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NEOLAP asked whether switching to FOLFIRINOX after two months of gemcitabine and nab-paclitaxel converts more inoperable pancreatic cancers to operable ones; about a third to 44 percent were removed with either sequence and survival was similar, so both induction regimens are acceptable.
NEOLAP randomised 130 of 168 registered patients (64 to continued nab-paclitaxel plus gemcitabine, 66 to sequential FOLFIRINOX) between November 2014 and April 2018. Surgical exploration was done in 63 and 64 percent; complete macroscopic resection in 23 and 29 patients, a conversion rate of 35.9 percent (95 percent confidence interval 24.3 to 48.9) against 43.9 percent (31.7 to 56.7) (odds ratio 0.72; p 0.38). Median overall survival was 18.5 months against 20.7 months (hazard ratio 0.86; p 0.53), with better histopathological downstaging after FOLFIRINOX (ypT1/2 in 69 against 17 percent). Grade 3 or worse events during induction occurred in 55 and 53 percent, including bile duct obstruction with cholangitis in 9 and 11 percent. The trial underpins the corpus's locally advanced row: four to six months of multi-agent induction, surgical exploration for responders, and no proven advantage of one backbone over the other.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
130 randomised.
95% CI 24.3 to 48.9 · 95% CI 31.7 to 56.7
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Surgical conversion rate (complete macroscopic resection)primary | Nab-paclitaxel + gemcitabine x4 | 64 | 35.9% | - | 0.38 | link |
| Nab-paclitaxel + gemcitabine x2 then FOLFIRINOX x4 | 66 | 43.9% | ||||
| Overall survival | Nab-paclitaxel + gemcitabine x4 | - | 18.5 months | 0.86 (0.55 to 1.36) | 0.53 | link |
| Nab-paclitaxel + gemcitabine x2 then FOLFIRINOX x4 | - | 20.7 months |
Shares AIO (Arbeitsgemeinschaft Internistische Onkologie), Gemcitabine + nab-paclitaxel, Nab-paclitaxel, Cytotoxic chemotherapy.
Shares Resectable, borderline resectable and unresectable, Gemcitabine + nab-paclitaxel, FOLFIRINOX / mFOLFIRINOX, Nab-paclitaxel.
Shares Gemcitabine + nab-paclitaxel, Nab-paclitaxel, Locally advanced unresectable pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy.
Shares Resectable, borderline resectable and unresectable, FOLFIRINOX / mFOLFIRINOX, Locally advanced unresectable pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy.
Shares Cholangitis: infection of a blocked bile duct, FOLFIRINOX / mFOLFIRINOX, Locally advanced unresectable pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma.
Shares Gemcitabine + nab-paclitaxel, Nab-paclitaxel, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma.
Shares Gemcitabine + nab-paclitaxel, Locally advanced unresectable pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy.
Shares Gemcitabine + nab-paclitaxel, Locally advanced unresectable pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy.