Frontier Progress PRODIGE 24 Study 5-Year Follow-up Results Announced! mFOLFIRINOX adjuvant chemotherapy can significantly benefit patients with pancreatic cancer

From April 16, 2012 to October 3, 2016, a total of 493 patients were included in the study, including 247 in the mFOLFIRINOX group; There were 246 cases in the gemcitabine group, and the grouping of the study is shown in Figure 1²
.

Fig.
1 Randomization of patients

Lymphovascular invasion was higher in the mFOLFIRINOX group (73.
7% vs.
63.
1%; P=0.
02), there was no significant difference in
baseline characteristics between the two groups.
(95% CI, 67.
1 to 73.
9), as of 28 June 2021, the median duration of treatment in the mFOLFIRINOX and gemcitabine groups was 24.
6 weeks and 24.
0 weeks
, respectively.

Survival analysis

After a median follow-up of 69.
7 months, disease progression
occurred in 367 patients in the intention-to-treat (ITT) population.
As shown in Figure 2, the median DFS in the mFOLFIRINOX and gemcitabine groups was 21.
4 months and 12.
8 months, respectively (stratified HR = 0.
66; 95% C, 0.
54-0.
82; P<0.
001), and the 5-year DFS rates in the two groups were 26.
1% (95% CI, 20.
5%-32.
1%) and 19.
0% (95%CI, 14.
3%-24.
3%)<b11>, respectively.

Fig.
2 Patient DFS performance

As shown in Figure 3, the median OS in the mFOLFIRINOX and gemcitabine groups was 53.
5 months and 35.
5 months, respectively (stratified HR = 0.
68; 95% CI, 0.
54-0.
85; P<0.
001), and the five-year OS rates in the two groups were 43.
2% (95% CI, 36.
5%-49.
7%) and 31.
4% (95%CI, 25.
5%-37.
5%)<b10>, respectively.

Fig.
3 Patient OS performance

As shown in Figure 4, subgroup analysis found no heterogeneity in the effect of treatment strategies on OS
.

Fig.
4 OS subgroup analysis

The median metastasis-free survival and tumor-specific survival in the mFOLFIRINOX group and the gemcitabine group were 29.
4 months and 17.
7 months, respectively (stratified HR=0.
64; 95%C, 0.
52-0.
80; P<0.
001; Figure 5 left), and median tumor-specific survival was 54.
7 months and 36.
6 months, respectively (stratified HR=0.
65; 95%C, 0.
51-0.
82; P<0.
001; Figure 5 right).
<b10>

Fig.
5 Analysis of metastasis-free survival (left) and tumor-specific survival (right).

Analysis of prognostic factors related to OS

Univariate analysis showed that prognostic factors that were significantly associated with OS improvement included mFOLFIRINOX treatment, tumor location in the pancreas/tail of the pancreas, good tumor differentiation, tumor stage pT1-2, tumor pN0, and low tumor stage (I, IIA, and IIB).
Low nodal positivity (0.
0-0.
20 or 0.
20-0.
40), R0 resection, and unresected veins
.

As shown in Table 1, multivariate analysis showed that the prognostic factors that were significantly associated with the improvement of OS in patients included: patients receiving mFOLFIRINOX treatment, the number of patients enrolled in the hospital ≥ 10, the age of the patients< 70 years<b11>, good tumor differentiation and low
tumor stage.

Table 1 Multivariate analysis of OS prognostic factors

Security analysis

The safety analysis was consistent with previous reports² showing that grade 3 to 4 adverse events were 75.
9% and 52.
9% in the mFOLFIRINOX and gemcitabine groups, respectively, and 12.
2% and 12.
0% in the grade 4 adverse events (Table 2).

The safety profile of the mFOLFIRINOX regimen was lower than that of gemcitabine, but it was generally manageable, and no new safety signals
were found after long-term follow-up.

Table 2 Security analysis