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


RESULTS
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.
Recchia
Francesco
F
Unità Operativa di Oncologia, Ospedale Civile di Avezzano, Avezzano, Italy. frecchia1946@libero.it
Sica
Gigliola
G
Candeloro
Giampiero
G
Bisegna
Roberta
R
Bratta
Massimo
M
Bonfili
Pierluigi
P
Necozione
Stefano
S
Tombolini
Vincenzo
V
Rea
Silvio
S
D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D000328:Adult; D000368:Aged; D000465:Algorithms; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001661:Biliary Tract Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D000069287:Capecitabine; D002945:Cisplatin / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects; D007376:Interleukin-2 / Q000627:therapeutic use; D015474:Isotretinoin / Q000627:therapeutic use; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D007376:Interleukin-2; D003841:Deoxycytidine; D000069287:Capecitabine; D015474:Isotretinoin; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine