ABSTRACT
Background & objectives: FOLFIRINOX and gemcitabine plus nab-paclitaxel (GN) are the most commonly used regimens in advanced pancreatic ductal adenocarcinomas (PDACs). As there is limited data on comparison of these two regimens, the present study was aimed to compare survivals and tolerance for both regimens through a match-pair analysis. Methods: The data of 350 patients with metastatic and locally advanced PDAC, treated between January 2013 and December 2019, were retrieved. A 1:1 matching, using age and performance status, without replacement was performed by using nearest neighbour matching method. Results: A total of 260 patients (130 modified FOLFIRINOX and 130 GN) were matched. The median overall survival (OS) was 12.98 months [95% confidence interval (CI) 7.257-8.776 months] in modifications of FOLFIRINOX (mFOLFIRINOX) cohort and 12.06 months (95% CI 6.690-8.88 months) in GN group (P=0.080). The incidence of grade 3 and 4 infections, diarrhoea, oral mucositis, and fatigue was higher with mFOLFIRINOX. Patients who received second line therapy had improved OS as compared to those who did not (14.06 vs. 9.07 months, P<0.001). Interpretation & conclusions: GN and mFOLFIRINOX appear to have similar survival outcomes in an unselected match paired patient population with advanced PDAC. A markedly increased incidence of non-myelosuppressive grade 3 and grade 4 side-effects and lack of survival improvements suggest a need for nuanced use of the mFOLFIRINOX regimen. Administration of second-line chemotherapy improves OS in patients with advanced PDAC.
ABSTRACT
Objective To investigate the clinical efficacy of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.Methods The retrospective cross-sectional study was conducted.The clinicopathological data of 28 patients diagnosed as borderline resectable pancreatic cancer who were admitted to the Tianjin Medical University Cancer Institute and Hospital between April 2013 and October 2015 were collected.Twenty-eight patients were treated with modified FOLFIRINOX (irinotecan 135 mg/m2,oxaliplatin 64 mg/m2,leucovorin 400 mg/m2,5-FU 2 400 mg/m2,repeat the regimen every 2 weeks) as neoadjuvant chemotherapy.After the completion of neoadjuvant chemotherapy,patients were evaluated operation feasibility and developed surgical planning in 3 weeks.Observation indicators:(1) Efficacy of neoadjuvant chemotherapy;(2) adverse events of neoadjuvant chemotherapy;(3) surgical and postoperative situations;(4)follow-up situations.Follow-up using outpatient examination,telephone interview and we-chat was performed to detect survival of patients up to January 2017.Measurement data with skewed distribution were described as median (range).The survival curve was drawn by Kaplan-Meier method and the survival analysis was done by Log-rank test.Results (1) Efficacy of neoadjuvant chemotherapy:28 patients received chemotherapy with a median cycle of 6 cycles (range,3-12 cycles).Chemotherapy reaction of 28 patients:14 had partial remission,10 had stable disease and 4 had progressive disease.(2) Adverse events of neoadjuvant chemotherapy:there were 22 adverse events of 28 patients during chemotherapy,including 15 with grade1-2 and 7 with grade 3-4.(3)Surgical and postoperative situations:of 28 patients,18 received radical resection for pancreatic cancer including 11 receiving pancreaticoduodenectomy,7 receiving distal pancreatectomy with splenectomy.Surgeries included 6 with portal vein and superior mesenteric vein resection and reconstruction,1 with coeliac trunk resection.Ten patients received R0 resection and 8 received R1 resection.Of 18 patients,8 with postoperative complications were improved by conservative treatment,including 2 with pancreatic fistula,1 with biliary fistula,3 with delayed gastric empty,1 with anastomotic hemorrhage,1 with lympha fistula.No patient received re-operation or died within 30 days postoperatively.Pathological TNM staging:2 patients were detected in stage Ⅰ-Ⅱ,14 in stage Ⅲ and 2 in stage Ⅳ.All the 18 patients received chemotherapy after operation.Ten patients without operation continued chemotherapy.(4) Following up:28 patients were followed up for 5-21 months with a median time of 13 months.Of the 15 died patients,5 received operation and 10 received no operation.The median progressionfree survival time and median overall survival time were 14 months and 19 months in the 18 operative patients,7 months and 11 months in the 10 non-operative patients,respectively,with statistically significant differences (x2=7.335,9.950,P＜0.05).Conclusions Modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer is safe and effective,and patients can tolerate mild adverse reactions.Operable patients undergo surgeries after chemotherapy have relatively good outcome.
ABSTRACT
Objective To investigate the clinical efficacy of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.Methods The retrospective cross-sectional study was conducted.The clinicopathological data of 28 patients diagnosed as borderline resectable pancreatic cancer who were admitted to the Tianjin Medical University Cancer Institute and Hospital between April 2013 and October 2015 were collected.Twenty-eight patients were treated with modified FOLFIRINOX (irinotecan 135 mg/m2,oxaliplatin 64 mg/m2,leucovorin 400 mg/m2,5-FU 2 400 mg/m2,repeat the regimen every 2 weeks) as neoadjuvant chemotherapy.After the completion of neoadjuvant chemotherapy,patients were evaluated operation feasibility and developed surgical planning in 3 weeks.Observation indicators:(1) Efficacy of neoadjuvant chemotherapy;(2) adverse events of neoadjuvant chemotherapy;(3) surgical and postoperative situations;(4)follow-up situations.Follow-up using outpatient examination,telephone interview and we-chat was performed to detect survival of patients up to January 2017.Measurement data with skewed distribution were described as median (range).The survival curve was drawn by Kaplan-Meier method and the survival analysis was done by Log-rank test.Results (1) Efficacy of neoadjuvant chemotherapy:28 patients received chemotherapy with a median cycle of 6 cycles (range,3-12 cycles).Chemotherapy reaction of 28 patients:14 had partial remission,10 had stable disease and 4 had progressive disease.(2) Adverse events of neoadjuvant chemotherapy:there were 22 adverse events of 28 patients during chemotherapy,including 15 with grade1-2 and 7 with grade 3-4.(3)Surgical and postoperative situations:of 28 patients,18 received radical resection for pancreatic cancer including 11 receiving pancreaticoduodenectomy,7 receiving distal pancreatectomy with splenectomy.Surgeries included 6 with portal vein and superior mesenteric vein resection and reconstruction,1 with coeliac trunk resection.Ten patients received R0 resection and 8 received R1 resection.Of 18 patients,8 with postoperative complications were improved by conservative treatment,including 2 with pancreatic fistula,1 with biliary fistula,3 with delayed gastric empty,1 with anastomotic hemorrhage,1 with lympha fistula.No patient received re-operation or died within 30 days postoperatively.Pathological TNM staging:2 patients were detected in stage Ⅰ-Ⅱ,14 in stage Ⅲ and 2 in stage Ⅳ.All the 18 patients received chemotherapy after operation.Ten patients without operation continued chemotherapy.(4) Following up:28 patients were followed up for 5-21 months with a median time of 13 months.Of the 15 died patients,5 received operation and 10 received no operation.The median progressionfree survival time and median overall survival time were 14 months and 19 months in the 18 operative patients,7 months and 11 months in the 10 non-operative patients,respectively,with statistically significant differences (x2=7.335,9.950,P＜0.05).Conclusions Modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer is safe and effective,and patients can tolerate mild adverse reactions.Operable patients undergo surgeries after chemotherapy have relatively good outcome.