Nanoliposomal irinotecan with fluorouracil for the treatment of advanced pancreatic cancer, a single institution experience

Autor: Avni M. Desai, James J. Harding, Geoffrey Y. Ku, Danielle C. Glassman, Randze Lerie Palmaira, Anna M. Varghese, Eileen M. O'Reilly, Christina M. Covington, Jia Li, Kenneth H. Yu
Rok vydání: 2018
Předmět:
Male
0301 basic medicine
Oncology
Cancer Research
medicine.medical_treatment
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
5-fluorouracil
Aged
80 and over
MM-398
Middle Aged
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Nanoliposomal irinotecan
3. Good health
Fluorouracil
030220 oncology & carcinogenesis
Female
Research Article
medicine.drug
Adult
medicine.medical_specialty
Nal-IRI
Irinotecan
lcsh:RC254-282
Proto-Oncogene Proteins p21(ras)
03 medical and health sciences
Internal medicine
Pancreatic cancer
Genetics
medicine
Humans
Progression-free survival
Aged
Retrospective Studies
Chemotherapy
Performance status
business.industry
Cancer
medicine.disease
Gemcitabine
Pancreatic Neoplasms
030104 developmental biology
Liposomes
Mutation
Nanoparticles
business
Zdroj: BMC Cancer
BMC Cancer, Vol 18, Iss 1, Pp 1-10 (2018)
ISSN: 1471-2407
DOI: 10.1186/s12885-018-4605-1
Popis: Background Effective treatment options for advanced pancreatic cancer are finite. NAPOLI-1, a phase III randomized trial, demonstrated the efficacy of nanoliposomal irinotecan with fluorouracil/leucovorin (nal-IRI + 5-FU/LV) for the treatment of advanced pancreatic cancer following progression on gemcitabine-based chemotherapy. There are limited additional data on the safety and efficacy of nal-IRI + 5-FU/LV following FDA approval in October 2015. We examined the post-approval safety and effectiveness of nal-IRI + 5-FU/LV in advanced pancreatic cancer patients receiving treatment at Memorial Sloan Kettering Cancer Center. Methods A retrospective chart review was conducted of all patients beginning treatment with nal-IRI + 5-FU/LV from October 2015 through June 2017. Using the electronic medical record and institutional database, information was extracted pertaining to demographics, performance status (ECOG), prior therapies, dose, duration of treatment, adverse events, progression free survival (PFS), overall survival (OS) and treatment response. Results Fifty six patients were identified. Median progression free survival (PFS) was 2.9 months and median overall survival (OS) was 5.3 months. Patients with prior disease progression on irinotecan experienced PFS and OS of 2.2 and 3.9 mo, respectively. Patients without prior irinotecan exposure experienced significantly longer PFS (4.8 mo, p = 0.02) and OS (7.7 mo, p = 0.002), as did patients who received prior irinotecan without disease progression (PFS, 5.7 mo, p = 0.04; OS, 9.0 mo, p = .04). Progression on prior irinotecan was associated with greater lines of prior advanced disease chemotherapy (2 vs 1). Dose reductions (DR) were most frequently due to fatigue (42%) and diarrhea (37%), but were not associated with worse outcomes. In fact, patients with ≥1 DR experienced longer PFS (5.4 v 2.6 mo, p = 0.035). Sequential therapy with nab-paclitaxel + gemcitabine (nab-P + Gem) followed by nal-IRI + 5-FU/LV (n = 25) resulted in OS of 23.0 mo. Mutations in TP53 were associated with shorter PFS. Conclusions These data support the safety and efficacy of nal-IRI + 5-FU/LV, reinforcing results of NAPOLI-1. Patients without disease progression on prior irinotecan fared significantly better than patients with progression, when treated with nal-IRI + 5-FU/LV. Sequential therapy with nab-P + Gem followed by nal-IRI + 5-FU/LV demonstrates encouraging median OS. These findings provide guidance for patients most likely to benefit from nal-IRI + 5-FU/LV. Electronic supplementary material The online version of this article (10.1186/s12885-018-4605-1) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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