The phase I study of concurrent chemoradiotherapy using a combination of gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer: Update.

Authors

null

Tatsuya Ioka

Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

Tatsuya Ioka , Kazuhiro Katayama , Ryoji Takada , Kazuyoshi Ohkawa , Hidenori Takahashi , Teruki Teshima

Organizations

Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan, Department of Pancreatic Surgery, Osaka Medical Center for Cancer and CVD, Osaka, Japan, Osaka Med Center for Cancer and Cardiovascular Diseases, Osaka, Japan

Research Funding

Other

Background: Gemcitabine (GEM) plus nab-paclitaxel (nP) are one of the standard of care for metastatic pancreatic cancer, but it is still controversial about the value in non-metastatic patients. Purpose: The primary objective of this study is to assess the toxicity of concurrent chemoradiotherapy (CRT) with a combination of GEM and nP for unresectable locally advanced pancreatic cancer (UR-LAPC). Methods: Chemotherapy-naive patients with histologically or cytologically proven UR-LAPC were enrolled to this trial. The patients received GEM and nP intravenously over 30 min. respectively on days 1, 8 and 15 every 28 days. Cycles were repeated every 28 days during radiotherapy. Patients were scheduled to receive GEM (mg/msq/week) and nP (mg/msq/day) at six dose levels: 600/50 (level 1), 600/75 (level 2), 600/100 (level 3), 800/100 (level 4), 1,000/100(level 5) and 1,000/125(level 6). Radiation therapy was delivered through four fields as a total dose of 50.4 Gy in 28 fractions over 5.5 weeks, and no prophylactic nodal irradiation was given. Dose-limiting toxicity (DLT) was defined as grade 4 hematological toxicity, grade 3 non-hematological toxicity and >14 days delay of treatment. Every patients were evaluated for response with RECIST criteria. Results: Twenty one patients were enrolled in this study between 12/2013 and 05/2015. Treatment was well tolerated; Every 21 patients completed radiotherapy of 50.4 Gy. Our recommended dose was level 3, Gem 600mg/ nP 100mg. Nine patients experienced DLT. The response rate was 67% (CR 0, PR 14, SD 6 and PD 1). Median OS was 23.8 months (95%CI: 17.0, -) and median PFS was 9.0 months (95%CI: 4.8, 11.9). Conclusions: The CRT with a combination of GEM and nP can be delivered almost safely for UR-LAPC. Clinical trial information: UMIN000012254.

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Abstract Details

Meeting

2017 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Cancers of the Pancreas, Small Bowel and Hepatobiliary Tract

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

UMIN000012254

Citation

J Clin Oncol 35, 2017 (suppl 4S; abstract 462)

DOI

10.1200/JCO.2017.35.4_suppl.462

Abstract #

462

Poster Bd #

M2

Abstract Disclosures

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