Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets.

Abstract

OBJECTIVE:

The objective of the study is to evaluate the usefulness of neoadjuvant chemoradiotherapy in resectable pancreatic cancer.

METHODS:

A single-center RCT of patients affected by resectable pancreatic adenocarcinoma which included arm A (surgery alone) and arm B (neoadjuvant chemoradiation and surgery). The primary endpoint was R0 resection; the secondary endpoints were toxicity; number of patients who completed the neoadjuvant therapy; radiological and pathological response after chemoradiation; and pTNM stage, postoperative morbidity, mortality, and overall and disease-free survival. A sample size of 32 patients was required for each group.

RESULTS:

The study was terminated early, and 38 patients were randomized: 20 in arm A and 18 in arm B. There was no significant difference regarding R0 resection rate in the two groups (intention-to-treat, OR = 1.91, P = 0.489). Neoadjuvant chemoradiotherapy was completed in 14 out of 18 cases (77.8 %) and the radiological and pathological response was efficacious in 72.3 and 90.9 % of cases, respectively.

CONCLUSIONS:

Neoadjuvant chemoradiation was feasible, safe, and efficacious, although non-significant results were obtained as a result of the underpowered data due to the difficulty in recruiting patients. Additional multicenter RCTs are needed in the future.

• Authors: Riccardo Casadei, Mariacristina Di Marco, Claudio Ricci, Donatella Santini, Carla Serra, Lucia Calculli, Marielda D'Ambra, Alessandra Guido, Antonio Maria Morselli-Labate, Francesco Minni
• Journal: Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract (J Gastrointest Surg) Vol. 19 Issue 10 Pg. 1802-12 (Oct 2015) ISSN: 1873-4626 [Electronic] United States
• PMID: 26224039 (Publication Type: Journal Article, Randomized Controlled Trial)

Topics

• Adenocarcinoma (mortality, therapy)
• Aged
• Chemoradiotherapy, Adjuvant
• Disease-Free Survival
• Female
• Humans
• Italy (epidemiology)
• Male
• Middle Aged
• Pancreatectomy (methods)
• Pancreatic Neoplasms (mortality, therapy)
• Prospective Studies
• Survival Rate
• Treatment Outcome