Neoadjuvant chemotherapy may improve outcomes among patients with resectable pancreatic ductal adenocarcinoma, according to a study published in The Lancet Gastroenterology & Hepatology.1
The standard of care for patients with pancreatic adenocarcinoma is surgical resection followed by adjuvant combination chemotherapy, but the addition of preoperative chemotherapy may eradicate micrometastatic disease and direct postoperative therapy in the case of resistance.
For the open-label phase 2/3 PACT-15 study (ClinicalTrials.gov Identifier: NCT01150630), researchers randomly assigned 88 previously untreated patients to 3 groups: surgery followed by gemcitabine (Group A); surgery followed by adjuvant cisplatin, epirubicin, gemcitabine, and capecitabine (PEXG) (Group B); or 3 cycles of PEXG pre- and postoperatively (Group C). Overall, 26, 30, and 32 patients were enrolled into Groups A, B, and C, respectively.
After a median follow-up of 55.4 months, results showed that 23% (6) of patients in Group A, 50% (15) of patients in Group B, and 66% (19) in Group C remained event-free after 1 year.
The most frequently reported grade 3 toxicities before surgery in all study groups were neutropenia, anemia, and fatigue; all preoperative toxicities also occurred in Group C postoperatively, but none in Groups A and B. The main grade 4 adverse event observed was neutropenia in Groups A and B, and 1 case of febrile neutropenia was reported preoperatively in Group C. No deaths were considered to have been treatment-related.
Due to changes in the standard of care and the availability of new chemotherapeutic regimens for this population since study initiation, phase 3 of PACT-15 was discontinued.
The authors concluded that “we showed the safety and promising efficacy of using a combination of drugs in the neoadjuvant setting. Our results suggest that preoperative chemotherapy should be investigated further in a randomized, controlled phase 3 trial.”
- Reni M, Balzano G, Zanon S, et al. Safety and efficacy of preoperative or postoperative chemotherapy for resectable pancreatic adenocarcinoma (PACT-15): a randomised, open-label, phase 2-3 trial [published online April 3, 2018]. Lancet Oncol. doi: 10.1016/S2468-1253(18)30081-5