RESUMEN
Background: Pancreatic adenocarcinoma [PAC] forms 85 percent of pancreatic cancers. In Lebanon the annual mortality rate is 4.3 per 100 000 persons. Data are lacking in the Lebanese population on the treatment evolution of pancreatic adenocarcinoma. We conducted a study to compare two groups of pancreatic adenocarcinoma patients through time
Methods: We randomly assigned 70 patients from NDS-UH who were diagnosed having PAC from the beginning of the year 2000 until the end of 2017. All patients were above 18 years old at time of diagnosis, with an ECOG PS of 0 or 1. All of them had not received any prior chemotherapy or radiotherapy, and they all had a locally advanced i.e. inoperable or metastatic PAC. The 70 patients were divided into 2 groups. The first group is formed by all patients diagnosed before 2010 and the second group by all patients diagnosed after 2010. The primary endpoint is the OS rate in each group. The secondary endpoints are the PFS1, PFS2, RR and the mean OS variability in each gender with time
Results: The groups of people studied in this analysis were 64.3 percent male 35.7 percent female with a mean age of 64.37 years. 58.6 percent had an ECOG-PS of 0 while the remaining 41.4 percent had an ECOG-PS of 1. 60 percent of the cancers were located in the head of the pancreas, 14.3 percent in its tail and 22.9 percent in the body. The mean size of the tumor regarding the location was 36.24 mm [body: 36.88 mm, tail: 57.4 mm, head: 30.95 mm]. The stages were divided as follow: 17.15 percent stage IIB, 24.28 percent stage III and 58.57 percent stage IV. 40 percent of the patients had metastases in the lymph nodes at diagnosis while 44.3 percent, 5.7 percent, 4.3 percent and 5.7 percent had hepatic, pulmonary, hepatic and pulmonary metastases and peritoneal carcinoses at diagnosis respectively. The mean Ca 19-9 was 16 080.8197 U/ml. Our two groups were statistically similar in terms of sex, age, ECOG PS, stages and location of the cancer in the pancreatic gland at diagnosis with identical mean WBC, LDH, Ca19-9, total and direct bilirubin and HbA1C levels at time of diagnosis. The mean glycemia level was different in the 2 groups with 132 mg/ml in the group diagnosed before 2010 versus 181.32 mg/ml in the group diagnosed after 2010 with a p value of 0.019. The mean OS was 11.5 months [95 percent CI, 7.4 to 15.5] in patients diagnosed before 2010 vs. 14.39 months [95 percent CI, 11.4 to 17.3] in patients diagnosed after 2010. The median OS was 7.3 months [95 percent CI, 4.28-10.45] in the first group vs. 12.4 months [95 percent CI, 8.15-16.64] in the second group with a p value of 0.23; p > 0.005 percent. The mean PFS1 was 10.34 months [95 percent CI, 8.05 to 12.63] after 2010 vs. 7.94 months [95 percent CI, 4.7 to 11.14] in the first group. We saw an increase of 4 months in the median PFS1 between the 2 groups with 4.27 months [95 percent CI, 3.2 to 5.2] in the first group vs. 8.23 months [95 percent CI, 5.4 to 10.9] in the second with a p value of 0.18; p > 0.005 percent. Mean PFS2 in the first group is 6.08 months [95 percent CI, 3.4 to 8.7] vs. 6.96 months [95 percent CI, 1.088 to 4.8] in the second group. Median PFS2 is 3.8 months [95 percent CI, 1.84 to 5.76] for the former group vs. 6.1 months [95 percent CI, 2.68 to 9.5] for the latter group, with a p value of 0.43; p > 0.005 percent. The response rate was higher in the group of patients diagnosed after 2010 with 37.5 percent com- pared to 20 percent in the group of patients diagnosed before 2010. When comparing the OS between genders we saw a stable OS in female patients within the 2 groups while the male groups had an increase in their OS. In the group of patients diagnosed before 2010, males had a mean OS of 10 months [95 percent CI, 5.2 to 14.8] and females had a mean OS of 14.4 months [95 percent CI, 7.1 to 21.6]. In the group of patients diagnosed after 2010, males had a mean OS of 14.1 months [95 percent CI, 9.9 to 18.2] and females a mean OS of 14.8 months [95 percent CI, 11 to 18.6]. In other terms, the MR in female remained stable with time, while it decreased in the males that were diagnosed after 2010
Conclusion: Overall, there was an absolute increase of 5.1, 3.96 and 2.3 months in the median OS, PFS1 and PFS2 respectively, between the groups of patients diagnosed before and after 2010 without any statistical significance. This lack of significance can be due to the fact that our study was based on comparing two periods of time and not different chemotherapeutic regimens as seen in all the literature