p19q non-codeleted CNS WHO grade 3 should be offered RT and adjuvant TMZ. People with astrocytoma, IDH-mutant, CNS WHO grade 4 may follow recommendations for either astrocytoma, IDH-mutant, 1p19q non-codeleted CNS WHO grade 3 or glioblastoma, IDH-wildtype, CNS WHO grade 4. Concurrent TMZ and RT should be offered to patients with newly diagnosed glioblastoma, IDH-wildtype, CNS WHO grade 4 followed by 6 months of adjuvant TMZ. Alternating electric field therapy, approved by the US Food and Drug Administration, should be considered for these patients. Bevacizumab is not recommended. In situations in which the benefits of 6-week RT plus TMZ may not outweigh the harms, hypofractionated RT plus TMZ is reasonable. In patients age ≥ 60 to ≥ 70 years, with poor performance status or for whom toxicity or prognosis are concerns, best supportive care alone, RT alone (for MGMT promoter unmethylated tumors), or TMZ alone (for MGMT promoter methylated tumors) are reasonable treatment options. Additional information is available at www.asco.org/neurooncology-guidelines .


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 317-317
Author(s):  
Darren M. C. Poon ◽  
Chan Kuen ◽  
S.H. Lee ◽  
T.W. Chan ◽  
Chun-Kin Sze ◽  
...  

317 Background: Visceral metastases or poor performance status (ECOG 2 or above) were the major exclusion criteria in the COU-AA-302 study, and hence the efficacy of abiraterone acetate (AA) in chemo-naïve mCRPC patients with these characteristics remain undetermined. Our study compares the clinical efficacy of AA in chemo-naïve mCRPC patients with or without the aforementioned characteristics. Methods: The clinical records of chemo-naïve mCRPC patients from all 6 public oncology centers in Hong Kong between August 2011 and December 2014 were reviewed. Patients with visceral disease who were medically unfit for, or who declined, chemotherapy, were allowed for AA in the study period. The median overall survival (OS), progression-free survival (PFS), patient and disease characteristics were compared between groups which satisfied, and did not satisfy, the inclusion criteria of COU-AA-302 study. Results: Fifty-eight consecutive chemo-naïve mCRPC patients had received AA in the review period, of which 29 fulfilled the inclusion criteria for the COU-AA-302 study (Group Eligible). All the remaining patients (Group Ineligible) had ECOG 2 or above, including 3 who had non-nodal visceral metastases. Group Ineligible had higher baseline PSA, haemoglobin and alkaline phosphatase level than Group Eligible, but otherwise there was no significant difference in the baseline characteristics between the groups for age, Gleason score, and co-morbidities. Group Ineligible had significantly shorter OS than Group Eligible (7.7 vs 25.0 months, p = 0.0095) and also a shorter PFS that did not reach statistical significance (5.3 vs 9.8 months, p = 0.2936). The duration of use of AA, and frequency of employment of post-AA treatment were comparable between the groups. Conclusions: Our study demonstrated a poor efficacy of AA in chemo-naïve patients who did not fulfil the inclusion criteria for COU-AA-302 study, by virtue of poor performance status or presence of visceral metastases. The impact of AA in this group of patients warrants further examination in clinical trials before its routine clinical use in this subgroup.


2021 ◽  
Author(s):  
Nimish A Mohile ◽  
Hans Messersmith ◽  
Na Tosha N Gatson ◽  
Andreas F Hottinger ◽  
Andrew B Lassman ◽  
...  

Abstract Purpose To provide guidance to clinicians regarding therapy for diffuse astrocytic and oligodendroglial tumors in adults. Methods ASCO and the Society for Neuro-Oncology convened an Expert Panel and conducted a systematic review of the literature. Results Fifty-nine randomized trials focusing on therapeutic management were identified. Recommendations Adults with newly diagnosed oligodendroglioma, isocitrate dehydrogenase (IDH)–mutant, 1p19q codeleted CNS WHO grade 2 and 3 should be offered radiation therapy (RT) and procarbazine, lomustine, and vincristine (PCV). Temozolomide (TMZ) is a reasonable alternative for patients who may not tolerate PCV, but no high-level evidence supports upfront TMZ in this setting. People with newly diagnosed astrocytoma, IDH-mutant, 1p19q non-codeleted CNS WHO grade 2 should be offered RT with adjuvant chemotherapy (TMZ or PCV). People with astrocytoma, IDH-mutant, 1p19q non-codeleted CNS WHO grade 3 should be offered RT and adjuvant TMZ. People with astrocytoma, IDH-mutant, CNS WHO grade 4 may follow recommendations for either astrocytoma, IDH-mutant, 1p19q non-codeleted CNS WHO grade 3 or glioblastoma, IDH-wildtype, CNS WHO grade 4. Concurrent TMZ and RT should be offered to patients with newly diagnosed glioblastoma, IDH-wildtype, CNS WHO grade 4 followed by 6 months of adjuvant TMZ. Alternating electric field therapy, approved by the US Food and Drug Administration, should be considered for these patients. Bevacizumab is not recommended. In situations in which the benefits of 6-week RT plus TMZ may not outweigh the harms, hypofractionated RT plus TMZ is reasonable. In patients age ≥ 60 to ≥ 70 years, with poor performance status or for whom toxicity or prognosis are concerns, best supportive care alone, RT alone (for MGMTpromoter unmethylated tumors), or TMZ alone (for MGMT promoter methylated tumors) are reasonable treatment options. Additional information is available at www.asco.org/neurooncology-guidelines.


Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2600-2600
Author(s):  
Ashish Rai ◽  
Loretta J. Nastoupil ◽  
Jessica N. Williams ◽  
Joseph Lipscomb ◽  
Kevin Ward ◽  
...  

Abstract Background: PET-assisted initial staging (PET-staging) may be useful for the accurate identification of stage I and limited stage II FL patients (pts) as candidates for potentially curative radiotherapy, for guidance of biopsy, and in determining the field of radiation. However, most guidelines recommend its judicious use in FL because its impact on treatment decisions and outcomes remains unclear. We sought to identify the factors associated with the use of PET-staging in FL and its impact on survival. Methods: We used the linked Surveillance, Epidemiology, and End Results-Medicare database to identify FL patients (pts) ≥ 65 years diagnosed between 2001 and 2009. We defined PET-staging as any whole body PET scan received 3 months prior through 6 months after diagnosis, and before the receipt of any treatment. We used multivariable logistic regression models to evaluate the relationships between pt and treatment setting characteristics, and the use of PET-staging. We examined the effects of PET-staging on overall and lymphoma-related survival (OS and LRS) using standard and propensity score (PS) matched Cox proportional hazards (CPH) regression models adjusted for pt and treatment setting characteristics. We evaluated the effect of unmeasured confounders on survival advantage from PET-staging by performing an instrumental variable (IV) CPH analysis using regional patterns of PET-staging as an instrument associated with PET use but not associated with survival (Wright, J.D. et al. Cancer 2014; Hadley, J. et al. JNCI 2010). Results: Of the 4,409 eligible pts, 58% were female, 93% were white, 80% lived in metropolitan areas, 23% lived in areas where ≥ 25% of the population had not completed high school, 46% had stage III/IV FL, 18% had grade 3 FL, 6% had B-symptoms, 16% had extra-nodal involvement, 13% had ≥ 2 comorbidities, 13% had poor performance status, and 56% most frequently visited hospitals affiliated with a research network. The increasing use of PET-staging for FL by year is displayed in the figure. Pts were more likely to undergo PET-staging if they lived in metropolitan areas (ref. less urban/rural pts; odds ratio [OR] 1.30; 95% CI 1.04-1.63); in areas with higher education levels (ref. lower levels; OR 1.25; 95% CI 1.01-1.54); had grade 3 FL (ref. grade 1 or 2 FL; OR 1.56; 95% CI 1.29-1.90); and if they most frequently visited a hospital affiliated with a research network (ref. no affiliation; OR 1.29; 95% CI 1.11-1.49). PET-staging was less commonly associated with age ≥ 81 years (ref. age 66-70; OR 0.55; 95% CI 0.45-0.67), residence in the Midwest region (ref. Southern region; OR 0.49; 95% CI 0.38-0.63), African American race (ref. White race; OR 0.59; 95% CI 0.39-0.89), presence of B-symptoms (OR 0.70; 95% CI 0.53-0.91), and poor performance status (OR 0.63; 95% CI 0.51-0.77). Results from the CPH regressions are shown in the table. Even after controlling for pt demographics, comorbidities, performance status, disease characteristics, treatment, year of diagnosis, and characteristics of the most frequently visited hospital, PET-staging was associated with improved OS (hazard ratio [HR] 0.77; 95% CI 0.69-0.86) and LRS (HR 0.69; 95% CI 0.57-0.83). This survival advantage persisted after either PS or IV-based adjustments. Conclusion: PET-staging has been widely used in newly diagnosed FL patients as a baseline investigation before initiation of therapy without well-established evidence of benefits and increased substantially over the study period. Regional, institutional, and socio-demographic variability exists in the use of PET-staging. PET-staging has been more commonly used in higher grade patients, and less commonly used in the oldest patients, patients with poorer performance status, and in patients with B-symptoms, indicating that clinicians may selectively utilize PET-staging for certain subgroups. However, the apparent survival advantage associated with PET-staging may not be entirely due to selection based on observed or unobserved confounders. Further investigation is warranted into the mechanisms of the apparent survival advantage associated with the use of PET-staging in FL. Figure 1 Figure 1. Table. OS LRS Estimation method HR (95% CI) HR (95% CI) CPH 0.77 (0.69 - 0.86) 0.69 (0.57 - 0.83) Propensity score matched CPH (caliper width 0.005) 0.82 (0.70 - 0.95) 0.63 (0.50 - 0.79) Propensity score matched CPH (caliper width 0.01) 0.81 (0.69 - 0.94) 0.74 (0.59 - 0.92) IV 0.44 (0.26 - 0.78) 0.20 ( 0.09 - 0.46) Disclosures No relevant conflicts of interest to declare.


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