Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer: Results From a Randomized, Placebo-Controlled, Parallel-Arm, Phase II Trial

Abstract

Apatinib showed improved PFS and OS in heavily pretreated patients with mGC who had experienced treatment failure with two or more chemotherapy regimens.

A systematic review and meta-analysis of randomized trials on the role of targeted therapy in the management of advanced gastric cancer: Evidence does not translate?

“…[22][23][24] Recently, RCTs investigated the efficacy of the targeted therapy alone or in combination with chemotherapy, but results were mostly unsatisfactory. [25][26][27][28][29][30][31][32][33][34][35][36][37][38] While several RCTs demonstrated an improvement in terms of response rate (RR), and progression free survival (PFS) only one study reported a significant increase in terms of OS in a selected subgroup of patients in front-line treatment. 25 In that trial, patients were selected according to HER2 status (resulted to be overexpressed in 16-34% of patients with intestinal type and 2-7% of diffuse aGC), and subsequently treated with trastuzumab plus standard chemotherapy with a significant 2.7 months advantage in OS.…”

“…33,51 Moreover, 3 trials, both designed for multiple arms comparison, were analyzed for single comparison considering an aggregate arm of different drug concentrations. 33,34,59 One trial was evaluated only for survival endpoints, because missing RR and toxicity data, as reported, an abstract in the meeting ASCO 2011. 27 At least one data-comparison in terms of survival, RR, or toxicity was reported in all selected RCTs, which were therefore deemed eligible for the end-point analysis.…”

“…[25][26][27][28][29][30][31][32][33][34][35][36][37]44,[51][52][53][54][55][56][57][58][59] The TYTAN trial missed data about PFS. One trial missed results about OS.…”

Novel anti-angiogenic therapeutic strategies in colorectal cancer

“…Apatinib was especially investigated in advanced gastric cancer patients in phase II and III studies that confirmed the antitumor activity [100,101]. In a phase III study that recruited patients who failed at least two prior lines of therapy, apatinib compared to placebo demonstrated the prolongation of median OS and PFS [101].…”

“…Apatinib has a good safety profile [99][100][101], with grade 3-4 adverse reactions occurring in about 2%…”