Abstract
Until now, no standard chemotherapy has been widely accepted for advanced gastric cancer (GC). The current research aimed to compare folinic acid, fluorouracil with irinotecan (mFOLFIRI) or with oxaliplatin (mFOLFOX7) as first-line treatments in patients with locally advanced GC in an open, randomized, phase II study. Previously untreated metastatic or recurrent GC patients with measurable disease received mFOLFIRI (arm A) or mFOLFOX7 (arm B) every 2 weeks. The defined second-line treatment was mFOLFOX7 for arm A and mFOLFIRI for arm B. Primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), disease control rate (DCR) and toxicity. The evaluable population consisted of 128 patients (54 in arm A; 74 in arm B). Median PFS of arm A was 2.9 months (m) (95% confidence interval, CI, 1.9 to 4.1 m) versus 4.1 m (95% CI, 3.2 to 4.8 m) for arm B (p = 0.109). Median OS was 9.9 months (95% CI, 6.0 to 13.5 m) for arm A versus 12.0 m for arm B (95% CI, 10.3 to 13.7m; p = 0.431). DCRs for arm A and arm B were 59.3% and 66.3%, respectively (p = 0.850). In subgroup analysis of the patients who completed both treatment lines per protocol, the median first-line PFS was 2.1 m for the mFOLFIRI/mFOLFOX7arm versus 8.0 m for the mFOLFOX7/mFOLFIRI arm (p = 0.053), and the median second-line PFS values were 1.2 m versus 5.1 m (p = 0.287). Total PFS and OS were 8.1m and 11.0 m for the mFOLFIRI/mFOLFOX7 group compared with 12.2m and 20.2 m for the mFOLFOX7/mFOLFIRI group (p = 0.008, p = 0.030). Both regimens were well-tolerated with acceptable and manageable toxicities. Hence, there was no significant difference in the PFS or DCR. However, mFOLFOX7 followed by mFOLFIRI might have a better OS.
Highlights
The incidence and mortality rates have declined worldwide, as the most common cancer, gastric cancer (GC) still ranks fourth in incidence and second in annual cancer-related deaths [1]
For pts with advanced GC, palliative chemotherapy plays an important role in prolonging overall survival(OS) and improving the quality of life(QOL); until now, no standard chemotherapy has been widely accepted [5]
The assessable population consisted of 128 pts(54 in arm A; 74 in arm B), of which in the second-line treatment 13 pts received mFOLFOX7, 17 pts mFOLFIRI, 22 pts other regimens, such as paclitaxel, capecitabine, etoposide and so on, and the remaining 76 pts with no treatment after first-line chemotherapy (Supplementary Table 1)
Summary
The incidence and mortality rates have declined worldwide, as the most common cancer, gastric cancer (GC) still ranks fourth in incidence and second in annual cancer-related deaths [1]. The prognosis of advanced GC is poor, with a median survival of 3.0 to 5.0 months (m) if managed by best supportive care [4, 5]. For pts with advanced GC, palliative chemotherapy plays an important role in prolonging overall survival(OS) and improving the quality of life(QOL); until now, no standard chemotherapy has been widely accepted [5]. Chemotherapy regimens have been commonly used with a median survival of less than 10.0 months [6]. A well-recognized standard regimen for advanced or metastatic GC has not been established until now
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
