Alternating Gemcitabine/Nab-Paclitaxel (GA) and 5-FU/Leucovorin/Irinotecan (FOLFIRI) as First-Line Treatment for De Novo Metastatic Pancreatic Cancer (MPC): Safety and Effect.

Simple Summary: This study explores the efficacy and safety of alternating gemcitabine/nab-paclitaxel (GA) and 5-FU/leucovorin/irinotecan (FOLFIRI) regimens in patients with metastatic pancreatic cancer (MPC). The approach aims to reduce toxicity, slow resistant cancer biology, and facilitate the in...

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Publicado en:Cancers Vol. 15; no. 23; pp. 5588 - 5598
Autores principales: Schroeder, Brett A., Mandelson, Margaret T., Picozzi, Vincent J.
Formato: research tables/charts Journal Article
Publicado: MDPI Dec2023
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Dec2023
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      iid: 23
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      pub: MDPI
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        174115337
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        10.3390/cancers15235588
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        atl: Alternating Gemcitabine/Nab-Paclitaxel (GA) and 5-FU/Leucovorin/Irinotecan (FOLFIRI) as First-Line Treatment for De Novo Metastatic Pancreatic Cancer (MPC): Safety and Effect.
      aug:
        au:
          Schroeder, Brett A.
          Mandelson, Margaret T.
          Picozzi, Vincent J.
        affil: Virginia Mason Medical Center, Seattle, WA 98101, USA
      sug:
        subj:
          Pancreatic Neoplasms Drug Therapy
          Neoplasm Metastasis Drug Therapy
          Antineoplastic Agents, Combined
          Gemcitabine Therapeutic Use
          Paclitaxel Therapeutic Use
          Fluorouracil Therapeutic Use
          Leucovorin Therapeutic Use
          Irinotecan Therapeutic Use
          Drug Efficacy
          Patient Safety
          Human
          Retrospective Design
          Descriptive Statistics
          Data Analysis Software
          Male
          Female
          Adult
          Middle Age
          Aged
          Kaplan-Meier Estimator
          Confidence Intervals
          Cox Proportional Hazards Model
          Tomography, X-Ray Computed Methods
          Funding Source
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Aged: 65+ years
          Male
          Female
      ab: Simple Summary: This study explores the efficacy and safety of alternating gemcitabine/nab-paclitaxel (GA) and 5-FU/leucovorin/irinotecan (FOLFIRI) regimens in patients with metastatic pancreatic cancer (MPC). The approach aims to reduce toxicity, slow resistant cancer biology, and facilitate the incorporation of other therapeutic agents. The results show a median overall survival (mOS) of 13.2 months, competitive with standard regimens, and encouraging long-term survival rates at 18 and 24 months. The toxicity profile is favorable, and supportive growth factors were not needed. This regimen appears promising for MPC and warrants further investigation. Background: Both gemcitabine- and 5-fluorouracil (5-FU)-based chemotherapy regimens have demonstrated efficacy in metastatic pancreatic cancer (MPC). Alternating these regimens may reduce toxicity, slow resistant cancer biology emergence, and provide a platform for the addition of other therapeutic agents. Alternating gemcitabine/nab-paclitaxel (GA) and 5-FU/leucovorin/irinotecan (FOLFIRI) in MPC has previously been reported at our own institution and elsewhere. An extension of our institutional observations is reported here. Methods: Patient eligibility required the following: biopsy-proven de novo MPC, no prior evidence of disease on CT, ECOG performance status (PS) ≤ 2, and bi-dimensionally measurable disease. Treatment (Tx) entailed gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 1, (8), 15 alternating every 8 weeks (2 cycles) with FOLFIRI using standard dosing. Patients were radiographically re-staged every 8 weeks. Tx spanned up to 12 cycles. Tx thereafter was decided following patient/physician discussion. Results: Median overall survival (mOS) was 13.2 months (95% CI 10.9–16.5 months). Median progression-free survival (mPFS) was 8.5 months (95% CI, 7.1–9.9). The 6-, 12-, 18-, and 24-month OS rates were 88%, 54%, 36%, and 20%, respectively. The disease control rate at 16 weeks was 83% (37% PR, 46% SD). Hematologic toxicity grade ≥ 3 included 9.3% anemia, 10.2% neutropenia, and 4.6% thrombocytopenia. Neutrophil growth factors were not used in this cohort. Non-hematologic toxicities grade ≥ 3 included neuropathy 0.9%, nausea/vomiting 0.9%, and diarrhea 0.9%. No patients experienced mucositis on this regimen. Conclusions: Alternating GA/FOLFIRI in MPC has a favorable toxicity profile in comparison to current standard regimens. Median OS was at least competitive with standard regimens, and longer-term (18 and 24 months) OS seemed particularly encouraging. Treatment for ≥48 weeks and ECOG PS of zero at the time of treatment initiation were prognostically significant. Further investigation using this regimen including randomized comparisons, the incorporation of molecular data, and use of additional agents is merited.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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