Neoadjuvant FOLFIRINOX versus Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy for Resectable and Borderline Resectable Pancreatic Cancer: Update on the Nationwide Multicenter PREOPANC-2 Randomized Trial

315 Background: Because of the high incidence of local recurrence and liver metastasis, long-term outcomes of patients following resection of advanced pancreatic cancer are extremely poor. Facilitation of curative resection and prevention of micrometastasis are the goals of neoadjuvant therapy. We evaluated the feasibility and efficacy of our neoadjuvant chemoradiotherapy (NACRT) protocol for borderline resectable pancreatic cancer patients. Methods: During the period between 2003 and 2011, 24 patients with borderline resectable pancreatic cancers underwent NACRT comprising 5-FU (300 mg/body/day, day 1−5/week for 4 weeks), cisplatin (10mg/body day2, 9, 16, 23), mitomycin C (4mg/body/day, day 1, 8, 15, and 22), heparin (6000 IU/body/day for 4 weeks), and radiation (2 Gy/day, day 1−5/week for 4 weeks, total 40 Gy). They were reevaluated for resectability after therapy. Primary endpoints were toxicity and overall patient and disease-free survivals. Secondary endpoint was the ratio of microscopically margin negative resection. Results: All 24 patients completedNACRT. Grade 3−4 hematological adverse events were observed in 9 (38%) patients but none developed severe gastrointestinal toxicity. In 7 (29%) patients, restaging revealed distant metastasis or local disease progression not amenable to curative resection. The remaining 17 patients (71%) underwent surgery (pancreatoduodenectomy, 13 and distal pancreatectomy, 4) with zero 30-day postoperative or in-hospital mortality. The 5-year overall all patient and disease-free survival rates after pancreatectomy were 52.6% and 36.3%, respectively. Postoperative histopathological evaluation demonstrated a marked degenerative change in the specimen, achieving negative surgical margins in 15/17 (88%) patients and pathological complete response in the remaining 2 (12%) patients. Conclusions: Our NACRT protocol is feasible with a low toxicity profile and an excellent curative resection rate in the treatment of borderline resectable pancreatic cancer. It is a promising regimen associated with improved long-term prognoses than historical controls.

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Neoadjuvant chemoradiotherapy with S-1 in patients with borderline resectable pancreatic cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.3_suppl.302 ◽

2014 ◽

Vol 32 (3_suppl) ◽

pp. 302-302 ◽

Cited By ~ 3

Author(s):

Masashi Hattori ◽

Tsutomu Fujii ◽

Masaya Suenaga ◽

Suguru Yamada ◽

Mitsuro Kanda ◽

...

Keyword(s):

Pancreatic Cancer ◽

Radiation Therapy ◽

Neoadjuvant Chemoradiotherapy ◽

Venous System ◽

Pathological Examination ◽

Visceral Artery ◽

Portal Venous System ◽

Resectable Pancreatic Cancer ◽

Borderline Resectable ◽

Borderline Resectable Pancreatic Cancer

302 Background: The aim of this study was to investigate the efficacy and safety of neoadjuvant chemoradiotherapy (NACRT) with S-1 (oral fluoropyrimidine) followed by surgery for the treatment of borderline resectable pancreatic cancer that involved the major visceral artery or the portal venous system. Methods: Twenty-eight patients with pancreatic cancers that abutted the SMA in 10, the CHA in 7, the both SMA and CHA in 1, and occluded the SMV/PV in 10 were treated with NACRT at a single institution. Radiation therapy was delivered at a total dose of 50.4 Gy in 28 fractions. S-1 was administered orally at a dose of 80 mg/m(2)/day for 14 consecutive days followed by a 7-day rest period during radiation therapy. After radiotherapy and 2 courses of S-1, restaging was done to evaluate secondary resectability. Results: Of the all patients, 25 underwent a full course of NACRT, and NACRT terminated in 3 patients because of grade 3 leukopenia in 2 and tumor bleeding in 1. Partial response was achieved in 3 patients and stable disease in 22. Twenty-four patients (86%) underwent surgical resection, and all had margin-negative (R0) resections. Only two patients (8%) had major morbidity as Clavien-Dindo’s classification III or more, and there was no operative or in-hospital mortality. Pathological examination revealed that more than 50% of tumor cells had disappeared in 14 cases and all cases achieved Evans’ score IIa and more. Conclusions: Neoadjuvant chemoradiation with S-1 was feasible and promising therapy for borderline resectable pancreatic cancer that involves the major artery or the portal venous system.

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