Chemoradioimmunotherapy in locally advanced pancreatic and biliary tree adenocarcinoma: a multicenter phase II study.

Objectives: The antitumor activity and toxicity of a multi-step treatment were evaluated in patients with locally advanced, inoperable, or incompletely resected pancreatic (Pa) and biliary tree (Bt) adenocarcinomas (ADKs).

Methods: Fifty-four patients, 63% with Pa and 37% with Bt ADK, received 3 courses of cisplatin-gemcitabine induction chemotherapy. Progression-free (PF) patients were given consolidation radiotherapy with concurrent capecitabine. PF patients had, as maintenance immunotherapy (MI), interleukin 2 (1.8x10 IU) and 13-cis-retinoic acid (0.5 mg/kg) [DOSAGE ERROR CORRECTED].

Results: Thirty-eight patients, 27 with Pa and 11 with Bt ADKs, PF after cisplatin/gemcitabine, were treated with consolidation radiotherapy with concurrent capecitabine. Fourteen PF patients, 7 with Pa and 7 with Bt ADK, received MI. Median PF and overall survivals (OS) for all 54 patients were 6.8 and 12.1 months, respectively. Patients treated with MI had a median PF survival of 16.2 months, whereas median OS had not been reached yet, after a median follow-up of 27.5 months.

Toxicity: Grades 3 and 4 hematological and gastrointestinal in 30% and 37% of patients, respectively; grades 1 and 2 autoimmune reactions in 28% of patients.

Conclusions: These results support the efficacy and safety of a multi-step sequential treatment in patients with locally advanced, inoperable or incompletely resected Pa and Bt ADKs.