1629P - Modified-FOLFIRINOX-losartan followed by chemoradiotherapy for locally advanced pancreatic cancer: A phase II study

Background

The management of pancreatic adenocarcinoma continues to be challenging. Surgical resection is the only modality for a cure, with an overall survival rate of 10–20% at 5 years. However, only 20% of the patients are surgical candidates because of locally advanced disease or systemic stage at presentation.

Methods

A phase II clinical trial was carried out on 50 patients with previously untreated locally advanced, surgically unresectable pancreatic adenocarcinoma. Patients had ECOG PS 0 or 1 and adequate hematologic, renal, and hepatic function. They arranged to receive 3 cycles of modified FOLFIRINOX prior to CCRT, with losartan taken orally every day followed by chemoradiotherapy.

Results

Response after completion CCRT was assessed. 6% of patients achieved complete response. 38% of the patients had a partial response, while twenty-four patients (48%) had stable disease and 8% had progressive disease. Of the 50 patients, thirteen (26%) underwent surgery, with R0 resection achieved in 6 of 13 patients. Median follow-up period was 20.25 months (range, 6.0-34.5). The median PFS was 12 months (95% CI, 9.647 – 14.353), while Median OS was 21 months (95% CI, (10.200–31.800). The patients who underwent resection had longer survival 24 months (95% CI, (16.363 – 27.637) compared to those who did not undergo resection; mean OS was 14 months (95% CI, (9.205 – 18.795)). (P=0.271). The patients who achieved CR after modified Folforinox-losartan had a longer median OS of 33 months (95% CI, 19.918 – 46.082) compared to patients who had PR and SD, each had median OS of 13 months (95% CI, 6.768 – 19.232), (11.718 – 14.282) respectively (P=0.040*). The patients who achieved CR after CCRT had longer OS (NR) compared to those who had PR, SD and PD. median OS was 24, 14 and 8 months, respectively (95% CI, 6.761 – 41.239), (11.022 – 16.978), and (95% CI, 4.080 – 11.920) (P=<0.001*). The patients who achieved CR after CCRT had longer PFS (NR) compared to those who had PR, SD and PD. Median PFS was 24 (95% CI, 13.191 – 34.809), 10(95% CI, 4.973 – 15.027) and 5 (95% CI,4.823-5.124) months, respectively (P=<0.001*).

Conclusions

Induction chemotherapy with modified-FOLFIRINOX-losartan, followed by CCRT improved patient outcomes.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Menoufia University.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.