Prospective phase II trial of neoadjuvant chemotherapy with gemcitabine and cisplatin for resectable adenocarcinoma of the pancreatic head.

Details

Serval ID
serval:BIB_BEBDF51279E0
Type
Article: article from journal or magazin.
Collection
Publications
Title
Prospective phase II trial of neoadjuvant chemotherapy with gemcitabine and cisplatin for resectable adenocarcinoma of the pancreatic head.
Journal
Journal of clinical oncology
Author(s)
Heinrich S., Pestalozzi B.C., Schäfer M., Weber A., Bauerfeind P., Knuth A., Clavien P.A.
ISSN
1527-7755 (Electronic)
ISSN-L
0732-183X
Publication state
Published
Issued date
20/05/2008
Peer-reviewed
Oui
Volume
26
Number
15
Pages
2526-2531
Language
english
Notes
Publication types: Clinical Trial, Phase II ; Journal Article
Publication Status: ppublish
Abstract
To test the safety of neoadjuvant chemotherapy for resectable pancreatic cancer.
Patients with cytologically proven resectable adenocarcinoma of the pancreatic head were eligible for this prospective phase II trial. After confirmation of resectability by contrast-enhanced computed tomography (ceCT), positron emission tomography/CT, laparoscopy, and endoscopic ultrasound, patients received four biweekly cycles of gemcitabine 1,000 mg/m(2) and cisplatin 50 mg/m(2). Thereafter, staging was repeated and patients underwent surgery. Quality of life (QoL) and prealbumin serum levels were determined pre- and postchemotherapy. Follow-up included 3-month CA 19-9 measurements and ceCT after 6, 12, 18, and 24 months. Histologic tumor response was assessed by two scoring systems.
Twenty-eight patients entered this study. Adverse effects were mainly gastrointestinal and hematologic, most often mild, and never of grade 4. Twenty-six patients (93%) had resectable cancer on restaging examinations, and the R0 resection rate was 80%. Histologic tumor response and cytopathic effects were documented in 54% and 83% of patients, respectively. On intention-to-treat analysis, disease-free and overall survival were 9.2 months (95% CI, 5.6 to 12.9 months) and 26.5 months (95% CI, 11.4 to 41.5 months) and 9 months (95% CI, 6.99 to 10.1 months) and 19.1 months (95% CI, 15 to 23.1 months) for ductal adenocarcinoma, respectively. QoL improved in two items and was unchanged in all other items. Moreover, prealbumin serum levels significantly improved during chemotherapy (P = .008). CONCLUSION Neoadjuvant chemotherapy with gemcitabine and cisplatin is well tolerated and does not impair resectability of pancreatic cancer. Furthermore, it improves the QoL and the nutritional status of affected patients with favorable overall and disease-free survival.
Keywords
Adenocarcinoma/drug therapy, Adenocarcinoma/pathology, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Chemotherapy, Adjuvant, Cisplatin/administration & dosage, Deoxycytidine/administration & dosage, Deoxycytidine/analogs & derivatives, Disease-Free Survival, Female, Humans, Male, Middle Aged, Neoadjuvant Therapy, Neoplasm Recurrence, Local/drug therapy, Neoplasm Recurrence, Local/pathology, Neoplasm Staging, Pancreatic Neoplasms/drug therapy, Pancreatic Neoplasms/pathology, Prognosis, Prospective Studies, Quality of Life, Survival Rate
Pubmed
Web of science
Create date
11/12/2018 16:07
Last modification date
20/08/2019 16:33
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