Meeting
2023 ASCO Gastrointestinal Cancers Symposium
Metronomic oral cyclophosphamide as maintenance therapy in metastatic pancreatic ductal adenocarcinoma.
Authors
Michele Reni
Department of Medical Oncology, Pancreas Translational and Clinical Research Centre, Vita -Salute University, IRCCS San Raffaele Scientific Institute, Milan, Italy;
Michele Reni , Giulia Orsi , Umberto Peretti , Marina Macchini , Anna Maria Militello , Massimo Falconi , Stefano Cascinu
Organizations
Department of Medical Oncology, Pancreas Translational and Clinical Research Centre, Vita -Salute University, IRCCS San Raffaele Scientific Institute, Milan, Italy; , Pancreatic Surgery Unit, Pancreas Translational and Clinical Research Centre, Vita -Salute University, IRCCS San Raffaele Scientific Institute, Milano, Italy;
Research Funding
No funding received
None.
Background: Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) has a grim prognosis, with limited therapeutic options. In this context, treating patients (pts) with chemotherapy (CT) till progression is not supported by scientific evidence and must be weighed against quality of life impairment and cumulative toxicity. Therefore, we explored the role of metronomic oral cyclophosphamide (mCTX) as maintenance therapy (MT) in mPDAC pts. Methods: Any age mPDAC pts, with Karnofsky performance status >60 and wild-type germline BRCA1-2, who were progression-free after at least 6 months of any regimen and line CT and received mCTX (50 mg/die) MT between August 2020 and July 2022, were included in the analysis. An historical cohort (HC) of mPDAC pts, who were progression-free after 6 months of 1st-line platinum-based combination CT and did not receive MT between 2000 and 2016, was considered for exploratory comparison. Progression-free and Overall Survival (PFS and OS) were calculated from last CT administration for both cohorts. Results: 41 and 122 pts were included in mCTX and HC, respectively. Median PFS was 4.1 (range 1.5-18.4) and 3.1 (1-141) months for mCTX and HC, respectively (p= 0.003). PFS rates at 6 and 12 months were 34.7% and 11.1% in the mCTX cohort, 18.9% and 6.6% in the HC. Median OS was not reached (range 1.5-25) and 10.2 (1.3-142) months for mCTX and HC, respectively (p= 0.002). OS rates at 6 and 12 months were 96.9% and 74.6% in the mCTX cohort, 74.5% and 46.9% in the HC. Factors associated with longer PFS in the mCTX cohort were normal CA19.9 at CT start (p= 0.006), female gender (p= 0.036), no liver metastases (p= 0.01), normalized CA19.9 after CT (p= 0.01). Only 2 pts receiving mCTX had Grade 3 toxicity. Conclusions: mCTX MT extends PFS and OS of mPDAC pts not progressing after at least 6 months of CT with unremarkable toxicity in our exploratory non-randomized analysis.
| Cohort (N) | Cyclophosphamide (41) n, (%) | Historical (122) n, (%) |
|---|---|---|
| Age (years), median (range) | 68 (33-77) | 62 (32-75) |
| Gender female male | 17 (41) 24 (59) | 51 (42) 71 (58) |
| Karnofsky Performance Status 100 90 80-70 | 6 (15) 19 (46) 16 (39) | 27 (22) 52 (43) 43 (35) |
| Liver metastases at CT start Yes No | 27 (66) 14 (34) | 88 (72) 34 (28) |
| CA19.9 at CT start (U/ml) 0-34 >34 | 14 (34) 27 (66) | 26 (21) 96 (79) |
| Latest CT regimen Nab-paclitaxel + Gemcitabine PAXG Capecitabine + Oxaliplatin Capecitabine + Irinotecan PEXG/PEFG PDXG | 10 (24) 27 (66) 2 (5) 2 (5) - - | - 32 (26) - - 74 (61) 16 (13) |
| Number of prior CT, median (range) | 1 (1-2) | 1 |
| Response to prior CT Complete Response Partial Response Stable Disease | 1 (2) 24 (59) 16 (39) | 3 (3) 86 (70) 33 (27) |
| CA19.9 response to prior CT >90% 50-89% <50% | N=27 16 (59) 9 (33) 2 (7) | N=96 48 (49) 35 (36) 13 (15) |
CT: chemotherapy; CA19.9: Carbohydrate Antigen 19.9; PAXG/PEXG/PEFG/PDXG: Cisplatin, Nab-Paclitaxel or Epirubicin or Docetaxel, Capecitabine or 5-fluorouracil, Gemcitabine.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Track
Pancreatic Cancer,Hepatobiliary Cancer,Neuroendocrine/Carcinoid,Small Bowel Cancer
Sub Track
Therapeutics
Citation
J Clin Oncol 41, 2023 (suppl 4; abstr 716)
DOI
10.1200/JCO.2023.41.4_suppl.716
Abstract #
716
Poster Bd #
L3
Abstract Disclosures
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