Multicenter Phase II Study of Intravenous and Intraperitoneal Paclitaxel With S-1 for Pancreatic Ductal Adenocarcinoma Patients With Peritoneal Metastasis

Satoi, Sohei; Fujii, Tsutomu; Yanagimoto, Hiroaki; Motoi, Fuyuhiko; Kurata, Masahiro; Takahara, Naminatsu; Yamada, Suguru; Yamamoto, Tomohisa; Mizuma, Masamichi; Honda, Goro; Isayama, Hiroyuki; Unno, Michiaki; Kodera, Yasuhiro; Ishigami, Hironori; Kon, Masanori

doi:10.1097/sla.0000000000001705

Cited by 88 publications

(113 citation statements)

References 28 publications

(46 reference statements)

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“…Yamaguchi et al reported that IV and IP PTX with S-1 was well tolerated and highly effective against peritoneal metastases from gastric cancer (5), and the MPACT trial demonstrated that PTX was effective in metastatic pancreatic cancer (4). In fact, IV and IP PTX with S-1 recently exhibited promising results in gemcitabine-refractory pancreatic cancer (6). On pathological examination in our case, almost all peritoneal metastases appeared to have been eradicated by chemotherapy.…”

Section: Discussionmentioning

confidence: 65%

“…S-1, an oral 5-fluorouracil (5-FU) derivative and paclitaxel (PTX) have been proven to be effective in the treatment of metastatic pancreatic cancer (3,4). Combination chemotherapy consisting of intravenous (IV) and intraperitoneal (IP) PTX with S-1 was well-tolerated and achieved promising results against peritoneal metastases from gastric and pancreatic cancer (5,6). However, to the best of our knowledge, a conversion of an unresectable pancreatic cancer with peritoneal metastases to a resectable one by this combination chemotherapy has not yet been reported.…”

Section: Introductionmentioning

confidence: 93%

“…Unfortunately, the disease recurred at the Douglas pouch 8 months after surgery, which was likely due to drug resistance of the malignant cells. In a phase II study, all 8 pancreatic cancer patients with peritoneal metastases received the combination chemotherapy for >8 months prior to surgery (6). Additionally, a Japanese multicenter retrospective study demonstrated that preoperative treatment for >8 months was favorable in terms of overall survival for initially unresectable pancreatic cancer (12).…”

Section: Discussionmentioning

confidence: 99%

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Conversion therapy for pancreatic cancer with peritoneal metastases using intravenous and intraperitoneal paclitaxel with S-1

Kitayama

Tsuji

Kondo

et al. 2016

Molecular and Clinical Oncology

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Abstract. Combination chemotherapy consisting of systemic and intraperitoneal agents against peritoneal metastases from several types of cancer has shown promising results. We herein report a case in which combination therapy with intravenous and intraperitoneal paclitaxel with S-1 converted an unresectable pancreatic cancer with peritoneal metastases into a resectable one. The patient was a 65-year old woman with recurrent pancreatitis for 5 months. Endoscopic ultrasonography-guided fine-needle aspiration revealed minute epithelial masses composed of cells with irregular nuclei in the pancreatic body. The patient underwent abdominal surgery, but no excision was performed, as two peritoneal metastases in the bursa omentalis were detected. Combination therapy was initiated, consisting of intravenous and intraperitoneal paclitaxel with S-1 as a single-center clinical trial. The regimen consisted with 2-week administration of S-1 (80 mg per day) followed by 1 week of rest, intravenous paclitaxel 50 mg/m 2 , and intraperitoneal paclitaxel 20 mg/m 2 by a peritoneal access device on days 1 and 8. Over the seven cycles of the chemotherapy, the primary lesion did not change in size, and peritoneal lavage cytology remained negative. After confirming the disappearance of the peritoneal lesions by exploratory laparoscopy, the patient underwent distal pancreatectomy combined with resection of the transverse mesocolon and stomach wall. Thus, the 2-way chemotherapy of intravenous and intraperitoneal paclitaxel with S-1 was well-tolerated and was able to convert pancreatic cancer with peritoneal metastases to resectable disease.

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Section: Discussionmentioning

confidence: 65%

Section: Introductionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

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Conversion therapy for pancreatic cancer with peritoneal metastases using intravenous and intraperitoneal paclitaxel with S-1

Kitayama

Tsuji

Kondo

et al. 2016

Molecular and Clinical Oncology

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“…Satoi et al [38] assessed the combination of intravenous and intraperitoneal paclitaxel plus S-1 in chemotherapy-naive pancreatic ductal adenocarcinoma patients with peritoneal metastasis. PFS was not assessed.…”

Section: Resultsmentioning

confidence: 99%

“…S-1 was well tolerated in the adjuvant setting and could be administered with a higher relative dose-intensity than gemcitabine, even after pancreatectomy [11]. However, in non-adjuvant settings, S-1 alone [10,37] and its combinations, including, S-1 plus gemcitabine [10], S-1 plus oxaliplatin [32], S-1 plus leucovorin [36], and S-1 plus irinotecan [37], resulted in poor OS outcomes; in contrast, some studies found more promising results, such as the combination of S-1 with gemcitabine plus radiation [9] and S-1 plus paclitaxel [38]. The discrepancies in results may be because of differences in the study population in terms of progression of the disease.…”

Section: Discussionmentioning

confidence: 99%

Chemotherapy in Pancreatic Cancer: A Systematic Review

et al. 2018

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Background and Aim: Pancreatic cancer is one of the most fatal cancers. Cytotoxic chemotherapy remains the mainstream treatment for unresectable pancreatic cancer. This systematic review evaluated and compared the overall survival (OS) and progression-free survival (PFS) outcomes obtained from recent phase 2 and 3 clinical trials of pancreatic cancer chemotherapy. Materials and methods: Thirty-two studies were included and compared based on chemotherapy agents or combinations used. Additionally, outcomes of first-line versus second-line chemotherapy in pancreatic cancer were compared. Results: In studies that investigated the treatments in adjuvant settings, the highest OS reported was for S-1 in patients, who received prior surgical resection (46.5 months). In neoadjuvant settings, the combination of gemcitabine, docetaxel, and capecitabine prior to the surgical resection had promising outcomes (OS of 32.5 months). In non-adjuvant settings, the highest OS reported was for the combination of temsirolimus plus bevacizumab (34.0 months). Amongst studies that investigated second-line treatment, the highest OS reported was for the combination of gemcitabine plus cisplatin (35.5 months), then temsirolimus plus bevacizumab (34.0 months). Conclusions: There is a need to develop further strategies besides chemotherapy to improve the outcomes in pancreatic cancer treatment. Future studies should consider surgical interventions, combination chemotherapy, and individualized second-line treatment based on the prior chemotherapy.

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Surgical indication for and desirable outcomes of conversion surgery in patients with initially unresectable pancreatic ductal adenocarcinoma

Satoi

Yamamoto

Yamaki

et al. 2019

Annals of Gastroent Surgery

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Aim of this review is to propose an acceptable surgical indication for conversion surgery in patients with initially unresectable (UR) pancreatic ductal adenocarcinoma (PDAC) by considering desirable outcomes, including resectability, overall survival (OS), and disease-free survival (DFS). A comprehensive literature search of PubMed was conducted through July 15, 2019. Eligible studies were those reporting on patients with UR-PDAC who underwent surgery. We excluded case reports with fewer than 10 patients, insufficient descriptions of survival data, and palliative surgery.When patients with UR-PDAC with no progression after chemo(radiation) therapy were offered surgical exploration, resectability and median survival time (MST) of those who underwent conversion surgery ranged from 20% to 69% (median, 52%) and from 19.5 to 33 months (median, 21.9 months), respectively. When conversion surgery was carried out in patients with expected margin-negative resection or with clinical response by Response Evaluation Criteria In Solid Tumors (RECIST), resectability and MST ranged from 18% to 27% (median, 20%) and from 21 to 35.3 months (median, 30 months), respectively. Among patients who underwent conversion surgery based on clinical response and decreased CA19-9 level after multimodal treatment, resectability and MST ranged from 2% to 24% (median, 4.1%) and from 24.1 to 64 months (median, 36 months), respectively. Decreased CA19-9 level was a predictor of resectability, OS and DFS by multivariate analysis. In conclusion, decision-making for conversion surgery based on clinical response and decreased CA19-9 level after multimodal treatment may be appropriate. With regard to desirable outcomes of OS and DFS, conversion surgery may provide improved survival for patients with initial UR-PDAC. K E Y W O R D Sconversion surgery, overall survival, resectability, surgical indication, unresectable pancreatic ductal adenocarcinoma | 7 SATOI eT Al.

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Multicenter Phase II Study of Intravenous and Intraperitoneal Paclitaxel With S-1 for Pancreatic Ductal Adenocarcinoma Patients With Peritoneal Metastasis

Abstract: This regimen has shown promising clinical efficacy with acceptable tolerability in chemotherapy-naive PDAC patients with peritoneal metastasis.

Cited by 88 publications

References 28 publications

Conversion therapy for pancreatic cancer with peritoneal metastases using intravenous and intraperitoneal paclitaxel with S-1

Conversion therapy for pancreatic cancer with peritoneal metastases using intravenous and intraperitoneal paclitaxel with S-1

Chemotherapy in Pancreatic Cancer: A Systematic Review

Surgical indication for and desirable outcomes of conversion surgery in patients with initially unresectable pancreatic ductal adenocarcinoma

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