Adjuvant chemotherapy of S-1 versus gemcitabine for resected pancreatic cancer: a phase 3, open-label, randomised, non-inferiority trial (JASPAC 01)

Uesaka, Katsuhiko; Boku, Narikazu; Fukutomi, Akira; Okamura, Yukiyasu; Konishi, Masaru; Matsumoto, Ippei; Kikuchi, Yuji; Shimizu, Yasuhiro; Nakamori, Shoji; Sakamoto, Hirohiko; Morinaga, Soichiro; Kainuma, Osamu; Imai, Koji; Sata, Naohiro; Hishinuma, Shoichi; Ojima, Hitoshi; Yamaguchi, Ryuzo; Hirano, Satoshi; Sudo, Takeshi; Ohashi, Yasuo

doi:10.1016/s0140-6736(16)30583-9

Cited by 835 publications

(665 citation statements)

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“…18 F-Fluorodeoxyglucose positron-emission tomography (FDG-PET) scan and carbohydrate antigen 19-9 (CA19-9) were used to determine tumor status before and after two cycles of treatment. The GS regime comprised 50 mg/m 2 TS-1 on days 1-14 and 1000 mg/m 2 gemcitabine on days 8 and 15 for two 21-day cycles, as previously reported (16). Patients with stable or responding tumors were scheduled for surgical resection 6-8 weeks after the last chemotherapy dose.…”

Section: Methodsmentioning

confidence: 99%

Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-paclitaxel Reduces the Number of Cancer-associated Fibroblasts Through Depletion of Pancreatic Stroma

Miyashita

Tajima

Makino

et al. 2018

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Section: Methodsmentioning

confidence: 99%

Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-paclitaxel Reduces the Number of Cancer-associated Fibroblasts Through Depletion of Pancreatic Stroma

Miyashita

Tajima

Makino

et al. 2018

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“…Recently, a prospective study reported that the prognosis for advanced pancreatic cancer improves with the use of immunotherapy involving DCs and cytokineinduced killer cells administered with S-1 (38), thus suggesting the synergistic efficacy of S-1 therapy combined with immunotherapy. For resected pancreatic cancer, S-1 has better efficacy in preventing recurrence than that of gemcitabine (25). The use of immunotherapy, including the WT1-DC vaccine, may be another treatment option in the future.…”

Section: Figure 1 Results Of Immunological Evaluation In Two Of Eighmentioning

confidence: 99%

“…In a recent report, the administration of S-1 alone was shown to be superior to that of gemcitabine for pancreatic cancer after resection (25). However, recurrence after surgery remains a serious problem.…”

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confidence: 99%

WT1-pulsed Dendritic Cell Vaccine Combined with Chemotherapy for Resected Pancreatic Cancer in a Phase I Study

Yanagisawa

Koizumi

Koya

et al. 2018

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Abstract. Background/Aim: Wilms' tumor 1 (WT1) is a tumor-associated antigen highly expressed in cancer. We examined the safety of WT1-peptide pulsed dendritic cell (WT1-DC) vaccine in combination withAlthough several treatment approaches, such as surgery and chemotherapy, have been used for treating pancreatic cancer, its prognosis remains poor, and further improvement in the treatment outcome is required (1-4). Recently, immunotherapy has been put forward as a new treatment approach for such cancer types with poor prognosis, and various methods have been examined in practice (1, 2, 5-7). In immunotherapy, selection of the tumor-associated antigen (TAA) is important. It has been reported that the Wilms' tumor 1 (WT1) antigen is highly expressed in various malignancies (8), including pancreatic cancer (8,9). Therefore, WT1 has been used as one of the targets of immunotherapy for pancreatic cancer (1, 7). For advanced pancreatic cancer, a WT1-peptide vaccine and WT1-peptide pulsed-dendritic cell (WT1-DC) vaccine have already been used in combination with chemotherapy agents, such as gemcitabine and S-1, in multiple studies, and its safety has been verified (10-16). Additionally, its clinical effects have been reported (11)(12)(13). Positive findings, such as WT1-specific delayed-type hypersensitivity after administration of the WT1-DC vaccine, reduced neutrophil/lymphocyte ratio in peripheral blood before or after administration, increased expression of CD83/human leukocyte antigen (HLA)-DR on DCs after administration, and no increase in interleukin-6 levels in peripheral blood after administration, have been reported as prognostic factors (13,15,16 (11,12).For patients diagnosed with primary pancreatic cancer, resection is the most important treatment, and implementation of postoperative chemotherapy can improve prognosis. In a recent report, the administration of S-1 alone was shown to be superior to that of gemcitabine for pancreatic cancer after resection (25). However, recurrence after surgery remains a serious problem. Therefore, the use of immunotherapy in combination with standard chemotherapy in the early phase can be considered as a strategy for the prevention of the recurrence of pancreatic cancer. Thus, in this study, we examined the safety of WT1-DC vaccine and acquisition of WT1-specific CTLs after administration of the vaccine with OK-432 as an adjuvant combined with chemotherapy (mainly S-1) in patients with surgically resected pancreatic cancer. Materials and MethodsPatient selection. Between August 2013 and March 2016, patients with pancreatic cancer were consecutively enrolled in this study. During this period, patients with several types of cancer received the WT1-DC vaccine at the Center for Advanced Cell Therapy in Shinshu University Hospital (26). We selected those with pancreatic cancer who underwent resection after initial diagnosis and then received chemotherapy. We excluded patients who received chemotherapy before surgery. Other eligibility criteria have been previously described (27)....

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“…17 The patients received 40 mg S-1 per square meter of body surface area twice a day for 4 weeks, followed by 2 weeks of rest as 1 course (6-week schedule) or 2 weeks followed by 1 week of rest as 1 course (3-week schedule). 18 All of the patients in the present study received either gemcitabine or S-1 treatment for 6 months.…”

Section: Adjuvant Chemotherapymentioning

confidence: 99%

The Short- and Long-Term Outcomes of Pancreatic Resection for Pancreatic Adenocarcinoma in Patients Older Than 75 Years

Aoyama

Murakawa

Atsumi

et al. 2016

International Surgery

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The short-and long-term outcomes of pancreatic resection for pancreatic adenocarcinoma have not been fully evaluated in elderly patients. This retrospective study selected patients who underwent curative surgery for pancreatic cancer at our institution. Patients were categorized into 2 groups: nonelderly patients (age , 75 years; group A) and elderly patients (age 75 years; group B). The surgical morbidity, surgical mortality, overall survival (OS), and recurrence-free survival (RFS) rates in the 2 groups were compared. A total of 221 patients were evaluated in the study. The overall complication rates were 44.8% in group A and 52.6% in group B. Surgical mortality was observed in 2 patients due to an abdominal abscess and cardiovascular disease in group A (1.1%) and in 1 patient due to postoperative bleeding in group B (2.6%). There were no significant differences (P ¼ 0.379 and P ¼ 0.456, respectively). Furthermore, the 5-year OS and RFS rates were similar between the elderly patients and nonelderly patients (18.55 versus 20.2%, P ¼ 0.946 and 13.1% versus 16.0%, P ¼ 0.829, respectively). The short-term outcomes and long-term survival after pancreatic resection for pancreatic adenocarcinoma were almost equal in the elderly and the nonelderly patients in this study. Therefore, it is unnecessary to avoid pancreatic resection for pancreatic adenocarcinoma in elderly patients simply because of their age.Key words: Pancreatic cancer -Elderly patient -Pancreatic resection P ancreatic cancer is one of the most lethal human cancers. It is the fifth-most common cancer and the fourth leading cause of cancer-related mortality worldwide, with a 5-year survival rate of less than 5% in all stages.1,2 Complete resection is essential for obtaining a cure in patients with pancreatic cancer. However, the morbidity after pancreatic resection has been reported to range from 30% to 65%, and the complications are sometimes fatal. [3][4][5][6][7] The number of elderly patients is rapidly growing worldwide. With people aged 75 and older representing the fastest growing subset of the population, the management of complex surgical issues promises to become even more challenging. However, previous studies excluded patients over the age of 75. Furthermore, few authors have evaluated the short-and long-term outcomes of pancreatic resection for pancreatic adenocarcinoma in patients aged 75 years and older. [8][9][10][11] Therefore, the short-term outcomes and long-term survival of pancreatic resection for pancreatic adenocarcinoma in elderly patients are still unclear. In addition, generally, elderly patients often have comorbidities and age-related physiologic problems that can lead to greater postoperative complications or poor survival than in nonelderly patients.We retrospectively investigated the short-term outcomes and long-term survival after pancreatic resection for pancreatic adenocarcinoma in patients older than 75 years and compared them with nonelderly patients. Patients and Methods PatientsThe study subjects were selected from t...

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Adjuvant chemotherapy of S-1 versus gemcitabine for resected pancreatic cancer: a phase 3, open-label, randomised, non-inferiority trial (JASPAC 01)

Cited by 835 publications

References 18 publications

Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-paclitaxel Reduces the Number of Cancer-associated Fibroblasts Through Depletion of Pancreatic Stroma

Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-paclitaxel Reduces the Number of Cancer-associated Fibroblasts Through Depletion of Pancreatic Stroma

WT1-pulsed Dendritic Cell Vaccine Combined with Chemotherapy for Resected Pancreatic Cancer in a Phase I Study

The Short- and Long-Term Outcomes of Pancreatic Resection for Pancreatic Adenocarcinoma in Patients Older Than 75 Years

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