The Impact of Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer = The Impact of Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
저자
( Manabu Kawai ) ; ( Seiko Hirono ) ; ( Ken-ichi Okada ) ; ( Motoki Miyazawa ) ; ( Yuji Kitahata ) ; ( Ryohei Kobayashi ) ; ( Masaki Ueno ) ; ( Shinya Hayami ) ; ( Hiroki Yamaue )
발행기관
학술지명
권호사항
발행연도
2018
작성언어
Korean
자료형태
학술저널
수록면
462-462(1쪽)
제공처
Backgrounds: According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, pancreatic ductal adenocarcinoma (PDAC) can be classified as resectable, borderline resectable, or unresectable. Although borderline resectable PDAC (BRPC) may technically be resectable, it has particularly high risks of margin-positive resection and postoperative recurrence. Therefore, preoperative treatment is recommended for BRPC patients in both the NCCN Guidelines and an expert consensus statement. However, the establishment of the most appropriate neoadjuvant therapy is needed by further studies. The aim of these studies is to evaluate the impact of neoadjuvant chemotherapy for BRPC and confirm the safety and efficacy of two regimens of neoadjuvant therapy for BRPC.
Our Clinical Trials: First, we evaluated the impact of neoadjuvant chemotherapy for BRPC. 143 BRPC-A patients undergoing pancreatectomy were reviewed from among 330 pancreatic cancer patients, including 111 potentially resectable pancreatic cancer patients and 76 BRPC with portal vein involvement patients. We compared the clinicopathological factors of 40 BRPC-A patients treated with neoadjuvant treatment followed by surgery and those of 103 BRPC-A patients treated with upfront surgery. The R0 rate and progression-free survival of BRPC-A patients who received neoadjuvant therapy and subsequent surgical resection were significantly better compared to those who received upfront surgery (R0: P = 0.041; progression-free survival: P = 0.033), but overall survival was not significantly different. Neoadjuvant treatment followed by surgery might provide clinical benefits for BRPC-A patients; however, the establishment of the most appropriate neoadjuvant treatment is needed by further studies. To evaluate appropriate neoadjuvant treatment, two prospective pilot trials were conducted as follows; modified FOLFIRINOX (without bolus 5-FU and LV, also decreased the dose of irinotecan; FIRINOX) and nab-paclitaxel plus gemcitabine therapy. Modified FOLFIRINOX was given to the first five patients in the 4-cycle group of the regimen and next five patients in the 8-cycle group. The primary end point was the toxicity of the therapy and one of the secondary end points were the optimal duration. The overall rate of grade 3 and 4 events was 80 %: 3 patients (60%) in the four-cycle group and five patients (100%) in the eight-cycle group had grade 3 or 4 adverse events. There was no incidence of serious adverse effect such as febrile neutropenia, sepsis, liver abscess or uncontrollable diarrhea. There was no clinically relevant morbidity presented in patients who underwent surgery. R0 rates by intention to treat were 60.0% in the four-cycle group and 40 % in the eight-cycle group (P = 0.999). The histopathologic treatment effect based on the Evans grade revealed grade I (n = 1), IIa (n = 3) in the four-cycle group and grade I (n = 2), IIa (n = 1) in the eight-cycle group. Nab-paclitaxel plus gemcitabine therapy: the primary endpoint was the toxicity, and secondary endpoints were the resection rate, the R0 resection rate. The overall rate of any grade and grade 3-4 events were 100% and 90%. The majority of these adverse events represented expected neutropenia. The resection and R0 resection rates were 80% and 70%, respectively.
Conclusion: FIRINOX therapy was feasible and safe for strictly selected patients with BRPC. On the other hand, nab-paclitaxel plus gemcitabine therapy was safe and feasible without strict selection of patients with BRPC. A multicenter phase II study is in progress to investigate the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy on overall survival (UMIN000024154).
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