A phase-II study of liposomal doxorubicin and docetaxel in patients with advanced pancreatic cancer.

Background: Both liposomal doxorubicin (LD) and docetaxel (D) have a broad range of activity against solid tumors, including advanced pancreatic cancer (APC), as single agents, while their combination has produced encouraging response rates in the treatment of several malignancies. We have conducted a Phase-II study in order to evaluate the tolerance and efficacy of their combination as front-line treatment in patients with APC.

Patients And Methods: Twenty-one chemotherapy-naïve patients with unresectable, locally-advanced or metastatic pancreatic cancer were enrolled. These included 16 males and 5 females with median age 66 years (range 57-80). Performance status (PS) was 0 (n = 10 pts), 1 (n = 7 pts) and 2 (n = 4 pts). D (80 mg/m2), and LD (30 mg/m2) were administered on day 1, every 3 weeks. RhG-CSF s.c. was given to all patients. At the time of analysis, all included patients were evaluated for toxicity and for response.

Results: A total of 92 cycles were administered (4.38 cycles/patient). Partial response was achieved in 6 patients, with a median duration of response of 3 months. Stable disease was observed in 7 patients and progressive disease in 8 patients. The median duration of survival was 10 months (95% CI, 6-14 months) and the actuarial 1-year survival rate was 33.33%. With regard to toxicity, grades 3,4 neutropenia occurred in 8 (38%) patients and grades 3,4 thrombocytopenia in 4 (19%) patients. Non-hematological toxicity was recorded in 15 (71%) patients: grades 3,4 diarrhea (3 pts, 14%), hypersensitivity reactions (3 pt, 14%), grade 2 neurotoxicity (6 pts, 29%) and palmar-plantar erythrodysesthesia (9 pts, 43%).

Conclusion: The doxorubicin and docetaxel combination was well-tolerated by these poor prognosis patients. Although both drugs have a marginal activity in pancreatic cancer, most patients experienced significant clinical improvement, with acceptable toxicity.