- Email: [email protected]
Efficacy and safety of nab-Paclitaxel alone for advanced pancreatic cancer: A retrospective study
Abstracts / Pancreatology 16 (2016) S1eS192
Background: FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GNP) are the standard first-line chemotherapy regimens used for unresectable pancreatic cancer. FFX is the treatment of first choice at our institute if patients meet the criteria proposed by the JPS. The purpose of this study was to clarify the second-line treatment selection after FFX or GNP under real-life clinical conditions. Methods: We examined the safety and efficacy and the reasons for the discontinuation of second-line treatments in patients with unresectable pancreatic cancer who had received FFX or GNP as a first-line chemotherapy between December 2013 and September 2015. Results: Forty-eight patients were treated with FFX (20 patients) or GNP (28 patients). Patients in the FFX group tended to be younger than those in the GNP group (median age, 55 vs. 67 years, P¼0.092). No other differences in background characteristics were observed between the groups. The first-line chemotherapy had been discontinued in 36 patients (FFX, GNP：15, 21). The reasons for discontinuation were disease progression (12, 14), conversion to surgery (2, 1), adverse events (0, 4), death (0, 1), unsuccessful biliary drainage for obstructive jaundice (0, 1), and patient refusal (1, 0). As second-line treatments after first-line chemotherapy with FFX, GNP was used in 9, gemcitabine was used in 1, heavy ion radiotherapy was used in 1, and BSC was used in 2；after first-line GNP, S-1 was used in 8, fixed dose gemcitabine plus S-1 was used in 2, BSC was used in 11, and 1 patient was lost to follow up. Conclusions: When FFX was used properly, most patients in the FFX group received GNP as second-line treatment. Since GNP was used in elderly patients, treatment was discontinued in half of the patients because of disease progression, and less than 50% of the patients received secondline treatment.
S173
P-308. Efficacy and safety of nab-Paclitaxel alone for advanced pancreatic cancer: A retrospective study Shimpei Matsusaki 1, Hiroki Taoka 2, Takashi Hamada 2, Takao Omori 2 1 2
Department of Gastroenterology, Suzuka General Hospital, Japan Department of Surgery, Suzuka General Hospital, Japan
Background: nab-Paclitaxel plus gemcitabine (GEM) was superior to GEM alone for patients with metastatic pancreatic cancer in the phase III MPACT trial. Now we administer except for the GEM from nab-Paclitaxel plus GEM as the 3rd or 4th chemotherapy for advanced pancreatic cancer, however, its efficacy is unknown. Patients and methods: Out of 32 cases with advanced pancreatic cancer who had received chemotherapy in our hospital in 2015, we analyzed their therapeutic outcome and clinical course of 6 cases treated nab-Paclitaxel alone, retrospectively. Result: The mean age was 70 years (range, 57-81 years), 5 were men and 1 was woman. 1 of these cancers was located in the pancreatic head and 5 were in the body and tail. 2 cases had locally advanced lesion and 4 had metastatic lesions. 4 cases underwent the 3rd line chemotherapy and 2 cases underwent the 4th line chemotherapy. The relative dose intensity was 65% (33-100%). The median disease control period was six months. Two cases had a side effect of neutropenia (Gr3). Conclusion: nab-Paclitaxel alone treatment demonstrated sufficient disease control effect in the 3rd or 4th treatment for advanced pancreatic cancer, but needed dose reduction in almost all cases.
P-307.
P-310.
FOLFIRINOX combination chemotherapy for patients with unresectable pancreatic cancer: A single-institution experience
nab-Paclitaxel/gemcitabine as second-line therapy after FOLFIRINOX failure in advanced pancreatic cancer
Makoto Takeda, Takanori Sakaguchi, Ryouta Kiuchi, Yoshifumi Morita, Hiroyuki Konno
Rei Suzuki 1, Tadayuki Takagi 1, Mitsuru Sugimoto 1, Ko Watanabe 2, Yuichi Waragai 2, Hitomi Kikuchi 1, Hiroyuki Asama 1, Mika Takasumi 1, Takuto Hikichi 2, Hiromasa Ohira 1
Second Department of Surgery, Hamamatsu University School of Medicine, Japan Background and purpose: FOLFIRINOX combination chemotherapy (oxaliplatin, irinotecan, fluorouracil, and leucovorin) significantly improve prognosis of patients with metastatic pancreatic cancer. Herein, we retrospectively analyzed the efficacy of FOLFIRINOX combination chemotherapy for unresectable pancreatic cancer in our institute. Patients and methods: We conducted a retrospective analysis of patients receiving FOLFIRINOX combination chemotherapy for metastatic or marginally resectable pancreatic cancer between 2011 and 2014. Patients receiving prior other chemotherapy were excluded. Results: Of 12 analyzed patients, 6 were men；the median patient age was 69 years, and the Eastern Cooperative Oncology Group performance status (PS) ranged from 0 to 2. The major Grade 3 and 4 hematological toxicities were neutropenia (100%) and febrile neutropenia (50%). The major Grade 2 and 3 non-hematological toxicities were diarrhea (33.3%) and anorexia (66.7%). No case of treatment-related death was observed. The best overall response was complete response in 0 patients, partial response in 2, stable disease in 3, and progressive disease in 7. The response rate was 16.6%, and the disease control rate was 41.6%. The median overall survival was 201 days. The overall survival of patients aged over and under 70 years was 152 and 437 days, respectively (P¼0.056). The overall survival of patients with a PS 0 or 1 was 437 days, while that of patients with a PS 2 was 119 days (P¼0.005). The overall survival of patients with a PS 2 who underwent bile duct stenting or hepaticojejunostomy was 152 days while that of the other patients was 405 days (P¼0.069). Conclusion: FOLFIRINOX combination chemotherapy had better be chosen for selected patients according to the patients'status, such as obstructive jaundice, age, or PS.
1 Department of Gastroenterology and Rheumatology, Fukushima Medical University School of Medicine, Japan 2 Department of Endoscopy, Fukushima Medical University Hospital, Japan
Background: FOLFIRINOX (FFX) has shown improved survival in advanced pancreatic cancer comparing to gemcitabine alone. However, a choice of second line therapy after FFX failure has not been clearly determined. We evaluated the role of nab-paclitaxel plus gemcitabine (GnP) after FFX failure. Methods: We included patients who underwent GnP after FFX failure between April 2014 and December 2015. FFX was delivered at least 4 cycles as first-line therapy. Clinical backgrounds, hematologic toxicities, time to treatment failure (TTF) of GnP, and overall survival (OS) since FFX were evaluated. Results: During study period, we included 5 patients (3 female and 2 male) who underwent GnP as second line therapy. Median age was 59 years old (55-69) at the time of diagnosis. One locally advanced and 4 metastatic pancreatic cancers were included. Performance status was still 0 to 1 even after FFX in all patients (median duration of FFX：11.0 months (9.0-13.9)). Even though there were 4 SD and 1 PD, more than 50% reduction of tumor markers was observed in 4 patients and time to treatment failure of GnP was 4.6 months (1.0-11.3). Grade 3/4 hematologic toxicity was observed in 1 patient (neutropenia). Overall survival was 17.0 months (15.1-21.7) and 2 patients still survive and undergo chemotherapy. Conclusions: GnP can improve survival after FFX failure in advanced pancreatic cancer. Further study must be done to determine optimal patients who can benefit from this second line regimen.
Background: FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GNP) are the standard first-line chemotherapy regimens used for unresectable pancreatic cancer. FFX is the treatment of first choice at our institute if patients meet the criteria proposed by the JPS. The purpose of this study was to clarify the second-line treatment selection after FFX or GNP under real-life clinical conditions. Methods: We examined the safety and efficacy and the reasons for the discontinuation of second-line treatments in patients with unresectable pancreatic cancer who had received FFX or GNP as a first-line chemotherapy between December 2013 and September 2015. Results: Forty-eight patients were treated with FFX (20 patients) or GNP (28 patients). Patients in the FFX group tended to be younger than those in the GNP group (median age, 55 vs. 67 years, P¼0.092). No other differences in background characteristics were observed between the groups. The first-line chemotherapy had been discontinued in 36 patients (FFX, GNP：15, 21). The reasons for discontinuation were disease progression (12, 14), conversion to surgery (2, 1), adverse events (0, 4), death (0, 1), unsuccessful biliary drainage for obstructive jaundice (0, 1), and patient refusal (1, 0). As second-line treatments after first-line chemotherapy with FFX, GNP was used in 9, gemcitabine was used in 1, heavy ion radiotherapy was used in 1, and BSC was used in 2；after first-line GNP, S-1 was used in 8, fixed dose gemcitabine plus S-1 was used in 2, BSC was used in 11, and 1 patient was lost to follow up. Conclusions: When FFX was used properly, most patients in the FFX group received GNP as second-line treatment. Since GNP was used in elderly patients, treatment was discontinued in half of the patients because of disease progression, and less than 50% of the patients received secondline treatment.
S173
P-308. Efficacy and safety of nab-Paclitaxel alone for advanced pancreatic cancer: A retrospective study Shimpei Matsusaki 1, Hiroki Taoka 2, Takashi Hamada 2, Takao Omori 2 1 2
Department of Gastroenterology, Suzuka General Hospital, Japan Department of Surgery, Suzuka General Hospital, Japan
Background: nab-Paclitaxel plus gemcitabine (GEM) was superior to GEM alone for patients with metastatic pancreatic cancer in the phase III MPACT trial. Now we administer except for the GEM from nab-Paclitaxel plus GEM as the 3rd or 4th chemotherapy for advanced pancreatic cancer, however, its efficacy is unknown. Patients and methods: Out of 32 cases with advanced pancreatic cancer who had received chemotherapy in our hospital in 2015, we analyzed their therapeutic outcome and clinical course of 6 cases treated nab-Paclitaxel alone, retrospectively. Result: The mean age was 70 years (range, 57-81 years), 5 were men and 1 was woman. 1 of these cancers was located in the pancreatic head and 5 were in the body and tail. 2 cases had locally advanced lesion and 4 had metastatic lesions. 4 cases underwent the 3rd line chemotherapy and 2 cases underwent the 4th line chemotherapy. The relative dose intensity was 65% (33-100%). The median disease control period was six months. Two cases had a side effect of neutropenia (Gr3). Conclusion: nab-Paclitaxel alone treatment demonstrated sufficient disease control effect in the 3rd or 4th treatment for advanced pancreatic cancer, but needed dose reduction in almost all cases.
P-307.
P-310.
FOLFIRINOX combination chemotherapy for patients with unresectable pancreatic cancer: A single-institution experience
nab-Paclitaxel/gemcitabine as second-line therapy after FOLFIRINOX failure in advanced pancreatic cancer
Makoto Takeda, Takanori Sakaguchi, Ryouta Kiuchi, Yoshifumi Morita, Hiroyuki Konno
Rei Suzuki 1, Tadayuki Takagi 1, Mitsuru Sugimoto 1, Ko Watanabe 2, Yuichi Waragai 2, Hitomi Kikuchi 1, Hiroyuki Asama 1, Mika Takasumi 1, Takuto Hikichi 2, Hiromasa Ohira 1
Second Department of Surgery, Hamamatsu University School of Medicine, Japan Background and purpose: FOLFIRINOX combination chemotherapy (oxaliplatin, irinotecan, fluorouracil, and leucovorin) significantly improve prognosis of patients with metastatic pancreatic cancer. Herein, we retrospectively analyzed the efficacy of FOLFIRINOX combination chemotherapy for unresectable pancreatic cancer in our institute. Patients and methods: We conducted a retrospective analysis of patients receiving FOLFIRINOX combination chemotherapy for metastatic or marginally resectable pancreatic cancer between 2011 and 2014. Patients receiving prior other chemotherapy were excluded. Results: Of 12 analyzed patients, 6 were men；the median patient age was 69 years, and the Eastern Cooperative Oncology Group performance status (PS) ranged from 0 to 2. The major Grade 3 and 4 hematological toxicities were neutropenia (100%) and febrile neutropenia (50%). The major Grade 2 and 3 non-hematological toxicities were diarrhea (33.3%) and anorexia (66.7%). No case of treatment-related death was observed. The best overall response was complete response in 0 patients, partial response in 2, stable disease in 3, and progressive disease in 7. The response rate was 16.6%, and the disease control rate was 41.6%. The median overall survival was 201 days. The overall survival of patients aged over and under 70 years was 152 and 437 days, respectively (P¼0.056). The overall survival of patients with a PS 0 or 1 was 437 days, while that of patients with a PS 2 was 119 days (P¼0.005). The overall survival of patients with a PS 2 who underwent bile duct stenting or hepaticojejunostomy was 152 days while that of the other patients was 405 days (P¼0.069). Conclusion: FOLFIRINOX combination chemotherapy had better be chosen for selected patients according to the patients'status, such as obstructive jaundice, age, or PS.
1 Department of Gastroenterology and Rheumatology, Fukushima Medical University School of Medicine, Japan 2 Department of Endoscopy, Fukushima Medical University Hospital, Japan
Background: FOLFIRINOX (FFX) has shown improved survival in advanced pancreatic cancer comparing to gemcitabine alone. However, a choice of second line therapy after FFX failure has not been clearly determined. We evaluated the role of nab-paclitaxel plus gemcitabine (GnP) after FFX failure. Methods: We included patients who underwent GnP after FFX failure between April 2014 and December 2015. FFX was delivered at least 4 cycles as first-line therapy. Clinical backgrounds, hematologic toxicities, time to treatment failure (TTF) of GnP, and overall survival (OS) since FFX were evaluated. Results: During study period, we included 5 patients (3 female and 2 male) who underwent GnP as second line therapy. Median age was 59 years old (55-69) at the time of diagnosis. One locally advanced and 4 metastatic pancreatic cancers were included. Performance status was still 0 to 1 even after FFX in all patients (median duration of FFX：11.0 months (9.0-13.9)). Even though there were 4 SD and 1 PD, more than 50% reduction of tumor markers was observed in 4 patients and time to treatment failure of GnP was 4.6 months (1.0-11.3). Grade 3/4 hematologic toxicity was observed in 1 patient (neutropenia). Overall survival was 17.0 months (15.1-21.7) and 2 patients still survive and undergo chemotherapy. Conclusions: GnP can improve survival after FFX failure in advanced pancreatic cancer. Further study must be done to determine optimal patients who can benefit from this second line regimen.