Journal
CURRENT ONCOLOGY
Volume 28, Issue 3, Pages 1761-1772Publisher
MDPI
DOI: 10.3390/curroncol28030164
Keywords
metastatic pancreatic cancer; nab-paclitaxel; FOLFIRINOX; dose finding
Categories
Funding
- GOIRC
- Celgene International Sarl [IIT33321_AX0103_NABUCCO Ver05-29 oct13]
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The study evaluated the efficacy of Nab-FOLFIRI and Nab-FOLFOX as first-line chemotherapy for metastatic pancreatic cancer patients, showing high overall response rates and clinical benefit rates, as well as promising 1-year survival rates.
Background: Relevant improvement in first-line treatment of metastatic pancreatic cancer (mPC) was provided by FOLFIRINOX and by gemcitabine (gem) plus nab-paclitaxel (Nab-p) regimens. Regardless of the first-line treatment survival benefit, most patients survive less than 1 year. Aim: The objectives of this multicenter phase I/II study were to evaluate as first-line chemotherapy (CT) two modified regimens of FOLFIRINOX, replacing either oxaliplatin (Oxa) or irinotecan with Nab-p, in patients with mPC. Methods: The primary objectives of phase 1 were the definition of the dose limit binations, while for phase II they were the characterization of safety and activity of Nab-FOLFIRI and Nab-FOLFOX in mPC. Results: Sixty-three patients received Nab-FOLFIRI or Nab-FOLFOX in phase I. We defined MTD at 120 mg/m(2) for Nab-p with FOLFIRI and 160 mg/m(2) with FOLFOX. In phase II, we randomized 42 patients for each arm with the following results: (1) overall response rate (ORR) was 31% for both schedules; (2) a clinical benefit rate (CBR) of 69% and 71%; (3) 1-year survival was 41% and 50%; (4) progression free survival (PFS) was 6 months and 5.6 months; (5) median overall survival (OS) was 10.2 and 10.4 months for Nab-FOLFIRI and Nab-FOLFOX, respectively. (6) Neutropenia was the most common grade >= 3 adverse event in our regimens, significantly lower than that reported for the FOLFIRINOX triplet. Conclusion: Nab-FOLFIRI and Nab-FOLFOX might be hopeful first-line CT options for mPC patients, with promising activity and a good safety profile.
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