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Phase II clinical trial of gemcitabine plus oxaliplatin in patients with metastatic pancreatic adenocarcinoma with a family history of pancreatic/breast/ovarian/prostate cancer or personal history of breast/ovarian/prostate cancer (FABRIC study).
- Source :
-
International journal of clinical oncology [Int J Clin Oncol] 2020 Oct; Vol. 25 (10), pp. 1835-1843. Date of Electronic Publication: 2020 Jun 13. - Publication Year :
- 2020
-
Abstract
- Background: A family/personal history of breast, ovarian, or pancreatic cancer is a useful predictive marker for response to platinum-based chemotherapy in treating patients with pancreatic cancer. These cancers, and prostate cancer, are known as BRCA-related malignancies. We evaluated the efficacy of gemcitabine plus oxaliplatin (GEMOX) in patients with metastatic pancreatic cancer with a family/personal history of these cancers.<br />Methods: Chemotherapy-naïve patients with metastatic pancreatic cancer with a family history of pancreatic/breast/ovarian/prostate cancer or a personal history of breast/ovarian/prostate cancer were included. Patients received fixed dose-rate gemcitabine (1000 mg/m <superscript>2</superscript> ) and oxaliplatin (100 mg/m <superscript>2</superscript> ) every 2 weeks. The primary endpoint was 1-year survival, and the threshold and expected values were set at 30 and 50%, respectively. The target sample size was determined to be 43, with a one-sided alpha value of 5% and power of 80%. A total of 45 patients were enrolled.<br />Results: Among the first 43 enrolled patients, the 1-year survival rate was 27.9% [90% confidence interval (CI) 17.0-41.3], which did not meet the primary endpoint. Median overall survival, progression-free survival, and response rates were 7.6 months (95% CI 6.0-10.7), 4.0 months (95% CI 2.0-4.6), and 26.7% (95% CI 14.6-41.9), respectively, in all registered patients. The GEMOX regimen was generally tolerated; the most common grade three or higher adverse events were hematological toxicities.<br />Conclusion: GEMOX did not show the expected efficacy in patients with metastatic pancreatic cancer with a family or personal history of pancreatic/breast/ovarian/prostate cancer. Selection of GEMOX based on family/personal history is not recommended.<br />Trial Registration Number: UMIN000017894.
- Subjects :
- Adenocarcinoma mortality
Adenocarcinoma pathology
Adult
Aged
Breast Neoplasms
Deoxycytidine therapeutic use
Female
Humans
Male
Medical History Taking
Middle Aged
Organoplatinum Compounds therapeutic use
Ovarian Neoplasms
Pancreatic Neoplasms mortality
Pancreatic Neoplasms pathology
Progression-Free Survival
Prostatic Neoplasms
Survival Rate
Treatment Outcome
Adenocarcinoma drug therapy
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Deoxycytidine analogs & derivatives
Pancreatic Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1437-7772
- Volume :
- 25
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- International journal of clinical oncology
- Publication Type :
- Academic Journal
- Accession number :
- 32535711
- Full Text :
- https://doi.org/10.1007/s10147-020-01721-x